The British and German drug regulatory bodies were contacted via telephone and mail requesting all relevant information in their possession. The FDA report pertaining to quinine and leg cramps was reviewed, 12 and the FDA was asked to forward all relevant dockets to us. 13 – 17 The objectives for this analysis were to determine whether the inclusion of data from these unpublished studies can provide more precise estimates of the efficacy and side effect profile of quinine when used for the treatment of nocturnal leg cramps, or significantly alter the findings of the original meta-analysis, and whether publication bias is present in this area. We recently obtained copies of all relevant studies in their possession. 11 From 1974 to 1986, while preparing to issue a final regulation concerning the use of quinine for nocturnal leg cramps as a prescription product, 12 the FDA accepted submissions from interested parties. 10 Moreover, unpublished studies may be of inferior methodologic quality, and thus their results could be less reliable.Īfter publication of our original meta-analysis, 3 it came to our attention that the United States Food and Drug Administration (FDA) possessed relevant unpublished information pertaining to the efficacy of quinine for nocturnal leg cramps. 9 The contrary perspective is that it is not worthwhile to attempt to search for these studies as there is no systematic way of locating all relevant literature. 8 Some meta-analysts suggest that every attempt should be made to locate relevant unpublished studies because the added data will only augment the results. There is considerable controversy about the need to search for relevant unpublished trials for inclusion in meta-analyses. Insufficient data were available to draw conclusions about the side effect profile of quinine. The results of the original meta-analysis showed that quinine was efficacious in the prevention of nocturnal leg cramps but did not affect the severity or duration of cramps. 4 – 7 Despite review of relevant articles and textbooks, and communication with authorities on the subject, we were unable to locate any unpublished studies that met our inclusion criteria. 3 The main study results combined data from four published randomized, double-blind, placebo-controlled crossover trials. In 1995, we published a meta-analysis examining the short-term efficacy of quinine (up to 4 weeks) for the treatment of nocturnal leg cramps. 1 Many nonpharmacologic and pharmacologic treatments have been proposed, 2 the most studied therapy being quinine taken at bedtime. They are a common condition, occurring in 70% of elderly persons at one time or another. Meanwhile, there are several remedies you can try yourself.Nocturnal leg cramps are painful involuntary muscle contractions that usually occur while the patient is recumbent. If the frequency of your cramps bothers you, tell your doctor. Cramps might be related to alcoholism, hypothyroidism, or diabetes. People who are 65 and older are at greater risk for them. Most cases of muscle cramps don’t indicate a worrisome underlying condition. These minerals help your muscles work more smoothly, and fluids help your body process the minerals. Or maybe you’re not getting enough electrolytes, such as potassium or magnesium. If you haven’t strained a muscle, you’re probably cramping because your muscle is fatigued or overused or your body is dehydrated. Usually, you feel a hard lump at the point of pain - that’s the contracted muscle.Ĭramps usually occur for a reason. Muscle cramps happen when a muscle involuntarily contracts on its own. Other practices, like staying hydrated and changing up your diet, may help prevent leg cramps. If you have a leg cramp, rest and gentle stretching may help relax the muscle.
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