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 Table of Contents  
ORIGINAL ARTICLE
Year : 2015  |  Volume : 9  |  Issue : 3  |  Page : 167-175

A multicentric observational study to evaluate the role of homoeopathic therapy in vitiligo


1 Scientist-4, Dr. Anjali Chatterjee Regional Research Institute (H), Kolkata, India
2 Scientist-4, Central Research Institute (H), NOIDA, India
3 Scientist-1,Scientist-3, Regional Research Institute (H), Puri, India
4 Scientist-3, Regional Research Institute (H), Gudivada, India
5 Scientist-4, Clinical Research Institute (H), Chennai, India
6 Scientist-4, Homoeopathic Drug Research Institute, Lucknow, India
7 Scientist-3, Drug Standardisation Unit (H), Hyderabad, India
8 Statistician, Former Director General, Deputy Director (H), CCRH, Headquarters, New Delhi, India

Date of Submission10-Jul-2013
Date of Acceptance19-Aug-2015
Date of Web Publication30-Sep-2015

Correspondence Address:
Lipipushpa Debata
Regional Research Institute (H), Marchikote Lane, Puri, Odisha - 752 001
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0974-7168.166378

Clinical trial registration CTRI/2012/04/002591.

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  Abstract 

Background: Vitiligo has an immense psychological impact on the affected individual and a reason for low self-esteem. Considering the disappointing outcomes, A multicentric open clinical study was undertaken by the Central Council for Research in Homoeopathy, at five institutes and units in India from October 2005 to September 2010.
Aims and Objectives: This observational study aimed to see the usefulness of homoeopathic therapy in the management of vitiligo.
Materials and Methods: 432 patients of all age groups suffering from vitiligo were enrolled in the study. Out of that, 169 patients completed 2 years of follow-up and were considered for analysis. Homoeopathic medicines, based on the totality of symptoms and repertorization were prescribed. The analysis of the cases was based on the Vitiligo Symptom Score (VSS) and photographs of the patients. Result was analyzed using statistical method of SPSS version 20.
Results: The changes in the mean VSS at intervals of every 6 months was found to be statistically significant. Homoeopathic treatment was found to be useful in relieving vitiligo in varying degrees in 126 patients, out of which 4 (2.94%) cases showed marked improvement, 15 (11.03%) cases showed moderate improvement, 77 (56.62%) cases showed mild improvement, and 30 patients although improved, fell in the category of not significant improvement group (below 25% improvement). Ten homoeopathic medicines were found useful in the study of which Sulphur (n = 27), Arsenicum album (n = 19), Phosphorus (n = 19), and Lycopodium clavatum (n = 10) were the most commonly indicated and useful medicines.

Keywords: Homoeopathy, Multicenter open clinical trial, Observational study, Vitiligo


How to cite this article:
Chakraborty P S, Kaushik S, Debata L, Ram B, Kumar R, Shah M, Jha D K, Ramesh D, Padmanabhan M, Nayak C, Singh V. A multicentric observational study to evaluate the role of homoeopathic therapy in vitiligo. Indian J Res Homoeopathy 2015;9:167-75

How to cite this URL:
Chakraborty P S, Kaushik S, Debata L, Ram B, Kumar R, Shah M, Jha D K, Ramesh D, Padmanabhan M, Nayak C, Singh V. A multicentric observational study to evaluate the role of homoeopathic therapy in vitiligo. Indian J Res Homoeopathy [serial online] 2015 [cited 2018 Sep 21];9:167-75. Available from: http://www.ijrh.org/text.asp?2015/9/3/167/166378


  Introduction Top


Vitiligo is an acquired loss of pigmentation characterized histologically by the absence of epidermal melanocytes. It may be an autoimmune disease associated with antibodies to melanocytes, but the pathogenesis is still not understood. Studies suggest there is some genetic mechanism involved in the etiology of vitiligo and that it is polygenic in nature. [1]

Vitiligo is the most prevalent pigmentary disorder occuring worldwide, affecting about 1% of the world population irrespective of age, race, ethnic origin or skin color. [2]

Although any part of the skin and/or mucous membranes may be affected, the disease has a predilection for normal hyperpigmented regions such as the face, groin, axillae, areola, and genitalia. Furthermore, lesions may develop in other areas such as the ankles, elbows, knees which are subjected to repeated trauma/friction, an outcome of Koebner's phenomenon. [3] White areas are common around the body openings such as the eyes, nostrils, mouth, nipples, umbilicus and anus and beside these, the palms, soles, scalp and mucous membranes may also be affected. [1]

The disease is having a major impact on the quality of life of patients. Many patients feel distressed and stigmatized by their condition. Most of the patients report the feelings of embarrassment, which can lead to a low self-esteem and social isolation. [4]

