Homoeopathy For Induction of Labour (Review PDF

Homoeopathy for induction of labour (Review)
Smith CA
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2010, Issue 3
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Homoeopathy for induction of labour (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
T A B L E O F C O N T E N T S
1 HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1 ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2 PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2 BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3 OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3 METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5 RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7 DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7 AUTHORS CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7 ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9 CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12 DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.3. Comparison 1 Homoeopathy versus placebo, Outcome 3 Caesarean section. . . . . . . . . . . 13
Analysis 2.1. Comparison 2 Homoeopathy versus placebo, Outcome 1 Vaginal delivery not achieved within 24 hours. 14
Analysis 3.1. Comparison 3 Homoeopathy versus placebo, Outcome 1 Augmentation with oxytocin. . . . . . . 14
Analysis 4.1. Comparison 4 Homoeopathy versus placebo, Outcome 1 Instrumental delivery. . . . . . . . . 15
Analysis 5.2. Comparison 5 Homoeopathy versus placebo, Outcome 2 Length of labour. . . . . . . . . . . 15
Analysis 6.1. Comparison 6 Homoeopathy versus placebo, Outcome 1 Difcult labour. . . . . . . . . . . 16
16 APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
16 WHATS NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
17 HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
17 CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
17 DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
17 SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
18 INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
i Homoeopathy for induction of labour (Review)
[Intervention Review]
Homoeopathy for induction of labour
Caroline A Smith
1
1
Centre for Complementary Medicine Research, The University of Western Sydney, Penrith South DC, Australia
Contact address: Caroline A Smith, Centre for Complementary Medicine Research, The University of Western Sydney, Locked Bag
1797, Penrith South DC, New South Wales, 1797, Australia. caroline.smith@uws.edu.au.
Editorial group: Cochrane Pregnancy and Childbirth Group.
Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 3, 2010.
Review content assessed as up-to-date: 13 January 2010.
Citation: SmithCA. Homoeopathy for inductionof labour. Cochrane Database of Systematic Reviews 2003, Issue 4. Art. No.: CD003399.
DOI: 10.1002/14651858.CD003399.
A B S T R A C T
Background
This is one of series of reviews of cervical ripening and labour induction using standardised methodology. Homoeopathy involves
the use, in dilution, of substances which cause symptoms in their undiluted form. A type of herb, caulophyllum is one type of
homoeopathic therapy that has been used to induce labour.
Objectives
To determine the effects of homoeopathy for third trimester cervical ripening or induction of labour.
Search methods
The Cochrane Pregnancy and Childbirth Groups Trials Register (1 December 2009), and bibliographies of relevant papers.
Selection criteria
Randomised controlled trials comparing homeopathy used for third trimester cervical ripening or labour induction with placebo/no
treatment or other methods listed above it on a predened list of labour induction methods.
Data collection and analysis
A generic strategy was developed to deal with the large volume and complexity of trial data relating to labour induction. This involved
a two-stage method of data extraction. The initial data extraction was done centrally.
Main results
Two trials, involving 133 women, were included in the review. The trials were placebo controlled and double blind, but the quality was
not high. Insufcient information was available on the method of randomisation and the study lacked clinically meaningful outcomes.
This trials demonstrated no differences in any primary or secondary outcome between the treatment and control group.
Authors conclusions
There is insufcient evidence to recommend the use of homoeopathy as a method of induction. It is likely that the demand for comple-
mentary medicine will continue and women will continue to consult a homoeopath during their pregnancy. Although caulophyllum
is a commonly used homoeopathic therapy to induce labour, the treatment strategy used in the one trial in which it was evaluated may
not reect routine homoeopathy practice. Rigorous evaluations of individualised homeopathic therapies for induction of labour are
needed.
1 Homoeopathy for induction of labour (Review)
P L A I N L A N G U A G E S U M M A R Y
Homoeopathy for induction of labour
There is not enough evidence to show the effect of homoeopathy for inducing labour. Sometimes it is necessary to induce labour
(getting labour started articially) when a pregnant woman or her unborn child are at risk. Homoeopathy involves the use of diluted
substances which in their undiluted form, cause certain symptoms. The principle is that a homoeopathic substance will stimulate the
body and healing functions so that a state of balance is gained and symptoms are relieved. The review of two trials, involving 133
women, found there was not enough evidence to show the effect of a homoeopathy as a method of induction. More research is needed.
B A C K G R O U N D
Sometimes it is necessary to bring on labour articially because
of safety concerns for the mother or baby. This review is one of a
series of reviews of methods of labour induction using a standard-
ised protocol. For more detailed information on the rationale for
this methodological approach, please refer to the currently pub-
lished generic protocol (Hofmeyr 2009). The generic protocol
describes how a number of standardised reviews will be combined
to compare various methods of preparing the cervix of the uterus
and inducing labour.
Homoeopathy is used around the world and is most widely used
in Europe and India. Homoeopathy is a form of pharmacological
therapy based on the concept that a substance which gives rise
to specic symptoms, when given in pharmacological doses to
healthy individuals, can be used to treat patients presenting with
the same symptoms. This is described as the Law of Similars.
Homoeopathy seeks to strengthen the bodys immune system, the
principle of the treatment being that the homoeopathic substance
will stimulate the body and healing functions so that a state of
balance is attained and the symptoms are relieved. Homoeopathic
remedies are all natural medicines, with some remedies derived
from herbs, minerals or other natural substances.
