Saudi Pharmaceutical Journal xxx (2017) xxxxxx

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Original article

The comparative study of clinical efficacy and safety of baclofen vs

tolperisone in spasticity caused by spinal cord injury
Dejun Luo , Guoyong Wu, Yong Ji, Zhaoyao Zhang, Fayou He, Xiaping Mou, Qingmao Zhu, Bo Yang
Department of Orthopedics, Jianyang Peoples Hospital of Sichuan, Jianyang 641400, China

a r t i c l e i n f o a b s t r a c t

Article history: In the present study we compared the clinical efficacy and safety of baclofen vs tolperisone in spasticity
Available online xxxx caused by spinal cord injury. A total of 150 patients were enrolled in the present study and were divided
into two groups with 75 patients in each group, receiving baclofen or tolperisone, respectively. We used
Keywords: Modified Ashworth Scale, Medical research council scale, Barthel Index, and Coefficient of efficacy to
Spinal cord injury measure clinical efficacy. After 6-week treatment, both groups demonstrated significant improvement
Spasticity in muscle tone, muscle strength and functional outcome (Group I, 1.55 0.053, 2.79 0.032,
Baclofen
59.31 1.32; Group II, 1.57 0.053, 3.04 0.032, 73 1.32 respectively). There was no significant differ-
Tolperisone
ence regarding improvement in muscle tone and muscle strength between the two groups (Group I,
1.055 0.053 vs Group II, 1.57 0.053; Group I, 2.79 0.032 vs Group II, 3.04 0.032, p > 0.05).
However, the improvement in functional outcomes was greater in group II as compared to that in group
I (Group I, 59.31 1.32 vs Group II, 73 1.32, p < 0.05). In addition, overall efficacy coefficient was greater
for group II as compared to group I (Group I, 3.6 vs Group II, 2.3, p < 0.05). Group I had more side effects
compared to Group II. Compared to baclofen, tolperisone offers greater improvement in activities of daily
living compared to baclofen.
2017 The Authors. Production and hosting by Elsevier B.V. on behalf of King Saud University. This is an
open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

1. Introduction
As a typical sign of upper motor neuron dysfunction, spasticity
happens due to disruptions in inhibitory descending spinal motor
pathways (Lance, 1980). The characteristics of spasticity appear
due to hyper excitability of the stretch reflex including exaggerated
tendon jerks and a velocity dependent increase in muscle tone
(Lance, 1980). Currently, there are 12 million patients suffering
from spasticity worldwide. The commonest causes of spasticity
include cerebral palsy (CP), and spinal cord injury (Wang et al.,
2015; Lance, 1980; Halim et al., 2017).
A variety of underlying mechanisms of spasticity have been
reported for spasticity, including damage of descending inhibitory
pathways and creation of new synapses by motor neurons which
have lost their supraspinal innervations (Young, 1994). Spasticity
Corresponding author. Tel.: +86 13982937426, +86 02827237810.
E-mail address: luodejunde@qq.com (D. Luo).
Peer review under responsibility of King Saud University.
Production and hosting by Elsevier
can be classified into two categories including positive and nega-
tive spasticity, depending upon the upper motor neuron signs. Pos-
itive spasticity signs include hyperreflexia, clonus, spasms, and
postural abnormalities, while negative spasticity signs include loss
of dexterity, loss of strength, fatigue, and pain. The spasticity treat-
ment is usually focused on the positive upper motor neuron signs
(Luo et al., 2016; Dietz and Sinkjaer, 2007). The spasticity treat-
ment objectives are to facilitate rehabilitation, increase daily activ-
ities, prevent contractures, and relieve pain. The previous studies
have shown that the maintenance of a certain level of spasticity
may be beneficial for some patients to support body posture
(Taricco et al., 2000; Shakespeare et al., 2003). Currently, all
reviews based on clinical trials demonstrated limited evidence
for evaluating the clinical efficacy of a variety of drugs to relieve
spasticity.
As one of the most common drug used for the treatment of
spasticity, oral baclofen has been used on a long term basis
(Dario and Tomei, 2004), which is a c-aminobutyric acid receptor
B (GABA-B) agonist. Although there are a variety of GABA-B recep-
tors in the spinal cord (Liu et al., 2015; Yine et al., 2015; Yang et al.,
2001), baclofen preferentially binds to pre-synaptic receptors,
resulting in a decrease of release of neurotransmitters (Khaliq
et al., 2016; Price et al., 1984). In addition, baclofen increases the

