Degreef 2014.
Methods | Single‐centre Belgian study Randomised controlled clinical trial Study period not stated |
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Participants | 30 participants 26 male:4 female Mean age: 63.5 (SD 8) years Inclusion criteria: Adult patients scheduled for subtotal fasciectomy to treat Dupuytren's disease were eligible for inclusion if they had a D score > 4 Exclusion criteria: patients undergoing a reintervention for recurrent contractures; patients with a need for skin grafts or flaps; premenopausal women; patients using anti‐inflammatory drugs; patients with a history of malignancy; patients with a known allergy to tamoxifen |
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Interventions | Segmental fasciectomy with 80 mg oral tamoxifen daily for 6 weeks before surgery continuing until 12 weeks after surgery vs Segmental fasciectomy with 80 mg oral placebo daily for 6 weeks before surgery continuing until 12 weeks after surgery |
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Outcomes |
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Notes | Length of follow‐up: 24 months Low‐quality evidence, as inadequate details on study design and imprecision Funding source: Belgian Orthopaedic Society |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Inadequate detail: not described |
Allocation concealment (selection bias) | Unclear risk | Inadequate detail: boxes used to store allocation, but opacity not described; second copies of allocations stored in envelopes with inadequate details provided |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition described; systematic differences between groups unlikely |
Selective reporting (reporting bias) | Unclear risk | No data presented for hand function (DASH) at 3 months |
Other bias | Low risk | Blinded study; hence blocked randomisation not problematic |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded outcome measurements |