Ta. Syed et al., MANAGEMENT OF GENITAL HERPES IN MEN WITH 0.5-PERCENT ALOE-VERA EXTRACT IN A HYDROPHILIC CREAM - A PLACEBO-CONTROLLED DOUBLE-BLIND-STUDY, Journal of dermatological treatment, 8(2), 1997, pp. 99-102
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.