In an eight-week randomised trial 23 female patients received placebo and 22 the combination of carisoprodol, paracetamol and caffeine (Somadril comp) for the symptoms of fibromyalgia. 45 of the initial 58 (74%) completed the trial. In the placebo group 57% of patients used additonal analgesics compared to 20% in the active treatment group. In the placebo group 43% used tricyclic antidepressants, anxiolytics or sedatives compared to none in the active treatment group. Active treatment gave statistically significant improvement for pain, sleep quality and for the general feeling of sickness.
Comment: The quality of evidence is downgraded by sparse data and potential reporting bias.
The European Medicines Agency (EMEA) concluded in November 2007, that the risks of carisoprodol outweigh the benefits, and all marketing authorisations for products containing carisoprodol should be suspended. There was a concern about abuse, psychomotor impairment, and intoxication.