Kim 2013.
Study characteristics | ||
Methods | Design: cross‐over 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: no Inclusion criteria
Exclusion criteria
Total participants randomised: 20 Age in years (mean, SD): 47.6 (9.1) Gender: 18/20 were female Pain duration in years (mean, SD): NR |
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Interventions | Placebo
Milnacipran 12.5‐200 mg
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Outcomes | AEs SAEs |
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Missing data methods | ITT with LOCF | |
Funding source | Pharmaceutical: "This study was supported by Forest Laboratories through an Investigator‐Initiated Award." | |
Conflicts of interest | "Dr Marks has served as a consultant to Forest, Dey, Gilead, and TTK; has received grant/research support from Bristol‐Myers Squibb, Dov, Eli Lilly, Endo, GlaxoSmithKline, Janssen, Johnson & Johnson, Pfizer, Saegis, Sepracor, and Somaxon; and has served on the speakers or advisory boards of Alkermes, Bristol‐Myers Squibb, Dey, Pfizer, and Sunovion. Dr Masand has served as a consultant to Forest, Lundsbeck, Merck, Pfizer, and Sunovion; has received grant/research support from Forest; has received honoraria from or served on the speakers or advisory boards of Forest, GlaxoSmithKline, Merck, Pfizer, and Sunovion; and is a stock shareholder in Global Medical Education. Dr Millet has received grant/research support from Forest. Dr Keefe has served as a consultant to Abbvie, Akebia, Amgen, Asubio, BiolineRx, Biomarin, Boehringer‐Ingelheim, Eli Lilly, EnVivo, Lundbeck, Merck, Mitsubishi, Novartis, Otsuka, Pfizer, Roche, Shire, Sunovion, Takeda, and Targacept; has received grant/research support from Feinstein Institute for Medical Research, GlaxoSmithKline, National Institute of Mental Health, PsychoGenics, Research Foundation for Mental Hygiene, and Singapore Medical Research Council; is a stock shareholder in NeuroCog Trials; and has received royalties from the Brief Assessment of Cognition in Schizophrenia (BACS) and MATRICS Battery (BACS Symbol Coding). Dr Patkar has served as a consultant to Dey, Forest, Gilead, and TTK; has received grant/research support from Dey, Duke Endowment, Envivo, Forest, Janssen, Lundbeck, National Institutes of Health (National Institute on Drug Abuse/National Institute on Alcohol Abuse and Alcoholism), Pfizer, Shire, Sunovion, and Titan; and has served on the speakers or advisory boards of Alkermes, BristolMyers Squibb, Dey, Pfizer, and Sunovion. Dr Kim and Mss Rele and Yerramsetty report no conflicts of interest related to the subject of this article. |
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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 procedures not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Says double‐blinded but no specific information given regarding identical medication |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Self‐reported outcomes by participants but not enough information regarding blinding |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Authors state that the same 20 participants completed both phases of study (20) but LOCF numbers are 31. Not clear about ITT, imputation or handling of missing data Attrition Not clearly reported, unable to establish total attrition and attrition per arm |
Selective reporting (reporting bias) | Unclear risk | Protocol lists pain, fatigue and cognition prospectively but doesn't mention any of the secondary measures. A lot of missing outcomes |
Other bias | Unclear risk | Data NR in numerical forms ‐ all secondary outcomes are classified e.g. "transient change" which has no interpretation |