Russell 2008.

Methods	Randomised, double‐blind, placebo‐controlled, parallel group trial in fibromyalgia
Participants	520 participants Female and male outpatients ≥ 18 years of age who met criteria for fibromyalgia as defined by the American College of Rheumatology. Participants were required to have a score ≥ 4 on the average pain severity item (in the past 24 hours) of the Brief Pain Inventory (BPI‐modified Short Form at screening and at baseline. The study included people with or without current major depressive disorder and evaluated them for the presence of psychiatric disorders using the MINI. Prior to randomisation, the study required participants to discontinue any medications that might interfere with the evaluation of pain improvement, including analgesics (with the exception of up to 325 mg/day of aspirin for cardiac prophylaxis and paracetamol up to 2 g/day for pain), antidepressants, anticonvulsants, or other medications taken for fibromyalgia or pain
Interventions	Duloxetine 20 mg daily, 60 mg daily or 60 mg twice daily versus placebo for 6 months
Outcomes	BPI average pain severity score Short Form 36 Health Survey (SF‐36) patient global impression of clinical change
Notes	Company sponsored and run trial
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A computer‐generated random sequence determined assignment to treatment groups and the study randomly assigned each stratum (depressed and non‐depressed) within sites to achieve a relative balance across treatments
Allocation concealment (selection bias)	Unclear risk	Unclear although other trials from the same group have been adequate
Blinding (performance bias and detection bias) All outcomes	Low risk	Double‐blind
Incomplete outcome data (attrition bias) All outcomes	High risk	35% to 40% dropout at the 3 month interim analysis phase and up to 46% dropout for the 6 month phase. "Intention‐to‐treat unless otherwise specified". Safety analyses in all participants and others with data for at least 1 measure
Selective reporting (reporting bias)	Unclear risk	See above
Other bias	Low risk	Lilly study. No other bias identified