|
Brief Summary
|
Research Gap:
Dermatophytosis has been treated in homeopathy using various potencies, with Centesimal potencies (like 6C, 30C, 200C) being the most commonly used and widely studied for dermatological conditions. It is generally understood that higher C potencies, such as 200C, are more intense and are prescribed in smaller doses. On the other hand, the 50 Millesimal Potency (LM) is a newer scale that is believed to provide a gentler, more gradual therapeutic effect compared to Centesimal potencies. The key difference between LM and C potencies lies in their preparation process, which may influence how they act in the body. However, there is a lack of direct, comparative studies that evaluate the effectiveness of LM versus C potencies specifically for treating dermatophytosis. Most existing research focuses on C potencies, while the use of LM potencies for this condition remains underexplored and has not been rigorously compared to Centesimal potencies.
Research Question: Is 50 millesimal potency effective over Centesimal potency in homoeopathic management of dermatophytosis?
Hypothesis:
Alternative: 50 millesimal potency will be more effective over Centesimal potency in homoeopathic management of dermatophytosis.
Null: 50 millesimal potency will not be more effective over Centesimal potency in homoeopathic management of dermatophytosis
Introduction: Dermatophytosis, commonly known as cutaneous tinea infection, is a widespread superficial fungal infection affecting the skin, hair, and nails.(1)(2) It is predominantly caused by fungi from the genera Trichophyton, Microsporum, and Epidermophyton.(1) These infections present as erythematous, itchy patches that typically develop in a well-demarcated, annular shape with a raised leading edge.(2) Dermatophytosis is common worldwide, with an estimated prevalence of over 25% of the global population, and is particularly prevalent in regions with warm and humid climates. In India, the incidence is approximately 4.1%.(2) Conventional treatment involves topical and systemic antifungal medications; (1) however, recent research has explored the potential role of homeopathy in managing dermatophytosis, offering individualized treatments based on the law of similia.(3) Homeopathy, introduced by Dr. Samuel Hahnemann, relies on the use of both Centesimal and 50-Millesimal potency scales for treatment. Recent studies have investigated the effectiveness of these two potency scales in managing dermatophytosis, with particular interest in comparing their comparative efficacy. A pilot study has shown that both potency scales yield comparable results in treating tinea corporis.(4) This study will Investigate how LM potencies (50 Millesimal) compare with Centesimal potencies (30C, 200C, etc.) in treating dermatophytosis, including speed of recovery, duration of treatment, and recurrence prevention. This research aims to further explore the comparative effects of 50-millesimal and centesimal potencies in managing dermatophytosis, with the hypothesis that 50 millesimal potency may offer enhanced outcomes in terms of symptom resolution and recurrence prevention. The findings from this study could contribute to the growing body of evidence supporting the use of homeopathy as an effective treatment modality for dermatophytosis.
Review of Literature:
Dermatophytes are a group of fungi that infect and multiply in keratinized tissues, such as the skin, hair, and nails, leading to various skin infections.(1) These infections are commonly referred to as tinea or dermatophytosis.(8) Tinea infections are superficial, affecting the outer layer of the skin, and are caused by fungi from the Trichophyton, Microsporum, or Epidermophyton genera.(1)(2) These dermatophytes invade the keratinized epithelial layer, causing inflammation, itching, and other symptoms characteristic of dermatophytosis. (1)(2)
• PATHOGENESIS (8) When a dermatophyte infects the skin, it triggers the up-regulation of specific genes in the pathogen that are essential for infection, leading to the release of mycotic virulence factors. This, in turn, activates the host’s inflammatory defense mechanisms. Dermatophytes typically penetrate the skin through hair follicles, reaching the dermis and upper subcutis, but they rarely invade deeper tissues or internal organs. The host’s response to the infection depends on both the dermatophyte species (or even strain) and the host’s immune defenses. Zoophilic and geophilic dermatophytes often provoke stronger inflammatory reactions compared to anthropophilic species. Additionally, factors such as the patient’s age, sex, immune status, and possibly genetic predisposition influence the nature of the host’s defense response. The body’s defense against the infection involves keratinocytes,
defense cells, antimicrobial factors, and both unspecific and specific immune responses, all working together to combat the pathogen.
