MANAGEMENT OF GENITAL HERPES IN MEN WITH 0.5-PERCENT ALOE-VERA EXTRACT IN A HYDROPHILIC CREAM - A PLACEBO-CONTROLLED DOUBLE-BLIND-STUDY

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 wa s to determine the clinical efficacy and tolerability of Aloe vera ext ract 0.5% in a hydrophilic cream to cure patients afflicted with the f irst episodes of genital herpes. METHODS Preselected patients (n= 60), aged 18-40 years (mean 23.6), with culture-confirmed diagnosis of her pes simplex genitalis, harboring 738 lesions (mean 12.3), were randomi zed to active or placebo treatment. Patients entered the study within 7 days (mean 4.1) of the onset of the lesions. Each patient was provid ed with a preceded 40-g tube, containing placebo/active preparation wi th instructions on self-application of the trial medication to their l esions three times daily for 5 consecutive days (maximum 15 topical ap plications per week). To assess the clinical efficacy and other benefi cial effects patients were examined twice weekly and reepithelialized lesions with some residual erythema were considered as healed. Patient s whose lesions resolved during the active treatment period (1 or 2 we eks) were spared further medication, and were requested to report to t he clinic as scheduled for review and recurrence control. Empty tubes were collected from the remaining patients, and similarly coded replac ement tubes were given to continue the treatment (in total 102 tubes w ere 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 exp erienced nonobjective mild itching which resolved within 24 h. The tre atment was well tolerated by all patients, and there were no dropouts. After 16 weeks all the patients were followed-up an a monthly basis f or up to 20 months. Of the 22 healed patients, 3 (13.6%) showed recurr ence after 15 months. CONCLUSION The clinical results suggest that Alo e vera extract (0.5%) in a hydrophilic cream is more efficacious than placebo, thus supporting the benefits of Alae vera therapy as an alter native, reliable and effective treatment to cure the first episodes of genital herpes in men.