Hemorhoid

Alimentary Pharmacology & Therapeutics
Volume 31, Supplement 1, May 2010
The Diagnosis and Management

of Haemorrhoidal Disease
from a Global Perspective
Guest Editor
Laurent Abramowitz
L. Abramowitz, G. H. Weyandt, B. Havlickova, Y. Matsuda, J.-M. Didelot, A. Rothhaar,

C. Sobrado, A. Szabadi, T. Vitalyos, P. Wiesel
The preparation of this paper was funded in part by Intendis GmbH, Berlin, Germany
Volume 31, Supplement 1, May 2010
The Diagnosis and Management

of Haemorrhoidal Disease from a Global Perspective
Contents
1 The diagnosis and management of haemorrhoidal disease from a global perspective. L. Abramowitz,
G. H. Weyandt, B. Havlickova, Y. Matsuda, J-M. Didelot, A. Rothhaar, C. Sobrado, A. Szabadi, T. Vitalyos
& P. Wiesel
2 The management of haemorrhoidal diseases. L. Abramowitz
12 Haemorrhoidal disease: the dermatological differential diagnoses of symptoms and anal findings.
G. H. Weyandt
19 Topical corticosteroid therapy in proctology indications. B. Havlickova
33 The treatment of haemorrhoids: a Japanese perspective. Y. Matsuda
36 Case Study 1: debilitating external haemorrhoidal thrombosis. L. Abramowitz
37 Case Study 2: external haemorrhoidal thrombosis in pregnancy. L. Abramowitz
39 Case Study 3: intensely painful external and internal haemorrhoidal thrombosis. L. Abramowitz
41 Case Study 4: pruritus ani and haemorrhoids-meddle at your peril.... J.-M. Didelot
43 Case Study 5: perianal eczema with ulceration healed after 2 weeks of topical treatment. A. Rothhaar
45 Case Study 6: topical treatment of anal fissure. B. Rothhaar
47 Case Study 7: clinical treatment of haemorrhoidal disease and acute anal fissure. C. Sobrado
50 Case Study 8: the topical treatment of haemorrhage by stage IV haemorrhoids. A. Szabadi
52 Case Study 9: the treatment of haemorrhoidal symptoms and perianal eczema with topical corticosteroid.
T. Vitalyos
53 Case Study 10: the symptomatic and causal therapy of haemorrhoidal disease of 10 years duration.
G. H. Weyandt
56 Case Study 11: the conservative therapy for perianal thrombosis. P. Wiesel
The diagnosis and management of haemorrhoidal disease from a

global perspective
L. ABRAMOWITZ*, G. H. WEYANDT , B. HAVLICKOVAà, Y. MATSUDA§, J.-M. DIDELOT–,
A. ROTHHAAR**, C. SOBRADO , A. SZABADIàà, T. VITALYOS§§ & P. WIESEL––
*Paris, France; Wuerzburg, Germany; SUMMARY

àBerlin, Germany and Prague, Czech
Republic; §Shizuoka, Japan; Background
–Montpellier, France; **Berlin,
A treatment approach for patients with haemorrhoidal disease and other
Germany; São Paulo, Brazil;
ààKaposvár, Hungary; §§Budapest, anal disease, which includes the use of topical corticosteroids and other
Hungary; ––Berlin, Germany topical combination products, is widely accepted, but little has been
published to compare such treatments. This publication is a valuable
Correspondence to:
collection of reading material for gastroenterologists, proctologists, gen-
Dr L. Abramowitz, Medical and
Surgical Anorectal Disease unit, eral practitioners, dermatologists and other clinicians who are responsi-
AP-HP Bichat University Hospital, 46, ble for diagnosing and managing patients with haemorrhoidal disease.
rue Henri Huchard, 75877 Paris,
Cedex 1, France. Aims
E-mail: laurent.abramowitz@
To review and collect existing treatment approaches for haemorrhoidal
bch.aphp.fr
disease, by reviewing global experience from clinicians that will con-
tribute towards improving best practice in the management of patients.
Methods
The articles include overviews of haemorrhoidal disease, differential
diagnosis, topical treatment and surgical practices and patient outcomes.
Case studies further reinforce treatments from individual specialists.
Results
The articles between them address the classification of haemorrhoids,
dermatological differential diagnoses of anal and perianal disease, and
the therapeutic management of different haemorrhoidal diseases includ-
ing invasive surgical and non-invasive topical combination treatments.
The case studies indicate the positive impact of appropriate treatment in
everyday clinical practice.
Conclusion
This publication will reinforce best practice in the causative and symp-
tomatic treatment of haemorrhoidal disease.
Aliment Pharmacol Ther 31 (Suppl. 1), 1–58
ª 2010 Blackwell Publishing Ltd 1

doi:10.1111/j.1365-2036.2010.04278.x
2 L . A B R A M O W I T Z et al.
The management of haemorrhoidal diseases

L. ABRAMOWITZ
AP-HP Bichat University Hospital, rue Henri Huchard, Paris, Cedex, France
Correspondence to:
Dr L. Abramowitz, AP-HP Bichat University Hospital, 46 rue Henri Huchard, 75877 Paris, Cedex 18, France.
E-mail:laurent.abramowitz@bch.aphp.fr
consultations.1 A national survey conducted in 2004

SUMMARY
revealed that 40% of a representative sample of the
Haemorrhoidal symptoms are the most frequent reason French population, aged over 15 years, had presented
for consultation in proctology. Although haemorrhoidal anorectal symptoms (bleeding, pain, constipation and
pathology may be the main reason for the initial proc- incontinence) during the preceding 12 months.2 It is
tological consultation, physicians need to diagnose and well known that haemorrhoidal disease is the most
differentiate haemorrhoids from other conditions as frequent anorectal pathology in this population.
symptoms may be similar and yet appropriate treat- Despite this high prevalence and regular presentation
ment will differ. in clinical consultations, medical education on this
Once haemorrhoids are diagnosed and their exact subject is lacking. This article reviews various options
nature is determined, clinicians need to decide on the in current therapy for haemorrhoids including medical
best treatment strategy. Treatment is essentially medi- (topical and systemic drug therapy), instrumental and
cal for the majority of patients, but there are a vast surgical procedures.
number of treatment options including non-invasive
options, topical agents and suppositories, venotonics,
PATHOPHYSIOLOGY
oral anti-inflammatory drugs, instrumental treatments
(such as sclerotherapy, infrared photocoagulation, Haemorrhoids (or piles) are normal anal vascular cush-
rubber band ligation) and surgical treatment. ions of tissue filled with blood vessels (haemorrhoidal
This article reviews the different treatment options plexus) at the junction of the rectum and the anus.
in some detail and indicates the most appropriate The expansion of these vascular cushions is important
treatment for different types of haemorrhoidal disease. in providing a watertight seal to the anus and plays a
For instance, less invasive, mild treatment measures role in anal occlusion; the vascular cushions provide
are initially recommended; however, for chronic or approximately 15—20% of the resting anal pressure
severe haemorrhoids, medical, instrumental and ⁄ or required to maintain continence.3 Haemorrhoids
surgical treatment may be necessary. It should be become a disease when pathological changes occur in
noted that drug and instrumental therapy is used in the anal cushions causing the development of symp-
approximately 90% of haemorrhoidal disease presen- tomatic haemorrhoids i.e. haemorrhoids with associ-
tations. ated symptoms such as bleeding, prolapse, pruritus,
soiling and thrombosis.
There are two types of haemorrhoids: internal–above
INTRODUCTION
the dentate line, and external–below the dentate line.
Proctological diseases are common and are treated by Internal haemorrhoids are supported within the anal
many different types of physicians depending on the canal by connective tissue. When this supporting tissue
country and local clinical practice: gastroenterologists, is weakened by straining or ageing, haemorrhoids may
colorectal surgeons, dermatologists, gynaecologists, prolapse (i.e. distend so that they are pushed outside the
internists and general practitioners. Indeed, anal anus) (Figure 1). They may or may not bleed, and they
pathologies are very common and therefore many rarely cause thrombosis. External haemorrhoids are
medical disciplines ⁄ specialities need to be aware of prone to thrombosis (Figure 2), and when they dis-
them. In a French national screening, proctological appear and heal, marisca (skin tags) frequently occur
diseases represented 20% of all gastroenterological (Figure 3).

ª 2010 Blackwell Publishing Ltd
DIAGNOSIS AND MANAGEMENT OF HAEMORRHOIDAL DISEASE 3
Figure 1. Haemorrhoidal prolapse grade 3 (after

defecation).
Figure 3. Marisca after external haemorrhoids thrombosis.
The most important risk factors for all haemorrhoid- groups, sociological categories or anal intercourse:
al pathologies are difficulty in defecating associated haemorrhoids may develop without a defecation
with straining (dyschesia), constipation and diarrhoea.4 disorder.
No association has been demonstrated with other fac- The very widely used Goligher classification system
tors such as spices, coffee, alcohol, sports, ethnological describes four grades of haemorrhoids on the basis of
degree of prolapse only.5 This grading system does not
take into account bleeding and pain, the other impor-
tant haemorrhoidal symptoms. First-degree haemor-
rhoids bleed, but do not protrude; second-degree
protrude with defecation, but show spontaneous repo-
sition; third-degree protrude and require digital inser-
tion and fourth-degree are permanently prolapsed and
no reduction is possible.
EPIDEMIOLOGY
Haemorrhoidal symptoms are the most frequent
reason for consultation in proctology, the actual
prevalence in the general population remains
unknown. Studies have reported a prevalence rate
ranging from 4.4%6 to 86%7 depending on the defi-
nition of the disorder, study design, data collection
and screened populations. More precise epidemiologi-
cal data, along with systematic anal examination, are
available among sub-populations. Among pregnant
women, external haemorrhoidal thrombosis occurred
in 8% during the last trimester and in 20% after
delivery.8 A recent study in 473 HIV-infected
patients undergoing systematic anal screening
reported haemorrhoidal disease in 14% (67 ⁄ 473)
Figure 2. External multiple haemorrhoids thrombosis.
of cases: 15 of 67 patients had haemorrhoidal throm-

Table 1. Differential diagnosis of the most frequent symptoms associated with haemorrhoidal pathologies
Bleeding Anal pain Swelling Commentary Photo
Haemorrhoids Typically into Only in case of Grade 2–3: Different

the toilet or thrombosis or if after defecation symptoms
on toilet paper associated with Grade 4: depending on
and underwear anal fissure continuous haemorrhoids
in case of Thrombosis: localization
big prolapse painful (internal or
(grade 3 or external) and
grade 4) pathologies:
thrombosis,
prolapse or bleeding
Anal fissure On paper after During and ⁄ or Frequent marisca Loosening anal
defecation after defecation below and ⁄ or pleats with
papilla above the 2 thumbs
chronic fissure
Marisca No No Like skin tag Secondary

to healed chronic
anal fissure
or external
thrombosis
Condyloma No No For anal margin Diagnosis only

(or wart) lesion after specialized
examination with
systematic anoscopy
to look for
internal canal
condyloma
Other sexual Rarely on paper Depending on Usually no, Patient situation
infectious if margin lesion but sometimes is very important
diseases lesion or localisation inflammation (immuno-depression,
(Chlamydia, into toilet gives swelling anal intercourse
Mycoplasma, if rectitis sensation without condom,
CMV, herpes, multiple partners).
gonorrhoea) Chlamydia,
mycoplasma,
gonorrhoea:
ulcerative anal
or rectal
lesions with pus
CMV: large ulcer
lesion among
immune-depressed
patients
Herpes: painful
little vesicle or
ulcer. Frequent
relapse

Table 1. (Continued)
Suppurative Rarely, but In case of In case of Pain is the

disease sometimes on abscess: big abscess most important
(abscess, toilet paper beating and and a symptom
fistula, or underwear continuous that requires
Chron’s disease in case of immediate
fistula attention i.e.
(with pus) an emergency
Dermatological Sometimes on Anal itch Sometimes Very different

lesion toilet paper kind of lesions:
psoriasis,
eczema,
candidiasis,
lichen ruber
Anal cancer On paper When important In case of Systematic

invasive lesion vegetant lesion. diagnosis to
(grade 3 or 4) But ulcerative eliminate.
lesion possible. Never treat
anal symptoms
without
examination.
Rectal cancer Into the toilet Usually no. Not outside Diagnosis by
Sometimes endoscopy and
in case of biopsy
significant
invasive lesion

Table 1. (Continued)
Rectal prolapse On paper No After Associated with

defecation or defecation or chronic
underwear standing position constipation
and chronic
straining
defecation
bosis and 52 of 67 had haemorrhoidal bleeding. (iv) Topical and systemic drug therapy is possible
Haemorrhoids of grade 1 were found in 41 patients, for all haemorrhoidal pathologies.
grade 2 were found in 14 patients, grade 3 in 5 (v) The only treatment for the long-term is preven-
patients and grade 4 in 2 patients.9 tion of defecation disorder.
(vi) Less invasive, mild treatment measures are
initially recommended. For chronic or severe haemor-
DIFFERENTIAL DIAGNOSIS
rhoids, medical, instrumental and ⁄ or surgical treat-
Although haemorrhoidal pathology may be the main ment may be necessary. Drug and instrumental
reason for initial proctological consultation, physicians therapy is used in approximately 90% of haemorrhoid-
need to diagnose and differentiate between other dis- al disease.9–11
eases such as anal fissure, condyloma, anal cancer and
dermatological or infectious disease as symptoms may
Non-invasive treatment
be similar. Misdiagnosis may be very prejudicial, for
example, in the case of a suppurative lesion or cancer. Defecation regulators. Straining, constipation and
Table 1 shows the manifestation of the three most fre- diarrhoea are the most important factors responsible
quent anal symptoms associated with haemorrhoids, for haemorrhoidal disease. Dietary fibre and laxatives
i.e. bleeding, pain and swelling, in various differential (for constipation) or specific systemic treatment for
anorectal diagnoses. diarrhoea may be prescribed, if necessary. Defecation
regulation is the only preventive treatment recom-
mended for haemorrhoidal disease.
TREATMENT
Principal considerations10–12 Topical agents and suppositories. Available topical

agents for the symptomatic treatment of haemorrhoids
(i) Haemorrhoids are not associated with, nor do
include local anaesthetics (e.g. lidocaine), astringents
they increase the risk of infection, cancer, embolic
(e.g. policresulene), corticosteroids and antiseptics.
disease and portal hypertension.
Several clinical studies have shown the efficacy of
(ii) The main objective of treatment is to reduce the
topical treatments in the reduction of haemorrhoidal
symptoms associated with haemorrhoids (pain, bleed-
symptoms and these are recommended as an initial
ing or embarrassing swelling) when all other differen-
treatment in different anal and perianal diseases
tial diagnoses are excluded.
including haemorrhoids.9–11 International guidelines
(iii) Treatment should not commence without physi-
recommend their use. Topical agents containing corti-
cal examination.

costeroids are particularly useful for treating local

inflammation and swelling.
Venotonics. Some randomized studies have shown

benefit of high dose venotonics for acute haemor-
rhoidal flare-up of bleeding, pain and swelling. How-
ever, a recent meta-analysis concluded that limitations
in the methodological quality and potential publica-
tion bias raise doubts about the benefits of these
agents in treating haemorrhoids.13
Oral anti-inflammatory drugs. Non-steroidal anti-

inflammatory drugs (NSAIDs), although with potential
side effects, seem particularly useful and are recom-
Figure 4. Sclerotherapy apparatus.
mended by many proctologists for pain associated
with haemorrhoidal thrombosis;9–11 no clinical study
has, however, confirmed clear evidence of efficacy in
this indication. photocoagulation. Each instrumental treatment is gen-
Oral corticosteroids are useful for inflammation erally carried out 1, 2 or 3 times with a 1 or 2 month
associated with haemorrhoidal thrombosis when NSA- interval between each session. If after 2 or 3 sessions
IDs cannot be prescribed, for example, during preg- treatment is ineffective, alternative instrumental proce-
nancy or breast-feeding.14 dures or surgery should be recommended.11
In a randomized study comparing infrared photo-
coagulation, rubber band ligation and injection
Instrumental treatment
sclerotherapy, Johanson and Rimm favoured infrared
Three well described and validated methods are avail- photocoagulation as a non-operative treatment.15 A
able: meta-analysis by MacRae et al.,16 comparing rubber
(i) Sclerotherapy (Figure 4). band ligation, infrared photocoagulation, sclerothera-
(ii) Infrared photocoagulation (Figure 5). py, haemorrhoidectomy and manual dilation of the
(iii) Rubber band ligation (Figure 6). anus (an old procedure now excluded because of anal
Cryotherapy and bipolar diathermy electrocoagula- incontinence risk) for patients with first-, second-, or
tion are high-risk methods and are not validated or
recommended.
Sclerotherapy, infrared photocoagulation and rubber
band ligation are usually performed in a clinical office
setting and do not require anaesthesia. They are
applied above the haemorrhoids i.e. on the rectal
mucosa at the proximal end of the haemorrhoids,
where there is little sensitivity. Normally, these proce-
dures are not painful, but they can result in tissue loss
and ulceration causing fibrosis to fix the mucosa of
the prolapsed tissue back onto the underlying muscle.
Short-term efficacy is 80%; this is similar between
instrumental treatments.11 In the long-term, rubber
band ligation gives better results, with 75% achieving
‘good’ results after 3 years (with best results for pro-
lapse), versus only 25% with infrared photocoagulation
and sclerotherapy injection.11 The latter treatment has
Figure 5. Infrared photocoagulation apparatus.
been associated with more local infection than infrared

Surgical treatment
Only 10% of patients referred to a coloproctologist for
treatment of haemorrhoids undergo surgery.17 Hence,
medical or instrumental treatments are generally effec-
tive in treating haemorrhoids.
Haemorrhoidectomy is the most effective surgical
treatment with best results for long-term efficacy
among all haemorrhoidal treatments; however, compli-
cations are not uncommon.9–11 Post-operative pain
requiring systemic analgesics is the most frequent
symptom. Post-operative bleeding requiring haemo-
stasis is reported in 2–4% of all cases, urinary reten-
tion in 2–10%, infection in 0.5–5.5%, anal stenosis in
0–6% and fecaloma in 2% (prevented by defecation
Figure 6. Rubber band ligation apparatus. regulation before and after surgery). The most severe
complication is anal incontinence, reported in 2–12%.
Haemorrhoids play a role in anal continence, and
surgical error (internal anal sphincter section or anal
third-degree haemorrhoids recommended the use of dilatation) may cause complications. The latter compli-
rubber band ligation because of its higher rate of effi- cation is particularly difficult to treat because the
cacy. French guidelines11 recommend the use of infra- internal sphincter muscle is poorly re-trainable and
red photocoagulation for bleeding haemorrhoids cannot be repaired surgically.18 Thus, surgery should
without significant prolapse and rubber band ligation only be performed after the failure of drug or instru-
for prolapsed haemorrhoids less than fourth-degree mental treatment, or in cases of severe haemorrhoids
with or without bleeding. (grade 4, anaemia because of haemorrhoids or after
Thrombosed haemorrhoids are treated primarily by failure of drug treatment in patients with painful
topical and systemic drug therapy. However, in some thrombosis) and in patients who have been informed
patients- for example those with painful thrombosis of the alternatives and potential complications.
without oedema and a single lesion- excision or Surgical techniques can be distinguished acco-
incision under local anaesthesia can be performed rding to whether haemorrhoids are removed
in a clinical office setting. Local surgery, however, is (haemorrhoidectomy) or fixed (haemorrhoidopexy or
relatively uncommon in clinical practice because the Longo technique and Doppler guided haemorrhoidal
pain associated with thrombosis is usually because artery ligation).
of oedema and ⁄ or multiple thromboses. Furthermore, Various haemorrhoidectomy techniques have been
this procedure cannot be performed for internal described, but the two most widely used are the Fergu-
thrombosis because of the risk of development of son technique, where wounds are closed primarily and
anal fissure after treatment. The value of incision the Milligan Morgan technique, where haemorrhoids
or excision for the treatment of haemorrhoids is are excised without wound closure. No study has dem-
debateable, as no study has demonstrated any bene- onstrated significant differences in morbidity between
fit of either technique. Some proctologists prefer the two procedures. In fact, the choice depends on
excision to avoid the development of marisca (skin both surgical expertise and local clinical practice.
tags), but neither technique increases the risk of Haemorrhoidopexy was developed and described by
relapse. Longo in the late 1990s in Italy.19 It is carried out
All instrumental treatments risk minimal complica- using a specially designed transanal circular stapling
tions (pain, infection, urinary retention, bleeding); gun that reduces prolapse by excising a circumferen-
with infrared photocoagulation showing the least. tial ring of mucosa approximately 2–3 cm above the
Patients should always be informed of the potential dentate line. This technique is significantly less painful
complications and procedures performed in clinical with a more rapid return to normal activities than
centres. haemorrhoidectomy. However, it is also associated

with complications, such as bleeding, urinary reten- (a)

tion, anal incontinence and, more rarely, rectal perfo-
ration, recto-vaginal fistulas, anastomotic leak, anal
stricture, severe pelvic sepsis and chronic pain.20
Recently, long-term follow-up studies suggest that
recurrence rates are higher after stapled haemor-
rhoidopexy than after conventional haemorrhoidecto-
my.21 This seems obvious because haemorrhoids are
not removed, but only fixed in place with Longo’s
technique. Haemorrhoidopexy is particularly indicated
for grade 3 haemorrhoids without marisca, associated
anal fissure and external haemorrhoids in patients
without receptive anal intercourse. It results in less
pain after surgery, and faster recovery time, and has
long-term benefits.
The latest technique is surgical pedicle ligature of
haemorrhoids under Doppler inspection. It is per- (b)
formed using a specially designed proctoscope with an
inbuilt Doppler probe that can locate feeding arteries;
these vessels are then ligated using absorbable sutures.
Disrupting the inflow to the vascular cushion is
thought to reduce the size of the haemorrhoids. In a
recent prospective study with 100 patients treated with
this technique,22 the recurrence rate was only 12%
after 1 year. Best results were observed for grade 3
haemorrhoids. Randomized controlled trials are needed
to confirm the benefits and efficacy of this technique
in comparison with haemorrhoidectomy, haemor-
rhoidopexy and conventional ligature.
TREATMENT RECOMMENDATIONS FOR

