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Summary
A double-blind, placebo-controlled, between-patient evaluation of the analgesic properties of oral meptazinol was carried out in 60 patients suffering from chronic pain due to rheumatoid arthritis and osteoarthritis. Patients were allocated, at random, to receive either 200 mg meptazinol every 3 to 6 hours as required or identical matching placebo for a total period of 72 hours. Data from 57 patients (30 on meptazinol, 27 on placebo) were suitable for analysis. Pain intensity in five major categories was assessed using a 4-point verbal rating scale by a clinician before the first dose and at the end of the trial period. Patients performed a self-assessment of pain prior to taking the first dose and subsequently at 2, 4, 24, 48 and 72 hours using 100 mm visual analogue scales and verbal rating scales. The clinician-rated pain scores showed no significant difference between the two groups in initial pain intensity. After 72-hours' treatment, there was a significant (p<0.01) reduction in pain intensity in each of the five categories in patients taking meptazinol which was not observed in patients taking placebo. Patients taking meptazinol reported a significant reduction in pain intensity after 2 hours which was maintained throughout the trial period. There was no significant reduction in pain intensity in patients taking placebo. Visual analogue scale scores and pain intensity difference scores showed significantly (p<0.01) greater reduction in pain intensity at all time points in the meptazinol-treated patients. A significantly greater number of patients in the placebo treatment group required additional analgesic medication and the average daily intake of tablets over the 24 to 48-hour trial period was significantly greater in the placebo-treated group. The average daily intake of meptazinol was 3.8 tablets and 4.5 tablets in the placebo-treated group (p<0.01). No significant difference existed between the treatment groups in the incidence of adverse events reported. These events were all of a minor nature and principally involved with the gastro-intestinal system. Side-effects were reported in 16 (53%) meptazinol-treated patients and 12 (44%) placebo-treated patients. The main side-effects reported were nausea, indigestion and dizziness. The overall efficacy of each treatment was scored by the clinician on visual analogue scales based on his own observations, the patients' comments and the incidence of adverse events. There was a significant difference between the two treatments and meptazinol was considered to be more effective than placebo (p<0.001).