Natelson 2015.
Study characteristics | ||
Methods | Design: parallel Duration: 8 weeks Assessment: baseline and post‐intervention Country: USA |
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Participants | Pain condition: fibromyalgia Population: adults aged 18‐68 with fibromyalgia Minimum pain intensity: no Inclusion criteria
Exclusion criteria
Total participants randomised: 34 Age in years (mean, SD): 46.8 Gender: 33/34 were female Pain duration in years (mean, SD): NR |
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Interventions | Placebo
Milnacipran 100 mg
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Outcomes | Pain intensity AEs SAEs Withdrawal |
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Missing data methods | Completer‐only analysis | |
Funding source | Part funded by pharmaceutical: "This work was supported by a Forest Laboratories Investigator‐initiated grant to B.H.N., and, in part, by National Institutes of Mental Health (NIMH) grant R01 MH100005 to D.C.S." | |
Conflicts of interest | "J.D.C. has been a speaker for Pfizer, Forest, Bristol Myers Squibb, Glaxo Smith Kline, Eli Lilly, and Sunovion. He has received grants from Pfizer Pharmaceuticals, GSK, Corcept, and Neurocrine. There were no other conflicts of interest in doing this research. This work was supported by a Forest Laboratories Investigator‐initiated grant to B.H.N., and, in part, by National Institutes of Mental Health (NIMH) grant R01 MH100005 to D.C.S. The sources of funding had no involvement in any of the aspects of running this study, analyzing the data, or preparing this manuscript." | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation methods not specified |
Allocation concealment (selection bias) | Low risk | Mount Sinai Beth Israel Pharmacy dispensed the drug or placebo according to the randomisation list in sequential order. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, with identical study drugs and matched dosage schedule |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes from blinded participants |
Incomplete outcome data (attrition bias) All outcomes | High risk | Completer‐only analysis Attrition Total: 8/34 (23.5%) Placebo: 4/17 (23.5%) Milnacipran 100 mg: 4/17 (23.5%) |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration found |
Other bias | Low risk | No other sources of bias were identified |