Matthey 2013.
Study characteristics | ||
Methods | Design: parallel Duration: 7 weeks Assessment: baseline and post‐intervention Country: Switzerland |
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Participants | Pain condition: fibromyalgia Population: adult women with fibromyalgia Minimum pain intensity: ≥ 40 on 0‐100 VAS Inclusion criteria
Exclusion criteria
Total participants randomised: 80 Age in years (mean): 49.7 Gender: 80/80 were female Pain duration in years (mean, SD): NR |
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Interventions | Placebo
Milnacipran 100‐200 mg
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Outcomes | Pain intensity Quality of life Physical function Mood Sleep Withdrawal |
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Missing data methods | ITT wit h LOCF | |
Funding source | Pharmaceutical: This trial was supported by a grant from Pierre Fabre Médicament. | |
Conflicts of interest | "Each author certifies that he or she, or a member of his or her immediate family, has no commercial association, (i.e., consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might post a COI in connection with the submitted manuscript." | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A randomisation list was computer‐generated. |
Allocation concealment (selection bias) | Low risk | Allocation of treatments was done by the investigator according to the chronological order of the occurring visit 2 |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | State double‐blind but not enough information about study drug appearance and dosing |
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, high attrition Attrition Total: 37/80 (46.3%) Placebo: 16/40 (40.0%) Milnacipran 100‐200 mg: 21/40 (52.5%) |
Selective reporting (reporting bias) | Unclear risk | No changes to protocol, but it's registered 2 years after trial start |
Other bias | Low risk | No other sources of bias were identified. |