Author: Chan, Po-ming
Title: Clinical evaluation of the effect of an alternative topical essential oil on clients with tinea pedis
Degree: M.Sc.
Year: 2007
Subject: Hong Kong Polytechnic University -- Dissertations.
Athlete's foot
Foot -- Wounds and injuries -- Treatment.
Essences and essential oils.
Department: School of Nursing
Pages: ix, 75 leaves : ill. ; 30 cm.
Language: English
Abstract: Objective: (1) To compare the effect of an ointment with selected essential oils to a placebo ointment on subjects with tinea pedis. (2) To provide tolerability information associated with the intervention ointment. Background: Tinea pedis is a common foot disease and a public health problem. Although tinea pedis is not life threatening, risks of secondary bacterial infection and complications such as lower limb cellulitis are unavoidable. Antifungal medications are available to treat tinea pedis but adverse effects are reported. With the growing recognition of aromatherapy and antifungal properties of essential oils, it is worth developing an ointment containing essential oils in treatment of tinea pedis. Design: This was a double-blind, placebo-controlled, randomised study with a treatment of eight weeks. Setting: The Hong Kong community. Potential subjects were recruited through advertisements posted on the Hong Kong Polytechnic University campus or in local newspapers. Intervention: Participants randomised to the intervention group received essential oil ointment comprising a mixture of 3% tea tree oil, 3% thyme oil, 3% lemongrass oil and 1% peppermint oil in placebo ointment base. Participants randomised to the control group received placebo ointment which contained a mixture of Manuka honey, olive oil and shea butter. Outcome measures: The primary outcome measure was the conversion of mycological culture. Other than reports of adverse effects and rating in clinical global evaluation, the secondary outcome measures included mean changes from baseline in the following aspects: presence of odour; presence of a burning sensation; total number of inter-digital space; total clinical score; total area of involvement; clinical severity and influence on daily activities. Method: Eligible subjects were randomly assigned to receive either the intervention ointment or placebo ointment. Skin scrapings for mycology cultures and data collections were set at baseline before intervention, with follow-ups one week and four weeks after the completion of the ointment regimen. Intention to treat principle and last observation carried forward imputation were employed for statistical analysis. Success rates of mycological cure at the week one and week four were considered to account for global clinical evaluation and adverse events. Mean changes of outcome measures were compared using the Mann-Whitney test for between group comparisons and the Friedman test for within group comparison. Findings: Eighty three healthy volunteers from the community were recruited. The rate of successful mycological cure was achieved for 43% of the intervention group and 19.0% of the control group at the one-week follow up (p=0.02). At the post four-week follow up, the rate of successful cure was 17% for the intervention group and 26.5% for the control group (p=0.14). One mild adverse event was reported in the intervention group. In terms of clearance of signs and symptoms associated with tinea pedis, more than half of the participants in both groups reported clearance in both post baseline measurements. There was no statistical difference between two ointments in treatment of tinea pedis by the Mann-Whitney test over the secondary outcomes (presence of odour, presence of burning sensation, total inter-digital spaces, total clinical score, total area of involvement, clinical severity and influences on daily activities (all p>0.05). Regarding the within group comparison, control group participants showed significant improvement in clinical score (p=0.01) and clinical severity (p=0.01) over the course of the study. The influence on daily activities was significantly reduced in both groups over the course of the study (both p <0.05). Conclusion: The intervention ointment had no obvious superior effect over the placebo ointment. One possible reason may be that the ingredients in the placebo ointment also carry antifungal properties. Both ointments were considered safe and well tolerated, as only one mild adverse effect was reported.
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