Acute otitis externa is a diffuse inflammatory condition of the external auditory canal that commonly presents with otalgia, itching, aural fullness, otorrhoea, canal oedema and tenderness on manipulation of the tragus or pinna. It can occur at any age but is particularly common among individuals exposed to swimming, humid environments, excessive sweating, instrumentation of the ear canal or prolonged use of earphones and hearing aids. Disruption of the protective cerumen layer and local epithelial trauma alter the acidic environment of the external auditory canal, facilitating microbial proliferation. Pseudomonas aeruginosa and Staphylococcus aureus are the organisms most frequently associated with bacterial acute otitis externa ^[1,2]. The primary objectives of treatment are rapid relief of pain, reduction of canal oedema, eradication of infection and prevention of complications. Topical antimicrobial preparations, with or without corticosteroids, are recommended as first-line therapy for uncomplicated acute otitis externa because they achieve high local drug concentrations while minimizing systemic adverse effects and antimicrobial exposure ^[2,3]. Corticosteroid–antibiotic ear drops combine antibacterial action with suppression of inflammation, thereby reducing oedema, erythema and discomfort. However, marked canal swelling, debris and discharge may restrict penetration of drops, while treatment effectiveness may also be affected by incorrect administration and poor adherence. An ear wick or medicated pack may improve contact between the therapeutic agent and the inflamed canal epithelium when oedema obstructs the canal ^[3,4]. Ichthammol–glycerin has traditionally been used as an economical topical preparation for otitis externa. Glycerin exerts a hygroscopic effect that helps reduce oedema, whereas ichthammol possesses anti-inflammatory and mild antiseptic properties. The pack also mechanically splints the swollen canal and maintains prolonged contact with the affected skin. Comparative studies have demonstrated improvement in pain, tenderness, oedema and discharge following ichthammol–glycerin packing, although differences between this treatment and antibiotic–steroid preparations have not been consistent ^[4,5]. Steroid–antibiotic drops may offer easier administration and direct antimicrobial activity, whereas ichthammol–glycerin packing may be particularly useful in patients with substantial canal oedema and may reduce unnecessary exposure to topical antibiotics. Evidence directly comparing these two commonly used approaches remains limited, particularly regarding the speed of pain relief, resolution of canal oedema, clinical cure, treatment-related adverse effects, need for additional medication and overall cost. Therefore, the present study compared the effectiveness of ichthammol–glycerin ear packing with steroid–antibiotic ear drops in patients with uncomplicated acute otitis externa.

AIM

To compare the clinical effectiveness of ichthammol–glycerin ear packing and steroid–antibiotic ear drops in the management of acute otitis externa.

OBJECTIVES

1. To compare the reduction in pain, tragal tenderness, external auditory canal oedema and ear discharge between patients treated with ichthammol–glycerin ear packs and those treated with steroid–antibiotic ear drops.
2. To compare clinical recovery, time to symptom resolution, requirement for additional treatment, adverse effects, treatment adherence and recurrence between the two groups.

