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Patients with acute, painful musculoskeletal spasms of the lower back appear to get better and faster relief from the muscle relaxant carisoprodol soma than from placebo.

In a clinical trial involving more than 800 patients, researchers said the 250mg dose of carisoprodol soma taken 4 times daily was superior to placebo and similar to the 350mg tablets of carisoprodol soma. However, the larger dose of carisoprodol somaincreased adverse events more than either of the comparator preparations.

"This study demonstrated that patients with acute muscle spasms of the lower back had significantly greater relief of the acute discomfort associated with lower back spasm, and had improved functional status during treatment with carisoprodol soma250mg pills compared with placebo," said Gregory Serfer, DO, Head, South Florida Clinical Research Center, Hollywood, Florida, United States.

Dr. Serfer presented the findings in a poster session on February 15 here at the American Academy of Pain Medicine (AAPM) 24th Annual Meeting.

In the trial, 264 patients were randomly assigned to receive carisoprodol soma 250mg, 273 patients were assigned to carisoprodol soma 350mg, and 269 patients were assigned to the placebo arm.

Carisoprodol Soma 250mg was significantly superior to placebo in patients' global impression of change -- increasing about 2.2 points on the 4-point scale compared with an increase of 1.9 for placebo patients (P < .01).

Carisoprodol Soma was also significantly more effective than placebo in patient-rated relief of backache, measured from baseline to day 3. Patients taking carisoprodol soma 250mg showed about a 1.7-point improvement compared with a 1.5-point improvement for placebo, also statistically significant (P < .01).

Discontinuation due to treatment-emergent adverse events occurred more frequently in the carisoprodol soma 350 mg group of patients compared with the carisoprodol soma 250mg group and placebo (3.9% vs 0.7% vs 1.8%, respectively), Dr. Serfer said.