None, D. S. N., None, D. S. P. & None, D. A. P. (2025). Steroid–Antibiotic Ear Drops versus Ichthammol–Glycerin Ear Pack for Acute Otitis Externa: A Randomized Comparative Study. Journal of Contemporary Clinical Practice, 11(12), 999-1009.
MLA
None, Dr Sunitha N, Dr Sowmyashree P and Dr Abhaykiran P . "Steroid–Antibiotic Ear Drops versus Ichthammol–Glycerin Ear Pack for Acute Otitis Externa: A Randomized Comparative Study." Journal of Contemporary Clinical Practice 11.12 (2025): 999-1009.
Chicago
None, Dr Sunitha N, Dr Sowmyashree P and Dr Abhaykiran P . "Steroid–Antibiotic Ear Drops versus Ichthammol–Glycerin Ear Pack for Acute Otitis Externa: A Randomized Comparative Study." Journal of Contemporary Clinical Practice 11, no. 12 (2025): 999-1009.
Harvard
None, D. S. N., None, D. S. P. and None, D. A. P. (2025) 'Steroid–Antibiotic Ear Drops versus Ichthammol–Glycerin Ear Pack for Acute Otitis Externa: A Randomized Comparative Study' Journal of Contemporary Clinical Practice 11(12), pp. 999-1009.
Vancouver
Dr Sunitha N DSN, Dr Sowmyashree P DSP, Dr Abhaykiran P DAP. Steroid–Antibiotic Ear Drops versus Ichthammol–Glycerin Ear Pack for Acute Otitis Externa: A Randomized Comparative Study. Journal of Contemporary Clinical Practice. 2025 Dec;11(12):999-1009.
Background: Acute otitis externa is a painful inflammatory disorder of the external auditory canal commonly treated with topical antimicrobial–corticosteroid preparations or ichthammol–glycerin packing. Evidence directly comparing their clinical effectiveness, safety and patient acceptability remains limited. Aim: To compare the clinical effectiveness and safety of steroid–antibiotic ear drops with ichthammol–glycerin ear packing in patients with acute otitis externa. Materials and Methods: This prospective randomized comparative study included 250 patients with uncomplicated acute otitis externa. Participants were randomized equally to receive steroid–antibiotic ear drops (n=125) or ichthammol–glycerin ear packing (n=125). Clinical findings and symptom scores were assessed at baseline, 48–72 hours and day 7, with recurrence assessed up to day 14. The principal outcomes were clinical resolution, early improvement, reductions in otalgia, canal oedema, erythema, otorrhoea and overall symptom score. Time to resolution, additional treatment, adherence, acceptability and adverse events were also compared. A two-sided p value <0.05 was considered statistically significant. Results: Clinical resolution by day 7 was significantly higher with steroid–antibiotic drops than with ichthammol–glycerin packing (89.6% versus 76.8%; RR=1.17, 95% CI: 1.05–1.29; p=0.006). Marked improvement within 72 hours was observed in 86.4% and 71.2%, respectively (p=0.003). The mean reduction in the overall symptom score was greater with ear drops (8.31±1.72 versus 7.14±1.89; MD=1.17, 95% CI: 0.72–1.62; p<0.001). Ear drops produced significantly greater improvement in otalgia, canal oedema, erythema and otorrhoea. Mean time to clinical resolution was shorter with ear drops (5.36±1.48 versus 6.27±1.76 days; p<0.001), and treatment failure was less frequent (7.2% versus 18.4%; p=0.008). Complete adherence (92.8% versus 80.8%; p=0.005) and treatment acceptability (90.4% versus 73.6%; p<0.001) were higher with ear drops. Recurrence and overall adverse-event rates did not differ significantly. Conclusion: Steroid–antibiotic ear drops provided faster and more complete clinical improvement, lower treatment failure and better adherence and acceptability than ichthammol–glycerin ear packing, without a significant difference in short-term adverse events. They may therefore be preferred for uncomplicated acute otitis externa with an intact tympanic membrane
Keywords
Acute otitis externa
Steroid–antibiotic ear drops
Ichthammol–glycerin ear pack.
