Article: N-of-1 trials of quinine efficacy in skeletal muscle cramps of the leg.
The British journal of general practice : the journal of the Royal College of General Practitioners
2005 Volume 55, Issue 512, Page(s) 181–185
Abstract: Background: Skeletal muscle cramps affect over a third of the ambulatory elderly population. Quinine is the established treatment, but there are safety concerns, and evidence for efficacy is conflicting. A recent meta-analysis established a small ... ...
| Abstract | Background: Skeletal muscle cramps affect over a third of the ambulatory elderly population. Quinine is the established treatment, but there are safety concerns, and evidence for efficacy is conflicting. A recent meta-analysis established a small advantage for quinine, but identified the need for additional studies. N-of-1 trials compare two treatments, in a randomised, double-blind, multiple crossover study on a patient-by-patient basis. They have been used to compare treatments in osteoarthritis and may be suitable for determining the individual efficacy of quinine. Aim: To establish efficacy and safety of quinine sulphate use for the treatment of leg-muscle cramp. Design of study: Double-blind, randomised series of n-of-1 controlled trials of quinine versus placebo for muscle cramps. Setting: New Zealand general practices. Method: The participants were 13 general practice patients (six males; seven females; median age = 75 years) already prescribed quinine. Following a 2-week washout, each patient received three 4-week treatment blocks of quinine sulphate and matched placebo capsules with an individual, randomised crossover design. The main outcome measures were: patient diaries of cramp occurrence, duration and severity; capsule counts; and blood quinine levels in the final treatment block. Results: Ten patients completed the trial. Three patients were identified for whom quinine was clearly beneficial (P <0.05), six showed non-significant benefit and one showed no benefit. All patients elected to continue quinine post-study. Conclusion: Series of n -of-1 studies differentiated patients whom quinine had statistically significant effects; those with trend towards effectiveness; those for whom quinine was probably not effective. Ideally n-of-1 trial should be performed when a patient is commenced on quinine. More cycles in n-of-1 studies of quinine may address issues of statistical power. |
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| MeSH term(s) | Aged ; Cross-Over Studies ; Double-Blind Method ; Female ; Humans ; Leg ; Male ; Muscle Cramp/drug therapy ; Muscle, Skeletal/drug effects ; New Zealand ; Patient Compliance ; Quinine/adverse effects ; Quinine/therapeutic use ; Sleep-Wake Transition Disorders/drug therapy ; Treatment Outcome | ||||||||||
| Chemical Substances | Quinine (A7V27PHC7A) | ||||||||||
| Language | English | ||||||||||
| Publishing date | 2005-03 | ||||||||||
| Publishing country | England | ||||||||||
| Document type | Clinical Trial ; Journal Article ; Meta-Analysis ; Multicenter Study ; Randomized Controlled Trial | ||||||||||
| ZDB-ID | 1043148-2 | ||||||||||
| ISSN | 1478-5242 ; 0960-1643 ; 0035-8797 | ||||||||||
| ISSN (online) | 1478-5242 | ||||||||||
| ISSN | 0960-1643 ; 0035-8797 | ||||||||||
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| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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