A comparative study of homoeopathic medicine – Sulphur with the Multidrug therapy in the treatment of paucibacillary leprosy

India accounts for 60% of the world’s new leprosy cases, the WHO says, and New Delhi is among regions that recorded an increased prevalence of the curable disease which often attracts social ostracism because of ignorance.
The country registered more than 127,000 confirmed cases of leprosy in 2015, show data in the Fourth WHO Report on Neglected Tropical Diseases released on Wednesday.
“Four states, Delhi, Lakshadweep, Chandigarh and Odisha, reported increased prevalence over the past year, though they had earlier achieved elimination,” a health ministry official said.
India has not recorded a drastic fall in new cases since successfully eliminating leprosy — less than one case for 10,000 people — in December 2005.
The annual new case detection and prevalence rates, indicators of the eradication programme’s success, have not improved since 2005, largely because India stopped active surveillance after reaching elimination levels.

 
New cases have gone down marginally over the past decade: from 139,000 in 2006 to 127,000 in 2015. But 118 districts still have to reach the elimination level. Chhattisgarh and Dadar and Nagar Haveli are the worst affected.
The number of new cases with Grade 2 disability — affecting the eyes, hands and feet — has gone up from 3,015 in 2005-2006 to 5,851 in 2005-2016, shows Union health ministry data.
Finance Minister Arun Jaitley has set out in the 2017 budget speech an aim to eradicate leprosy from India by 2018. Through the increased health budget, drives are taking place in order to “not just eliminate [the disease], but eradicate it as well” says the Times of India.
This is by no means a new programme; government programmes dating back to 1955 have aimed to eradicate the disease. It is undeniable that there has been a large degree of success in the area. Prime Minister Narendra Modi said recently:  “The goal of leprosy elimination as a public health problem that its prevalence rate of less than one case per 10,000 population at the national level, was achieved in 2005”. The standard for elimination of a disease is less than one case per 10,000, eradication being the complete absence of new cases.
The current prevalence rate as of 2014 is 0.68 per 10,000 (86,000 cases). Though the prevalence of the disease has been reduced, it is still higher in India than the global average of 0.2 cases per 10,000. India currently holds 57 percent of the world’s leprosy patients, with Brazil and Indonesia also having high numbers of leprosy cases.
The strategy set out in the budget and in the campaign kickstarted by health authorities on the 2nd February has placed a focus on grassroots campaigns to identify cases in the early stages. The Sparsh Leprosy Awareness Campaign (SLAC), launched from Gurgaon under the National Leprosy Eradication Programme (NLEP) aims to entirely eradicate the disease.
In the early stages the disease can be treated with little long lasting effects to the patient. However, left untreated the disease causes permanent deformations to the extremities, leading to disability.
Though total eradication of leprosy is an admirable goal, it may be one that is entirely out of reach. Reduction to lower levels, perhaps that of the global average, is entirely possible, though few countries can boast of total eradication. In cases where eradication has been achieved, it is typically in a country with a small population such as Malta. For India, with a population of over one billion, and a far higher number of initial cases of leprosy this is far more of a challenge.
Leprosy is infamous for being difficult to study. Mycobacterium leprae, the bacteria which causes the disease, has yet to be cultured in vitro (outside of a human host). As such, many aspects of the disease are poorly understood. For example, in most bacterial infections, an established period of higher transmission rates is well understood. In leprosy, the method of transfer, as well as periods of heightened risk of transmission, are not established.
The time frame may be unrealistic. To reduce approximately 86,000 cases to nothing in the space of two years in itself is a challenge. This is without further infection or the possibility of cases slipping under the radar. Specific usage of the term eradication in the budget speech may be either wishful thinking or simply political point scoring. It is however a push in the right direction in terms of budget and grass root campaigns to further address and possibly reduce the number of disease cases.
[pdfjs-viewer url=”http%3A%2F%2Fwww.bjain.com%2Fhomeopathy360%2Fwp-content%2Fuploads%2F2017%2F11%2FNOTIFICATION-FINAL.pdf” viewer_width=100% viewer_height=1360px fullscreen=true download=true print=true]ABSTRACT
Background: Substantial number of patients with paucibacillary leprosy may still have active skin lesions at the end of MD treatment because of the continuing immune responses, though this does not denote failure of treatment. A clinical trial was conducted to compare efficacy of a homoeopathic medicine with MDT for the cure of leprosy.
Aim: To compare the effect of a homoeopathic medicine – Sulphur with the Multi drug in the treatment of Paucibacillary leprosy according to WHO guidelines.
Materials and Methods: Out of total 90 patients enlisted, 60 confirmed Borderline Tuberculoid (BT) leprosy patients of the age 14 years to less than 60 years were registered under this trial. All the patients were allotted a precoded number, randomly and equally divided in two groups. One group was treated with Sulphur in 200 potency in liquid orally once in week for two years and the other group received Paucibacillary (PB) regimen as recommended by WHO. At the end of two years findings were corroborated.
Results: The study showed that MDT therapy (PB regimen) and homoeopathic medicine were found equally effective as histopathology of skin showed no granulomatous lesion. The most significant clinical sign observed in all cases treated with Sulphur was reappearance of normal skin colour and regain of loss of sensation of the skin lesion.
Conclusions: MD therapy (PB regimen) and homoeopathic medicine were found equally effective. The patients of paucibacillary leprosy could get rid of the skin symptoms if treatment with Sulphur (is also given with MDT).
 