Homeopathic remedies are applied as potencies as a result of tiny
and highly diluted amounts of the substances fromwhich they are
derived. They are prepared by a process of step by step repeated
dilution and vigorous shaking, which is thought to make themca-
pable of stimulating the bodys own defence system. The resulting
potency is labelled on the basis of the ratio of dilutent and diluted
agent (D = decimal dilution = 1/10 diluted agent/dilutent; C =
centesimal dilution = 1/100 diluted agent/dilutent) and the num-
ber of dilution steps (e.g. C5 indicates 5 dilution steps 1/100). The
repetitive dilutions are thought to produce results more quickly,
act on symptoms more effectively and are less likely to lead to side
effects than the original substances.
The resulting homoeopathic medicine may contain very few or
no single molecules of the original solute. For this reason many
scientists have suggested the clinical effects resulting from ho-
moeopathic remedies are due to the placebo effect (Vandenbrouke
1997). However, data from two meta-analyses of placebo con-
trolled clinical trials have found a greater therapeutic effect from
homoeopathy compared with the placebo (Boissel 1996; Linde
1997). The precise biophysical mechanismunderlying homoeopa-
thy remains undened.
There are different traditions in the prescribing of homoeopathic
formulations. Classical homoeopathy refers tothe practitioner pre-
scribing a single therapy to treat the individuals illness based on
the patients general constitution. This involves consideration of
the individuals current illness, medical history, personality and be-
haviour. Other practitioners prescribe a combination of homoeo-
pathic therapies, complex homoeopathy, on the basis of a con-
ventional diagnosis. Clinical homoeopathy uses the same remedy
in patients presenting with a homogenous pathology or constella-
tion of symptoms. There is no evidence that describes the benets
of one approach compared with another approach. Homoeopathy
is practiced on different levels. Many homoeopathic therapies are
available over the counter in pharmacies and health food shops.
However, homoeopaths require several years of study to achieve
their qualication. The trained homoeopath will treat an individ-
ual based on a detailed case history and the homoeopathic treat-
ment will be tailored to the individuals constitution.
In recent years the use of alternative and complementary medicine
has become popular in many Western countries (MacLennan
2002). Unconventional therapies are more common among
women of reproductive age, with almost half of all women (49%)
reporting that they have used them(Eisenberg 1998). It is possible
that a signicant proportion of women are using these therapies
during pregnancy. The use of homoeopathy has beenapplied at the
time of conception, pregnancy and labour to treat some of the dis-
comforts and imbalances that can arise during pregnancy such as
backache, constipation, morning sickness and heartburn. A recent
survey described the prevalence and use of complementary thera-
pies among 82 nurse-midwives in North Carolina (Allaire 2000).
Over 30%of nurse-midwives reported recommending homoeopa-
thy for use in pregnancy. Homoeopathy was recommended for use
to ripen the cervix, induce labour and to augment labour.
For some women with a prolonged pregnancy, an induction of
labour may be perceived to intervene in the natural process of
pregnancy and may drastically change their expected plan of care
during pregnancy. The reasons why pregnant women are inter-
ested in using complementary therapies to ripen the cervix or in-
duce labour, or both, is an important question and needs to be
answered when evaluating new options of care. Serious adverse
effects from homoeopathy are rare, and remedies recommended
for use in pregnancy are not thought to cause any problems in
pregnancy.
Caulophyllum thalictroides is proposed to be extremely useful
with establishing labour, or when uterine contractions are short
and irregular or when uterine contractions stop (Priestman 1988).
Some homoeopaths suggest taking one tablet daily for the last
few days before labour starts, or alternatively to dissolve a tablet
in a glass of water and sip from the glass from time to time, or
whenever a contraction is imminent. A non-randomised clinical
trial was carried out to examine the efcacy of caulophyllumbefore
birth for the treatment of uterine inertia and reducing the risk
of postpartum haemorrhage (Ventoskovskiy 1990). The authors
concluded this remedy has a role in preventing poor contraction
patterns.
O B J E C T I V E S
To determine, from the best available evidence, the effectiveness
and safety of homoeopathy for third trimester cervical ripening
and induction of labour.
M E T H O D S
Criteria for considering studies for this review
Types of studies
Clinical trials comparing homoeopathy for cervical ripening or
labour induction, with placebo/no treatment or other methods
listed on a predened list of methods of labour induction (see
Methods); the trials included random allocation to either group;
and they reported one or more of the prestated outcomes.
Types of participants
Pregnant women due for third trimester induction of labour, car-
rying a viable fetus.
Types of interventions
Homoeopathy compared with placebo/no treatment or any other
method on a predened list of methods of labour induction.
Types of outcome measures
Clinically relevant outcomes for trials of methods of cervical ripen-
ing/labour induction have been prespecied by two authors of
labour induction reviews (Justus Hofmeyr and Zarko Alrevic).
Primary outcomes
Five primary outcomes were chosen as being most representative
of the clinically important measures of effectiveness and compli-
cations:
(1) vaginal delivery not achieved within 24 hours;
(2) uterine hyperstimulation with fetal heart rate (FHR) changes;
(3) caesarean section;
(4) serious neonatal morbidity or perinatal death (e.g. seizures,
birth asphyxia dened by trialists, neonatal encephalopathy, dis-
ability in childhood);
(5) serious maternal morbidity or death (e.g. uterine rupture, ad-
mission to intensive care unit, septicemia).
