Pilot Randomized Double-Blind Trial of Treatment of Mycobacterium ulcerans Disease (Buruli Ulcer) with Topical Nitrogen Oxides

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dc.contributor.authorPhillips, Richard Odame
dc.contributor.authorAdjei, O.
dc.contributor.authorLucas, S.
dc.contributor.authorBenjamin, N.
dc.contributor.authorWansbrough-Jones, Mark
dc.date.accessioned2020-01-09T12:05:54Z
dc.date.accessioned2023-04-19T01:40:26Z
dc.date.available2020-01-09T12:05:54Z
dc.date.available2023-04-19T01:40:26Z
dc.date.issued2004-08
dc.descriptionAn article published by Antimicrobial Agents and Chemotherapy and is available at DOI: 10.1128/AAC.48.8.2866–2870.2004en_US
dc.description.abstractMycobacterium ulcerans disease (Buruli ulcer) is a serious ulcerating skin disease which is common in many tropical countries. Standard treatment, by extensive excision and skin grafting, is not available in rural communities where the disease is common. We evaluated the efficacy and safety of treatment with topical nitrogen oxides. Thirty-seven patients with a clinical diagnosis of Buruli ulcer caused by M. ulcerans disease were randomly assigned to one of two groups. In one group, two creams containing sodium nitrite (6%, wt/wt) or citric acid monohydrate (9%, wt/wt) were applied daily for 6 weeks, while the other group received a placebo. In the second 6 weeks, both groups received the nitrogen oxide-generating combination of creams. Treatment was continued for another 4 weeks for patients whose ulcers were not healed after 12 weeks. The ulcer surface area was monitored by weekly tracings made by assessors blinded to the treatment. In the first 6 weeks, patients on sodium nitrite and citric acid monohydrate (group I, active treatment) showed a rapid decrease in ulcer size from 28.6 5.6 cm2 (mean standard error) to 12.6 3.2 cm2, a decrease significantly greater than that in group II (from 15.3 3.1 to 11.7 3.7 cm2; P 0.03). Five ulcers in the placebo group enlarged during this period, compared with one in the active group. In the second 6 weeks (both groups on active treatment), the rates of healing were similar for the two groups and there was a significant reduction in ulcer size in group II (previously on placebo) compared to the first 6 weeks. Yellow pigmentation of the skin, which disappeared 3 days after treatment was stopped, was the only side effect to date. We conclude that creams releasing nitrogen oxides increase the healing rate of ulcers caused by M. ulcerans infection with minimal adverse events. This is the first controlled trial of any form of therapy which demonstrates efficacy in treating this disease.en_US
dc.description.sponsorshipKNUSTen_US
dc.identifier.citationAntimicrobial Agents and Chemotherapy Vol. 48, No. 8en_US
dc.identifier.urihttps://ir.knust.edu.gh/handle/123456789/11870
dc.language.isoenen_US
dc.publisherAntimicrobial Agents and Chemotherapyen_US
dc.titlePilot Randomized Double-Blind Trial of Treatment of Mycobacterium ulcerans Disease (Buruli Ulcer) with Topical Nitrogen Oxidesen_US
dc.typeArticleen_US
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