SUMMARY

TOPIC – EFFECTIVENESS OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES IN THE MANAGEMENT OF CHRONIC SUPPURATIVE OTITIS MEDIA (CSOM) IN CHILDREN 0-5 AN EXPERIMENTAL NON-CONTROLLED STUDY.

INTRODUCTION

This study investigates the effectiveness of individualized homoeopathic medicines in treating Chronic Suppurative Otitis Media (CSOM) in children aged 0-5 years, a condition characterized by persistent ear discharge and hearing loss. While conventional treatments involve antibiotics and surgery, homoeopathy offers a holistic approach addressing underlying susceptibilities and immune function.

The research gap highlights the scarcity of large-scale, controlled studies and mechanistic understanding of homoeopathy’s role in CSOM management. The study aims to evaluate symptom improvement and quality of life using the Chronic Ear Survey (CES) as an objective tool.

A non-controlled experimental design will be employed at an institutional out patient department over 18 months, with 33 pediatric patients selected through purposive sampling. Each case will undergo detailed homoeopathic case taking, individualized remedy selection and follow up over six months. Remedies such as Hepar Sulph, Silicea, Merc sol, Pulsatilla, Calcarea Carb will be used based on individual symptomatology.

Clinical outcomes will be analyzed statistically using SPSS software, applying paired t-tests and Wilcoxon signed-rank tests to compare pre and post-treatment CES scores.

Ethical clearance has been obtained, and informed consent will be taken from parents or guardians. The study expects to demonstrate that individualized homoeopathic treatment can reduce symptoms, symptoms, improve hearing, and prevent recurrence in pediatric CSOM, providing a safe, cost- effective and holistic alternative to conventional therapy.

EPIDEMIOLOGY

 1.Chronic suppurative otitis media in children of India was 3.78% (95% CI 2.72 – 4.84). Few communities based observational studies done in Indian context including children (0-18 years) have shown the prevalence of otic ailments like otitis media in the range of 4.5% to 25.78%.

 2. CSOM is frequent, especially prevalent in underprivileged communities and developing nations. Its predominance varies between 1 and 46% according to the demographic region and population. Although CSOM affects adults too, it primarily strikes children, mainly from 2 to 5 years old.

 3. Globally, the illness impacts many individuals, ranging from 65 to 330 million. It has been approximated that there is an annual incidence of 31 million new cases of CSOM, out of which approximately 1/5th account for children below 5 years old.

4. India has the highest prevalence rate i.e. >4% of CSOM and countries like Australia, Saudi Arabia, etc. have the lowest prevalence rate of CSOM i.e. <1% according to the world health organization.

OBJECTIVES

Primary Objective - To study the effectiveness of Individualized Homoeopathic Medicines in the management of Chronic Suppurative Otitis Media in children- of 0 – 5 years of age. Other Objectives –

 1. To assess the patient pre-treatment & post-treatment for Chronic Suppurative Otitis Media on the basis of Pre validated Scale - Chronic ear survey.

2. To study the symptomatology of various remedies indicated in Chronic Suppurative Otitis Media from different sources.

3. To understand miasmatic aspect in cases of Chronic Suppurative Otitis Media.

                                             METHODS OF SELECTION OF STUDY SUBJECTS

INCLUSION CRITERIA

1. Clinically diagnosed cases of Chronic Suppurative Otitis Media.

2. History of symptoms more than 2 weeks.

3. Patients of 0 to 5 years of age.

4. Patients of all genders.

5. Patients who are willing to give written consent will be considered.

EXCLUSION CRITERIA

1.Patient with irreversible pathological changes like Mastoid abscess, Tympanosclerosis, Cholesteatoma, cases of tympanic membrane perforation, etc.

2.Patient having Congenital Anomalies which can lead to Chronic Suppurative Otitis Media.

3.Patient who are having immunocompromised illness.

4.Patients who are taking any other medication for any other ailments or for Chronic Suppurative Otitis Media in the last 3 months.

SUBJECT WITHDRAWAL CRITERIA:

1.Patient/Parent/Guardian who fail to give a regular follow-up.

2.Patient/Parent/Guardian who wish to discontinue homoeopathic treatment.

3.Patient who develops complications during the course of treatment like hearing loss, tympanosclerosis, etc. with referral to specialist for further evaluation.

4.Patients who require surgical intervention for tympanic perforation.

Operational definition:

Chronic Suppurative Otitis Media (CSOM) is operationally defined as a persistent infection of the middle ear characterized by recurrent or persistent ear discharge (otorrhea) through a perforated tympanic membrane for at least

two - six weeks or more (WHO, 2004). It is commonly associated with inflammation,

hearing loss, and can lead to complications if untreated.