 
Keywords: 
 
 
 
 
INTRODUCTION
 
Leprosy is a chronic granulomatous disease caused by the bacillus Mycobacterium leprae which is still endemic in various parts of the world. It primarily
 
 
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How to cite this article: Chakraborty D, Das P, Dinda AK, Sengupta U, Chakraborty T, Sengupta J. A comparative study of homoeopathic medicine – Sulphur with the Multidrug therapy in the treatment of paucibacillary leprosy. Indian J Res Homoeopathy 2015;9:158-66.
 
 
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Chakraborty, et al.: Comparative study between Sulphur and MDT for treatment of paucibacillary leprosy
 
 
affects the skin and peripheral nerves. Clinical presentation depends on the patient’s immune status at the time of infection and during the course of the disease.
 
Due to the implementation of Multidrug Therapy (MDT), the prevalence of the disease has remarkably gone down. Incidence refers to the number of newly detected case in the same period and population (1). Despite an efficient MDT coverage, new case detection rate remains at 4.41 per 10,000 as revealed from a survey conducted in year 2009 in selected endemic districts of two states.[1] Despite an efficient MDT coverage, new case detection rate remains at 4.41/10,000 as revealed from a survey conducted in the year 2009 in selected endemic districts of two states. However, National Leprosy Eradication Programme report revealed that the new case detection rate has declined further as shown 9.98/100,000 in 2013–14.[2‑4] and a significant percent of these are children.[4‑7] After completion of MDT for 6 month in paucibacillary (PB) leprosy and 1 year in multibacillary (MB) leprosy, clinically most of the patients do not feel cured because of the existence of the symptoms of lesion for a long time. Further viable M. leprae have been convincingly detected from such lesions after completion of MDT.[19,20] Due to this therapy persisters may get an opportunity for relapse[20,21] and resistant organisms may propagate slowly to infect a host with the primary resistant organism.[8,9] Studies from India and Mali showed that patients with a very high initial bacterial load (bacterial index more than 4+ on skin smear) have higher relapse rates (4– 7/100 person years) and these relapses may occur late (averaging 5 years after treatment).[10] Therefore, all these factors might be playing an important role in the efficacy reduction of incidence rate in endemic population in India.
 
