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. 2015 Dec 9;2015(12):CD010143. doi: 10.1002/14651858.CD010143.pub2

Degreef 2014.

Methods Single‐centre Belgian study
Randomised controlled clinical trial
Study period not stated
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
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
Outcomes
  • Improvement in extension deficit by joint

    • No differences at MCPJ at 3 months, 12 months or 24 months; significantly greater differences for tamoxifen group at PIPJ at 3 months and 12 months; not significantly different at 24 months

  • Tubiana index

    • Significantly greater differences in tamoxifen group at 3 months; not significantly different at 12 months nor 24 months

  • Satisfaction visual analogue scale

    • Significantly higher in tamoxifen group at 3 months; no significant differences at 12 months or 24 months

  • Hand function (DASH)

  • No significant differences at 12 months nor 24 months

Notes Length of follow‐up: 24 months
Low‐quality evidence, as inadequate details on study design and imprecision
Funding source: Belgian Orthopaedic Society
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
HHS Vulnerability Disclosure