Rofecoxib Is Safe and Effective for Chronic Low Back Pain

The pain reliever rofecoxib--originally developed for treatment of arthritis--is also effective for patients with chronic low back pain, reports a study in the May 1 issue of the journal Spine.

Led by Dr. Nathaniel Katz of Brigham and Women's Hospital, Boston, the study included 690 patients taking daily pain medications for chronic low back pain. All had moderate to severe pain, averaging 76 on a 100-point scale and present for an average of 12 years. The patients were randomly assigned to receive either a high or low dose of rofecoxib, or an inactive placebo.

Although individual responses varied, rofecoxib was effective in reducing back pain. At both doses of rofecoxib, pain scores averaged about 14 points lower than with the placebo.

Patients taking rofecoxib also had greater improvement in a wide range of other outcomes, including the extent to which back pain interfered with everyday activities. Compared to the placebo group, patients taking rofecoxib were nearly twice as likely to rate their treatment response as good or excellent.

Side effects were no more frequent with rofecoxib than with placebo. The most common side effects were headache, diarrhea, and upper respiratory tract infections. However, these were rarely severe enough to cause patients to stop taking rofecoxib.

Chronic back pain--defined as pain lasting three months or longer--is a common problem, affecting five to ten percent of people. In addition to pain, chronic low back pain is a major source of disability and missed work time.

Most patients with chronic low back pain use traditional pain relievers, such as aspirin or ibuprofen. However, these drugs--known as nonsteroidal anti-inflammatory drugs (NSAIDs)--can cause problems related to irritation of the stomach and gastrointestinal tract, including ulcers and bleeding. Rofecoxib and other new cyclooxygenase-2 inhibitor drugs are intended to reduce gastrointestinal irritation while effectively relieving pain. They were developed for and are now widely used by patients with arthritis, another common and disabling pain condition.

Rofecoxib is also an effective treatment for chronic low back pain, the new results suggest. For most patients, even a low dose of rofecoxib significantly reduces the severity of pain and its impact on patients' lives. Side effects are no more frequent than with inactive placebo and are generally mild.

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