In leprosy, the peripheral neuropathy is caused by the M. leprae and its accompanying immunologic events. The course and sequelae of the immunologic events often extend many years, may continue long after effective antimicrobial treatment and may have severely debilitating physical, social, and psychological consequences. The immune system of the host gets adversely affected, and available drugs do not promote a symptomatic recovery.
 
Homoeopathic medicine is known to cure or improve the clinical symptoms of many chronic diseases.[11‑18] This system of medicine has recently been shown
to cure allergic individuals by modulating the immune status.[20] It has also been shown that these medicines are capable to increase the number of CD4+ T cells in AIDS patient.[16] In the recent past, a randomized double blind clinical controlled trial conducted on multidrug treated leprosy patients who have been released from treatment has demonstrated remarkable success in the treatment of chronic ulcer and loss of sensation.[17] It has been reported that the some homoeopathic medicine does possess reversal efficacy of peripheral nerve function in leprosy.[18,19]  
Leprosy still poses major therapeutic challenges. It has been reported that a substantial number of patients with PB leprosy may still have active skin lesions at the end of treatment because of the continuing immune responses though this does not denote failure of treatment.[21]  
A clinical trial was undertaken to prove and compare the efficacy of homoeopathic medicine with MDT for the cure of leprosy.
 
MATERIALS AND METHODS
 
In compliance with the WHO guideline on clinical research trial, this trial was registered with Clinical Trial Registry – India (www.ctri.nic.in), Registration No. CTRI/2008/091/000080 Dated – 25.11.2008. This project was approved by the IEC of this Institute and subsequently by the Ministry of Health and Family Welfare, Government of India. Informed written consent was obtained from all the participants included in this study.
 
A total of 90 patients reported with hypopigmented and hypoesthetic skin lesion with or without neural pain between the period, ‘June to August 2007’ were enlisted. All these patients were examined thoroughly based on the classification on the Ridley‑Jopling scale.[22] Out of these patients, 60 confirmed borderline tuberculoid (BT) leprosy patients of the age 14 years of age to <60 years were registered under this trial. All the patients were allotted a precoded number, randomly and equally divided into two groups. One group (Group A) was treated with Sulphur in 200c potency in liquid per os once in the week for 2 years.
 
The selection of Sulphur was based on the cardinal sign and symptoms of shown by Tuberculoid leprosy (TT) and BT leprosy patients, mainly sensory loss
 
 
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Chakraborty, et al.: Comparative study between Sulphur and MDT for treatment of paucibacillary leprosy
 
 
over the lesion area due to damage of peripheral nerve by M. leprae. The signs and symptoms simulate the indication of sulfur are listed below.
Indication of Sulphur
 

1. In leprosy sign and symptoms exhibit through various types of skin patches which are dry with complete loss of sensation. Sensory loss is due to damage of peripheral nerve by leprae

 

2. Sulphur is the king of anti‑psoric medicine having special affinity for the skin and nervous system

 

3. Characteristic skin symptoms of Sulphur are very similar to the skin lesion of tuberculoid type of leprosy which are almost dry and scaly

 

4. Sulphur patient subjected to venous plethora manifested by redness of skin which is similar to erythematous lesion of BT leprosy

 

5. Sulphur frequently arouses the reactionary power of the organism[23] and make the organ reactive
6. Skin has symptoms as burning sensation on hands and feet

 

7. Physically, most of the patients are weak, unhealthy and dirty. Mentally they are always found irritable and forgetful.

 
Leprosy is the mother of chronic miasm, psora, so an indication of Sulphur prompted to be selected for the treatment of a tuberculoid type of leprosy cases.
 
The other group (Group B) received PB regimen. This regimen includes Rifampicin 600 mg once monthly and dapsone 100 mg daily for 6 months as recommended by WHO.
 
After registration all the patients were subjected for detail clinical examination and clinical sign were recorded in details by a dermatologist and physiotherapist. During the study, all the patients were subjected for clinical examination every 6 month interval. Slit skin smear was done in each patient of both the groups at the time of registration and at the end of 2 years.
 