DIFFERENT HAEMORRHOIDAL DISEASES
For each haemorrhoidal disease, defecation regulation Figure 7. a. Very painful external haemorrhoids with
should be recommended for acute and chronic symp- thrombosis after childbirth and before treatment; b.
External haemorrhoids with thrombosis after childbirth
toms.
without pain after 1 day of medical treatment.
Haemorrhoidal thrombosis (Figure 7a and 7b)

their haemorrhoids after defecation. Analgesics can
With haemorrhoidal thrombosis, topical treatment is also be prescribed for pain. In patients with severe
most frequently prescribed because pain is secondary inflammation, NSAIDs are useful and recommended
to inflammation and excludes local surgery possibili- for a few days. In our clinical experience, it is worth
ties. Additionally, defecation regulation is necessary considering that without treatment, thrombosed haem-
and particularly useful in case of difficulties in defecat- orrhoids will disappear in a few days or weeks; medical
ing (dyschesia). Topical treatment containing cortico- treatment can reduce this time to 1–3 days.
steroids is the most effective in treating pain associated
with inflammation.11 Some physicians prescribe oint-
Haemorrhoidal bleeding
ment only for external haemorrhoids, while others pre-
scribe suppositories in addition to ointment to facilitate Anaemia caused by haemorrhoidal bleeding is rare;
defecation; these can be self-applied by the patient on the source of excess bleeding needs to be confirmed

before attributing anaemia to haemorrhoids. Where strated an increased incidence of other haemor-
there is evidence of haemorrhoidal bleeding because rhoidal diseases (prolapse or bleeding). The only
of anaemia, surgical treatment with haemorrhoidecto- controlling risk factor for external haemorrhoidal
my is generally necessary, particularly when haemo- thrombosis is pushing ⁄ straining defecation:7 pregnant
globin level is low. women need to be aware of this for prevention of
Generally, frequent haemorrhoidal bleeding is not haemorrhoids and in case of acute flare-up. NSAIDs
associated with anaemia; in such cases, drug therapy cannot be prescribed without risk during the last tri-
is the first step with defecation regulation, followed by mester of pregnancy and while breast-feeding. Local
the use of suppository and topical cream. When drug treatment with corticosteroids and ⁄ or analgesics (e.g.
treatment is ineffective, infrared photocoagulation lidocaine) is probably the most useful13 because such
should be used because it has shown better efficacy thrombosis is particularly inflammatory with oedema
and minimal complications. If bleeding is associated resulting in pain (Figure 7). Oedema frequently con-
with prolapse, rubber band ligation is recommended. traindicates excision or incision, as discussed above;
In the event of failure of drug therapy and instru- however, analgesia such as paracetamol can be pre-
mental treatment surgery may be necessary, particu- scribed. Drug therapy for pain is generally very effi-
larly if the risk associated with bleeding is higher than cient and effective in 1 or 2 days. Skin tags may
that associated with surgery.11 stay or disappear according to skin elasticity. In
very rare cases with severe pain still presenting after
2 days of treatment, or in the case of necrosis
Haemorrhoidal prolapse (Figure 1)
(internal and external thrombosis with intense
Defecation regulation is the only treatment to prevent inflammation), haemorrhoidectomy should be per-
disease progression. Frequently, patients are seen in formed as an emergency so that mother and baby
whom the haemorrhoid grade has decreased and who can be managed effectively. Hence, it is vital that
do not need to push (strain) any more after treatment proctologists follow-up and monitor any change ⁄
with defecation regulation. improvement in pain in all pregnant women on drug
The most effective treatment for prolapsed haemor- therapy for pain.
rhoids is rubber band ligation particularly in grade 2 In some cases of bleeding caused by haemorrhoids
or grade 3.11 With grade 4 haemorrhoids, the only during pregnancy, defecation regulation or topical
potential curative treatment is surgery. Haemor- treatment (suppository and cream) is the only available
rhoidopexy does not give good results with high-level option. Haemorrhoidal prolapse is not an emergency;
grade haemorrhoids, and surgical pedicle ligature of treatment with topical agents is standard. Instrumental
haemorrhoids under Doppler produces similar results treatment or surgery should only be performed after
as reported in initial studies.22 Haemorrhoidectomy delivery or breast-feeding, if bleeding and ⁄ or prolapse
using the Milligan Morgan or Ferguson technique is persist.
the best technique for treatment of grade 4 haemor-
rhoids.
CONCLUSIONS
All humans have haemorrhoids. Their possible pathol-
HAEMORRHOIDS IN PREGNANT AND
ogies and symptoms are prolapse, bleeding and
POST-DELIVERY WOMEN
thrombosis. Treatment is essentially medical for the
International guidelines for the treatment of haemor- majority of patients. Defecation regulation is system-
rhoids usually do not describe specific treatment for atic for all haemorrhoids pathology and is the only
pregnant and newly delivered women although 1 of treatment to prevent disease. Ointment and supposi-
5 women suffer from haemorrhoidal pathology dur- tory are the first line treatments with steroid prefer-
ing this period. In an analysis of 165 pregnant ence in case of thrombosis. Instrumental treatment is
women, 13 (8%) suffered from thrombosed external performed after consultation and is relatively easy to
haemorrhoids during the last trimester of pregnancy do. In the case of severe haemorrhoids, where medi-
and 33 women (20%) developed anal thrombosis cal and instrumental treatment has failed, surgery is
within 2 months after delivery. No study has demon- deemed necessary.

D I A G N O S I S A N D M A N A G E M E N T O F H A E M O R R H O I D A L D I S E A S E 11
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Haemorrhoids. In: Coloproctology and the 13 Alonso-Coello P, Zhou Q, Martinez- rhoids (stapled hemorrhoidopexy). Dis
pelvic floor, Henry M, Swash M (eds), Zapata MJ, Mills E, et al. Meta-analysis Colon Rectum 2007; 50: 878–92.
2nd edn. Butterworth, London, 1992: of flavonoids for the treatment of haemo- 21 Jayaraman S, Colquhoun PH, Malthaner
373–93. rrhoids. Br J Surg 2006; 93: 909–20. RA. Stapled versus conventional surgery
6 Johanson JF, Sonnenberg A. The 14 Abramowitz L. Management of hemor- for hemorrhoids. Cochrane Database Syst
prevalence of hemorrhoids and chronic rhoid disease in the pregnant woman. Rev 2006; 4: CD005393.
constipation. An epidemiologic study. Gastroenterol Clin Biol 2008; 32 (5 pt 2): 22 Faucheron JL, Gangner Y. Doppler-guided
Gastroenterology 1990; 98: 380–6. S210–4. hemorrhoidal artery ligation for the treat-
7 Haas PA, Haas GP, Schmaltz S, et al. The 15 Johanson JF, Rimm A. Optimal nonsurgical ment of symptomatic hemorrhoids: early
prevalence of hemorrhoids. Dis Colon treatment of hemorrhoids: a comparative and three-year follow-up results in 100
Rectum 1983; 26: 435–9. analysis of infrared coagulation, rubber consecutive patients. Dis Colon Rectum
8 Abramowitz L, Sobhani I, Benifla JL, bad ligation, and injection sclerotherapy. 2008; 51(6): 945–9.
et al. Anal fissure and thrombosed exter- Am J Gastroenterol 1992; 87: 1600–6.

Haemorrhoidal disease: the dermatological differential diagnoses

of symptoms and anal findings
G. H. WEYANDT
Department of Dermatology, University Clinics of Wuerzburg, Josef Schneider Strasse, Wuerzburg, Germany
Correspondence to:
Dr G. H. Weyandt, Department of Dermatology, University Clinics of Wuerzburg, Josef Schneider Strasse 2, DE-97080, Wuerzburg, Germany.
E-mail: Weyandt_G@Klinik.uni-wuerzburg.de
line and participate in the regulation of continence.

SUMMARY
External haemorrhoids originate only from a venous
Haemorrhoids consist of internal aterio-venous plexus plexus located below the dentate line. The perianal
with arterioles, venules and arteriolar-venular connec- venous plexus is also called the ‘inferior haemorrhoid-
tions embedded in connective tissue and fixed onto al plexus’. This nomenclature is confusing and should
muscular fibres. Haemorrhoids can become enlarged, be revised because this plexus is not involved in conti-
inflamed, thrombosed or prolapsed, causing attendant nence regulation. Only the internal aterio-venous
symptoms such bleeding, weeping, perianal pruritus, plexus should be named haemorrhoids and the terms
burning pain, and foreign body and pressure sensation. ‘internal’ and ‘external’ should be abandoned.
Symptoms typical of haemorrhoidal disease may be Haemorrhoids are often accompanied by bleeding,
caused by anal venous thromboses, benign skin tags, weeping, perianal pruritus, burning pain, and foreign
hypertrophic papillae, prolapsing rectal tissue, genital body and pressure sensation. These symptoms are, how-
warts, tumours, anal eczema, psoriasis, lichen ruber, ever, relatively nonspecific and may be similar to those
lichen sclerosis and anal candidiasis or other infec- observed in a variety of benign, as well as malignant
tions. The differential diagnosis of these anal and peri- diseases. A thorough, differentiated proctological exam-
anal diseases and their pathogeneses are discussed. ination may be required to determine the precise genesis
Symptomatically, it is difficult to differentiate haemor- of the disease, with case history, inspection, digital
rhoidal disease from other anal disorders. examination, proctoscopy, endoscopy if necessary,
A thorough, differentiated proctological examination bacteriological, mycological, virological and parasito-
may be required to determine the precise genesis of the logical examination, and histological examination.
disease, with case history, inspection, digital examina- An increase in perianally visible tissue, with result-
tion, proctoscopy, endoscopy if necessary, bacterio- ing foreign body and pressure sensation, pain and,
logical, mycological, virological and parasitological sometimes, bleeding and the development of eczema,
examination, and histological examination. may not only be the result of prolapsing internal
haemorrhoids of Grades 2–4 but may also be caused
by anal venous thromboses, benign skin tags, hyper-
INTRODUCTION
trophic papillae, prolapsing rectal tissue, genital warts
Haemorrhoids are physiological elements in the main- and tumours (Table 1).
tenance of continence. They consist of vascular plex-
uses (haemorrhoidal cushions) with arterioles, venules
DIFFERENTIAL DIAGNOSIS
and arteriolar-venular connections embedded in con-
nective tissue and fixed onto muscular fibres. When
Anal venous thrombosis
these vascular cushions become enlarged, inflamed,
thrombosed or prolapsed, they may cause attendant Anal venous thromboses are frequently mistaken for
symptoms and are then also referred to as haemor- prolapsing haemorrhoid tissue (Figure 1). They develop,
rhoidal disease. There are two types of haemorrhoids either singly or locularly, following a sudden intravas-
described: internal and external, which are anatomi- cular thrombosis in the region of the cavernous veins in
cally separated by the dentate line (anorectal junction). the perianal venous plexus (‘external haemorrhoidal
Internal haemorrhoids are located above the dentate plexus’) located at the anal verge and in the lower anal

Table 1. Range of differential diagnoses for the most frequent symptoms of haemorrhoidal disease
Main haemorrhoidal symptoms
Proctological disorders with

symptoms similar to those Foreign body ⁄
of haemorrhoidal disease Bleeding Discharge Pruritus Pain pressure sensation
Abscess x x x 4 4
Anal prolapse 4 4 x 4 4
Anal venous thrombosis 4 4 x 4 4
Candidiasis x 4 4 x x
Carcinoma 4 4 4 4 4
Condyloma 4 4 4 x 4
Defecation disorder x x 4 4 4
Eczema 4 4 4 4 x
Fissure 4 4 4 4 x
Fistula 4 4 4 4 4
Incontinence x 4 4 x x
Lichen ruber 4 4 4 x x
Lichen sclerosus 4 4 4 x x
Parasitic diseases 4 4 4 4 x
Proctocolitides 4 4 4 x 4
The 4 indicates that the symptom is typical in that disorder.

The x indicates that the symptom is not typical in that disorder.
canal. When these veins become thrombosed, the

Skin tags (marisca)
thrombosis causes a bluish anal swelling, which is
referred to as an ‘external haemorrhoid’. The clinical These are anal skin folds, which occur singly or in
picture varies from an indolent small bluish nodule to multiples, dispersed or annular around the anus. Sec-
an extremely painful, oedematous, multilocular, bluish- ondary skin tags are typically the remnants of perianal
livid node. Spontaneous rupture is possible. If this does or intra-anal inflammatory conditions or may occur
not occur, however, conservative or operative measures after surgery. They should not be regarded as the end-
are indicated, depending on size and symptoms. result of old perianal venous thromboses, which is
often what they are assumed to be. Asymptomatic skin
tags do not require any treatment. They may occasion-
ally lead to irritative-toxic anal eczemas because anal
hygiene has been compromised: excision under local
anaesthesia in combination with improved anal
hygiene may become necessary (Figure 2).
Hypertrophic anal papillae

Hypertrophic anal papillae, also referred to as anal
fibroma, are solitary or multiple pedunculated poly-
poid anodermal tumours located at the level of the
dentate line. They have a firm consistency and a
relatively smooth whitish surface. Anal papillae occur-
ring at the dentate line increase in size by proliferative
fibrotization because of chronic recurrent inflamma-
Figure 1. Anal venous thrombosis.
tory processes. They may grow to 3–4 cm in size and

alia, perineum or perianal area is the most common

symptom. Pain and bleeding may also occur from
scratching. Wide local excision or margin-controlled
surgical excision of the affected area to an adequate
depth is the most effective treatment.2
Genital warts
Genital warts (Condylomata acuminata) are induced
by human papilloma viruses (HPVs). They manifest
themselves mostly as skin-coloured to reddish, or
grey-brown to whitish, papillomatous papules, which
become confluent and form plaques and may also
Figure 2. Skin tag at 6 o’clock with eczema and perianal develop into large cauliflower-like tumours (Fig-
faecal traces. ure 4). Approximately 130 HPV types have been
identified.3
Genital warts are frequently caused by HPV types 6
prolapse anteriorly to the anus (Figure 3). Small papil- and 11, which have only a weak carcinogenic poten-
lae are mostly asymptomatic. Very large or prolapsing tial. The occurrence of cervical or anal high grade
fibromas may lead to foreign body sensation and dis- intraepithelial neoplasias and invasive carcinomas is
turbance of anal continence. If there are symptoms, associated with papillomas showing evidence of HPV
ablation under local anaesthesia is possible. Histologi- 16, 18 and other so-called high-risk types of HPV.
cal examination is mandatory in such cases.
Anal intraepithelial neoplasia (bowenoid
Extramammary Paget’s disease papulosis)
Extramammary Paget’s disease is a rare, non-invasive Bowenoid papulosis describes a characteristic clinical
intraepithelial adenocarcinoma outside the mammary appearance, which, histopathologically, constitutes an
gland, and includes Paget’s disease of the vulva and of anal intraepithelial neoplasia (AIN) and thus is a pre-
the penis. The disease involves mainly the epidermis, cursor lesion of a squamous cell carcinoma. Like other
but sometimes continues into the underlying dermis. It genital intraepithelial neoplasias, it is classified as
usually occurs in women aged between 50 and Grade 1–3. AINs may also occur in the epithelium of
60 years.1 Itching of a lesion around the groin, genit- hair follicles. AIN of Grade 1 or Grade 2 is considered a
Figure 4. Genital warts distributed in a circle round the

Figure 3. Hypertrophic anal papilla. anus, with irritative-toxic anal eczema.

Figure 6. Anal rim carcinoma.

Figure 5. Eczema-like perianal bowenoid papulosis.
precancerous condition with slight-to-medium dyspla-

Anal eczema
sia. Severe dysplasias (AIN Grade 3) correspond to a
carcinoma in situ and have an unknown risk of The most frequent diagnosis associated with haemor-
progression to an invasive carcinoma over time.4 A rhoidal disease is anal eczema. Nevertheless, it is nei-
central role in its pathogenesis is ascribed to viral ther an independent disease nor related solely to
infection, particularly one with oncogenic HPV types haemorrhoidal disease, but is also the sequela of dif-
16 and 18 and other so-called high-risk types of HPV. ferent dermatological, microbiological and proctolo-
In the case of bowenoid papulosis, peak frequency is gical entities. In the perpetually closed anal fold, the
between the ages of 20 and 40.5, 6 secretion from eccrine and apocrine sweat glands cre-
Multiple sharply circumscribed, rapid-growing grey- ates a humid microclimate that provides an ideal
brown to reddish-brown papules up to 10 mm in size environment for irritative-toxic, constitutional and
with a verruciform surface and sometimes associated contact-allergic provoking factors. Depending on the
with pruritus are seen as typical of the disease. None- aetiology, anal eczema is subdivided into irritative-
theless, many atypical, more eczematous forms may be toxic, atopic and allergic types. In many cases, a
observed (Figure 5). From the diagnostic viewpoint, mixed aetiology with contributing factors of varying
histological examination and HPV classification pro- importance is found. Depending on disease acuity, the
vide further evidence. clinical appearance of anal eczema varies from an
acute, most notably erosive-weeping subacute, to a
chronic, mainly lichenified picture (Figure 7). The
Anal carcinoma
main symptom is persistent, extremely troublesome
Most carcinomas of the anal region are squamous pruritus, accompanied by burning and weeping. Anal
cell carcinomas. They are divided into carcinomas of eczema treatment should cover both the causes and
the anal canal and the anal rim (Figure 6).7 Such the symptoms. Side-by-side with differentiation
carcinomas may occur by the progression of a high- between acute and chronic anal eczema when deciding
grade anal intraepithelial neoplasia (AIN), and from on local treatment, the initial addition of corticoster-
long-standing chronic anal eczema, lichen ruber or oids with a potency of class II or class III may be indi-
lichen sclerosus. Immunosuppression promotes the cated. In addition, mechanical irritation should be
occurrence of tumours. Clinically, these are solid, avoided by reducing the frequency of washing and
sometimes smooth, but mostly verrucous, skin-col- dispensing with wet wipes. Instead, the area should be
oured to reddish tumours. In the case of ulcers, cleansed with water and patted or blowed dry.
patients present with additional symptoms, such as Psoriasis inversa, lichen sclerosus, lichen ruber,
pruritus, weeping and pain. Diagnosis is made by anal candidiasis and bowenoid papulosis all show
means of inspection and palpation and is confirmed symptoms similar to those observed in anal eczema.
histologically. Thus, verification of the diagnosis by histological

rhinoconjunctivitis allergica. Atopic eczema occurs as

a result of dermal and mucosal hypersensitivity to
environmental factors of various kinds (Type 1 allergy)
in association with increased IgE formation and altered
unspecific reactivity. In the case of dermal barrier
impairment manifesting itself clinically as sebostasis, a
humid microclimate environment and sweat secretion
are the sole factors responsible for the occurrence of
eczema in the anal region. Other trigger factors
include excretory diseases, such as irritative-toxic anal
eczema. It must be emphasized that pronounced itch-
ing may occur even in the case of mild haemorrhoidal
disease.
Figure 7. Anal eczema.
Allergic contact eczema
A skin reaction to specific immunologically mediated
examination is advised, especially if there is resis- inflammation caused by exogenous substances (Type 4
tance to treatment or progression of the disease. allergy) leads to allergic anal eczema. Mostly, the
ingredients of proctological preparations, skin care
agents, hygiene sprays and wet toilet tissues, which
Irritative-toxic anal eczema
have been used for years without any problems, are
Wienert describes a relationship between the incidence responsible. Proven allergens include gentamycin,
of anal eczema and the severity grade of haemorrhoids. propolis, lidocaine, clotrimazole, hexyl resorcinol,
This ranges from an incidence of 30% in the case of chamomile flower extract, perfume blend, lanolin
Grade 1 haemorrhoids to 56% in the case of Grade 3.8 alcohols and Amerchol L-101. IVDK (The Information
The presence of prolapsing haemorrhoidal tissue Network of Departments of Dermatology in Germany)
leads to impairment of anal fine occlusion accompanied data for 1999–2003 with regard to cinchocaine, buf-
by repeated leakage of secretion into the perianal examac and benzocaine show significantly increased
region.9 Faecal secretion, in particular, causes direct sensitisation rates for anogenital dermatoses compared
damage to the epidermal barrier. This results in irrita- with control groups. Detection of the allergen is car-
tive-toxic eczema caused by exogenous irritants with- ried out by means of patch tests during a remission
out the development of specific immune reactions. Via period.10
the same mechanism, other proctological diseases asso-
ciated with a disturbance of fine continence (prolapse,
Psoriasis inversa
anal fissure, incontinence) can lead to irritative-toxic
eczema either by excreting directly into the perianal Psoriasis is an inflammatory non-infectious dermatitis,
region (anal fistulas) or by impairing anal hygiene which is distinguished by erythematous, sharply cir-
(tumours, condylomas). Furthermore, undue mechanical cumscribed plaques of various shapes and sizes and,
stress caused by toilet paper, excessive cleaning proce- typically, by a glossy silvery scaling. The latter is
dures using desiccant or irritative detergents (soaps, wet entirely absent in the intertriginous region. Here, pso-
wipes) may also lead to irritative-toxic eczema. riasis inversa presents as sharply delineated, partially
erosive dermatitis in which, patho-gnomonically, a
central fissure terminates at the anal rim (Figure 8).
Atopic anal eczema
Psoriasis inversa may also occur as monolocular peri-
The perianal region is a typical site of predilection for anal lesions without further integumental stigmata. In
atopic eczema, which is easy to diagnose if other sites terms of an isomorphic response, also known as the
of predilection, such as the popliteal fossae and elbows Köbner phenomenon, sweat and secretion may support
are likewise affected. Atopy is a genetic predisposition the occurrence of the disease. The diagnosis must be
to the development of atopic eczema, asthma and verified histologically.

