of the risk of gynaecomastia associated with cimetidine, omeprazole and other antiulccr medications. BM J 1994; 308: 503-06. Jick H, Jick SS, Gurewich V, Myers MW, Vasilakis C. Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components. Lancet 1995; 346: 1589-93. Methods This randomised, double-blind, placebo-controlled, parallel-group trial consisted of three consecutive 2-week periods: qualification, treatment, and washout. 68 women and 44 men who had at least three muscie cramps per week w ere e n ro lle d . D uring th e tre a tm e n t period, participants were randomly assigned 300 mg daily dose of hydroquinine hydrobromide dihydrate (54 participants) or placebo (58). The frequency, severity (1-10), duration, and location of muscle cramps, as well as any side-effects, were recorded by participants in daily diaries. The primary outcome measures were the number of muscle cramps and the number of days during which the participants had muscle cramps (cramp-days).Findings We excluded five participants from both groups from the analysis. Thus, data from 49 hydroqulnine-group p a rticip a n ts and 53 placebo-group p a rtic ip a n ts were analysed. In both groups the to ta l number of muscle cramps and the number of cramp-days decreased during the tre a tm e n t period compared w ith the qualification period. However, these improvements were greater in the hydroquinine group th a n in th e placebo group. The Correspondence to: Prof A L M Verbeek hydroquinine-group participants reported a median of 8 (95% Cl 7-12) fewer cramps and median of 3 (1-4) fewer cramp-days, whereas those on placebo reported only 3 (0-5) fewer cramps and 1 (0-5) fewer cramp-days. 32 (65%) of participants in the hydroquinine group had a 50% or greater reduction in the number of muscle cramps. After the onset of cramps, hydroquinine did not reduce the severity or duration of cramps. We also found a sustained effect after treatment had stopped. Hydroquinine was well tolerated, and resulted in only mild side-effects.
InterpretationIn our study, 300 mg hydroquinine was safe to take in the short-term and significantly more effective than placebo in the prevention of frequent, ordinary muscle cramps. This therapeutic effect outlasted the duration of treatment.