INTRODUCTION
Acute otitis externa is a diffuse inflammatory condition of the external auditory canal that may also involve the pinna or tympanic membrane. It commonly presents with otalgia, itching, aural fullness, otorrhoea, tragal tenderness, canal erythema and oedema. Moisture exposure, swimming, local trauma from ear cleaning, hearing-aid use, dermatological disorders and loss of the protective cerumen barrier are important predisposing factors. The condition affects individuals of all ages and is especially common in warm and humid environments. Pseudomonas aeruginosa and Staphylococcus aureus are the predominant bacterial pathogens, although polymicrobial infection may occur [1,2]. The principal objectives of treatment are rapid relief of pain and inflammation, eradication of infection, restoration of canal patency and prevention of complications. Topical antimicrobial preparations are recommended as the initial treatment for uncomplicated acute otitis externa because they achieve high local drug concentrations while limiting systemic adverse effects [1,3]. Steroid–antibiotic ear drops combine antibacterial activity with the anti-inflammatory effects of corticosteroids and may provide early improvement in pain, oedema and erythema. Their effectiveness, however, depends on adequate delivery into the external auditory canal, which may be difficult when marked canal oedema, debris or discharge is present. In such circumstances, careful aural toilet and placement of an ear wick or medicated pack may improve contact between the therapeutic agent and the inflamed canal [1,4].
Ichthammol–glycerin packing represents an established alternative treatment, particularly when canal oedema is prominent. Glycerin exerts hygroscopic and osmotic effects that may reduce oedema, while ichthammol possesses anti-inflammatory and mild antiseptic properties. The pack also mechanically maintains canal patency and permits prolonged contact with the affected skin. Previous comparative studies have shown that both steroid–antibiotic preparations and ichthammol–glycerin packs can improve the clinical manifestations of acute otitis externa, although their relative effects on the speed of pain relief, overall clinical resolution, frequency of hospital visits, patient comfort and adverse events have varied [4,5]. Ear packing may require repeated clinical visits and can cause temporary discomfort or blockage, whereas ear drops are convenient for home administration but depend on correct application and treatment adherence. Evidence from adequately powered randomized comparisons remains limited, particularly in routine clinical settings. Therefore, the present randomized comparative study was undertaken to evaluate the clinical effectiveness, safety and acceptability of steroid–antibiotic ear drops compared with ichthammol–glycerin ear packing in patients with acute otitis externa.
AIM
To compare the clinical effectiveness and safety of steroid–antibiotic ear drops with ichthammol–glycerin ear packing in patients with acute otitis externa.
OBJECTIVES
To compare the reduction in otalgia, canal oedema, erythema, otorrhoea and overall symptom score between the two treatment groups. To compare the time to clinical resolution, need for additional treatment, treatment adherence, patient acceptability and adverse events between the two groups.
MATERIALS AND METHODS
Source of Data
The study participants were recruited from patients attending the outpatient and emergency services of the Department of Otorhinolaryngology. Patients presenting with symptoms and clinical findings suggestive of acute otitis externa were screened for eligibility. Data were obtained through clinical interviews, otorhinological examination, otoscopic assessment, laboratory investigation when indicated and scheduled follow-up evaluations.
Study Design
This study was conducted as a prospective, open-label, parallel-group, randomized comparative study. Eligible participants were allocated in a 1:1 ratio to receive either steroid–antibiotic ear drops or ichthammol–glycerin ear packing.
Study Location
The study was carried out in the Department of Otorhinolaryngology.
Study Duration
The study was conducted over 12 months, including participant recruitment, treatment, follow-up, data verification and statistical analysis.
Sample Size
A total of 250 patients with acute otitis externa were included. The sample size was determined using the expected difference in clinical resolution between the treatment groups, a two-sided significance level of 5%, statistical power of 80% and allowance for possible loss to follow-up. Participants were allocated equally:
Group A: steroid–antibiotic ear drops, 125 patients
Group B: ichthammol–glycerin ear pack, 125 patients .
Inclusion Criteria
Patients were included when they fulfilled the following criteria:Patients aged 18 years or older. Clinical diagnosis of diffuse acute otitis externa with onset within the preceding three weeks.
Presence of otalgia with tragal or pinna tenderness and external auditory canal erythema or oedema.
Intact tympanic membrane or no clinical evidence of tympanic membrane perforation.
Mild-to-moderate uncomplicated acute otitis externa suitable for outpatient treatment.
Willingness to comply with treatment and scheduled follow-up. Provision of written informed consent.
Exclusion Criteria
Patients were excluded if they had:
Chronic, recurrent, eczematous, fungal or malignant otitis externa.
Tympanic membrane perforation, tympanostomy tube or active chronic suppurative otitis media.
Furunculosis confined to a localized portion of the external auditory canal. Cellulitis or infection extending beyond the external auditory canal. Diabetes mellitus with poor glycaemic control, immunodeficiency or another condition increasing the risk of invasive infection.