Source of Data The study included patients presenting with symptoms and clinical signs suggestive of acute otitis externa to the outpatient and emergency services of the Department of Otorhinolaryngology. Eligible patients were enrolled consecutively after the diagnosis had been confirmed through history and otoscopic examination. Study Design The study was conducted as a hospital-based, prospective, open-label comparative study with two parallel treatment groups. Study Location The study was carried out in the Department of Otorhinolaryngology. Study Duration The study was conducted over a period of 12 months, including enrolment, treatment and follow-up. Sample Size A total of 150 patients with acute otitis externa were included. They were assigned in a 1:1 ratio to two treatment groups: • Group A: 75 patients treated with ichthammol–glycerin ear packing. • Group B: 75 patients treated with steroid–antibiotic ear drops. The sample size was considered sufficient to identify a clinically meaningful difference between the groups at a 5% level of significance and 80% statistical power, after allowing for possible loss to follow-up. Inclusion Criteria Patients were included when they: 1. Were aged 18 years or older. 2. Had a clinical diagnosis of uncomplicated diffuse acute otitis externa. 3. Had symptoms of three weeks or less in duration. 4. Had otalgia with diffuse oedema or erythema of the external auditory canal. 5. Had tenderness on manipulation of the tragus or pinna. 6. Had an intact tympanic membrane on otoscopic examination. 7. Were willing to participate and provided written informed consent. 8. Were available for the scheduled follow-up visits. Exclusion Criteria Patients were excluded when they had: 1. Chronic or recurrent otitis externa. 2. Fungal otitis externa or clinically evident otomycosis. 3. Furunculosis confined to the external auditory canal. 4. Chronic suppurative otitis media or acute otitis media. 5. Tympanic membrane perforation or a tympanostomy tube. 6. Malignant or necrotizing otitis externa. 7. Cellulitis extending beyond the external auditory canal. 8. Diabetes mellitus with poor glycaemic control or an immunocompromised state. 9. Previous ear surgery or structural abnormality of the external auditory canal. 10. Known hypersensitivity to any study medication. 11. Use of topical or systemic antibiotics during the preceding seven days. 12. Pregnancy or lactation, when the proposed medication was considered unsuitable. 13. Inability to comply with treatment or follow-up instructions. Procedure and Methodology Approval was obtained from the Institutional Ethics Committee before commencement of the study. Written informed consent was obtained from every participant. Demographic information, presenting symptoms, duration of illness, predisposing factors, comorbidities, previous treatment and history of drug allergy were recorded using a predesigned case-record form. Each patient underwent examination of the pinna, tragus, external auditory canal, tympanic membrane and regional lymph nodes. Otoscopic or otoendoscopic examination was performed to confirm the diagnosis and exclude middle-ear disease, tympanic membrane perforation and fungal infection. When discharge or debris obscured the canal, careful aural toilet was performed under direct visualization without causing additional trauma. Baseline pain intensity was recorded using an 11-point Numerical Rating Scale, ranging from 0 for no pain to 10 for the worst imaginable pain. Tragal tenderness was categorized as absent, mild, moderate or severe. Canal oedema was graded as: • Grade 0: no oedema; • Grade 1: mild oedema without canal narrowing; • Grade 2: moderate oedema with partial canal narrowing; • Grade 3: severe oedema with near-complete or complete canal obstruction. Ear discharge was documented as absent, scanty, moderate or profuse. Patients in Group A received a sterile cotton wick impregnated with 10% ichthammol in glycerin. The pack was inserted gently into the affected external auditory canal under direct visualization. It was replaced after 24–48 hours, depending on canal oedema and saturation of the wick, and continued until adequate reduction of oedema had occurred, for a maximum of five to seven days. Patients in Group B received steroid–antibiotic ear drops, preferably ciprofloxacin 0.3% with dexamethasone 0.1%, four drops into the affected ear twice daily for seven days. Patients were instructed to lie with the affected ear upward, instil the prescribed drops without touching the applicator to the ear and remain in that position for approximately three to five minutes. Both groups received the same standard oral analgesic, such as paracetamol, according to body weight and clinical requirement. Systemic antibiotics were not routinely administered. Patients were instructed to keep the affected ear dry and avoid swimming, scratching, ear buds, oil instillation and other forms of instrumentation during treatment. Clinical assessments were conducted at baseline, 48–72 hours and on day 7. An additional assessment was performed on day 14 when symptoms had not completely resolved or when recurrence was suspected. At every visit, pain score, tragal tenderness, canal oedema, erythema, discharge and adverse effects were documented. Treatment adherence and the requirement for rescue analgesics, additional topical medication or systemic antibiotics were also recorded. The primary outcome was clinical recovery on day 7, defined as absence or clinically meaningful reduction of pain, tragal tenderness, canal oedema and discharge without the need for alternative therapy. Secondary outcomes included change in pain score, time to pain relief, reduction in oedema, treatment adherence, number of visits, adverse effects, additional treatment requirement and recurrence within 14 days. Sample Processing Routine microbiological culture was not required in uncomplicated acute otitis externa. However, before aural cleaning and initiation of treatment, an external auditory canal swab was collected from patients with profuse discharge, recurrent infection, previous treatment failure or clinically severe disease. The specimen was collected aseptically using a sterile swab, labelled and immediately transported to the microbiology laboratory. The sample was subjected to Gram staining and inoculated onto appropriate culture media, including blood agar and MacConkey agar. Isolated organisms were identified using standard microbiological procedures, and antimicrobial susceptibility testing was performed by the Kirby–Bauer disc-diffusion method according to prevailing laboratory standards. When fungal infection was suspected, potassium hydroxide mount and fungal culture were performed, and confirmed cases were excluded from the comparative analysis. Data Collection Data were collected prospectively using a pretested, structured case-record form. Information included age, sex, occupation, affected ear, duration of symptoms, water exposure, ear instrumentation, comorbidities, baseline clinical severity, treatment received and follow-up findings. Pain and clinical severity were recorded using standardized scales at each visit. Treatment adherence in the ear-drop group was assessed through patient questioning and review of the medication container, while adherence in the ear-pack group was assessed according to pack retention and attendance for scheduled replacement. Data were checked for completeness and consistency before being entered into a password-protected electronic database. Each participant was assigned a unique identification number to maintain confidentiality. Statistical Methods Data were entered into Microsoft Excel and analysed using IBM SPSS Statistics version ___ or equivalent statistical software. Continuous variables were summarized as mean and standard deviation when normally distributed and as median and interquartile range when the distribution was skewed. Categorical variables were expressed as frequencies and percentages. The independent-samples Student’s t-test was used to compare normally distributed continuous variables between the two treatment groups. The Mann–Whitney U test was used for non-normally distributed variables or ordinal scores. Within-group changes in pain and clinical scores were evaluated using the paired t-test or Wilcoxon signed-rank test. Repeated observations were analysed using repeated-measures analysis of variance or an appropriate non-parametric alternative. Categorical outcomes, including clinical recovery, adverse effects, additional treatment and recurrence, were compared using the chi-square test or Fisher’s exact test. Effect estimates were reported as mean differences, risk differences, relative risks or odds ratios with 95% confidence intervals. Multivariable logistic regression was used, when required, to adjust for baseline differences and identify independent predictors of clinical recovery. All tests were two-tailed, and a p value below 0.05 was considered statistically significant. Analyses were performed according to the treatment received, with reasons for loss to follow-up documented.

