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Abstract
BACKGROUND Genital herpes simplex virus infection is unique to humans, and is one of the commonest sexually transmitted diseases worldwide.
OBJECTIVE The purpose of this double-blind placebo-controlled study was to determine the clinical efficacy and tolerability of Aloe vera extract 0.5% in a hydrophilic cream to cure patients afflicted with the first episodes of genital herpes.
METHODS Preselected patients (n=60), aged 18–40 years (mean 23.6), with culture-confirmed diagnosis of herpes simplex genitalis, harboring 738 lesions (mean 12.3), were randomized to active or placebo treatment. Patients entered the study within 7 days (mean 4.1) of the onset of the lesions. Each patient was provided with a precoded 40-g tube, containing placebo/active preparation with instructions on self-application of the trial medication to their lesions three times daily for 5 consecutive days (maximum 15 topical applications per week). To assess the clinical efficacy and other beneficial effects patients were examined twice weekly and reepithelialized lesions with some residual erythema were considered as healed. Patients whose lesions resolved during the active treatment period (1 or 2 weeks) were spared further medication, and were requested to report to the clinic as scheduled for review and recurrence control. Empty tubes were collected from the remaining patients, and similarly coded replacement tubes were given to continue the treatment (in total 102 tubes were used).
RESULTS The group treated with Aloe vera extract cream had both significantly shorter mean time to healing than the placebo group (4.9 days vs 12 days; P<0.001) and a higher number of healed patients (20/30 (66.7%) vs 2/30 (6.7%); P<0.001). Of the 60 patients, 55 (91.6%) complained of no drug-related side-effects. However, 5 patients experienced nonobjective mild itching which resolved within 24 h. The treatment was well tolerated by all patients, and there were no dropouts. After 16 weeks all the patients were followed-up on a monthly basis for up to 20 months. Of the 22 healed patients, 3 (13.6%) showed recurrence after 15 months.
CONCLUSION The clinical results suggest that Aloe vera extract (0.5%) in a hydrophilic cream is more efficacious than placebo, thus supporting the benefits of Aloe vera therapy as an alternative, reliable and effective treatment to cure the first episodes of genital herpes in men.