Yeephu 2013.
Study characteristics | ||
Methods | Design: parallel Duration: 13 weeks Assessment: baseline and post‐intervention Country: Thailand |
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Participants | Pain condition: fibromyalgia Population: Thai adults with fibromyalgia Minimum pain intensity: ≥ 40 on 0‐100 scale Inclusion criteria
Exclusion criteria
Total participants randomised: 40 Age in years (mean, SD): 44.66 (10.77) Gender: 40/40 were female Pain duration in years (mean, SD): 3.44 (2.71) |
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Interventions | Placebo
Mirtazapine 15 mg
Mirtazapine 30 mg
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Outcomes | Moderate pain relief PGIC AEs SAEs Withdrawal |
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Missing data methods | ITT with LOCF, BOCF | |
Funding source | Non‐pharmaceutical: This study was supported by a scholarship from the Commission on Higher Education Staff Development Project for the Joint PhD Program in Biopharmaceutical Sciences, Thailand. | |
Conflicts of interest | Study authors reported no conflicts of interest. | |
Notes | Same study as Suttiruksa 2016 ‐ however different outcomes were reported in the two papers. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The patients were allocated using a block size of 3 in a ratio of 1:1:1 with parallel assignment to 1 of 3 groups using a pharmacy‐controlled randomisation process. |
Allocation concealment (selection bias) | Low risk | Participants were allocated with sequentially numbered identical containers. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, identical study drugs |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes from blinded participants |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | State that they use LOCF and BOCF measures, but don't present the numbers of participants in each of these analyses. Low attrition rates across all arms. Attrition Total: 8/40 (20.0%) Placebo: 3/13 (23.1%) Mirtazapine 15 mg: 2/13 (15.4%) Mirtazapine 30 mg: 3/14 (21.4%) |
Selective reporting (reporting bias) | Low risk | All outcomes in protocol reported either in this article or Suttiruksa 2016 |
Other bias | Low risk | No other sources of bias were identified |