Table 1: Overall clinical effectiveness of ichthammol–glycerin ear packing compared with steroid–antibiotic ear drops (N=150)

Among the 150 patients, overall clinical success on day 7 was observed in 126 (84.0%) patients. Clinical success was higher in the ichthammol–glycerin pack group than in the steroid–antibiotic drops group (89.3% versus 78.7%; RR=1.14, 95% CI: 0.99–1.31), although the difference was not statistically significant (χ²=3.18, p=0.075). Similarly, pain-free status was more frequent with ichthammol–glycerin packing (81.3% versus 69.3%; RR=1.17, 95% CI: 0.97–1.41; p=0.088). Complete normalization of the external auditory canal was achieved in 85.3% and 73.3% of patients, respectively (RR=1.16, 95% CI: 0.99–1.37; p=0.070). No additional topical or systemic treatment was required by 90.7% of patients in the packing group compared with 80.0% in the ear-drop group (RR=1.13, 95% CI: 0.97–1.32; p=0.067). Although these categorical outcomes consistently favoured ichthammol–glycerin packing, none reached statistical significance. However, the mean patient-satisfaction score was significantly higher in the packing group than in the ear-drop group (8.34±1.12 versus 7.76±1.31), with a mean difference of 0.58 points (95% CI: 0.19–0.97; t=2.92, p=0.004).

Table 2: Comparison of reduction in pain, tragal tenderness, external auditory canal oedema and ear discharge (N=150)