known but unquantifiable (because of inadequate data)

risk of cancer occurring are indicated.12–14
Lichen sclerosus
Lichen sclerosus (previously known as lichen sclerosus
et atrophicus – LSA) is considered a cutaneous con-
nective tissue disease of unknown aetiology. More
females than males are affected by this disease (ratio
of 6:1) with the onset of the disease typically, in the
5th–6th decade of life. Most cases of lichen sclerosus
occur in postmenopausal women, with 7–15% of cases
occurring in prepubertal girls.15
Figure 8. Psoriasis inverse with typical central fissure in The initial inflammatory stage is marked by primary
anal rim. circular erythematous papules, which develop into
small porcelain-bluish, flat, atrophic plaques. Occa-
sionally, a haemorrhagic halo develops. Long-stand-
Lichen ruber ing, increasingly whitish, atrophic and wrinkled
lesions show a rough surface in the centre due to
Lichen ruber is an inflammatory dermatosis of the dense dark-brownish follicular hyperkeratoses. The
skin, mucosae and nails, and T-cell-mediated autoim- clinically characteristic diagnosis must be confirmed
mune processes are assumed to be the cause for this. histologically. In particular, as in the case of lichen
In its classic manifestation, lichen ruber can be easily ruber, the evidence of erosions should entail clinical
diagnosed in the form of livid polygonal papules with and histological checks at regular intervals, because in
milky white markings (Wickham’s stripes) at sites such about 3–5% of women with hypertrophic genital
as the forearms, malleolar region and lower legs. How- lichen sclerosus, a transition to a vulvar squamous cell
ever, the clinical picture can vary greatly from local- carcinoma has been described.16
ized isolated areas to extensive erosion (Figure 9). In
20–50% of all patients with lichen ruber, the disease
presents additionally or alone on mucosal surfaces.11 Anal candidiasis
In the anogenital area, isomorphic responses may trig- Candidiasis of the perianal skin is an inflammatory
ger the disease. The diagnosis must be verified histo- reaction induced by blastomycetes of the genus Can-
logically. Regular clinical and, if there is progression dida. Evidence of Candida albicans in the stools should
of the disease, histological checks with regard to the not primarily be regarded as pathological as it occurs
in approximately 27–70% of healthy subjects.17
Multiple, small papulopustular foci of infection in the
marginal area of an extensively infiltrated, polycyclic
and sharply circumscribed erythema are characteristic
of anal candidiasis (Figure 10). Diagnosis is made by
microscopy of the pathogens (KOH preparation) or by
fungal culture. Predisposing factors (e.g. diabetes mell-
itus, immune defect) and factors like impairment of the
skin barrier function caused by, for example, pre-exist-
ing irritative-toxic anal eczema, may lead to a super-
infection and, thereby, to worsening of the disease.
Other infectious diseases with similar symptoms

Other infectious diseases that can have symptoms sim-
Figure 9. Lichen rubber with whitish marking.
ilar to those of haemorrhoidal disease, but which occur

develop into moist, warty patches on the genitalia or

skin folds; and genital herpes caused by herpes sim-
plex viruses (HSV) 1 and 2. Symptoms include itching,
severe pain and the development of anal sores and
blisters.
CONCLUSIONS
Anal symptoms associated with haemorrhoidal disease,
are very common. Symptomatically, it is difficult to
differentiate them from other anal disorders. Good
clinical examination, further diagnostics and the
knowledge of the differential diagnoses with their clin-
Figure 10. Perianal candidamycosis with satellite foci. ical presentation, are essential for definitive therapy.
ACKNOWLEDGEMENTS
rarely, include perianal tuberculosis – presenting as
nonhealing, ulcer-like fissures, recurrent fistulas, peri- We thank Marian East of MedSense Ltd for her assis-
anal warty growths, abscesses and lupoid miliary tance in the development of this manuscript.
forms; syphilis – (caused by the spirochete Treponema
pallidum) starting with a lesion or ulcer that may
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importance of pain, pruritus and soiling agement. J Urol 2007; 178: 2268–76.
1 DermNet NZ. Extramammary Paget disease. as symptoms of haemorrhoids and their 16 Hagedorn M, Golüke T, Mall G. Lichen
http://dermnetnz.org/site-age-specific/ex- response to haemorrhoidectomy or rubber sclerosus and squamous cell carcinoma of
tra-mammary-paget.html. Accessed 23 band ligation. Br J Surg 1981; 68: 247–9. the vulva. JDDG 2003; 1: 864–8.
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2 Sarmiento JM, Wolff BG, Burgart LJ, W. Anogenital dermatoses – allergic and eczema in adults and children. Hautarzt
Frizelle FA, Istrup DM. Paget’s disease of irritative causative factors. Analysis of 1972; 23: 228–9.
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94. 11 Stein E. Proktologie Lehrbuch und Atlas, FURTHER LITERATURE
3 Doorbar J. Molecular biology of human 44th edn. Berlin: Springer Verlag, 2003 S
papillomavirus infection and cervical can- 184. Brühl W, Wienert V, Herold A. Aktuelle Prok-
cer. Clin Sci (Lond) 2006; 110: 525–41. 12 Weyandt GH, Vetter-Kauczok CS, Becker tologie, 2nd edition, Uni-Med Verlag, Bremen,
4 Herat A, Whitfield M, Hillman R. Anal JC, Brocker EB, Hamm H. Successful 2005.
intraepithelial neoplasia and anal cancer in dexamethasone pulse therapy for wide- Burgdorf W, Plewig G, Wolff HH, Landthaler
dermatological practice. Aust J Dermatol spread erosive perianal lichen planus. M (Hrsg). Braun Falco’s Dermatology,
2007; 48: 143–55. Hautarzt 2007; 58: 241–2, 244–5. Springer, Berlin, 2009.
5 Schwartz RA, Janninger CK. Bowenoid 13 Meij van der EH, Schepman KP, Waal van Hartschuh W, Lenhard BH, Tilgen W. Prokto-
papulosis. J Am Acad Dermatol 1991; 24: der I. The possible premalignant character logische Erkrankungen. Hautarzt 2004; 55:
261–4. of oral lichen planus and oral lichenoid 231–72.
6 Wacker J, Hartschuh W. Differential diag- lesions: a prospective study. Oral Surg Leitlinien der Arbeitsgemeinschaft der Wis-
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7 Hermanek P, Merkel S. Pathology and Hamm H. Squamous epithelial carcinoma & rectum, Churchill Livingstone, New York,
classification of anal carcinomas. Onko- at the site of lichen ruber hypertrophicus London, 1997.
loge 2007; 13: 982–92. of the glans penis. Hautarzt 1991; 42: Raulf F, Kolpert GW. Praxishandbuch Kolo-
8 Wienert V, Mlitz H, Raulf F (ed). Hand- 112–5. proktologie, Dr Kade, Berlin, 2006.
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Topical corticosteroid therapy in proctology indications

B. HAVLICKOVA
Global Clinical Development, Intendis GmbH, Berlin, Germany; Third Faculty of Medicine, Charles University Prague, Prague, Czech Republic
Correspondence to:
Dr B. Havlickova
Global Clinical Development, Intendis GmbH, Berlin, Germany.
E-mail: blanka.havlickova@intendis.com
tomatic individuals. Conversely, many nonspecific

SUMMARY
anorectal symptoms can be reflexively and falsely
Topical corticosteroids and local anaesthetics have been attributed to haemorrhoidal disease without an appro-
used for many years to relieve symptoms of anorectal priate workup. The incidence of haemorrhoidal disease
diseases, such as pain, pruritus and bleeding. Few clin- increases with age3 and is most common between the
ical trials have been published to allow comparisons of ages of 30 and 60, but lesions may be present at any
different combinations or different formulations, mainly age, even in childhood.6
because many of these products came to market before Although clinicians believe that haemorrhoidal dis-
stringent peer review of clinical trials data was a ease is caused by chronic constipation, prolonged sit-
prerequisite for registration. ting and vigorous straining, little evidence to support
This article highlights why topical medications are causative links exists. Other risk factors historically
necessary for the treatment of anorectal diseases, espe- associated with the development of haemorrhoids
cially of inflammatory symptoms of haemorrhoids, anal include pregnancy, lack of erect posture, familial ten-
eczema and others, particularly with respect to improv- dency, higher socioeconomic status, chronic diarrhoea,
ing the quality of life of patients living with the pain colon malignancy, hepatic disease, obesity, elevated
and discomfort associated with such symptoms. It also anal resting pressure, spinal cord injury, loss of rectal
demonstrates the efficacy and safety of combinations of muscle tone, rectal surgery, episiotomy, as well as anal
topical corticosteroids and local anaesthetics in cream intercourse.7, 8
and suppository through reference to published clinical Although haemorrhoids and other anorectal diseases
trials data, previously unpublished clinical trials data are not life-threatening, individual patients can suffer
and real life clinical experience with these products. from agonizing symptoms such as painful defecation,
itching with the urge to scratch, weeping of the wound
and bleeding, which can limit social activities and
INTRODUCTION
have a negative impact on quality of life. In a ran-
Anorectal disease, such as haemorrhoidal disorders, domized, controlled study, 70% of patients with haem-
anal eczema and anal fissures, occurs frequently in orrhoids had a reduced feeling of well being.9
industrialized countries. Significantly more patients with haemorrhoids
Between 50% and 90% of the general US and Euro- reported disturbances in social life (36%) than in con-
pean population will experience haemorrhoidal dis- trols (2%; P < 0.0001),9 which might affect their
ease, specifically, at least once in life, with one in ten enjoyment of sports activities or their willingness to
million Americans suffering from this condition.1–4 travel, for example.
Haemorrhoidal disease is the most common cause of Despite the increasing use of surgical procedures to
rectal bleeding in adults and generally one of the most treat haemorrhoids, topical products are still frequently
frequent diagnoses in almost any anorectal complaint.5 used first-line in clinical practice. There are many
Although haemorrhoidal disease is very common, its products, combining different topical preparations, for
true prevalence remains unknown and may be under- the relief of symptoms of haemorrhoidal disease, but
estimated because of the large proportion of relatively little confirmed clinical evidence is available to
asymptomatic patients. Haas et al.2 have indicated that demonstrate that these treatments are effective because
the prevalence of haemorrhoids may be as high as few clinical trials data for topical products have been
82% in asymptomatic individuals and 88% in symp- published.

In this article, we discuss why anorectal disease, in Topical medications with analgesic, anaesthetic and
particular haemorrhoids, respond well to topical anti-inflammatory activity provide fast local relief
therapy and present some clinical data for some from discomfort, itch, pain and bleeding. More invas-
selected topical preparations containing anaesthetic ive therapies, such as sclerotherapy, coagulation,
and corticosteroid combinations for the treatment of rubber band ligation and surgery, are reserved for
symptoms of haemorrhoids. patients who have severe forms of the disease or per-
sistent symptoms after several months of conservative
therapy.7, 8
CLINICAL MANIFESTATION AND SYMPTOMS
Each anorectal disease has a multifactorial aeti-
OF ANORECTAL DISEASE
ology, is usually chronic and often requires an indi-
Anorectal diseases present with various forms of vidualized treatment regimen. The aims of topical
inflammatory changes of the skin and mucous mem- treatment are to ameliorate inflammation, decrease
branes in the rectal, anal and perianal region. They disease symptoms, return patient to normal activities
may manifest as deep or superficial ulcerations; anal and minimize impact on quality of life.
fissures or anal fistulae; haemorrhoids; perianal
thrombosis; proctitis; anal and periananal eczema; and
TOPICAL THERAPEUTIC AGENTS FOR THE
irritative perianal dermatitis – manifesting with
SYMPTOMATIC TREATMENT OF
inflammatory erythema, weeping and erosions.10–12
HAEMORRHOIDAL DISEASE
Irritative dermatitis is mostly caused by faecal
enzymes, topical preparations or mycotic and bacterial Topical anti-haemorrhoidals containing steroidal or
infection.12 Haemorrhoids are usually assessed and nonsteroidal anti-inflammatory agents, local anaes-
compared using the Goligher classification,13 which thetics, astringents and emollients or a combination of
describes four grades of disease based on the presence these agents, are indicated for the symptomatic treat-
of bleeding and presence and type of prolapse. ment of haemorrhoidal disorders in all stages of the
The most common symptoms of haemorrhoidal dis- disease.17, 18 Topical agents are also used as adjuncts
ease may include perianal itching and burning (pruri- to sclerotherapy or surgical intervention. Most of these
tus ani) that is sometimes severe and induces an products help the patient maintain personal hygiene
irresistible urge to scratch, bright red blood on toilet and alleviate symptoms of itching and pain. There are
paper after a bowel motion, soreness and discomfort almost no prospective randomized trials suggesting
during and immediately after a bowel motion, a feel- that they reduce bleeding or prolapse. Preparations
ing that the bowels have not been completely emptied, used in proctology treatment are usually creams or
visible and ⁄ or palpable perianal swelling, erythema, ointments for perianal, anal and rectal use, or rectal
weeping, soiling and pain. Inflammation plays an suppositories. Table 1 lists the most commonly used
important role especially in the cutaneous symptoms topical preparations registered for haemorrhoidal
of haemorrhoidal disease.14 indications.
Topical preparations contain the following types of
ingredients, alone or in combination:19
TREATMENT OF HAEMORRHOIDAL DISEASE
Protectants: such as aluminium hydroxide gel,
The choice of therapy depends primarily on the sever- cocoa butter, glycerine, kaolin, lanolin, mineral oil,
ity of the disease. Most symptoms of haemorrhoids white petrolatum, starch, zinc oxide or calamine
can be successfully treated by increasing fibre content (which contains zinc oxide), cod liver oil or shark
in the diet, administering stool softeners, increasing liver oil (containing vitamin A at least 10 000 USP
liquid intake, regular exercise and improved toilet units ⁄ day). Protectants prevent irritation of the
habits and hygiene.7, 8, 15 perianal area by forming a physical barrier on the
Conservative pharmacologic therapy of symptoms skin that prevents contact of the irritated skin
includes oral and topical treatments. Oral treatment with aggravating liquid or stool from the rectum.
with rutosides, hidrosamine, centella asiatica, disodium This barrier reduces irritation, itching, pain and
flavodate, French maritime pine bark extract or grape burning.
seed extract decreases capillary fragility and improves Analgesics: such as menthol, camphor and juniper
microcirculation in venous insufficiency.16 tar relieve pain and itching.

Table 1. Commonly used topical preparations for haemorrhoidal indications*
Main drug active substances Tradename
Topicals containing corticosteroids

1. Combination products containing corticosteroids and local anaesthetics
Hydrocortisone, lidocaine Anamantle HC
Betamethasone, lidocaine, phenylephrine Anovate
Triamcinolone acetonide, lidocaine, hexetidine, pentosan polysulfate sodium Anso
Prednisolone, lidocaine, allantoin, vitamin E Borraginol
Fluocortolone pivalate, lidocaine hydrochloride Doloproct
Hydrocortisone, prednisone, benzocaine, Aesculus hippocastanum Hemorrane
Fluocinonide, lidocaine Jelliproct
Diflucortolone valerate, lidocaine hydrochloride Neriproct
Fluocinolone acetonide, ketocaine Proctolyn
Hydrocortisone, cinchocaine (or amylocaine, benzocaine) plus optionally one or Proctosedyl
more of esculin, neomycin, benzalkonium chloride, framycetin
Hydrocortisone, pramocaine Proctofoam, Pramosone
Hydrocortisone, benzocaine, heparin Proctosoll
Prednisolone, cinchocaine, menthol, ruscogenin, zinc Ruscus llorens
Prednisolone hexanoate, cinchocaine hydrochloride Scheriproct
Fluocinolone acetonide, lidocaine, bismuth, menthol Synalar rectal
Hydrocortisone, pramocaine, ergocalciferol, glycerol, retinol, starch, Tucks
zinc, Hamamelis virginiana
Fluocortolone pivalate, fluocortolone caproate, cinchocaine (plus clemizole Ultraproct
in some countries)
Hydrocortisone, lidocaine, zinc, aluminium Xyloproct
2. Single and combination products containing corticosteroids without local anaesthetics
Hydrocortisone, benzyl benzoate, bismuth, peru balsam, zinc Anusol HC
Hydrocortisone, Escherichia coli Posterisan
Hydrocortisone, phenylephrine, paraffin oil, glycerol Preparation H
Hydrocortisone Procto-Kit
Hydrocortisone, squalus carchorious, zinc Relief
Topicals without corticosteroids
3. Single and combination products containing local anaesthetics
Lidocaine, nifedipine Antrolin
Pramocaine, zinc, peru balsam, bismuth, boric acid, hamamelis, resorcinol, paraffin oil Anusol, Anusol Plus
Lidocaine, tribenoside Borraza G
Cinchocaine DoloPosterine
Cinchocaine + policresulen or lidocaine + bufexamac, bismuth, titanium Faktu
Lidocaine, benzalkonium chloride, bismuth, chlorhexidine, chloroxylenol, menthol, Germoloids
phenol, salicylic acid, zinc
Benzocaine, benzoxiquine, benzyl benzoate, bismuth, peru balsam, zinc Hemorrhoidal LU
Benzocaine, ephedrine Hemoal Combe
Benzocaine, Achillea millefolium, Aesculus hippocastanum, Atropa belladonna, Hemorol
Matricaria chamomilla, Potentilla tormentilla, Sarothamnus scoparius
Benzocaine, chlorothymol, resorcinol (with ⁄ without aloe) Lanacane
Lidocaine, bufexamac Mastu S
Benzocaine, epinephrine, menthol, Aesculus hippocastanum Proctosan
Benzocaine, ephedrine, epinephrine, zinc Rectinol
Tetracaine, ruscogenin Ruscoroid

Table 1. Continued
Main drug active substances Tradename
Benzocaine, butylcaine, dodeclonium hydroxide, enoxolone, esculin Sedorrhoide

