Hannonen 1998.
Study characteristics | ||
Methods | Design: parallel Duration: 12 weeks Assessment: baseline and post‐intervention Country: Finland |
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Participants | Pain condition: fibromyalgia Population: women with fibromyalgia Minimum pain intensity: ≥ 4 on 0‐10 VAS Inclusion criteria
Exclusion criteria
Total participants randomised: 130 Age in years (mean): 48.7 Gender: 130/130 were female Pain duration in years (mean): 8.2 |
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Interventions | Placebo
Moclobemide 450‐600 mg
Amitriptyline 25‐37.5 mg
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Outcomes | Pain intensity Sleep Mood Physical function AEs Withdrawal |
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Missing data methods | States ITT but no methods reported | |
Funding source | Partly supported by pharmaceutical: "The financial support by Roche Oy, Finland, is gratefully acknowledged." | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation methods NR |
Allocation concealment (selection bias) | Low risk | The randomisation was organised centrally with sequentially numbered envelopes consisting of blocks of 6 |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded, study drugs were identical, double‐dummy design |
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 | States ITT but no methods reported Attrition Total: 38/130 (29.2%) Moclobemide 450‐600 mg: 13/43 (30.2%) Amitriptyline 25‐37.5 mg: 10/42 (23.8%) Placebo: 15/45 (33.3%) |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration found |
Other bias | Low risk | No other sources of bias identified |