To assess the immunological status or cell‑mediated immune state in leprosy patients across the spectrum of disease, Lepromin test was carried in each patient of both the groups at the time of registration and at the end of 2 years using Dharmendra antigen, a suspension of defatted leprosy bacilli first reported by Dharmendra.[24] It was further standardized by bacterial count.[25] This antigen evokes an early as well as late reaction with an intradermal dose of 0.1 ml. Early reaction (Fernandez) was read after 48 to 72 hour and late reaction (Mitsuda) after 21 to 28 days of inoculation over the flexor surface of
the right forearm. Induration of 5 mm and above with erythema of 10 mm or more was considered as positive. The early responses were graded as erythematous edema doubtful E (<5 mm), 1+ (5–9 mm), 2+ (10–14 mm) and 3+ (15 mm and above). The absence of any response was considered negative. Similarly, late response graded as lack
 
of  evident  response  negative  (−ve).  Elevation  or
 
infiltration 3 o 4 mm doubtful (±) nodule (5 mm) 1+, 5 mm to 10 mm, and 2+, 10 mm above, 3+.
 
For the histopathologic study, using a 6 mm punch, skin biopsy was taken from the edge of the lesional area before the onset of treatment and at the end of treatment. The biopsies were fixed in 10% buffered formalin and processed. Five micron thick paraffin sections were cut and stained with hematoxylin and eosin, modified Fite‑Faraco method for demonstration of lepra bacilli in tissue sections.[26] All the biopsies were given coded number and evaluated under a light microscope by three pathologists independently to avoid any bias on interpretation among pre‑ and post‑treatment biopsies.
 
At the end of 2 years, on completion of treatment the code allotted to the patients were disclosed to the investigators and assessor for corroborating the findings of histopathology and immunology study.
 
All the patient were subjected to follow‑up study for another period of 2 years.
 
RESULTS AND DISCUSSION Clinical Signs
 
The clinical signs of all the patients are presented in Table 1.
 
Group A (before treatment)
 
Single large, well defined hypopigmented, hypoesthetic dry skin lesion was noticed in almost all the patients suggestive of BT leprosy. Single well defined reddish coloured patch with elevated margin present in hand with complete loss of sensation was recorded in some patients [Figure 1a]. The appearance of the patients was, in general, dull and psychological depression was noted in most of the cases [Figure 2a]. More than one lesion was found in 11 cases. These well‑defined hypopigmented, dry lesions were found on both hand and/or feet with the complete loss of sensation, perspiration, and hairs. In 6 cases, no nerve involvement was noticed.
 
 
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Chakraborty, et al.: Comparative study between Sulphur and MDT for treatment of paucibacillary leprosy
 
Table I: Comperative study between two groups (TT/BT) treated with a homoeopathic medicine and MDT in respect of reappearance of normal skin colour

