Murakami 2015.
Study characteristics | ||
Methods | Design: parallel Duration: 14 weeks Assessment: baseline and post‐intervention Country: Japan |
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Participants | Pain condition: fibromyalgia Population: adults aged 20‐75 with fibromyalgia Minimum pain intensity: ≥ 4 on 0‐10 scale Inclusion criteria
Exclusion criteria
Total participants randomised: 393 Age in years (mean, SD): 48.7 (11.9) Gender: 321/393 were female Pain duration in years (mean): 5.6 |
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Interventions | Placebo
Duloxetine 60 mg
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Outcomes | Pain intensity Mood Sleep Quality of life Physical function PGIC AEs SAEs Withdrawal |
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Missing data methods | ITT with LOCF, MMRM, and sensitivity analyses using BOCF and WOCF | |
Funding source | Pharmaceutical: Shionogi & Co. Ltd., Eli Lilly Japan K.K., and Eli Lilly & Company provided funding for the study | |
Conflicts of interest | HM and TO are employees of Shionogi & Co. Ltd. LA is an employee of Eli Lilly Japan K.K. MM, KO, and KN have provided consultancy services and MM and KO received compensation from Shionogi & Co. Ltd. for their participation in this study. MM, KO, and KN did not receive any compensation for their input into this study. The authors confirm that there are no non‐financial competing interests to declare in relation to this article. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Patients were assigned randomly to receive duloxetine or placebo in a 1:1 ratio, using a web‐based patient registration system (ACRONET Corp., Tokyo, Japan) with a stochastic minimisation procedure. |
Allocation concealment (selection bias) | Unclear risk | Allocation procedure not specified |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, study drugs had identical appearance, packaging, and labelling, matched dosing schedule |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes from blinded participants |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Although there was attrition, sensitivity analyses of the primary outcomes with LOCF, BOCF, and WOCF showed no signficiant differences. Attrition Total: 78/393 (19.9%) Placebo: 48/198 (24.4%) Duloxetine 60 mg: 30/196 (15.3%) |
Selective reporting (reporting bias) | Low risk | All outcomes listed prospectively on clinicaltrials.gov |
Other bias | Low risk | No other sources of bias were identified. |