Lidocaine, benzocaine, triclosan, camphor, linoleic acid, linolenic acid, menthol, Sulgan
aluminium, urea, zinc, Anthemis nobilis, Hamamelis virginiana
Lidocaine, titanium, zinc, Chondrus crispus Titanoreine
Lidocaine, hyaluronidase, neomycin Xilodase
4. Single and combination products without local anaesthetics
Chlorocarvacrol, ichtyolammonium, menthol Haedensa
Atropa belladonna, Hamamelis virginiana, paraffin oil, wool fat Hemovirtus
Alantoin, dexpanthenol, heparin Hepathrombin H
Ambra, musk, pearl, Bezoar bovis Musk Hemorrhoids
Alginic acid Natalsid
Lupinus albus, Aloe barbadensis, Mentha piperata, Vateria indica Neo Healar
Nitroglycerine Nitrong
Squalus carchorious glycerol, phenylephrine, methylparaben, cacao butter, Preparation H
Hamamelis virginiana and others
Ruscogenin, trimebutine Proctolog
Eucalyptus globulus, honey, Matricaria chamomilla, Psidium guajava, Relif
Tilia vulgaris, Zingiber officinale
Escherichia coli, phenol Reparon
Chondrus crispus, titanium, zinc Titanoreine
Aluminium, potassium, tannic acid Zione
* Products with annual sales of more than 1 000 000 Euro in the period from April 2008 to March 2009, based on average
exchange rates for Q1 ⁄ 2009.
Drug active substances and trade names may vary from country to country.
Source: IMS Processing and Data Delivery System (PADDS; data for 66 countries).
Vasoconstrictors: such as ephedrine sulphate, epi- pain and itching. Local anaesthetics produce a surface
nephrine and phenylephrine (Preparation H). These or topical loss of sensation (anaesthesia) by blocking
may reduce pain and itching because of their mild the generation and conduction of sensory nerve
anaesthetic effects. Vasoconstrictors prolong the expo- impulses near the application site. The primary site of
sure of nerve endings to local anaesthetics. action is the axon cell membrane where they interact
Astringents: such as calamine and witch hazel. with the voltage-gated sodium channels. Local anaes-
Astringents cause coagulation of proteins in the cells thetics provide immediate relief of itching and pain
of the perianal skin or the lining of the anal canal. upon application. Local anaesthetics of the amide-type
This action promotes dryness of the skin, which in such as pramocaine, lidocaine hydrochloride and
turn helps relieve burning, itching and pain. cinchocaine hydrochloride are the most frequently
Antiseptics: such as boric acid, hydrastis, phenol, used anaesthetics in topical anti-haemorrhoidal prepa-
benzalkonium chloride, cetylpyridinium chloride, ben- rations. Amide-type anaesthetics are preferred to those
zethonium chloride and resorcinol. Antiseptics reduce of the ester-type – such as procaine, benzocaine and
bacteria introduced from faecal leakage. tetracaine – which are metabolized to methyl-paraben-
Keratolytics: such as aluminium chlorhydroxy allan- zoic acid (PABA) and are therefore associated with a
toinate (alcloxa) and resorcinol, allow agents applied higher incidence of allergic reactions and skin sensit-
to the anus and perianal area to penetrate into the ization.20 Amide-type anaesthetics do not undergo this
deeper tissues. metabolic transformation.
Local anaesthetics: Topical anti-haemorrhoidal prep- Steroids: About 60% of all topical anti-haemor-
arations often contain a local anaesthetic for relief of rhoidal preparations contain corticosteroids due to

their anti-inflammatory, anti-allergic and anti-pruritic haemorrhoids, thereby supporting the healing process
properties. Corticosteroids diffuse into cells and bind and eventually resulting in relief from symptoms of
to steroid receptors within the cytoplasm giving a pain, itching and pressure. As the mechanism of action
steroid–receptor complex.21 The activated corticoid– of corticosteroids is via the expression and suppression
receptor complex binds to specific DNA sequences to of cellular proteins, symptomatic relief is delayed.
modify gene transcription, ultimately affecting the Fast-acting local anaesthetics relieve pain and itching
synthesis of inflammatory mediators.22 Capillary dila- upon administration. Thus, an additive or synergistic
tation, intercellular oedema and tissue infiltration are effect in the fixed combination is achieved.
reduced and capillary proliferation is suppressed.23 In addition to the duel mechanism of action, it is
simpler to apply one combination preparation as com-
pared with the separate application of corticosteroid
RATIONALE FOR COMBINATION THERAPY IN
and local anaesthetic from two separate preparations.
INFLAMMATORY ANAL DISEASE
This may improve compliance with treatment. Further-
Haemorrhoidal preparations are mainly combinations more, the fixed dosage of the active ingredients in the
of different agents. Fixed combination topical anti- combination preparations ensures that all components
haemorrhoidal preparations containing a corticosteroid, are applied in the intended proportions and dose.
such as hydrocortisone, prednisolone or fluocortolone, There are many corticosteroids and local anaesthetic
plus a local anaesthetic, such as cinchocaine or lido- combinations available with various corticosteroids
caine, are extensively used and this use is supported by and anaesthetics selected based on potency and phar-
current medical practice.17, 18, 24, 25 Such combination macokinetic properties (Table 2).
products do not constitute a cure for haemorrhoidal
conditions, but they can be successfully used to allevi-
CORTICOSTEROID POTENCY
ate symptoms and improve patients’ quality of life.
The anti-inflammatory, anti-pruritic, anti-allergic, Most synthetic corticosteroids are derived from cortisol
anti-proliferative, vasoconstrictive and anti-exudative with the aim of increasing inflammatory potency and
effects of corticosteroids ameliorate the inflammation, bioavailability. The potential for corticosteroids to
vasodilatation, bleeding, and oozing associated with inhibit inflammatory skin reactions can be quantified
Table 2. Potency of corticosteroids in combination products with anaesthetics
Corticosteroid and anaesthetic combinations Corticosteroid class* Brand name(s)
Hydrocortisone, lidocaine I Anamantle HC, Xyloproct

Hydrocortisone, cinchocaine I Proctosedyl
Hydrocortisone, benzocaine I Proctosoll
Hydrocortisone, pramocaine I Proctofoam, Pramasone,
Tucks
Hydrocortisone, prednisolone, benzocaine I Hemorrane
Prednisolone, lidocaine I Borraginol
Prednisolone, cinchocaine I Ruscus llorens,
Scheriproct
Triamcinolone acetonide, lidocaine II Anso
Betamethasone, lidocaine III Anovate
Diflucortolone valerate, lidocaine III Neriproct
Fluocortolone pivalate, lidocaine III Doloproct
Fluocinonide, lidocaine III Jelliproct
Fluocinolone acetonide, ketocaine III Proctolyn
Fluocinolone acetonide, lidocaine III Synalar Rectal
Fluocortolone pivalate, fluocortolone caproate, cinchocaine III Ultraproct
* According to the Anatomical Therapeutic Chemical (ATC) classification system of the World Health Organization.

and classified in indirect tests in humans such as the ing administration of two suppositories containing
vasoconstriction test and the UV erythema suppression 1 mg fluocortolone pivalate and 40 mg lidocaine
test. The vasoconstriction test is used to demonstrate hydrochloride per suppository (Doloproct; Intendis,
the potency of action of a topical corticosteroid, as Berlin, Germany).
there is a very good correlation between the vasocon- It can be concluded that after local rectal application
striction (blanching) achieved by a corticosteroid and of fluocortolone pivalate, systemic bioavailability is
its efficacy in clinical use.26, 27 This pharmacological about 5% from suppositories and 15% from rectal
model is accepted for the prediction of clinical efficacy cream. The bioavailability of lidocaine is similar when
and local bioavailability and is the basis for the Miller administered as a rectal cream or suppository (24–30%
and Munro28 classification for the relative clinical of the applied dose).30 Lidocaine plasma levels obtained
potencies of topical corticosteroids. after rectal administration of lidocaine hydrochloride
In Europe, the Anatomical Therapeutic Chemical (in Doloproct rectal cream) were £0.1 lg ⁄ mL. In con-
(ATC) classification system – developed by the World trast, cardiovascular effects are only seen at lidocaine
Health Organization – is the most frequently used plasma levels 20- to 50-fold higher than this and cen-
scheme for assessing the potency of corticosteroid tral nervous side effects of lidocaine occur at plasma
preparations. This classification divides topical corti- levels above 5–6 lg ⁄ mL. Therefore, Doloproct rectal
costeroids into four groups: group I = weak (e.g. cream used, as recommended by the manufacturer,
hydrocortisone, prednisolone); group II = moderately would not be expected to exert toxic effects.30 Studies
potent (e.g. dexamethasone, triamcinolone); group with creams containing fluocortolone pivalate or fluo-
III = potent (e.g. betamethasone, diflucortolone) and cortolone caproate show that fluocortolone pivalate
group IV = very potent (e.g. clobetasol, halcinonide). penetrates the skin more quickly than fluocortolone
caproate, leading to a fast onset of action and a long-
lasting corticoid activity at the application site.31
PHARMACOKINETIC PROPERTIES OF TOPICAL
Cinchocaine HCl is one of the most potent long-act-
COMBINATIONS
ing, amide-type, local anaesthetics. It is generally
Few studies of the pharmacokinetics of topical anti- used for surface anaesthesia in creams and ointments,
haemorrhoidal combination preparations exist; hence, in concentrations up to 1%, and in suppositories for
it is necessary to consider their pharmacokinetic prop- the temporary relief of pain and itching associated
erties separately. with skin and anorectal conditions.
Because of their higher lipophilicity, corticoid esters In an investigation in two women suffering from
like prednisolone caproate, fluocortolone pivalate, flu- pain at episiotomy sites, locally applied 2% cincho-
ocortolone caproate and difluocortolone valerate pen- caine spray resulted in cinchocaine plasma concentra-
etrate the skin more easily than free corticosteroid tions close to the lower limit of quantification.32
alcohols. Therefore, they are frequently used in topical Following absorption, cinchocaine is biotransformed
preparations. These 21-esters of corticosteroids are into a number of basic metabolites.33–35
actually pro-drugs and are at least partially hydrolysed The composition of the vehicle used in cream and
within the skin into the free corticosteroid,29 which ointment preparations can influence the efficacy (i.e.
binds more readily to the glucocorticoid receptor than absorption), tolerability and application properties of
the parent compound. the active ingredients carried in them. Creams and
A fraction of the topically applied corticosteroid ointments both contain mixtures of water-based and
dose will be systemically absorbed, distributed, metab- oil-based vehicles. The higher proportion of oil-based
olized and excreted. Systemic bioavailability is not vehicle in ointments increases absorption of active
needed for local therapeutic anti-inflammatory effi- ingredients. Creams, which are rapidly absorbed
cacy, but it is necessary to know the extent of through the epidermis, are generally preferred for
systemic corticosteroid bioavailability after rectal acute and subacute dermatoses in intertriginous areas,
or perianal application to assess the risk of systemic such as the perianal area, but the enhanced occlusive
adverse corticosteroid effects. properties of ointments may have advantages in
In a study of repeated administration of a rectal chronic stages where anal eczema has resulted in
suppository formulation, corticosteroid and lidocaine lichenification.36, 37 Some constituents of the vehicle,
absorption during steady state was determined follow- such as lanolin or PABA, can result in skin hyper-

sensitivity,38 which may aggravate itching, erythema similar or superior to those with the reference standards,
and oedema associated with anorectal diseases. but these differences were not significant. Overall,
physicians and patients assessed performance of all
three products as ‘good’ in 72–85% of cases. Notable
EFFICACY OF SELECTED COMBINATIONS
regression of symptoms such as weeping and rhagades
FROM CLINICAL STUDY RESULTS
was also recorded in all groups.39
A number of the products used to treat haemorrhoids In the second study,40 patients were randomized to
were registered more than 40 years ago, at a time treatment with Doloproct (n = 109), Procto-Celestan
when there was no requirement to demonstrate their (n = 112) or Mykoproct (n = 113) suppositories. The
efficacy and safety in specifically designed randomized dose was one suppository twice daily for 20 days. As
clinical trials. For this reason, this clinical data for with the ointments, all three preparations gave high
many anti-haemorrhoidals are lacking. Available stud- symptom improvement rates after treatment (Figure 1).
ies (as well as more than 40 years of experience in This can be ascribed to the potent anti-inflammatory
patients) have, however, shown that symptomatic activity of the corticosteroids in the preparations.
treatment of haemorrhoidal disorders with combi- Objective measures of inflammation, such as erythema
nation products – such as Ultraproct, Doloproct, and oedema, also improved rapidly.40
Neriproct and Scheriproct (all Intendis, Berlin, Ger- Taken together, these studies indicate that improve-
many) – is safe and effective.17 Some of the clinical ments with Doloproct cream and suppositories were
data for these products are discussed below. similar or superior to those with the reference stan-
dards, but these differences were not significant.
Several noncontrolled studies involving 929 patients
Fluocortolone pivalate ⁄ lidocaine hydrochloride
with inflammatory conditions of the rectum and ⁄ or
(Doloproct)
anal region, including haemorrhoidal conditions, were
The combination product, fluocortolone pivalate plus also conducted.41–44 Patients received Doloproct oint-
lidocaine hydrochloride (Doloproct), was compared ment or suppositories or both, for up to 4 weeks, with
with betamethasone valerate plus lidocaine hydro- most patients being treated for between 8 and 21 days.
chloride plus phenylephrine hydrochloride (Procto- Assessments of improvement in symptoms and
Celestan, no longer marketed) and triamcinolone treatment efficacy were made as described for the
acetonide plus lidocaine hydrochloride plus nystatin controlled trials above. High rates of symptom
(Mykoproct; Stegropharm, Munich, Germany) in two improvement were reported in all studies, in particular,
randomized open-label trials, one with ointments39 for relief of pain and itching. Physician and patient
and one with suppositories.40 All patients in both stud- assessment were ‘good’ in >80% of cases in all studies.
ies were being treated for anal eczema in connection The treatments were generally well tolerated. The
with haemorrhoidal disorders. results of one of these studies (Study 5710),41 which
The outcome measures were patient and physician compared Doloproct cream applied simultaneously to
ratings for subjective (pain, burning, itching) and the rectal and perianal areas with Doloproct cream
objective (erythema, oedema, superficial anal fissure, applied to the perianal area plus a suppository for
sphincterismus, rhagades, weeping, lichenification, rectal application are shown in Figure 2. The figure
peeling and infection with Candida albicans) symp- shows physician- and patient-assessed regression rates
toms. Patients rated symptoms as ‘severe’, ‘slight’ or for individual symptoms in the rectal area (a) and
‘absent’ before, during and after treatment. In addition, perianal area (b) with suppositories and application of
patients and physicians rated the therapeutic effect of cream to the perianal area, and in the rectal area (c)
the medicine as ‘good’, ‘moderate’ or ‘poor’. and perianal area (d) with cream simultaneously
In the first study,39 patients applied Doloproct applied to the rectal and perianal areas.
(n = 117), Procto-Celestan (n = 115) or Mykoproct On the basis of results of the studies and more than
(n = 117) ointments to the anal ⁄ perianal areas twice 20 years of clinical experience in patients, it is reason-
daily until the symptoms disappeared or for a maximum able to conclude that the combination of fluocortolone
of 20 days. High improvement rates in both subjective pivalate and lidocaine hydrochloride is effective in the
and objective symptoms were found for all three prepa- treatment of inflammation and other symptoms of
rations (Figure 1). Improvements with Doloproct were haemorrhoidal disorders.

(a) Pain
Cream Suppository Figure 1. Change from baseline** in proportion of
60 patients reporting severe symptoms of (a) pain, (b) burn-
Proportion of patients reporting
ing and (c) itching following Doloproct, Procto-Celestan

50 or Mykoproct cream* or suppositories twice daily for
2 weeks.39, 40 * Doloproct cream: fluocortolone pivalate
severe pain, %
40
0.1% (1 mg ⁄ g) and lidocaine hydrochloride 2%
(20 mg ⁄ g); Doloproct suppository: fluocortolone
30
pivalate 0.05% (1 mg) and lidocaine hydrochloride 2.2%
20 (40 mg). ** Baseline figures are for all patients before
randomization to three treatment groups.
10
0
Baseline** Doloproct Procto- Mykoproct
Celestan
End of week 2 with haemorrhoidal disorders (haemorrhoids, anal
eczema, proctitis, anal fissures).45 Forty-one patients
(b) Burning
45
were treated with Scheriproct suppositories (first week)
and Scheriproct ointment (second week) twice daily
40
for total of 2 weeks and 51 patients with the nonster-
35
oidal antiphlogistic agent bufexamac combined with
severe burning, %
30
lidocaine (Proctoparf; Wyeth but no longer marketed)
25
in the same treatment regimen. Among these, 25
20
patients had undergone sclerotization of their haemor-
15
rhoids before the start of topical treatment. Efficacy
10 was evaluated by improvement in haemorrhoidal
5 symptoms (erythema, itch, burning, pain, bleeding,
0 secretion, erosions and skin infiltration). On average,
Baseline** Doloproct Procto- Mykoproct
Celestan
efficacy was judged by the investigator as ‘good’
End of week 2
(range: very good–good–satisfactory–mild–unsatisfac-
tory). About 85.7% of patients in the Scheriproct
(c) Itch group judged treatment to be ‘good’ or ‘very good’
70 compared with 72.6% in the Proctoparf group. There
60 were significant reductions in burning (P £ 0.01), ery-

thema, pruritus and serious secretion (P £ 0.001) with
severe itching, %
50
Scheriproct. Similar significant reductions in these
40 symptoms were also observed for Proctoparf (Fig-
30
ure 3). In both groups, 98% of patients rated toler-
ability as ‘very good’ to ‘good’.
20 The efficacy of prednisolone plus cinchocaine
10 (Scheriproct) has been evaluated in a series of eight
uncontrolled clinical studies dating back to 1960 and
0
Baseline** Doloproct Procto- Mykoproct including 627 patients. The conservative or post-surgi-
Celestan cal treatment of haemorrhoids, anal fissures, perianal
End of week 2 eczema, pruritus ani or proctitis with Scheriproct oint-
ment or suppositories led to a substantial improvement
or total relief of clinical symptoms within 3–21 days
Prednisolone hexanoate ⁄ cinchocaine
in almost all patients.46 Based on the results of these
hydrochloride (Scheriproct)
studies, the combination of prednisolone plus cincho-
The efficacy and tolerability of Scheriproct were evalu- caine in Scheriproct has been proven to be effective
ated in a comparative, parallel-group double-blind and well tolerated in the treatment of haemorrhoidal
study in 100 male and female patients (14 to 76 years) disorders.

