Efficacy and safety of tolperisone versus baclofen among Chinese patients with spasticity associated with spinal cord injury: a non-randomized retrospective study

There are many medications available to treat spasticity, but the tolerability of medications is the main issue for choosing the best treatment. The objectives of this study were to compare the efficacy and adverse effects of tolperisone compared to baclofen among patients with spasticity associated with spinal cord injury. Patients received baclofen plus physical therapy (BAF+PT, n=135) or tolperisone plus physical therapy (TOL+PT, n=116), or physical therapy alone (PT, n=180). The modified Ashworth scale score, the modified Medical Research Council score, the Barthel Index score, and the Disability Assessment scale score were improved (P<0.05 for all) in all the patients at the end of 6 weeks compared to before interventions. After 6 weeks, the overall coefficient of efficacy of the intervention(s) in the BAF+PT, TOL+PT, and PT groups were 1.15, 0.45, and 0.05, respectively. The patients of the BAF+PT group reported asthenia, drowsiness, and sleepiness and those of the TOL+PT group reported dyspepsia and epigastric pain as adverse effects. When comparing drug interventions to physical therapy alone, both baclofen plus physical therapy and tolperisone plus physical therapy played a significant role in the improvement of daily activities of patients. Nonetheless, baclofen plus physical therapy was tentatively effective. Tolperisone plus physical therapy was slightly effective. In addition, baclofen caused adverse effects related to the sedative manifestation (Level of Evidence: III; Technical Efficacy Stage: 4).

A comparative study on safety and efficacy of tolperisone with etodolac and thiocolchicoside with etodolac in patients of acute low back pain with musculoskeletal spasm

Background: Low back pain is one of the most common health problems in society which leads to considerable disability, loss of work days, and puts a huge burden on socioeconomic and healthcare system. It is often associated with musculoskeletal spasm. The aim of the study was to compare the efficacy and safety of tolperisone and thiocolchicoside in combination with etodolac in patients of acute low back pain associated with musculoskeletal spasm.Methods: it was a prospective, randomized, open label study which included patients of either sex between age 18-50 years of acute low back pain with musculoskeletal spasm. Patients were allocated in two groups. Patients in 慓roup A� were given tolperisone 150 mg + etodolac 400 mg twice a day and patients in 慓roup B� were given thiocolchicoside 4 mg + etodolac 400 mg twice a day. Efficacy of two drugs was assessed by decrease in finger to floor distance (FFD), decrease in pain as per visual analog scale (VAS) and global assessment of efficacy of treatment by physician. Follow-up of the patients was done on day 3 and 7 of treatment. Various side effects reported by patients in both the groups were also recorded and compared.Results: Both tolperisone and thiocolchicoside caused significant decrease in FFD, reduced pain score thus indicating decrease in pain and spasm. Side effects reported in both groups were mild and did not result in discontinuation of therapy.Conclusions: Tolperisone was found to have efficacy similar to that of thiocolchicoside though number of side effects reported was more with tolperisone.

Simultaneous UV-Spectrophotometric estimation of Diclofenac and Tolperisone Hydrochloride in Tablet Dosage Form.

Diclofenac sodium is a non-steroidal anti-inflammatory drug (NSAID) taken to reduce inflammation and as an analgesic reducing pain in certain conditions. Tolperisone hydrochloride is a piperidine derivative, is a centrally-acting muscle relaxant. Two simple, accurate and economic methods; Q analysis and first order derivative method have been described for the simultaneous spectrophotometric estimation of Diclofenac sodium and Tolperisone hydrochloride in tablet dosage form. Absorption maxima of Diclofenac sodium and Tolperisone hydrochloride in distilled water were found to be 275.0 nm and 260.0 nm respectively. Beer’s law was obeyed in the concentration range 5-50 μg/ml for Diclofenac and 5-60 μg/ml for Tolperisone hydrochloride. In Q analysis method, absorbances were measured at the selected wavelengths, 237.0 nm (isoabsorptive point) and 260.0 nm (λmax of Tolperisone). In first order derivative method, zero crossing point of Diclofenac sodium and Tolperisone hydrochloride were selected at 275.0 nm and 260.0 nm respectively. The analysis of binary pharmaceutical formulation was carried by both methods. Results of two methods were validated statistically by recovery studies and were found to be satisfactory.

Clinical Comparative Study: Efficacy and Tolerability of Tolperisone and Thiocolchicoside in Acute Low Back Pain and Spinal Muscle Spasticity

STUDY DESIGN: We performed a multicentric, randomized, comparative clinical trial. Eligible patients were randomly assigned to receive 150 mg of Tolperisone thrice daily or 8 mg of Thiocolchicoside twice daily for 7 days. PURPOSE: To assess the efficacy and tolerability of Tolperisone in comparison with Thiocolchicoside in the treatment of acute low back pain with spasm of spinal muscles. OVERVIEW OF LITERATURE: No head on clinical trial of Tolperisone with Thiocolchicoside is available and so this study is done. METHODS: The assessment of muscle spasm was made by measuring the finger-to-floor distance (FFD), articular excursion in degrees on performing Lasegue's maneuver and modified Schober's test. Assessment of pain on movement and spontaneous pain (pain at rest) of the lumbar spine was made with the help of visual analogue scale score. RESULTS: The improvement in articular excursion on Lasegue's maneuver was significantly greater on day 3 (p = 0.017) and day 7 (p = 0.0001) with Tolperisone as compared to Thiocolchicoside. The reduction in FFD score was greater on day 7 (p = 0.0001) with Tolperisone. However there was no significant difference in improvement in Schober's test score on day 3 (p = 0.664) and day 7 (p = 0.192). The improvement in pain score at rest and on movement was significantly greater with Tolperisone (p = 0.0001). CONCLUSIONS: Tolperisone is an effective and well tolerated option for treatment of patients with skeletal muscle spasm associated with pain.