• Effects of the location(8) Tinea can affect any part of the body, with its progression influenced by local conditions. Areas prone to occlusion and maceration, such as intertriginous regions, provide more favorable conditions for dermatophyte growth. The nails and hair follicles, particularly on the scalp and beard, represent two unique "ecotopes" that differ from the rest of the body. Nail infections, or onychomycosis, caused by dermatophytes are among the most common fungal infections, but the lack of circulation in the mature nail plate hinders immune response, making it difficult for the body to eliminate the infection. As a result, onychomycosis often becomes a chronic, non-inflammatory condition, particularly in older individuals or those with slower nail growth. Hair follicle infections, such as tinea capitis (scalp) and tinea barbae (beard), are another distinctive habitat for dermatophytes. These infections are typically non-inflammatory when the fungus colonizes the hair shaft internally (endothrix), as the pathogen remains isolated from the immune system. Tinea capitis is more common in children and rare after puberty, likely due to hormonal changes during puberty that affect hair follicle biology. The slow progression of the infection in hair follicles and nails often complicates treatment and resolution.
• FACTORS INCREASING THE PREVALENCE (9) Dermatophytes thrive in hot and humid environments, leading to a rise in infections in many tropical and developing countries. India, in particular, has seen a significant increase in chronic and recurrent dermatophyte infections, largely due to the country’s tropical and subtropical climate, which provides an ideal environment for these fungi. Additionally, factors such as overcrowding, shared living spaces, and rapid urbanization have further contributed to the growing prevalence of dermatophytosis.
FACTORS INCREASING PREVALENCE(9)
Hot and humid climate
Tropical and subtropical climate
Overcrowding
Shared living space
Rapid urbanization
ICD 10 CLASSIFICATION
B35 Dermatophytosis B35.0 - Tinea barbae and tinea capitis B35.1 - Tinea unguium B35.2 - Tinea manuum B35.3 - Tinea pedis B35.4 - Tinea corporis B35.5 - Tinea imbricata B35.6 - Tinea cruris B35.8 - Other dermatophytoses B35.9 - Dermatophytosis, unspecified T. mentagrophytes, T. tonsurans • CLASSIFICATION OF TINEA (9)
| Tinea Infection | Body Area Affected | Most Common Causative Pathogens | | Tinea Capitis | Head and scalp | T. tonsurans, Microsporum canis | | Tinea Corporis | Trunk and extremities | T. rubrum, T. mentagrophytes, T. tonsurans | | Tinea Cruris | Groin, pubic region, intertriginous anogenital region | T. rubrum, T. mentagrophytes | | Tinea Faciei | Face | T. rubrum, T. mentagrophytes | | Tinea Barbae | Beard and mustache area | T. verrucosum, T. rubrum, T. mentagrophytes | | Tinea Manuum | Hands | T. rubrum | | Tinea Pedis | Feet | T. rubrum, T. mentagrophytes, Epidermophyton floccosum | | Tinea Unguium | Nails | T. rubrum, T. mentagrophytes |
Homoeopathic management (3)
Homoeopathic treatment is based on a thorough investigation of the patient’s physical and mental status to form the totality of symptoms for individualization. By applying the principle of similia, the most effective and indicated medicine is selected to treat dermatophyte infections. Homoeopathic remedies have been proven to improve person, leading to a successful cure. There are some homoeopathic remedies mentioned below which the study has done previously.
1. Sulphur: It is a great antipsoric homoeopathic remedy used frequently for treating dermatophyte infections, patients complaining of dry, dirty, scaly unhealthy skin with itching, scratching caused burning sensation, pimply eruptions, pustules, hang-nails, excoriation especially folds areas, scalp dry with falling of hairs, aggravation from washing, from the heat of bed, sometimes relaspsing of skin complaints, many time observed skin affections that have been treated for long period by medicated soaps and wash, with other associated constitutional symptoms have been cured.
2. Rhus toxicodendron: It is also a great useful remedy for treating dermatophyte infection, patients with complaints of red circular swollen, intense itching, and burning eczematous eruptions with a tendency to scale formation. Also sometimes recurrent bacterial infection characterized by a large red patch on the skin of the body, vascular lesion, cellulitis, herpes-like eruption mostly worsen during rainy weather, at rest, at night, in rest condition and ameliorated in dry weather, rubbing, warm application applied with associated constitutional symptoms will be useful.
