Table 9.
Adverse effects of thermotherapy
| Study | Method of assessment | Timing | Interventions | Adverse effects |
| Reithinger 2005 | Quote: "The occurrence of adverse effects was evaluated blindly by means of participant interviews and physical examinations." | Quote: "The occurrence of adverse effects was evaluated … during follow‐up visits." | I1: ILSSG 2‐5 mL per lesion I2: IMSSG 20 mg/kg I3: thermotherapy |
138‐108 participants evaluated for AEs. Secondary infections: 8 (5.7%). Quote: "The original CL ulcer often increased in size immediately after and up to 2 weeks after treatment." |
| Sadeghian 2007 | Quote: "Appearance of lesions at subsequent follow‐up visits and occurrence of unwanted side‐effects were also recorded on the form." | Weekly 4 weeks and monthly up to 6 months | I1: thermotherapy I2: ILMA weekly |
57 participants (83 lesions) evaluated for AEs. Satellite lesions: 1 (1.7%) |
| Aronson 2010 | Quote: "Interview, physical examination, laboratory testing (complete blood count, creatine phosphokinase, amylase, lipase, complete metabolic profile), and electrocardiograms." | Quote: "Daily for the first 10 days and follow‐up at 2, 6, and 12–24 months post treatment" | I1: thermotherapy I2: ILSSG |
27 participants evaluated for AEs. Serious AE: 4 (15%); ECG changes: 10 (37%); abdominal discomfort: 1 (4%); wound infection: 5 (19%); musculoskeletal: 5 (19%); headache: 3 (11%); fatigue: 5 (19%); rash: 1 (4%); blister reaction: 25 (93%); erythema: 7 (26%); oozing: 21 (78%) |
| Safi 2012 | Quote: "The occurrences of adverse effects were evaluated by means of participant interviews and physical examinations during follow‐up visits." | Quote: "During treatment, all participants were then followed for four visits at weekly intervals … After initial treatment, all participants were scheduled for four subsequent follow‐up visits: 10 days after baseline and 1‐month, 2 months and 6 months after treatment." | I1: thermotherapy I2: ILMA weekly |
189 participants evaluated for AEs Not reported |
| Bumb 2013 | Not described | Not described | I1: radiofrequency heat treatment I2: ILSSG |
Quote: "RFHT was cosmetically acceptable because it was associated with less scarring and hyperpigmentation compared with intralesional SSG injections." |
| Jebran 2014 | Quote: "In case of clinical signs for a superinfection, a smear was taken, Gram stained and microscopically evaluated for the presence of bacteria and/or fungi." | Quote: "Adverse events such as bacterial or fungal superinfections of the wounds, the formation or scars and the rate of re‐ulcerations were monitored during the treatment and follow‐up period." | I1: electrocauterisation + DAC N‐055. I2: electrocauterisation + placebo. |
Intervention 1: 38 participants evaluated for AEs. Bacterial and fungal superinfections: 3 (8.0%); Keloïd formation: 2 (5%) Intervention 2: 32 participants evaluated for AEs. Bacterial and fungal superinfections: 3 (9.0%); Keloïd formation: 2 (6%) |
AE: adverse effect; CL: cutaneous leishmaniasis; ILMA: intralesional meglumine antimoniate; ILSSG: intralesional sodium stibogluconate; IMSSG: intramuscular sodium stibogluconate.