Perinatal and maternal morbidity and mortality are composite
outcomes. This is not an ideal solution because some components
are clearly less severe than others. It is possible for one intervention
to cause more deaths but less severe morbidity. However, in the
context of labour induction at termthis is unlikely. All these events
will be rare, and a modest change in their incidence will be easier
to detect if composite outcomes are presented. Where possible, the
incidence of individual components were explored as secondary
outcomes (see below).
Secondary outcomes
Secondary outcomes relate to measures of effectiveness, complica-
tions and satisfaction.
Measures of effectiveness
(6) Cervix unfavourable/unchanged after 12 to 24 hours;
(7) oxytocin augmentation.
Complications
(8) Uterine hyperstimulation without FHR changes;
(9) uterine rupture;
(10) epidural analgesia;
(11) instrumental vaginal delivery;
(12) meconium-stained liquor;
(13) Apgar score less than seven at ve minutes;
(14) neonatal intensive care unit admission;
(15) neonatal encephalopathy;
(16) perinatal death;
(17) disability in childhood;
(18) maternal side effects (all);
(19) maternal nausea;
(20) maternal vomiting;
(21) maternal diarrhoea;
(22) other maternal side-effects;
(23) postpartum haemorrhage (as dened by the trial authors);
(24) serious maternal complications (e.g. intensive care unit ad-
mission, septicaemia but excluding uterine rupture);
(25) maternal death.
Measures of satisfaction
(26) Woman not satised;
(27) caregiver not satised.
While all the above outcomes were sought, only those with data
appear in the analysis tables.
The terminology of uterine hyperstimulation is problematic
(Curtis 1987). In the reviews we use the termuterine hyperstimu-
lationwithout FHRchanges to include uterine tachysystole (more
than ve contractions per 10 minutes for at least 20 minutes) and
uterine hypersystole/hypertonus (a contraction lasting at least two
minutes) and uterine hyperstimulation with FHR changes to de-
note uterine hyperstimulation syndrome (tachysystole or hyper-
systole with fetal heart rate changes such as persistent decelera-
tions, tachycardia or decreased short-term variability).
Outcomes were included in the analysis if reasonable measures
were taken to minimise observer bias; and data were available for
analysis according to original allocation.
Search methods for identication of studies
Electronic searches
We searched the Cochrane Pregnancy and Childbirth Groups Tri-
als Register by contacting the Trials Search Co-ordinator (1 De-
cember 2009).
The Cochrane Pregnancy and Childbirth Groups Trials Register
is maintained by the Trials Search Co-ordinator and contains trials
identied from:
1. quarterly searches of the Cochrane Central Register of
Controlled Trials (CENTRAL);
2. weekly searches of MEDLINE;
3. handsearches of 30 journals and the proceedings of major
conferences;
4. weekly current awareness alerts for a further 44 journals
plus monthly BioMed Central email alerts.
Details of the search strategies for CENTRAL and MEDLINE,
the list of handsearched journals and conference proceedings, and
the list of journals reviewed via the current awareness service can
be found in the Specialized Register section within the edito-
rial information about the Cochrane Pregnancy and Childbirth
Group.
Trials identied through the searching activities described above
are each assigned to a review topic (or topics). The Trials Search
Co-ordinator searches the register for each review using the topic
list rather than keywords.
Searching other resources
We searched the reference lists of identied papers.
We did not apply any language restrictions.
Data collection and analysis
A strategy was developed to deal with the large volume and com-
plexity of trial data relating to labour induction. Many methods
have been studied, in many different categories of women under-
going labour induction. Most trials are intervention-driven, com-
paring two or more methods in various categories of women. Clin-
icians and parents need the data arranged by category of woman,
to be able to choose which method is best for a particular clinical
scenario. To extract these data from several hundred trial reports
in a single step would be very difcult. We, therefore, developed
a two-stage method of data extraction. The initial data extraction
is done in a series of reviews arranged by methods of induction of
labour, following a standardised methodology.
To avoid duplication of data in the primary reviews, the labour
induction methods have been listed in a specic order, from one
to 25. Each review includes comparisons between one of the
methods (from two to 25) with only those methods above it on
the list. Thus, the review of intravenous oxytocin (4) includes
only comparisons with intra cervical prostaglandins (3), vaginal
prostaglandins (2) or placebo (1). Methods identied in the future
will be added to the end of the list. The current list is as follows:
1. placebo/no treatment;
2. vaginal prostaglandins (Kelly 2003);
3. intracervical prostaglandins (Boulvain 2008);
4. intravenous oxytocin (Kelly 2001c);
5. amniotomy (Bricker 2000);
6. intravenous oxytocin with amniotomy (Howarth 2001);
7. vaginal misoprostol (Hofmeyr 2003);
8. oral misoprostol (Alrevic 2006);
9. mechanical methods including extra-amniotic Foley
catheter (Boulvain 2001);
10. membrane sweeping (Boulvain 2005);
11. extra-amniotic prostaglandins (Hutton 2001);
12. intravenous prostaglandins (Luckas 2000);
13. oral prostaglandins (French 2001);
14. mifepristone (Neilson 2000);
15. oestrogens with/without amniotomy (Thomas 2001);
16. corticosteroids (Kavanagh 2006a);
17. relaxin (Kelly 2001a);
18. hyaluronidase (Kavanagh 2006b);
19. castor oil, bath, and/or enema (Kelly 2001b);
20. acupuncture (Smith 2004);
21. breast stimulation (Kavanagh 2005);
22. sexual intercourse (Kavanagh 2001);
23. homoeopathic methods;
24. nitric oxide (Kelly 2008);
25. buccal or sublingual misoprostol (Muzonzini 2004)
26. hypnosis
27. other methods for induction of labour.
