Gilron 2016.
Study characteristics | ||
Methods | Design: cross‐over Duration: 6 weeks Assessment: baseline and post‐intervention Country: Canada |
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Participants | Pain condition: fibromyalgia Population: people with fibromyalgia Minimum pain intensity: ≥ 4 on 0‐10 VAS Inclusion criteria
Exclusion criteria
Total participants randomised: 41 Age in years (median, range): 56 (20‐71) Gender: 36/41were female Pain duration in years (mean, SD): NR |
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Interventions | Placebo
Pregabalin ≤ 450 mg
Duloxetine ≤ 120 mg
Pregabalin ≤ 450 mg + duloxetine ≤ 120 mg
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Outcomes | Pain intensity Quality of life Physical function Mood Sleep Withdrawal |
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Missing data methods | NR | |
Funding source | Part funded by pharmaceutical: "This work was supported by CIHR (Canadian Institutes ofHealth) Grant CIHR‐MOP‐106489 and a CIHR‐Pfizer R&D Collaborative Research Investigator Program (CIHR Grant MSH‐55041)." | |
Conflicts of interest | I. Gilron has received support from Adynxx, Taris Biomedical, Astra Zeneca, Pfizer, and Johnson & Johnson and has received grants from the Canadian Institutes of Health Research, Physicians' Services Incorporated Foundation, and Queen's University. L. E. Chaparro received a John J. Bonica Training Fellowship from the International Association for the Study of Pain and also financial support from the Queen's University Department of Anesthesiology and Perioperative Medicine. R. R. Holden has received research funding from the Canadian Institutes of Health Research, the Social Sciences and Humanities Research Council of Canada, the American Foundation for Suicide Prevention, and Queen's University. R. Milev has received financial support and research grants from CIHR, Ontario Brain Institute, Ontario Mental Health Foundation, Lundbeck, Lilly, Sunovion, BMS, Otsuka, Pfizer, Paladin, and Merck. T. Towheed has received financial support from Abbvie and Bristol‐Meyers‐Squibb and research funding from the Canadian Institutes of Health Research. D. D. Shore. and S. Walker received no external financial support. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised using computer randomisation of the 3 sequences in blocks of 3. |
Allocation concealment (selection bias) | Low risk | A trial pharmacist prepared a concealed allocation schedule, and the pharmacist had no further involvement in the trial. Patients were assigned in turn to the next consecutive number, and the corresponding series of study drugs was dispensed. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, matched dosing schedule and double dummy design |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes from blinded participants |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information on missing data methods Attrition Total: 8/41 (19.5%) Placebo: 1/41 (2.4%) Pregabalin ≤ 450 mg: 1/41 (2.4%) Duloxetine ≤ 120 mg: 3/41 (7.32%) Pregabalin ≤ 450 mg + duloxetine ≤ 120 mg: 4/41 (9.76%) |
Selective reporting (reporting bias) | Low risk | Everything as reported in prospectively registered protocol |
Other bias | High risk | Taper and washout period were combined, only 1 day complete washout. They state that "primary analysis revealed no significant effects of sequence or carryover, but effects of period and treatment were significant". |