(a) Slight intensity 1 = Initial value (b) Slight intensity 1 = Initial value
Severe intensity 2 = Last value Severe intensity 2 = Last value
Regression rate, perianal area (%)

100
Regression rate, rectal area (%)

100
1
80 1 1 1
1 80
1
1 1
60 60
1 1
1 1 1
40 40
1
1 1
2 2 1
20 2 20 2 1 1
2 2 2 2 2 2
2 2 2 2 2 2 2 2
2
0 0
in g g a a n g re us in ting ing ma ma ure ing des tion ling
Pa ar tin Itchin them edem cretio eedin issu rism a
P ar Itch the ede iss eep ga ica ca
Sm Er
y O Se Bl F te Sm Er
y O F W a if S
c Rh hen
hin Lic
Sp
(c) (d)
Slight intensity 1 = Initial value Slight intensity 1 = Initial value
Severe intensity 2 = Last value Severe intensity 2 = Last value
Regression rate, perianal area (%)

100 100
Regression rate, rectal area (%)
80 1 80
1 1 1
1
60 1 60
1 1
1 1
40 40
2 1 1 1 1
1 2 1
20 20 2 1
2 2 1
2 2 2 2 2 2 2 2 2
2 2 2 2 2
0 0
in g g a a n g re us i ting ing ma ma ure ing des tion ling
n
Pa ar tin Itchin them edem cretio eedin issu rism a
P ar Itch the ede iss eep ga ica ca
m Er
y O Se l F
cte Sm Er
y O F W a if S
S B Rh hen
hin Lic
Sp
Figure 2. Physicians’ and patients’ assessments of regression rates of individual symptoms in the rectal (a, c) and perianal
(b, d) areas for patients treated either with Doloproct cream plus suppository* (a, b) or Doloproct cream only (c, d) after
1–3 weeks of treatment.41 * Fluocortolone pivalate 0.05% (1 mg) and lidocaine hydrochloride 2.2% (40 mg) per supposi-
tory. Fluocortolone pivalate 0.1% (1 mg ⁄ g) and lidocaine hydrochloride 2% (20 mg ⁄ g).
and oedema before and after haemorrhoidectomy

Fluocortolone pivalate plus fluocortolone
(Figure 4).47
caproate plus cinchocaine hydrochloride
(Ultraproct)
Diflucortolone valerate ⁄ lidocaine hydrochloride
Long-term routine use of fluocortolone pivalate plus
(Neriproct)
fluocortolone caproate plus cinchocaine hydrochloride
(Ultraproct) ointment and suppositories in humans The safety and efficacy of the more recently intro-
over a period of more than 40 years has proven its duced combination of diflucortolone valerate and lido-
efficacy and safety. In a study with 250 patients trea- caine hydrochloride (Neriproct) have been confirmed
ted for different forms of haemorrhoidal disease with in a number of pilot studies and clinical trials.
Ultraproct ointment and ⁄ or suppository, 76% of In a multicentre study conducted in Japan, more
patients rated the combination product as ‘good’ or than 500 patients with internal, external, thrombotic
‘very good’ for relief of symptoms, such as anal and ⁄ or strangulated haemorrhoids of all grades were
fissure, anal puritus, proctitis, internal and external treated twice daily for 1 week with either Neriproct
haemorrhoids and for reduction of inflammation ointment or suppositories.48

Scheriproct Proctoparf 100

100
†
80 76%
with symptoms improvement
†
80 † †
** *
Percentage of patients
Therapy success
†
†
**
60
60
40
40
20 16%
20
8%
0 0
Very good – good Moderate Unsatisfactory
ma h
Itc rnin
g in g n n
Pa edin retio rosio ion o in
f
he
Eryt Bu Ble Sec E
il t ra t sk
l
Inf riana
pe Figure 4. Patient satisfaction with fluocortolone pivalate
plus fluocortolone caproate plus cinchocaine hydro-
chloride* for a treatment period of up to 4 weeks.47
Figure 3. Prednisolone hexanoate plus cinchocaine * Ultraproct ointment: fluocortolone pivalate 0.09%
hydrochloride (Scheriproct)à (n = 49) and bufexamac plus (0.92 mg ⁄ g), fluocortolone caproate 0.09% (0.93 mg ⁄ g)
lidocaine (Proctoparf) (n = 51) provide relief of all relev- and cinchocaine hydrochloride 0.5% (5 mg ⁄ g); Ultraproct
ant symptoms.45 * P £ 0.05; ** P £ 0.01; P £ 0.001. suppository: fluocortolone pivalate 0.03% (0.61 mg),
à Scheriproct ointment: prednisolone hexanoate 0.2% fluocortolone caproate 0.03% (0.63 mg) and cinchocaine
(1.9 mg ⁄ g) and cinchocaine hydrochloride 0.5% (5 mg ⁄ g); hydrochloride 0.05% (1 mg).
Scheriproct suppository: prednisolone hexanoate 0.07%
(1.3 mg) and cinchocaine hydrochloride 0.05% (1 mg) per
suppository.
local side effects such as skin atrophy, telangiectasia
and impaired wound healing. Clinically relevant sup-
Prior to treatment, the severity of any bleeding, pain pression of the pituitary–adrenal axis following exter-
(duration, degree), swelling or prolapse and haemor- nal application of corticosteroids is observed only if
rhoid size was evaluated using a four-point scale, for potent or very potent corticosteroids are applied on
each symptom. Improvements in symptom severity extensive areas and especially under occlusive condi-
were also assessed comprehensively using a five-point tions.49, 50
scale, where 1 = ‘excellent’, 2 = ‘good’, 3 = ‘fair’, In products for rectal and perianal use therefore
4 = ‘not good’ and 5 = ‘inaccessible’. the use of corticosteroids and local anaesthetics with
Patients experienced rapid symptom relief and high limited bioavailability following rectal administration
response rates after 1 week of treatment (Figure 5 and is preferred. To avoid local and systemic adverse
Table 3).48 Overall, 70% of patients had a ‘good’ or effects of corticosteroids, mild or less potent cortico-
‘excellent’ response. This increased to around 95% for steroid preparations are used in topical anti-haemor-
‘fair’ to ‘excellent’ responses. The excellent response rhoidal preparations for chronic use. Potent steroid
rates obtained by many patients with thrombotic or preparations are recommended for short-term use
strangulated haemorrhoids in the inflammatory phase when fast onset of action and strong efficacy are
illustrate the potent anti-inflammatory activity of the required.
medications. Moreover, the high degree of improve- Frosch et al.51 evaluated the extent of visible atro-
ment seen with just 1 week of treatment confirms the phy and telangiectasia associated with the use of a
rapidity of the action of these formulations. selection of corticosteroids in an occlusive fashion
using Duhring chambers. Twenty healthy volunteers
had the corticosteroids applied to the skin of their
TOLERABILITY AND SAFETY PROFILE
forearms and, after 3 weeks, the skin was evaluated
As with any topical corticosteroid preparation, excess- via stereomicroscopy according to a validated five-
ively prolonged use – i.e. more than 2–4 weeks point scale. Diflucortolone valerate 0.1% (in Neri-
(depending on the corticosteroid strength) – can cause proct) showed a low level of atrophogenicity, second

Neriproct ointment Neriproct suppository only to hydrocortisone acetate 1% and the two base
100 control formulations. In contrast, atrophogenic effects
were judged moderate for betamethasone valerate
Percentage of patients with good
80 0.1% and very severe for clobetasol propionate

to excellent improvement
0.05% (Figure 6).51

60 In rare cases, allergic skin reactions to either the
local anaesthetic or the steroid may occur. Allergic
40 reactions are not necessarily connected to the duration
of use and may even appear after the first application.
Prolonged use may increase the likelihood of develop-
20
ing an allergic skin reaction. To reduce the risk of
sensitizing the skin to a topical product, products
0
g ) e) ng se e with fewer ingredients are preferred over the multi-
edin tion gre elli lap siz
Ble (du
ra d e S w r o h o id compound combinations.52
in in ( P
orr
Pa Pa em Cinchocaine is known for its sensitizing potential.
Ha
Individual symptoms
Analysis of data between 1999 and 2003 from a net-
work of dermatology departments in Göttingen indic-
ated positive reactions to cinchocaine at 6.6% in
Figure 5. Proportion (%) of patients with ‘good’ to ‘excel-
lent’ response for individual symptoms following twice- patients with anogenital dermatitis.53 Apart from its
daily treatment with diflucortolone valerate and lidocaine known potential as a contact sensitizer, single cases of
hydrochloride (Neriproct) ointment* and suppositories** systemic contact dermatitis with clinical presentations
for 1 week.48 * Ointment: diflucortolone valerate 0.01% of erythemato-vesicular exudative lesions, erythemato-
(0.1 mg ⁄ g) and lidocaine hydrochloride 2% (20 mg ⁄ g). papular eruptions and intense pruritus have been
** Suppositories: diflucortolone valerate 0.01% (0.2 mg)
reported in the literature.54–56 However, contact sensit-
and lidocaine hydrochloride 2.2% (40 mg) per
suppository. ization to lidocaine, a newer generation amide anaes-
thetic, is not common.57
When used as directed by manufacturers, corticoster-
oid plus local anaesthetic combination products mark-
eted worldwide for anorectal diseases have very
favourable safety profiles. Periodic safety review
reports for the aforementioned products that have
been on the market for up to 40 years indicate that
Table 3. Proportion (%) of patients with ‘good’ to ‘excel- despite tens-of-millions of patient exposures, <1% of
lent’ response following twice daily treatment with diflu- patients have reported adverse events and these are all
cortolone valerate and lidocaine hydrochloride (Neriproct)
nonserious.58 Data from specific products are discussed
ointment* and suppositories for 1 week47
below.
Ointment Suppository
(response (response
rate, %) rate, %) Doloproct
In clinical trials involving more than 1,100 patients
Internal haemorroids 71.3 69.6
External haemorrhoids 79.0 66.2 exposed to Doloproct, adverse events occurred in
Thrombotic external 80.2 70.0 around 30 patients (i.e. fewer than 3%).39–44 Itching
haemorrhoids and burning sensations – mostly mild in nature – were
Strangulated 70.6 92.3 the most frequently observed reactions with both for-
haemorrhoids mulations. Some patients using Doloproct supposit-
ories experienced diarrhoea. In the randomized,
* Ointment: diflucortolone valerate 0.01% (0.1 mg ⁄ g) and
controlled trials, the nature and numbers of adverse
lidocaine hydrochloride 2% (20 mg ⁄ g).
Suppositories: diflucortolone valerate 0.01% (0.2 mg) and events were similar in all three arms of the trials.39, 40
lidocaine hydrochloride 2.2% (40 mg) per suppository. The numbers of reported adverse events in clinical
practice, during the nearly 25 years that Doloproct has

5 Ultraproct
4
No systematic clinical safety studies have been per-
formed with Ultraproct because of its age, but the
Atrophy score
3 safety profiles of the individual active ingredients have

been investigated in other products.59 Clinical data
2 from comparable topical medications for haemor-
rhoidal disorders including Doloproct (fluocortolone
1 pivalate ⁄ lidocaine hydrochloride) and Scheriproct
(prednisolone hexanoate ⁄ cinchocaine hydrochloride)
0 are discussed above. Cumulative clinical experience
BH BD HCA DFV BMV BDP FAC TAC HAL CBP
with Ultraproct over more than 40 years duration has
Study group
shown that compared with the number of applications
of the product (many millions), the number of reported
Figure 6. Mean atrophy scores in healthy volunteers
(n = 20) after 3 weeks of occlusive treatment with various
adverse reactions is extremely low indicating a favour-
corticosteroid creams and two base formulations.51 able risk-benefit ratio.58 Sporadic side effects that have
* Atrophy score: 0–1 = normal vascular pattern; been reported are mainly concerned with suspected
1–2 = slightly increased transparency and irregularity contact allergy.
of dermatoglyphic pattern; 2–3 = moderate thinning of
epidermis, moderately increased transparency and
flattening of furrows and ridges; 3–4 = severe thinning Neriproct
and increased transparency, dermatoglyphic pattern
severely affected; 4+ = very severe thinning of epidermis The incidence of adverse events in studies with
with complete loss of dermatoglyphics. BH = halcinonide Neriproct has been very low.
steroid free base; BD = diflucortolone valerate steroid In a study involving 516 patients using Neriproct
free base; HCA = hydrocortisone acetate 1%; DFV = cream or suppositories twice daily for 1 week, four
diflucortolone valerate 0.05% (i.e. as in Neriproct);
BMV = betamethasone valerate 0.1%; BDP = betametha-
patients (0.8%) experienced mild adverse reactions
sone dipropionate 0.05%; FAC = fluocinolone acetonide (namely increased abdominal gas or flatulence – two
0.2%; TAC = triamcinolone acetonide 0.5%; HAL = patients; feeling of abdominal distension and constipa-
halcinonide 0.1%; CBP = clobetasol propionate 0.05%. tion; and feeling of abdominal distension).48 No
adverse reaction required any particular treatment.
Laboratory blood tests were carried out before and
been on the market, have been extremely low and after treatment in 17 patients, but no abnormal
nonserious in nature.58 changes in laboratory values were identified.
Scheriproct CONCLUSIONS
The safety of Scheriproct has been evaluated in nine Most people will experience some form of haemor-
clinical studies including 727 patients of both gen- rhoidal disease at least once in their life. Most cases
ders.58 Only one adverse event (irritation) was reported are mild and do not require invasive treatment, being
and the general tolerability was judged as excellent. indicated for conservative treatment only. The corner-
The active components of Scheriproct have been in stone of therapy is lifestyle modification including diet
use for more than five decades and are well-estab- and exercise. Additionally, topical preparations offer
lished medications. Scheriproct itself has been on the patients fast symptom relief and alleviation of the
market for more than 50 years and periodic safety most uncomfortable manifestations of haemorrhoidal
update reports on its use in clinical practice prepared disease as well as safety and convenience. Topical
for health authorities reveal that the incidence of treatment allows patients to resume normal activities
reported adverse events is <1%.58 These are nonserious and enjoy their usual state of well being.
in nature and include hypersensitivity reactions, The advantages of using fixed dose combination
burning sensation, itching (including anal pruritus) products over individual products are to ensure that
and abdominal discomfort. all components are applied in the intended proportions

and help ensure good compliance. The potent anti- The use of fixed combination topical products
inflammatory activity of topical corticosteroids brings containing a corticosteroid and a local anaesthetic for
rapid relief from pain and itching and objective signs anorectal disease including haemorrhoidal disease is
(such as oedema and erythema) associated with firmly established based on decades of experience
inflammation in anorectal diseases. This is particularly demonstrating symptomatic relief and excellent toler-
apparent with strangulated and thrombotic haemor- ability. And, while this does not constitute a cure of
rhoids, where the tissues are severely inflamed. primary disease, patients do profit from a better
Patients with advanced (i.e. grade III or IV) internal quality of life through rapid and effective alleviation
haemorrhoids may undergo a course of treatment with of symptoms.
a topical corticosteroid to reduce oedema and inflam- Topical medications based on combinations of
mation before undergoing surgery to complete their corticosteroids and local anaesthetics are clearly
treatment. The addition of an anaesthetic to a cortico- meeting an important need in the treatment of
steroid means that pain and itch can be ameliorated haemorrhoidal diseases and are currently indicated
almost immediately. The effect of the anaesthetic is for the treatment of internal and external haemor-
temporary, but allows time for the anti-inflammatory rhoids, pruritus ani, anal fissures, proctitis and anal
action of the corticosteroid to take effect. eczema.
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1–15. tion of rectal hydrocortisone acetate foam

The treatment of haemorrhoids: a Japanese perspective

Y. MATSUDA
Colo-Proctological Institute, Matsuda Hospital, Nishi-ku, Hamamatsu, Shizuoka, Japan

Correspondence to:
Dr Y. Matsuda, Colo-Proctological Institute, Matsuda Hospital, 753 Irino-cho, Nishi-ku, Hamamatsu, Shizuoka, Japan.
E-mail: cra@matsuda-hp.or.jp
According to Thomson, the tissue of the membrane

SUMMARY
mucosa and submucosa of the right anterior, right
Recently, there has been a significant change from the posterior and left anterior anal canal plays a crucial
‘vascular theory’, in which it is believed that the com- role in anal closure. This ‘cushion’ consists of venous
ponent and clinical condition of haemorrhoids concerns plexuses and arterial vessels with numerous arteriove-
the varicosity of the venous plexus, to the sliding anal nous connections, embedded in a stroma and tacked
lining theory involving the supportive tissue of the onto muscular fibres.
recto-anal area. Wang et al.3 found significant pathological changes
According to Thomson’s cushion theory, it is said in the anal cushions of patients with haemorrhoids,
that ‘haemorrhoids are an age-related physiological including structural impairment, retrograde changes in
effect on the tissue. Haemorrhoids are caused by the the cavernous vessels, hypertrophy, distortion, rupture
Treitz muscle being stretched and ruptured by long and tortility of the Trietz’s muscle and the fibroelastic
years of straining and the slippage of cushion tissues’. tissues and injury to the mucous membranes. Haas
Treatment methods for haemorrhoids went through et al.4 suggest that these changes are caused by
some changes linked to this concept. Other than the increasing age.
standard operative method of ligation and excision
(LE), in the West, Longo’s stapled anopexy (PPH, pro-
Classification of haemorrhoids
cedure for prolapse and haemorrhoids) in which the
haemorrhoids are lifted upwards with a suturing Symptoms of haemorrhoids include bleeding, prolapse,
instrument is used, whereas in the East, aluminium the feeling of incomplete bowel evacuation and pain.
potassium sulphate and tannic acid (ALTA)-based Goligher5 classifies haemorrhoids according to the
haemorrhoid sclerotherapy developed by Dr Shi along degree of severity:
with ALTA treatments developed in Japan, have made (i) First-degree haemorrhoids – the anal cushions
an appearance and are becoming standardized. look normal (i.e. not prolapsed) but bleed.
The main issue is the application method, with the (ii) Second-degree haemorrhoids – bleed and pro-
LE technique combined with the application of stapled lapse, but reduce spontaneously after defecation.
anopexy and excision of skin tags as well as the com- (iii) Third-degree haemorrhoids – bleed and prolapse
bined application of ALTA treatment and LE being and do not reduce spontaneously.
important themes in Japan. (iv) Fourth-degree haemorrhoids – permanently pro-
lapsed at the anal verge.
The mild forms (first-degree and second-degree) can
INTRODUCTION
be dealt with conservatively, while third- and fourth-
Tradition held that haemorrhoids arose from varicose degree haemorrhoids require surgery.
veins in the venous plexus. This theory was challenged
by Hancock,1 who stated that over-activity of the
TREATMENT OF HAEMORRHOIDS
internal anal sphincter might be important in the
pathogenesis of symptomatic haemorrhoids, and
Conservative therapy
Thomson,2 who claimed that haemorrhoids are pro-
lapsed (and ⁄ or bleeding) specialized ‘cushions’ of sub- Treatment for haemorrhoids varies widely and is
mucosal tissue lining the anal canal. aimed initially at relieving symptoms. Lifestyle

changes, such as exercise (including walking) and

increased fibre in the diet, help reduce constipation
and straining by producing stools that are softer and Superior
easier to pass. Drug intervention, primarily through rectal artery
1
means of suppositories and ointments, is also com- Muscular layer
monly used for the treatment of haemorrhoids. Drugs of mucosa
for external use (including steroids that have potent 3
2
anti-inflammatory effects) are also administered, if
necessary, prior to haemorrhoid surgery. In Japan,
ointments and suppositories containing diflucortolone 4
valerate and lidocaine (Neriproct)6 have been approved Dentate line
and are widely used. These drugs not only signifi-

cantly reduce pre- and post-operative oedema and
pain but also have a haemostatic effect on haemor-
rhoidal bleeding.6
Ligation surgery
The current global standard for the surgical treatment of
haemorrhoids is ligation excision (LE). This method, Figure 1. Aluminium potassium sulphate and tannic acid
which is based on that of Milligan et al.,7 was first solution slowly injected into four sections of the haemor-
reported in 1955. With recent technological advances, rhoid. (1) Internal haemorrhoid submucosal layer
(superior rectal artery pulsating section) 3 mL. (2) Medial
day surgery for such complete- and semi-closure meth-
haemorrhoid submucosal layer 3–4 mL. (3) Medial
ods has become commonplace. The procedure is not haemorrhoid lamina propria mucous 1–2 mL. (4)
without complications, however; for example, not all Anal haemorrhoid submucosal layer 3–4 mL.
patients undergoing such procedures will recover and
return to work quicker than after an open procedure. In
Stapled anopexy
some patients, even in cases where the wounds heal
quickly, there is a high level of post-operative haemor- This is also known as PPH (procedure for prolapse and
rhaging for up to 2 weeks after the operation. An alter- haemorrhoids) or stapled haemorrhoidectomy. In this
native form of closed LE surgery, proposed by Ferguson procedure, the prolapsed tissue is pulled into a device
and Heaton8 in 1959, is now the universal method of that allows excess tissue to be removed, while any
treatment, particularly in the US. remaining haemorrhoidal tissue is stapled.9 In the
Understanding the crucial role played by the anal West, the procedure is performed under a general
cushions in anal closure2, 4 has resulted in changes anaesthetic. As with ligation surgery, improvements in
to the surgical LE methods. In these procedures, anaesthesia mean that the incidence of post-operative
haemorrhoidal tissue is exposed and removed surgi- anastomotic haemorrhage has decreased considerably,
cally; any remaining supporting tissue – including allowing the possibility of day surgery.
connective tissue and muscle fibres – is either Although stapled anopexy is considered a pain-free
sutured or sealed. procedure, there are some common concerns – such as
treatment of post- and pre-operative perianal skin tags
and the prevention of persistent anorectal pain that
DEVELOPMENTS IN THE TREATMENT OF
sometimes occurs following the operation and which
HAEMORRHOIDS
can affect patients’ quality of life.
Two new techniques have recently emerged for the
treatment of haemorrhoids – stapled anopexy and alu-
ALTA therapy
minium potassium sulphate and tannic acid (ALTA)
therapy. Both methods have produced major changes Aluminium potassium sulphate and tannic acid ther-
to established treatments. apy was developed in China, where it is known as

Xiao Zhen Ling (XZL). The therapy uses a fast-acting, of ALTA therapy for internal haemorrhoids and made
water-soluble sclerosing agent, consisting mainly of this treatment subject to health insurance in 2005. In
ALTA. The ALTA solution is slowly injected into four the intervening 4½ years, the treatment has gradually
sections of the haemorrhoid (Figure 1), using a pur- become widely used, and now over 100 000 patients
pose-built, trumpet-type anal speculum, under either a have been treated this way.10 ALTA, alone or in com-
local or lumbar spinal anaesthetic. It interrupts the bination with LE, currently accounts for 20–30% of all
blood flow to the haemorrhoid and causes it to con- haemorrhoidal surgery in Japan, and this proportion is
tract rapidly so that any bleeding ceases. Maximum increasing. Some clinical practices even provide day
effect is seen 1 month after injection.10 Continuous surgery.10
sterile inflammation and the fibrosis of haemorrhoid In Japan, ALTA therapy cannot be utilized without
tissue means the muscle and submucousal layers practical and theoretical training; surgeons should be
adhere and become fixed, thus preventing prolapse. specially trained, mentored and monitored in their use
The main post-operative adverse events include a high of the therapy.
temperature (of around 38–39 C) on days 4 or 11 (5% Aluminium potassium sulphate and tannic acid ther-
of cases), a minor rectal ulcer (<1%), and rectal stric- apy is also used in South Korea and China and it is
ture (0.7%). In 3–5% of cases, relapse occurs within hoped that this procedure will be used worldwide in
4 years. It is thought that this procedure does not the future.
cause post-operative pain or prolapse, allowing the
patient to return to work the following day. It is, how-
CONCLUSIONS
ever, crucial to adhere strictly to the procedure and to
be cautious when administering the injections (Y. Mat- Stapled anopexy is the standard treatment for internal
suda personal data). haemorrhoids in Europe, but that does not mean that
LE is no longer necessary. Like ALTA treatment in
Japan, neither is applicable where both external haem-
THE JAPANESE PERSPECTIVE
orrhoids and skin tags are present. Therefore, the com-
Stapled anopexy and LE are used routinely to treat bined application of stapled anopexy and excision of
haemorrhoids in the West, although the actual choice skin tags, ALTA treatment and LE or the combined
of treatment differs according to country and region. application of ALTA treatment and excision of skin
In Europe, stapled anopexy is generally preferred. In tags is likely to become the standard operative method
Japan, patients are offered a choice of three treatment for haemorrhoid cases with external haemorrhoids and
approaches: LE, stapled anopexy and ALTA therapy. skin tags in the future.
The Japanese Health Ministry approved the application
REFERENCES 5 Goligher JC. Surgery of the Anus, Rectum 9 Longo A. Treatment of hemorrhoids dis-
and Colon, 5th edn. London: Bailliere Tin- ease by reduction of mucosa and hemor-
1 Hancock BD. Internal sphincter and the dall & Cassell, 1984. rhoidal prolapse with a circular suturing
nature of hemorrhoids. Gut 1977; 18: 6 Iwadare J. Clinical evaluation of Neriproct device: a new procedure. 6th World Con-
651–5. ointment and suppository on hemor- gress of Endoscopic Surgery, Rome, 3–6
2 Thomson WHF. The nature of hemorrhoids. J New Remedies Clinics 1994; 43: June, 1998: 777–84.
rhoids. Br J Surg 1975; 62: 542–52. 2396–407. 10 Takano T. Sclerosing therapy of internal
3 Wang ZJ, Tang XY, Wang D, et al. The 7 Milligan ETC, Morgan CN, Jones LE, et al. hemorrhoids with a novel sclerosing
pathological characters and its clinical sig- Surgical anatomy of the anal canal and agent. Comparison with ligation and exci-
nificance of internal hemorrhoids. Zhong- operative treatment of hemorrhoids. Lan- sion. Int J Colorectal Dis 2006; 21:
hua Wai Ke Za Zhi 2006; 44: 177–80. cet 1937; 2: 1119–24. 44–51.
4 Haas TA, Fox TA Jr, Haas GP. The patho- 8 Ferguson JA, Heaton JR. Closed hemor-
genesis of hemorrhoids. Dis Colon Rectum rhoidectomy. Dis Colon Rectum 1959; 2:
1984; 27: 442–50. 176–9.