The reviews are analysed by the following subgroups:
1. previous caesarean section or not;
2. nulliparity or multiparity;
3. membranes intact or ruptured;
4. cervix favourable, unfavourable or undened.
The trials included in the reviews were extracted froman initial set
of trials covering all interventions used in induction of labour (see
above for details of search strategy). The data extraction process
was conducted centrally. This was co-ordinated from the Clini-
cal Effectiveness Support Unit (CESU) at the Royal College of
Obstetricians and Gynaecologists, UK, in co-operation with the
Pregnancy and Childbirth Group of The Cochrane Collaboration.
This process allowed the data extraction process to be standardised
across all the reviews.
The trials were initially reviewed oneligibility criteria, using a stan-
dardised form and the basic selection criteria specied above. Fol-
lowing this, data were extracted to a standardised data extraction
form which was piloted for consistency and completeness. The
pilot process involved the researchers at the CESU and previous
review authors in the area of induction of labour.
Information was extracted regarding the methodological quality
of trials on a number of levels. This process was completed without
considerationof trial results. Assessment of selectionbias examined
the process involved in the generation of the random sequence
and the method of allocation concealment separately. These were
then judged as adequate or inadequate using the criteria described
in Appendix 1 for the purpose of the reviews.
Performance bias was examined with regards to whomwas blinded
in the trials, i.e. patient, caregiver, outcome assessor or analyst.
In many trials the caregiver, assessor and analyst were the same
party. Details of the feasibility and appropriateness of blinding at
all levels were sought.
Predened subgroup analyses are: previous caesarean section or
not; nulliparity or multiparity; membranes intact or ruptured, and
cervix unfavourable, favourable or undened. Only those out-
comes with data will appear in the analysis tables.
Individual outcome data were included in the analysis if they met
the pre stated criteria in Types of outcome measures. Included
trial data were processed as described in the Cochrane Reviewers
Handbook (Clarke 2002). Data extracted from the trials were
analysed on an intention-to-treat basis (when this was not done in
the original report, re-analysis is performedif possible). Where data
were missing, clarication was sought fromthe original authors. If
the attrition was such that it might signicantly affect the results,
these data are excluded from the analysis. This decision rests with
the review authors of primary reviews and is clearly documented.
Once missing data become available, they will be included in the
analyses.
Data were extracted from all eligible trials to examine how issues
of quality inuence effect size in a sensitivity analysis. In trials
where reporting was poor, methodological issues were reported as
unclear or clarication sought.
Due to the large number of trials, double data extraction was
not feasible and agreement between the three data extractors was
therefore assessed on a random sample of trials.
Once the data had been extracted, they were distributed to indi-
vidual review authors for entry onto the Review Manager com-
puter software (RevMan 2003), checked for accuracy, and anal-
ysed as above using the RevMan software. For dichotomous data,
risk ratios and 95% condence intervals were calculated, and in
the absence of heterogeneity, results were pooled using a xed-
effect model.
The predened criteria for sensitivity analysis included all aspects
of quality assessment as mentioned above, including aspects of se-
lection, performance and attrition bias. Letters are used to indi-
cate the quality of the included trials as described by Clarke 2002.
The sensitivity analysis explores the inuence of high-quality trials
(dened as A), versus moderate quality trials (dened as B),
and high-quality trials (dened as A) versus low-quality trials
(dened as C), as well as the effects of analysing by intention to
treat on the effect size.
Primary analysis was limited to the prespecied outcomes and
subgroup analyses. In the event of differences in unspecied out-
comes or sub-groups being found, these were analysed post hoc,
but clearly identied as such to avoid drawing unjustied conclu-
sions.
R E S U L T S
Description of studies
See: Characteristics of includedstudies; Characteristics of excluded
studies.
Four studies were identied. Two were included and two were ex-
cluded. The search strategy identied two randomised controlled
trials for inclusion in this review (Beer 1999; Dorfman 1987).
The study by Beer et al (Beer 1999) compared caulophyllum in a
placebo double blind controlled trial and was undertaken in Ger-
many. The authors of this trial examined the efcacy and tolerabil-
ity of the homoeopathic remedy caulophyllum D4 in 40 women
at term with prelabour rupture of membranes (PROM) at term
and not in labour. The trial examined the effect of caulophyllum
on the time interval from entry to the onset of regular uterine
contractions. Other outcomes examined the effect on the dura-
tion of labour, oxytocin requirements, mode of delivery and the
rate of maternal and neonatal infection. Women were adminis-
tered caulophyllum or a placebo hourly for seven hours. Each ac-
tive tablet consisted of 250 mg caulophyllum trituration D4, a
mixture of magnesium stearate and a wheat starch mixture. The
placebo contained no active ingredients but contained the mag-
nesium stearate and a wheat starch mixture.
