Vitiligo-Ayurvedic Treatment Approach

This is a single-blind clinical trial on patients of vitiligo, a disease rather difficult for a cure. Aetiology is multifactorial. It can be hereditary, autoimmune, hormonal, dietary, stress or secondary to other systemic diseases like diabetes mellitus, hypothyroidism, etc. This study was carried out on 200 outdoor patients suffering from vitiligo. Patients from both sexes, from age group five to seventy years complaining mainly as white patches over skin were studied. Patients were treated with an Ayurvedic polyherbal powder mixture containing Psoralia corylifolia (Bakuchi) as the main ingredient supplemented with local application and phototherapy (natural). Most of the patients undergo intermittent body purification i.e. shodhana-panchakarma treatments like Vamana (therapeutic emesis), Virechan (purgation), Basti (enematous treatment for Vaatadoosha) raktamokshana, etc., as per ayurvedic guidelines. Duration of treatment was of one month to one year depending upon response and requirement for the treatment. Follow-up was biweekly to monthly. The response to treatment was observed in terms of reduction in the area of depigmentation after treatment. Complete cure was noted in 12% of patients. A good result is noted in 18% cases, moderate in 45% cases and mild result in 25% cases noted. The result is statistically highly significant at 0.1% level. No major side effects of the treatment given were observed. The treatment is effective in kaphaja and pittaja types of vitiligo as per Ayurvedic classification. The results of internal medications and local treatment were aggregated especially after panchakarma treatment.

In Ayurveda, it is classified as Vaataja, Pittaja, and Kaphaja as per dosha vitiated.Vataja shwitra is dry (ruksha) and of Red-black (arun) in color.Pittaja is coppery or lotus-like in color and associated with inflammation (daha) and loss of hair.Kaphaja shwitra is hard, heavy with white color and associated with itching.It is associated with rakta (blood), mansa (Muscle tissue) and meda (lipid) dhatus as per Vaata, Pitta, and Kapha Dosha-vitiation respectively [1,2].In fact, these are the progressive stages of the disease, so also prognosis worsens accordingly.
Madhavnidan classified shwitra on the basis of the causative factors viz., Doshaja and vranaja [3].Acharya Charaka has described some special causes for vitiligo e.g.telling lie, not believing God, not apologizing someone's good deeds, performing sins, deeds of pervious life (poorvakarma) etc. [1] (charak chikitsa 7/177).These causes point to the inheriting nature of the disease in some cases and towards mal or abnormal thinking by the brain (pradnyaparadha) as a major cause.Unbalanced diet (Virrudhahara) is also an important cause.It signifies production of toxic metabolites as an important cause for the development of the disease.It is different from Leprosy (kushtha) in the respect that it is non-contagious, non-bacterial, it doesn't destroy body tissues, doesn't have any discharge (vyadhiswabhava).Leprosy

Introduction
Since long ago, the treatment of vitiligo is a challenge to the medical fraternity.It creates a very bad social stigma for the victim.In my clinical practice, I came across the number of patients suffering from vitiligo.The victims are physically affected and also under very gross psychological stress.Allopathic skin specialists have no satisfactory permanent cure for vitiligo.In fact, allopathic skin specialists are

Investigations
The commonly needed laboratory investigations like Complete Blood Count (CBC), BSL, Urine-Routine and Microscopic examination, and some hormonal assays like T3, T4, TSH estimation was done in suspected patients.In some patients, skin biopsy was required to confirm the diagnosis.Also enquired about MSH hormone estimation, but such investigation technique was not found in available laboratories.
In suspected hereditary cases the diagnosis can be confirmed by DNA analysis also.In this study hereditary factor is decided by detailed family history taking.

Treatment
In allopathic system no satisfactory and permanent cure is available.Treatment is steroid based, systemic psoralens with exposure to long wave UV radiation.Topical potent corticosteroids are used.Other treatment options are surgical and cosmetic.Skin grafting is practiced but again it has its serious side effects and limitations [4].

Aims and Objectives
A. To study the efficacy of Ayurvedic Polyherbal mixture 'shwitrayoga' with local application and natural phototherapy and panchakarma in vitiligo (Shwitra) patients.B. To note side effects of the treatment if any.

Materials and Methods
The following methodology is adopted to conduct the study.

Clinical study
Study design: This is a single-blind clinical trial in patients with vitiligo.The study was carried out on 200 outdoor patients.Patients were just informed that they are undergoing ayurvedic medicine treatment for vitiligo.They were not informed about the exact medicines or the identity of medicines.No written prescriptions of the medicines given to patients under trial.The hospital staff was also unaware of the formulation.The study was conducted for last 12 years.

Selection of patients:
The study was carried out on outdoor patients suffering from vitiligo.(Kushtha) deeply goes up to all Dhatus.Vitiligo (shwitra) occupies only skin, blood, muscle tissue (mansadhatu) and fat (medadhatu).