Available treatment options are disappointing and sufferers often use various forms of camouflage (remedial cosmetic cover creams) to conceal the blemish of vitiligo temporarily. [5] In the surgical method, cellular grafts have an established role in the management of vitiligo. However, possible risk of cancer, the cost of treatment, and the need for special reagents are its disadvantages. [6] Instead, phototherapy with narrow band ultraviolet B therapy and psoralen + UVA therapy are the most recent advances in the medical front. [7]

Unlike other systems of treatment, Homoeopathy treats the local maladies as the local expression of the internal derangement. The exact treatment is determined only after in depth evaluation of individual case for enhancing the body's own pigment system naturally. The scope of homoeopathic treatment extends beyond the physical symptoms and the approach is more holistic in nature. Homoeopathy, does not consider any one part as being ill but considers the manifestations of illness in one part in its relation to the whole man. [8] The management of vitiligo goes no exception to it.

Many cases are documented in homoeopathic journals regarding the therapeutic value of Homoeopathy in vitiligo by different clinicians. [9],[10],[11],[12],[13],[14],[15],[16],[17],[18]


  Objectives Top


A multicentric open clinical trial was taken up by the Central Council for Research in Homoeopathy, with a primary objective to identify usefulness of individualized homoeopathic medicine in repigmentation of the patches in patients suffering from vitiligo and a secondary objective to identify a group of homoeopathic medicines in the management of this disease.


  Materials and methods Top


Design

This was a multicenter, observational study conducted at Regional Research Institute, Gudivada (Andhra Pradesh); Regional Research Institute, Puri (Odisha); Homoeopathic Drug Research Institute, Lucknow (Uttar Pradesh); and Clinical Research Unit, Chennai, (Tamil Nadu), India from October 2005 to September 2010. The study was conducted in accordance with the Declaration of Helsinki on Human Experimentation. The Council's Ethical Committee approved the study protocol. The investigators engaged in the study collected all data as per a pre-designed protocol. These investigators were trained on the protocol before initiation of the study. A dermatologist was engaged as a consultant at each study center to assess the study participants as per the protocol. The study is registered in Clinical Trial Registry of India vide registration number CTRI/2012/04/002591.

Patient and Settings

Patients of either gender, identified in the outpatient department (OPD) of the respective research centers, fulfilling the inclusion criteria, were enrolled in the study only after getting the written informed consent. In case of minors, written informed consent was obtained from the parents/guardians of the patients. All the patients presenting with vitiligo without any systemic disorder were included in the study. 432 patients, including of 227 males and 205 females were enrolled in the study after screening 698 patients. Patients with any severe systemic disease, pernicious anemia, alopecia areata, lichen planus, psoriasis, Down's syndrome, hypothyroidism, Hyperthyroidism, Addison's disease, Systemic lupus erythematosus, Graves disease and those unable were excluded from the study.

The investigators made an in-depth interview with each patient and his/her guardian, as per the guidelines laid down by Dr. S. Hahnemann in Organon of Medicine. [19] For this purpose, a specially evolved case recording form was used for case taking. Care was taken to record the details of evolution of the complaints, Case processing was done through analysis and evaluation of symptoms, miasmatic diagnosis, and determining the totality of symptoms. A selection of medicine of each patient was done with the Complete Repertory in consultation with Materia Medica. The severity of the vitiligo symptoms were measured by a Vitiligo Symptom Score (VSS) Sheet which was developed by the Council in order to get a quantitative assessment of improvement of all the enrolled cases, at baseline and during each follow-up of the patients [Table 1]. This scale was approved by the Scientific Advisory Committee of the Council. The severity of vitiligo was categorized on the basis of baseline scores as mild (1-6), moderate (7-12) and severe (13-19). Physical examination was done for all the enrolled cases by the consultant dermatologist of every study center, at baseline and at every follow-up visit of the patient. Photographs of the patients were taken, focusing vitiligo affected areas at the baseline as well as during every follow-up.
Table 1: Baseline data

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Treatment and follow-up

Each patient was administered a single dose of the indicated medicine in 30C potency, consisting of four pills, size 40, on empty stomach and placebo, three times a day for one month, from next day onward. As per the instructions in Hahnemann's Organon of Medicine and Kent's twelve observations, each patient was followed up every month, and subsequent prescriptions were made. Assessment of improvement was done after all the potencies (30, 200, and 1M) of the selected remedy had been used.

The change in symptom score was assessed using the formula:. Patients with 75-100% improvement were considered as marked, 50-74% as moderate improvement, 25-49% as mild improvement, <25 as not significant improvement, no change in base line score as static, an increase in symptoms score was considered as worse.

Statistical analysis

The statistical analysis of all the baseline components such as type of lesions, patches, hair in patch, margin of patch and re-pigmentation of the patches were compared at the end of treatment by Friedman test and the baseline score values and all the mean values were compared by using repeated ANOVA test and Mcnemar test, wherever applicable, by using the SPSS 20 software. P < 0.05 was considered as significant.


