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. 2017 Mar 27;3(3):CD012332.
doi: 10.1002/14651858.CD012332.pub2.

Oral nonsteroidal anti-inflammatory drugs for fibromyalgia in adults

Sheena Derry  1 , Philip J Wiffen  1 , Winfried Häuser  2 , Martin Mücke  3 , Thomas Rudolf Tölle  4 , Rae F Bell  5   6 , R Andrew Moore  1
Affiliations

Oral nonsteroidal anti-inflammatory drugs for fibromyalgia in adults

Sheena Derry et al. Cochrane Database Syst Rev. .

Abstract

Background: Oral nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used in the treatment of pain in fibromyalgia, despite being considered not to be effective.

Objectives: To assess the analgesic efficacy, tolerability (drop-out due to adverse events), and safety (serious adverse events) of oral nonsteroidal anti-inflammatory drugs for fibromyalgia in adults.

Search methods: We searched CENTRAL, MEDLINE, and Embase for randomised controlled trials from inception to January 2017. We also searched the reference lists of retrieved studies and reviews, and online clinical trial registries.

Selection criteria: We included randomised, double-blind trials of two weeks' duration or longer, comparing any oral NSAID with placebo or another active treatment for relief of pain in fibromyalgia, with subjective pain assessment by the participant.

Data collection and analysis: Two review authors independently extracted data and assessed trial quality and potential bias. Primary outcomes were participants with substantial pain relief (at least 50% pain relief over baseline or very much improved on Patient Global Impression of Change scale (PGIC)) or moderate pain relief (at least 30% pain relief over baseline or much or very much improved on PGIC), serious adverse events, and withdrawals due to adverse events; secondary outcomes were adverse events, withdrawals due to lack of efficacy, and outcomes relating to sleep, fatigue, and quality of life. Where pooled analysis was possible, we used dichotomous data to calculate risk difference (RD) and number needed to treat for an additional beneficial outcome (NNT), using standard methods. We assessed the quality of the evidence using GRADE and created a 'Summary of findings' table.

Main results: Our searches identified six randomised, double-blind studies involving 292 participants in suitably characterised fibromyalgia. The mean age of participants was between 39 and 50 years, and 89% to 100% were women. The initial pain intensity was around 7/10 on a 0 to 10 pain scale, indicating severe pain. NSAIDs tested were etoricoxib 90 mg daily, ibuprofen 2400 mg daily, naproxen 1000 mg daily, and tenoxicam 20 mg daily; 146 participants received NSAID and 146 placebo. The duration of treatment in the double-blind phase varied between three and eight weeks.Not all studies reported all the outcomes of interest. Analyses consistently showed no significant difference between NSAID and placebo: substantial benefit (at least 50% pain intensity reduction) (risk difference (RD) -0.07 (95% confidence interval (CI) -0.18 to 0.04) 2 studies, 146 participants; moderate benefit (at least 30% pain intensity reduction) (RD -0.04 (95% CI -0.16 to 0.08) 3 studies, 192 participants; withdrawals due to adverse events (RD 0.04 (95% CI -0.02 to 0.09) 4 studies, 230 participants; participants experiencing any adverse event (RD 0.08 (95% CI -0.03 to 0.19) 4 studies, 230 participants; all-cause withdrawals (RD 0.03 (95% CI -0.07 to 0.14) 3 studies, 192 participants. There were no serious adverse events or deaths. Although most studies had some measures of health-related quality of life, fibromyalgia impact, or other outcomes, none reported the outcomes beyond saying that there was no or little difference between the treatment groups.We downgraded evidence on all outcomes to very low quality, meaning that this research does not provide a reliable indication of the likely effect. The likelihood that the effect could be substantially different is very high. This is based on the small numbers of studies, participants, and events, as well as other deficiencies of reporting study quality allowing possible risks of bias.

Authors' conclusions: There is only a modest amount of very low-quality evidence about the use of NSAIDs in fibromyalgia, and that comes from small, largely inadequate studies with potential risk of bias. That bias would normally be to increase the apparent benefits of NSAIDs, but no such benefits were seen. Consequently, NSAIDs cannot be regarded as useful for treating fibromyalgia.

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Conflict of interest statement

SD: none known.

PW: none known.

WH is a specialist in general internal medicine, psychosomatic medicine and pain medicine, who treats patients with fibromyalgia. He is a member of the medical board of the German Fibromyalgia Association. He is the head of the steering committee of the German guideline on fibromyalgia and a member of the steering committee of the European League Against Rheumatism (EULAR) update recommendations on the management of fibromyalgia. He received speaking fees for one educational lecture each from MSD Sharpe & Dohme (2014) and Grünenthal (2015) on pain management.

MM: none known; MM is a specialist physician who treats patients with fibromyalgia.

TRT is a site investigator for the Neuropain project, funded by Pfizer. Since 2014 TRT has consulted with or received lecture fees from pharmaceutical companies related to chronic pain and analgesics: Allergan, Boehringer, Esteve, Hexal, Jannssen‐Cilag, RB.

RB: none known; RB is a retired specialist pain physician who worked with chronic pain patients, including fibromyalgia patients.

RAM has received grant support from Grünenthal relating to individual patient‐level analyses of trial data regarding tapentadol in osteoarthritis and back pain (2015). He has received honoraria for attending boards with Menarini concerning methods of analgesic trial design (2014), with Novartis (2014) about the design of network meta‐analyses, and RB on understanding pharmacokinetics of drug uptake (2015). He has received honoraria from Omega Pharma (2016) and Futura Pharma (2016) for providing advice on trial and data analysis methods.

This review was identified in a 2019 audit as not meeting the current definition of the Cochrane Commercial Sponsorship policy. At the time of its publication it was compliant with the interpretation of the existing policy. As with all reviews, new and updated, at update this review will be revised according to 2020 policy update.

Figures

1
1
Study flow diagram
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
1.1
1.1. Analysis
Comparison 1 NSAID versus placebo, Outcome 1 Substantial pain relief.
1.2
1.2. Analysis
Comparison 1 NSAID versus placebo, Outcome 2 Moderate pain relief.
1.3
1.3. Analysis
Comparison 1 NSAID versus placebo, Outcome 3 Adverse event withdrawal.
1.4
1.4. Analysis
Comparison 1 NSAID versus placebo, Outcome 4 Participants with at least one adverse event.
1.5
1.5. Analysis
Comparison 1 NSAID versus placebo, Outcome 5 All‐cause withdrawal.
See this image and copyright information in PMC

Update of

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