Abstract
Purpose: To investigate the efficacy and tolerability of CMO (cerasomol- cis -9-cetyl myristoleate) in the treatment of fibromyalgia. Design: Open study: 21 days' treatment following a 7-day baseline without treatment. Materials and Methods: Thirteen adult patients with fibromyalgia. Following a 7-day pre-treatment baseline, patients were treated with a mixture of CMO + sea cucumber and shark cartilage extracts. All treatments were administered orally. Patients kept daily diary cards recording the severity of generalized pain, fatigue and sleep disturbance (scale 0-4). A symptom profile was made using an 84-point questionnaire. Adverse events were recorded. Results: Ten patients completed the study. One subject did not record baseline symptoms. Two patients had to discontinue treatment because of adverse effects. One had severe indigestion and the other developed muscle spasms and a skin rash. The mean (SD) scores for the severity of pain, fatigue, and sleep disturbance during the baseline were 2.63 (0.55), 2.50 (0.54) and 2.33 (0.480). These improved to 1.70 (0.82), 1.83 (0.82) and 1.73 (1.11) during the last 7 days of treatment. There were individual differences in response with five patients showing good response and five showing little or no response. From the questionnaires those showing the best response had more severe pain and cognitive dysfunction than the non-responders. In addition to the two withdrawals, one further patient reported gastrointestinal symptoms. Conclusions: This open study provides evidence of a beneficial effect of CMO in the treatment of fibromyalgia. A double-blind, placebo-controlled study is now required to confirm this. This should also include a symptom profile questionnaire, which may help to distinguish responders and non-responders.