  Results Top


Out of 698 patients screened, 266 patients were excluded due to various reasons and 432 patients were included in the study. Out of these included patients, 169 patients (93 males and 76 females) completed 2 years treatment and follow-up as per protocol and were analyzed after the conclusion of the study. At the end of the study, it was seen that some patients did not turn up for the complete follow-up; instead, they were followed up partially for 6 or 12 or 18 months with some improvement. Those cases were analyzed separately under intention to treat (ITT) group and the results were compared and it was identified that even in a short-term follow-up, those patients did show a positive result with homoeopathic medicines.

It was found that generalized type (n = 108, 50.9%) was the most common type of vitiligo, followed by segmental type (n = 40, 36.7%) and single patch lesions (n = 21, 12.4%). Similarly in the ITT group generalized type was found in 153 (38.9%) patients, segmental type found in 76 (48.4%) patients, and single patch lesions in 34 (12.7%) patients [Table 1].

The changes in VSS variables with the outcome status, of the cases with complete 2 years follow-up were studied (before and after treatment). The results of all the variables were found statistically significant at P < 0.05 [Table 2].
Table 2: Changes in VSS variables with the outcome status of per protocol cases

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As per the distribution of site of lesion, it was found that the acral variety was the most common (n = 106, 62%) form of vitiligo followed by follicular (n = 36, 21.3%) and mucosal (n = 27, 16%) [Table 2]. Post treatment results showed significant improvement in the per protocol group that is, treatment group (P = 0.001, <0.05) [Table 2].

On analyzing the type of patches, progressive type was the commonest of all (n = 136, 80.5%). The patches were found to be stationary in 20 patients (11.83%) and resistant in [12 (7.1%) patients. It was also seen in the ITT group that 180 cases (73.1%) were of progressive type, 58 cases (18.1%) of stationary type, and 6 cases (4.2%) of resistant type. Post treatment results showed significant improvement in both the groups. The number of progressive cases reduced to 30 after treatment in the per protocol group whereas 103 cases were in the improving category.

Out of 169 cases, 78.1% (n = 132) patients were found to be of severe intensity and 21.9% (n = 37) patients of moderate intensity at baseline. A significant difference was found when improvement rate was measured within the intensity sub-groups [Table 3]. In ITT group too, it was found that most of the symptoms showed a consistent improvement and was statistically significant.
Table 3: Changes in VSS score

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On analyzing the color of the patches, it was found that at baseline, milky white patches were seen in 59.2% (n = 100) patients, pink/red patches in 32.5% (n = 55) cases, and pigment spots in 8.3% (n = 14) patients. Post-treatment results showed a significant improvement in the color of patches where milky white patches were found in 15.4% (n = 26), pink/red patches in 27.2% (n = 46), and pigment spots were seen in 55% (n = 93) patients which was statistically significant. Also in 4 patients, the normal skin color (complete re-pigmentation) was restored after treatment [Table 2].

At entry level, 92.9% (n = 157) patients showed white patches without any pigmentation, 9 cases (5.3%) showed hyperpigmentation of margins and 3 (1.8%) cases showed perifollicular pigmentation [Table 2]. Post-treatment results showed highly significant and consistent improvement with 122 cases having re-pigmentation [Figure 1],[Figure 2],[Figure 3] and [Figure 4].
Figure 1: (a) Before treatment (b) After treatment

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Figure 2: (a) Before treatment (b) After treatment

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Figure 3: (a) Before treatment (b) After treatment

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Figure 4: (a) Before treatment (b) After treatment

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On analyzing the improvement status, Post-treatment results showed a significant and consistent improvement in the symptom score [Table 3]. Of the 169 cases, 69 cases (40.8%) showed mild improvement, 15 cases (9%) showed moderate improvement and 4 patients (2.36%) showed marked improvement. There was no significant change in 35 cases whereas 7 cases were worsened after treatment. A total of 102 (60.35%) patients out of 169 showed improvement in the patches [Table 4]. Of these 169 cases, 136 patients (80.5%) showed positive result with single medicine and there was change of medicine in the remaining 33 patients since there were no signs of improvement even after all the potencies of the first medicine were exhausted.By using repeated measure ANOVA, both per protocol and ITT group showed the mean changes from baseline to end of the treatment [Table 3]. These changes were also statistically significant.
Table 4: Homoeopathic medicine and the improvement status of per protocol cases

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An analysis of the prescribed medicines in the 169 cases of treatment group, the use of 12 homoeopathic medicines for the treatment of vitiligo was found, among which Sulphur (n = 51) was the commonest followed by Arsenicum album (n = 38), Phosphorus (n = 30), Lycopodium clavatum (n = 12), Natrum muriaticum (n = 12), Calcarea carbonica (n = 10), Mercurius solubilis (n = 5), Silicea (n = 4), Pulsatilla nigricans (n = 2), Sepia (n = 2), and nitric acid (n = 1). All these medicines were found to have statistically significant results (P < 0.05) except Silicea, P. nigricans and Nitric acid, and Nux vomica where statistical assessment could not be done due to less number of patients covered under these medicines [Table 4].


