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. 2018 Aug 23;2018(8):CD012118. doi: 10.1002/14651858.CD012118.pub2

Agbenorku 2011.

Methods Prospective observational study
Participants Inclusion criteria: clinically + laboratory‐confirmed BU (exclusion: none stated)
Laboratory confirmation: any 2 positives of ZN test for AFB, PCR, and histopathology
Enrolled: 189 participants
Participant characteristics: 113 males, 60%; age N/A
Lesion types: ulcer 145 (76.7%), nodule 38 (20.1%), plaque 6 (3.2%)
WHO category I: 44 (22.3%), categories II + III: 145 (76.7%)
Interventions Rifampicin (10 mg/kg/d) + streptomycin (15 mg/kg/d), 8 weeks, with surgery
Surgery: all cases
Follow‐up: 2 years after discharge from hospital
Outcomes
  1. Healing rate

  2. Recurrence

  3. Adverse effects

  4. Mean hospital stay days

  5. Number of new BU cases and their disease stage at the study site after counselling and health education activities


Standardized outcome: cure
Notes Trial location: Ghana
Enrolment dates: January 2005 to December 2005
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (Trials) High risk
Allocation concealment (Trials) High risk
Blinding of participants and personnel (Trials) High risk
Blinding of outcome assessment (Trials) High risk
Selection of participants into the study (Prospective observational studies) Low risk Selection not related to intervention or outcome.
Measurement of outcomes (Prospective observational studies) Low risk Objective outcome measure (healing)
Incomplete outcome data / missing data (All studies) Low risk 3 participants (3.2%) were lost to follow‐up but for different outcomes.
Selective reporting (All studies) Low risk Reported all expected outcomes
Other bias Low risk No other bias identified.