	Patient treated with Sulphur (Gr – A)						Patient treated with MDT (PB) (Gr – B)
Code	Type	Regain of normal skin colour			Code Type			Regain of normal skin colour
		Before treatment	After treatment					Before treatment	After treatment
112/08 BT		Hypopigmented	Normal	101/08 BT				Hypopigmented	No change
118/08 BT		Dry, Hypopigmented	Normal	129/08 BT				Hypopigmented	No change
127/08 BT		Dry, Hypopigmented	Normal	102/08 BT				Dry, Hypopigmented	Disappeared
130/08 BT		Well marked Hypopigmented	Area decreased	105/08 BT				Dry, Hypopigmented	No change
131/08 BT		Dry, Hypopigmented	Normal	107/08 BT				Dry, Hypopigmented	No change
133/08 BT		Hypopigmented	Normal	108/08 BT				Well marked	Area decreased
136/08 BT		Hypopigmented	Normal	109/08 BT				Well marked copper coloured	No change
145/08 BT		Erythromatous with elevated margin	Normal		114/08 BT			Dry,Hypopigmented	No change
146/08 BT		Well marked, copper coloured	No change		I20/08	BT		Hypopigmented	No change
152/08 BT		Dry, Hypopigmented	Normal	124/08 BT				Dry, Hypopigmented	No change
159/08 BT		Erythromatous with elevated margin	Normal	123/08 BT				Dry, Hypopigmented	No change
283/08 BT		Dry, Hypopigmented	Normal	140/08 BT				Dry, Hypopigmented	No change
168/08 BT		Dry, Hypopigmented	Normal	143/08 BT				Dry, Hypopigmented	No change
183/08 BT		Copper coloured	Normal	151/08 BT				Dry, Hypopigmented	No change
190/08 BT		Dry, Hypopigmented patch	Normal	156/08 BT				Erythromatous with elevated margin	No change
191/08 BT		Dry, Hypopigmented patch	Normal	157/08 BT				Erythromatous with elevated margin	No change
113/08 BT		Blackish patch	Normal	163/08 BT				Dry, Hypopigmented	New Blister developed
144/08 BT		Hypopigmented	Normal	166/08 BT				Copper coloured patch	No change
202/08 BT		Dry, Hypopigmented	Normal	170/08 BT				Erythromatous patch	No change
209/08 BT		Hypopigmented	Normal	176/08 BT				Erythromatous with elevated margin	No change
211/08 BT		Hypopigmented	Normal	185/08 BT				Dry, Hypopigmented patch	No change
221/08 BT		Dry,Hypopigmented	Normal	193/08 BT				Hypopigmented	No change
232/08 BT		Hypopigmented	Normal	177/08 BT				Erythromatous patch	Disappear
237/08 BT		Dry,Hypopigmented	Normal	204/08 BT				Dry,Hypopigmented	No change
240/08 BT		Hypopigmented	Normal	216/08 BT				Dry,Hypopigmented	No change
246/08 BT		Dry,Hypopigmented	Normal	225/08 BT				Dry,Hypopigmented	No change
128/08 BT		Erythromatous with elevated margin	Normal	230/08 BT				Dry,Hypopigmented	No change
139/08 BT		Dry,Hypopigmented	Normal	235/08 BT				Dry,Hypopigmented	No change
138/08 BT		Well marked dry, Hypopigmented patch Normal		241/08 BT				Dry,Hypopigmented	Disappeared
117/08 BT		Dry,Hypopigmented	Normal	245/08 BT				Dry, Hypopigmented	No change

 
TT: Tuberculoid leprosy, BT: Borderline Tuberculoid, MDT: Multidrug Therapy, PB: Paucibacillary
 
 
Group A (after treatment)
 
After treatment, in 96.6% cases, the hypopigmented patch disappeared. The reappearance of normal skin color was gradual. Initially, at the end of 6 months the lesion was found to be less shiny. After 1 year of treatment all the hypopigmented patches nearly disappeared. At the end of 1½ years, the skin regained its normal texture and color and was found almost normal [Figure 1b]. Regain of sensation was recorded. Touch sensation was recovered first, and then pain and gradually heat and cold. The appearance was normal and no dullness or psychological depression was noted [Figure 2b]. The condition of the nerve was normal in all the cases except 2 cases.
Group B (before treatment)
 
The subjects of this group showed clinical signs identical to Group A. Single well defined reddish colored patch on hand, feet or any other part of the body was recorded with complete loss of sensation [Figure 3a]. Multiple hypopigmented patches were also found to be present on hand, feet and face with loss of sensation. Muscular atrophy was noticed in 1 case. Involvement of single nerve was recorded in 3 cases.
 