The mean baseline pain scores were comparable between the ichthammol–glycerin and steroid–antibiotic groups (7.42±1.08 versus 7.36±1.06; MD=0.06, 95% CI: −0.28 to 0.40; p=0.732), indicating similar initial pain severity. On day 7, the mean pain score was significantly lower in the packing group (1.38±1.17) than in the ear-drop group (1.91±1.30), with a mean difference of −0.53 points (95% CI: −0.93 to −0.13; t=−2.62, p=0.010). The reduction in pain from baseline was also significantly greater with packing (6.04±1.62 versus 5.45±1.76; MD=0.59, 95% CI: 0.04–1.14; p=0.034). Complete resolution of tragal tenderness occurred in 88.0% of the packing group and 76.0% of the ear-drop group, although the difference narrowly missed statistical significance (RR=1.16, 95% CI: 0.99–1.35; p=0.056). Reduction in canal-oedema score was significantly greater with packing (2.41±0.58 versus 2.12±0.66; MD=0.29, 95% CI: 0.09–0.49; p=0.005). Complete resolution of canal oedema (84.0% versus 73.3%; p=0.110) and absence of ear discharge (90.7% versus 80.0%; p=0.067) were more frequent in the packing group, but these differences were not statistically significant. The composite symptom-score reduction was significantly greater with ichthammol–glycerin packing (8.13±1.94 versus 7.22±2.15; MD=0.91, 95% CI: 0.25–1.57; t=2.72, p=0.007).

Table 3: Comparison of recovery, symptom-resolution time, additional treatment, adverse effects, adherence and recurrence (N=150)

Clinical recovery by day 7 was achieved in 126 (84.0%) patients overall and was more frequent in the ichthammol–glycerin group than in the steroid–antibiotic group (89.3% versus 78.7%; RR=1.14, 95% CI: 0.99–1.31), although the difference was not statistically significant (p=0.075). The mean time to meaningful symptom relief was significantly shorter with ichthammol–glycerin packing (3.84±1.21 days) than with steroid–antibiotic drops (4.62±1.46 days), representing a mean reduction of 0.78 days (95% CI: 0.35–1.21; t=−3.56, p<0.001). Additional treatment was required by 9.3% of patients in the packing group compared with 20.0% in the ear-drop group (RR=0.47, 95% CI: 0.20–1.08; p=0.065). The requirement for rescue analgesia after 72 hours was significantly lower with packing (12.0% versus 26.7%; RR=0.45, 95% CI: 0.22–0.94; χ²=5.21, p=0.022). Treatment-related adverse effects were reported in 8.0% and 14.7% of patients, respectively (p=0.198). Satisfactory adherence was higher in the packing group (92.0% versus 82.7%; p=0.086), while unscheduled hospital visits (8.0% versus 17.3%; p=0.085) and recurrence within 14 days (5.3% versus 13.3%; p=0.091) were less frequent.

