Carette 1986.
Study characteristics | ||
Methods | Design: parallel Duration: baseline and post‐intervention Assessment: 9 weeks Country: Canada |
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Participants | Pain condition: primary fibrositis/fibromyalgia Population: people with fibromyalgia Minimum pain intensity: NR Inclusion criteria
Exclusion criteria
Total participants randomised: 70 Age in years (mean): 41 Gender: 54/70 were female Pain duration in months (mean): 84 |
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Interventions | Placebo
Amitriptyline 10‐50 mg
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Outcomes | Pain intensity AEs Withdrawal |
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Missing data methods | Completer analysis only | |
Funding source | Non‐pharmaceutical ‐ Arthritis Grant | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation methods not specified |
Allocation concealment (selection bias) | Unclear risk | Allocation procedure not specified |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Although the study used double‐blind procedures, the authors noted that 70% of the amitriptyline participants experienced side effects that, in some cases, unblinded participants and research staff. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Self‐reported outcomes from participants who may have been unblinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | Completer analysis only Attrition Total: 11/70 (15.7%) Placebo: 4/32 (11.1%) Amitriptyline 10‐50 mg: 7/27 (20.6%) |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration found |
Other bias | Low risk | No other sources of bias were identified. |