  Discussion Top


This multicentric observational study is one of its kinds in India for treating the most common pigmentary disorder in the world that is, vitiligo, with homoeopathic medicines in a systematic way which reflects positive results of homoeopathic treatment. This study was conducted on the basis of homoeopathic principles of individualization, single medicine, and minimum dose.

Most of the cases (80.5%) included in the study were of the progressive type that is, vitiligo patches were gradually increasing and spreading before the treatment. But during the course of homoeopathic treatment, progression of the disease was arrested as noted in 79.41% (108 out of 136) cases, which identified usefulness of homoeopathic medicines in controlling progress of the disease.

The present study finds that the generalized type of patches were more common than the segmental type as reported. [20]

There was a significant reduction in intensify of white patches after the treatment. Initially, there were 78.1% patients in severe intensity group and 21.9% patients in moderate intensity group. But after treatment it was identified that only 24.3% patients were in severe intensity group, 66% in moderate intensity group, and 10% in mild intensity group.

There was marked improvement in the color of the patches. Only 14 patients were noticed with pigment spots on the white patches before commencement of treatment, and it increased to 55% (n = 92) after treatment which is noteworthy.

Vitiligo treatment encompasses various strategies depending on the form of vitiligo and its anatomical locations with varying rates of success. Principally, results of treatment are better when the patches are within relatively short time on the face and neck, and constitute the so called 'bland areas;' next proximal extremities and trunk respond effectively constituting the 'intermediate areas;' and poorest on the acral part of extremities or 'hard area'. [21],[22] In this study too, similar patches were identified. There was a marked improvement in the patches of face and neck, trunks and flexor aspect of the extremities whereas unsatisfactory results were noticed in extensor aspect of extremities, bony areas and joints. However, numerical assessment of these cases is not done since this was not an objective of the study.

In an earlier pilot study on vitiligo, it was seen that out of 560 patients with vitiligo on homoeopathic treatment, a total of 328 patients (58.57%) showed significant improvement of which 4 patients showed complete re-pigmentation, 17 of them showed more than 90% improvement, and 307 patients were in the improving category. [23]

This study showed significant improvement in 70.6% cases with varying improvement status such as marked improvement in 4 cases, moderate improvement in 15 cases, and mild improvement in 77 cases.

The study also identified frequently indicated medicines which are Sulphur, Arsenicum album, and Phosphorus are also seen in earlier studies. [17],[18]

Apart from the 169 cases which were followed completely for 2 years, the rest 263 cases were also followed for a period varying from 6 months to 18 months but did not complete the 2 years follow-up. The improvement status of those patients (under ITT group) was also studied basing upon the VSS score in their last follow-up. To sum up, the improvement status and medicines used in all the 432 cases were studied together of these, 7 cases showed marked improvement, 16 moderate, and 126 mild improvements in the patches. In 121 cases, there were no significant changes, 109 patients did not show any change, and in 53 patients the patches were worsened.

In this study, it was seen that a considerable number of patients were dropped out after some months of continuing treatment. They were followed up for some months and then did not turn up. This was due to the reason that it was a long continued treatment for two years and, the disease has an unpredictable course.

The above discussion shows that the patients kept in the ITT group who could not be followed up completely due to a longer follow-up period, showed positive results even in their short-term follow-ups of 6, 12, and 18 months. In the majority of patients, even though no complete repigmentation was seen, the progression was checked, which could have given better results from a long continued follow-up.

There were no adverse events noticed during the study. This reaffirms the importance of individualization approach of Homoeopathy in treating the patients. This also confirms the observations of Samuel Hahnemann in aphorism ͷ 18 Organon of Medicine in treating the chronic illnesses, which laid emphasis on totality of symptoms of a patient which ultimately becomes the only guide to select a similar medicine from Materia Medica. [19]


  Conclusion Top


The results of current observational study suggests the usefulness of homoeopathic medicines in the management of vitiligo. The approach and methodology adopted in this study will definitely help to design further clinical trials in Homoeopathy, focusing on the symptom totality which makes it possible to stress upon the individualization of homoeopathic treatment and obtain better results. It is suggested to undertake a randomized controlled trial to study the efficacy of Homoeopathy in the treatment of vitiligo for further scientific validation of results.

Financial Support and Sponsorship

Nil.

Conflicts of Interest

There are no conflicts of interest.

The authors have obtained appropriate patient consent for the information published in this article

 
  References Top

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