Duration of the Study 18 months

Type of study design A Non-Controlled Experimental Study.

Specification of Instruments & Related Measurements

Standardized homeopathic case taking proforma.

Outcome assessment tool - Pre validated Chronic Ear Survey scale

Sampling technique Non probability purposive sampling will be based on Inclusion and Exclusion criteria.

Methods of data collection relevant to the objective

1.Informed consent will be taken from Patient/Parent/Guardian before taking each case. Verbal consent will be taken from the child before taking each case.

2.Non probability purposive sampling technique will be applied.

3.Clinically diagnosed cases of Chronic Suppurative Otitis Media will be recorded from the outpatient department of the Institute considering the inclusion and exclusion criteria.

4.Detailed Homoeopathic case taking will be done as per the proforma for collecting and analysing data prepared to arrive at the appropriate Individualized Homoeopathic Medicine.

5.Depending upon the clinical picture of the patient and acute totality erected, the patient will be administered the appropriate Individualized Homoeopathic Medicine

6. Posology will be selected as per the requirement of the case.

 Study instrument/data collection tools

1. Complete Homoeopathic Case Taking Proforma to form acute totality.

2. Clinical score system for assessing the severity of illness will be used to assess before and after the treatment for Chronic Suppurative Otitis Media.

3. Appropriate reference books like Pediatrics textbooks, Homoeopathic Materia Medica books, Homoeopathic Repertory books, Medicine books, Surgery books, Pathology books, different Homoeopathic journals, research articles will be considered.

4. Appropriate software will be used for repertorization of case.

5. Detailed Homoeopathic case taking will be done as per the proforma for collecting and analyzing data prepared to arrive at the appropriate Individualized Homoeopathic Medicine.

6. Depending upon the clinical picture of the patient and acute totality erected, the patient will be administered the appropriate Individualized Homoeopathic Medicine.

7.Posology will be selected as per the requirement of the case.

 Data management and analysis procedure

1. Framing of totality of symptoms will be done as per principles of homoeopathy.

2. Selection of remedy: Individualized homoeopathic medicine will be given as per totality of symptoms and prescribed to the patient.

3. Posology: Appropriate potency for each case will be selected based on the susceptibility of each patient. Potency will be modified and when required.

4. Duration of Study:

• Duration of Study – 18 months

• Duration of each case – Each case will be studied for 06 months.

• Duration of follow up – Each case will be followed up after 15 days or as and when required.

• Clinical Outcome assessment will be done at baseline 1 month, 3 months and 6 months and at termination of treatment.

 Plan for Statistical Analysis

Statistical techniques

1 Data collected will be compiled into MS Office Excel worksheet & will be subjected to statistical analysis using an appropriate package like SPSS software. Descriptive statistics like frequency (n) & percentage (%) of categorical data, mean & Standard deviation of numerical data in each time interval will be depicted.

2 The normality of numerical data will be checked using the Shapiro–Wilk test or Kolmogorov-Smirnov test. Depending on the normality of the data, statistical tests will be determined.

3 Intra-group comparisons for numerical continuous data following a normal distribution will be done using paired t test (for 2 observations) else a non-parametric substitute like Wilcoxon signed rank test (for 2 observations) will be used.

4 Frequency (n) & percentage (%) of various categories in each time interval will be compared using chi square test.

Keeping alpha error at 5% and Beta error at 20%, power at 80%, p<0.05 will be considered statistically significant.

ETHICAL CLEARANCE

Ethical clearance was given by Institutional Ethical Committee.

Background - 

Chronic Suppurative Otitis Media (CSOM) is a persistent inflammation of the middle ear and mastoid cavity characterized by recurrent ear discharge (otorrhoea) through a perforated tympanic membrane. It is one of the most common chronic infections, especially in developing countries, due to poor hygiene, recurrent upper respiratory tract infections, and inadequate treatment of acute otitis media.

If left untreated, CSOM can lead to complications such as hearing loss, mastoiditis, or intracranial infections, affecting quality of life and communication skills, particularly in children.

In conventional medicine, management is often limited to antibiotics and surgery, which may not always provide long-term relief. Homoeopathy, based on the principle of individualization, aims to treat the underlying susceptibility and enhance the body’s natural healing mechanism, thus preventing recurrence and complications.

Purpose 

To evaluate the efficacy of homoeopathic remedies in the management of Chronic Suppurative Otitis Media.

To understand the miasmatic background and constitutional factors associated with CSOM.

To assess the changes in symptomatology and hearing improvement after individualized homoeopathic treatment.

To explore the role of homoeopathic management in reducing recurrence and preventing complications.