Case Study 1: debilitating external haemorrhoidal thrombosis

L. ABRAMOWITZ
Medical and Surgical Anorectal Disease Unit, AP-HP Bichat University Hospital, Paris, France
Correspondence to:
Dr L. Abramowitz, Medical and Surgical Anorectal Disease Unit, AP-HP Bichat University Hospital, 46, rue Henri Huchard, 75877 Paris,
Cedex 18, France.
E-mail: laurent.abramowitz@bch.aphp.fr
INTRODUCTION PROCTOLOGICAL INVESTIGATIONS

All humans have internal and external haemorrhoids Inspection of the anal verge revealed a circular, highly
yet only some develop haemorrhoidal disease. Both oedematous anal swelling (Figure 1). It was not poss-
internal and external haemorrhoids may thrombose, ible to perform anorectal palpation and anoscopy.
but this is much more common with external haemor- External haemorrhoidal thrombosis was diagnosed.
rhoids than with internal haemorrhoids. ‘Haemorrhoidal The severe oedema was a contraindication to any
crisis’ is an intensely painful, very severe episode of attempt at excision or incision; hence, the only option
(mostly) external thrombosis or internal haemorrhoidal was drug therapy.
bleeding of varying frequency and is classified as a
therapeutic emergency. Its prevalence among the gen-
eral population is not known, although anal pain
(which, in addition to haemorrhoidal thrombosis, may
be caused by anal fissure or abscess) is known to be the
most common (48%) proctological complaint seen by
GPs.1 As the pain associated with thrombosis is usually
caused by the presence of oedema, precluding local
treatment, drug therapy is the treatment of choice in
practice.
PATIENT HISTORY
A male patient presented to the proctology clinic
with symptoms that had commenced 2 days previ-
ously with gradual swelling of several anal ‘lumps’.
These had appeared after an episode of diarrhoea
with six to eight bowel movements per day. On the
first day, the patient had consulted his pharmacist
and received a ‘neutral’ topical ointment (containing
no lidocaine or corticosteroid) and loperamide for his
diarrhoea. On the following day, he consulted an
emergency general practitioner who prescribed a topi-
cal circulatory preparation and paracetamol. On pre-
sentation in our office, the patient was experiencing
constant anal pain (rated 9 ⁄ 10) that made sitting
down impossible; he was classified as a therapeutic
Figure 1. Oedematous and intensely painful external
emergency. haemorrhoidal thromboses.

style and a diet rich in starchy foods and low in fibre,

TREATMENT AND OUTCOMES
combined with diosmectite.
A topical agent containing a potent corticosteroid (flu- This combination of local and systemic management
ocortolone hexanoate ⁄ fluocortolone pivalate) and an was, as usual, very effective against the pain,2 which
anaesthetic [cinchocaine hydrochloride; Ultraproct (In- significantly decreased (visual analogue score 1–2 ⁄ 10)
tendis, Berlin, Germany)] were prescribed. The patient over a 24-h period as the external haemorrhoids ceased
applied the ointment onto a suppository prior to to be pressurized once the oedema had disappeared.
inserting in the anus morning and evening for 8 days.
Extra ointment was then applied to the external
DISCUSSION
thromboses to reduce inflammation and local oedema
and hence relieve pain and facilitate insertion of the Haemorrhoidal thrombosis is usually a consequence of
suppository in the first days. A nonsteroidal anti- straining associated with dyschezia, but may also
inflammatory drug and a step 2 analgesic were also result from repeated defecation, irritating the anus, in
prescribed. The loperamide was discontinued, as it was the context of diarrhoea.3 In cases like this, it is there-
causing alternating bouts of constipation and diar- fore a priority to stop the diarrhoea (whether it be
rhoea that were equally detrimental to his anal lesions. acute or chronic) and to establish regular bowel move-
The patient was recommended to stop straining to ments.
pass bowel motions and to adhere to a healthy life-
REFERENCES 2 Madoff RD, Fleshman JW. Clinical Practice 3 Johanson JF. Association of hemorrhoidal
Committee, American Gastroenterological disease with diarrheal disorders: potential
1 Pigot F, Siproudhis L, Bigard MA, Staumont Association technical review on the diag- pathogenic relationship? Dis Colon Rectum
G. Ano-rectal complaints in general practi- nosis and treatment of hemorrhoids. Gas- 1997; 40: 215–9.
tioner visits: consumer point of view. Gas- troenterology 2004; 126: 1463–73.
troenterol Clin Biol 2006; 30: 1371–4.
Case Study 2: external haemorrhoidal thrombosis in pregnancy

L. ABRAMOWITZ
Correspondence to:
Dr L. Abramowitz, Medical and Surgical Anorectal Disease Unit, AP-HP Bichat University Hospital, 46, rue Henri Huchard, 75877 Paris, Cedex
18, France.
external haemorrhoidal thromboses are painful, few in

INTRODUCTION
number and non-oedematous.1 This scenario is rela-
Little is known about the prevalence of haemorrhoidal tively rare during pregnancy and patients will there-
thrombosis in the general population,1 but it would fore usually be given drug therapy, which includes an
appear to be particularly common in pregnant women. agent to regulate transit1 (in 23% of cases) an osmotic,
Dyschezia is the only factor to have been scientifically lubricant or bulk-forming laxative that is not absorbed
proven to put pregnant women at risk for haemor- and therefore poses no risk to the constipated parturi-
rhoidal thrombosis.2 ent.2 Non-steroidal anti-inflammatory drugs are con-
Treatment for these patients needs to be chosen traindicated in women in the third trimester of
carefully to avoid risks associated with pregnancy. pregnancy.3 In cases of highly oedematous thrombosis
Incision or excision can be performed only where the during pregnancy, it is possible to prescribe a systemic

Figure 2. Postoperative appearance immediately after

haemorrhoidectomy.
increased over a 2-day period. She was in the seventh

month of her first pregnancy, which was progressing
well. Patient history revealed the existence of long-
standing dyschezia that had deteriorated over the past
Figure 1. Circular external haemorrhoidal thrombosis in few months, although she still had a bowel movement
a pregnant woman. every 1–2 days. There was no rectal bleeding.
corticosteroid at the moderate dose of 40 mg for 3–

PROCTOLOGICAL INVESTIGATIONS
5 days. Topical circulatory preparations can be pre-
scribed at any point during pregnancy, although their Examination of the anal verge showed the presence of
efficacy against pain is sometimes disputed.4 several oedematous swellings that were extremely
Even though there are no studies confirming the effi- painful to palpation (Figure 1). Digital anorectal
cacy of local topical agents in haemorrhoidal throm- examination and anoscopy, even on a paediatric scale,
bosis, they are widely prescribed.1 As their action is were impossible because of the pain.
exclusively local, they can be prescribed without risk External haemorrhoidal thrombosis was diagnosed.
at any stage of pregnancy and it is logical to favour Treatment by excision or incision was impossible
those containing high-dose corticosteroids. Lastly, the because of oedema and the circular multiple throm-
management of such women presenting with pain boses.
should also include mainly paracetamol-based anal-
gesics, which are risk-free at the usual dosage.
TREATMENT AND OUTCOME
In practice, topical corticosteroids, step 1 analgesics
and establishment of regular transit are often suffi- The patient was treated with a gentle osmotic laxative
cient for the management of patients with haemor- and paracetamol at the usual doses, and a topical
rhoidal thrombosis. Haemorrhoidectomy is only agent containing fluocortolone pivalate, fluocortolone
considered if there is no marked improvement in the caproate and cincochaine hydrochloride (Ultraproct;
pain within a few days or if the pain actually worsens. Intendis, Berlin, Germany) was applied morning and
evening for about 10 days. The patient was advised to
avoid any straining associated with dyschezia to
PATIENT HISTORY
reduce the risk of recurrence. Advice on lifestyle and
A 29-year-old woman presented with constant anal diet were therefore given to the patient with a
pain that was worse in the sitting position. The pain, prescription for an osmotic laxative to be taken
in association with several anal swellings gradually prophylactically in the event of constipation.

At a follow-up visit 8 months after delivery, the important time in their lives, especially as medical
patient reported that pain caused by the haemorrhoidal treatment is very effective in a vast majority of cases.
thrombosis disappeared after 1–2 days of treatment Such treatment combines administration of cortico-
and there was no further anal discomfort. A rectal steroid-based topical agents, a regulator of bowel
examination at that time was completely normal with transit and paracetamol.
no secondary skin tags. If there had been no response to the combination of
local topical agent, laxative and paracetamol after
2 days, a short course of an oral corticosteroid (e.g.
DISCUSSION
40 mg orally in the morning for 4–5 days) would be
Haemorrhoidal thrombosis in pregnancy is common prescribed. Haemorrhoidectomy (Figure 2) is performed
(8%)2 and an oedematous presentation contraindicates only in exceptional cases.
local procedures. The only way of preventing such This group of patients are at no greater risk of
thromboses is by avoiding straining associated with recurrence of thrombosis after the pregnancy than the
dyschezia. population in general, and, because most are young
It is the physician’s role to question and examine patients whose cutaneous tissue is rich in elastic fibres,
patients who might not always have the courage to the risk of secondary skin tags, which can remain once
report an ‘unfortunately situated’ lesion that may have the thromboses has been reabsorbed, is much reduced.
a major impact on quality of life at a particularly
REFERENCES 2 Abramowitz L, Sobhani I, Benifla JL, et al. 4 Alonso-Coello P, Zhou Q, Martinez-Zapata

Anal fissure and thrombosed external hem- MJ, et al. Meta-analysis of flavonoids for
1 Abramowitz L, Godeberge P, Soudan D, orrhoids before and after delivery. Dis the treatment of haemorrhoids. Br J Surg
et al. Société Nationale Française de Colo- Colon Rectum 2002; 45: 650–5. 2006; 93: 909–20.
Proctologie. French recommendations for 3 Risser A, Donovan D, Heintzman J, et al.
treatment of hemorrhoidal disease. Gastro- NSAID prescribing precautions. Am Fam
enterol Clin Biol 2001; 25: 674–702. Physician 2009; 80: 1371–8.
Case Study 3: intensely painful external and internal haemorrhoidal

thrombosis
L. ABRAMOWITZ
Correspondence to:
Dr L. Abramowitz, Medical and Surgical Anorectal Disease Unit, AP-HP Bichat University Hospital, 46 rue Henri Huchard, 75877 Paris,
Cedex 18, France.
Key words: haemorrhoids, haemorrhoidal thrombosis, pain, dyschezia, proctological, cincochaine hydrochloride, Ultraproct
because of the presence of oedema under tension, may

INTRODUCTION
be particularly intense, necessitating emergency treat-
Haemorrhoidal thrombosis is common in certain sub- ment. Timely and appropriate treatment is usually very
populations, for example, Abramowitz et al. report effective.
prevalence rates of 20% in the postpartum period1 and In the more usual case of a solitary external haem-
3% in patients with HIV infection.2 Such thromboses orrhoidal thrombosis that is not oedematous and pain-
seem to involve predominantly external, but also ful, it is possible to perform an incision or excision
(more rarely) internal haemorrhoids. The pain associ- procedure to remove the clot.2 Local procedures
ated with one or more haemorrhoidal thromboses, are strictly contraindicated for internal or multiple

thromboses, however, because of the risk of anal fis-

sure and of not being able to remove all the clots
respectively. In these cases, patients should receive
drug therapy, which should consist of laxatives for
constipation or treatment for diarrhoea with optional
topical agents containing corticosteroids to reduce
pain caused by inflammation (although the latter has
not been formally demonstrated in studies).3–5 If the
pain is severe, topical anti-inflammatories can be aug-
mented with oral anti-inflammatory drugs, although,
again, this has not been demonstrated in studies.3
PATIENT HISTORY
A 33-year-old man presented as an emergency with very
intense anal pain rated as 9 ⁄ 10 on a visual analogue Figure 1. Intensely painful external (black arrow) and
internal (white arrow) haemorrhoidal thrombosis. The
scale (VAS). The pain that had commenced suddenly the circular oedema (black arrow) is a manifestation of the
previous evening was constant and prevented the patient external haemorrhoidal congestion that is readily identifi-
from sitting down. The patient had experienced episodes able, whereas the thrombosed prolapsing internal haemor-
of dyschezia and spent long periods sitting on the toilet. rhoid (white arrow) is located above the dentate line
The patient described a circular anal swelling that was (white dotted line).
too painful to touch; attempts to reintroduce the swell-
ing into the anus had proved unsuccessful.
PROTOLOGICAL INVESTIGATIONS
Inspection of the anal verge confirmed a diagnosis of
external and internal haemorrhoidal thrombosis as
suggested by the constant anal pain (Figure 1). As the
patient had not experienced any recent and unusual
changes in bowel transit or other concomitant clinical
signs, a full rectal examination to eliminate any
underlying anorectal lesion (e.g. anal fissure) was
postponed until a later stage.

An osmotic laxative was prescribed, together with an
ointment containing cinchocaine hydrochloride, fluo-
cortolone hexanoate and fluocortolone pivalate (Ultra-
proct; Intendis, Berlin, Germany) for application to the
anal swellings. Subsequently, once the patient was
able to insert them (1–3 days), suppositories based on
the same composition were prescribed for several
weeks. In view of the severity of the oedema and the Figure 2. Complete healing 8 weeks after an extensive
pain, a non-steroidal anti-inflammatory drug was also episode of haemorrhoidal thrombosis.
prescribed for 1 week, with the option of adding a step
2 analgesic should the pain persist. The patient was The patient reported that 24 h after commencing
also given an emergency telephone number in case his treatment, the severity of the pain had decreased to
condition deteriorated (risk of necrosis). 2 ⁄ 10 on the VAS. Two months after this episode, a

physical examination showed no underlying lesions majority of cases, the type of drug therapy described
(Figure 2). Subsequent management consisted of here is very effective. Patients treated in this way
advice on healthy living and diet so as to avoid fur- should be warned that they might be left with skin
ther dyschezia-related straining. The patient was also tags, but that these pose no risk of recurrence or of a
prescribed a gentle laxative to be used in the event of poor outcome. In younger patients, where the cutane-
further episodes of constipation (e.g. when travelling). ous tissue is still very elastic, there is no secondary
skin tag formation even after an episode of severe
inflammation such as that described here. In very rare
DISCUSSION
cases where drug therapy is unsuccessful, haemorrhoid-
Dyschezia is the main cause of haemorrhoidal throm- ectomy is indicated.
bosis of external and internal haemorrhoids. In a vast
patients during HAART era. Dis Colon 4 Madoff RD, Fleshman JW; Clinical Practice
REFERENCES Rectum 2009; 52(6): 1130–6. Committee American Gastroenterological
3 Abramowitz L, Godeberge P, Soudan D, Association technical review on the
1 Abramowitz L, Sobhani I, Benifla JL, et al.
et al. Société Nationale Française de diagnosis and treatment of hemorrhoids.
Anal fissure and thrombosed external hem-
Colo-Proctologie. French recommenda- Gastroenterology 2004; 126: 1463–73.
orrhoids before and after delivery. Dis
tions for treatment of hemorrhoidal dis- 5 Alonso-Coello P, Zhou Q, Martinez-Zapata
Colon Rectum 2002; 45: 262.
ease. Gastroenterol Clin Biol 2001; 25: MJ, et al. Meta-analysis of flavonoids for
2 Abramowitz L, Benabderrahmane D, Baron
674–702. the treatment of haemorrhoids. Br J Surg
G, et al. Systematic evaluation and descrip-
2006; 93: 909–20.
tion of anal pathologies in HIV-infected
Case Study 4: pruritus ani and haemorrhoids-meddle at your peril …

J.-M. DIDELOT
Service d’Hepato-Gastroenterologie, Centre Hospitalo-Universitaire Saint Eloi, Montpellier, France

Correspondence to:
Dr J.-M. Didelot, Centre Hospitalo-Universitaire Saint Eloi, 80, avenue Augustin Fliche, 34295 Montpellier, Cedex 5, France.
E-mail: dr-jm.didelot@orange.fr
nal haemorrhoids (thrombosis) or with internal

INTRODUCTION
haemorrhoids (straightforward haemorrhoidal conges-
Pruritus ani is a common symptom characterised by tion, internal haemorrhoidal thrombosis, oozing asso-
an unpleasant cutaneous sensation that prompts ciated with an internal haemorrhoid). Pruritus ani is
scratching of the anal canal or the skin of the anal associated with anorectal disease in 75% of cases;
verge. Pruritus ani is thought to affect up to 5% of the haemorrhoids are the cause of pruritus ani in 20% of
population.1, 2 Amongst anorectal symptoms, pruritus cases.6 It has been proven that haemorrhoids are
ani accounts for 24% of GP visits3 and 18% of anorec- a risk factor, increasing the risk of occurrence of
tal consultations with a gastroenterologist.4 More than pruritus ani 5.5-fold.7
half of patients have often had pruritus ani for over a We report here the case of a patient treated for
year before presenting for treatment.5 pruritus ani with an ointment based on a combination
The cause of pruritus ani may be dermatological, of a steroid (fluocortolone hexanoate 0.95 mg plus
proctological or even psychological. The main causes fluocortolone pivolate 0.92 mg) and a local anaesthetic
are listed in Table 1. Pruritus ani secondary to haem- (cinchocaine hydrochloride 5 mg) (Ultraproct; Intendis,
orrhoidal disease may be associated either with exter- Berlin, Germany).