The trial presented information on the baseline characteristics be-
tween the two randomised groups. No differences in age, weight,
height, cervical score at trial entry and time since PROM were
found between study groups.
The study by Dorfman et al (Dorfman 1987) was undertaken
in France. The trial compared ve homoeopathic therapies with
placebo in 93 women from 36 weeks pregnant; 53 women were
randomised to the treatment group and 40 to the placebo group.
The trial examined the effect of the homoeopathic therapy on
length of labour and the proportion of women experiencing a
difcult labour. No details were provided on the placebo. The
groups were comparable with respect to parity.
Excluded studies
The use of caulophyllum for the preparation of labour (Arnal-
Laserre 1986) and for use in false labour and dystocia (Coudert-
Deguillaume 1981) have been examined in two research theses.
Extensive efforts have been made to contact the authors and we
do not have enough information to make a decision whether the
trial meets the inclusion criteria.
Risk of bias in included studies
The method of randomisation in both trials was not described and
was therefore unclear. Both trials were reported as double blind
although there was no information as to whether caregivers and
the outcome assessors were blind to the womens group allocation.
There were no withdrawals from the trials. The authors of the tri-
als did not state they performed an intention-to-treat analysis, al-
though the studies did analyse outcome data from the same num-
ber of women who were reported as having been randomised. The
sample size was small in both trials and there was no description
of the sample size calculation or if a calculation was undertaken.
The information on any side effects arising from caulophyllum
was unclear and it was unclear as to how women assessed the tol-
erability of caulophyllum. No data were provided on side effects
from the Dorfman 1987 trial.
Effects of interventions
Two trials involving 133 women were included in the review.
Caulophyllum versus placebo
Forty women with a singleton pregnancy and prelabour rupture
of membranes were randomised to caulophyllumor placebo (Beer
1999).
Primary outcomes
Vaginal delivery not achieved within 24 hours was reported for
one woman in the control group (1/20) and no women in the
treatment group (risk ratio (RR) 0.33, 95% condence interval
(CI) 0.01 to 7.72). Data on uterine hyperstimulation were not
recorded. Two women in the group given caulophyllum had cae-
sarean sections compared with no women in the placebo group
(RR 5.0, 95% CI 0.26 to 98.00). No data were presented on fetal
heart rate changes although the author describes that slight but not
signicant differences were noted. No data were reported on se-
rious maternal or neonatal morbidity such as; meconium-stained
liquor; Apgar score less than seven at ve minutes; neonatal in-
tensive care unit admission; postpartum haemorrhage; or serious
maternal complications (e.g. intensive care unit admission, septi-
caemia).
Secondary outcomes
No data were presented on cervical change, however the author
reported minor differences between groups. Oxytocin augmenta-
tion was administered to nine women (45%) in each group, no
differences were found (RR 1.0, 95% CI 0.50 to 1.98). There was
no difference in the rate of instrumental delivery between the two
groups (RR 1.0 95%CI 0.54 to 1.86). No differences were found
in Apgar scores between groups. Womens and midwives views on
this method were sought and all described the method as tolerable.
Additional data
The difference in the interval between administration of the in-
tervention and regular uterine contractions was 13 hours in the
treatment group and 13.4 hours in the control group (mean dif-
ference -0.40, 95% CI -7.21 to 6.41).
In the Dorfman 1987 trial only two outcomes were reported. The
mean length of labour for women receiving the homoeopathic
therapy was 5.1 hours compared with 8.48 hours in the placebo
group (P less than 0.001). Data could not be entered into the
meta-analysis due to the absence of data on standard deviation.
A difcult labour was reported for six women (11.3%) in the
treatment group and 16 (40%) in the placebo group (RR 0.28,
95%CI 0.12 to 0.66). Mode of delivery was not reported by study
group.
D I S C U S S I O N
This review included two trials. There were no differences seen
in any of the primary outcome measures described in this review.
Unfortunately, the quality of the trials was difcult to assess be-
cause of insufcient detail in the research papers, and the small
sample sizes provide inadequate power.
There is little research to assess the effectiveness of remedies in
stimulating the onset of labour. The lack of data inthis area is com-
pounded by a lack of relevant clinical outcome data which could
be included into this review. The use of caulophyllum may not
represent common homoeopathic practice, where the prescribing
of a therapy would be more individualised.
A U T H O R S C O N C L U S I O N S
Implications for practice
There is insufcient evidence to recommend the use of any ho-
moeopathic therapies as a method of induction of labour.
Implications for research
Given that some women are likely to continue to seek homoeo-
pathic therapies for induction of labour, there is a need for rig-
orous, adequately powered trials that assess clinically meaningful
outcomes. Such trials should include assessment of uterine hyper-
stimulation as well as indicators of maternal and neonatal morbid-
ity. Further research using classical homoeopathy might be more
relevant toassessing boththe effectiveness andsafety of homoeopa-
thy.
A C K N O W L E D G E M E N T S
The author would like to thank Bettina Hinger for the German
to English translation (Beer 1999) and Alison Ledward for the
French to English translation (Dorfman 1987).
