Trial reportAntimicrobial agents and chemotherapy2004
Pilot randomized double-blind trial of treatment of Mycobacterium ulcerans disease (Buruli ulcer) with topical nitrogen oxides.
Trial report in Antimicrobial agents and chemotherapy, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it, 65 citations in OpenAlex.
- Drugs for treating Buruli ulcer (Mycobacterium ulcerans disease).The Cochrane database of systematic reviews · 2018Pooled it
- Efficacy of the combination rifampin-streptomycin in preventing growth of Mycobacterium ulcerans in early lesions of Buruli ulcer in humans.Antimicrobial agents and chemotherapy · 2005Trial
- Review
- Antimicrobial resistant bacteria isolated from Buruli ulcer lesions in Ghana.PLoS neglected tropical diseases · 2025Article
- Floristic Diversity as an Indicator in Low and High Endemic Buruli Ulcer Areas in Côte d'Ivoire.International journal of environmental research · 2023Article
- Efficacy of an Acid-Oxidizing Solution against Mycobacterium ulcerans.Antimicrobial agents and chemotherapy · 2022Article
- Nitric Oxide-Releasing Hyaluronic Acid as an Antibacterial Agent for Wound Therapy.Biomacromolecules · 2021Article
- Nitric oxide for the prevention and treatment of viral, bacterial, protozoal and fungal infections.F1000Research · 2021Review
- The Bactericidal Tandem Drug, AB569: How to Eradicate Antibiotic-Resistant BiofilmFrontiers in microbiology · 2021Review
- Nanomaterial Nitric Oxide Delivery in Traumatic Orthopedic Regenerative Medicine.Frontiers in bioengineering and biotechnology · 2020Review
- Nitric Oxide Therapy for Diabetic Wound Healing.Advanced healthcare materials · 2019Review
- In vitro antibacterial activity and in vivo efficacy of hydrated clays on Mycobacterium ulcerans growth.BMC complementary and alternative medicine · 2016Article
- Topical sodium nitrite for chronic leg ulcers in patients with sickle cell anaemia: a phase 1 dose-finding safety and tolerability trial.The Lancet. Haematology · 2014Article
- Model-driven identification of dosing regimens that maximize the antimicrobial activity of nitric oxide.Metabolic engineering communications · 2014Article
- Screening of antifungal azole drugs and agrochemicals with an adapted alamarBlue-based assay demonstrates antibacterial activity of croconazole against Mycobacterium ulcerans.Antimicrobial agents and chemotherapy · 2012Article
- Biomedical evaluation of a novel nitrogen oxides releasing wound dressing.Journal of materials science. Materials in medicine · 2012Article
- Review
- An observational prospective study of topical acidified nitrite for killing methicillin-resistant Staphylococcus aureus (MRSA) in contaminated wounds.BMC research notes · 2011Article
- Article
- Evaluation of the medicinal use of clay minerals as antibacterial agents.International geology review · 2010Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Mycobacterium 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.
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