Enter the popular nonsteriodal anti-inflammatory drug Vioxx, known generically as rofecoxib. A curious study was recently reported in the journal Spine, 2003; 28(9): 851-9. Two groups of low back pain sufferers who were already taking some form of analgesic were recruited. These people had an average history of 12 years of pain. In order to make the comparisons between Vioxx and a placebo, all volunteers were asked to stop taking their previous medications. This is known as the “flare” method of study. You stop taking a drug long enough to let your symptoms get bad, and then you begin to take another drug, and then you measure the differences before the flare up, after the flare and after the subjects have used the drug being tested.
Sounds simple, right? The only problems with a flare study are that you prejudice your results in that your subjects a) are primed to expect relief from pills, b) are consciously selected as a population who are tolerant to drugs in general and nonsteriodal anti-inflammatories specifically, as the general population is not, and c) are a group of people who have had success with NSAIDs controlling their pains, and d) are in pain and desperate to get their lives back on track.
So, with these potential pitfalls in mind, how did it all work out? At the beginning of the study, the mean average pain level was gauged to be moderate at 50 on a visual scale of 1-100 with 100 being severe and debilitating. After the flare period, the average pain level of the subjects went to 75 or moderately severe. The group given the placebos or dummy pills had their pain levels revert to 50, which begs the question: what were these folks taking before? The Vioxx group meanwhile, reported pain levels of 35. Hallelujah! Now Vioxx can be touted to be the saviour for lower back pain. Now this study can be flashed into every major glossy medical trade magazine in the county. Drug salesmen can visit doctor’s offices and hammer home the message: Vioxx for all your low back patients.
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