R E F E R E N C E S
References to studies included in this review
Beer 1999 {published data only}
Beer AM, Heiliger F. Randomized, double blind trial
of Caulophyllum D4 for induction of labour after
premature rupture of membranes at term. Gerburtshilfe und
Frauenheilkunde 1999;59:4315.
Dorfman 1987 {published data only}
Dorfman P, Lasserre M, Tetau M. Homoeopathic
preparation for labour: two fold experiment comparing
a less widely known therapy with a placebo. Cahiers de
Biotherapie 1987;94:7781.
References to studies excluded from this review
Arnal-Laserre 1986 {published data only}
Arnal-Laserre MN. Preparation a laccouchement par
homeopathie: experimentation en double insu versus placebo
(Dissertation). Paris: Academie de Paris, Universite Rene
Descartes, 1986.
Coudert-Deguillaume 1981 {published data only}
Coudert-Deguillaume M. Etude laccouchement par
homeopthie: experimentation en double insu versus placebo
[Dissertation]. Limoges: Faculte de Medecine et de
Pharmacie, Universite de Limoges, 1981.
Additional references
Alrevic 2006
Alrevic Z, Weeks A. Oral misoprostol for induction of
labour. Cochrane Database of Systematic Reviews 2006, Issue
2. [DOI: 10.1002/14651858.CD001338.pub2]
Allaire 2000
Allaire AD, Moos M, Wells SR. Complementary and
alternative medicine in pregnancy: a survey of North
Carolina nurse-midwives. Obstetrics & Gynecology 2000;95
(1):1923.
Boissel 1996
Boissel JP, Cucherat M, Haugh M, Gauthier E. Critical
literature on the effectiveness of homoeopathy: overview of
data from homoeopathic medicine trials.. Homoeopathic
Medicine Research Group, editors. Report. Brussels:
Commission of the European Communities 1996:195-210.
Boulvain 2001
Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical
methods for induction of labour. Cochrane Database
of Systematic Reviews 2001, Issue 4. [DOI: 10.1002/
14651858.CD001233]
Boulvain 2005
Boulvain M, Stan C, Irion O. Membrane sweeping
for induction of labour. Cochrane Database of
Systematic Reviews 2005, Issue 1. [DOI: 10.1002/
14651858.CD000451.pub2]
Boulvain 2008
Boulvain M, Kelly AJ, Irion O. Intracervical prostaglandins
14651858.CD006971]
Bricker 2000
Bricker L, Luckas M. Amniotomy alone for induction of
4. [DOI: 10.1002/14651858.CD002862]
Clarke 2002
Clarke M, Oxman AD, editors. Cochrane Reviewers
Handbook 4.2.0 [updated March 2003]. In: The Cochrane
Library, Issue 2, 2003. Oxford: Update Software. Updated
quarterly.
Curtis 1987
Curtis P, Evans S, Resnick J. Uterine hyperstimulation.
The need for standard terminology. Journal of Reproductive
Medicine 1987;32:915.
Eisenberg 1998
Eisenberg DA, Davis RB, Ettner SL, Appel S, Wilky S,
Van Rompay M. Trends in alternative medicine use in the
United States, 1990-1997: results of a follow up national
survey. JAMA 1998;280:156975.
French 2001
French L. Oral prostaglandin E2 for induction of labour.
Cochrane Database of Systematic Reviews 2001, Issue 2.
[DOI: 10.1002/14651858.CD003098]
Hofmeyr 2003
Hofmeyr GJ, Glmezoglu AM. Vaginal misoprostol for
cervical ripening and induction of labour. Cochrane
Database of Systematic Reviews 2003, Issue 1. [DOI:
10.1002/14651858.CD000941]
Hofmeyr 2009
Hofmeyr GJ, Alrevic Z, Kelly AJ, Kavanagh J, Thomas
J, Neilson JP, Dowswell T. Methods for cervical ripening
and labour induction in late pregnancy: generic protocol.
[DOI: 10.1002/14651858.CD002074.pub2]
Howarth 2001
Howarth GR, Botha DJ. Amniotomy plus intravenous
oxytocin for induction of labour. Cochrane Database
14651858.CD003250]
Hutton 2001
Hutton E, Mozurkewich E. Extra-amniotic prostaglandin for
induction of labour. Cochrane Database of Systematic Reviews
2001, Issue 2. [DOI: 10.1002/14651858.CD003092]
Kavanagh 2001
Kavanagh J, Kelly AJ, Thomas J. Sexual intercourse for
10.1002/14651858.CD003093]
Kavanagh 2005
Kavanagh J, Kelly AJ, Thomas J. Breast stimulation for
10.1002/14651858.CD003392.pub2]
Kavanagh 2006a
Kavanagh J, Kelly AJ, Thomas J. Corticosteroids
14651858.CD003100.pub2]
Kavanagh 2006b
Kavanagh J, Kelly AJ, Thomas J. Hyaluronidase for cervical
priming and induction of labour. Cochrane Database
14651858.CD003097.pub2]
Kelly 2001a
Kelly AJ, Kavanagh J, Thomas J. Relaxin for cervical
ripening and induction of labour. Cochrane Database
14651858.CD003103]
Kelly 2001b
Kelly AJ, Kavanagh J, Thomas J. Castor oil, bath and/
or enema for cervical priming and induction of labour.
