Hammody 2015.
Study characteristics | ||
Methods | Design: parallel Duration: 12 weeks Assessment: baseline, week 4, week 8, post‐intervention Country: Iraq |
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Participants | Pain condition: fibromyalgia Population: adults with fibromyalgia Minimum pain intensity: no Inclusion criteria
Exclusion criteria
Total participants randomised: 123 Age in years (mean, SD): NR Gender: NR Pain duration in years (mean, SD): NR |
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Interventions | Pregabalin 75 mg
Amitriptyline 25 mg
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Outcomes | Pain intensity Quality of life |
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Missing data methods | NR | |
Funding source | NR | |
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 procedures not specified |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | States double‐blind, but no information regarding blinding procedures |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Self‐reported outcomes from participants, but unsure of blinding procedures |
Incomplete outcome data (attrition bias) All outcomes | High risk | High attrition, analysis of per‐protocol population Attrition Total: 45/123 (36.6%) Attrition per arm NR |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration found |
Other bias | High risk | Poorly reported ‐ mistakes throughout document, figures not really adding up and tables wrongly titled |