A Prospective Experimental Study To Understand Causative Factor In Management Of Urticaria By Individualized Homoeopathic Medicine

RESEARCH QUESTION:

Whether the causative factors of urticaria can be understand and will get beneficial results after prescribing suitable homoeopathic medicine?

HYPOTHESIS:

Null Hypothesis (H0): There will be no significant improvement in cases of urticaria after prescribing suitable homoeopathic medicines.

Alternative Hypothesis (H1): There will be improvement in cases of urticaria after prescribing suitable homoeopathic medicines.

NEED FOR THE STUDY:

In the landscape of urticaria research, this study stands out by adopting a holistic approach within the realm of homeopathy, particularly emphasizing mental causes often overlooked in previous research. While conventional studies predominantly focus on physical causes and anti-allergic drugs, this research explores a more comprehensive range of factors, including causation, disposition, expression, the miasmatic manifestation, and the type of urticaria (acute or chronic). Significantly, it delves into the individualized treatment approach of homeopathy, acknowledging diverse patient characteristics.

The worldwide incidence is 0.1%–3% of the population with women affected twice more likely than men. It is estimated that about 1 in 5 people will have urticaria once in their lifetime and this seems to be the case across all age groups. Up to 1% of the population suffers from chronic urticaria (CU) and all age groups appear to be affected, although the peak incidence is between 20 and 40 years of age. In most cases, the disease lasts between 1 or 5 years, but the duration can be longer for those with severe urticaria, those with concurrent angioedema, those with the physical component, and those with a positive autologous serum skin test.[1]

In India, the incidence of the non-infectious disease urticaria has increased over the past three decades. According to the 2017 Global Burden of Disease study, there were 1.02 million cases (95% uncertainty interval, 0.06-1.44), reflecting a percentage increase of 48.9% and 45.7% respectively.[2]

In addition, the study recognizes the potential role of psychological factors in each case, understanding that underlying stressors or emotional triggers may contribute to the manifestation of urticaria. By considering the number of homeopathic medicines that can be prescribed and their impact on urticaria, the study aims to contribute valuable insights into the nuanced management of the condition. The prospective experimental design, coupled with the utilization of the Urticaria Activity Score (UAS) tool for assessment, enhances the robustness of the research, promising a more complete understanding of the effectiveness of individualized homeopathic interventions for urticaria and the intricate interplay of psychological factors in its manifestation.

Homoeopathy believes in individualization. every individual will present with different symptoms during disease state. Homoeopathy believes that for every chronic disease the cause is fundamental miasms[3]. It treats the root cause of disease and constitution as a whole and not just local disease. Urticaria is an external expression of internal disturbance & homoeopathy believes in treating that internal disturbance with internal malady.

Every individual suffering from urticaria will throw different symptoms during that state, as well as every individual will be having different constitution, will have different cause either at mental or at physical plane for developingurticaria, so homoeopathic medicine will be different for each individual.

Acute urticaria is common and affects approximately 20% of the population. Urticaria lasting ≥6 weeks without an obvious trigger is defined as chronic spontaneous urticaria (CSU). The prevalence of CSU is reported to be 0.5–1% in the general population. Most patients with CSU are aged 20–40[4]

v RESEARCH QUESTION:

Whether the causative factors of urticaria can be understand and will get beneficial results after prescribing suitable homoeopathic medicine?

v HYPOTHESIS:

Null Hypothesis (H0): There will be no significant improvement in cases of urticaria after prescribing suitable homoeopathic medicines.

Alternative Hypothesis (H1): There will be improvement in cases of urticaria after prescribing suitable homoeopathic medicines.

 Many factors may be responsible in the etiology of the disease. Often, encountered factors include:[8]

1. Psychogenic factors: Reasons such as anger, stress, sadness, and depression may aggravate the preexisting urticaria and also induce urticaria.
2. Medications: Any drug may cause urticaria. It may manifest from 1–2 h to 15 days after oral intake. Urticaria related to the drugs given intravenously will occur immediately. While the drugs generally cause acute urticaria, they may cause emergence or exacerbation of CSU.
3. Foods: Foods often encountered as causes of urticaria include nuts, eggs, fish, seafood, chocolate, meat, cow’s milk, fruits (citrus fruits, grapes, plums, pineapples, bananas, apples, and strawberries), vegetables (tomatoes, garlic, onions, peas, beans, and carrots), mushrooms, fermented foods and spices.
4. Physical factors: Urticaria may develop due to external factors such as pressure, hot, cold, and dermographism. Urticaria secondary to pressure generally manifests an average of 3–4 h after exposure to pressure. Therefore, they are termed as delayed pressure urticaria.
5. Hereditary: Hereditary urticaria is seen in types of urticaria as angioedema and familial cold urticaria.
6. Idiopathic urticaria without any known cause may be also seen.
7. Respiratory allergens: Pollen, mold spores, mites, animal dandruff, and hairs may cause urticaria when taken through the respiratory tract. Smoking is also an important factor since it contains many chemicals and can worsen the urticaria, hives should be advised to stop smoking. Urticaria caused by respiratory allergens usually occurs immediately after contact.
8. Contact urticaria: Latex, cosmetics, and chemicals may cause urticaria by contact.
9. Insect bites: They should be questioned, especially in children.

