A double blind, randomised placebo controlled trial of rifampicin with omeprazole in the treatment of human cutaneous leishmaniasis.
OBJECTIVE
This study was conducted on 50 patients of Anthroponotic cutaneous leishmaniasis (oriental sore) to assess the efficacy of rifampicin and omeprazole through a double blind, randomised placebo control study.


METHODS
The diagnosis of Anthroponotic cutaneous leishmaniasis (ACL) caused by Leishmania tropica was done by demonstration of Leishmania tropica (LT) bodies from the painless, dry ulcerative lesion. Each patient was assessed clinically in the beginning of the study, at the end of 2,4 and 6 weeks and all observations were compared in both the groups. Twenty-five patients received rifampicin with omeprazole (Group A) whereas other 25 patients received placebo (Group B) for a period of six weeks.


RESULTS
Altogether 23 cases in group Aand 21 cases in group B completed the study. About 16 (69.7%) cases in group A and 3 (14.29%) cases in group B had complete healing, whereas 3 patients (13.04%) of group A and 4 patients (19.05%) of group B had partial response and 4 patients (17.93%) of group A and 14 patients (66.67%) of group B had no response at the end of study. The difference of two groups was statistically highly significant (p < 0.00025). All patients tolerated the drug and placebo very well and no side effect was reported.


CONCLUSIONS
In our opinion rifampicin and omeprazole is a highly effective, less toxic and cheaper alternative for the management of cutaneous leishmaniasis.
Kochar
D K
DK
Department of Medicine, SP Medical College, Bikaner, Rajasthan, India. drdkkochar@yahoo.com
Saini
Govind
G
Kochar
S K
SK
Sirohi
P
P
Bumb
R A
RA
Mehta
R D
RD
Purohit
S K
SK
D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D000981:Antiprotozoal Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007895:Leishmania tropica / Q000187:drug effects* / Q000254:growth & development; D016773:Leishmaniasis, Cutaneous / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D012293:Rifampin / Q000627:therapeutic use*; D016896:Treatment Outcome
D000981:Antiprotozoal Agents; D009853:Omeprazole; D012293:Rifampin