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

Drugs for treating Buruli ulcer (Mycobacterium ulcerans disease)

Rie R Yotsu  1 , Marty Richardson, Norihisa Ishii
Affiliations
Meta-Analysis

Drugs for treating Buruli ulcer (Mycobacterium ulcerans disease)

Rie R Yotsu et al. Cochrane Database Syst Rev. .

Abstract

Background: Buruli ulcer is a necrotizing cutaneous infection caused by infection with Mycobacterium ulcerans bacteria that occurs mainly in tropical and subtropical regions. The infection progresses from nodules under the skin to deep ulcers, often on the upper and lower limbs or on the face. If left undiagnosed and untreated, it can lead to lifelong disfigurement and disabilities. It is often treated with drugs and surgery.

Objectives: To summarize the evidence of drug treatments for treating Buruli ulcer.

Search methods: We searched the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL), published in the Cochrane Library; MEDLINE (PubMed); Embase (Ovid); and LILACS (Latin American and Caribbean Health Sciences Literature; BIREME). We also searched the US National Institutes of Health Ongoing Trials Register (clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en/). All searches were run up to 19 December 2017. We also checked the reference lists of articles identified by the literature search, and contacted leading researchers in this topic area to identify any unpublished data.

Selection criteria: We included randomized controlled trials (RCTs) that compared antibiotic therapy to placebo or alternative therapy such as surgery, or that compared different antibiotic regimens. We also included prospective observational studies that evaluated different antibiotic regimens with or without surgery.

Data collection and analysis: Two review authors independently applied the inclusion criteria, extracted the data, and assessed methodological quality. We calculated the risk ratio (RR) for dichotomous data with 95% confidence intervals (CI). We assessed the certainty of the evidence using the GRADE approach.

Main results: We included a total of 18 studies: five RCTs involving a total of 319 participants, ranging from 12 participants to 151 participants, and 13 prospective observational studies, with 1665 participants. Studies evaluated various drugs usually in addition to surgery, and were carried out across eight countries in areas with high Buruli ulcer endemicity in West Africa and Australia. Only one RCT reported adequate methods to minimize bias. Regarding monotherapy, one RCT and one observational study evaluated clofazimine, and one RCT evaluated sulfamethoxazole/trimethoprim. All three studies had small sample sizes, and no treatment effect was demonstrated. The remaining studies examined combination therapy.Rifampicin combined with streptomycinWe found one RCT and six observational studies which evaluated rifampicin combined with streptomycin for different lengths of treatment (2, 4, 8, or 12 weeks) (941 participants). The RCT did not demonstrate a difference between the drugs added to surgery compared with surgery alone for recurrence at 12 months, but was underpowered (RR 0.12, 95% CI 0.01 to 2.51; 21 participants; very low-certainty evidence).An additional five single-arm observational studies with 828 participants using this regimen for eight weeks with surgery (given to either all participants or to a select group) reported healing rates ranging from 84.5% to 100%, assessed between six weeks and one year. Four observational studies reported healing rates for participants who received the regimen alone without surgery, reporting healing rates ranging from 48% to 95% assessed between eight weeks and one year.Rifampicin combined with clarithromycinTwo observational studies administered combined rifampicin and clarithromycin. One study evaluated the regimen alone (no surgery) for eight weeks and reported a healing rate of 50% at 12 months (30 participants). Another study evaluated the regimen administered for various durations (as determined by the clinicians, durations unspecified) with surgery and reported a healing rate of 100% at 12 months (21 participants).Rifampicin with streptomycin initially, changing to rifampicin with clarithromycin in consolidation phaseOne RCT evaluated this regimen (four weeks in each phase) against continuing with rifampicin and streptomycin in the consolidation phase (total eight weeks). All included participants had small lesions, and healing rates were above 90% in both groups without surgery (healing rate at 12 months RR 0.94, 95% CI 0.87 to 1.03; 151 participants; low-certainty evidence). One single-arm observational study evaluating the substitution of streptomycin with clarithromycin in the consolidation phase (6 weeks, total 8 weeks) without surgery given to a select group showed a healing rate of 98% at 12 months (41 participants).Novel combination therapyTwo large prospective studies in Australia evaluated some novel regimens. One study evaluating rifampicin combined with either ciprofloxacin, clarithromycin, or moxifloxacin without surgery reported a healing rate of 76.5% at 12 months (132 participants). Another study evaluating combinations of two to three drugs from rifampicin, ciprofloxacin, clarithromycin, ethambutol, moxifloxacin, or amikacin with surgery reported a healing rate of 100% (90 participants).Adverse effects were reported in only three RCTs (158 participants) and eight prospective observational studies (878 participants), and were consistent with what is already known about the adverse effect profile of these drugs. Paradoxical reactions (clinical deterioration after treatment caused by enhanced immune response to M ulcerans) were evaluated in six prospective observational studies (822 participants), and the incidence of paradoxical reactions ranged from 1.9% to 26%.

