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Buruli ulcer can be treated successfully without surgery

10 Feb 2010

Paul Chinnock

Source: Lancet (see original article or PDF)

Citation: Nienhuis WA, Stienstra Y, Thompson WA, Awuah PC, Abass KM, Tuah W, Awua-Boateng NY, Ampadu EO, Siegmund V, Schouten JP, Adjei O, Bretzel G, van der Werf TS (2010). Antimicrobial treatment for early, limited Mycobacterium ulcerans infection: a randomised controlled trial. Lancet; 2010 Feb 3.


Buruli ulcer on a woman's leg. [Credit National Buruli ulcer control programme, Benin/WHO.]

A randomized controlled trial in Ghana has demonstrated that antibiotics can be successfully used to treat early stage Buruli ulcer, without the use of surgery.

Buruli ulcer, caused by infection of a wound with Mycobacterium ulcerans, is a dreadful condition that affects thousands of people in endemic areas every year. It is known to be present in 30 countries in Africa, the Americas, Asia and the Western Pacific. In West Africa, it seems to be growing more common.

The only recommended treatment for Buruli ulcer was, for many years, wide surgical removal of the affected skin plus surrounding normal tissue. Research had not provided evidence for the effectiveness of antibiotics, though it suggested that combining surgery and antibiotic treatment reduced the chances of relapse. Since 2004, WHO has recommended treatment with antibiotics (streptomycin plus rifampicin) in addition to surgery.

Surgery is, however, not readily available to people in most communities where the disease is endemic. It is unpleasant and many patients are reluctant to undergo it. Surgery is particularly difficult to perform when, for example, the ulcer is located on the face. The big question has therefore been whether antibiotic treatment without surgery can heal the ulcer.

Observational studies and one pilot investigation have provided encouraging results but no trial had been carried out until the present study, conducted by a Dutch–Ghanaian team. All of the patients in this trial were given antibiotics and none received surgery as part of their initial treatment.

A total of 151 patients, all aged over five years, with early Buruli ulcer (i.e. less than six months duration) were randomized to receive one of two types of antibiotic treatment – either intramuscular streptomycin and oral rifampicin for eight weeks or streptomycin and rifampicin for four weeks followed by rifampicin and clarithromycin both orally, for four weeks. (One novel element of the trial methods was the way in which randomization was conducted; it was done in the Netherlands and communicated to the field sites in Ghana via mobile phone messages.)

The primary outcome measure for the trial was healing of the ulcer (with no recurrence and no need for surgery) within one year of the treatment commencing. The researchers were able to examine all except four patients in their final follow-up at one year. (The ulcers of the missing four had been observed to have healed at their last assessment.)

Only five patients in total required surgery; 73 (96%) in the streptomycin–rifampcin group and 68 (91%) in the streptomycin– rifampcin –clarithromycin group had healed lesions at one year and were free of recurrence.

The findings of the research are warmly welcomed in an accompanying Lancet editorial [1] that describes it as a study that will change clinical practice, having “established beyond reasonable doubt that early and limited Buruli ulcer can be effectively treated with antibiotics without surgery”.

The researchers themselves express concern that the ulcers did take many weeks to heal. More effective treatments are therefore still required. They also point out that their study did not include any assessment of disabilities caused by the infection. (Ulcers close to joints often lead to contractures and functional disability.)

It is important to underline the fact that the trial only included patients with early-stage Buruli ulcer. Many patients present late with this condition and the very early stages of the ulcer are in any case not always recognized by health workers. Now that we know how to treat the disease in its early stages, the need for prompt diagnosis becomes more important than ever.

Note: The Lancet is not an open-access journal. While it sometimes allows free access to articles on global health topics, it has not done so with this study. A subscription to the journal will therefore be needed to read it in full. Readers in certain developing countries may be able to access it through the HINARI programme.

Reference

1. Johnson PD (2010). Should antibiotics be given for Buruli ulcer? Lancet; 2010 Feb 3. [Epub ahead of print]. Available from: http://www.ncbi.nlm.nih.gov/pubmed/20137806

2010 Elsevier Limited

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