Effectiveness of Individualization in Homoeopathic Management of Migraine Among Adults an Experimental Non Controlled Study

Introduction:

Migraine is classified in 2025 ICD 11-MMS as diagnostic code 8A80.

Migraine is a complex neurological disorder that manifest with recurrent headache associated with nausea, vomiting, photophobia or Phonophobia. There may or may not be a neurological accompaniment in the form of aura. It is more common in women than in men (2:1 to 3:1) and a family history is present in more than 60% of cases.

Homoeopathy is based on the principle of Individualization, which means no two persons can be same and hence medicine given to every other individual is different though the disease is same. ‘Individualization’ provides personalized approach to treatment with an aim to address the underlying causes of Migraine, rather then just for symptomatic treatment.

The concept of individualization takes into consideration the total response of the organism to the unfavorable environment. This total response is seen through signs and symptoms on three planes i.e. emotional, intellectual (spiritual) and physical where the life force manifests it. Homoeopathy gives cures to the patient if exact similimum is prescribed. Hence this study is undertaken to understand the effectiveness of individualization in cases of Migraine.

Epidemiology: Attacks often begin in late childhood, adolescence and early twenties

Migraine is highly prevalent affecting approximately 12% of the population, up to 17% in women and 6% in men

Its prevalence increases during puberty and peaks between ages 35 and 39

Several studies suggest that Migraine prevalence is steadily increasing

Aims And Objectives:

Primary Objective:

1. To assess the Effectiveness of Individualization in Homoeopathic Management of Migraine.

Other Objective:

1. To compare the pre-treatment and post-treatment scores in cases of Migraine on pre-validated “Migraine Disability Assessment Score” (MIDAS) Scale.

2. To analyse and evaluate the Characteristic Symptoms.

3. To study the Clinical Presentation of Migraine.

Materials And Methodology

1. Type of study design: - A Non-Controlled Experimental Study.

2. Study setting: - Patients of Migraine will be enrolled from Outpatient Department of the Institute.

3. Duration of Study: 18 Months

Study population: - Clinically pre-diagnosed patients of Migraine.

4. Methods of selection of study subjects: -

a. Inclusion Criteria: -

i. Clinically pre diagnosed patients of Migraine with Aura and Migraine without Aura.

ii. Patients of Migraine of adult age group from 20- 50 years

iii. Patients of Migraine of all genders.

b. Exclusion Criteria: -

i. Patients of Chronic Migraine, Basilar Migraine, Vestibular Migraine.

ii. Patients of Migraine with complications of Migraine such as Status Migrainosus, Migrainous Infarction, Migralepsy.

iii. Patients of Migraine with neurological symptoms such as Vertigo, Paresthesia, Dysarthria.

iv. Patients of Migraine taking medication within one month of start of treatment.

v. Suspected Immunocompromised patients.

vi. Pregnant and Lactating females.

Subject withdrawal Criteria: -

1. Patients with irregular follow ups.

2. Patients who withdraw their Consent from the study.

3. Patients developing any of the exclusion criteria during the study.

4. Patients taking any other medication during the treatment.

5. Method of Selection of Comparison or Control Group: Not Applicable.

6. Matching Criteria: Not Applicable.

7. Specification of Instruments & Related Measurements:

8. Standardized Homoeopathic Case Record.

9. Pre- validated Migraine Disability Assessment Test:

10. MIDAS scale will be operated by a Researcher.

11. Operator and Assessor of MIDAS scale are different.

Outcome assessment criteria: -

Clinical outcome:

i. Intensity and Frequency of the Migraine headache.

ii. Improvement of the patient will be assessed as a whole on the basis of Physical general symptoms and Mental state

Statistical outcome:

i. As per comparison of the pre-treatment and post-treatment scores in cases of Migraine on “Migraine Disability Assessment Score” (MIDAS) Scale.

ii. Assessment outcome :3 month Post Treatment Score as:

a) Improved: score 0-5 : little or no disability

b) Not Improved: score > 5 : mild disability,

moderate disability,

severe disability.

1. SAMPLE SIZE: 36 patients will be selected.

2) SAMPLING TECHNIQUE: Non-Probability Purposive Sampling.

3) Methods of data collection relevant to objective:

1. Clinically Pre-Diagnosed patients of Migraine will be enrolled from the Outpatient Department of the Institute.
2. Non probability Purposive Sampling based on Inclusion and Exclusion criteria will be done.
3. Detailed Case Taking will be done as per the Organon Guidelines.
4. Follow up criteria:

             Chief complaints i.e. Particular symptoms

Physical Generals (if any),

Mental Generals (if any).

4) Study Instrument/ Data Collection Tools:-

1. Standardized Homoeopathic Case Record.

2. MIDAS scale will be used to assess the pre-treatment and post treatment scores.

3. Standard Literature of Homoeopathic Philosophy, Materia Medica, Medicine and Homoeopathic Journals, Research Articles and Websites will be used.

4. Written Informed Consent.

5) Data management and analysis Procedure:

1. Characteristic symptoms in cases of Migraine will be analyzed.

2. Case evaluation will be done according to Kent’s Philosophy.

3. Selection of remedy: Remedy selection will be based on Totality of symptoms according to Kent’s Philosophy.

4. The Posology: Potency and repetition will be done as per the Susceptibility in each case.

Duration:

1. Duration of study: Duration of study- 18 months.

2. Duration of each case: Each case will be studied for 9 months.

3. Duration of Follow up: Each case will be followed up at the interval of 15 days or earlier, if required.

4. Statistical outcome assessment will be done at the baseline, 3 months, 6 months, 9 months i.e. 3 months after conclusion of the treatment.

6) Plan for Statistical analysis :-

Statistical techniques:-

1. Data collected will be compiled on to a 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. Normality of numerical data will be checked using Shapiro – Wilk test or Kolmogorov-Smirnov test. Depending on the normality of data, statistical tests will be determined.

3. Intra group comparisons for a 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

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