Previous ear surgery or a congenital external auditory canal abnormality. Use of topical or systemic antibiotics, corticosteroids or antifungal treatment during the preceding seven days.
Known hypersensitivity to any study medication or packing material. Pregnancy or lactation when the selected preparation was considered unsuitable.
Inability to complete follow-up or provide reliable clinical information.
Procedure and Methodology
The study commenced after approval had been obtained from the Institutional Ethics Committee. Written informed consent was obtained from every participant. Demographic characteristics, presenting complaints, possible risk factors, previous treatment and relevant medical history were recorded using a predesigned case-record form.
Each patient underwent examination of the pinna, tragus, external auditory canal and tympanic membrane. Otalgia was assessed using an 11-point numerical rating scale ranging from 0, indicating no pain, to 10, indicating the worst possible pain. Canal oedema, erythema, otorrhoea and tenderness were graded using a uniform clinical scoring system. The same scoring criteria were used at baseline and follow-up visits.
When necessary, visible debris and discharge were gently removed by dry mopping or suction under direct visualization without causing canal trauma. Eligible participants were randomly assigned to either treatment group using a computer-generated random sequence. Allocation was concealed in sequentially numbered, opaque, sealed envelopes that were opened only after enrolment.
Patients in Group A received a prespecified steroid–antibiotic combination ear-drop preparation according to the manufacturer’s recommended dose, generally three to four drops into the affected ear three times daily for seven days. Participants were instructed to lie with the affected ear upward, instil the prescribed drops without touching the ear canal and remain in that position for approximately three to five minutes.
Patients in Group B underwent insertion of a sterile ribbon-gauze or ear-wick pack impregnated with 10% ichthammol in glycerin. The pack was inserted gently under direct visualization so that it contacted the oedematous canal without excessive pressure. It was reviewed and removed or replaced after 24–48 hours according to canal oedema and clinical response. Packing was discontinued once sufficient canal patency and symptom improvement had been achieved.
Both groups received the same rescue oral analgesic when required. Systemic antibiotics were not routinely administered and were reserved for documented extension of infection or other clinically justified indications. Patients were evaluated at 48–72 hours and on day 7. An additional assessment was conducted on day 14 when symptoms had not completely resolved.
The primary outcome was clinical effectiveness at day 7, assessed through reduction in the composite symptom-and-sign score or complete clinical resolution. Secondary outcomes included change in pain score, reduction in canal oedema and otorrhoea, time to symptom relief, number of clinical visits, requirement for rescue analgesia or additional antimicrobial treatment, treatment adherence, patient-reported acceptability, recurrence and adverse events.
Treatment failure was defined as persistence or worsening of symptoms, absence of clinically meaningful improvement within 72 hours, development of complications or need to change the assigned treatment. Participants with treatment failure were reassessed for an alternative diagnosis, and appropriate rescue treatment was provided.
Sample Processing
Microbiological sampling was not required routinely in uncomplicated cases. An external auditory canal swab was collected before starting treatment when discharge was profuse, the infection was recurrent or severe, or there was an inadequate response within 48–72 hours. The specimen was obtained aseptically from the affected canal without contaminating it with the pinna.
The swab was transported promptly to the microbiology laboratory. Direct microscopy and Gram staining were performed, followed by inoculation on appropriate culture media. Bacterial isolates were identified using standard microbiological methods, and antimicrobial susceptibility testing was performed according to the prevailing Clinical and Laboratory Standards Institute recommendations. Fungal microscopy and culture were undertaken when otomycosis was clinically suspected. Microbiological findings were used to guide rescue therapy but did not replace the predefined clinical outcome assessment.
Data Collection
Data were collected prospectively using a structured and pretested case-record form. The recorded variables included age, sex, affected ear, symptom duration, precipitating factors, comorbidities, baseline pain score, canal oedema, erythema, otorrhoea, tenderness, microbiological findings when available, allocated intervention, rescue-analgesic use, adherence, follow-up findings, clinical resolution, treatment failure and adverse events.
Treatment adherence in the ear-drop group was assessed through patient interview and review of the returned medication container. Adherence in the packing group was evaluated through attendance for pack review and documentation of premature displacement or removal. Completed forms were checked for accuracy and completeness before entry into an electronic database. Participant confidentiality was maintained through unique identification codes.
Statistical Methods
Data were entered into Microsoft Excel and analysed using IBM SPSS version version 28.0. Continuous variables were presented as mean with standard deviation or median with interquartile range according to their distribution. Categorical variables were summarized as frequencies and percentages. Normality was assessed using graphical methods and the Shapiro–Wilk test.
