Abstract | BACKGROUND: 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 muscle cramps per week were enrolled. During the treatment 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 participant 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 hydroquinine-group participants and 53 placebo-group participants were analysed. In both groups the total number of muscle cramps and the number of cramp-days decreased during the treatment period compared with the qualification period. However, these improvements were greater in the hydroquinine group than in the placebo group. The hydroquinine-group participants reported a median of 8 (95% CI 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. INTERPRETATION:
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Authors | P H Jansen, K C Veenhuizen, A I Wesseling, T de Boo, A L Verbeek |
Journal | Lancet (London, England)
(Lancet)
Vol. 349
Issue 9051
Pg. 528-32
(Feb 22 1997)
ISSN: 0140-6736 [Print] England |
PMID | 9048790
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Parasympatholytics
- Tablets
- hydroquinidine
- Quinidine
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Topics |
- Administration, Oral
- Adolescent
- Adult
- Aged
- Double-Blind Method
- Female
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Muscle Cramp
(drug therapy, prevention & control)
- Parasympatholytics
(therapeutic use)
- Quinidine
(analogs & derivatives, therapeutic use)
- Tablets
- Treatment Outcome
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