A Comparative Clinical Study on the Efficacy of Granthi Śāmaka Lepa And Śotha Nāśaka Lepa in the Management of Medaja Granthi W.S.R to Lipoma

Introduction

Āyurveda is a holistic science which aims to show the right path to attain puruṣarthās. The medium through which these puruṣarthās can be attained is a health body and mind. A person can only be called healthy if he possesses a healthy body along with a healthy mind. Diseases affecting the body invariably affects the mind & vice versa and results in ill-health of the patient. One of the best examples for such a disease is Medaja granthi i.e Lipoma. Even though it is a physical disease i.e. mainly affecting the body, it also affects the mind as it results in cosmetic disfigurement of the body; especially for women when the lipoma is located over the exposed body parts like arms, forearms, neck or face. Due to beauty related issues, the social stigma associated with this may lead to anxiety and also severe depression in long standing cases.

The most accepted conventional line of treatment of lipoma in the contemporary science is surgical excision of the swelling. Common removal techniques are limited by the risk of scarring and recurrence. Various other methods like liposuction, infiltration of steroids etc are also being practiced by many surgeons but with minimal success rate.

Āyurveda provides solution to various ailments where the contemporary science fails to give a permanent cure, provided the condition is properly understood as per the classics and treated as per the classical line of treatment given by our ācharyas. Same in the case of Medaja granthi i.e lipoma. There is an intense need of research to dig out a permanent solution from our ayurvedic classics as the modern science doesn’t provide complete relief from this condition. Unfortunately, there is limited work that has been done so far on this condition and hence it opens up a huge opportunity for young researchers to work on it and try to find out an efficient treatment as per our ayurvedic classics.

The present study was taken up with the same intension to find an efficient treatment for medaja granthi and form a standard protocol to manage the condition with ayurvedic medicines.

Review Of Literature

• Vedic Period (8000 BC – 6000 BC): Though there are no direct references of medaja granthi in vedās that can be correlated to lipoma, the word Granthi is seen in various contexts. Some of them are mentioned below:

• In Ṛigveda – The word Granthi has been used in the verse:

“Granthim naviṣya grathitam punāna rujum ca gaatum vṛjinam ca soma

Atyo na krado harirā sṛjāno maryo deva dhanva pastyāvān” ¹

Meaning of the verse is: (Soma), when filtered loose (me) bound (by sin) as (one loose) a knot; (grant me) a straight path and strength. You, green tinted, neigh like a horse (when you are) let loose: proceed divine (soma) who are friendly to man, and have a dwelling.

The word Granthi here refers to a Knot of sins.

• In Atharva veda - The word Granthi has been used which bears the meaning as - bunch or protuberance of any kind (especially if produced by tying several things together).²
• The word Granthi is also mentioned in Srīmad Bhāgavatam, Taittarīya saṃhitā, Prabodha Candrodaya, Pāṭha rāmāyaṇa, Shree Rāmacaritamānasa and Saṃsāra rāmāyaṇa which means a Knot.²
• In Cāndogya-upaniṣad, Kaṭha-upaniṣad and Māṇdūka-upaniṣad, the reference for the use of the word Granthi is available, which means ‘a knot tied closely and therefore difficult to be undone’.² In Mahābhārata, one can find the reference for the word Granthi in Kīcaka Vadhā parva, which means a knot.² In Pañcatantra, the word Granthi is mentioned which means a knot, tie, knot of a cord, knot tied in the end of a garment for keeping money.²
• Granthi also means the joint of the body as per Mṛcchākaṭikā, Dhūrtasamāgama and Sāhitya darpaṇa.²

The word Granthi in all the above context means a knot or a protuberance. This gives an insight about the presentation of the granthi over the body and also justifies the use of the word Granthi for this condition by our ācharyās.

• Post-Vedic Period (after 6000 BC):

1. Samhita Period (1000 BC - 700 BC): This period was the golden era for Ayurveda. During this period, both Suśruta and Charaka explained in detail about Granthi roga, Nidāna, Samprāpti, Lakshana, Cikitsā and Pathyāpathya.

2. Sangraha Period (7th AD): Vridha vāgbhatta and laghu vāgbhatta both mentioned regarding granthi in their treatises.

3. Medieval Period (1000 AD- 1800 AD): description regarding granthi can also be obtained from Mādhava nidāna, Chakradatta, Gada Nigraha, Cikitsāsārasaṇgraha of Vangasena, Śāraṅgadhara saṃhita, Yoga Ratnākara and Bhaishajya Ratnavali.

