Cochrane for Clinicians

Putting Evidence into Practice

Pregabalin for Fibromyalgia Pain in Adults


Am Fam Physician. 2017 Sep 1;96(5):291-292.

Author disclosure: No relevant financial affiliations.

Clinical Question

Does pregabalin (Lyrica) reduce the pain associated with fibromyalgia in adults?

Evidence-Based Answer

There is high-quality evidence that pregabalin in daily dosages of 300 mg, 450 mg, and 600 mg reduces pain associated with fibromyalgia. The most effective dosage seems to be 450 mg daily; this dosage is more effective than placebo at reducing pain by at least 50% (number needed to treat [NNT] = 9.7). Compared with patients taking placebo, those taking pregabalin who tolerate titration to an effective dosage are more likely to maintain at least a 30% pain reduction for 13 weeks (NNT = 5.3).

Discontinuation of therapy occurs more often in patients taking pregabalin than in those taking placebo. For example, patients often quit taking pregabalin (450 mg daily) because of adverse effects (number needed to harm [NNH] = 11).1 (Strength of Recommendation: A, based on consistent, good-quality patient-oriented evidence.)

Practice Pointers

Fibromyalgia is the second most common rheumatologic condition in the United States, occurring in 2.4% of the population.2,3 Fibromyalgia negatively affects quality of life, with 35% of patients reporting difficulty with activities of daily living.4 The authors of this review sought to evaluate the effect of pregabalin on fibromyalgia pain in adults.

This Cochrane review included five randomized trials with 3,283 patients who had pain from fibromyalgia.1 Studies lasted two to three months. Two additional studies followed patients for 13 to 26 weeks after titration of pregabalin to monitor maintenance of benefit.

The most effective daily dosage of pregabalin was 450 mg, which reduced pain by at least 50% vs. placebo (NNT = 9.7; 95% confidence interval [CI], 7.2 to 15), although with more discontinuation for adverse effects (NNH = 11; 95% CI, 8.4 to 17). Patients treated with 150 mg of pregabalin had no more pain relief than those taking placebo. Patients who took 300 mg of pregabalin also experienced at least a 50% pain reduction over baseline compared with patients taking placebo (NNT = 14; 95% CI, 8.9 to 32). Of note, the patients taking 300 mg of pregabalin daily were less likely to discontinue treatment because of adverse effects (NNH = 17; 95% CI, 10 to 41) when compared with patients taking 450 mg daily. Patients taking 600 mg of pregabalin daily were less likely to see at least a 50% reduction in their level of pain (NNT = 11; 95% CI, 7.1 to 21) than patients taking 450 mg; they were also more likely to discontinue treatment due to adverse effects (NNH = 5.9; 95% CI, 4.6 to 8) vs. patients taking 450 mg daily. Common adverse effects in patients taking pregabalin included somnolence, dizziness, weight gain, and peripheral edema. Meta-analysis demonstrated that approximately 10% of patients with fibromyalgia were not able to tolerate the medication at doses that provided moderate or greater pain relief compared with placebo.

The authors evaluated two trials involving 687 patients who were monitored for at least 13 weeks after titration of pregabalin or placebo. Compared with patients taking placebo, those taking pregabalin were more likely to maintain at least 30% pain reduction over baseline at the study conclusion (NNT = 5.3; 95% CI, 3.9 to 8.2). In another recent meta-analysis, duloxetine (Cymbalta) at a dosage of 60 mg daily was more effective than pregabalin at a dosage of 300 mg daily at reducing fibromyalgia pain.5 Guidelines on the management of fibromyalgia from the European League Against Rheumatism give a weak recommendation for the use of pregabalin, the same recommendation given to other U.S. Food and Drug Administration–approved medications such as duloxetine.6

The practice recommendations in this activity are available at

The views expressed in this article are those of the author and do not necessarily reflect the official policy or position of the Department of the Navy, the Department of Defense, or the U.S. government.

Author disclosure: No relevant financial affiliations.


show all references

1. Derry S, Cording M, Wiffen PJ, Law S, Phillips T, Moore RA. Pregabalin for pain in fibromyalgia in adults. Cochrane Database Syst Rev. 2016;(9):CD011790....

2. Lawrence RC, Felson DT, Helmick CG, et al.; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008;58(1):26–35.

3. Heidari F, Afshari M, Moosazadeh M. Prevalence of fibromyalgia in general population and patients, a systematic review and meta-analysis [published online ahead of print April 26, 2017]. Rheumatol Int. [subscription required]. Accessed July 7, 2017.

4. Chinn S, Caldwell W, Gritsenko K. Fibromyalgia pathogenesis and treatment options update. Curr Pain Headache Rep. 2016;20(4):25.

5. Lee YH, Song GG. Comparative efficacy and tolerability of duloxetine, pregabalin, and milnacipran for the treatment of fibromyalgia: a Bayesian network meta-analysis of randomized controlled trials. Rheumatol Int. 2016;36(5):663–672.

6. Macfarlane GJ, Kronisch C, Dean LE, et al. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis. 2017;76(2):318–328.



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