An Army Sergeant With Mysterious Pain: Crack the Case

Christopher L. Tracy, MD


November 10, 2014

Medications for FMS

There is no evidence for the efficacy of oxycodone (as oxycodone controlled-release [CR]) in the treatment of fibromyalgia. A recent meta-analysis found no high-quality studies that meet current best standards for demonstration of a substantial reduction in pain intensity. Adverse events were more common with oxycodone CR; in clinical studies, the number needed to harm with this therapy was 4.3.[16] In fact, opioids in general may worsen fibromyalgia-related hyperalgesia and other centralized pain states, leading to opioid-induced hyperalgesia.[17]

The general approach to pharmacologic therapy in fibromyalgia is to dial down facilitatory neurotransmission (eg, gabapentinoids dampen glutamate signaling) or to boost the activity of neurotransmitters, such as norepinephrine and serotonin (eg, tricyclics, serotonin/norepinephrine reuptake inhibitors [SNRIs]). Several drugs or classes of drugs have strong evidence for treatment efficacy in fibromyalgia; these include tricyclics, gabapentinoids, SNRIs, and gamma-hydroxybutyrate.[1]

Three medications have been approved by the US Food and Drug Administration for the treatment of FMS: pregabalin, duloxetine, and milnacipran. Pregabalin is a gamma-aminobutyric acid (GABA) analog and an antiepileptic agent approved in 2007 at doses of 300, 400, and 600 mg/day. A meta-analysis of four randomized controlled trials (RCTs) has shown that a 30% pain reduction was reported by 40% of patients receiving pregabalin vs 28% of those receiving placebo.[18]

Duloxetine and milnacipran are SNRIs. Duloxetine was approved in 2008, and four separate RCTs showed > 30% improvement in clinical efficacy in 48% of those treated at doses of 60 mg and 120 mg daily vs 32% of those taking placebo. Approved in 2009, RCTs with milnacipran reported > 30% clinical improvement in 52%-61% of patients treated with 100-200 mg daily, vs 36% of placebo recipients. Extension trials of duloxetine and milnacipran have reported improvements at 1 year and 3 years, respectively. Comparative evaluation of pregabalin, milnacipran, and duloxetine has shown they are similarly effective in reducing pain.[19]

The relatively high placebo response rates for these trials have raised concerns about the true treatment efficacy of these medications, however. According to an analysis of 18 placebo-controlled trials in more than 3500 patients with fibromyalgia, approximately 50% of treatment response to these drugs can be attributed to placebo.[20]

Our case patient started a low-impact daily exercise regimen and is starting cognitive-behavioral therapy. No further medications have been recommended for her treatment plan.

Author's note: The views expressed in this article are those of the authors and do not necessarily reflect the official policy or position of the Department of the Navy, Army, Department of Defense, or the US Government.

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