The present prospective comparative study evaluated 150 patients with acute otitis externa and demonstrated that both ichthammol–glycerin ear packing and steroid–antibiotic ear drops produced high clinical-response rates. However, ichthammol–glycerin packing showed a consistent numerical advantage in overall clinical success, pain relief, normalization of the external auditory canal, avoidance of additional treatment, symptom-resolution time and patient satisfaction. In Table 1, overall clinical success by day 7 was achieved in 84.0% of patients. The success rate was higher with ichthammol–glycerin packing than with steroid–antibiotic drops (89.3% versus 78.7%), although the difference was not statistically significant (RR=1.14; p=0.075). The confidence interval crossed unity, suggesting that the study could not conclusively establish superiority for this outcome despite the clinically relevant absolute difference of 10.6 percentage points. This overall response was consistent with Wiegand et al. (2019)[4], who reported that topical treatment generally produces clinical cure in most uncomplicated cases within 7–10 days. Jackson et al. (2023)[8] similarly observed that approximately 65–90% of patients experience clinical resolution after topical therapy, depending on disease severity, drug delivery and adherence. Monga et al. (2017)[1] found that both ichthammol–glycerin and steroid–antibiotic packs were effective as initial treatments and reported no definite difference in overall efficacy, supporting the present finding that both modalities were clinically useful. Pain-free status on day 7 was more frequent with packing than with ear drops (81.3% versus 69.3%; RR=1.17; p=0.088). Complete normalization of the external auditory canal also favoured packing (85.3% versus 73.3%; RR=1.16; p=0.070). Although these comparisons were not statistically significant, their consistent direction suggested a possible clinical advantage of prolonged contact between the medicated wick and the oedematous canal. Demir et al. (2018)[3] demonstrated that ear wicks and ribbon gauze effectively reduced otalgia, oedema, erythema and tenderness, particularly during the early treatment period. Shyamala et al. (2024)[10] also reported faster improvement in pain and oedema with cotton ichthammol–glycerin wicks than with hydroxylated polyvinyl acetate wicks, indicating that both the medication and physical properties of the packing material may influence clinical response. No additional topical or systemic treatment was required by 90.7% of patients in the packing group compared with 80.0% in the ear-drop group (p=0.067). This finding was clinically important because unnecessary systemic antibiotic use increases the risk of adverse effects and antimicrobial resistance. Mughal et al. (2021)[6] emphasized that topical treatment is generally adequate for uncomplicated acute otitis externa and that systemic antibiotics should be reserved for infection extending beyond the external auditory canal or for high-risk patients. Khatri et al. (2021)[7] similarly recommended topical antibiotic therapy as first-line treatment and highlighted the importance of aural toilet and wick placement when canal oedema prevents adequate drug penetration. Patient satisfaction was the only Table 1 outcome showing a statistically significant difference. The mean satisfaction score was higher with ichthammol–glycerin packing than with steroid–antibiotic drops (8.34 versus 7.76; MD=0.58; p=0.004). The sustained contact of the pack with the inflamed canal, reduced need for self-administration and earlier symptom relief may have contributed to greater satisfaction. Nevertheless, packing requires insertion and replacement by trained personnel, whereas drops offer convenience and home administration. Therefore, treatment preference may vary according to access to follow-up care, severity of canal obstruction, cost and the patient’s ability to administer drops correctly. Table 2 showed that baseline pain severity was comparable between the groups (7.42 versus 7.36; p=0.732), supporting the validity of the subsequent comparison. By day 7, the pain score was significantly lower in the ichthammol–glycerin group (1.38 versus 1.91; MD=−0.53; p=0.010), and the mean reduction from baseline was significantly greater (6.04 versus 5.45; MD=0.59; p=0.034). Monga et al. (2017)[1] likewise observed substantial reductions in pain after ichthammol–glycerin packing. Mustafa (2018)[2], however, found better pain control with ciprofloxacin–dexamethasone than with 10% ichthammol–glycerin. Similarly, Asghar Ullah et al. (2024)[11] reported significantly lower day-3 pain scores and higher early efficacy with ciprofloxacin–dexamethasone wicks. Differences in these findings may be explained by the antibiotic formulation, method of delivery, baseline severity, frequency of wick replacement and timing of outcome assessment. Complete resolution of tragal tenderness occurred in 88.0% of patients treated with ichthammol–glycerin and 76.0% treated with steroid–antibiotic drops (p=0.056). This result approached statistical significance and suggested a possible advantage of packing. In contrast, Khan et al. (2021)[5] found that the ciprofloxacin–dexamethasone wick produced greater improvement in tenderness than the ichthammol–glycerin wick, although the two treatments had similar overall efficacy and discharge clearance. The contrasting findings may have resulted from the present study comparing an ichthammol–glycerin pack with freely instilled drops, whereas Khan et al. compared two agents delivered through wicks. Thus, the drug-delivery mechanism may have contributed to the observed differences. Reduction in canal-oedema score was significantly greater with ichthammol–glycerin packing (2.41 versus 2.12; p=0.005). This advantage was biologically plausible because glycerin is hygroscopic and draws fluid from oedematous tissue, while the wick maintains continuous contact and mechanically splints the swollen canal. Demir et al. (2018)[3] demonstrated significant early improvement in canal oedema with wick and ribbon-gauze packing. Sabarinath et al. (2024)[9] also observed significantly greater reductions in pain and oedema with antibiotic–steroid ear packing than with the corresponding ear drops, suggesting that packing itself can improve treatment delivery and local clinical response. Complete resolution of canal oedema (84.0% versus 73.3%; p=0.110) and absence of discharge (90.7% versus 80.0%; p=0.067) were more frequent with ichthammol–glycerin packing, although statistical significance was not achieved. The lack of significance despite favourable numerical differences may reflect limited power for categorical outcomes. Khan et al. (2021)[5] similarly found comparable discharge reduction between steroid–antibiotic and ichthammol–glycerin wicks. The significant improvement in the composite symptom score observed in the present study (MD=0.91; p=0.007) suggested that the combined effects on pain, tenderness, oedema and discharge were more apparent than the effect on any single categorical endpoint. In Table 3, mean time to meaningful symptom relief was significantly shorter with ichthammol–glycerin packing than with steroid–antibiotic drops (3.84 versus 4.62 days; MD=−0.78 days; p<0.001). Shyamala et al. (2024)[10] similarly reported faster pain and oedema reduction with cotton ichthammol–glycerin wicks. Sabarinath et al. (2024)[9] found that ear packing resulted in a greater degree of symptomatic improvement than drops containing a comparable antibiotic–steroid combination. These findings support the concept that continuous drug contact and improved delivery across an obstructed canal can accelerate symptom relief. Additional treatment was required by 9.3% of the packing group and 20.0% of the ear-drop group (RR=0.47; p=0.065). Although not statistically significant, the estimate suggested a 53% relative reduction in additional treatment with packing. Rescue analgesia after 72 hours was significantly less frequent with ichthammol–glycerin packing (12.0% versus 26.7%; RR=0.45; p=0.022), reinforcing its beneficial effect on pain. Adequate analgesia is an essential component of acute otitis externa management because ear-canal oedema and inflammation can produce severe pain disproportionate to the apparent local findings, as emphasized by Jackson et al. (2023)[8]. Treatment-related adverse effects were relatively uncommon in both groups and did not differ significantly (8.0% versus 14.7%; p=0.198). Wiegand et al. (2019)[4] reported that topical therapies are generally safe, although hypersensitivity, local irritation and ototoxicity must be considered when selecting an agent. Bhattarai (2025)[12] concluded in a systematic review that antibiotic–steroid packs often provide superior early outcomes in some studies, while ichthammol–glycerin remains an effective, inexpensive alternative with potential advantages related to cost and reduced antibiotic exposure. Differences among studies indicate that conclusions depend on disease severity, comparator formulation and whether the medication is administered as drops or through a wick. Satisfactory adherence was higher with packing (92.0% versus 82.7%; p=0.086). Unscheduled hospital visits (8.0% versus 17.3%; p=0.085) and 14-day recurrence (5.3% versus 13.3%; p=0.091) were also less frequent, although these differences were not statistically significant. Correct administration of ear drops can be difficult, particularly in patients with severe pain, canal oedema or limited assistance. Khatri et al. (2021)[7] and Jackson et al. (2023)[8] emphasized that treatment effectiveness depends on adequate delivery and adherence and recommended wick placement when canal obstruction restricts penetration of drops.

