Clinical efficacy of Shiva Guggulu and Simhanada Guggulu in Amavata (Rheumatoid Arthritis).

Amavata is the second most common joint disorders. Nowadays erroneous dietary habits, lifestyle and environment have led to various autoimmune disorders i.e. Amavisajanya Vikaara and Amavata is one among them. Rheumatoid arthritis can be correlated with Amavata in view of its clinical features. Many research studies have been done to solve this clinical enigma, but an effective, safe, less complicated treatment is still required for the management of Amavata. In the present study, 24 patients of Amavata were registered and randomly grouped into two. In group A, Shiva Guggulu 6 g/day in divided doses and in group B, Simhanada Guggulu 6 g/day in divided doses were given for 8 weeks. On analysis of the results, it was found that Simhanada Guggulu provided better results as compared to Shiva Guggulu in the management of Amavata.

RCT Entities:   Population Interventions Outcomes

Introduction

Amavata (Rheumatoid Arthritis) is a challenge to the physician owing to its chronicity, incurability, complications, morbidity and crippling nature. The word Amavata is made up of a combination of two words, Ama and Vata.[1] The disease is mainly due to derangement of Agni, resulting in the production of Ama which circulates in the body and gets located in the Sandhis (joints) causing pain, stiffness, and swelling over the joints.[2] According to modern medicine, it can be correlated with Rheumatoid Arthritis (RA),[3] which is a chronic autoimmune disease that causes inflammation and deformity of the joints. RA can also cause inflammation of the tissues around the joints as well as other organs in the body. It is a common disorder, with varied clinical signs and symptoms related to multiple anatomical sites, both articular and extra-articular.

Allopathic system of medicine has got an important role to play in overcoming symptoms of articular diseases. Drugs[4] are available to ameliorate the symptoms due to inflammation, in the form of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), and the long-term suppression is achieved by the Disease-Modifying Antirheumatic Drugs (DMARDs).[5] But most of the NSAIDs[6] have gastrointestinal side effects, whereas DMARDs have marrow, renal, and hepatic suppression. Hence, the management of this disease is merely insufficient in other systems of medicine and patients are continuously looking with a hope towards Ayurveda to overcome this challenge.

Many research works have been done to solve this clinical enigma, but an effective, safe, less complicated treatment is still required in the management of Amavata. In this clinical study, two drugs Shiva Guggulu[7] and Simhanada Guggulu[8] have been attempted to evaluate their comparative efficacy in Amavata.

Materials and Methods

Selection criteria

Patients between 18-60 yrs of age with classical features of Amavata[9] from OPD and IPD of Government Akhandanand and Maniben Ayurvedic Hospital were selected for the present work; irrespective of their sex, religion, education, etc. Detailed research proforma was prepared incorporating all the signs and symptoms of the disease.

Inclusion criteria

The criteria laid down by American Rheumatism Association (ARA) - 1988[10] were also taken into consideration as follows:

Morning stiffness lasting for b1 h,

Arthritis of three or more joints

Arthritis of hand joints

Symmetrical arthritis

Presence of rheumatoid nodules

Presence of rheumatoid factor (RA factor)

Radiological changes.

* First four criteria must be present for duration of 6 weeks or more.

** Diagnosis of RA is made with four or more criteria.

Chronicity for more than 10 years

Having severe crippling deformity

Patients suffering with cardiac disease, pulmonary TB, Diabetes Mellitus, etc.

Investigations

For the purpose of assessing the general condition of the patient and to exclude other pathologies, the following investigations were carried out.

RA factor

Hematological investigations: The routine hematological examination was carried out which included total leukocyte count, differential count, hemoglobin, packed cell volume, and Erythrocyte Sedimentation Rate (ESR).

Urine analysis: Routine urine analysis was carried out to detect the involvement of kidneys and to exclude the urinary tract infections and conditions like gonorrhea.

Follow-up

A follow-up study was carried out for 8 weeks after completion of treatment.

Dietary restrictions

The patients were strictly advised to follow dietary restrictions and changes in lifestyle.

Criteria for assessment

The results of the therapy were assessed on the basis of clinical signs and symptoms mentioned in Ayurvedic classics as well as by ARA (1988). Functional capacity was also assessed and laboratory investigations were repeated at the end of the treatment. The scoring pattern adopted for the assessment is as follows:

Functional assessment

The following periodical functional tests were carried out for objective assessment of the improvement of Àmavata patients.

Walking time: The patients were asked to walk a distance of 25 feet and the time taken was recorded before and after the treatment by using stop watch.

Grip strength: To find out the functional capacity of the affected upper limb, the patient′s ability to compress an inflated ordinary sphygmomanometer cuff under standard conditions was recorded before and after the treatment.

Foot pressure: To have an objective view of the functional capacity of the legs, foot pressure was recorded by the ability of the patients to press a weighing machine.

General functional capacity:

Degree of disease activity

For diagnostic as well as for assessment purpose, the degree of disease activity was estimated on the basis of criteria laid down by ARA (1967) [Table 1].