PATIENT HISTORY
A 30-year-old man presented with a 3-year history
of pruritus ani for which he had been treated for
1 year. He experiences anal discharge daily and his
stools are usually soft. He has no notable medical or
surgical history and has already received numerous
treatments of varying efficacy (e.g. anti-herpetic
treatment, topical nonsteroidal anti-haemorrhoidal
agents, anthelmintics). Stool tests were all negative.
Inspection of the anal verge showed erosive inflam-
mation of the anus with pruriginous lesions, pre-
dominantly at the anterior end of the anus. Areas of Figure 2. Lichenified and eczematous inflammation of
lichenification were also visible (Figures 1 and 2). the anus.
Anorectal digital palpation established that resting
tone and voluntary contraction were normal. There
was no abdominoperineal asynchronism. No suspi-
cious masses were visible. Anoscopy, however, Table 1. Main causes of pruritus ani
showed the presence of a grade 1 internal hae-
Dermatological causes: atopic dermatitis, contact eczema,
morrhoid, together with anterior rectal mucosal psoriasis, lichen sclerosus, Paget’s disease, Bowen’s disease,
prolapse. anal squamous cell carcinoma
Infectious causes: bacteria (Staphylococcus aureus,
TREATMENT AND OUTCOME Streptococcus A or B, Corynebacterium minutissimum),
fungi (Candida, dermatophytes), parasites (oxyuriasis,
Topical treatment was prescribed, combining use of an scabies), viruses (herpes, papillomavirus)
antipruriginous liquid soap (Hydralin apaisa; Bayer, Proctological causes: haemorrhoids, anal fissure, anal
Berlin, Germany) and application of ointment contain- fistulae
ing fluocortolone and cinchocaine to the inside and
Local irritation as a result of maceration or anal oozing
Drug aetiologies: colchicine, quinidine
Systemic causes: diabetes, lymphomas, cholestasis, renal
failure
Psychogenic pruritus
outside of the anal canal every night for 7 days, then

every other night for a further 7 days.
The patient was re-examined two weeks after start-
ing the treatment, allowing us to note the healing of
the peri-anal skin and the resolution of the pruritus.
Maintenance treatment consisting of daily application
of Eryplast (Boots, Germany) ointment was then
recommended to protect the peri-anal skin from the
discharge associated with the internal haemorrhoid
and mucosal prolapse. Rubber-band ligation could
Figure 1. Erosive inflammation of the anus with
also be used to reduce prolapse should the pruritus
lichenification.
recur.

ations, occasionally lichenification in the form of whit-

DISCUSSION
ish thickening of the skin of the anal verge), a visible
Pruritus ani is a common complaint. Appropriate cause or a normal anal verge. A psychological cause is
management, following a careful physical examination, then often put forward, even though studies have
may often provide relief and mean that it is possible to shown no significant difference in personality profile
prevent the frantic scratching by some patients that between patients with pruritus ani said to be of ‘psycho-
then aggravates the infernal pruritic process.8 genic’ origin and control subjects.10
A careful physical examination involves inspection Topical treatment with corticosteroids is generally
of the anal verge and all the surrounding skin, anorectal effective in the treatment of pruritus ani,11 including
digital palpation and anoscopy. Physical examination is the treatment of pruritus associated with haemorrhoidal
usually sufficient, but additional investigations (scotch disease, as in this case. However, these treatments
tape test, swabs for bacteriological, mycological and should only be administered for short periods and
virological studies, viral serologies and biopsies) may generally at tapering doses so as to prevent local side
sometimes also be necessary.9 The examination may effects (steroid-induced skin fragility).
show; merely the complications of the pruritus (excori-
REFERENCES 4 Siproudhis L, Favreau C, Éléouert M. Le 8 Kumar M. Don’t forget your toothbrush!

prurit anal est il un témoin de troubles de Br Dent J 2001; 191: 27–8.
1 Mazier WP. Hemorrhoids fissures end la continence et de l’évacuation? Journées 9 Petit P. Le prurit anal. Traité des maladies
pruritus ani. Surg Clin North Am 1994; Francophones de Pathologie Digestive, de l’anus et du rectum. Siproudhis L,
74: 1277–92. SNFGE 2007. Panis Y, Bigard M-A. Paris: Elsevier-
2 Lysy J, Sistiery-Ittah M, Israelit Y, et al. 5 Kränke B, Trummer M, Brabek E, et al. Masson, 2006.
Topical capsaicin – a novel and effective Etiologic and causative factors in perianal 10 Laurent A, Boucharlat J, Bosson JL, et al.
treatment for idiopathic intractable dermatitis: results of a prospective study Psychological assessment of patients with
pruritus ani: a randomised, placebo con- in 126 patients. Wien Klin Wochenschr idiopathic pruritus ani. Psychother
trolled, crossover study. Gut 2003; 52: 2006; 118: 90–4. Psychosom 1997; 66: 163–6.
1233–5. 6 Daniel GL, Longo WE, Vernava AM III. 11 Al Ghnaniem R, Short K, Pullen A, et al.
3 Pigot F, Siproudhis L, Bigard MA, et al. Pruritus ani. Causes and concerns. Dis 1% hydrocortisone ointment is an effec-
Ano-rectal complaints in general practi- Colon Rectum 1994; 37: 670–4. tive treatment of pruritus ani: a pilot
tioner visits: a consumer point of view. 7 Delco F, Sonnenberg A. Associations randomized controlled crossover trial. Int
Gastroenterol Clin Biol 2006; 30: 1371–4. between hemorroids and other diagnoses. J Colorectal Dis 2007; 22: 1463–7.
Dis Colon Rectum 1998; 41: 1534–41.
Case Study 5: perianal eczema with ulceration healed after 2 weeks

of topical treatment
A. ROTHHAAR
Berlin, Germany
Correspondence to:
Dr A. Rothhaar, Bülowstr. 23, 10783, Berlin, Germany.
E-mail: info@rothhaar.com
possibly with weeping wounds and ulcerations.

INTRODUCTION
Bacteria and fungi may subsequently aggravate the
Perianal eczema is an inflammatory skin condition in clinical condition. Common causes of perianal eczema
the anal region in which the skin appears reddened, are poor anal hygiene, haemorrhoids, anal fissure,

sphincter muscle weakness and skin tags. Typical

symptoms are itching, burning, weeping, soiling and
traces of blood on toilet paper and underwear.
PATIENT HISTORY
A 39-year-old male patient, known to the practice,
presented repeatedly with itching and burning at the
anus. The patient was known to have psoriasis at
the elbows and knees, which had been treated to date
with corticosteroid-containing topical agents. Topical
antifungals were used to treat recurrent perianal
eczema. Grade 2 haemorrhoids were additionally trea-
ted with sclerotherapy with 2-dodecoxyethanol (Thesit;
Gepepharm, Munich, Germany), previously and at this
visit.
The patient was examined in the supine position on a
proctological examination chair. The investigations
performed were a visual and a digital rectal examina-
tion and proctoscopy. The examination revealed
perianal eczema (Figure 1), several ulcerations and
grade 2 haemorrhoids (Figure 2).
Figure 2. Grade 2 haemorrhoids.
The perianal eczema was treated with cream contain-
ing fluocortolone pivalate and lidocaine hydrochloride
(Doloproct; Intendis, Berlin, Germany), which was
applied twice daily, externally and internally. The
haemorrhoids were treated with sclerotherapy using
0.9 mL Thesit. At a follow-up appointment 2 weeks
Figure 3. Two weeks after treatment.
later, the patient reported that he now had no symp-

toms. On examination, eczema and ulcers were no
longer detectable (Figure 3). The patient was advised
to continue the treatment with (Doloproct; Intendis,
Berlin, Germany) cream for a further week to prevent
Figure 1. Perianal eczema.
rebound.

The itching and the burning will improve immediately

DISCUSSION
because of the lidocaine and the inflammatory compo-
The patient’s response was excellent and the symptoms nent will be introduced in a sustainable development.
have not re-appeared up to this point. This treatment Under this condition, combined with carefully
is advantageous because of the double effect. performed anal hygiene, no setback will be expected.
Case Study 6: topical treatment of anal fissure

A. ROTHHAAR
Berlin, Germany
Correspondence to:
Dr A. Rothhaar, Bülowstr. 23, 10783 Berlin, Germany.
E-mail: info@rothhaar.com
INTRODUCTION PROCTOLOGICAL INVESTIGATIONS

An anal fissure is an elongated, poorly healing tear in The patient was examined in the supine position on a
the anal canal, usually situated near the coccyx. There proctological examination chair. The investigations
may additionally be a painful nodule at the external performed were a visual examination, a digital rectal
margin of the fissure. The severity of the fissure examination and proctoscopy. The examination
depends on whether it occurs in conjunction with indicated that the patient had anal fissures in the
hypertrophy of the anal papilla and the outpost fold. 7 o’clock position (Figure 1) and grade 1—2 haemor-
Common causes of the occurrence of anal fissures may rhoids (Figure 2). The examination also confirmed the
be hard stools or enlarged haemorrhoids. Other causes presence of genital warts (Figure 3).
include irregularity of diet, consumption of spicy and
pungent food, faulty bowel habits, and lack of local
hygiene. In females, the ailment is usually triggered
during pregnancy and following childbirth. Typical
symptoms are severe pain during and after defecation,
bleeding, cramp-like narrowing of the anus and, in
consequence, pencil-thin stools.
Nonsurgical treatment is recommended as first-line
treatment for acute and chronic anal fissures. These
include warm sitz baths, topical anaesthetics, high-
fibre diet and stool softeners. For chronic anal fissures,
conservative treatments with nitroglycerine, botulin
toxin and oral nifedipine are effective methods that
may reduce the need for surgery.1
PATIENT HISTORY
A 30-year-old male patient with concurrent perianal
and intra-anal genital warts presented with anal pain.
The genital warts had been treated with cryotherapy
for the first time by the patient’s family doctor pre-
viously (1-week earlier). The patient was found to be
infected with HIV, but was not receiving antiretroviral
Figure 1. Anal fissures in the 7 o’clock position.
therapy at that time.


The fissure was treated with cream containing
1 mg fluocortolone pivalate and 20 mg lidocaine
hydrochloride (Doloproct; Intendis, Berlin, Germany)
applied twice daily, externally and internally. No
Figure 2. Grade 1—2 haemorrhoids.
additional therapy was prescribed.
The patient presented for a follow-up examination
2 weeks later. On this occasion, he reported a marked
reduction in the pain. On examination, while the fissure
was still present, it was reduced in size (Figure 4). The
patient was advised to continue treatment with Dolo-
proct cream and to present again in 8 days’ time. At fol-
low-up, the patient status was further improved.
DISCUSSION
The treatment was very effective in this case. Use of
the cream was to control itching and burning which is
also often caused by condylomas (genital warts). As
the patient contracts his sphincter muscle, higher rest-
ing pressure causes damage to the sensitive internal
skin and, as a consequence, a fissure starts to develop.
Figure 3. Presence of genital warts.
HAART is not compromised by the treatment.
REFERENCE
1 Gupta P. Treatment of fissure in ano-revis-
ited. Afr Health Sci 2004; 4: 58–62.

Case Study 7: clinical treatment of haemorrhoidal disease and acute

anal fissure
C. SOBRADO
Rua Itapeva, Bairro: Bela Vista (Centro), São Paulo – SP, Brazil
Correspondence to:
Dr C. Sobrado, Rua Itapeva, 500 Conjunto 7B – 7º andar, Bairro: Bela Vista (Centro), 01332-000 São Paulo – SP, Brazil.
E-mail: sobrado@iconet.com.br
Depending on her diet, she strained excessively upon

INTRODUCTION
defecation, and she had no prior surgery.
There is a wide choice of clinical or surgical options Proctological examination showed a posterior midline
to treat patients with haemorrhoidal disease and the superficial fissure, external haemorrhoid piles and
therapy selected is generally based on the type of anterior hypertrophic papillae.
symptoms, their severity and degree of prolapse. Exp- There was pain upon rectal touch and the sphincter
erienced proctologists will determine the most appro- was hypertonic. Rigid proctosigmoidoscopy was
priate treatment for each case. normal, without any other abnormalities up to 15 cm
Conservative treatment, ranging from hygiene and from the pectinate line (anorectal junction).
dietary measures with or without the use of topical
proctological preparations, to minimally invasive pro-
Treatment
cedures such as elastic ligation, is adequate for most
patients.1 Such treatments are recommended for The patient was given instructions on adapting her
patients with mild, sporadic symptoms that do not diet, such as gradually increasing fibre intake
constitute a serious problem for the patient and, in (25 g ⁄ day), and drinking at least 2 litres of liquids per
certain circumstances, when the patient is in poor day. She was instructed to take sitz baths with warm
general health or when there is a surgical risk. water, three to four times a day and to apply (Ultra-
In this paper, we report on two cases of symptom- proct) ointment to the anal region, twice a day, for
atic anorectal disease, one of acute anal fissure and 14 days. She was also prescribed acetaminophen
another of haemorrhoidal disease. Conservative treat- 750 mg three times a day for pain relief.
ment involved hygiene and change of diet, combined At the 4-week follow-up visit, she was experiencing
with the application of (Ultraproct; Intendis, Berlin, regular bowel movements (one defecation per day) and
Germany) ointment, i.e. a corticoid, local anaesthetic no proctological complaints. Images of the proctologi-
and anti-inflammatory base. In the follow-up visits at cal examination before (Figure 1) and after treatment
4 weeks, all three cases showed good responses, with (Figure 2) are shown on page 48.
relief of the symptoms and improvement in the
patient’s quality of life, thus avoiding or postponing
Discussion
the need for surgical intervention.
A non-specific anal fissure is an ulcer located in the
anal canal, distal to the pectinate line and generally
CASE 1
located around the posterior midline. It is a common
complaint in young people (20–40 years) and can also
History
affect children and the elderly. Both genders are
RBS, a Caucasian female lawyer, aged 30, visited the equally affected. Although its aetiopathogenesis is not
clinic with anal pain and bleeding upon defecation, completely clear, alterations in bowel movement hab-
over the previous 2 weeks. She complained of chronic its, more precisely, intestinal constipation and blood
constipation, with defecation once every 3 days. perfusion deficit in the mid-posterior commissure are

On the other hand, acute fissures, which are superfi-

cial in most cases, should be treated conservatively,
characterised by increased intake of liquids (2 litres ⁄ -
day) and a gradual increase of fibre in the diet, up to
25 g ⁄ day. Obeying the urge to defecate, sitz baths with
warm water, not using toilet paper and washing the
anus with water only are other measures that have
shown beneficial effects.
Anti-inflammatory medications and topical anaes-
thetics should be used for periods of 1–3 weeks,
depending on the severity of the inflammatory–infec-
tious process, with encouraging results in the majority
Figure 1. Proctological examination. of patients.5 This local treatment, which can lead to a
decrease in oedema, discomfort and anal pain, should
always be used in conjunction with hygiene and
dietary measures to facilitate painless defecation,
breaking the cycle (fissure-pain-chronic constipation-
fissure) and promoting healing of the fissure and an
improvement in quality of life.
Conclusion
The conservative treatment is preferred for acute non-
specific anal fissure, associated with hygiene and diet-
ary measures, plus topical treatment with compounds
containing anti-inflammatory drugs and local anaes-
thetics.
Figure 2. Post-treatment.
CASE 2
factors that are believed to cause and perpetuate these
History
fissures.
The main symptom is anal pain during, or immedi- PA, a Caucasian male mechanic, aged 45, visited the
ately after, defecation, lasting from several minutes to clinic complaining of sporadic anal bleeding upon defe-
several hours. The second most common symptom is cation over the past 3 years. He reported prolapse of
bleeding upon defecation, generally of a small, limited the ‘nodulation’ when straining to defecate, over the
amount. Anal itching and a local burning sensation previous 12 months, which subsided spontaneously. He
may also be present. also reported a large, painful anal ‘lump’, present for
In a study involving 876 patients with anal fissure, 1 week, which made defecation difficult, and which
the most common complaints were pain (90%) and was not reducing in size. This anal mass appeared
bleeding (71%). Twenty nine per cent of patients after intense strain upon defecation and was accompa-
reported straining while defecating and 14% reported nied by bright red blood in the faeces.
not defecating for periods longer than 3 days.2 The patient also reported the increase of mucorrhoea
For cases of chronic anal fissure in which the char- and anal itching. He experienced regular bowel move-
acteristic triad is observed (sentinel skin tags, deep ments, with a single defecation every 2–3 days and
ulcer with raised, fibrous edges and hypertrophic hard, fragmented stools, requiring excessive straining
papillae), and cases where the symptoms have to eliminate the stool. The patient reported no weight
persisted for more than 90 days, despite treatment, loss and has no family history of cancer.
surgical intervention is necessary, namely internal Proctological examination showed right lateral muco-
lateral fissurectomy and sphincterotomy.3, 4 sal prolapse, with scarification of the mucosa and right

Figure 3. Proctological examination. Figure 4. Post-treatment.
lateral skin tags with presence of oedema. Anoscopy Adequate knowledge of the anatomy, physio-
showed first degree internal haemorrhoid piles, as well pathology and different forms of clinical presentation
as haemorrhoidal prolapse in the right lateral quad- of the disease, together with a good knowledge of the
rant, already seen upon visual inspection. Rigid procto- conservative and surgical techniques available, are
sigmoidoscopy was performed to 15 cm above the essential requirements for the successful treatment of
pectinate line (anorectal junction), showing no other haemorrhoidal disease.
abnormalities. It is currently estimated that 10–20% of symptom-
atic haemorrhoidal patients will require surgical treat-
ment, reserved for the following cases: grades 3 and 4
Treatment
haemorrhoidal disease, grades 1 and 2 cases that do
The patient was instructed to increase intake of fluids not clear up when treated with medications; cases with
and fibre in his diet, using a psyllium fibre supple- complications (thrombosis, phlebitis, pseudo-strangul-
ment, take warm water sitz baths three or four times a ation) and cases associated with another anorectal
day, and apply (Ultraproct Intendis, Berlin, Germany) complaint, such as abscess, fistula, chronic anal fissure
to the anal region twice a day for 3 weeks. He was or condyloma.7 Haemorrhoidectomy by the open or
also instructed not to use toilet paper, to wash the closed technique, or by the stapling technique (Proce-
affected area with water only and to obey the urge to dure for Prolapsed Haemorrhoids) are the two most
defecate. Avoidance of strong or spicy foods, alcohol commonly used techniques. These can be performed in
and pepper was also recommended because of their the outpatient unit, not requiring hospitalisation,
irritant action on the mucosae. thereby reducing hospital costs.8
At the 4-week follow-up visit, the patient reported Conservative treatment is reserved for patients with
regular bowel movements, without any proctological grades 1 and 2 haemorrhoidal disease, pregnant
complaints. Images of the proctological examination women (particularly those in the third term) and
before (Figure 3) and after treatment (Figure 4) are patients with conditions that have severely compro-
shown above. mised their overall health and who are unable to
undergo surgery, such as cirrhosis, severe Chronic
Obstructive Pulmonary Disease (COPD) or heart dis-
Discussion
ease.
The haemorrhoidal vessels are part of the normal Hygiene and dietary measures will help soften the
human anatomy, and it is only when they cause faeces and decrease intestinal transit time, resulting in
symptoms (anal bleeding upon defecation, prolapse, a decrease in straining upon defecation. Patients
mucorrhoea, itchiness, discomfort and local oedema) should be encouraged to eat a high-fibre diet and to
that they require treatment.6 use psyllium, consuming approximately 25—30 g of

fibre a day. In addition to diet, patients should be

Conclusion
advised to drink approximately 2 litres of liquids a
day and to obey the urge to defecate. Through these If anal bleeding persists following the treatment
measures, it is possible to regulate the bowel move- described, oral administration of vasoactive drugs,
ments in 60–80% of cases. such as Diosmin can be prescribed to alleviate local
In addition to changing diet and hygiene measures, symptoms by reducing congestive oedema and by act-
ointments and suppositories containing anaesthetic ing as a local anti-inflammatory. This is useful in
and anti-inflammatory agents should be used, cases where the haemorrhoidal disease increases in
wherever possible. These will relieve the pain and local severity. Oral use of Diosmin to decrease the bleeding
discomfort and reduce local secretion and mucorrhoea, in the post-operative period of a haemorrhoidectomy
as can be observed in this case, where the patient used has been described with promising results.9
(Ultraproct Intendis, Berlin, Germany) ointment twice a In conclusion, in certain cases of grades 1 and 2
day, for 2 weeks. However, these topical agents should symptomatic haemorrhoids with acute inflammation,
not be used continuously for longer than 3–4 weeks, conservative treatment is preferred.
as they can produce local hypersensitivity.
REFERENCES revisited. Dis Colon Rectum 1997; 40: hemorrhoidal disease in 475 patients. Rev
597–602. Hosp Clin Fac Med São Paulo 1997; 52:
1 Sardinha TC, Corman ML. Hemorrhoids. 5 Jensen SL. Treatment of first episodes of 175–9.
Surg Clin North Am 2002; 82: 1153–67. acute anal fissure: prospective randomised 8 Sobrado CW, Bringel RW, Nahas SC, et al.
2 Hananel N, Gordon PH. Re-examination of study of lignocaine oitment versus hydro- Ambulatory anorectal surgery under local
clinical manifestations and response to cortisone ointment or warm sitz baths plus anesthesia: analysis of 351 procedures. Rev
therapy of fissure-in-ano. Dis Colon bran. Br Med J (Clin Res Ed) 1986; 292: Hosp Clin Fac Med São Paulo 1998; 53:
Rectum 1997; 40: 229–33. 1167–9. 277–82.
3 Nelson R. A systematic review of medical 6 Haas PA, Haas GP, Schmaltz S, et al. The 9 Ho YH, Foo CL, Seow-Choen F, et al. Pro-
therapy for anal fissure. Dis Colon Rectum prevalence of hemorrhoids. Dis Colon Rec- spective randomized controlled trial of a
2004; 47: 422–31. tum 1983; 26: 435–9. micronized flavonidic fraction to reduce
4 Hananel N, Gordon PH. Lateral inter- 7 Nahas SC, Sobrado CW, Araujo SEA, et al. bleeding after hemorrhoidectomy. Br J
nal sphincterotomy for fissure-in-ano: Surgical treatment outcome of Surg 1995; 82: 1034–5.
Case Study 8: the topical treatment of haemorrhage by stage IV

haemorrhoids
A. SZABADI
Kaposi Mór Hospital, Kaposvár, Hungary

Correspondence to:
Dr A. Szabadi, Kaposi Mór Hospital, Tallián str. 20-32 Kaposvár, Hungary.
E-mail: szabadi.andras@kmmk.hu
common in youngsters.1 This may be as a result of the

