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

O'Brien 2013b.

Methods Prospective observational study
Participants Inclusion criteria: clinically + laboratory‐confirmed BU; received antibiotics with or without surgery (exclusion criteria: none stated)
Laboratory confirmation: any of (1) a culture of Mycobacterium ulcerans from the lesion, (2) PCR(+), or (3) histopathology showing a necrotic granulomatous ulcer with the presence of AFB
Enrolled: 160 participants; 2 deaths, 2 lost to follow‐up; 156 participants analysed
Participant characteristics: 86 males, 55.1%; 13 participants (8.3%) < 15 years, 62 participants (39.7%) 15 to 59 years, 81 participants (51.9%) > 60 years
Lesion types: ulcer 137 (87.8%), nodules 10 (6.4%), oedematous lesion 9 (5.8%)
WHO classification: N/A
Interventions Different oral antibiotic treatments.
Participants received combinations of the following.

  • Rifampicin 147 (94.2%)

  • Ciprofloxacin 101 (64.7%)

  • Clarithromycin 48 (30.8%)

  • Ethambutol 11 (7.1%)

  • Amikacin 5 (3.2%)

  • Moxifloxacin 2 (1.5%)


Drug dosages

  • Rifamipicin 10 mg/kg/day (up to a maximum of 600 mg/day)

  • Ciprofloxacin 500 mg twice daily

  • Clarithromycin 7.5 mg/kg/twice daily (up to maximum of 500 mg twice daily)

  • Moxifloxacin 400 mg daily

  • Amikacin 15 mg/kg/day


Surgery: when indicated
Follow‐up: at least 12 months
Outcomes

  1. Episodes of paradoxical reactions

  2. Lesion site

  3. Diagnosis and treatment

  4. Healing of paradoxical reactions

  5. Predictors of paradoxical reactions
Notes Trial location: Australia
Enrolment dates: 1 January 1998 to 31 December 2011
13 (8.3%) participants were complicated with diabetes mellitus and 11 (7.1%) with immune suppression (defined as current treatment with immunosuppressive medication (for example, prednisolone) or an active malignancy).
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 Small number (4) not included as did not have 12 months follow‐up or had died.
Measurement of outcomes (Prospective observational studies) Low risk Paradoxical reaction clearly defined.
Incomplete outcome data / missing data (All studies) Low risk No missing data
Selective reporting (All studies) Low risk Reported all expected outcomes
Other bias Low risk No other bias identified.