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Soma safe for Acute back pain

Started by ronr, February 03, 2009, 09:57:24 AM

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AAPM: Low-Dose Carisoprodol Safe Option for Acute Back Pain
By John Gever, Senior Editor, MedPage Today
Published: February 02, 2009
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine.   

HONOLULU, Feb. 2 -- A low-dose formulation of carisoprodol (Soma) may revive interest in this old-line muscle relaxant for treating acute back pain, a researcher said here.

Patients diagnosed with lower back spasm showed faster improvement in self-reported symptom severity with 250 mg of carisoprodol four times a day than with placebo in a randomized trial, Lee Ralph, M.D., of San Diego Sports Medicine and Family Health Center, reported at the American Academy of Pain Medicine meeting here.

Half the patients in the carisoprodol arm showed marked or moderate improvement within three days, whereas it took five days for half the placebo group to respond, said Dr. Ralph.

Drowsiness, dizziness, and headache were more common with carisoprodol in the 561-patient study, but only about 25% of patients were affected -- less than would be expected with the 350-mg dose, said Dr. Ralph. Action Points 
Explain to interested patients that carisoprodol (Soma) is FDA-approved for treating acute musculoskeletal pain.

Explain that the drug is known to have significant abuse potential.

Explain that, according to the study's lead author, abuse is seldom a problem in short-term use, which was the focus of this study.

Note that this study was published as an abstract and presented orally at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
The rate of adverse effects in the two treatment groups were:

Drowsiness: 13.4% carisoprodol, 4.6% placebo

Dizziness: 9.7% carisoprodol, 3.2% placebo

Headache: 3.6% carisoprodol, 1.4% placebo

There were no discontinuations because of drowsiness or serious adverse events.

Carisoprodol has been used as a muscle relaxant for many years. Until recently, it was available only in a 350-mg dose. However, a 250-mg dose was recently approved and is now being marketed aggressively.

Dr. Ralph noted that a major concern with carisoprodol has been that patients may misuse or abuse it. Its major metabolite is meprobamate, long sold as an anxiolytic drug (Miltown) and famous for its dependence liability.

These concerns have brought carisoprodol under the regulatory microscope, especially in Europe, where several agencies have suggested it should be banned.

In the U.S., it does not carry a boxed warning and federal controls are relatively loose, but some states have restricted access.

Dr. Ralph said the really serious problems were seen almost exclusively when carisoprodol was prescribed for long-term treatment, and at the 350-mg dose.

"In my use for a week or two [in acute back pain], I've not seen [abuse] to be a problem," he said. "But in your chronic use, absolutely, be cautious."

He said earlier pharmacokinetic studies showed that the level of meprobamate produced from a 250-mg carisoprodol dose is about 30% lower than from the 350-mg pill, and much lower than the dose of meprobamate prescribed for anxiety.

The current study enrolled adult patients with acute low back pain for no more than three days' duration. Exclusion criteria included sciatic pain, history of spinal pathology, neurologic signs, concurrent chronic back pain, osteoporosis, or rheumatic disease.

Medications were given for one week.

In addition to patients' global assessments of symptom severity, the Roland-Morris Disability Questionnaire was administered on the third and seventh days of treatment.

At baseline, 74% of patients characterized their pain as moderate and the remainder called it severe.

Mean baseline scores on the disability questionnaire were 10.3 (SD 4.9).

By day 3, the carisoprodol group showed a mean disability score of about 7.2, versus about 9.0 for placebo (P<0.001).

On day 7, the corresponding scores were 5.0 and 7.3, respectively (P<0.0001).

Dr. Ralph said that lower back pain often resolves on its own, accounting for the relatively modest difference between the treatment groups.

But he pointed out that speeding up the improvement by two days is clinically important.

Ajay Wasan, M.D., of the pain management clinic at Brigham and Women's Hospital in Boston, said the study would probably not alleviate physicians' long-standing concerns with carisoprodol.

However, he said the research on this and other pain medications has tended to focus on treatment of chronic pain.

"The issues [involved with chronic treatment] take up more resources and time," said Dr. Wasan.

He said the issues surrounding short-term treatment of acute pain are also important and may not get as much research attention as they deserve.

The study was funded by Meda Pharmaceuticals.

Primary source: American Academy of Pain Medicine
Source reference:
Ralph L, et al "Improvement in functional status with carisoprodol 250-mg tablets in patients with acute lower back spasm: a randomized, double-blind, placebo-controlled trial" AAPM 2009; Abstract 231.
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