v INVESTIGATIONS:[5]

• cbc – for differential blood count analysis.
• Serum IgE and absolute eosinophil count.
• Autologous serum skin test for diagnosing auto reactive urticaria
• Anti-nuclear antibody (ANA) to rule out systemic lupus erythematous and other autoimmune pathology.
• Thyroid peroxidase antibody to rule out autoimmune thyroid disorder.

v MANAGEMENT:[5]

·            Antihistamine

·            Corticosteroids/ cyclosporine

·            Epinephrine, intubation/tracheostomy in severe laryngeal odema in angioedema.

v differntial DIAGNOSIS [10]

•                                       Atopic Dermatitis

•                                       Urticarial Vasculitis

•                                       Drug Eruption

•                                       Erythema Multiforme

•                                       IgA Vasculitis (Henoch-Schonlein Purpura)

•                                       Mastocytosis

•                                       Pityriasis Rosea

•                                       Scabies

v homeopathic view

Homoeopathy, the distinctive blend of art and science in medicine, proves to be a blessing to humanity as it treats the ill based on the principle of the law of similar.

According to classification of disease given by Dr Hahnemann urticaria falls under dynamic. chronic disease, with few symptoms, local disease of non-surgical origin.

Homoeopathy focuses on treating man as a whole and not just symptoms of urticaria. It believes in individualization, and law of similia. It does not belief in treating it superficially but treats disease from its root. It offers effective treatment in acute, recurrent and chronic urticaria. As Urticaria is an expression of internal disturbance and hypersensitive reaction reflected on skin. In Aphorism 87-190 Dr. Hahnemann says "local disease without any external cause is due to some internal disturbance and requires internal malady for their cure." Medicines are selected on basis of symptom similarity in each suffering individual. It when taken reduces hypersensitivity to allergen and reduces dependency on antihistamine.

In Aphorism 191 he states that the medicine administered is homoeopathic only when the internal remedy brings restoration to health of entire body, along with disappearance of external affection.

In Aphorism 5 it is mentioned " that while treating chronic disease fundamental cause is to be removed, which is mainly due to chronic miasms, and to ascertain these, physical constitution of patient. his moral and intellectual character, his occupation, mode of living, social and domestic relations, his age and sexual function etc... are to be taken into consideration.

In Aphorism 7 it is mentioned that in cases where there is no obvious cause of illness to remove, only the symptoms are observable. Therefore, it is through these symptoms, considering the possibility of underlying miasms and relevant circumstances, that the disease indicates the appropriate remedy for its relief. The totality of these symptoms, reflecting the internal essence of the disease or the affection of the vital force, becomes the primary or sole means by which the disease communicates its remedy requirements.

In Aphorism 187 it is mentioned that those affections, ailment, appearing on external parts, which do not arise from external injury, are all produced by some internal cause and so treating them surgically with topical application is most absurd.

In Aphorism 61 it is mentioned that "safe true cures are only obtained through similar homoeopathic drugs, by producing stronger similar disease by giving most minute dose." Medicine is selected on the basis of these guidelines.[3]

Dr. Hahnemann has recognized 3 forms of miasms in his book “The Chronic Diseases

Their Peculiar Nature and Their Homoeopathic Cure” as below [9]

1.PSORA: Leading to irritability and inflammation

2.SYCOSIS: Leading to contraction, relaxation or induration

3.SYPHILIS: Leading to destruction

v homoeopathic materia medica view

There are group of remedies for urticaria given in repertory and materia medica, but only one which is capable of producing similar state in patient, one that covers similar miasms, and constitution, present in patient, is selected accordingly.

