Original paperHomeopathic treatment of minor aphthous ulcer: a randomized, placebo-controlled clinical trial
Introduction
Recurrent aphthous ulcer (RAU) is a common oral condition, affecting around 20% of the population.1 It is usually involves the nonkeratinized oral mucosa, such as the buccal and labial mucosa, and causing painful ulcers. Based on the size, number, and duration of the ulcers, RAU is classified into 3 classes: minor, major, and herpetiform. Minor recurrent aphthous ulceration (MiRAU) is the most common form, comprising 70–87% of the population with RAU.2 MiRAU usually manifests with 1–5 ulcers per episode, with each ulcer less than 1 cm in diameter. These ulcers are self-limiting and can resolve in 4–14 days without scarring,3 most episodes last for 7–10 days.1 The minor aphthous ulcer is typically shallow and less than 1 cm in diameter with a necrotic centre covered by a grey or yellow pseudomembrane. A major aphthous lesion is typically larger, deeper, and persists longer than its minor counterpart (up to four weeks). It is also more painful and heals with scarring, a clinical finding used to distinguish between the ‘minor’ and ‘major’ subtypes.4
The aetiology of aphthosis is not clear. One third of patients give a positive family history, and there is an association with certain HLA types. In addition, the occurrence of recurrent aphthosis could be due to an underlying disease, such as anaemia due to folic acid or iron deficiency or familial selective vitamin B12 absorption deficiency, or cyclical neutropenia. Other aetiological factors may be stress, trauma, cessation of tobacco smoking or celiac disease.5
Treatment of RAU is symptomatic and mainly empirical. It is mainly directed at relieving pain and diminishing functional disability, inhibition of the acute inflammatory reaction as well as the frequency and the degree of severity of the recurrences.6
We did not find any documented study on the effect of homeopathic treatment on aphthous ulcers. In order to clinically determine the efficacy of homeopathy for the treatment of MiRAU, a randomized, controlled clinical trial was performed.
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Patients
An experimental, prospective, single blind (patient blind), randomized controlled clinical trial was implemented. One hundred patients with minor aphthous ulcer referred to Oral Medicine Clinic of Tehran University from March 2002 to March 2004, were enrolled in this study and each patient signed a detailed informed consent form.
Patients between 18 and 65 years old were included if they presented with 1–5 aphthous ulcers of less than 24 h duration and had a RAU (more than 5 episodes in the
Results
One hundred patients (fifty patients in treatment group and fifty patients in placebo group) accepted participating and were randomized to each group (see flowchart, Figure 1). The mean age of cases was 37.6 years old (36.2 years old for women & 39.1 years old for men) (Female/Male = 48/52).
All patients completed the study protocol. No adverse drug reaction to a treatment solution was reported as a reason for leaving the study. Table 1 shows the homeopathic medicines. Borax and Natrum muriaticum
Discussion
Our findings suggest that individualised homeopathy can reduce pain intensity and size of aphthous ulcer. To our knowledge this is the first published study of homeopathy to treat aphthous ulcer. It suggests that homeopathy is a potentially low-risk, option in an integrated package of care for the treatment of aphthous ulcer. It is an attractive option for several reasons including the lack of definitive treatment, the lack of known aetiologic factor and the high rate of utilization of
Conclusion
This study shows that homeopathic treatment can reduce minor aphthous ulcer lesion size, and appears to be safe. It is only the first step in understanding the potential of such treatment and, therefore, should be seen as a starting point. More research with larger sample sizes is warranted.
Conflict of interest
None declared.
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