Effect of Shatyadi kwatha in the management of Amavata

INTRODUCTION

Formation of Ama due to several external and internal factors, along with vitiation of vata is the basic pathology in Amavata . This Ama and Vata complexhas special affinity towards the sites of Shleshma particularly Shleshmadhara Kala in joints. Persistent joint inflammation caused by Ama, results in permanent joint deformities. The physical, mental, emotional and financial burden of this disease on patient, his family, and on society is immense due to crippling nature of the condition. To make matters worse, the available treatment in modern medical science which relies heavily on highly toxic immune suppressants, NSAIDS, steroids etc. do not provide a cure. The only hope in this scenario is Ayurveda which offers ameticulous, highly effective and complete treatment with minimal adverse effects. The initial step to treat Amavata is to stimulate Agni and digest the Ama by Deepana Pachana, followed by Shodhana, Shamana and Rasayana treatment to ensure complete cure of the disease. Chakrapani Dutta has mentioned Shatyadi Kashaya for Deepana Pachana in Amavata comprises seven herbs viz Shati, Shunthi, Devadaru, Vacha, Ativisha, Haritaki and Guduchi .

AIMS AND OBJECTIVES

The study was carried out with an aim of assessing effect of Deepan-Pachana on the patients of Amavata (Rheumatoid Arthritis). Initiating Samprapti-Vighatana by Agni Deepana and Ama pachana, assessing anti-inflammatory, analgesic and immuno-regulatory effect of Shatyadi Kwatha, assessing change in GIT symptoms of Amavata after Deepana-Pachana Chikitsa were the objectives of this study.

MATERIAL AND METHODS :

This was an open label single arm study, carried out at Ayurvedic and Unani Tibbia college and Hospital, New Delhi and its satellite OPDs at Hindustaani Dawakhana, Old Delhi and LNJP Hospital, New Delhi for a duration of three months. Total 52 patients were enrolled byConvenient sampling method. Meticulous physical, systemic and joint examination as well as Shadanga Pareeksha, Ashtavidha Pareeksha, Prakriti Pareeksha, DashavidhaPareeksha were done before starting the trial. Functional tests to assess joint function were done at the commencement of the trial and every month thereafter. Patients' opinion about the effect of trial drug on disease severity was also taken in consideration. Required laboratory tests were done before, during and after the trial. Several grading and scoring criteria were used during the trial to facilitate data collection. Shatyadi Kwatha was dispensed in Yavakuta Churna form in airtight packs. Dose, method of preparation of Kwatha.Pathya- Apathya, AharaVihara were explained to each patient. Duration of trial was of three months with checkups every fortnight. After one month of completion of the trial, the patients were reassessed for any toxic effects of the drug. The assessment of the results was done on the basis of relief in joint symptoms, improvement in functional power of the joints, reduction in ESR levels, elevation in Hb%, conversion to sero-negativity, change in incidence of constitutional symptoms, GIT symptoms, joint symptoms and incidence of adverse effects of the trial drug if any. The data collected was subjected to a simple statistical analysis (Student's Paired t-test) for assessing significance of difference of means. Standard Deviation, standard Error, t value and p value were calculated.

Inclusion and Exclusion Criteria: All the patients between the age of 16- 55 years who fulfilled the diagnostic criteria, who were willing to follow the instructions and gave informed written consent for trial were enrolled for the study.Patients with any serious complications of the disease were excluded.

Diagnostic Criteria:

The patients were diagnosed on the basis of symptoms of Amavata and diagnostic criteria laid down by American Rheumatism Association(1987) Hb% (Sahili's method), TLC, DLC, ESR (Westergreen method), C-Reactive proteins and serum RA factor (Latex Agglutination method) were done to aid diagnosis. Serum uric acid, ASO titer, Antinuclear antibody were done for excluding other conditions with similar clinical features. Liver and kidney function tests were done to assess trial drug toxicity if any.

Assessment criteria

Several grading criteria were used to assess joint inflammation during the trial. The score obtained were subjected to statistical analysis.Assessment of general symptoms of Amavata done on the basis of number of patients exhibiting the symptom on each follow up. Walking time, foot pressure Power, writing time, hand pressing and grip power and dressing time were noted to assess the function of various joints before starting the trial and every month thereafter. Assessment of daily function, pain and discomfort was done with the help of Health Assessment Questionnaire(HAQ) . Change in Hb% and ESR levels was statistically analyzed at the end of the trial.

