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. 2014 Jan 3;2014(1):CD007115. doi: 10.1002/14651858.CD007115.pub3

Raskin 2005.

Methods Randomised, double‐blind, placebo‐controlled, parallel group trial in diabetic peripheral neuropathic pain
Participants 348 participants
Participants ≥ 18 years, with pain due to bilateral peripheral neuropathy caused by type 1 or type 2 diabetes mellitus. The pain had to begin in the feet with relatively symmetrical onset and be present for at least 6 months. Participants had to have a mean score of ≥ 4 when assessed for 24‐hour average pain severity on the Michigan Neuropathy Screening Instrument (MNSI) 11‐point Likert scale (from the patient diary prior to randomisation), and stable glycaemic control. Concomitant pain medications excluded.
Interventions Duloxetine 60 mg daily or duloxetine 60 mg twice daily versus placebo for 12 weeks
Outcomes

  • 24‐hour average pain severity

  • Patient global impression of clinical change,

  • pain at rest

  • Brief Pain Inventory (BPI) severity

  • Clinical Global Impression of Pain Severity scale (CGI‐S)

  • Short Form McGill pain questionnaire

  • BPI interference scale
Notes Company sponsored and run trial
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation performed at visit 3 in a 1:1:1 ratio. A computer‐generated random sequence determined assignment to treatment groups, using an IVRS
Allocation concealment (selection bias) Low risk Participants received either of (or a combination of, depending on their randomly assigned treatment) the following: 30 mg capsules of duloxetine hydrochloride or placebo capsules identical to duloxetine capsules. Participants randomly assigned to each treatment group were instructed to take two capsules (by mouth) every morning and every evening.
Treatment was assigned using IVRS
Blinding (performance bias and detection bias) 
 All outcomes Low risk Double‐blind
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Dropouts were 52/340 (15%). Analysis was by ITT
Selective reporting (reporting bias) Low risk See above
Other bias Low risk Lilly study. No other bias identified