4. Ādhunika Kāla (1800 AD onwards): All the Āchāryas like Vaidya Yadavaji Trikambji Acharaya, kaviraja Ramaprakash Pathak, Vidhyadhara Shukla, Shivacharana Dhyaani etc. have described and compared medaja granthi to lipoma in their respective books.

Disease Review

Nidāna of Medaja Granthi

No specific Nidāna of medaja granthi is mentioned in the classics. The general causative factors that are mentioned for granthi which lead to vitiation of tridoṣas can be considered for the formation of medaja granthi are as follows:

Factors which directly result in the vitiation of tridoṣās form the cause for the granthi. Medo dhātu prakopakara nidānās³ like avyāyāma, divāswapna, medhyānna (excess intake of fatty animal meat) and consumption of vāruṇi (a variety of fermented drink prepared by palm dates and date fruits) etc act as the primary factors for the causation of medaja granthi.

Alongside, diets that are of mixed variety and incompatible in nature, indigestion, improper timing of food, combination of food stuffs of opposite quality, putrefied water, liquor and flesh, dried vegetables especially mūlaka can be few other factors. Improper diet, abnormal seasonal variations, wind blowing from east, exertion, weakness, abhighāta etc also play their role in causation of medaja granthi.

The classification of granthi is based on the predominant doṣa and the site of manifestation (Table 1). Suśruta, Mādhavakara, Bhāvamiśra, Yogaratnākara, Bhoja classified granthi into five types. Caraka has explained 6 types of granthi while Vāgbhaṭa and śārangadhara explained nine types of granthi.

Samprāpti of Medaja Granthi

Doṣās being aggravated by their respective causative factors lead to the māndyatā of pācakāgni and result in the formation of āma. This āma produced causes vitiation of tridoṣās and in turn leads to vitiation of rasādi dhātwāgnīs. Vitiation of subsequent dhatwāgnīs result in abnormal nourishment of their respective dhatūs. In the progression of samprāpti of medaja granthi, vitiation of medo dhātwāgni leading to its mandyatā results in the vṛdhi of the dhātu.⁹ This dhātu vṛdhi which has occurred here is the product of deviation of normal metabolic process resulted because of māndyatā of medo dhātwāgni and quantitatively increase the vikruta medo dhātu or mala rūpī medo dhatu that does not involve in the poṣaṇa of the subsequent dhatūs. The vikruta mala rūpī medo dhatu along with vitiated rakta, maṃsa and kapha gets accumulated below the tvak region giving rise to a swelling which is soft, mobile and slightly elevated above the skin level, causing mild itching and exudes a secretion resembling piṇyāka or ghṛta. It increases or decreases in size with the increase or decrease of body weight depending on the growth of the body.

Cikitsā of Medaja Granthi

Specific treatment of Medaja granthi as per various treatise is as follows:

1. Suśruta Samhita:¹⁰

In a case of medaja granthi, a plaster of pasted sesamum placed inside the folds of a piece of linen should be applied to the seat of the affected part and fomentation with hot iron rods should be frequently applied, as application of heat is effective in such cases.

As an alternative method, the affected part should be fomented with a ladle, pasted with heated lakshā (shellac). The granthi should be opened by an incision, fat to be removed and the operated wound should then be cauterized. On the outer hand, the granthi when fully suppurated should be incised and washed with cow’s urine. Then a paste of sesamum, suvarcikā, haritāla and rock salt pounded together and mixed with honey, ghee and copious quantity of yava kṣāra should be applied to the operative wound for purifying purposes. Oil cooked with two kinds of karanja, gunjā, the green scrapings of bamboo, ingudi and cow’s urine should be used for healing of wound.

2. Aṣtāṅga Sangraha:¹¹

As per vṛdha Vāgbhaṭa, the treatment principles for medaja granthi are similar to that of maṃsaja granthi and rest of the treatment (agni karma) is similar to that mentioned by suśruta.

3. Aṣtāṅga Hṛdaya:¹²

Laghu Vāgbhaṭa also explains the same treatment like that of suśruta, but he advices to use double folded cloth over the applied paste of sesamum before agnikarma. A red-hot metal plate is used to flatten the granthi by giving indirect heat over the granthi or alternatively complete expulsion of the contents of the granthi followed by agnikarma is advised. Here, Agnikarma is advised at the end of the procedure by all the authors to avoid recurrence of the granthi.

4. Yogaratnākara¹³, Chakradatta¹⁴, Gada Nigraha¹⁵, Bhāvaprakāśa¹⁶

Treatment mentioned is similar to that of suśruta. Apakva granthi should be surgically removed and vraṇavat cikitsā should be done using jātyādi ghṛta or any vraṇa ropaṇa yogās.