[DOI: 10.1002/14651858.CD003099]
Kelly 2001c
Kelly AJ, Tan BP. Intravenous oxytocin alone for cervical
14651858.CD003246]
Kelly 2003
Kelly AJ, Kavanagh J, Thomas J. Vaginal prostaglandin
(PGE2 and PGF2a) for induction of labour at term.
[DOI: 10.1002/14651858.CD003101]
Kelly 2008
Kelly AJ, Kavanagh J. Nitric oxide donors for cervical
14651858.CD006901]
Linde 1997
Linde K, Clausius N, Ramirez G, Melchart D, Eitel F,
Hedges LV, et al.Are the clinical effects of homoeopathy
placebo effects? A meta analysis of placebo controlled trials.
Lancet 1997;350:8343.
Luckas 2000
Luckas M, Bricker L. Intravenous prostaglandin for
induction of labour. Cochrane Database of Systematic Reviews
2000, Issue 4. [DOI: 10.1002/14651858.CD002864]
MacLennan 2002
MacLennan AH, Wilson DH, Taylor AW. The escalating
cost of alternative medicine. Preventive Medicine 2002;35:
16673.
Muzonzini 2004
Muzonzini G, Hofmeyr GJ. Buccal or sublingual
misoprostol for cervical ripening and induction of labour.
[DOI: 10.1002/14651858.CD004221.pub2]
Neilson 2000
Neilson JP. Mifepristone for induction of labour. Cochrane
10.1002/14651858.CD002865]
Priestman 1988
Priestman KG. A few useful remedies in pregnancy, labour
and the rst few days of the babies life. British Homeopathy
Journal 1988;77:1723.
RevMan 2003
The Cochrane Collaboration. Review Manager (RevMan).
4.2 for Windows. Oxford, England: The Cochrane
Collaboration, 2003.
Smith 2004
Smith CA, Crowther CA. Acupuncture for induction of
1. [DOI: 10.1002/14651858.CD002962.pub2]
Thomas 2001
Thomas J, Kelly AJ, Kavanagh J. Oestrogens alone or with
amniotomy for cervical ripening or induction of labour.
[DOI: 10.1002/14651858.CD003393]
Vandenbrouke 1997
Vandenbroucke JP. Homoeopathy trials: going nowhere.
Lancet 1997;350:824.
Ventoskovskiy 1990
Ventoskovskiy BM, Popov AV. Homeopathy as a practical
alternative to traditional obstetric methods. British
Homeopathy Journal 1990;79(4):2015.
References to other published versions of this review
Smith 2003
Smith CA. Homoeopathy for induction of labour (Cochrane
Review). Cochrane Database of Systematic Reviews 2003,
Issue 4. [DOI: 10.1002/14651858.CD003399]
Indicates the major publication for the study

C H A R A C T E R I S T I C S O F S T U D I E S
Characteristics of included studies [ordered by study ID]
Beer 1999
Methods Double-blind placebo controlled trial. The method of allocation concealment was unclear
Participants 40 women 38-42 weeks gestation with PROM. The study was undertaken in Germany
Interventions Caulophyllum D4 or a placebo tablet. Doses were repeated hourly for 7 hours or until labour started
Outcomes Time to the onset of regular uterine contractions, labour and delivery outcomes. Maternal and neonatal
infection
Notes No sample size calculation. No losses to follow up.
Risk of bias
Item Authors judgement Description
Allocation concealment? Unclear B - Unclear.
Dorfman 1987
Methods Double-blind placebo controlled trial. The method of concealment was not described
Participants 93 women were recruited to the study at 36 weeks gestation. The study was undertaken in France.
Women were excluded from the study if they had a history of a poor obstetric history, a current history
of hypertension, diabetes, previous caesarean section or cephalo-pelvic disproportion
Interventions The treatment group received 5 homoeopathic therapies: caulophyllum, arnica, actea racemosa, pulsatilla
and gerenium, with three granules administered morning and evening from 36 weeks gestation. When
labour commenced, the same dosage was given every 15 minutes and stopped after 2 hours or sooner if
the woman was comfortable. Not details were provided on the placebo or the precise dosage
Outcomes Average length of labour and difcult labour.
Notes No sample size calculation. No losses to follow up.
Risk of bias
Item Authors judgement Description
Allocation concealment? Unclear B - Unclear.
PROM: prelabour rupture of membranes
Characteristics of excluded studies [ordered by study ID]
Study Reason for exclusion
Arnal-Laserre 1986 We have been unable to contact the authors, and do not have enough information to make a decision
whether the trial meets the inclusion criteria
Coudert-Deguillaume 1981 We have been unable to contact the authors, and do not have enough information to make a decision
whether the trial meets the inclusion criteria
D A T A A N D A N A L Y S E S
Comparison 1. Homoeopathy versus placebo
Outcome or subgroup title
No. of
studies
No. of
participants
Statistical method Effect size
3 Caesarean section 1 40 Risk Ratio (M-H, Fixed, 95% CI) 5.0 [0.26, 98.00]
No. of
studies
No. of
participants
1 Vaginal delivery not achieved
within 24 hours
1 40 Risk Ratio (M-H, Fixed, 95% CI) 0.33 [0.01, 7.72]
No. of
studies
No. of
participants
1 Augmentation with oxytocin 1 40 Risk Ratio (M-H, Fixed, 95% CI) 1.0 [0.50, 1.98]
No. of
studies
No. of
participants
1 Instrumental delivery 1 40 Risk Ratio (M-H, Fixed, 95% CI) 1.0 [0.54, 1.86]
No. of
studies
No. of
participants
2 Length of labour 1 40 Mean Difference (IV, Fixed, 95% CI) -0.40 [-7.21, 6.41]
No. of
studies
No. of
participants
1 Difcult labour 1 93 Risk Ratio (M-H, Fixed, 95% CI) 0.28 [0.12, 0.66]
Analysis 1.3. Comparison 1 Homoeopathy versus placebo, Outcome 3 Caesarean section.
