Treatment of nocturnal leg cramps. A crossover trial of quinine vs vitamin E.

OBJECTIVE

This study compared the efficacy and safety of quinine sulfate, vitamin E, and placebo in the treatment of nocturnal leg cramps.

DESIGN

A random-order, double-blind, placebo-controlled crossover trial was performed.

SETTING

The study was conducted at the Veterans Affairs Medical Center, White River Junction, Vt.

PARTICIPANTS

Twenty-seven male veterans, aged 38 to 73 years, who experienced at least six leg cramps per month were recruited through the general medicine walk-in clinic or were referred from other clinics. Fifty-five subjects were contacted, 30 were enrolled consecutively, and 27 completed the study.

INTERVENTION

Subjects received, in random order, quinine sulfate (200 mg at supper and 300 mg at bedtime), vitamin E (800 U at bedtime), or placebo for 4-week periods. These periods were separated by 4-week washout intervals.

OUTCOME MEASURES

Patients reported cramp frequency, severity, and sleep disturbance caused by cramps.

RESULTS

Compared with treatment with placebo, quinine reduced the frequency of cramps and sleep disturbance, but not the average cramp severity. Thirteen of 27 patients had at least a 50% reduction in the number of cramps while receiving quinine; the response was usually seen within 3 days. There was evidence of a mild increase in side effects while subjects received quinine. Vitamin E was not effective in reducing leg cramp frequency, severity, or sleep disturbance.

CONCLUSIONS

Quinine sulfate, but not vitamin E, is superior to placebo in the treatment of nocturnal leg cramps.