Staud 2015.
Study characteristics | ||
Methods | Design: parallel Duration: 6 weeks Assessment: baseline and post‐intervention Country: USA |
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Participants | Pain condition: fibromyalgia Population: adults with fibromyalgia Minimum pain intensity: ≥ 4 on 0‐10 VAS Inclusion criteria
Exclusion criteria
Total participants randomised: 61 Age in years (mean, SD): NR Gender: 56/61 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 Mood Withdrawal |
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Missing data methods | ITT with LOCF | |
Funding source | Pharmaceutical: This study was supported by an investigator‐initiated grant from Forest Laboratories. All study drugs were provided by Forest Laboratories. | |
Conflicts of interest | Funded by an investigator‐initiated grant from Forest Laboratories. All study drugs were provided by Forest Laboratories. The sponsors of this trial had no role in planning and implementing the study, and in the analysis of the data. They were not involved in the writing of this report. None of the authors have any financial or other relationships that might lead to a COI. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised using Research Randomizer (http://www.randomizer.org/) |
Allocation concealment (selection bias) | Unclear risk | Allocation procedure not specified |
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 | Similar attrition in both arms, report that they will use LOCF for missing data but then state that as "missing data did not result in different conclusions, we report only the results of uncorrected analyses", so completer analysis. Attrition Total: 26/62 (41.9%) Placebo: 5/23 (21.7%) Milnacipran 100 mg: 6/23 (26.1%) 15 participants (8 milnacipran, 7 placebo) withdrew post‐randomisation prior to receiving study medication, so were not included in the arm‐specific totals above. No reasons were given for the withdrawals of these 15 participants. |
Selective reporting (reporting bias) | High risk | Protocol only lists mechanical and heat hyperalgesia and clinical pain as outcomes. Doesn't specify how these will be collected or the other measures used in the study. |
Other bias | High risk | Create a second baseline essentially: a lot of participants withdrew after randomisation and so the authors ignore that in final analysis and only include those who came back for a second study visit. |