Placebo-controlled clinical trial of meglumine antimonate (glucantime) vs. localized controlled heat in the treatment of cutaneous leishmaniasis in Guatemala.
Sixty-six Guatemalans with parasitologically proven cutaneous leishmaniasis were randomly and equally divided into 3 treatment groups: those receiving meglumine antimonate (Glucantime), 850 mg antimony/day im for 15 days; those receiving localized controlled heat from a radio-frequency generator, 50 degrees C for 30 sec, 3 treatments at 7 day intervals; and those receiving treatment with a placebo. Of 53 isolates identified, 40 were Leishmania braziliensis braziliensis and 13 were L. mexicana mexicana. Thirteen weeks after beginning treatment, the number of patients from each group with completely healed and parasitologically negative lesions were as follows: meglumine antimonate, 16 (73%); localized heat, 16 (73%); and placebo, 6 (27%). The cure rate for those with infections due to L. b. braziliensis in each group was as follows: meglumine antimonate, 11 out of 14 (79%); controlled heat, 9 out of 14 (64%); and placebo, 0 out of 11.
Navin
T R
TR
Division of Parasitic Diseases, Centers for Disease Control, Atlanta, Georgia.
Arana
B A
BA
Arana
F E
FE
de Mérida
A M
AM
Castillo
A L
AL
Pozuelos
J L
JL
D000328:Adult; D000818:Animals; D000965:Antimony / Q000009:adverse effects / Q000627:therapeutic use*; D000981:Antiprotozoal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006166:Guatemala; D006358:Hot Temperature / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007896:Leishmaniasis / Q000188:drug therapy / Q000628:therapy*; D008297:Male; D008536:Meglumine / Q000009:adverse effects / Q000627:therapeutic use*; D000077485:Meglumine Antimoniate; D008875:Middle Aged; D008889:Military Personnel; D009942:Organometallic Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D011846:Radio Waves; D016032:Randomized Controlled Trials as Topic; D013012:Sorbitol / Q000031:analogs & derivatives*
D000981:Antiprotozoal Agents; D009942:Organometallic Compounds; D013012:Sorbitol; D008536:Meglumine; D000077485:Meglumine Antimoniate; D000965:Antimony