title: Inefficacy of allopurinol as monotherapy for Colombian cutaneous leishmaniasis. A randomized, controlled trial.
abstract: BACKGROUND
  Hundreds of thousands of cases of cutaneous leishmaniasis occur each year worldwide. Available therapies are parenteral, moderately toxic, and costly.
  
  
  OBJECTIVE
  To determine the efficacy of and tolerance for oral allopurinol as monotherapy for cutaneous leishmaniasis.
  
  
  METHODS
  Randomized, controlled trial.
  
  
  METHODS
  Outpatient clinics in 11 regions of Colombia in which cutaneous leishmaniasis is endemic.
  
  
  METHODS
  187 otherwise healthy adults with cutaneous leishmaniasis. Eighty-four percent of patients were infected with or were from regions with Leishmania panamensis; 16% were infected or were from regions with L. braziliensis.
  
  
  METHODS
  Patients were randomly assigned to one of three treatment groups. The first group received allopurinol, three 100-mg tablets four times daily (20 mg/kg of body weight per day) for 28 days. The second group received three placebo tablets four times daily for 28 days. The third group received Glucantime, 20 mg of intramuscular antimony/kg per day for 20 days.
  
  
  METHODS
  Complete cure was defined as complete clinical reepithelialization of all lesions at 3 months and no relapse during 12 months of follow-up.
  
  
  RESULTS
  Of 182 patients whose data could be analyzed, 157 (86%) were evaluated. In the allopurinol group, 18 of 55 (33% [95% CI, 21% to 47%]) patients were cured; in the placebo group, 17 of 46 patients (37% [CI, 23% to 52%]) were cured (difference, 4% [CI, -14% to 22%]; P = 0.68); and in the Glucantime group, 52 of 56 patients (93% [CI, 83% to 98%]) were cured (P < 0.001 compared with the allopurinol and placebo groups combined). In most cases, therapy was considered to have failed because the lesion did not reepithelialize by 1.5 months after the end of therapy. Three cases of relapse (two in the allopurinol group and one in the placebo group) at the nasal mucosa (mucosal leishmaniasis) had occurred by the end of 12 months of follow-up.
  
  
  CONCLUSIONS
  Allopurinol monotherapy has no effect on Colombian cutaneous disease primarily caused by L. panamensis and therefore is unlikely to be effective against cutaneous leishmaniasis in other endemic regions.
authors.affiliation: PECET, Universidad de Antioquia, Madellin, Colombia.
authors.forename: I
authors.initials: I
authors.lastname: Velez
authors.forename: S
authors.initials: S
authors.lastname: Agudelo
authors.forename: E
authors.initials: E
authors.lastname: Hendrickx
authors.forename: J
authors.initials: J
authors.lastname: Puerta
authors.forename: M
authors.initials: M
authors.lastname: Grogl
authors.forename: F
authors.initials: F
authors.lastname: Modabber
authors.forename: J
authors.initials: J
authors.lastname: Berman
mesh_terms: D000328:Adult; D000493:Allopurinol / Q000009:adverse effects / Q000627:therapeutic use*; D000963:Antimetabolites / Q000009:adverse effects / Q000627:therapeutic use*; D000965:Antimony / Q000627:therapeutic use; D000981:Antiprotozoal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016773:Leishmaniasis, Cutaneous / Q000188:drug therapy*; D008297:Male; D008536:Meglumine / Q000627:therapeutic use; D000077485:Meglumine Antimoniate; D009942:Organometallic Compounds / Q000627:therapeutic use; D017211:Treatment Failure
chemical_list: D000963:Antimetabolites; D000981:Antiprotozoal Agents; D009942:Organometallic Compounds; D000493:Allopurinol; D008536:Meglumine; D000077485:Meglumine Antimoniate; D000965:Antimony