Lipoma

Lipomas are the commonest form of benign soft tissue tumours arising from yellow fat, with a prevalence of 2.1 per 100 people.¹⁷ Often it can be hyperplasia or a combination of neoplasm and hyperplasia with karyotype 12q change.¹⁸ They are usually subcutaneous and present as a soft, fluctuant, lobulated masses due to thin fibrous septa which are neither fixed to skin nor to deep tissues. The lesions grow slowly and as they have features similar to the surrounding fat, they usually have to reach 2–3 cm in diameter before a patient presents.¹⁹ A lipoma is composed of mature adipocytes and uniform nuclei that are identical to those seen in normal adult fat. The fat in lipoma is considered unavailable for general metabolism.18 Lipomas may arise in any connective tissue, especially in the subcutaneous fat, particularly around the shoulder and over the trunk. It is called as universal tumour (ubiquitous tumour) as it can occur anywhere in the body (except in brain). They do not occur in the palm, sole of the foot or the scalp because in these areas, the fat is contained within dense fibrous septa. They can be single or multiple (5%).

Pathogenesis of Lipoma20

1. Biochemical and Genetic Pathology

A genetic link has been demonstrated that cites that about two-thirds of lipomas exhibit genetic abnormalities. In a subgroup of lipomas, the HMGA² gene (located on 12q14.3) was involved in tumor pathogenesis.

2. Post – trauma pathology

A possible mechanism of action of lipoma development is post-trauma to the respective area. It has also been theorized that this is true only for traumas that result in necrosis of adipose/fat cells and subsequent local inflammation, and that these are what are responsible for triggering the lipoma formation.

Treatment of Lipoma

Excision is the most preferred form of procedure in treating lipoma along with other modalities like liposuction, microwave ablation etc.²¹

Research Materials And Methodology Research Materials:

The present clinical study included 40 patients who were randomly divided into two groups: Group-A and Group-B with 20 patients each. Group-A patients were treated with Granthi śāmaka lepa and Group-B patients were treated with Śotha nāśaka lepa. Patients in both the groups received Śiva gutika as internal medicine.

Description of the Yoga as per the classics:22 (Table 2)

The reference of Granthi śāmaka lepa is taken from Sidha bheṣaja maṇimāla which is mentioned in caturtha guccha, under the context of Gaṇdamālagranthyādi cikitsā.

Bhasma of both kārpāsa and mudga are prepared separately and mixed in equal proportion. This mixture is used for lepana karma over the granthi mixed with sufficient quantity of water. The lepa is removed before it is completely dried and Ghṛta is applied over the granthi in the end once the lepa is removed (to avoid vāta prakopa).

Description of the Yoga as per the classics:23 (Table 3)

The reference of Śotha nāśaka lepa is taken from Śārangadhara Saṃhita which is mentioned in Uttara khaṇda 11th adhyāya.

Equal quantity of sūkshma chūrṇa of Punarnavā, Devadārū, Śuṇṭhī, Sidhārtha and Śigru should be taken and made into paste form by mixing it with sufficient quantity of kāñji and this paste should be applied over the granthi.

Required quantity of Śotha nāśaka lepa cūrṇa was taken in a clean vessel, thoroughly mixed with sufficient quantity of āranāla and the paste obtained was daily applied over the medaja granthi.

The patient was asked to remove the lepa as soon as he starts to feel the tightness of the skin or feels itching over the lepa region. After removing the lepa over the granthi, 1-2 drops of ghrīta was applied over the granthi to prevent vata prakopa due to dryness of the skin.

Research Methodology:

Present study is a randomized, comparative clinical study conducted to compare the efficacy of two lepana karma along with a śamana auṣadhi in the management of Medaja granthi w.s.r to Lipoma. The total duration of the intervention in both the groups was 30 days. The observations and results obtained from the clinical study were analysed statistically to evaluate the significance of the curative properties of therapies.

Patients suffering from medaja granthi fulfilling the inclusion criteria were selected. The patients were subjected for detailed clinical examination and investigations as per the specially designed proforma.

Inclusion criteria:

1. Subjects with the clinical features of Medaja Granthi / Lipoma were included.

2. Subjects of all age groups were included irrespective of sex.

3. Both solitary and multiple lipomas were included.

In case of subjects with multiple lipomas, each lipoma was taken as an individual unit, considering it as a separate sample. So even though the size of both the groups were fixed to be 20 for the purpose of statistical analysis, ‘n’ was decided based on the total number of lipomas included for clinical trial in that particular group of 20 subjects.

