Table 1
Characteristics of trials included in the systematic review.
Authors/country Study design and sample size
(gender; male and female)
Beltrame. Observational study
et al. (2008)/Italy N = 100 (M: 38 and F: 62)
N = 96 subjects completed the
study
Sartini and Guerra Observational study
(2008)/Italy N = 100 (M: 41 and F: 59)
N = 100 patients completed the
study
Sakai et al. A randomized controlled trial
(2008)/Japan N = 74 (M) subjects randomized
to control (n = 25), eperisone
(n = 24) and McKenzie (n = 25)
group
Cabitza and Randelli A multicentre randomized,
(2008)/Italy double blind, double-dummy
clinical trial study
N = 160 (M: 49 and F: 111);
eperisone (n = 80; M: 28 and F:
52) and thiocolchicoside (n = 80;
M: 21 and F: 59)
Age in year Treatments and Duration Outcome measures Adverse effects
(mean age  SD) dosage
type of pain
19–75 years Eperisone 50 mg 10 days Eperisone therapy showed GI tract (nausea; n = 2 and nausea
(50.02  47) TID significant VAS score reductions and epigastric pain; n = 2)
Acute LBP in
- Spontaneous and provoked
pain
- Muscle contracture
- Resistance to passive
movement
- Antalgic rigidity and
- Hand-to-floor distance
18–70 years Eperisone100 mg 10 days Eperisone treatment Light-headedness (n = 1), vertigo
(47.62  14.6) TID significantly decreased (VAS) (n = 2), loss of equilibrium (n = 1),
Acute LBP - Spontaneous pain and pain somnolence (n = 2) and
on movement epigastric pain (n = 1)
S. Bavage et al. / Pharmacological Reports 68 (2016) 903–912
- Muscle contracture
- Resistance to passive
movements
- Antalgic rigidity
- Spinal functional impairment
and
- Hand-to-floor distance
>20 years Eperisone 50 mg 4 weeks Eperisone therapy Eperisone in all treated subjects
Chronic LBP TID - Reduced VAS pain score when showed no adverse events
(>6 months) compared with control group,
but not with McKenzie group
- Showed significant relative
change of oxygenated (p < 0.01)
as well as deoxygenated
(p < 0.05) haemoglobin,
respectively, during lumbar
extension and lumbar flexion
- Shortened (p < 0.01) the time
to peak of oxygenated
haemoglobin rise
Eperisone (47.43  10.94) Eperisone; 100 mg 12 days Eperisone and thiocolchicoside Eperisone group; GI side effects
and thiocolchicoside TID and showed comparable efficacy in (n = 4; 5%)
(48.49  11.75) thiocolchicoside; - In spontaneous and Thiocolchicoside; GI side effects
Acute LBP 8 mg TID movement related pain (VAS with diarrhoea of moderate
score) intensity (n = 17; 21.25%)
- Hand-to-floor distance and
- Articular excursion
(Lasegue’s Manoeuvre)
Eperisone presented more
percentage of patients free from
pain on movement
905
 906
Table 1 (Continued )

Authors/country Study design and sample size Age in year Treatments and Duration Outcome measures Adverse effects
(gender; male and female) (mean age  SD) dosage
type of pain

Rusinyol et al. A randomized, double blind,
(2009)/Spain clinical trial
N = 90; eperisone 50 mg (n = 30;
M: 15 and F: 15), eperisone
100 mg (n = 26; M: 11 and F: 15)
and diazepam 5 mg (n = 30; M:
18 and F: 12)
Eperisone 50 mg; 19–74
years (39.27  13.25);
Eperisone 100 mg; 18–67
years (35.69  11.89)
Diazepam 5 mg; 19–74
years (39.27  13.25)
Acute LBP
Eperisone 50 mg 7 days Eperisone (50 mg) and diazepam
and 100 mg TID (5 mg) showed comparable
Diazepam 5 mg TID efficacy in
- Reduction of pain at rest and
pain on palpation
- Muscular contracture
- Impaired working capacity
and
- Hand-to-floor distance
Eperisone at 100 mg had
significant (p < 0.01) effects
compared to diazepam in
- Muscular contracture (at day
3) and
- Impaired working capacity
Eperisone (50 mg; n = 5; 17%):
epigastric pain (n = 3),
somnolence (n = 1), headache
(n = 1)
Eperisone (100 mg; n = 6; 23%):
somnolence (n = 2), epigastric
pain (n = 1), vertigo (n = 1),
urinary retention (n = 1; patient
had history of nephritic colic),
slight anorexia (n = 1)
Diazepam (5 mg; n = 23; 77%):
somnolence (n = 19), tachycardia
with vertigo (n = 1), epigastric
pain (n = 2), diarrhoea (n = 1)

S. Bavage et al. / Pharmacological Reports 68 (2016) 903–912

Chandanwale A multicentre, prospective,
et al. (2011)/India randomized, double blind,
placebo-controlled phase III trial
N = 225; eperisone (n = 112; M:
50 and F: 62) and placebo
(n = 113; M: 56 and F: 57)
Rossi et al. A randomized controlled trial
(2012)/Italy N = 60; eperisone and tramadol
(n = 30; M: 11 and F: 19)
tizanidine and tramadol (n = 30;
M: 7 and F: 23)
(at day 3 and 7)
18–60 years Eperisone (50 mg 14 days Eperisone treated patients Nausea; eperisone (n = 8) and
Acute LBP TID) or identical evidenced successful outcomes placebo (n = 10)
placebo tablet in Abdominal pain; eperisone
- Finger-to-floor distance (n = 4) and placebo (n = 7)
(p = 0.0002) as compared to
placebo
- Lumbar and dorsal
hypermyotonia (p < 0.001)
- Lasegue’s sign (p < 0.002)
- Tenderness of paravertebral
muscles (p < 0.001)
- Mean score for leg tendon
reflexes (p < 0.001)
- Lumbar pain (p < 0.001)
- Paraesthesia (p = 0.018)
- GART and GATT profile
(p < 0.001)
Need for rescue medication was
less in eperisone group
(p < 0.001) than placebo
62.8  12.1 years Tramadol 100 mg/ 30 days Eperisone and tizanidine with Eperisone with tramadol; tremor
Chronic LBP (>12 weeks) day and eperisone tramadol showed a significant (n = 1), somnolence (n = 2),
(100 mg TID) or reduction in nausea/vomiting and dizziness
tizanidine (2 mg - All the tested pain (at rest and (n = 2)
TID) for 10 days. with efforts) parameters Tizanidine with tramadol;
Further treated Rescue analgesics for eperisone somnolence with nausea (n = 7)
with eperisone or (n = 11) and tizanidine (n = 9) and dizziness (n = 2)
tizanidine for next treated patients was statistically
20 days in insignificant
respective groups

GI, gastrointestinal; LBP, low back pain; N, total number of subjects in the trial; n, number of subjects in the group; SD, standard deviation; TID, three times in a day; VAS, visual analogue scale.