Ultimately individualized medicine is selected on basis of totality, which is framed on the basis of guidelines given in aphorism 5.

v homoeopathic repertory view

The group of characteristic symptoms can be repertorized and a group of remedies can be obtained which can be ultimately referred to homoeopathic materia medica for final selection of the remedy. Repertory with relative gradation of medicines to facilitate the quick selection of medicine. Urticaria is manifested in various repertories.

OBJECTIVE OF THE STUDY:

AIM:To assessment the effectiveness of individualized homoeopathic medicine in cases of urticaria diagnosed on the basis of clinical presentation of the patient and assessed with the help of urticaria activity score (UAS) tool.OBJECTIVE:To ascertain the role of causative factor in cases of urticaria.

To ascertain the role of individualized homoeopathic medicines in cases of urticaria.

material and methods

SOURCES OF DATA:

Patients will be chosen from the Outpatient Departments (OPDs), Peripheral OPDs, and organized camps conducted by "Sainath Homoeopathic Hospital" affiliated with Rajkot Homoeopathic Medical College

 THE MATERIAL UTILIZED FOR THE STUDY:

o  MATERIAL UTILIZED FOR THE STUDY –

•      Informed consent is mandatory and must be signed by each patient.

•      Case taking Pro-forma especially designs for the study of urticaria.

•      The USA Score Sheets will be utilized for evaluation.

•      Medicine selection will be based on relevant Materia Medica.

•      Cases will undergo repertorization using appropriate repertories.

Medicines, obtained from a reputable Homoeopathic pharmacy, will be dispensed through the dispensary of Sainath Homoeopathic Hospital.

 Â·      METHOD OF COLLECTION OF DATA:

·      Type of Study – Experimental, Prospective.

·      Sample Size – 40 cases

·      Selection of Cases –Simple Random sampling method based on the criteria set by "Sainath Homoeopathic Hospital" affiliated with Rajkot Homoeopathic Medical College.

·      Statistical Methods – Data analysis, descriptive statistics and the results will be presented by using frequency table, percentage, diagrams and graphs. The significance of treatment will be tested using paired ‘t’ test.

·        STUDY DURATION –

·         The study will last for 09 months.

·         First-time screening, case-taking [3], and processing registration will occur within 6-7 months of starting the research.

INCLUSION CRITERIA****–

·         Inclusion criteria: Age 10 – 60 will be consider.

·         Both genders (Male and Female) will be considered.

·         Diagnostic criteria mainly done on basis of clinical history presentation and examination finding.

·        Already taken other treatment but not cured or having relapse again.

·         EXCLUSION CRITERIA****–Age below 10 and more than 60

·         Pregnant and lactating women.

·         Patient with urticaria who are on therapeutic measure with other disciplines.

·         Drug induced urticaria.

Ø  Serum sickness, blood product reaction.

CRITERIA FOR WITHDRAWAL AND DROP-OUT:

Withdrawal Criteria:

Patients may withdraw if they do not benefit from the treatment.

Withdrawal is also considered if the disease worsens or advances despite treatment.

Drop-Out Criteria:

Cases with no follow-ups are considered for drop-out.

Cases with inadequate follow-ups (less than 3 irregular follow-ups) are also eligible for drop-out

INTERVENTION GUIDELINES:

Individualized Homoeopathic Medicine selection is based on the Totality of Symptoms for each case as their similimum.

Potency, dose, and repetition are determined by the patient’s susceptibility.

·        METHODOLOGY:

The case will be taken as per my inclusion and exclusion criteria.

Guidelines for case taking, as outlined by Dr. Hahnemann in aphorisms §83-§104[3], are adhered to when using the Case Performa at Sainath Homoeopathic Hospital.

CASE RECORD BRIEF:

A standardized case record is maintained through the following steps:

1.      Case taking.

2.      Recording and interpretation.

3.      Analysis of the case.

4.      Erecting totality.

5.      Repertorization.

The repertorized chart is analyzed for higher matched and graded medications. These medications are then validated from Homoeopathic Materia Medica to arrive at the prescription.

A paired t-test will be conducted to analyze the statistical significance between paired observations.

o   SELECTION OF MEDICINE –

The choice of medication for each case will rely on data analysis, encompassing etiological factors, qualified mental and physical generalities, concomitants, characteristic particulars, repertorial approach, and clinical indications sourced from diverse authoritative references.

SELECTION OF POTENCY –specific requirements of the case, adhering to the principles of Homeopathy. This selection process will involve a thorough assessment of factors including the nature of the condition (whether acute or chronic), the individual’s susceptibility, vitality, any instances of suppression, as well as an evaluation of structural and functional changes. The ultimate decision will prioritize alignment with the remedies in terms of their effectiveness and compatibility.