OBSERVATIONS:

In majority of the patients, the disease started in fourth decade of their life (30.78%), closely followed by in fifth decade (23.08%). The female to male ratio was 6.7:1. Majority of the patients (80.76%) were married. Most patients (82.69%) were from urban areas, and more than half patients (51.9%) were living in damp and congested areas. About 32.7% patients were accustomed to sedentary life style. About 65% were of poor socioeconomic status. Constipation was present in 50% of the cases. A sizable number of patients (63.46%) reported Mandagni at the time of registration. Lack of sleep at night was a common feature (53.85%), also majority of the patients (65.48%) were having some amount of emotional stress, while 15.38% of them were on medication for anxiety and related disorders. Among 52 cases of Amavata 94.23% of the cases were of Madhya Vaya, while 3.85% were Bala. Majority of the patients had Krura Koshtha (50%). The most prominent Prakriti was Vataja (46.15%), followed by Vata-Kaphaja (23.08%). There was a positive family history of Amavata in 5.77% of the patients. In more than half (57.69%) the disease had an insidious onset. More than half of the patients (57.7%) the duration of disease was between 1-5 years. Most of the patients were treated with NSAIDs and steroids in past. A good proportion of patients (61.54%) were able to carry out daily functions of life adequately, while 3.85% were completely disabled. Most commonly involved joints were metacarpo-phalangeal(MCP) joints (84.62%), followed by wrist and proximal interphalangeal (PIP) joints (82.69% each). The most common joint deformity found was ulnar deviation of fingers which was present in 26.92% of patients. Radial deviation of carpals (21.15%), volar subluxation of MCP joints (19.23%) and elbow flexion deformity was present in 19.23% of patients. Jadyata (90.39%) and Angavaikalya were very common (61.54%). Other constitutional symptoms commonly present were Utsaha-hani (57.72%), Alasya (51.92%), Angamarda (51.92%), Anga-Gaurava (44.23%), Jwara (42.31%), Alasya (51.92%). Most common GIT symptoms were Agni-Daurbalya (59.62%), Apaka (59.62%), Vairasya (50%), Vibandha (50%)and Aruchi (46.15%). This study showed prevalence of Vata Kaphaja Amavata in 42.3%, Vata Pittaja Amavata in 17.31% and Sannipataja Amavata in 23.08% of the patients.Laboratory analysis revealed presence of anemia in 90.38% of the patients. More than half (55.77%) of the patients had very high levels of ESR (>50mm/hr).

RESULTS:

Effect of Trial Drug on Joint Symptoms, GIT Symptoms and Constitutional Symptoms:

The trial drug showed remarkable improvement in joint symptoms after three months. There was 38.40% relief in pain, 39.98% relief in morning stiffness, 34.57% relief in joint swelling, 47.25% relief in tenderness and 37.94% relief in warmth at the end of trial. These changes were statistically significant. (P<0.001)

The study showed incidence of GIT symptoms declining steadily over the time during trial. The percentage of relief for Agni-Daurbalya was 61.29%, for Apaka 51.61%, for Vibandha 76.92%, for Aruchi 75% and for Kukshi Shoola it was 63.63%. There was considerable reduction in incidence of constitutional symptoms. The percentage of relief was 61.7% in Jadyata, 59.09% in Jwara, 77.77% in Angamarda, 60% in Utsaha Hani, 70.37% in Alasya and 56.52% in Anga Gaurava.

Effect of trial drug on Hemoglobin, ESR levels and RA Factor:

A mean increase of 0.67gm% was noted in Hb level after completion of one month which indicates an early and prompt effect of trial drug on erythropoiesis. At the end of trial the mean increase in Hb level was 1.5gm% (p<0.001). At the end of the trial the mean reduction in ESR was 30.66% which was statistically highly significant (p< 0.001). The study shows that 7 out of 43 patients who were sero-positive before the trial turned sero-negative.

