Interventions strongly supported by evidence

Evidence on the most frequently used treatments of FMS is summarized in Box 11.1. Of the pharmaco-logic treatments, only duloxetine, milnacipran and pregabalin had been approved for use in FMS in the USA, but not by the EMEA for use in FMS in Europe.


The German FMS guideline group systematically reviewed 26 RCT on antidepressants. Amitriptyline, studied in 13 RCT, was efficient in reducing pain with a moderate magnitude of benefit (pain reduction by a mean of 26%, improvement in quality of life by 30%). Selective serotonin reuptake inhibitors (SSRI) were studied in 12 RCT, which also gave positive results, except for the two studies on citalopram and one on fluoxetine. Three RCT on the dual serotonin and noradrenaline reuptake inhibitors (SNRI) duloxetine and milnacipran reported positive results at the end of therapy. Results concerning the effectiveness of the monoamine oxidase inhibitor (MAOI) moclobemide (300-600 mg/day) were conflicting [71]. Eighteen RCT (median duration 8 weeks, range 4-38 weeks) involving 1427 subjects were suitable for meta-analy-sis. There was strong evidence for an association of antidepressants with reduction in pain (standard mean difference (SMD) -0.43, 95% confidence interval (CI) -0.55 to -0.30), fatigue (SMD -0.13, 95% CI -0.26 to -0.01), depressed mood (SMD -0.26, 95% CI -0.3 to -0.12) and sleep disturbances (SMD -0.32, 95% CI -0.46 to -0.18). There was strong evidence

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