http://dx.doi.org/10.1016/j.jsps.2017.04.041
1319-0164/ 2017 The Authors. Production and hosting by Elsevier B.V. on behalf of King Saud University.
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Please cite this article in press as: Luo, D., et al. The comparative study of clinical efficacy and safety of baclofen vs tolperisone in spasticity caused by spinal
cord injury. Saudi Pharmaceutical Journal (2017), http://dx.doi.org/10.1016/j.jsps.2017.04.041
2 D. Luo et al. / Saudi Pharmaceutical Journal xxx (2017) xxxxxx
total persistent inward current in motoneurons as it increases
more of sodium current compared to the calcium flow reduction
(Bennett, 2004). The previous studies have shown that baclofen
decreases hyperreflexia, muscle tone and contractions of paralyzed
muscles (Li et al., 2005; Taricco et al., 2006) and just one-week
treatment has shown positive impact on voluntary muscle strength
for patients with multiple sclerosis (Pedersen et al., 1970; Nielsen
and Sinkjaer, 2000).
Recently, tolperisone has been to be an effective and safe mus-
cle relaxant for patients with spasticity. It stabilizes nerve mem-
brane and inhibits pathologic mono- and polysynaptic reflex
activity (Dulin et al., 1998; Pratzel et al., 1996). Unlike other mus-
cle relaxants, tolperisone has no substantial affinity to cholinergic,
serotonergic, dopaminergic or adrenergic receptors in the central
nervous system, thus without sedation or withdrawal phe-
nomenon (Dulin et al., 1998). However, there are very few trials
available which ensures the clinical efficacy and safety of tolperi-
sone. In addition, only few studies are available assessing the clin-
ical efficacy and safety of tolperisone in spasticity after stroke and
no studies are available for SCI and CP related spasticity
(Stamenova et al., 2006; Rahman et al., 2017; Sarfraz et al.,
2017). The aim of the present study is to compare and evaluate
the clinical efficacy and safety of baclofen vs tolperisone for spas-
ticity of patients with spinal cord injury.
2. Materials and methods
2.1. Patients
A total of 150 patients with spasticity due to spinal cord injury
were enrolled in the present study. Patients were enrolled from
January 2011 to Dec 2014. The study protocol was reviewed
approved by the Medical Ethics Committee of West China Hospital
(Chengdu, Sichuan, China). All patients provided written consent
forms. The patients were randomly divided into two groups includ-
ing group I patient receiving baclofen and group II patients
receiving tolperisone.
2.2. Inclusion criteria
(a) lower limb muscles spasticity including medial hamstring
and hip adductors muscle; (b) diagnosis of severe chronic spastic
hypertonia in the lower extremities for
six-month duration; (c)
the degree of spasticity
level 3 according to the Ashworth Scale;
(d) muscle strength 2 according to the medical research council
scale (MRC); (e) functional outcomes 50 according to the Barthal
Index (BI).
2.3. Exclusion criteria
(a) Concomitant neurological disease, orthopedic illness or any
other disease likely to alter muscle tone, hamper motility, or influ-
ence the aim of the trial otherwise; (b) allergy to tolperisone or
baclofen; (c) women in reproductive age without safe contracep-
