A separate Cochrane review of 5 studies with 219 women with fibromyalgia found that moderate-to- high intensity resistance training improves function and reduces pain and tenderness vs. control, and that eight weeks of aerobic exercise was superior to moderate-intensity resistance exercise for reducing pain, although the quality of the evidence was rated as low. 129 Tai chi may help reduce pain and other symptoms related to fibromyalgia. One trial randomized 66 patients with fibromyalgia to tai chi twice weekly for 12 weeks vs. wellness education and stretching exercises. Tai chi improved scores on the Fibromyalgia Impact Questionnaire (FIQ) that assessed pain, physical functioning, fatigue, morning stiffness, and on the Medical Outcomes Study 36 Item Short Form Health Survey (SF-36) both at the end of the intervention (12 weeks) and at 24-week follow-up. At 12 weeks, mean between group difference was -18.4 FIQ points (P<0.001). 130 Acupuncture, massage, and TENS One in five patients with fibromyalgia try acupuncture within two years of diagnosis, 131 and low-quality evidence suggests that acupuncture may be associated with reduced fibromyalgia-related pain. A 2013 Cochrane review of 9 RCTs with 395 adults with fibromyalgia found reduced pain and stiffness at 1 month with electro-acupuncture compared to either placebo or sham acupuncture, but there were no significant differences in pain, fatigue, or sleep comparing manual acupuncture to placebo or sham acupuncture (4 trials, 182 adults). 131 Based on two small trials, myofascial massage may improve pain over placebo. 132 Although data recommending other forms of massage for reducing pain are limited, most styles of massage therapy consistently improved quality of life for patients with fibromyalgia. Six RCTs failed to show that TENS reduced pain in fibromyalgia. 133 Cognitive and behavioral interventions A Cochrane Review of 18 RCTs showed a small benefit from traditional CBT programs on pain and function. 134 Controls included waitlist controls, active controls, or treatment as usual, and the overall quality of evidence was rated as low. In seven RCTs of mindfulness medication, no reduction in pain was observed. Methods were varied and incorporated different components of mindfulness-based stress relief, CBT, and yoga. 34 In two RCT, self-management education did not improve pain or disability, as compared to controls. 34
Drug options The FDA has approved three drugs for the treatment of fibromyalgia: duloxetine, milnacipran and pregabalin. Other options used off-label include gabapentin, amitriptyline, and SSRIs. Acetaminophen and NSAIDs No data support the efficacy of acetaminophen or NSAIDs for treating pain in patients with fibromyalgia, 135 although they may be useful to treat pain triggers of fibromyalgia. 125
reporting at least moderate global pain relief) vs. either pregabalin (39%) or duloxetine (42%) alone (P<0.05 for both comparisons with combination). 142 Gabapentin Evidence supporting the use of gabapentin for fibromyalgia is limited. A Cochrane review of RCTs lasting 8 weeks or longer (searched through May 2016) identified two trials, one of which was only a conference abstract. The other trial randomized 150 patients with fibromyalgia to gabapentin 1200-2400 mg/day vs. placebo for 12 weeks. 143 Gabapentin was associated with a small reduction in pain (mean difference between groups at 12 weeks: -0.92 points on 0-10 point BPI scale; 95% CI: -1.75 to -0.71 points) but this difference may not be clinically important. Cannabinoids Two small trials have evaluated the oral cannabinoid nabilone (a synthetic form of THC) in patients with fibromyalgia. One trial randomized 46 patients to nabilone 0.5 mg to 1 mg twice daily for 4 weeks vs. placebo and found significant reductions in pain and improvements in anxiety on the Fibromyalgia Impact Questionnaire (P<0.05 for both outcomes). 144 Another trial randomized 31 patients with fibromyalgia and chronic insomnia to nabilone 0.5 mg to 1 mg at bedtime vs. amitriptyline 10-20 mg at bedtime for 4 weeks. 145 Although nabilone was associated with improved sleep quality, no significant effects were reported for pain, mood, or quality of life.
SNRIs
Duloxetine A 2014 Cochrane review included six RCTs randomizing 2249 adults with fibromyalgia to duloxetine vs. placebo with 12-week to 6-month follow-up. 136 At 12 weeks, duloxetine was superior to placebo for pain reduction, with superiority also shown at 28 weeks. Milnacipran In a Cochrane meta-analysis of three RCTs evaluating milnacipran 100 mg daily vs. placebo in 1,925 patients with fibromyalgia, milnacipran was more effective for inducing at least 30% reduction in pain. 137 A similar effect on pain relief was noted with milnacipran 200 mg daily. An updated Cochrane review identified additional 7 trials of duloxetine and 9 of milnacipran. 138 The updated analysis did not change findings from previous reviews: both drugs were better than placebo in reducing pain by at least 30%. Both drugs were also found to improve health-related quality of life, although more SNRI patients dropped out of trials due to adverse events as compared to placebo. Antidepressants A meta-analysis of nine trials of the TCA amitriptyline found a small improvement in pain. 139 A Cochrane review of seven RCTs found a small difference in patients who reported a 30% pain reduction between SSRIs (33%) and placebo (23%). SSRIs included in the review included citalopram, fluoxetine, and paroxetine. 140 These data are insufficient to recommend SSRIs for the treatment of pain alone in patients with fibromyalgia.
Conclusions
This learning activity has reviewed an evidence- based path toward increasing use of non-opioid therapies for treating acute and chronic pain conditions, emphasizing holistic assessment, individualized treatment planning, and multi-modal therapeutic approaches. Pain treatment plans should be grounded on realistic functional goals. The level of pain management needed to reach those goals should be determined using a shared decision-making approach. In general, non-drug options (which can be as effective as drug options) should be tried first. When drug options are considered, it is important to maximize non-opioid options before trying opioids. Since much acute pain is self-limiting and remits with healing (typically within a month), helping patients frame expectations about acute pain and pain relief can provide reassurance and reduce fear, worry, and distress. Multimodal approaches should be used to manage acute pain, combining non-drug as well as appropriate drug-based options.
Anticonvulsants Pregabalin
A meta-analysis of five RCTs found pregabalin, overall, had a small effect on pain. Low doses (150 mg per day) were no different than placebo, but doses of 300 mg daily or greater were more likely to result in a 50% reduction in pain than placebo. 141 A crossover randomized trial with 41 patients with fibromyalgia found that combining pregabalin with duloxetine more effectively reduced pain (68%
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