Randomized, double-blind trial of carisoprodol 250 mg compared with placebo and carisoprodol 350 mg for the treatment of low back spasm.

Abstract

BACKGROUND:

Carisoprodol, a centrally active skeletal muscle relaxant, is widely used for the treatment of acute, painful musculoskeletal disorders. When administered at a dose of 350 mg four times daily, carisoprodol demonstrated significant clinical benefit in its early clinical development trials; however, some unfavorable side effects, such as drowsiness and dizziness, were reported. Recently, research was conducted to determine if a lower dose of carisoprodol would retain efficacy but improve tolerability compared to the higher 350-mg dose.

OBJECTIVE:

The purpose of this multicenter study was to compare the efficacy and safety of carisoprodol 250-mg tablets four times daily to 350-mg tablets four times daily and to placebo in patients with acute, painful musculoskeletal spasm of the lower back.

RESEARCH DESIGN AND METHODS:

In this 1-week double-blind, placebo-controlled, parallel-group multicenter trial, patients 18 to 65 years of age with moderate to severe back spasm were randomly assigned to treatment with carisoprodol 250-mg tablets (n = 264), 350-mg tablets (n = 273), or matching placebo tablets (n = 269) three times daily and at bedtime.

MAIN OUTCOME MEASURES:

The coprimary efficacy variables were patient-rated relief from starting backache and patient-rated global impression of change assessed on treatment day 3.

RESULTS:

The carisoprodol 250-mg regimen was significantly more effective than placebo as assessed by both patient-rated relief from starting backache (p = 0.0001) and patient-rated global impression of change (p = 0.0046). There were no significant differences between the 250-mg and 350-mg dosages for the coprimary efficacy endpoints, and patients improved with or without sedation. Fewer than 1% of patients in the carisoprodol 250-mg group discontinued prematurely because of treatment-emergent adverse events, and no patient discontinued because of drowsiness.

CONCLUSIONS:

When administered three times daily and at bedtime, carisoprodol 250 mg was as effective as 350 mg three times daily and at bedtime with a lower incidence of adverse events and fewer discontinuations of therapy due to adverse events. Patients improved whether or not they reported sedation as an adverse event.

• Authors: Gregory T Serfer, William J Wheeler, Harry J Sacks
• Journal: Current medical research and opinion (Curr Med Res Opin) Vol. 26 Issue 1 Pg. 91-9 (Jan 2010) ISSN: 1473-4877 [Electronic] England
• PMID: 19908948 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Muscle Relaxants, Central
• Placebos
• Carisoprodol

Topics

• Carisoprodol (administration & dosage, therapeutic use)
• Double-Blind Method
• Humans
• Lumbar Vertebrae
• Muscle Relaxants, Central (administration & dosage, therapeutic use)
• Placebos
• Prospective Studies
• Spasm (drug therapy)