3. Graphites: It is an effective remedy for various skin conditions. Its symptoms are quite evident, including moist scabby eruptions on the scalp, Sepia: This remedy is selected when patients having complaints of circular patches, itching, and swelling of skin at various parts of the body, which is not ameliorated by scratching, apt to cause burning. Soreness of skin and itching in bends of joints, with itching on other area. The eruptions prominently behind the ears and on the eyelids are herpes-like eruptions. It can also be useful in itching of the hands and feet, ring-shaped lesions in various parts of the body having an offensive odor, and complaints that worsen with friction, touching, cold weather, rest, and at night.
4. Thuja occidentalis: This remedy is recommended for treating dermatophyte infections and patients with unhealthy dirty brownish colour of the skin, mottled spots on the skin, scaly, dry eruptions on the skin. Eruptions burn violently after scratching. Eruptions are present on covered parts only. Pustular eruptions face skin waxy and greasy, and genital folded areas lesions which aggravates from cold damp air, from the heat of the bed, and motion, relieved from drawing up limbs, left side.
5. Graphites: It is an effective remedy for various skin conditions. Its symptoms are quite evident, including moist scabby eruptions on the scalp, face, bends of joints, between fingers, and behind the ears. It also causes cracking, bleeding, and oozing of a thick, and tenacious discharge from the corners of the mouth and eyes. It is useful for dry and scaly skin, hair loss, and skin eruptions with a tendency to malignancy for instance pimples, keloids, fibromas, eczema, acne, cancer of the breast, and hard and old, painful cicatrices. Skin complaints tend to aggravated during bed warmth at night, during weather changes, and before and during menstruation. However, they are better in the dark, from wrapping up, and by exposure to open air.
6. Tellurium: This remedy is of great helpful for tinea infections. This medicine is useful for patients who experience slight inflammation, red spots on the scalp and include ichthyosis, venereal bubo, debilitating night sweats, Psorinum: Psorinum is a highly effective remedy for chronic skin conditions when prescribed with its other constitutional symptoms. It has a dull, dark, and unpleasant appearance of skin , as if it is covered in dirt, and cannot be cleaned thoroughly. The skin is dirty, unhealthy, rough, lumpy, and easily cracked, sometimes causing bleeding. It also becomes scaly and itchy, particularly when the patient is warm or in contact with woollen fabric. After scratching the affected area, it becomes raw and scabby. It is useful of various eruptions such as papules, pimples, crusts, boils, and vesicles that ooze watery moisture. Over time, the crusts and vesicles blend together, leading to thick and hardened skin. Patient is worsen with bathing and when warm in bed.
7. Arsenicum iodatum: This medicine has good role in treating various skin conditions. Some of the common skin conditions that can be treated with this medication are dry and scaly itching skin, as well as marked exfoliation of skin in large scales, which can leave a raw exuding surface beneath. Other conditions such as some herpes circinate on isolated spots on upper parts of the body, with deformity of nails, all complaints are worsen on dampness, sweat, washing, and better by warmth, pressure, from cold bath, sitting cross-legged with associated constitutional symptoms have been a cured.
8. Tellurium: This remedy is of great helpful for tinea infections. This medicine is useful for patients who experience slight inflammation, red spots on the scalp and include ichthyosis, venereal bubo, debilitating night sweats, eczema of the beard with watery oozing, and itchy - and gets aggravated on washing.
9. Bacillinum: -Bacillinum is an useful indicated remedy for fungal infections such as ringworms of the scalp, groin, and other areas of the body. It produces ringworm and pityriasis vesicularis all over the skin on the body. Patient is aggravated at night, while lying down in bed, in the early morning, or in cold air. Symptoms may relieved with warmth.
10. Antimoinum crudum: In skin complaints, patient complains about skin becoming very thick and dirties at various places. In Antim crud, there is a tendency for abnormal growth of skin. Nails of the fingers crack, grow in and can split and also have warts and horny spots. Eczema associated with gastric derangements. Skin complaints include pimples, vesicles and pustules, urticaria, measle-like eruptions. Itching aggravated by warmth of bed. Pustular eruptions with burning and itching and dry skin, worsen at night. Effective for the cracked and fissured corners of the mouth. The skin is very dirty and unhealthy.