Table 1

ARA criteria for RA

In the criteria given above, the maximum score is 30, which represents an average of grade 3 (severely active). By dividing the total score by 10, the grade of disease is obtained and denoted by figures from 0 to 3.

Total effect of therapy was assessed on the basis of the criteria given as below

Statistical analysis

The obtained information was analyzed statistically. Paired t-test was carried out to evaluate statistical significance of the therapy. P `0.01 is considered as significant and P ` 0.001 is considered as highly significant.

Trial Drug and Posology: Both the trial drugs were prepared at Govt. Ayurvedic Pharmacy, Gujarat. The composition is provided at Tables 2 and 3.

Table 2

Composition of Shiva Guggulu

Table 3

Composition of Simhanada Guggulu

Shiva Guggulu (group A): The patients of this group were treated with Shiva Guggulu at a dose of 6 g/day for 8 weeks with Luke warm water.

Simhanada Guggulu (group B): The patients of this group were treated with Simhanada Guggulu at a dose of 6 g/day for 8 weeks with Luke warm water.

Results and Observations

Maximum number of patients (41.66%) belonged to the age group of 41–50 years. Majority of the patients were females (91.66%), 75% patients were Hindus, and 91.66% were married. 66.66% patients were housewives, 50% were from middle class, and 33.33% were uneducated patients. Maximum numbers of patients were of Vata-Kapha Prakriti (45.83%), Mandagni (62.5%), Madhyama Sara (54.16%), Madhyama Sattva (50%) and Madhyama Samhanana (58.33%) were found in majority of the patients. 50% of patients had negative family history, 58% patients had a gradual onset and 37.5% patients had chronicity of 2–4 years. Most of the patients were found to be indulged in Viruddha Ahara (66.66%), Snigdha Ahara (45.83%), Vishamashana (62.5%), Bhojanottara Vyayama, Adhyasana (54.16%), and Diwasvapa (50%). It was observed that maximum (41.6%) patients had Atichinta, followed by 33.33% with Manodvega and 25% with Shoka as Manasika Nidana. It was observed that maximum numbers of patients (100%) have Sandhishoola followed by Sandhishotha (91.66%), Sparshasahyata (75%), and Sandhigraha (87.50%). Among the general symptoms, Angamarda was observed in 79.16%, Aruchi in 70.83%, Gaurva in 83.33%, Apaka in 62.50%, Sunata-Anganama in 54.16%, Alasya in 37.5%, Trishna in 41.66%, and Jwara in 37.5% of patients. Majority of the patients (83.33%) had Vibandha and 75% had Ushnata around the joints and Anaha, followed by 70.83% with Daurbalya, 66.66% with Agnimandya, 58.33% with Nidraviparyaya, 45.83% with Bahumutrata, 29.16% with Daha, 25.00% had Kandu and Bhrama each, 20.83% had Kukshishula, Hridgraha, Chhardi each, while 12.5% had Praseka and 4.16% had Antrakujana.

In majority of patients, Proximal Inter Phalangeal (PIP) joint was involved (91.66%), followed by involvement of wrist in 83.33%, knee in 79.16%, elbow in 62.50%, hip in 58.33%, shoulder in 54.16%, ankle in 50%, neck joint in 45.83%, Distal Inter Phalangeal (DIP) joint and Meta-Carpals (MC) each in 41.66%, inter-phalangeal joint of foots in 37.50%, and jaw in 4.16% of the patients.

Comparative effect of Shiva Guggulu and Simhanada Guggulu on cardinal symptoms of Amavata

Effect of therapy on Sandhishoola, Sandhishotha, Sandhigraha and Sparshasahyata with the treatment of trial drugs is provided at Tables 4-14.

Table 4

Effect of group A in Sandhishoola

Table 14

Comparative effect of both groups in patients of Amavata (by unpaired t-test)

Functional assessments

In group A, the mean score of grip strength was 1.14 before treatment, which was reduced to 0.57 after treatment, with 50% relief. It was statistically insignificant. The mean score of grip strength in group B was 2.4 before treatment, which was reduced to 1.5 after treatment, with 37.5% relief. It was statistically highly significant.

Before treatment the mean score of walking time in group A was 2, which was reduced to 1 after treatment, with 50% relief. It was statistically insignificant. The mean score of walking time in group B was 1.75 before treatment, which was reduced to 0.75 after treatment, with 45.71% relief. It was statistically significant.

In group A, the mean score of foot pressure was 1 before treatment, which was decreased to 0.66 after treatment, with 33.33% relief. It was statistically insignificant. The mean score of foot pressure in group B was 2.3 before treatment, which was decreased to 1.4 after treatment with, 39.13% relief. It was statistically highly significant.

In group A, the mean score of general functional capacity was 1.33 before treatment, which was reduced to 0.66 after treatment, with 50% relief. It was statistically highly significant. The mean score of general functional capacity in group B was 1.66 before treatment, which was reduced to 0.66 after treatment, with 60% relief and was statistically insignificant.

In group A, the mean score of degree of disease activity was 1.75 before treatment, which was reduced to 1 after treatment, with 42.85% relief. It was statistically highly significant. The mean score of degree of disease activity in group B was 1.5 before treatment, which was reduced to 0.75 after treatment, with 50% relief. It was statistically significant.