Authors' conclusions: While the antibiotic combination treatments evaluated appear to be effective, we found insufficient evidence showing that any particular drug is more effective than another. How different sizes, lesions, and stages of the disease may contribute to healing and which kind of lesions are in need of surgery are unclear based on the included studies. Guideline development needs to consider these factors in designing practical treatment regimens. Forthcoming trials using clarithromycin with rifampicin and other trials of new regimens that also address these factors will help to identify the best regimens.

PubMed Disclaimer

Conflict of interest statement

Rie Roselyne Yotsu acts as a WHO consultant for leprosy and also has financial support for an epidemiological study on Buruli ulcer in Cote d'Ivoire and in Ghana. However, there are no financial relationships with any organizations that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work.

Marty Richardson has no known conflicts of interest.

Norihisa Ishii has no known conflicts of interest.

Figures

1
1
Study flow diagram.
2
2
‘Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
‘Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
4
4
Forest plot of comparison: 1 Rifampicin plus streptomycin (experimental) versus surgery alone (control), outcome: 1.1 Recurrence.
5
5
Forest plot of comparison: 2 Rifampicin combined with clarithromycin versus rifampicin combined with streptomycin in the consolidation phase, outcome: 2.1 Cure.
6
6
Forest plot of comparison: 2 Rifampicin plus clarithromycin (experimental) versus rifampicin plus streptomycin in the consolidation phase (control), outcome: 2.2 Recurrence at 12 months.
1.1
1.1. Analysis
Comparison 1 Rifampicin combined with streptomycin versus surgery alone, Outcome 1 Recurrence.
2.1
2.1. Analysis
Comparison 2 Rifampicin combined with clarithromycin versus rifampicin combined with streptomycin in the consolidation phase, Outcome 1 Cure.
2.2
2.2. Analysis
Comparison 2 Rifampicin combined with clarithromycin versus rifampicin combined with streptomycin in the consolidation phase, Outcome 2 Recurrence at 12 months.
See this image and copyright information in PMC

Comment in

References

References to studies included in this review

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References to studies excluded from this review

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Klis 2014b {published data only}
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Klis 2014c {published data only}
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Klis 2014d {published data only}
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Phanzu 2006 {published data only}
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Saka 2013 {published data only}
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References to ongoing studies

NCT01432925 {published and unpublished data}
    1. NCT01432925. Timing of surgical intervention in Buruli ulcer patients treated with antibiotics (Burulitime) [Timing of the decision on surgical intervention for Buruli ulcer patients treated with rifampicin/streptomycin]. clinicaltrials.gov/ct2/show/NCT01432925 (first received 13 September 2011).
NCT01659437 {published and unpublished data}
    1. NCT01659437. WHO drug study for Buruli ulcer‐comparison of SR8 and CR8 [Randomized controlled trial comparing efficacy of 8 weeks treatment with clarithromycin and rifampicin versus streptomycin and rifampicin for Buruli ulcer (M. ulcerans infection)]. clinicaltrials.gov/ct2/show/NCT01659437 (first received 7 August 2012).

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