11. Anagallis: This homoeopathic remedy is marked effective on the skin. It is often used to treat skin disease with itching and dryness, as well as bran-like eruptions. Anagallis is useful where the vesicles and swellings that occur on folded joints, especially on the hands and fingers. 1
12. Mascanella: This medicine is helpful for various skin diseases. Skin complaints include dermatitis with excessive vesiculation, oozing of sticky serum and crust formation, erythema, vesicles, blisters, as from scalds, heavy brown crusts and scabs, erysipelas.
13. Rhus venenata: - It is indicated in skin diseases where patient complaints itching, vascular inflammation red patches of skin, many rashes on the skin, skin is dark red, erythema nodosum, itching relieved by applied on hot water.
14. Tuberculinum: -This medicine is also indicated for ringworm infection, patients having symptoms of patches of skin which is rough and inflamed with blisters that causes intense itching and sometimes bleeding, bran like scales, infolds of skin with rawness and soreness sensation, fieryredskin. This complaints are better by cool wind, open air, motion. worse at night when undressing, from bathing.
HOMOEOPATHIC REMEDIES FROM HOMEOPATHIC MATERIA MEDIA BY W. BOERICKE. (13)
1. SULPHUR: Dry, scaly, unhealthy; every little injury suppurates. Itching, burning: worse scractching and washing. Pruritus, especially from warmth, in evening, often recurs in spring-time, in damp weather.
2. BACILLINUM: Ringworm: pityriasis. Glands of neck enlarged and tendder. Worse at night and early morning, cold air.
3. SEPIA: Itching not relieved by scratching; worse in bend of elbows and knees. Ringworm like eruptions in spring.
4. TELLURIUM: Itching of hands and feets. Herpetic spots; Ringworm. Ring shape lesions, offensive odors from affected parts. Barber’s itch.
• Organon Application:
1. Maintaining cause (6): Causa occasionalis has to be investigated and removed for better and fast cure mentioned in organon of medicine 6th edition.
2. In Chronic Disease by Dr. Hahnemann has explained in the preface 3 about the doses of water potency and repetition of watery potency in both acute and chronic diseases. (12)
3. Homoeopathic Potency Scales (11) (6)
A. 50- Millesimal Scale or LM Scale: a. Introduced by Dr. Hahnemann o Introduced in 6th edition as Renewed Dynamisation in Aphorism 161. IN footnote of Aphorism 11 describes 50 millesimal potency as New altered but perfect method. b. Pierre Schmidt gave the term 50- Millesimal scale or LM scale.
c. Aphorism 270 gives the detail method of preparation of 50- Millesimal scale or LM scale.
d. Aphorism 247 state the repetition of Homoeopathic dosses in water potency to avoid Homoeopathic aggravation.
e Advantages of 50 Millesimal potency:
i. Rapid Homoeopathic medicinal action
ii. Minimal quantity of the medicine reduces the chance of Homoeopathic aggravation.
iii. Frequent repetition is possible in acute and chronic diseases.
f. Administration of 50 Millesimal dose: Take new unused phial/ bottle and it is filled up 3/4th with purified or distilled water. Add one medicated no.10 globule in it and mark the phial with doses like 16/8/7/4. Before taking the dose, patient has to give strong and equal downward succussion to phial and add one cap of medicine in 3/4th cup of water. Patient has to consume 1-2 teaspoon from this solution and discard the rest medicine in cup. Patient has tot follow this procedure each time he /she takes the doses from phial as guided by physician.
B. Centesimal Potency (11)
a. Introduced by Dr. Hahnemann in fifth edition of organon of medicine in aphorism 270.
b. Too frequent repetition should not be done with the centesimal potency.
c. Repeat the doses when improvement comes to standstill.
