Role of Individualization in Homoeopathic management of Acne Vulgaris in Adult age group: An experimental non controlled study

INTRODUCTION:

Acne Vulgaris is a common cutaneous inflammatory disorder of the pilosebaceous unit, which runs a chronic course. The condition commonly manifests with papules, pustules, or nodules primarily on the face, although it can also affect the upper arms, trunk, and back. Acne leads to significant morbidity that is associated with residual scarring and psychological disturbances such as poor self-image, depression, and anxiety, which leads to a negative impact on quality of life. The causes of the affections are well-known to be local irritants, cosmetics, want of cleanliness, exposure to heat, cold winds, some varieties of soaps, too rich or insufficient food, onanism or sexual excesses, liver, stomach, uterine derangements. Scrofulous subjects are very prone to this form of skin disease. Homoeopathy recognizes the individuality of each patient. Every person reacts to any external agent according to his/her individuality and so a person’s individuality is reflected in his/her disease too. The goal of a patient’s complete examination is to identify not only the common symptoms of a disease or case that may be used to classify it pathologically and diagnostically, but also characteristic symptoms that set the case apart from others in the same general class and help determine the patient’s individuality. Homoeopathy does not treat the disease it treats the patient. In other words, it individualizes. Homoeopathic medicines selected on the basis of individualization can treat cases of Acne Vulgaris effectively and improve the quality of life of the patient. Hence this study is undertaken to understand the role of individualization in Homoeopathic Management of Acne vulgaris. Epidemiology: The prevalence of Acne has risen over the years. Currently it affects 80% of the population in the age group of 11 to 30 years in the developed world is probably equally common in urban India. It precedes puberty by a year or two, peaks between 14-16 years in females and 17-19 years in males. Acne is more common in males (55%) than females (45%). Females have more severe acne, often with added stigmata of cutaneous hyperandrogenism, namely, seborrhea, hirsutism, and alopecia. Acne Vulgaris (AV) can persist into adulthood, with a 50.9% prevalence rate of acne in women ages 20 to 29 years versus 26.3% in women ages 40 to 49 years. Acne Vulgaris is a multifactorial disorder which requires an integrated therapeutic approach. It may occur due to endocrinal imbalance that need to be addressed. Conventional line of treatment requires continuous use of medications, without which symptoms would reappear; also, they are very expensive and they again have their own side effects. Homoeopathy individualizes each patient and treats it from the root cause. Acne Vulgaris can be considered as one of the common diagnosis brought forward by the patients to a homoeopath. The problem should never be tackled with superficial, local acting remedies. Instead, deep acting constitutional remedies should be bombarded judiciously as soon as the complete totality is available. Homoeopathy gives more importance to the diseased individual then the disease itself. 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. The concept of individualization takes into consideration the total response of the organism to the unfavourable 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. This study bridges the gap by assessing the impact Acne Vulgaris on Quality of Life in adults as well as the role of Individualization in Homoeopathic Management of Acne Vulgaris. Thus, it will provide the clinical evidence for its effectiveness. It will show the role of Individualization in the management of Acne Vulgaris in adult age group of 18-40 yrs.

AIMS AND OBJECTIVES:

Primary Objective: -To assess the role of Individualization in Homoeopathic management of Acne Vulgaris in Adult age group.

Other objective 1: - To assess pre and post treatment scores of pre-validated GAGS [Global Acne Grading System] scale in Homoeopathic Management of Acne Vulgaris in Adult age group.

Other objective 2: - To assess pre and post treatment scores of Acne Vulgaris in Adult age group on quality of life using pre-validated Acne-QoL [Acne- Specific Quality of Life] questionnaire.

Other objective 3: - To study characteristic symptoms in cases of Acne Vulgaris in Adult age group.

MATERIALS AND METHODOLOGY:

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

2 Setting (location of study): - Patients will be enrolled from Outpatient department of the institute.

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

4 Methods of selection of study subjects (eligibility criteria): -

(a) Inclusion Criteria: -

1. Clinically diagnosed patients of Acne vulgaris of Grade I, II, or III.

2. Literate patients.

3. Patients aged 18-40 years.

4. Patients of all genders.

(b) Exclusion Criteria: -

1. Patients presently on any other treatment for their Acne Vulgaris.

2. Suspected immuno-compromised patients.

3. Pregnant and lactating women.

(c) Subject withdrawal Criteria: -

1. Patients with irregular follow up.

2. Patients who discontinue treatment.

3. Any exclusion criteria developing during the study.

4. Any other medication taken during the course of treatment, for Acne Vulgaris.

5 Method of selection of comparison or control group: - Not Applicable

6 Matching criteria: Not Applicable

7Specification of instruments and related measurements: -

1. Case taking proforma

2. Outcome assessment tool:

(A) Pre-validated GLOBAL ACNE GRADING SYSTEM (GAGS)

(B) Pre-validated ACNE SPECIFIC QUALITY OF LIFE QUESTIONNAIRE (ACNE- QOL)

Outcome Assessment Criteria:

a. Outcome shall be assessed on pre and post GAGS Scores.

The GAGS score of each patient pre-treatment and post treatment were assessed by the formula.

[Score at baseline – Score at the end] / Score at baseline   X 100

Improved=More than and equal to 25%

Not Improved= less than 25%

b. Outcome shall be assessed as per statistical analysis of pre and post Acne-QoL Scores for each domain.

c. Clinical Presentation: Generals and Particulars of the patient.

Sample Size: 34 Subjects/Patients will be selected.

Sampling technique: Non probability purposive sampling based on inclusion and exclusion criteria.

Methods for data collection relevant to objectives: -

1. Non probability purposive sampling based on inclusion and exclusion criteria.

2. Clinically diagnosed patients of Acne Vulgaris of Grade I, II or III will be recorded from Outpatient Department of Institute.

3. Detailed case taking will be done as per the case taking proforma.

4. Depending upon the individualization the totality will be erected and the appropriate Similimum will be administered.

Study instrument or data collection tools: -

a. Complete homoeopathic case taking proforma to form totality with special emphasis on individual case.

b. Appropriate reference books like Homoeopathic books, Dermatology books, Medicine books, different Homoeopathic Journals, research papers & websites will be considered.

c. Appropriate Homoeopathic Software will be used for Repertorization of case.

d. Written Informed Consent

.

Data management and analysis procedure (coding and use of computers): -

a. Framing of totality of symptoms: Totality will be framed as per principles of homoeopathy.

b. Selection of remedy: Remedy selection will be based on individualization.

c. Posology: Potency and repetition will be done as per the requirement of each case.

d. 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.

Duration:

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

ii. Duration of each case: Each case will be studied for a period of 6 months or till remission occurs, whichever is earlier.

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

iv. GAGS and Acne-QoL scale will be applied at baseline, 3rd month and 6th month, or till remission occurs.

Plan for Statistical Analysis: -

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.

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.

Intra group comparisons for a numerical continuous data following a normal distribution will be done using paired t test (for 2 observations) or Wilcoxon signed rank test (for 2 observations) will be used.

Frequency (n) & percentage (%) of various categories in each time interval will be compared using Chi square test Keeping alpha (Type 1 error) at 5% and Beta (Type 2 error) at 20%, power at 80%, p<0.05 will be considered statistically significant.