Pickering 2018.
Study characteristics | ||
Methods | Design: parallel Duration: 4 weeks Assessment: baseline and post‐interventions Country: France |
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Participants | Pain condition: fibromyalgia Population: adult women with fibromyalgia Minimum pain intensity: no Inclusion criteria
Exclusion criteria
Total participants randomised: 54 Age in years (mean, SD): 46.7 (10.6) Gender: 54/54 were female Pain duration in months (mean): 71.9 |
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Interventions | Placebo
Milnacipran 100 mg
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Outcomes | Pain intensity Moderate pain relief AEs SAEs Withdrawal |
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Missing data methods | Completer analysis only | |
Funding source | Non‐pharmaceutical: "We thank the Apicil foundation for their financial support" | |
Conflicts of interest | The study authors report no conflicts of interest in this work. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The randomisation sequence was generated using random blocks. |
Allocation concealment (selection bias) | Low risk | Treatment allocation followed a predefined randomisation plan and was conducted by a person independent from the protocol. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, identical study drugs with matched dosing |
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 analysis only Attrition: Total: 6/54 (11.1%) Placebo: 1/29 (3.5%) Milnacipran 100 mg: 5/25 (20.0%) |
Selective reporting (reporting bias) | Low risk | Study protocol published: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4393595/ All outcomes matched those published |
Other bias | Low risk | No other sources of bias were identified. |