Baseline characteristics were compared using the independent-samples t test or Mann–Whitney U test for continuous variables and the chi-square test or Fisher’s exact test for categorical variables. Changes in pain and composite clinical scores within groups were assessed using the paired t test or Wilcoxon signed-rank test. Repeated measurements were evaluated using repeated-measures analysis of variance or an appropriate mixed-effects model.
Clinical resolution, treatment failure and adverse-event rates were compared using relative risks or risk differences with 95% confidence intervals. Time to clinical resolution was analysed using Kaplan–Meier curves and the log-rank test when exact time-to-event data were available. Multivariable logistic regression was used, where appropriate, to adjust for baseline severity and other potential confounders. The primary analysis followed the intention-to-treat principle, with an additional per-protocol analysis used as a sensitivity assessment. A two-sided p value below 0.05 was considered statistically significant.
RESULTS
Table 1: Overall clinical effectiveness and safety of steroid–antibiotic ear drops compared with ichthammol–glycerin ear packing (N=250)
Outcome Total (N=250), n (%) or Mean (SD) Steroid–antibiotic drops (n=125) Ichthammol–glycerin pack (n=125) Effect estimate (95% CI) Test of significance P value
Clinical resolution by day 7 208 (83.2) 112 (89.6) 96 (76.8) RD=12.8% (4.0% to 21.6%); RR=1.17 (1.05–1.29) χ²=7.43 0.006*
Marked clinical improvement within 72 hours 197 (78.8) 108 (86.4) 89 (71.2) RD=15.2% (5.1% to 25.3%); RR=1.21 (1.07–1.38) χ²=8.71 0.003*
Overall symptom-score reduction at day 7, Mean (SD) 7.73 (1.90) 8.31 (1.72) 7.14 (1.89) MD=1.17 (0.72–1.62) Independent t=5.12 <0.001*
Treatment failure 32 (12.8) 9 (7.2) 23 (18.4) RD=−11.2% (−19.1% to −3.3%); RR=0.39 (0.19–0.81) χ²=7.01 0.008*
Recurrence within 14 days 19 (7.6) 7 (5.6) 12 (9.6) RD=−4.0% (−10.6% to 2.6%); RR=0.58 (0.24–1.43) χ²=1.44 0.230
Any treatment-related adverse event 31 (12.4) 12 (9.6) 19 (15.2) RD=−5.6% (−14.0% to 2.8%); RR=0.63 (0.32–1.24) χ²=1.79 0.181
Table 1 presents the overall clinical effectiveness and safety outcomes among 250 patients equally allocated to steroid–antibiotic ear drops and ichthammol–glycerin packing. Clinical resolution by day 7 was achieved in 208 (83.2%) patients and was significantly more frequent with steroid–antibiotic drops than with ichthammol–glycerin packing (89.6% versus 76.8%; RR=1.17, 95% CI: 1.05–1.29; p=0.006). Similarly, marked clinical improvement within 72 hours was observed in 86.4% of the ear-drop group compared with 71.2% of the packing group, representing an absolute benefit of 15.2% (95% CI: 5.1%–25.3%; p=0.003). The mean reduction in the overall symptom score was also significantly greater with steroid–antibiotic drops (8.31±1.72) than with ichthammol–glycerin packing (7.14±1.89), with a mean difference of 1.17 points (95% CI: 0.72–1.62; p<0.001). Treatment failure occurred significantly less frequently in the ear-drop group than in the packing group (7.2% versus 18.4%; RR=0.39, 95% CI: 0.19–0.81; p=0.008). Although recurrence within 14 days (5.6% versus 9.6%; p=0.230) and treatment-related adverse events (9.6% versus 15.2%; p=0.181) were numerically less frequent with steroid–antibiotic drops, these differences were not statistically significant.
