A major study published in the British Medical Journal explains that the real risk rates and harm from the use of nonsteroidal anti-inflammatory drugs (NSAIDs) are not known. This is because participants in NSAIDs drug trials “were mainly patients known to have benefited from NSAIDs and in whom the risk of adverse events was small.” For example “those with toxicity to NSAIDs or at risk of gastrointestinal or renal problems were specifically excluded,” and those over age 75 are excluded from most trials.
Although the quality of trials was generally good “some aspects of the reporting of these trials was poor.” In particular
“serious gastrointestinal events such as bleeding were poorly reported” and “other serious adverse events (including renal toxicity) were not mentioned in any trial.”
In this study, under the auspices of the Medical Research Council and led by Professor Paul Dieppe from the Department of Social Medicine, University of Bristol, there was a comparison of patients in the trials and patients who actually use NSAIDs in the community. The study focused on osteoarthritis (OA), because NSAIDs are used primarily for arthritis and OA is the most common form. The study’s overall conclusions are that the risks of NSAIDs use are under-represented in the controlled trials which, apart from excluding many types of patients at risk and focusing on those known to be benefi ting from NSAIDs, are small (average size 67 patients) and brief (mostly focusing on use for a period of six weeks or less, whereas NSAIDs are commonly used over a much longer period in the community). More community studies now need to be done.
Terrett has reported that there are 32,000 hospitalizations and 3,2000 deaths per year in the US because of GI bleeding and other complications for patients receiving NSAIDs for OA. (Current Concepts in Vertebrobasilar Complications following Spinal Manipulation, Terrett AGJ, 2nd edition 2001, NCMIC, West Des Moines, IA, 118-119.) These figures may now be conservative. Prolonged use of NSAIDs should be avoided if possible.
-Written by David Chapman-Smith LL.B. (Hons.) 2004