Randomized, double-blind, comparative clinical trial on the efficacy and safety of intralesional sodium stibogluconate and intralesional 7% hypertonic sodium chloride against cutaneous leishmaniasis caused by L. donovani.
BACKGROUND
Since cutaneous leishmaniasis (CL) is a self healing disease, an ideal therapy should be rapidly effective, easily administered, cheap, available at all times at all centers and should have no side effects.


OBJECTIVE
To determine the efficacy and safety of intralesional 7% hypertonic saline in comparison to intralesional sodium stibogluconate against L. donovani CL.


METHODS
Intralesional hypertonic saline (HS) and sodium stibogluconate (SSG) were randomly allocated to 154 patients (229 lesions); these were followed-up for 18 months.


RESULTS
The M:F ratio was 1.8:1 (99:55). The average age of our population was 32 years. SSG was given to 87 patients (136 lesions); HS was given to 67 patients (93 lesions). SSG showed a 100% cure rate within one to six injections (average 3.24); HS showed a 92.2% cure rate within one to 10 injections (average 5.27). The average duration of treatment with SSG and HS was 5.11 and 8.78 weeks respectively. There was no difference in efficacy for both therapies with regard to ulcers or papules, and small or large, exposed or unexposed lesions. There was no association between the rapidity of clinical response and the duration and location of lesions. There were no local or systemic side effects except pain during injection. The lesions in the two groups showed post-inflammatory hyperpigmentation after treatment. During 18 months of follow-up there were no recurrences and no visceralization.


CONCLUSIONS
The most effective therapy for Leishmania donovani cutaneous leishmaniasis was intralesional SSG (average 3.24 injections). HS was effective, but needed an average of 5.27 injections in total per lesion. HS was cheap, with no risk of systemic side effects and was easily available at all centers.
Ranawaka
Ranthilaka R
RR
Anuradhapura Teaching Hospital, Anuradhapura, Sri Lanka. ranthilaka37@yahoo.com
Weerakoon
Hema S
HS
D000293:Adolescent; D000328:Adult; D000368:Aged; D000967:Antimony Sodium Gluconate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000981:Antiprotozoal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D015552:Injections, Intralesional; D007893:Leishmania donovani / Q000302:isolation & purification; D016773:Leishmaniasis, Cutaneous / Q000175:diagnosis* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012462:Saline Solution, Hypertonic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000981:Antiprotozoal Agents; D012462:Saline Solution, Hypertonic; D000967:Antimony Sodium Gluconate