QUOTE (Arbuscule @ Oct 7 2009, 05:14 PM)

Thanks for the link Arbuscule; I checked the site and searched for quinine. This following Q and A is what I found - it includes a reference to a 1995 study which showed that 27% of respondents with leg cramps achieved relief from the use of quinine:
TITLE 1: “Ask the Doctor”
DATE: August 2000
AUTHOR/S: Dr. Mark Buchfuhrer
Q. My mother, who is 91, has had severe RLS symptoms for years; I have occasional cramps (so far) but cannot sit through an evenings’ entertainment without looking like I have attention deficit disorder. I previously used Q-Vel with success when I knew I would be attending a theater performance, for instance. Then suddenly, several years ago, the product was taken off the market. What can you tell me about the use of quinine and why Q-Vel-type products were removed from the shelves?
A. Quinine sulfate is an alkaloid derived from the cinchona tree and was originally used as a treatment for malaria. It was then found to be helpful for muscle cramps and has been widely used for this problem. Many physicians have recommended quinine for RLS due to mistaking the patient’s RLS complaints for leg cramps or incorrectly thinking that quinine is an effective treatment for RLS. A small percentage of RLS sufferers (less than 5%) will get some relief with quinine, but most do not get any help from this medication.
Quinine sulfate was available as an over-the-counter product (Q-Vel by Ciba, Legatrin by Columbia, etc.) until February 22, 1995. The FDA had two reasons for making this decision. The first was that the FDA did not find sufficient evidence to demonstrate that quinine was effective for leg cramps. Until 1995 the effectiveness of quinine was based mainly on case reports. In 1995, Man-Son-Hing and Wells performed a study systematically examining the effect of quinine sulfate on legs cramps. The study showed that quinine, over a four week period, reduced the number of cramps by 27% but did not improve the severity or duration of the attacks.
The second reason was due to 157 adverse reports that the FDA received for quinine between 1969 and 1992. Of these, 60 were considered serious reactions: death (16), hospitalizations (40) and disabilities (4). The FDA also found that the incidence of side effects has been increasing during the last four years of the reporting period. On February 22, 1995, the FDA banned all over-the-counter quinine-containing products labeled for use in treating leg cramps. The FDA also concluded that prescription quinine can no longer be labeled for leg cramps because “data do not support the safe and effective use of these products at any dose under the care of a health care practitioner in the treatment and or prevention of nocturnal leg cramps.” Since 1995, the only approved use of quinine is the treatment of malaria. It is still used extensively for leg cramps, but this is now considered an off-label use of quinine and patients should be made aware of the risks (hypersensitivity reactions, headache, vomiting, tinnitus, cardiac arrhythmias, visual problems, liver and kidney problems, convulsions, coma) of taking this medication compared to its potential benefits.
Dr. Mark Buchfuhrer
Gallatin Medical Clinic
Downey, CA