Branco 2010.
Study characteristics | ||
Methods | Design: parallel Duration: 17 weeks Assessment: baseline and post‐intervention Country: Czech Republic, Denmark, Finland, France, Germany, Italy, Norway, Poland, Portugal, Romania, Spain, Sweden, UK |
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Participants | Pain condition: fibromyalgia Population: adults with fibromyalgia Minimum pain intensity: baseline VAS pain intensity rating between 40 and 90 (0‐100 scale) Inclusion criteria
Exclusion criteria
Total participants randomised: 884 Age in years (mean): 48.4 Gender: 826 were female Pain duration in years (mean): 9.5 |
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Interventions | Placebo
Milnacipran 200 mg
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Outcomes | Pain intensity Quality of life Physical function Mood PGIC AEs SAEs Withdrawal |
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Missing data methods | ITT with LOCF, and BOCF sensitivity analyses | |
Funding source | Pharmaceutical ‐ Pierre Fabre Medicament, France | |
Conflicts of interest | Dr Branco has received grant support as an investigator and consultant for Pierre Fabre Medicament. Drs Zachrisson and Perrot have served as speakers and consultants for Pierre Fabre Medicament. Dr Mainguy is an employee and shareholder of Pierre Fabre Medicament. Medical writing assistance provided by Prescott Medical Communications Group was supported by Pierre Fabre Medicament. | |
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) | Unclear risk | Allocation procedure not specified |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Matched dosing but no information regarding appearance of drugs |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Self‐reported outcomes from participants, but unsure of blinding procedures |
Incomplete outcome data (attrition bias) All outcomes | High risk | ITT with LOCF and BOCF as sensitivity analysis. More dropouts in antidepressant arm related to side‐effects Attrition Total: 206/882 (23.3%) Placebo: 79/449 (17.6%) Milnacipran 200 mg: 127/435 (29.2%) |
Selective reporting (reporting bias) | Unclear risk | Primary outcome matches trial registry, but secondary outcomes not listed |
Other bias | Low risk | No other sources of bias were identified. |