Acetic Acid Ear Drops Versus 0.3 % Ciprofloxacin for Chronic Suppurative Otitis Media.

Background and rationale:

Chronic Suppurative Otitis Media (CSOM) is a chronic inflammatory condition of the middle ear and mastoid cavity characterized by persistent or recurrent ear discharge through a perforated tympanic membrane. It is more common in developing countries and can lead to complications including tympanosclerosis, cholesteatoma, and ossicular necrosis if inadequately treated.

Current treatment:

Tubotympanic CSOM is primarily managed conservatively with aural toilet and topical antimicrobial therapy. Topical ciprofloxacin is commonly used because of its effectiveness against CSOM pathogens and favorable safety profile. However, increasing antibiotic resistance has encouraged the evaluation of alternative topical treatment options.

Rationale for acetic acid:

Previous studies have reported beneficial outcomes with topical acetic acid in patients with CSOM. Acetic acid has also been reported as a potentially cost-effective and readily available alternative treatment. The present study will evaluate whether 2% acetic acid ear drops are effective in achieving a dry ear compared with conventional topical ciprofloxacin therapy.

Study objective:

The objective of this study is to compare the effectiveness of 2% acetic acid ear drops versus 0.3% ciprofloxacin ear drops in the medical management of chronic suppurative otitis media. Effectiveness will primarily be assessed by achievement of a dry ear after one month of treatment, defined as absence of moisture or discharge on clinical examination with an otological symptom score of ≤2.

Study design and setting:

This is a parallel-group randomized controlled trial with 1:1 allocation. The study will be conducted in the Department of Otorhinolaryngology, Dr. Ruth K.M. Pfau Civil Hospital, Karachi. The study will be conducted over a period of six months following approval from the College of Physicians and Surgeons Pakistan (CPSP) and the Institutional Review Board (IRB) of Dow University of Health Sciences.

Study population:

The study will include 146 participants aged 18-70 years with tubotympanic-type CSOM who fulfil the predefined inclusion and exclusion criteria. The calculated sample size was 124 participants (62 per group), with an additional 15% allowance for anticipated dropouts and loss to follow-up, resulting in a final recruitment target of 146 participants (73 per group).

Randomization and allocation:

Eligible participants who provide written informed consent will be randomly allocated to one of two treatment groups using a computer-generated randomization sequence. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes, which will be opened after baseline assessment. The study will use a single-blinded design in which the outcome assessor will remain unaware of the treatment allocation.

Intervention group:

Participants allocated to the acetic acid group will receive 2% acetic acid ear drops, with 3 drops administered into the affected ear three times daily for one month.

Comparator group:

Participants allocated to the comparator group will receive 0.3% ciprofloxacin otic drops, with 3 drops administered into the affected ear three times daily for one month.

Follow-up and assessment:

Participants will undergo clinical assessment at baseline and follow-up visits on the 7th, 14th, and 30th days. Otoscopic examination and otological symptom scoring will be performed to assess treatment response. Treatment compliance will be assessed through medication review, treatment diaries, and participant reporting.

Primary outcome:

The primary outcome is achievement of a dry ear after one month of treatment, defined as absence of moisture or discharge on clinical examination with an otological symptom score of ≤2.

Secondary outcomes:

Secondary outcomes include reduction in ear discharge, improvement in otological symptoms such as otorrhea, ear discomfort and itching, treatment compliance and tolerability, recurrence or persistence of ear discharge, and adverse effects associated with treatment.

Data analysis:

Data will be entered and analyzed using SPSS version 26. Descriptive statistics will be reported with 95% confidence intervals. Continuous variables will be assessed for normality using the Shapiro-Wilk test. The Chi-square test will be used to compare treatment efficacy between the two groups, while Fisher's exact test will be used where appropriate. A p-value ≤0.05 will be considered statistically significant.

Expected contribution:

The study aims to determine whether 2% acetic acid ear drops can provide an effective, safe, and potentially cost-efficient alternative to conventional topical ciprofloxacin therapy in the medical management of CSOM. The findings may contribute to evidence-based treatment of CSOM and help identify an accessible treatment option for patients.