Table 2: Reduction in otalgia, canal oedema, erythema, otorrhoea and overall symptom score between the treatment groups (N=250)
Clinical outcome at day 7 Total (N=250), n (%) or Mean (SD) Steroid–antibiotic drops (n=125) Ichthammol–glycerin pack (n=125) Effect estimate (95% CI) Test of significance P value
≥50% reduction in otalgia 213 (85.2) 114 (91.2) 99 (79.2) RD=12.0% (3.3%–20.7%); RR=1.15 (1.04–1.27) χ²=7.16 0.007*
Reduction in otalgia score, Mean (SD) 6.02 (1.45) 6.42 (1.31) 5.61 (1.47) MD=0.81 (0.46–1.16) Independent t=4.60 <0.001*
Clinically meaningful reduction in canal oedema 201 (80.4) 109 (87.2) 92 (73.6) RD=13.6% (3.9%–23.3%); RR=1.18 (1.05–1.34) χ²=7.31 0.007*
Reduction in canal-oedema score, Mean (SD) 1.97 (0.73) 2.18 (0.66) 1.76 (0.73) MD=0.42 (0.25–0.59) Independent t=4.77 <0.001*
Clinically meaningful reduction in erythema 204 (81.6) 111 (88.8) 93 (74.4) RD=14.4% (5.0%–23.8%); RR=1.19 (1.06–1.34) χ²=8.64 0.003*
Reduction in erythema score, Mean (SD) 1.71 (0.69) 1.89 (0.61) 1.53 (0.68) MD=0.36 (0.20–0.52) Independent t=4.40 <0.001*
Resolution or marked reduction of otorrhoea† 189 (75.6) 103 (82.4) 86 (68.8) RD=13.6% (3.3%–23.9%); RR=1.20 (1.05–1.37) χ²=6.27 0.012*
Complete/near-complete symptom resolution 196 (78.4) 107 (85.6) 89 (71.2) RD=14.4% (4.5%–24.3%); RR=1.20 (1.06–1.37) χ²=7.70 0.006*
Overall symptom score at baseline, Mean (SD) 11.86 (2.08) 11.91 (2.06) 11.81 (2.11) MD=0.10 (−0.42 to 0.62) Independent t=0.38 0.705
Overall symptom score at day 7, Mean (SD) 4.13 (1.78) 3.60 (1.62) 4.67 (1.78) MD=−1.07 (−1.49 to −0.65) Independent t=−4.98 <0.001*
Reduction in overall symptom score, Mean (SD) 7.73 (1.90) 8.31 (1.72) 7.14 (1.89) MD=1.17 (0.72–1.62) Independent t=5.12 <0.001*
Table 2 compares the improvement in individual clinical manifestations and overall symptom severity at day 7. A reduction of at least 50% in otalgia was achieved in 91.2% of patients receiving steroid–antibiotic drops compared with 79.2% receiving ichthammol–glycerin packing (RR=1.15, 95% CI: 1.04–1.27; p=0.007). The mean reduction in otalgia score was correspondingly greater in the ear-drop group (6.42±1.31 versus 5.61±1.47; MD=0.81, 95% CI: 0.46–1.16; p<0.001). Clinically meaningful reductions in canal oedema (87.2% versus 73.6%; p=0.007) and erythema (88.8% versus 74.4%; p=0.003) were also significantly more frequent with ear drops. The mean reductions in canal-oedema and erythema scores were greater by 0.42 points (95% CI: 0.25–0.59; p<0.001) and 0.36 points (95% CI: 0.20–0.52; p<0.001), respectively. Resolution or marked reduction of otorrhoea occurred in 82.4% of the ear-drop group and 68.8% of the packing group (RR=1.20, 95% CI: 1.05–1.37; p=0.012). Complete or near-complete symptom resolution was also significantly higher with ear drops (85.6% versus 71.2%; p=0.006). Baseline overall symptom scores were comparable between the groups (11.91±2.06 versus 11.81±2.11; p=0.705), confirming similar initial disease severity. By day 7, however, the mean symptom score was significantly lower in the ear-drop group (3.60±1.62 versus 4.67±1.78; p<0.001), while the mean reduction was significantly greater (8.31±1.72 versus 7.14±1.89; MD=1.17, 95% CI: 0.72–1.62; p<0.001).