tion, pregnancy or lactation period.
2.4. Treatment
In group I, baclofen was initiated at 510 mg 2 or 3 times per
day, and the dosage was gradually increased at 510 mg per week,
until up to 80 mg per day. In group II, tolperisone was initiated at
150450 mg per day until up to 600 mg per day. The data were
measured before treatment, at week 2, 4, and 6.
Please cite this article in press as: Luo, D., et al. The comparative study of clinical efficacy and safety of baclofen vs tolperisone in spasticity caused by spinal
cord injury. Saudi Pharmaceutical Journal (2017), http://dx.doi.org/10.1016/j.jsps.2017.04.041
2.5. Outcome measures
2.5.1. Muscle tone
Muscle tone was measured by MAS (Bohannon and Smith,
1987) with 0 = No increase in muscle tone, 1 = Slight increase in
muscle tone, manifested by a catch and release or by minimal
resistance at the end range of motion when the part is moved in
flexion or extension/abduction or adduction, etc, 1 + = Slight
increase in muscle tone, manifested by a catch, followed by mini-
mal resistance throughout the remainder (less than half) of the
range of motion (ROM), 2 = More marked increase in muscle tone
through most of the ROM, but the affected part is easily moved,
3 = Considerable increase in muscle tone, passive movement is dif-
ficult, 4 = Affected part is rigid in flexion or extension (abduction or
adduction, etc.).
2.5.2. Muscle strength
Muscle strength was measured by MRC (Paternostro-Sluga
et al., 2008) with 0 = No contraction, 1 = Flicker or trace of contrac-
tion, 2 = Active movement with gravity eliminated, 3 = Active
movement against gravity, 4 = Active move-ment against gravity
and resistance, 5 = Normal power.
2.5.3. Functional outcomes
Functional outcomes were measured by BI (Collin et al., 1988)
in the form of 0100 scores with 0 = total dependence and
100 = total independence.
2.6. Safety
The adverse events and side effects were observed and recorded
by attending physicians and nurses by daily monitoring.
2.7. Statistical analysis
SPSS 17.0 package was used for statistical analyses. Parameters
were expressed in mean standard deviation (x s) using repeated
measures analysis of variance. When the spherical test condition
(a = 0.1) was unsatisfied, Greenhouse-Geisser adjustment was
applied. Paired t test or paired rank sum test method were used
for the self-comparison in each time point. T test or rank sum test
method was used for the comparison of the changes of parameters
with the significance level of P < 0.05. Sigmaplot 10.0 software was
used for plotting.
3. Results
3.1. Baseline characteristics
As shown in Table 1, Group I had 75 patients with mean age
36.6 1.7 years and group II had 75 patients with mean age
35.5 1.5 years. The body weight for group I and group II were
57.7 5.6 kg and 55.2 5.0 kg, respectively. There were no signifi-
cant differences regarding age and body weight between the two
groups.
Table 1
Demographic and baseline characteristics of all patients.
Indexes Group I (n = 75) Group II (n = 75) P value
Sex (M/F) 20/55 27/48
Age (years) 36.6 1.7 35.5 1.5 0.105
Body weight (kg) 57.7 5.6 55.2 5.0 0.175
Mean dosage 24.33 12.5 mg/day 378.2 102.1 U
Values are expressed as Mean + SEM.
 D. Luo et al. / Saudi Pharmaceutical Journal xxx (2017) xxxxxx 3