INTRODUCTION
very low levels of physical activity and the high pro-
It is well known that haemorrhoidal disease is a severe portion of overweight people in Hungary. The lack of
problem in Hungary. Half of the population aged over health education means that only a few of these
50 years suffers from this disease and it is increasingly patients ask for any medical treatment, most of them

using OTC ointments. He is a typical student with a

sedentary lifestyle and no sport activities.
The patient’s symptoms were painful defecation and
bleeding. He had a defecation disorder and constipa-
tion, but was not taking any medication.
Diagnosis was achieved using physical examination
and anoscopy. The main findings were bleeding and
oedema; some inflammation was also observed. Our
diagnosis was grades 3–4 external haemorrhoids
(Figure 1).
Figure 1. Grade 3–4 external haemorrhoids.
We prescribed suppositories and cream containing fluo-
cortolone and lidocaine (Doloproct; Intendis, Berlin,
Germany) twice daily for 2 weeks. The patient reported
that the bleeding had stopped and the pain was con-
siderably less after 2 days. After 1 week, the pain had
disappeared. After 2 weeks, the patient’s symptoms
were almost entirely gone: there was no bleeding,
oedema or inflammation (Figure 2).
At the initiation of therapy, the patient’s condition
was severe, but it improved to moderate after 2 weeks
of treatment. The treatment was continued for a few
more days and the patient was advised about physical
exercise, weight loss, if possible, and more fibre in the
diet. During the 2-week treatment, no side effects were
observed and the medication was well tolerated.
DISCUSSION
try over-the-counter (OTC) treatments first and only Haemorrhoids can greatly affect the patient’s quality
the serious cases – still more than 70 000 cases per of life and treatment should be personalised and moni-
month – appear in the healthcare system.2 tored. In most cases, surgical treatment is the only
option, but we choose local treatment, creams and
suppositories containing a corticosteroid (such as fluo-
PATIENT HISTORY cortolone) and an analgesic (such as lidocaine) because
The patient is a 28-year-old man who had had haem- they treat aggravating symptoms and inflammation
orrhoids for two weeks. He is the exception rather than simultaneously.
the rule because he visited a specialist before he tried
Abstracts of: A Magyar Sebész Társaság 2 Based on Hungarian IMS sales data, ATC
REFERENCES Coloproctológiai Szekciójának 20, tisztújı́tó CO5A. 2009.
kongresszusa, Debrecen, 2007, március 22–
1 Hungarian Journal of Surgery, Vol. 60, No.
24.
2, April 2007, pp. 103–11, Congress

Case Study 9: the treatment of haemorrhoidal symptoms and

perianal eczema with topical corticosteroid
T. VITALYOS
St Imre Hospital, Budapest, Hungary

Correspondence to:
Dr T. Vitalyos, St Imre Hospital, Tétényi str. 12-16, Budapest, Hungary.
E-mail: vitalyost@freemail.hu
and external haemorrhoids and mild perianal

INTRODUCTION
oedema and eczema. Our diagnosis was inflamed inter-
Haemorrhoids are very common in people with seden- nal and external grade 2 (mild) haemorrhoids (Figure 1).
tary lifestyles – for example, those whose jobs require Dermatological investigations revealed that the patient
them to stand or sit for long periods every day and also had perianal eczema.
those who do no exercise outside work – which causes
congestion in the veins of the lower parts of the body.
Haemorrhoids affect many aspects of everyday living,
including work, hobbies, family-life and sexual rela- We prescribed suppositories containing fluocortolone
tionships. Serious bleeding can lead to anaemia and and lidocaine (Doloproct; Intendis, Berlin, Germany)
even hospitalisation. inserted once a day for 2 weeks and a cream contain-
Hungary has an obese population with low rates of ing the same active ingredients (also Doloproct) twice
physical activity. As a result, haemorrhoidal nodes are a day for 2 weeks.
very common pathologies in Hungary. Almost one- The patient experienced immediate relief (within
third of the adult population has problems with haem- 3 days) of the subjective symptoms. After 2 weeks of
orrhoids and this proportion is much higher in patients therapy, there was total regression of inflammation
aged over 50.1 and oedema, and no pain or burning (Figure 2). At the
This case involves a secretary – a typical candidate end of treatment, the patient was clear of symptoms
for haemorrhoids. and needed no further medication.
During the 2-week treatment period, the patient did
experience some flatulence and headache, which were
PATIENT HISTORY
The patient was a 59-year-old woman with a 2-month
history of haemorrhoids. This was her first haemor-
rhoidal event. She had unsuccessfully used a nonsteroi-
dal over-the-counter anti-haemorrhoidal cream prior to
consulting a specialist. The patient has hypertension,
for which she takes antihypertensives, and uses the
contraceptive pill. At the time of diagnosis, she was
also suffering from diarrhoea.
The patient presented with symptoms of burning,
pain, weeping and painful defecation.
Figure 1. Inflamed internal and external grade 2 haem-
The patient underwent a physical examination and
orrhoids and perianal eczema.
rectoscopy, which revealed inflammation of the internal

possibly not related to suppository use. However, the

drug was generally well tolerated and no atrophy was
observed.
DISCUSSION
Treatment with (Doloproct Intendis, Berlin, Germany)
suited this patient. The combination of a steroid (fluo-
cortolone) and an analgesic (lidocaine) simultaneously
reduced symptoms of pain and inflammation meaning
that her quality of life improved significantly follow-
ing therapy, allowing her to return to work without
Figure 2. Patient clear after 2 weeks of treatment.
pain and bleeding.
REFERENCE
1 Based on Hungarian IMS sales data, ATC:
C05A. 2009.
Case Study 10: the symptomatic and causal therapy of

haemorrhoidal disease of 10 years duration
G. H. WEYANDT
Department of Dermatology, University Clinics of Wuerzburg, Wuerzburg, Germany

Correspondence to:
Dr G. H. Weyandt, Department of Dermatology, University Clinics of Wuerzburg, Josef Schneider Strasse 2, DE-97080 Wuerzburg, Germany.
E-mail: weyandt_g@klinik.uni-wuerzburg.de
marked impairment of quality of life that prompts the

INTRODUCTION
patient to present acutely to a doctor in the hope of
Haemorrhoids are convoluted arteriovenous plexuses, obtaining rapid relief of the symptoms.
situated in a ring shape in the submucosa of the distal
rectum and extending to just above the dentate line.
PATIENT HISTORY
Their role is fine control of continence so as to prevent
the unintended passage of gas, mucus or loose stool. A 62-year-old male patient presented acutely with a
Increasing enlargement and associated displacement of 8-week progressive history of perianal burning, a con-
this tissue are classified into grades from 1 to 4. Only stant urge to defecate, pruritus and blood evident on
if the haemorrhoids cause symptoms, however, is this toilet paper. Prior treatment with antifungals and topi-
then known as haemorrhoidal disease. These symptoms cal steroids had resulted in only short-term improve-
do not necessarily correlate with the grading. The most ment. The patient reported that symptoms had
commonly cited symptoms are bleeding, discharge, occurred intermittently for 10 years in the form of
eczema and related symptoms such as itching and blood on toilet paper, traces of stool on underwear and
burning. Anal pruritus and pain, in particular, lead to persistent itching. When asked about defecation, he

reported passing a bowel movement of moderate con-

sistency once a day, without the need for straining.
Wiping was performed with dry toilet paper, sometimes
moistened with water, or with a flannel.
Ten years ago, he was diagnosed with anal fissures
and was treated with unknown ointments with moder-
ate success. Gastroscopy and colonoscopy were also
performed previously (i.e. 4 years ago) for clarification
of bleeding.
The anus was oval and funnel-shaped, with erosive anal
eczema from 9 o’clock to 3 o’clock (Figure 1). Intense Figure 3. Two days after commencement of treatment
pain was reported, particularly at the extensively ero- and of incipient epithelialisation externally.
sive areas in the intergluteal region. Pruritus was espe-
cially marked in the region of the dentate line, which tal examination showed a somewhat decreased resting
was abundantly soiled with stool (Figure 2). Digital rec- tone and strong squeeze pressure. Anoscopy showed
first-degree haemorrhoids at 7 o’clock and 4 o’clock.
Rectoscopy showed no abnormalities.
MICROBIAL INVESTIGATIONS
Investigations showed: mycology – no growth present;
bacteriology – Escherichia coli positive; direct
immunofluorescence assay – fluorescein-labelled
monoclonal antibodies specific for herpes simplex
virus 1 and Varicella zoster virus (VZV) negative.

In addition to advice on defecation and wiping, topical
treatment was instituted with methylrosanilinium-
Figure 1. Acute anal eczema.
chlorid solution 0.1% once daily and cream containing
1 mg fluocortolone pivalate and 20 mg lidocaine
hydrochloride (Doloproct; Intendis, Berlin, Germany)
twice daily. Following an initial escalation of the
symptoms a few hours after the topical therapy, the
patient presented again on day 3 (the second day after
beginning of treatment). On that occasion, a marked
improvement was noted externally, with incipient epi-
thelialisation (Figure 3). In the vicinity of the anus,
there was distinct stool soiling with areas of erosion,
explaining the acute symptoms. Following in-depth
advice on wiping after defecation, the treatment was
continued unchanged. The patient’s symptoms disap-
peared after 2 weeks and the eczema healed, apart from
postinflammatory hyperpigmentation and residual ery-
thema (Figures 4 and 5). As traces of stool were still
Figure 2. Acute anal eczema with traces of stool.
visible perianally, treatment with rubber-band ligation

Figure 4. Patient documentation showing course of Figure 6. Ligation treatment at 8 o’clock and 4 o’clock.
pruritus and pain during treatment on a scale of 0—10
(0 = asymptomatic, 10 = maximum symptoms).
relief of the symptoms within a short period. The symp-
toms may not initially subside in a linear pattern,
instead, relapse for a while to a varying degree. Con-
trolled use of a potent steroid for a limited period is an
important risk-free element of the treatment.
Continued irritation, as a result of interference with
fine continence, may lead to a recurrence of irritation-
induced anal eczema. Only by reduction of the hyper-
plastic haemorrhoidal tissue by means of rubber-band
ligation can the normal anatomic situation be restored,
resulting in the disappearance of the stool spotting.
In addition to topical treatment, the patient was
advised to take sufficient exercise, to eat a balanced,
high-fibre diet with adequate fluid intake and to
establish regular bowel habits, with avoidance of
Figure 5. Fourteen days after treatment.
severe straining and with gentle wiping.
The most common cause of occurrence of anal
was performed at 8 o’clock and 4 o’clock (Figure 6). eczema is haemorrhoidal disease.1 Anal eczema is
The patient was subsequently asymptomatic. nevertheless not a uniform entity and may occur as a
result of various proctological, dermatological, allergic
DISCUSSION and microbial diseases or may be a sign of a condition
mimicking the clinical picture of anal eczema.
This case is a good example of the need for multimodal Additional diagnostic investigations are necessary to
treatment of haemorrhoidal disease. Combined topical exclude other causes, particularly malignancies.
treatment with Doloproct cream and antiseptic astrin-
gents allowed healing of the anal eczema and complete
REFERENCE
1 Handbuch Hämorrhoidalleiden Volker
Wienert, Horst Mlitz, Franz Raulf Uni-med
Bremen-London-Boston, 12, 2008.

Case Study 11: the conservative therapy for perianal thrombosis

P. WIESEL
Berlin, Germany
Correspondence to:
P. Wiesel, Landhausstr. 36, 10717 Berlin, Germany.
E-mail: drwiesel@yahoo.de
in the lithotomy position. The thrombosis could be

INTRODUCTION
grasped on palpation and thereby differentiated from a
Perianal thrombosis is a harmless, painful swelling in thrombosed haemorrhoidal nodule. There was no
the region of the anal margin (anal margin plexus).1 perianal dermatitis. Proctoscopy revealed known grade
It usually occurs acutely, often triggered by an 1—2 haemorrhoids.
increase in intra-abdominal pressure, such as that
which occurs with frequent straining associated with
constipation, lifting and coughing, and with an
unaccustomed increase in physical exertion.2 The The findings were discussed with the patient and the
condition may additionally be triggered by thermal possible treatment options were considered.
factors, such as heat and cold. Likewise, it may With a choice between surgical treatment (excision
occasionally be associated with diarrhoea and diet. A of the thrombosis) and conservative therapy, it was
gender predisposition is not verifiable with certainty decided that the patient should be treated conserva-
in the literature, although there would appear to be a tively. Treatment took the form of systemic therapy
predisposition in men.2 A predisposing factor may be with one ibuprofen 600 mg tablet twice daily and top-
enlarged haemorrhoids that are in contact with the ical therapy with twice-daily application of a cream
anal margin plexus. containing fluocortolone pivolate (1 mg) and lidocaine
hydrochloride (20 mg) (Doloproct; Intendis, Berlin,
Germany). This offers the benefit of both the anti-
PATIENT HISTORY
inflammatory and swelling-reducing effect of ibupro-
A 36-year-old man presented with a painful swelling fen and the local analgesic and swelling-reducing
in the region of the anal margin that had appeared action of fluocortolone plus lidocaine.
about 4 days previously. This had been preceded by The patient presented again 1 week later and
constipation, leading to frequent straining during defe- reported that a marked improvement in the symptoms
cation. There was additionally a burning sensation in had occurred within 2—3 days. The swelling was
the anal region, but no bleeding or mucus in the stools. resolving and there was hardly any pain. The ibupro-
Prior to presentation, he had not self-medicated.
The patient was known to have grades 1–2
haemorrhoids and a small skin tag at 7 o’clock in the
lithotomy position. Sclerotherapy had been performed
repeatedly.
On initial examination, a distinct, oedematous,
swollen, perianal thrombosis was noted at 7 o’clock in
the lithotomy position (Figure 1). In addition, there
was a smaller thrombosis in the anoderm at 6 o’clock Figure 1. Perianal thrombosis on day of presentation.

Figure 2. Findings after 1 week of treatment. Figure 4. Findings after 4 weeks of treatment.
the lithotomy position had been almost completely

absorbed, while the larger lesion at 7 o’clock in the
lithotomy position had further decreased in size.
There was a known skin tag at 7 o’clock in the
lithotomy position. After 4 weeks, the thrombosis
was not detectable. Only the pre-existing anal skin
tag at 7 o’clock in the lithotomy position remained
(Figure 4).
DISCUSSION
When treating perianal thrombosis conservatively,
co-administration of a non-steroidal anti-inflamma-
tory such as ibuprofen with a cream containing
Figure 3. Findings after 2 weeks of treatment.
fluocortolone and lidocaine is a useful and safe com-
bination.3 This expediently combines the local effects
fen was discontinued. Twice-daily topical application of the Doloproct with the systemic effects of the ibu-
of the fluocortolone plus lidocaine was continued profen. The treatment ensures swift resolution of the
(Figure 2). After a further week, the patient presented oedema and the pain. The thrombosis is absorbed fas-
again (Figure 3). There were no longer any local ter. If a skin tag persists and causes discomfort, this
symptoms. The swelling was continuing to resolve. can be removed under local anaesthesia.
The pre-existing smaller thrombosis at 6 o’clock in
REFERENCES 2 Raulf F, Kolbert Gerd W. Analvenenthrom- 3 Stein E. 1.3. Analvenenthrombose.

bose. Praxishandbuch Koloproktologie. Ber- Proktologie, Lehrbuch und Atlas. Berlin
1 Winkler R, Otto P. Perianale thrombose. lin: Dr. Kade GMBH, 2006: 52–4. Heidelberg: Springerverlag, 1997: 82–4.
Proktologie, Georg Thieme. New York:
Stuttgart, 1997: 82–4.

rado, András Szabadi, Tibor Vitalyos, Peter Wiesel

ACKNOWLEDGEMENTS
have stated no personal conflict of interest. Blanka
Declaration of personal interests: Laurent Abramowitz Havlickova, MD, PhD, is an employee of Intendis
is a consultant for proctological diseases for labora- GmbH. Gerhardt Weyandt has a consultancy agree-
tories: Intendis, Nycomed, Sanofi, Pierre Fabre, Mundi- ment with Intendis GmbH. Declaration of funding
pharma, NetNormandy and Meda Pharma. Jean-Michel interests: The preparation of this paper was funded in
Didelot, Yasuhide Matsuda, Alex Rothhaar, Carlos Sob- part by Intendis GmbH.


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Alimentary Pharmacology & Therapeutics

Volume 31, Supplement 1, May 2010

The Diagnosis and Management

L. Abramowitz, G. H. Weyandt, B. Havlickova, Y. Matsuda, J.-M. Didelot, A. Rothhaar,

Volume 31, Supplement 1, May 2010

The Diagnosis and Management

The diagnosis and management of haemorrhoidal disease from a

*Paris, France; Wuerzburg, Germany; SUMMARY

Aliment Pharmacol Ther 31 (Suppl. 1), 1–58

ª 2010 Blackwell Publishing Ltd 1

The management of haemorrhoidal diseases

consultations.1 A national survey conducted in 2004

Aliment Pharmacol Ther 31 (Suppl. 1), 1–58

Figure 1. Haemorrhoidal prolapse grade 3 (after

Aliment Pharmacol Ther 31 (Suppl. 1), 1–58

Bleeding Anal pain Swelling Commentary Photo

Haemorrhoids Typically into Only in case of Grade 2–3: Different

Marisca No No Like skin tag Secondary

Condyloma No No For anal margin Diagnosis only

Aliment Pharmacol Ther 31 (Suppl. 1), 1–58

Bleeding Anal pain Swelling Commentary Photo

Suppurative Rarely, but In case of In case of Pain is the

Dermatological Sometimes on Anal itch Sometimes Very different

Anal cancer On paper When important In case of Systematic

Aliment Pharmacol Ther 31 (Suppl. 1), 1–58

Bleeding Anal pain Swelling Commentary Photo

Rectal prolapse On paper No After Associated with

Principal considerations10–12 Topical agents and suppositories. Available topical

Aliment Pharmacol Ther 31 (Suppl. 1), 1–58

costeroids are particularly useful for treating local

Venotonics. Some randomized studies have shown

Oral anti-inflammatory drugs. Non-steroidal anti-

Aliment Pharmacol Ther 31 (Suppl. 1), 1–58

Aliment Pharmacol Ther 31 (Suppl. 1), 1–58

with complications, such as bleeding, urinary reten- (a)

TREATMENT RECOMMENDATIONS FOR

Haemorrhoidal thrombosis (Figure 7a and 7b)

Aliment Pharmacol Ther 31 (Suppl. 1), 1–58

Aliment Pharmacol Ther 31 (Suppl. 1), 1–58

Aliment Pharmacol Ther 31 (Suppl. 1), 1–58

Haemorrhoidal disease: the dermatological differential diagnoses

line and participate in the regulation of continence.

Aliment Pharmacol Ther 31 (Suppl. 1), 1–58

Main haemorrhoidal symptoms

Proctological disorders with

The 4 indicates that the symptom is typical in that disorder.

canal. When these veins become thrombosed, the

Hypertrophic anal papillae

Aliment Pharmacol Ther 31 (Suppl. 1), 1–58

alia, perineum or perianal area is the most common

Figure 4. Genital warts distributed in a circle round the

Aliment Pharmacol Ther 31 (Suppl. 1), 1–58

Figure 6. Anal rim carcinoma.

precancerous condition with slight-to-medium dyspla-

Aliment Pharmacol Ther 31 (Suppl. 1), 1–58

rhinoconjunctivitis allergica. Atopic eczema occurs as

Aliment Pharmacol Ther 31 (Suppl. 1), 1–58

known but unquantifiable (because of inadequate data)

Other infectious diseases with similar symptoms

Aliment Pharmacol Ther 31 (Suppl. 1), 1–58

develop into moist, warty patches on the genitalia or

Aliment Pharmacol Ther 31 (Suppl. 1), 1–58

Topical corticosteroid therapy in proctology indications

tomatic individuals. Conversely, many nonspecific