Heymann 2001.
Study characteristics | ||
Methods | Design: parallel Duration: 8 weeks Assessment: baseline and post‐intervention Country: Brazil |
|
Participants | Pain condition: fibromyalgia Population: women with fibromyalgia Minimum pain intensity: no Inclusion criteria
Exclusion criteria
Total participants randomised: 118 Age in years (mean): 50.5 Gender: 118/118 were female Pain duration in years (mean, SD): NR |
|
Interventions | Placebo
Amitriptyline 25 mg
Nortriptyline 25 mg
|
|
Outcomes | Quality of life SAEs Withdrawal |
|
Missing data methods | Completer analysis | |
Funding source | NR | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised using random number tables |
Allocation concealment (selection bias) | Unclear risk | Allocation procedures NR |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, all study drugs were identical in appearance and packaging |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes from blinded participants |
Incomplete outcome data (attrition bias) All outcomes | High risk | Much higher attrition in the placebo group than intervention groups. No missing data methods; report only completer analysis Attrition Total: 12/118 (10.2%) Amitriptyline 25 mg: 3/40 (7.5%) Nortriptyline 25 mg: 2/38 (5.3%) Placebo: 7/40 (17.5%) |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration found |
Other bias | Low risk | No other sources of bias were identified |