3.2. Muscle tone 3.4. Functional outcome

As shown in Tables 2 and 3 and Fig. 1A, MAS was significantly
decreased over the six-week period in both groups, from
3.34 0.05 to 1.55 0.05 and 3.33 0.03 to 1.57 0.05, for group
I and II, respectively. In addition, compared with those in group
II, MAS at week 2 and 4 in group I were significantly lower
(1.77 0.05 vs 2.39 0.03; 1.59 0.08 vs 2.21 0.08; p = 0.003
and 0.02, respectively). However, at the week 6, the difference
was not significant (1.55 0.05 vs 1.57 0.05, p = 0.25).
As shown in Tables 2, 3 and Fig. 1C, There were significant
increases in BI score at week 6 as compared to the baseline for both
groups, from 36.05 1.41 to 59.31 1.32 and from 38.53 1.41 to
73.35 1.32 for group I and II, respectively. In addition, compared
with those in group I, BI scores in group II were significantly higher
at week 2, 4, and 6, respectively (42.05 2.75 vs 51.53.80 1.63;
52.32 2.75 vs 63.8 1.63; 59.31 1.43 vs 73 1.24, P = 0.035,
0.022, 0.037).

3.5. Adverse events and side effects

3.3. Muscle strength
As shown in Table 4, asthenia was the most frequent adverse
As shown in Tables 2 and 3 and Fig. 1B, MRC was significantly event both in the group I (26.7% of patients) and in the group II
increased over the six-week period in both groups, from (4%) followed by sleepiness in the group I (6.7%) and in group II
1.31 0.05 to 2.79 0.03 and 1.41 0.06 to 3.05 0.03, for group (1.3%). In all cases, adverse events were of mild intensity and
I and II, respectively. In addition, compared with those in group resolved rapidly.
II, MRC at week 2 and 4 in group I were significantly higher
(1.77 0.05 vs 2.39 0.03; 1.59 0.08 vs 2.21 0.08; p = 0.003
and 0.02, respectively). However, at the week 6, there was no sig-
nificant difference between the two groups at week 6 (2.79 0.03
vs 3.05 0.03, P = 0.07).

Table 2
Effect of baclofen on muscle strength, muscle tone and functional outcomes.

Indexes Time points Values P values

MAS Baseline 3.34 0.05
Week 2 1.77 0.05* 0.001
Week 4 1.59 0.08* 0.045
Week 6 1.55 0.05* 0.048
MRC Baseline 1.31 0.05
Week 2 2.90 0.09* 0.001
Week 4 3.11 0.03# 0.043
Week 6 2.79 0.03y 0.033
BI Baseline 36.05 1.41
Week 2 42.05 2.34* 0.045
Week 4 52.32 2.05# 0.039
Week 6 59.31 1.32y 0.041

Values are expressed as Mean SEM.

Abbreviations: MAS, Modified Ashworth Scale; MRC, Medical Research Council; BI,
Barthel Index.
*
Note: Significantly different from baseline (P < 0.05).
#
Significantly different from 2nd week (P < 0.05).
y
Significantly different from 4th week (P < 0.05).

Table 3
Effect of tolperisone on muscle strength, muscle tone and functional outcomes.

Indexes Time points Values P values

MAS Baseline 3.33 0.03
Week 2 2.39 0.03* 0.012
Week 4 2.21 0.08* 0.035
Week 6 1.57 0.05y 0.002
MRC Baseline 1.41 0.06
Week 2 1.71 0.09* 0.023
Week 4 2.46 0.03# 0.040
Week 6 3.05 0.03y 0.014
BI Baseline 38.53 1.41
Week 2 51.53 2.34* 0.001
Week 4 63.80 2.50# 0.021
Week 6 73.35 1.32y 0.034

Values are expressed as Mean SEM.

Abbreviations: MAS, Modified Ashworth Scale; MRC, Medical Research Council; BI,
Barthel Index.
*
Note: Significantly different from baseline (P < 0.05).
#
Significantly different from 2nd week (P < 0.05). Fig. 1. Differences between the groups (a) Change in MAS, (b) Change in MRC score,
y
Significantly different from 4th week (P < 0.05). (c) Change in BI index. Values are expressed as Mean + SEM.

Please cite this article in press as: Luo, D., et al. The comparative study of clinical efficacy and safety of baclofen vs tolperisone in spasticity caused by spinal
cord injury. Saudi Pharmaceutical Journal (2017), http://dx.doi.org/10.1016/j.jsps.2017.04.041
4 D. Luo et al. / Saudi Pharmaceutical Journal xxx (2017) xxxxxx

Table 4 Kovalchuk et al. (2008) have found that patients receiving tolper-
Adverse events and side effects during the study. isone treatment demonstrated higher level of daily domestic skills
Adverse events/side effects Group I (n = 75) Group II (n = 75) compared with those receiving baclofen. Therefore, baclofen was
Amenorrhea 1(1.3) 0(0.0) found to be inferior to tolperisone in terms of exerting reliable sig-
Anorexia 1(1.3) 0(0.0) nificant positive effect on the level of domestic adaptation for
Asthenia 20(26.7) 3(4.0) patients with stroke.
Cramps 0(0.0) 1(1.3) However, there were some limitations in the present study.
Dyspepsia 0(0.0) 1(1.3)
Eczema 0(0.0) 1(1.3)
Firstly, the present study was conducted using relatively small
Epigastric pain 0(0.0) 2(2.7) sample size of patients in a single institution. Therefore,
Headache 0(0.0) 1(1.3) multiple-centered studies with larger sample size of penitents will
Hypochondrial pain 1(1.3) 0(0.0) be needed to verify our results and conclusions. Secondly, in the
Hyposthenia in lower limbs 4(5.3) 0(0.0)
present study, baclofen and tolperisone were given based on our
Hypotonia 0(0.0) 1(1.3)
Insomnia 0(0.0) 1(1.3) clinical experience. However, the best regimen for baclofen and
Itching 0(0.0) 1(1.3) tolperisone administration has been unknown. Therefore, we rec-
Paresthesia 1(1.3) 0(0.0) ommended conduct further studies to verify our results and con-
Sciatica 1(1.3) 0(0.0) clusion and determine the best regimen for baclofen and
Sleepiness 5(6.7) 1(1.3)
tolperisone administration.
Sweating 1(1.3) 0(0.0)
Vertigo 1(1.3) 1(1.3)
Total 36(48.0) 14(18.7) 5. Conclusions

