Two small blinded randomized trials measured effectiveness of Naltrexone on fibromyalgia symptoms. The larger study found 0.34 points reduction in pain (95% confidence interval -0.95 to 0.27, scale from 0 to 10), which translates to about 6% reduction in pain (1). The total fibromyalgia symptoms decreased - 2.50 points (–6.73 to 1.72, FIQR [0-100]), also suggesting little or no benefit from the treatment.
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias |
|---|---|---|---|---|---|
| RCT=randomized controlled trial; SR=systematic review; MA=meta-analysis; FIQR = Fibromyalgia impact questionnaire revised; SPIR = summed pain intensity raiting | |||||
| «Due Bruun K, Christensen R, Amris K, et al. Naltre...»1 | RCT | Women, age 18-64, with fibromyalgia. | Naltrexone 6 mg once daily vs placebo | BPI | low |
| «Bested K, Jensen LM, Andresen T, et al. Low-dose n...»2 | RCT, crossover study | Premenopausal women with fibromyalgia, referred to multidisciplinary pain treatment | Naltrexone 4,5 mg once daily vs placebo | FIQR, SPIR | low |
| «Younger J, Noor N, McCue R, et al. Low-dose naltre...»3 | RCT, crossover study | Women, age 18-64 with fibromyalgia. | Naltrexone 4,5 mg once daily vs placebo | Pain | low |
| Reference | Comments |
|---|---|
| «Due Bruun K, Christensen R, Amris K, et al. Naltre...»1 | 9/99 dropped out from the study before the end of follow up but were included in the ITT analysis. |
| «Bested K, Jensen LM, Andresen T, et al. Low-dose n...»2 | Fibromyalgia diagnosed by rheumatologist. |
| «Younger J, Noor N, McCue R, et al. Low-dose naltre...»3 | Participants with joint inflammation or with history of rheumatic diseases were excluded. Naltrexone 12 weeks and placebo 4 weeks. |
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Mean change from baseline (sd) I | Mean change from baseline (sd) C | Mean difference (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: moderate Assess the risk of bias and delete irrelevant sources of bias: The quality of evidence is downgraded due to imprecision. I=intervention; C=comparison; CI=confidence interval |
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| «Due Bruun K, Christensen R, Amris K, et al. Naltre...»1 | 50/49 | 12 weeks | - 10.8 (–13.8 to –7.8) | - 8.3 (–11.3 to –5.3) | - 2.50 (–6.73 to 1.72) |
| «Bested K, Jensen LM, Andresen T, et al. Low-dose n...»2 | 26/26 | 3 weeks + 3 weeks | −2.50, CI not reported, P-value = 0.34 | ||
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Mean change from baseline I (95% CI) | Mean change from baseline C (95% CI) | Mean difference (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: moderate Assess the risk of bias and delete irrelevant sources of bias: The quality of evidence is downgraded due to imprecision. I=intervention; C=comparison; CI=confidence interval |
|||||
| «Due Bruun K, Christensen R, Amris K, et al. Naltre...»1 | 49/50 | 12 weeks | –1,3 (–1,7 to –0,8) | –0,9 (–1,4 to –0,5) | –0,34 (–0,95 to 0,27) |
| «Bested K, Jensen LM, Andresen T, et al. Low-dose n...»2 | 26/26 | 3 weeks + 3 weeks | −0.40, CI not reported, P = 0.68 | ||
| «Younger J, Noor N, McCue R, et al. Low-dose naltre...»3 | 14/14 | 12 weeks | -11.2 | -15.5 | not reported, p = 0.016 |