Table 3: Time to resolution, additional treatment, adherence, acceptability and adverse events (N=250)
Outcome Total (N=250), n (%) or Mean (SD) Steroid–antibiotic drops (n=125) Ichthammol–glycerin pack (n=125) Effect estimate (95% CI) Test of significance P value
Time to clinical resolution, days, Mean (SD) 5.82 (1.68) 5.36 (1.48) 6.27 (1.76) MD=−0.91 days (−1.32 to −0.50) Independent t=−4.42 <0.001*
Clinical resolution within 5 days 159 (63.6) 91 (72.8) 68 (54.4) RD=18.4% (6.7%–30.1%); RR=1.34 (1.11–1.61) χ²=9.08 0.003*
Required additional topical treatment 29 (11.6) 8 (6.4) 21 (16.8) RD=−10.4% (−17.9% to −2.9%); RR=0.38 (0.18–0.83) χ²=6.55 0.010*
Required systemic antibiotics 17 (6.8) 6 (4.8) 11 (8.8) RD=−4.0% (−10.1% to 2.1%); RR=0.55 (0.21–1.43) χ²=1.58 0.209
Complete treatment adherence 217 (86.8) 116 (92.8) 101 (80.8) RD=12.0% (3.6%–20.4%); RR=1.15 (1.05–1.25) χ²=7.73 0.005*
Missed scheduled treatment/follow-up 21 (8.4) 7 (5.6) 14 (11.2) RD=−5.6% (−12.5% to 1.3%); RR=0.50 (0.21–1.19) χ²=2.57 0.109
Treatment rated acceptable or highly acceptable 205 (82.0) 113 (90.4) 92 (73.6) RD=16.8% (7.5%–26.1%); RR=1.23 (1.09–1.38) χ²=11.94 <0.001*
Patient-acceptability score‡, Mean (SD) 4.17 (0.76) 4.43 (0.62) 3.91 (0.79) MD=0.52 (0.34–0.70) Independent t=5.79 <0.001*
Local irritation or burning sensation 18 (7.2) 11 (8.8) 7 (5.6) RD=3.2% (−3.2% to 9.6%); RR=1.57 (0.63–3.94) χ²=0.96 0.327
Discomfort related to treatment/pack insertion 23 (9.2) 7 (5
Table 3 compares treatment duration, additional treatment requirements, adherence, acceptability and safety. The mean time to clinical resolution was significantly shorter with steroid–antibiotic drops than with ichthammol–glycerin packing (5.36±1.48 versus 6.27±1.76 days), representing an average reduction of 0.91 days (95% CI: −1.32 to −0.50; p<0.001). Clinical resolution within five days occurred in 72.8% of patients receiving ear drops compared with 54.4% receiving packing (RR=1.34, 95% CI: 1.11–1.61; p=0.003). Additional topical or alternative treatment was required significantly less frequently in the ear-drop group (6.4% versus 16.8%; RR=0.38, 95% CI: 0.18–0.83; p=0.010). The requirement for systemic antibiotics was also lower with ear drops, although the difference was not significant (4.8% versus 8.8%; p=0.209). Complete treatment adherence was significantly higher with ear drops (92.8% versus 80.8%; RR=1.15, 95% CI: 1.05–1.25; p=0.005), while missed treatment or follow-up was less frequent but not significantly different (5.6% versus 11.2%; p=0.109). Treatment was rated acceptable or highly acceptable by 90.4% of the ear-drop group compared with 73.6% of the packing group (RR=1.23, 95% CI: 1.09–1.38; p<0.001). The corresponding mean acceptability score was significantly higher with ear drops (4.43±0.62 versus 3.91±0.79; MD=0.52, 95% CI: 0.34–0.70; p<0.001). Overall adverse-event rates did not differ significantly between the groups (9.6% versus 15.2%; p=0.180). Local irritation, contact dermatitis and discontinuation due to adverse events were uncommon, and none showed a statistically significant between-group difference. Thus, steroid–antibiotic drops provided faster resolution, reduced the need for additional treatment and achieved better adherence and acceptability, with a safety profile comparable to ichthammol–glycerin packing.
DISCUSSION
The present randomized comparative study demonstrated that steroid–antibiotic ear drops provided better overall clinical effectiveness than ichthammol–glycerin ear packing in patients with acute otitis externa. By day 7, clinical resolution was significantly higher with steroid–antibiotic drops than with ichthammol–glycerin packing (89.6% versus 76.8%; p=0.006), while marked improvement within 72 hours was also more frequent (86.4% versus 71.2%; p=0.003). The observed day-7 resolution rate falls within the 65%–90% resolution range commonly reported after 7–10 days of topical treatment. Jackson et al. (2023)[12] similarly identified topical antimicrobial preparations as first-line therapy for uncomplicated acute otitis externa and noted that most patients improve within 24–72 hours.
The present findings agree with Ullah et al. (2024)[5], who compared ciprofloxacin–dexamethasone with 10% ichthammol–glycerin in patients with moderate-to-severe acute otitis externa. They reported a significantly lower day-3 pain score with ciprofloxacin–dexamethasone and treatment efficacy of 77.1%, compared with 40.0% for ichthammol–glycerin. The greater benefit from steroid–antibiotic treatment may result from its dual mechanism: the antibiotic controls the predominant bacterial pathogens, while the corticosteroid suppresses canal inflammation, oedema and erythema.
