Allen 2017.
Study characteristics | ||
Methods | Design: parallel Duration: 15 weeks (intended to be 27 weeks but terminated early) Assessment: baseline, study termination (15 weeks) Country: USA |
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Participants | Pain condition: fibromyalgia Population: adults with fibromyalgia Inclusion criteria
Exclusion criteria
Total participants randomised: 697 Age in years (mean, SD): NR Gender: NR Pain duration: NR |
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Interventions | Desvenlafaxine 50 mg
Desvenlafaxine 100 mg
Desvenlafaxine 200 mg
Desvenlafaxine 400 mg
Placebo
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Outcomes | Pain intensity 50% pain reduction PGIC AE SAE Withdrawal |
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Missing data methods | LOCF | |
Funding source | Pharmaceutical: Wyeth Research, now incorportated into Pfizer | |
Conflicts of interest | Rob Allen, MD, is a former Pfizer employee currently working as an independent consultant. Suna Barlas, PhD, is a Pfizer employee. Uma Sharma, PhD, is a former Pfizer employee and currently works at MMS Holdings Inc. | |
Notes | Study terminated early (at 15 weeks instead of 27 weeks) due to interim efficacy analysis not meeting the preplanned efficacy criteria | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not enough information ‐ just says 'randomly assigned' |
Allocation concealment (selection bias) | Unclear risk | No information given |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information on matching appearance or dosing schedules of antidepressants and placebo |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Self‐reported outcomes by participants, but blinding information unclear |
Incomplete outcome data (attrition bias) All outcomes | High risk | Study terminated, so missing data from all time points past 15 weeks. LOCF. Very high attrition across all arms before study termination. Attrition: Total: 445/697 (63.8%) Placebo: 84/130 (67.7%) Desvenlafaxine 50 mg: 87/136 (66.0%) Desvenlafaxine 100 mg: 81/140 (62.0%) Desvenlafaxine 200 mg: 100/142 (76.0%) Desvenlafaxine 400 mg: 93/149 (67.0%) |
Selective reporting (reporting bias) | Low risk | Protocol stated the interim analyses |
Other bias | Low risk | Study terminated early, but this was due to interim efficacy analyses not meeting the prespecified criteria. |