Ichthammol 10% in Yellow soft paraffin

Acute otitis externa is a common clinical condition that presents with rapid onset of otalgia, fullness, otorrhea and canal oedema. Moisture in-ear canal appears to be an important predisposing factor. The most common etiological agents include Pseudomonas aeruginosa and Staphylococcus aureus. Management includes control of otalgia and elimination of infection from the ear. Precipitating factors should be avoided. The main objective of this study is to compare the efficacy of 10% ichthammol glycerol ear pack with steroid antibiotic ear pack in the treatment of acute otitis externa. Institutional Review Board (IRB) clearance was obtained, and a prospective randomised clinical trial was conducted in the ENT outpatient department of Saveetha Medical College & Hospital, Thandalam, from January 2020 to March 2020. Patients were explained about the study in detail, and consent was obtained. The patients were randomised, and 10% ichthammol glycerol pack and steroid antibiotic pack were used in alternate turns for aural packing. Pain rating was done using Numerical rating scale (NRS) before and 48 hours post-treatment and also in each subsequent hospital visit till complete subsidence of symptoms. Among the 85 patients included in the study, 42 (49.4%) were males, and 43 (50.6%) were females. Most of them belonged to the age group 31-40 years (41.2%). Tragal tenderness and external auditory canal oedema were the most common ear findings noted. In the patients treated with steroid antibiotic pack, only 2.3% of the patients had severe pain, whereas 14% had moderate pain and 83.7% had only mild pain. Whereas among those treated with 10% ichthammol glycerol pack, 9.5% of the patients had severe pain, whereas 35.7% had moderate pain and 54.8% had mild pain. On analysis, the results were statistically significant, and there was considerable pain relief with steroid antibiotic pack. Therefore, our study showed that steroid antibiotic pack is more effective in relieving the symptoms, thereby reducing the number of hospital visits when compared to 10% ichthammol glycerol pack.

Abstract licence: CC BY-NC-ND 4.0

Ichthammol ointment is a sulfur-containing ointment which is used for the treatment of lower limb leg ulcerations and skin conditions such as atopic eczema and dermatitis. It has been in use for centuries as a topical ointment. The most common adverse drug reaction (ADR) associated with ichthammol use is skin irritation. This case was collected from the pediatric outpatient department as a part of the Pharmacovigilance elective under the Department of Pharmacology, Christian Medical College, Ludhiana, which is an ADR Monitoring Centre. The patient developed skin rashes and itching as adverse reactions to ichthammol and the medication was promptly discontinued to address the symptoms. The Naranjo’s score was 5 (probable) and the causality assessment showed a probable correlation of the current ADR with the suspect product. There are very few studies from India that have shown such reactions. Hence, this case study is rare and worth reporting to raise awareness of the same.

Abstract licence: CC BY-NC-SA 4.0