A) Inclusion criteria
Treatment needs a holistic approach.There is an imbalance of regulating hormones for melanin synthesis.For homeostasis of hormones and detoxifying body with Ayurvedic body purification treatment i.e., panchakarma is very useful.In fact, in Ayurveda, it is described as powerful purificatory treatment and it should be done before commencing any specific medical treatment for the disease.

Prognosis (Sadhyasadhyata)
Madhavanidana described that Vitiligo (shwitra) in which hairs are black, in a small percentage, with ununited spots, new (<1 year-charak) is curable.Others including developed due to burns, in genitals, hands, and feet, lips, with a history of inheritance are non-curable or difficult for a cure [2].

Modern (Allopathic Medicine) View
Vitiligo is a common acquired disorder of skin pigmentation characterized by localized loss of skin pigments secondary to melanocytes damage.It is estimated to affect approximately 0.5 to 1% of the population worldwide.It results from an autoimmune process that damages melanocytes.The disease disturbs individuals psychologically, particularly in dark-skinned victims.The cause is multifactorial, may be genetic, autoimmunity, neurologic factors, toxic metabolites, and lack of melanocyte production or early degeneration of melanocytes.
According to modern pathophysiology, in generalized vitiligo, melanocytes are not found in the affected skin.Melanocytes contain the pigment melanin which serves a protective action against the harmful effects of sunlight.
Phenylalanine → Tyrosine → Dihydroxyphenylalanine (DOPA) → Melanin (adrenals) Melanin formation in the skin is augmented by the hormone Melanocyte Stimulating Hormone (MSH) or intermedion secreted by the pars intermedia of the pituitary gland.ACTH by anterior pituitary has melanocyte stimulating activity similar to MSH although to a much lesser degree.25% of cases are autoimmune.
The pathogenesis is thought to involve an autoimmune process targeted against melanocytes.Histologic studies showed an absence of melanocytes in the affected skin.An autoimmune process is also suggested by the concomitant occurrence of other autoimmune diseases in patients with vitiligo.Patients with vitiligo have an increased incidence of several autoimmune disorders including hypothyroidism (common), Graves' disease, pernicious anemia, Addison's disease, alopecia areata, chronic mucocutaneous candidiasis, etc. Diabetes mellitus is also associated with some subjects.Vitiligo is a T-cell mediated autoimmune disease.Heat shock protein 70 (HSP70) plays a central nonredundant role in precipitating of depigmentation in vitiligo.

Informed consent
Informed consent about nature and purpose of study from each patient was taken.

Collection of Material:
From well known Ayurveda raw material dispenser.
Practically used dose: adults-3 to 5 grams Children-doses adjusted according to age and weight.
Local Application: as required Natural phototherapy (sunbath)-5 to 20 mins, early in the morning as required depending on sunrays intensity and body response.

Mode of administration
Patients were advised to take medicine as per scheduled dose 2 times a day after food.Also advised for applying local application once in a day in the early morning and advised to take natural sun exposure on affected areas.Intermittently panchakarma procedures like vamana, virechan, basti, and raktamokshan were carried out in these patients as and when required as per textual guidelines.

Duration of treatment
One month to one year.Follow up-Monthly for one year.

Observations Doshaja type of disease shwitra-vitiligo (classification)
It is shown in table 2 and figure 1.

Disease severity in observed patients
It is given in table 3 and figure 2.

Observations regarding etiology (Table 4 and Figure 3)
Observations were made in the following ways; Initial areas of white lesions were taken as 100% for each patient separately.The response to the treatment was observed in terms of normal pigmentation developed and reduction in the area of depigmentation after the treatment and expressed as percentage improvement in each patient.Most important factor noted was that the areas of repigmentation developed.Repigmentation developed by way of new spots of skin color at the base of hair follicles or as borders between the normal and affected skin and the baseline recoloration.Photographs before and after treatment were taken and shown in figures 4-20, also side effects if any were observed, noted and treated accordingly.
Percentage relief was calculated according to following formula:     The criteria for evaluation were decided which are presented in table 5.
Change in the mean of severity before and after treatment is calculated.Statistical methods like mean, Standard Deviation (SD), Standard Error (SE), etc., are applied to find out variations in observations.6 and Figure 21) Calculations [12] We take the sample size as 200 and apply paired "Z test".

1.
X1=% of vitiligo lesions before treatment i.e., 100% for a particular patient The observed 'Z' value is 31.53times the standard error.Here probability is <0.001.So it is highly significant at 99.9% confidence limits.

Journal of Clinical and Cosmetic Dermatology
Open Access Journal a b Probability comes to <0.001 (real variability).So the difference in the means of two sets of observations is highly significant at 1% (0.1%) level.So we reject the null hypothesis and accept the alternative hypothesis (H 1 ).So the Ayurvedic treatment approach with "Polyherbal powder mixture shwitrayoga along with local application, phototherapy and panchakarma therapy" is responsible for this difference.