DOSE & REPETITION –The administration of the remedy will adhere to the principles outlined in the Homoeopathic Organon of Medicine, with due consideration given to dosage and repetition.

o   ROUTE OF ADMINISTRATION OF MEDICINE –

All medications will be administered orally.

o   FOLLOW UP AND MONITORING –

The follow-up of cases will be done up to 6 - 8 follow – ups every 07 days.

o  RECORDS

All the records will be maintained as per standard procedure of institution.

o    EXPECTED OUTCOME –

The expected outcome of the study on exploring the utility of causative factors in the management of urticaria through individualized homeopathic medicine, using the Urticaria Activity Score (UAS) tool, is likely to provide insights into the effectiveness of this approach. The study aims to assess the impact of tailored homeopathic treatments based on identified causative factors on the severity and frequency of urticaria symptoms. The anticipated outcome includes a better understanding of the potential benefits and limitations of individualized homeopathic interventions in managing urticaria, contributing valuable information to both homeopathic practitioners.

o   ASSESSMENT CRITERIA

UAS7 disease activity score bands

UAS7 band

Rationale

|0

Itch and hive free—indicative of no symptoms of CSU and considered a full treatment response

|1–6

Well-controlled urticaria—indicates a good response to treatment

|7–15

Mild urticaria—indicates also a lower response level

|16–27

Moderate activity urticaria—entry criteria for clinical trials in CSU

|28–42

Severe activity urticaria

 According to UAS7 TWICE DAILY ASSESMENT:[11]

UAS twice- daily version: scoring for itch and hives at each assessment point.

|Itch severity score

Itch severity at each assessment(am/pm)

Hives severity score

Number of hives at each assessment

|0

None

0

None

|1

Mild, minimal, awareness, easily tolerated.

1

1-6

|2

Moderate, definite awareness, bothersome but tolerable

2

7-12

|3

Sever difficult to tolerate

3

12

 LIST OF REFERENCE:

1.      Khan S, Maitra A, Hissaria P, Roy S, Padukudru Anand M, Nag N, et al. Chronic Urticaria: Indian Context—Challenges and Treatment Options. Dermatology Research and Practice. 2013;2013:1–8.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3800585/

2.      Kavita A, Thakur JS, Narang T. The burden of skin diseases in India  2021 Oct 30;0:1–5.

https://ijdvl.com/the-burden-of-skin-diseases-in-india-global-burden-of-disease-study-2017/

3.      Hahnemann S, Sarkar BK, Dudgeon RE. Organon of medicine. Delhi: Birla Publications; 2006.‌

4.      Aviv Barzilai, Baum A, Ben-Shoshan M, Ido Tzanani, Journal of Clinical Medicine [Internet]. 2023 Dec 3 [cited 2024 Feb 23];12(23):7482–2.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10706916/#:~:text

5.      Britton R, Hobson R, Penman ID, Ralston S, Strachan MWJ. Davidson’s       Principles and Practice of Medicine. 23rd ed. Edinburgh: Elsevier; 2018.

6.      Loscalzo J, Fauci AS, Kasper DL, Hauser SL, Longo DL, Jameson JL. Harrison’s principles of internal medicine. 21st ed. New York: McGraw Hill; 2022.

7.      Goldsmith L, Katz S, Gilchrest B, Paller A, Leffell D, Wolff K. Fitzpatrick’s Dermatology in General Medicine, Eighth Edition, 2 Volume set. McGraw Hill Professional; 2012.

8.      Aslan Kayıran M. Diagnosis and treatment of urticaria in primary care. Northern Clinics of Istanbul. 2018;6(1). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6526977/

9.      Hahnemann S. The Chronic Diseases, Their Peculiar Nature and Their Homoeopathic Cure. 1904.

10.  Urticaria Differential Diagnoses [Internet]. emedicine.medscape.com. [ cited 2024 Feb 23]. Available from: https://emedicine.medscape.com/article/762917-differential.

11.  Hollis K, Proctor C, McBride D, Balp MM, McLeod L, Hunter S, et al. Comparison of Urticaria Activity Score Over 7 Days (UAS7) Values Obtained from Once-Daily and Twice-Daily Versions: Results from the ASSURE-CSU Study. American Journal of Clinical Dermatology [Internet]. 2018 [cited 2021 Apr 19];19(2):267–74. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC597889020