Review: Homoeopathy for induction of labour
Comparison: 1 Homoeopathy versus placebo
Outcome: 3 Caesarean section
Study or subgroup Treatment Control Risk Ratio Weight Risk Ratio
n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
Beer 1999 2/20 0/20 100.0 % 5.00 [ 0.26, 98.00 ]
Total (95% CI) 20 20 100.0 % 5.00 [ 0.26, 98.00 ]
Total events: 2 (Treatment), 0 (Control)
Heterogeneity: not applicable
Test for overall effect: Z = 1.06 (P = 0.29)
0.1 0.2 0.5 1 2 5 10
Favours treatment Favours control
Analysis 2.1. Comparison 2 Homoeopathy versus placebo, Outcome 1 Vaginal delivery not achieved within
24 hours.
Outcome: 1 Vaginal delivery not achieved within 24 hours
Beer 1999 0/20 1/20 100.0 % 0.33 [ 0.01, 7.72 ]
Total (95% CI) 20 20 100.0 % 0.33 [ 0.01, 7.72 ]
0.1 0.2 0.5 1 2 5 10
Analysis 3.1. Comparison 3 Homoeopathy versus placebo, Outcome 1 Augmentation with oxytocin.
Outcome: 1 Augmentation with oxytocin
Beer 1999 9/20 9/20 100.0 % 1.00 [ 0.50, 1.98 ]
Total (95% CI) 20 20 100.0 % 1.00 [ 0.50, 1.98 ]
0.1 0.2 0.5 1 2 5 10
Analysis 4.1. Comparison 4 Homoeopathy versus placebo, Outcome 1 Instrumental delivery.
Outcome: 1 Instrumental delivery
Beer 1999 10/20 10/20 100.0 % 1.00 [ 0.54, 1.86 ]
Total (95% CI) 20 20 100.0 % 1.00 [ 0.54, 1.86 ]
0.1 0.2 0.5 1 2 5 10
Analysis 5.2. Comparison 5 Homoeopathy versus placebo, Outcome 2 Length of labour.
Outcome: 2 Length of labour
Study or subgroup Treatment Control
Mean
Difference Weight
Mean
Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI
Beer 1999 20 13 (11.81) 20 13.4 (10.1) 100.0 % -0.40 [ -7.21, 6.41 ]
Total (95% CI) 20 20 100.0 % -0.40 [ -7.21, 6.41 ]
Test for subgroup differences: Not applicable
-10 -5 0 5 10
Favours control Favours treatment
Analysis 6.1. Comparison 6 Homoeopathy versus placebo, Outcome 1 Difcult labour.
Outcome: 1 Difcult labour
Dorfman 1987 6/53 16/40 100.0 % 0.28 [ 0.12, 0.66 ]
Total (95% CI) 53 40 100.0 % 0.28 [ 0.12, 0.66 ]
0.1 0.2 0.5 1 2 5 10
Favours control Favours treatment
A P P E N D I C E S
Appendix 1. Methodological quality of trials
Methodological item Adequate Inadequate
Generation of random sequence Computer-generated sequence, random num-
ber tables, lot drawing, coin tossing, shufing
cards, throwing dice
Case number, date of birth, date of admission,
alternation.
Concealment of allocation Central randomisation, coded drug boxes, se-
quentially sealed opaque envelopes
Open allocation sequence, any procedure based
on inadequate generation
W H A T S N E W
Last assessed as up-to-date: 13 January 2010.
Date Event Description
12 January 2010 New search has been performed Search updated. No newtrials identied. Two trials, previously identied, have
been translated and are now excluded
H I S T O R Y
Protocol rst published: Issue 2, 2000
Review rst published: Issue 4, 2001
Date Event Description
3 September 2008 Amended Converted to new review format.
29 July 2003 New citation required and conclusions have changed Substantive amendment.
13 May 2003 New search has been performed This update includes one new trial. Two further trials
have been identied and will be included in a future up-
date when they have been translated. The Implications
for research section has also been updated.
C O N T R I B U T I O N S O F A U T H O R S
The review author prepared the review, selected studies for inclusion, extracted the data and prepared the text of the review.
D E C L A R A T I O N S O F I N T E R E S T
None known.
S O U R C E S O F S U P P O R T
Internal sources
University of Adelaide, Adelaide, Australia.
University of South Australia, Adelaide, Australia.
External sources
No sources of support supplied
I N D E X T E R M S
Medical Subject Headings (MeSH)
Caulophyllum;

Cervical Ripening;

Homeopathy;

Labor, Induced; Randomized Controlled Trials as Topic
MeSH check words
Female; Humans; Pregnancy

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