Summary-Discussion
This is a single-blind clinical trial on patients with vitiligo.Total 200 patients were treated and observed for the response with Ayurvedic treatment with polyherbal powder mixture "shwitrayoga" along with local application and phototherapy with intermittent panchakarma treatment.Percentage of repigmentation noted with regular follow up of patients.
The observations can be summarized as follows: • Patients from all age groups and both sexes were treated and observed.
• Thirty patients were noted with history of inheritance.
• It was noted that some patients also suffered from other endocrine diseases like diabetes mellitus and hypothyroidism along with Journal of Clinical and Cosmetic Dermatology Open Access Journal vitiligo.In these patients management of these disorders was also needed along with treatment for vitiligo.
• Causative factors like unbalanced diet (viruddhahara), excessive consumption of milk, rice, non-vegetarian food, etc. were noted.Stress, disturbed lifestyle was also found in significant number of cases.In some patients, environmental factors like pollution, unmatched working atmosphere, etc might be the causative factors.In a significant number of patients cause of vitiligo was unknown; some of these categories might be of an autoimmune mechanism.
• Past history of taking allopathic medicines including steroids was noted in a significant number of cases for the cure of vitiligo at other treatment centers.Patients under trial were treated after many days, months or years after taking these types of drugs.So the probability of interference in the results of these drugs becomes very less or nil.
• The early cure was noted in patients with short duration of disease occurrence (few days to 2-3 months).Repigmentation was started between 3-4 weeks of starting the treatment in a significant number of cases.
• Duration of response to treatment varied with the individual patient.Some patients with fresh disease and a lesser percentage of depigmentation responded quickly in few days to months.Patients with chronic, longstanding disease (>year), and those who tried other treatment options previously responded irregularly and generally, longer time was taken for a response to treatment.
• Response to treatment in patients with a history of inheritance was guarded.It was very hard to get a complete cure in these patients.Although we got a moderate cure in these patients.
• Autoimmune and hereditary type patients were managed by doing frequent panchakarma treatments.It seems that the panchakarma brings very good immune-neuro-hormonal balance in human body.So better homeostasis is achieved which brings out faster results.
• The good or almost complete cure was achieved even in areas like lips, scalp, joints that are described as difficult for cure or incurable in texts.
• One patient with scar due to burns responded poorly probably due to fibrosis in the affected area.
• No major side effects of the treatment given were observed.
Minor side effects like gastrointestinal discomfort, redness, and itching of affected skin were noted in some patients.These were managed accordingly.
• Shwitrayoga formulation is safe and well tolerated by children and elderly also for long-term use.It is not tried in pregnant and lactating ladies.
• 10 patients left treatment for various reasons i.e., lack of time, money, longer duration of treatment, unable to follow pathya (Do's and dont's) etc.
• No negative results of the treatment were noted in any patient that means that disease didn't get worsened due to treatment.
• No recurrence after stoppage of treatment was noted even after one year or more in completely cured patients.In others, the progress remained stationary but didn't get worsened.
• The treatment was effective in almost all types of vitiligo except vranaja (Scar).Majority of patients observed were of kaphaja type followed by pittja shwitra (vitiligo).No patient of vatajashwitra (vitiligo) was observed.

Conclusion
The following conclusion can be drawn from the present study • The trial therapy with Ayurvedic polyherbal powder mixture 'Shwitrayoga' with a local application, Phototherapy (natural) and panchakarma has statistically highly significant results in vitiligo.
• The results of internal medications and local treatment were aggravated after the panchakarma procedures.
• Autoimmune and hereditary type patients can be better managed by doing frequent panchakarmas.It seems that the panchakarma brings very good immune-neuro-hormonal balance in human body.So better homeostasis is achieved which brings out faster results.
• The results of the present study need to be verified by taking larger sample size at institute level.
• There is also need to do some laboratory research like estimation of MSH and other related hormones in blood before, during and after the treatment.
• Results show that there is very effective and safe treatment available for vitiligo patients.
a. Patients complaining of white depigmentation areas over skin as the main complaint.b.Patients from age 5 to 60 years of age.c.Selection is irrespective of the constitution (prakruti), sex, duration of the disease.d.Patients with or without a family history (kulavrutta) of vitiligo.B) Exclusion criteria a. Patients below age of 5 years and above 70 years of age.
of vitiligo lesions before treatment A L =% of vitiligo lesions after 12 months of treatment.(After the end of treatment).

Figure 2 :Figure 3 :Table 2 :
Figure 2: Severity of vitiligo in observed patients hypothesis-there is no real difference between the means of two sets of observations.3. SD of differences=25.454. SE of difference= 25

Table 3 :
Disease severity in observed patients

Table 5 :
The criteria for evaluation was decided as