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Outcomes of interest were improvements in pain, fatigue, sleep disturbance, depressed mood and health-related quality of life, as well as adverse events.
The authors concluded that the three drugs were superior to placebo for all outcomes noted above, with the exceptions of duloxetine for fatigue, milnacipran for sleep disturbance, and pregabalin for depressed mood.
The most frequent 'class' effects seen with the two serotonin norepinephrine reuptake inhibitors (SNRIs—duloxetine and milnacipran) included nausea, headache, hyperhidrosis and constipation, and the most serious adverse effects were rare cases of uncontrolled hypertension, hepatotoxicity or suicidality. The most frequent class effects seen with the α2δ-subunit calcium-channel ligands (pregabalin as well as similar compounds such as gabapentin) are dizziness, somnolence, weight gain and peripheral edema.
And this is the part that I thought particularly interesting, and something we've noted quite often in treatment of other sources of chronic pain:In clinical practice, it is common to use one drug from each of these classes in combination. This approach is beginning to be supported by data showing much higher overall response rates in fibromyalgia patients treated with an SNRI and an α2δ-subunit calcium-channel ligand together, rather than with either class separately.
Finally, perhaps the most important lesson from the meta-analysis by Hauser et al. is that, as measured by standardized effect sizes, the overall analgesic efficacy of these drugs is no different for fibromyalgia than of other analgesics for other chronic pain states. Many practitioners feel that they can effectively treat 'real' pain states such as osteoarthritis, whereas they feel they do not have anything to offer individuals with fibromyalgia even though the data suggest otherwise. The standardized analgesic effect sizes of the three fibromyalgia drugs range from −0.19 to −0.33, which are small-to-modest. However, these effect sizes are nearly identical to those of acetaminophen, NSAIDs and opioids noted in meta-analyses of analgesic agents for osteoarthritis of the knee. For chronic pain treated with a single class of drugs, these effect sizes are 'as good as it gets'.
Because of the modest overall analgesic efficacy seen with any class of analgesic drug in any chronic pain state, we should be particularly aggressive about using more nonpharmacological therapies in treating patients with chronic pain, no matter what the 'cause' of the pain. Nonpharmacological approaches such as education, cognitive behavioral therapy and exercise have large effect sizes in fibromyalgia as well as in nearly any other chronic pain state studied, but at present these treatments are rarely used in clinical practice.