Homoeopathic repertory (16) - Synthesis repertory: 1. SKIN-Eruptions-herpetic-circinate 2. SKIN-Eruptions-ringworm 3. SKIN-Eruptions_dermatomycosis
- Boericke repertory: 1. SKIN-Tinea favosa,favus 2. SKIN-Trichophytosis-ringworm 3. SKIN-Tinea versicolor(chromophytosis)
- Phatak repertory: 1. R-Ringworm all over body
Previous Research:
1. “A Comparative Study of 50-Millesimal Potencies and Centesimal Potencies in the Treatment of Tinea Corporis: An Open, Randomised, Pilot Trial” in this pilot study conclusion was drawn as both the potencies were effectively worked for tinea corporis patients. (4)
2. “Homoeopathy in the treatment of tinea cruris and tinea corporis – A case series”, in this case series provides preliminary evidence for the usefulness of homoeopathic treatment for dermatophytosis, particularly tinea cruris and tinea corporis whose outcome was measured by Clinical Cure score, Skindex-16 score and MONARCH criteria. (2)
3. “A systemic review on efficacy of homoeopathic medicines in tinea infections (Ringworm)”, here articles where reviewed which were collected from the database like google scholar from 2017 to 2021. Throughout this whole review literature, it was concluded that homoeopathic medicines are effective in treatment or management of various types of tinea infections. (5)
4. “Effectiveness of Homoeopathy in Tinea corporis and Tinea cruris – A Prospective, Longitudinal Observational Study” in this study they concluded that homoeopathic medicines can be useful in treating chronic, recurrent fungal infections of skin, but it will require a sound knowledge of Repertory, Materia Medica and Organon of Medicine. (14)
Objective
Primary : To study the effectiveness of 50 millesimal potency in Homoeopathic management of dermatophytosis. First Secondary: To study the effectiveness of Centesimal potency in Homoeopathic management of dermatophytosis.
Second Secondary: To find the maintaining cause in treating patients suffering from dermatophytosis
Methodology - Type of Study Design: Comparative study
- Setting: Medical College and Hospital OPD and Peripheral OPDs, Medical camps.
- Duration of study: 18 months
- Method of selection of comparison or control group: Systematic odd and even method Odd number patients: Group A (50 millesimal potency) Even number patients: Group B (centesimal potency)
- Matching criteria: Cases having sign and symptoms of dermatophytosis
- Operational definition: In this study, dermatophytosis is defined as a fungal infection affecting keratinized tissues such as the epidermis, hair, and nails, presenting as erythematous, itchy, well-demarcated, oval or circular, scaly patches with a raised leading edge. Participants receive treatment with indicated homeopathic medicines, assessed using either repertorial or non-repertorial approaches, with follow-up evaluations to compare the efficacy of 50 millesimal potency versus centesimal potency in managing dermatophytosis using the clinical symptom score.
- Specific instruments and related measurement: Clinical system score(14) and MONARCH (Modified Naranjo Criteria)(15), CRF, RADAR 10 and Homoeopathic materia medica
Research Methodology specified and explained for data collection - Sample size : 30 sample size
- Sample technique : Systematic a) Group A: (Odd number Patients) 15 cases will be included for treating with Indicated Homoeopathic medicine with 50 millesimal potencies b) Group B: (Even number Patients) 15 cases will be included for treating with Indicated Homoeopathic medicine with centesimal potency.
- Method for data collection relevant to objectives:
- 30 patients with Dermatophytosis selected according to inclusion and exclusion criteria
- Consent will be taken from all patients
- Patients will be divided in two groups on basis of Systematic sampling
- Group A : (Odd number patients): Case taking with help of CRF and Filling of Clinical system score before Intervention. Repertorial approach using RADAR software or non repertorial approach and Intervention: Indicated Homoeopathic medicine with 50 millesimal potency
- Group B : (Even number patients): Case taking with help of CRF and Filling of Clinical system score before Intervention. Repertorial approach using RADAR software or or non repertorial approach and Intervention: Indicated Homoeopathic medicine with centesimal potency
- Follow up after 20 days or as per patient need Follow up in 12 months as per patient need Clinical system score on alternative follow up
- MORACH filled after last follow up in both the groups Interpretation of outcome by using appropriate statistical
- The change in scale will be helpful for direction of change of medicine or repetition of medicine in both the group.
- Data management and analysis procedure: Data will be analysed with help of appropriate statistical tool
- Plan for statistical analysis: On the basis of data appropriate statistical tool will be used.
- Ethical clearance: Confidentiality of all patients will be maintained.
Timeline: | TASK | Duration | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | | Case Collection | 6 months | X | X | X | X | X | X | | | | | | | | Follow up with patient | 12 months | X | X | X | X | X | X | X | X | X | X | X | X | | Data Analysis | 2 months | | | | | | | | | | | | | | Report writing and conclusion | 3 months | | | | | | | | | | | | | | TASK | Duration | 13 | 14 | 15 | 16 | 17 | 18 | | Case Collection | | | | | | | | | Follow up with patient | | | | | | | | | Data Analysis | 3 months | X | X | X | | | | | Report writing and conclusion | 3 months | | | | X | X | X | |