Group B (after treatment)
 
The patients with single well defined reddish colored patch changed into the ill‑defined patch with no regain of sensation. Muscular atrophy
 
 
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		b			a
a							b

 
 
Figure 1: (a) A boderline tuberculoid case with well defined erythromatous hypo-aesthetic patches present on left hand (wrist). Shape is irregular with elevated margin. (b) After one and half year of homoeopathic treatment of a Boderline Tuberculoid case the lesion disappeared
Figure 2: (a) A boderline tuberculoid case with psychological depression.
 

• After completion of homoeopathic treatment the lesion completely disappeared and the patient was found to get rid off psychological depression

 
 

		b
a

 
Figure 3: (a) A case of boderline tuberculoid leprosy showing well defined erythromatous hypo-aesthetic lesion in hand. (b) Photograph showing ill-defined erythromatous hypo-aesthetic lesion in hand of a Boderline Tuberculoid leprosy patient after two year of treatment with PB regimen of Multi drug
 
was present in 1 case. In 6.6% cases, patch almost disappeared without regain of sensation. In 94.6% cases, the hypopigmented, macular, hypoesthetic lesion remained unchanged. The clinical examination undertaken at 6 months period of interval demonstrated no change in the character of the lesion in 94.6% cases [Figure 3b]. No sweating was noted in the lesional area. Single nerve involvement was recorded in 3 cases as recorded at the time of registration.
 
Comparison between Groups A and B in respect of regain of sensation and reappearance of normal skin color are presented in graphical form in Graph 1 and Graph 2.
 
Slit skin smear of all patients of both the groups showed the absence of any organism before and after the treatment.
 

a		b

 
Figure 4: (a) Low power view of skin biopsy of a BT patient showing presence of multiple granuloma in the subepidermal region (H and E). (b) Extensive reduction in granuloma size. Cellular collection in the form of a streak and absence of infiltration around skin appendages are noted (H and E)
 
Histopathology
Group A (before treatment)
 
Epidermis unremarkable. Dermis showed a focal collection of lymphocytes and macrophages involving perivascular, periappendageal, and perineural spaces. Focal collection of epithelioid cell granulomas with giant cell formation was noticed in the subepidermal region [Figure 4a]. Sweat gland and sebaceous glands were found atrophied in many cases. Nerve fibers appeared swollen and infiltrated by lymphocytes in some cases.
 
Group A (after treatment)
 
In general, epidermis appeared unremarkable. Mild collagenization was noticed in the dermis. In dermis extensive reduction in granuloma sizes were recorded [Figure 4b]. No cellular infiltration around skin appendages was noticed. In some cases cellular collection in the form of a streak noted.
 
After 2 years, epidermis appeared unremarkable. Dermis showed normal appearance with dermal
 
 
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Chakraborty, et al.: Comparative study between Sulphur and MDT for treatment of paucibacillary leprosy
 
 
appendages and nerve twigs. No nerve infiltration was seen. Sweat glands and hair follicles were well defined. In some cases, mild collagenization was noticed in the dermis.
 
Group B (before treatment)
 
Sections showed a picture of hyperkeratosis and acanthosis of the epidermis. Dermis showed perineural, intraneural and periappendageal accumulation of macrophage cell and few epithelioid cells in granuloma formation. In 3 cases, multiple granuloma just below the epidermis and in the deep
 

		b
a

 
Figure 5: (a) A huge granuloma in the dermis extending upto skin appendages including hair follicle. Essentially a macrophage granuloma interspersed with a few lymphocytes (H and E). (b) Lower power view of the skin section showing resolution of all granuloma (H and E)
 

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Graph 1: Comparative study of homoeopathy and MDT [TT, BT] in respect of regain of sensation
 

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Graph 2: Comparative study of homoeopathy and MDT [TT,BT] inrespect of Reappearence of nofmal skin colour
dermis were seen. Flattening of the rete pegs of the epidermis was also noted [Figure 5a]. The presence of acid fast bacilli in the form of clusters and globi all throughout the granuloma was recorded in 1 case.
 
Group B (after treatment)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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