In conclusion, baclofen is inferior to tolperisone in terms of effi-

4. Discussion
In present study, both groups demonstrated significant decline
in MAS, suggesting that both drugs have beneficial effects on mus-
cle tone. However, the beneficial effects of baclofen were short
term and not significant between week 2 and week 4 & week 4
and week 6, which was consistent with the previous study
(Bresolin et al., 2009). The previous study suggested that baclofen
showed 50% reduction in MAS after 2-week treatment. However,
the difference between week 2 and week 6 became insignificant
(Safi et al., 2015; Atta et al., 2017). The possible reasons might be
that the long-term application of baclofen increases the motor unit
weakness which make the whole muscle weaker and fatigable.
Thomas et al. (2010) have shown that the long-term use of baclo-
fen reduced muscle activity and maximal tetanic forces.
In addition, the improvement of MAS by tolperisone treatment
were consistent with the previous studies (Stamenova et al., 2010).
Stamenova et al. (2010) have shown that tolperisone at 300
450 mg per day resulted in 42% improvement of the Ashworth
score in patients with stroke. Furthermore, The Ashworth score
was reduced by 1.03 0.71 in tolperisone subjects vs 0.47 0.54
in placebo subjects (p < 0.001). Van Denburg et al. (2008) have
found a 33% change in the Ashworth score to correlate with a 1-
point change in the Physicians global assessment score in patients
with post-stroke spasticity, indicating clinical relevance (Zhao and
Ashraf, 2016; Huang et al., 2015; Ishaq and Jafri, 2017).
To date, there is only one comparative trials (Kovalchuk et al.,
2008) comparing the clinical efficacy of baclofen vs tolperisone.
The results found that, compared with baclofen, tolperisone was
a more effective muscle relaxant, causing reliable improvement
in muscle tone for patients with stroke. Baclofen did not cause sig-
nificant positive effect for muscular tone for patients with stroke.
In the present study, we found that both groups had significant
improvement of muscle strength. However, there was a MRC
decline from the week 4 to week 6 in group I. In addition, com-
pared with that of group I, MRI of group II was significantly higher.
Furthermore, we found the significant changes regarding BI
scores in both the groups. At week 6, the group II showed signifi-
cantly higher BI score compared with that of the group I, which
was consistent with previous studies (Kovalchuk et al., 2008;
Muhammad et al., 2017). Fehr et al. (1985) have shown that, com-
pared with those in baclofen group, the Rivermead and the Barthel
scales was higher in tolperisone group, with the difference being
statistically significant for the Rivermead scale (P < 0.05).
cacy and safety in the treatment of spasticity for patients with
spinal cord injury. On long-term treatment, baclofen demonstrated
negative effect on muscle tone and strength, while tolperisone
showed high efficacy for improvement in daily domestic adapta-
tion and quality of life. In addition, tolperisone had lesser adverse
events and side effects compared to baclofen.
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Bajaj, P., Arendt-Nielsen, L., Madeleine, P., et al., 2003. Prophylactic tolperisone for
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motor development in children with cerebral palsy aged 1 to 15 years. Dev.
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Pandyan, A., Gregoric, M., Barnes, M., 2005. Spasticity clinical perceptions,
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representative of a class of centrally acting muscle relaxants with less sedative
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placebo-controlled study of the efficacy and safety of tolperisone in spasticity
following cerebral stroke. Eur. J. Neurol. 12, 453461.