So in Group A, n = 29 (i.e. in 20 patients, a total of 29 lipomas were considered in the study) and in Group B, n = 25 (i.e. in 20 patients, a total of 25 lipomas were considered in the study).

Exclusion criteria:

1. Subjects suffering from serious systemic disorders like HIV, HbsAg, DM etc were excluded.

2. Lipomas having malignant changes were excluded.

3. Neurolipoma, Naevolipoma, Fibrolipoma, lipomas having presence of other tissues along with adipocytes were excluded.

4. Lipomas with complications like calcification, myxomatous changes, ulceration etc were excluded.

5. Lipomas with sarcomatous changes were excluded.

6. Pregnant and lactating women were excluded.

Measuring the longest diameter of the lipoma in both the groups

Longest diameter of the lipoma was measured with the help of a vernier caliper and expressed in centimeters.

OBSERVED READING = Main Scale Reading + (Vernier scale coincidence x Least count)

Clinical Parameters of the study:

Objective Parameters –

1. Longest diameter of the lipoma

2. Number of lipomas

As the data collected in assessing the objective parameters of the present study are scaled data i.e simple, continuous numerical data, statistical analysis of the study was done using numerical values (longest diameter of the lipoma and number of lipomas) directly collected during assessment.

Discussion On Granthi Śāmaka Lepa

The drugs Kārpāsa and Mudga are the constituents of Granthi śāmaka lepa. As both the drugs were used in the form of bhasma, the absorption of the drugs was significantly high compared to regular lepa done with sūkṣhma chūrna of drugs.

Kārpāsa or cotton seeds are basically glanded seeds having traces of oil within them. One of the major compositions of this cotton seed oil is Gossypol - a natural phenol derived from the cotton seed. Gossypol is a phenolic aldehyde that permeates cells and acts as an inhibitor for several dehydrogenase enzymes. It is proved in various researches that the Gossypol-enriched cottonseed oil inhibits proliferation and adipogenesis of human breast pre-adipocytes.As per ayurvedic classics, kārpāsa has madhura, kaṣāya rasa, iṣat uṣṇa vīrya and laghu, tīkṣhṇa guṇa and does vāta śamana along with pitta shamana.

Mudga possesses properties like madhura and kaṣāya rasa, laghu and rūkṣṇa guṇa and it is a potent kapha - pitta hara. It also possesses grāhi property which helps in increasing the localized agni on application of its lepa, promoting its absorption into the skin and aiding penetration of medicine into the lipomatous tumour.

So these properties of the kārpāsa bīja and mudga, along with optimum absorption in the form of bhasma played a major role in reducing the size of the medaja granthi i.e. lipomas with adipocytes as their major composition.

Discussion On Śotha Nāśaka Lepa

Śotha nāśaka lepa contains punarnava, devadārū, ṣunṭi, sidhārtha (sarṣapa) and śigru. All the drugs of śotha nāṣaka lepa have vāta-sleṣma hara properties which directly pacify the doṣās responsible in the pathogenesis of medaja granthi. The drugs acted based on their katu, tikta and kaṣāya rasa, uṣṇa vīrya, laghu rūkṣa guṇa and their inherited vāta-sleṣma hara property. As the sūkṣma chūrṇa of all the drugs were used in the preparation of lepa, the absorption of the drugs was relatively less compared to Granthi śāmaka lepa where bhasmās of the drugs were used to prepare the lepa.

Kāñjī or dhānyāmla was used as the drava dravya for the application of lepa in group B. The doṣakarma of dhanyamla is vata kapha hara when there is an association with pitta dosha. In the present study, the predominant symptoms were of vata and kapha origin. So the doṣakarma of dhanyamla has worked positively on the above said criteria.

Conclusion Of The Study

• Based on the percentage of improvement seen (66.04% in group A and 47.64% in group B), we can conclude that the intervention in Group A is clinically more significant than the intervention in Group B on the parameter - longest diameter of the lipoma with 99.99% level of significance.
• Based on the percentage of improvement seen (23.56% in group A and 8% in group B), we can conclude that the intervention in Group A is clinically more significant than the intervention in Group B on the parameter - number of lipomas with 99.99% level of significance.
• The overall effect of Granthi śāmaka lepa was relatively better compared to Śotha nāśaka lepa in both the parameters of medaja granthi - clinically as well as statistically at 99.99% level of significance with a p value <0.001.
• During follow up assessment in both the groups, there was no increase in the previously regressed longest diameter of the lipoma observed and also there was no recurrence of the lipomas which had completely regressed during the study period.

Conflict of interest

None.