Treatment of fibromyalgia (fibrositis syndrome): a parallel double blind trial with carisoprodol, paracetamol and caffeine (Somadril comp) versus placebo.

Forty-three of fifty-eight (74.1%) female patients with fibromyalgia completed an eight-week treatment period testing the combination of carisoprodol, paracetamol (acetaminophen) and caffeine versus placebo. Twenty-three patients received placebo and twenty active medication. In the placebo group 56.5% of the patients used additional analgesics or nonsteroidal anti-inflammatory drugs compared to only 20% in the active treatment group (p = 0.015). Forty-three percent of the patients in the placebo group and none of the patients in the active treatment group used tricyclic antidepressants, anxiolytics or sedatives (p = 0.0008). Active treatment gave statistically significant improvement after treatment for pain (p less than 0.01), for sleep quality (p less than 0.01) and for the general feeling of sickness (p less than 0.05). In the active treatment group increased pressure pain threshold after eight weeks was found at 70% of the sites measured, while the pressure pain threshold was increased at only 30% of the sites in the placebo group. In the placebo group improvement was found for the pain and sleep quality (p less than 0.05). This improvement may in part be due to the large amounts of extra medication in this group. Thus, the combination of carisoprodol and paracetamol (acetaminophen) and caffeine are effective in the treatment of fibromyalgia.

RCT Entities:   Population Interventions Outcomes