Russell 2008.

Study characteristics
Methods	Design: parallel Duration: 28 weeks Assessment: baseline, 3 months, post‐intervention Country: USA and Puerto Rico
Participants	Pain condition: fibromyalgia Population: adults with fibromyalgia with or without MDD Minimum pain intensity: ≥ 4 on 0‐10 scale Inclusion criteria Outpatients at least 18 years of age who met criteria for fibromyalgia as defined by the ACR criteria Score ≤ 4 on the average pain severity item of BPI Patients with or without current MDD were included Exclusion criteria Physical health comorbidities Any current primary psychiatric diagnosis other than MDD Total participants randomised: 520 Age in years (mean, SD): 51.02 (10.87) Gender: 492/520 were female Pain duration in years (mean, SD): NR
Interventions	Placebo n = 144 Inert Matched dosing Duloxetine 20 mg then 60 mg n = 79 SNRI Forced titration to fixed dose Duloxetine 60 mg n = 150 SNRI Forced titration to fixed dose Duloxetine 120 mg n = 147 SNRI Forced titration to fixed dose
Outcomes	Pain intensity Quality of life Physical function Mood Moderate pain relief Substantial pain relief PGIC AEs SAEs Withdrawal
Missing data methods	ITT with LOCF
Funding source	Pharmaceutical: this work was sponsored by Eli Lilly and Company and Boehringer Ingelheim GmbH.
Conflicts of interest	Drs Chappell, Detke, Kajdasz, Walker, and Wohlreich are employees and stockholders of Eli Lilly and Company. Drs Arnold, Mease, Russell, and Smith were Principal Investigators at sites conducting the trial. Their sites received funds for participating in the research study. Dr Arnold has received grants/research support from Eli Lilly and Company, Pfizer Inc, Cypress Biosciences Inc, Wyeth Pharmaceuticals, Sanofi‐Aventis, Boehringer Ingelheim, Allergan, and Forest; she has been a consultant for Eli Lilly and Company, Pfizer Inc, Cypress Biosciences Inc, Wyeth Pharmaceuticals, Sanofi‐Aventis, Boehringer Ingelheim, Sepracor, Forest Laboratories Inc, Allergan, Vivus Inc, and Organon; and she is on the Speakers Bureau of Eli Lilly and Company and Pfizer, Inc. Dr Mease has received grants/research support from Eli Lilly and Company, Pfizer Inc, Cypress Bioscience, Forest, Allergan, Fralex, and Boehringer Ingelheim; he has been a consultant for Eli Lilly and Company, Pfizer Inc, Cypress Bioscience, Forest, Allergan, Fralex, Boehringer Ingelheim, Pierre Fabre, and Wyeth; and he is on the Speakers Bureau of Pfizer Inc. Dr Russell has received grants/research support from the National Institutes of Health, RGK Foundation of Austin Texas, The National Fibromyalgia Association, Autoimmune Technologies, LLC, New Orleans, Louisiana, LKB World (Southern France), Pfizer Central Research, Eli Lilly and Company, Orphan Medical/Jazz, Grutnenthal GmbH, Allergan, and Schwarz; and he is on medical advisory boards of Pfizer Inc, Eli Lilly and Company, Jazz Pharmaceutical, Gruenthal GmbH, and Allergan. Dr Smith has received grants/research support from Abbott, Allergan, AstraZeneca, Bristol‐Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson and Johnson, Merck, Ortho‐McNeil, Pfizer Inc, Minster, Novartis, Novo Nordisk, Orexigen, Shionogi, Schwarz, Vernalis, and Wyeth; he has been a consultant or on advisory boards of Allergan, Eli Lilly and Company, was previously on a medical advisory board for Eli Lilly and Compant, GlaxoSmithKline and Merck.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Assignment to treatment groups was determined by a computer‐generated random sequence
Allocation concealment (selection bias)	Unclear risk	Allocation procedures not specified
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	All participants only took 1 dose daily to maintain blinding. No information about appearance, taste etc. Possibly some participants in the 20/60 arm would become unblinded with the increase in dose.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Self‐reported outcomes but unsure of blinding
Incomplete outcome data (attrition bias) All outcomes	High risk	ITT with LOCF. High attrition Attrition Total: 24/520 (46.7%) Placebo: 72/144 (50.0%) Duloxetine 20 mg then 60 mg: 35/79 (44.3%) Duloxetine 60 mg: 68/150 (45.3%) Duloxetine 120 mg: 68/147 (46.3%)
Selective reporting (reporting bias)	High risk	Not completely clear in all outcome measures to be used ‐ only domains ‐ in the protocol. In the trial registry results submitted by study authors: they show they've measured the same outcomes with multiple scales (Hamilton Depression Rating Scale and BDI‐II) have also measured further outcomes like BPI interference but do not report these. Have reported significant results in the trial report.
Other bias	Low risk	No other sources of bias were identified.