The present results were also broadly consistent with Hussain et al. (2018)[2], who found superior immediate pain relief with steroid–antibiotic ear drops compared with an ichthammol–glycerin wick. Similarly, Shrestha et al. (2019)[3] reported that both ichthammol–glycerin and steroid–antibiotic packs reduced pain, but the reduction was significantly greater with the steroid–antibiotic preparation. These observations support the present finding that at least 50% reduction in otalgia was more common with steroid–antibiotic drops (91.2%) than with packing (79.2%). The mean reduction in pain score was also 0.81 points greater in the ear-drop group (p<0.001).
However, the results differ partly from Monga et al. (2017)[1], who observed significant improvement in pain, tragal tenderness and canal oedema with both ichthammol–glycerin and steroid–antibiotic packs but found no significant difference in overall efficacy between them. That study involved only 60 patients and compared two packing preparations rather than freely administered steroid–antibiotic drops with an ichthammol–glycerin pack. Differences in sample size, drug-delivery method, disease severity and outcome timing may explain the discrepancy. The present sample of 250 patients offered greater statistical power to identify clinically relevant differences.
Khan et al. (2021)[4] evaluated 250 patients treated with either a ciprofloxacin–dexamethasone wick or an ichthammol–glycerin wick. They found greater reduction in tenderness with the steroid–antibiotic wick but similar improvement in discharge and no clear difference in overall efficacy. In contrast, the present study demonstrated significantly better resolution of otorrhoea with steroid–antibiotic drops (82.4% versus 68.8%; p=0.012). The difference may relate to the route of delivery: repeated ear-drop administration could provide broader and more sustained distribution throughout the canal after aural toilet, whereas the effectiveness of a wick depends on its position, absorptive characteristics and frequency of replacement.
The reduction in canal inflammation also favoured steroid–antibiotic drops. Clinically meaningful reductions in oedema and erythema occurred in 87.2% and 88.8% of the ear-drop group, compared with 73.6% and 74.4% of the packing group, respectively. The anti-inflammatory component of the drops probably contributed to this relatively rapid improvement. Khatri et al. (2021)[11] similarly stated that topical antibiotic preparations, particularly those combined with corticosteroids, are appropriate first-line options because they control infection while reducing canal inflammation. Ellis et al. (2024) also observed that some evidence suggests antibiotic preparations containing corticosteroids reduce pain and oedema more effectively than antibiotics alone, although comparative evidence remains heterogeneous.
Complete or near-complete symptom resolution was achieved in 85.6% of the steroid–antibiotic group compared with 71.2% of the ichthammol–glycerin group (p=0.006). Baseline overall symptom scores were comparable, indicating that this difference was unlikely to have resulted from unequal initial severity. At day 7, the mean score was significantly lower with ear drops, and the reduction was 1.17 points greater. Wiegand et al. (2019)[9] emphasized that successful treatment requires suppression of infection and inflammation, adequate pain control, removal of obstructing debris and restoration of the normal canal environment. The present intervention combined aural toilet with repeated delivery of an antimicrobial–anti-inflammatory preparation, which may explain the larger multidimensional symptom response.
Clinical resolution occurred approximately 0.91 days earlier with steroid–antibiotic drops, and resolution within five days was 18.4 percentage points more frequent. Sabarinath et al. (2024)[6] compared steroid–antibiotic ear packing with drops and found both approaches effective for relieving pain and oedema. Their results indicated that the method of topical delivery can influence early response. In the current study, patients receiving drops may have avoided the mechanical discomfort and repeated attendance associated with pack replacement, thereby improving treatment continuity.
The treatment-failure rate was substantially lower with steroid–antibiotic drops (7.2% versus 18.4%; p=0.008), and fewer patients required additional topical therapy (6.4% versus 16.8%; p=0.010). These results support the effectiveness of topical therapy in uncomplicated disease. Gurov et al. (2017)[7] reported favourable clinical and bacteriological responses with antimicrobial therapy for external bacterial otitis, although systemic treatment was evaluated in their study. Current evidence recommends reserving systemic antibiotics for infection extending outside the ear canal or for patients with important host factors. In the present study, systemic-antibiotic requirements were low in both groups and did not differ significantly (4.8% versus 8.8%; p=0.209). This is consistent with Mughal et al. (2021)[10], whose systematic review highlighted substantial and often unnecessary oral-antibiotic prescribing for acute otitis externa despite recommendations favouring topical treatment.
