Ash 1999.
Study characteristics | ||
Methods | Design: parallel Duration: 10 weeks Assessment: baseline and post‐intervention Country: UK |
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Participants | Pain condition: RA Population: women with RA and depression Minimum pain intensity: NR Inclusion criteria:
Exclusion criteria
Total participants randomised: 48 Age in years (mean, SD): NR Gender: 48/48 were female Pain duration in years (mean, SD): NR |
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Interventions | Dothiepin
Placebo
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Outcomes | Pain intensity Mood Physical function Withdrawal |
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Missing data methods | ITT but does not state imputation methods | |
Funding source | Pharmaceutical ‐ Boots | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | States random allocation but no method given |
Allocation concealment (selection bias) | Unclear risk | No information given |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind with identical appearing antidepressants and placebo |
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 | Over 40% of participants did not compelte the study due to lack of effect or intolerable side effects. Attrition: Total: 21/48 (43.75%) Placebo: 10/23 (43.5%) Dothiepin 75 to 150 mg: 11/25 (44.0%) |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration found |
Other bias | Low risk | No other sources of bias were identified. |