Efficacy and tolerance of repeated oral doses of tolperisone hydrochloride in the treatment of painful reflex muscle spasm: results of a prospective placebo-controlled double-blind trial

Abstract

The efficacy and safety of oral tolperisone hydrochloride (Mydocalm) in the treatment of painful reflex muscle spasm was assessed in a prospective, randomized, double-blind, placebo-controlled trial. A total of 138 patients, aged between 20 and 75 years, with painful reflex muscle spasm associated with diseases of the spinal column or proximal joints were enrolled in eight rehabilitation centers. Patients were randomized to receive either 300 mg tolperisone hydrochloride or placebo for a period of 21 days. Both treatment groups recovered during the 3 weeks rehabilitation program. However, tolperisone hydrochloride proved to be significantly superior to placebo: the change score of the pressure pain threshold as the primary target parameter significantly increased during therapy with tolperisone hydrochloride (P = 0.03, valid-case-analysis) compared to the results obtained on placebo treatment. The overall assessment of efficacy by the patient also demonstrated significant differences in favor of tolperisone hydrochloride. Best results were seen in patients aged between 40 and 60 years with a history of complaints shorter than 1 year and with concomitant physical therapy. The evaluation of safety data, i.e., adverse events, biochemical and hematological laboratory parameters, demonstrated no differences between tolperisone hydrochloride and placebo. As a conclusion tolperisone hydrochloride represents an effective and safe treatment of painful reflex muscle spasm without the typical side effects of centrally active muscle relaxants.

Chapter 4 European guidelines for the management of chronic nonspecific low back pain

“…One high quality trial (N=112) showed that tolperisone is more effective than placebo for short-term (after 21 days) overall improvement, but not for pain relief or reduction of muscle spasm (Pratzel et al 1996).…”

“…All these sideeffects were consistently reported for many of the benzodiazepines and non-benzodiazepines reviewed, with the exception of addiction for non-benzodiazepines. However, two high quality trials showed that neither flurpirtin (Worz et al 1996) nor tolperisone (Pratzel et al 1996) were associated with a higher incidence of adverse events compared with placebo. It is known that tolperisone can have severe allergic side-effects and that flurpirtin can induce reversible reduction of liver function.…”

Outcome of non-invasive treatment modalities on back pain: an evidence-based review

“…Three studies were identified [13,153,209]. One high quality trial showed that there is moderate evidence (one trial; 107 people) that flupirtin is more effective than placebo for patients with chronic LBP on short-term pain relief and overall improvement after 7 days, but not on reduction of muscle spasm [209].…”

“…One high quality trial showed that there is moderate evidence (one trial; 107 people) that flupirtin is more effective than placebo for patients with chronic LBP on short-term pain relief and overall improvement after 7 days, but not on reduction of muscle spasm [209]. One high quality trial showed that there is moderate evidence (one trial; 112 people) that tolperisone is more effective than placebo for patients with chronic LBP on short-term overall improvement after 21 days, but not on pain relief and reduction of muscle spasm [153].…”

Painful Muscle Spasm: Diagnosis and Pathogenetic Therapy

“…в 1996 г. [6]. В этом исследовании толперизон гидрохлорид продемонстрировал существенное превосходство перед плацебо в отношении редукции рефлекторного болез-ненного мышечного спазма, обусловленного патологией позвоночника или проксимальных суставов.…”