The better adherence observed with ear drops (92.8% versus 80.8%; p=0.005) may have contributed to their higher effectiveness. Treatment acceptability was also significantly higher with drops (90.4% versus 73.6%), and the mean acceptability score differed by 0.52 points. Ichthammol–glycerin packing requires insertion into an already painful and oedematous canal, may cause a blocked sensation and often requires removal or replacement during follow-up. Ear drops permit self-administration and may reduce clinic visits, although their success remains dependent on correct technique. Jackson et al. (2023)[12] and Khatri et al. (2021)[11] emphasized that patient education regarding administration is essential because poor instillation technique can limit canal penetration.
Despite these advantages, ichthammol–glycerin packing remained clinically effective in a substantial proportion of patients: 76.8% achieved resolution by day 7, 79.2% experienced marked improvement in otalgia and 73.6% showed meaningful improvement in canal oedema. Ichthammol has mild antiseptic and anti-inflammatory activity, while glycerin is hygroscopic and helps reduce tissue oedema. Thus, packing may remain useful when marked canal swelling prevents adequate penetration of drops, particularly when cost or antimicrobial stewardship is a major concern. Hajioff et al. (2015)[8] concluded that several topical antibacterial, antiseptic and corticosteroid-based treatments are effective, but the comparative evidence is limited and heterogeneous.
Di Traglia et al. (2023)[13], in a systematic review and meta-analysis of randomized trials, found that topical antibiotics, antiseptics and steroid monotherapies were all effective and that pooled cure rates did not establish clear superiority of one class. This appears less definitive than the present results but does not necessarily conflict with them because ichthammol–glycerin packing is a specific antiseptic–astringent delivery strategy, while the current steroid–antibiotic regimen provided combined antimicrobial and anti-inflammatory effects. Differences in disease severity, aural toilet, tympanic-membrane status, adherence, outcome definitions and treatment duration may materially influence comparative effectiveness.
Regarding safety, overall adverse-event rates were not significantly different between the groups. Local irritation or burning was uncommon, and the numerical difference was not statistically significant. Recurrence within 14 days was also similar, indicating that the faster initial improvement with steroid–antibiotic drops was not accompanied by a demonstrably different short-term recurrence risk. Nevertheless, steroid–antibiotic selection should consider tympanic-membrane integrity, possible aminoglycoside ototoxicity, contact sensitization and local antimicrobial-resistance patterns. Quinolone-containing drops are generally preferred when tympanic-membrane perforation is suspected because of their more favourable ototoxicity profile[11,12].
CONCLUSION
Steroid–antibiotic ear drops were more effective than ichthammol–glycerin ear packing in treating acute otitis externa. They achieved significantly higher day-7 clinical resolution, earlier improvement, greater reductions in otalgia, canal oedema, erythema, otorrhoea and overall symptom scores, and a lower treatment-failure rate. Ear drops also shortened the time to clinical resolution, reduced the requirement for additional topical treatment and provided better treatment adherence and patient acceptability. Both interventions had comparable short-term recurrence and safety profiles, with no statistically significant difference in overall adverse events. Although ichthammol–glycerin packing remained an effective and economical option, particularly for markedly oedematous ear canals, steroid–antibiotic ear drops may be preferred as the initial treatment for uncomplicated acute otitis externa when the tympanic membrane is intact.
LIMITATIONS OF STUDY
This study had several limitations. First, it was conducted at a single centre, which may restrict the generalizability of the findings to other healthcare settings and patient populations. Second, blinding of patients and treating clinicians was not feasible because the interventions differed visibly in their mode of administration, creating a possibility of performance and assessment bias. Third, the follow-up period was limited to 14 days; therefore, late recurrence and delayed adverse effects could not be evaluated. Fourth, microbiological cultures were not routinely performed, preventing assessment of pathogen-specific treatment responses and antimicrobial-resistance patterns. Fifth, adherence to ear-drop administration was partly based on patient reporting, which may have introduced recall or social-desirability bias. Differences in administration technique and pack placement could also have influenced treatment effectiveness. Patient acceptability was measured using a subjective rating scale and may have been affected by awareness of treatment allocation. Analgesic consumption and other supportive measures might have influenced pain-related outcomes despite attempts to standardize management. Finally, the study excluded complicated disease, tympanic-membrane perforation, poorly controlled diabetes and immunocompromised patients; consequently, the findings should not be directly extrapolated to these high-risk groups.
REFERENCES
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2. Hussain B, Rehman A, Ahmad J. Immediate pain relief in otitis externa with ichthammol glycerine wick versus steroid antibiotic ear drops. Pak J Med Health Sci. 2018;12(3):1008-10.
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