Both ichthammol–glycerin ear packing and steroid–antibiotic ear drops were effective and well tolerated in patients with acute otitis externa. Ichthammol–glycerin packing produced significantly greater reductions in pain, external auditory canal oedema and the composite symptom score, along with faster symptom relief, higher patient satisfaction and a lower requirement for rescue analgesia. Although clinical success, complete canal normalization, treatment adherence and absence of discharge were more frequent with ichthammol–glycerin packing, these differences were not statistically significant. Ichthammol–glycerin ear packing may therefore represent an effective and economical treatment, particularly when marked canal oedema limits the penetration of ear drops. Larger randomized controlled trials are required to confirm its comparative superiority and long-term benefits.

LIMITATIONS OF STUDY

The study had several limitations. It was conducted at a single hospital with a relatively modest sample size, which might limit the generalizability of its findings. The open-label design meant that neither patients nor treating clinicians were blinded, creating the possibility of performance and assessment bias, particularly for subjective outcomes such as pain and satisfaction. Treatment allocation in a prospective comparative design might also have introduced selection bias if complete randomization was not employed. Differences in the mode of drug delivery made blinding difficult and prevented separation of the pharmacological effect of ichthammol–glycerin from the mechanical and sustained-contact effects of the ear pack. Pain, tenderness and satisfaction were patient-reported or partly subjective measures. Treatment adherence in the ear-drop group depended largely on self-reporting. Follow-up was limited to 14 days, so late recurrence and long-term adverse effects could not be evaluated. Microbiological testing was not performed routinely; therefore, treatment response could not be correlated with the causative organism or antimicrobial susceptibility. Cost-effectiveness and quality-of-life outcomes were also not formally assessed.