Ware 2010.
Study characteristics | ||
Methods | Design: cross‐over Duration: each cross‐over period lasted 2 weeks Assessment: baseline and post‐cross‐over period Country: Canada |
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Participants | Pain condition: fibromyalgia Population: adults with fibromyalgia and self‐reported chronic insomnia Minimum pain intensity: no Inclusion criteria
Exclusion criteria
Total participants randomised: 32 Age in years (mean, SD): 49.5 (11.2) Gender: 26/32 were female Pain duration in years (mean, SD): NR |
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Interventions | Nabilone 0.5‐1.0 mg
Amitriptyline 10‐20 mg
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Outcomes | SAEs | |
Missing data methods | Unclear | |
Funding source | Pharmaceutical: supported by an unrestricted grant from Valeant (Canada) Inc. | |
Conflicts of interest | MAW and MAF have received honoraria from Valeant Canada for CME activities. YS and LJ have no conflicts to declare. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The randomisation schedule was prepared (ralloc procedure, Stata version 8.0, Houston, TX) using randomly assigned block sizes ranging from 2 to 8." |
Allocation concealment (selection bias) | Low risk | "The schedule was kept by the study pharmacist away from the investigators. Study subjects were consecutively assigned to treatment order by the study nurse based on the randomisation schedule. A coded script was given to the subject with instructions on the use of the allocated treatment. The subject then collected the medication from the study pharmacy and began taking the medication the same night." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Identical opaque capsules for both nabilone and amitriptyline |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes by blinded participants |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear ‐ no missing data methods reported Attrition Total: 3/32 (9.4%) Attrition per arm NR |
Selective reporting (reporting bias) | Low risk | All outcomes are prespecified in protocol on clinicaltrials.gov |
Other bias | Low risk | No other sources of bias identified |