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. 2023 May 10;2023(5):CD014682. doi: 10.1002/14651858.CD014682.pub2

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
Participants Pain condition: fibromyalgia
Population: adults with fibromyalgia and self‐reported chronic insomnia
Minimum pain intensity: no
Inclusion criteria
  • People with a diagnosis of fibromyalgia who had self‐reported chronic insomnia


Exclusion criteria
  • Severe physical comorbidities and psychotic disorders


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
Interventions Nabilone 0.5‐1.0 mg
  • Synthetic cannabinoid

  • Flexible titration: started at 0.5 mg/day for the first week, physician assessed and if patient could benefit from higher dose the dose was doubled for the second week to 1 mg/day.


Amitriptyline 10‐20 mg
  • TCA

  • Flexible titration: started at 10 mg/day for the first week, physician assessed and if patient could benefit from higher dose the dose was doubled for the second week to 20 mg/day.

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