Arnold 2010c.

Study characteristics
Methods	Design: parallel Duration: 12 weeks Assessment: baseline and post‐intervention (12 weeks) Country: USA and Puerto Rico
Participants	Pain condition: fibromyalgia Population: adults with fibromyalgia Minimum pain intensity: ≥ 4 out of 10 Inclusion criteria Aged ≥ 18, met the criteria for fibromyalgia as defined by the ACR Scored ≥ 4 on the average pain item of the Brief Pain Inventory Short Form at visit 1 and visit 2. Exclusion criteria Current or diagnosed within the past year with any primary psychiatric disorder other than MDD or GAD defined by the DSM‐IV; clinically judged to be at serious risk of suicide; had any unstable medical illness that was likely to require intervention or hospitalisation; pain symptoms unrelated to fibromyalgia that could interfere with interpretation of outcome measures; regional pain syndromes; multiple surgeries or failed back syndrome; a confirmed current or previous diagnosis of RA, inflammatory arthritis, or other autoimmune disease; severe liver disease; pregnant or breastfeeding; or history of substance abuse within the past year Treated with an adequate trial of duloxetine and did not respond or could not tolerate duloxetine; were judged by the opinion of the investigator to be treatment‐refractory in fibromyalgia; or those in whom treatment response might be compromised by disability compensation issues Total participants randomised: 530 Age in years (mean, SD): 50.2 (11.1) Gender: 494/530 were female Pain duration in years: NR
Interventions	Duloxetine n = 263 SNRI 3 doses depending on patient tolerability: 60 mg/day, 90 mg/day, or 120 mg/day Mean dose 81.7 mg/day Placebo n = 267 Inert Identical appearance
Outcomes	Pain intensity Mood Physical function Moderate pain relief Substantial pain relief PGIC AEs SAEs Withdrawal
Missing data methods	LOCF and MMRM
Funding source	Pharmaceutical ‐ Lilly USA LLC
Conflicts of interest	Dr Mease has received grants/research support from Eli Lilly and Company; Pfizer, Inc; Cypress Bioscience, Inc; Forest Laboratories, Inc; Allergan; Fralex; and Boehringer Ingelheim. He has been a consultant for Eli Lilly and Company; Pfizer, Inc; Cypress Bioscience, Inc; Forest Laboratories, Inc; Allergan; Fralex; Boehringer Ingelheim; Pierre Fabre; and Wyeth; and he is on the Speakers Bureau of Pfizer, Inc. Dr Arnold has received grants/research support from Eli Lilly and Company; Pfizer, Inc; Cypress Bioscience, Inc; Boehringer Ingelheim; and Forest Laboratories, Inc, and received honoraria as a consultant to Eli Lilly and Company; Pfizer, Inc; Cypress Bioscience, Inc; Boehringer Ingelheim; Forest Laboratories, Inc; Allergan; Takeda; UCB Inc.; Theravance; AstraZeneca; Sanofi‐Aventis; and Grunenthal. Drs Mohs, Ahl, Gaynor, and Wohlreich are all employees and stockholders in Eli Lilly andCompany. Dr Wang is a former employee of Lilly USA, LLC.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random sequence
Allocation concealment (selection bias)	Low risk	Allocation was managed using an Interactive Voice Response System.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Good blinding procedures, identical appearing placebo
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	HIgh attrition but equal, ITT with LOCF and BOCF Attrition: Total: 167/530 (31.5%) Placebo: 80/267 (30.0%) Duloxetine 60‐120 mg: 87/263 (33.1%)
Selective reporting (reporting bias)	Low risk	Trial registered prospectively and all outcomes reported
Other bias	Low risk	No other sources of bias were identified.