Regarding ESR value, the mean scores before treatment in A and B groups were 54.5 and 55.2, respectively, and they were reduced to 45.3 and 40.1, respectively, after treatment. Group A percentage relief was 16.88%, while in group B it was 27.35%.

An apparent difference in improvement of all the cardinal symptoms was observed with the treatment. On comparing Group B proved to be better than Group A. Statistically highly significant difference was found in the improvement of Sandhigraha and statistically significant difference was found in the improvement of Sandhishoola and Sparshasahyata by Simhanada Guggulu than Shiva Guggulu, whereas insignificant difference was observed in the improvement of Sandhishotha. So, from the obtained data it may be inferred that group B is more effective than group A.

Discussion

Maximum numbers of patients had involvement of Kaphavriddhi and Prakopa, followed by Vata Vriddhi and Prakopa, Dosha and Dushti of Rasavaha, Asthivaha, Majjavaha, Purishvaha and Annavaha Srotas, which is in accordance with the main Srotas involved in the Amavata Roga Samprapti. Maximum number of patients (41.66%) belonged to the age group of 41–50 years, which shows its predominance in middle-age group. In this stage of life, Vyadhikshmatwa gradually decreases and accumulation of Dosha occurs, particularly Vata Dosha which acts as the major predisposing factor for this disease process. Thus, this age group is more prone for this disease. This data is slightly in accordance with the modern findings that the onset is most frequent during the fourth and fifth decades of life, with 80% of all patients developing the disease of age between 35 and 50 years. Majority of the patients (91.66%) were females, which clearly shows the predominance of the disease in females. Textual reference also reflects the predominance of rheumatoid arthritis in females. The nature of the household work especially after taking meal, which is one of the causative factors mentioned in Ayurvedic text, may be the responsible factor of Amavata. In this present study, data show that maximum (70.83%) patients were RA negative and 29.16% were RA positive. The presence of RA factor does not establish the diagnosis for RA, but it can be of prognostic significance because patients with high titers tend to have more severe and progressive disease with extra-articular manifestation.

Regarding the joint wise relief, Simhanada Guggulu showed better results than Shiva Guggulu. In both the groups, none of the patients were found to be completely cured because of the short duration course of therapy as well as chronic nature of the disease. In group A, marked improvement in 30% and moderate improvement in 70% of patients was observed, whereas in group B, 40% of patients showed marked improvement and moderate improvement was seen in 60%.

Probable mode of action of Simhanada Guggulu in Amavata

Both the trial drugs have Katu, Tikta Rasa, Laghu, Ruksha Guna, Ushna Virya, Katu Vipaka Vedanasthapana, Deepana-Pachana, Rasayana and Medhya Karma hence, it has Vatakaphashamaka, Amapachaka, Srotoshodhaka properties which helps in breaking the pathogenesis of Amavata. Specially Tikta and Katu Rasa present in Simhanada Guggulu possess the antagonistic properties to that of Ama and Kapha which are the chief causative factors in this disease. Because of their Agnivriddhikara property, they increase digestive power, which also digests Amarasa and reduces the excessive production of Kapha and also removes the obstruction of the Srotas. Because of Ushna Virya, it also alleviates vitiated Vata. Katu Rasa helps in Agni Deepana Pachana Karma of Ushna Virya, Katu Rasa and Kaphahara Karma of Ruksha, Laghu Guna, and Ushna Virya Amadosha Pachana occurs. Lekhana Karma of Laghu Guna and Tikta Rasa removes the adhered Dosha from the Dushita Srotas. The Ushna properties of Simhanada Guggulu do not allow the Ama to linger at the site of pathogenesis and to create Srotorodha. It reduces Srotorodha and pain. It has also the antagonistic action of Sheeta and Ruksha Guna of Vata. Thus, it controls Ama and Vata together and minimizes the process of pathogenesis. After Srotovivronoti Karma of Katu Rasa and Agnideepana, Srotovishodhona Karma by Tikta Rasa, Lekhana action Srotosodhana occurs. This leads to assimilation of undigested and immature Amarasa. By virtue of Shoshana and Pachana property of Katu, Tikta Rasa, and Ushna Virya, it absorbs excessive Dravta which leads to Samyaka Yuktamagni. Due to Ushna Virya and Katu Vipaka of Simhanad Guggulu, Vatashamana occurs. After Samyaka Yuktamagni and Vatasamana Amavata, Vyadhi Shamana occurs.

Conclusion

It was observed from the treatment that Simhanada Guggulu provided comparatively better relief in cardinal signs and symptoms of Amavata.

Table 5

Effect of group A in Sandhishotha

Table 6

Effect of group A in sandhigraha

Table 7

Effect of group A in sparshasahyata

Table 8

Effect of group B in sandhishoola

Table 9

Effect of group B in sandhishotha

Table 10

Effect of group B in sandhigraha

Table 11

Effect of group B in sparshashayata

Table 12

Percentage effect of therapy on cardinal symptoms

Table 13

Overall effects of Shiva Guggulu and Simhanada Guggulu in patients of Amavata