Effect of Trial Drug on Joint Function, Muscular Status and Weight:

The writing time improved by 6.54% (p<0.001), Dressing time by 12.70% (p<0.001) while walking time showed an improvement of 13.62%. The mean right foot pressure power increased by 16.9% and mean left foot power increased by 22.1%, (p<.001). The mean pressing power of right hand improved by 11.71% and of left hand by 14.37% at the end of the trial, both statistically highly significant. The mean hand grip of right hand improved by 20% and of left hand by 15.37%, both statistically highly significant.Effect of trial drug on muscular status and weight was significant. Statistically insignificant mean increment of 0.17% in midthigh circumference and 0.4% in mean mid arm circumference (p>0.05) was noted. A statistically significant increment of 1.18% in mean midcalf circumference (p<0.001) was seen. Mean mid forearm circumference increased by .86% at the end of the trial which was statistically significant(p<0.05). At the endof the trial there was an increase of 0.375 kg in mean weight which was statistically significant(P<0.05).

Assessment of the Results after the Trial:

Final assessment of results was done after three months of trial on the basis of Stienbroker's criteria . The trial drug showed major improvement in 34.62% patients, minor improvement in 50% patients, complete remission was achieved in 4 patients while 4 patients showed no improvement. The patient's estimation of disease severity (on the basis of HAQ) showed a reduction of 32.3%, which was statistically highly significant (p<0.001)

DISCUSSION:

As formation of Ama is the basic pathology of Amavata, the first and foremost therapeutic measure is directed towards prevention of Ama formation by stimulating Jatharagni (Deepana) and Pachana (digestion ) of already formed Ama. The Ama which is compactly adhered to Srotansi cannot be expelled from body by ShodhanaChikitsa without harming the body itself. Pachana chikitsa digests the adhered Ama thus helping in cleansing the srotansi. Deepana Pachana is followed by Shodhana, Shamana and Rasayana treatment to ensure complete cure of the disease.Shatyadi Kashaya is an excellent combination of Agni Deepana , Ama Pachana, Vyadhihara(disease modifying) , Shula Prashamana( pain relieving), Jwaraghna( anti pyretic) and Rasayana drugs viz Shati, Shunthi, amritha, Vacha, Devadaru, Ativisha and Haritaki. These drugs by virtue of their Katu, Tikta Rasa, Ushna Virya, and Katu Vipaka hasecxellent Deepana and Pachana effect. Allseven constituent drugs are effective in Amavata individually as well as collectively. Shati ( Hadychium spicatum) is useful in Shula, Anaha, Vibandha, Kaphaja and Vataja disorders. By virtue of its Vranahara property it may help in healing of inflamed synovium and injured microvasculature. Anti inflammatory and analgesic property of H. spicatum is proven in many studies. Shunthi( Zingiber officinale) is Deepaniya, Shulaprashamaniya and Trisna-Nigrahaniya. It is very useful in Ama Pradhana Kaphaja Vyadhi. Z. officinale has potent anti inflammatory and analgesic action. Haritaki (Terminalia chebula) is an excellent Rasayana, Jwara-Hara, Ama Pachana, Agni Vardhana , Shotha Hara and Vaya Sthapana . Being best among all Pathya it will have protective action on Patha / Srotasa preventing Kha- Vaiguna and Srotodushti, which play a crucial role in pathogenesis of Amavata. Chebulin and chebulinic acid present in Haritaki have shown anti inflammatory activity in many studies in vivo and vitro .Vacha ( Acorus calamus) being Medhya and Amapachana will releave stress associated with Amavata. It inhibits production of inflammatory cytokines Devadaru (Cedrus deodara) is Jwaraghna, Shotha Hara, Ama Hara. Vacha, Abhaya and Ativisha are in Vachadi Varga which is Amapachana It is useful in AmayuktaKapha Pradhana diseases and Vata Kapha Pradhana Jwara . Deodara bark has shown potent anti inflammatory activity in many studies. Ativisha (Aconitum heterophyllum) is Shothaghna, Amapachana and Jwaraghna which will help in relieving pain, edema and fever associated with Amavata. It is Kapha Hara, Vata Hara, Aruchi Hara, Agni Deepana, Ama Pachana and Shula Hara . It is best among Deepana , Pachana, Sangrahaka and SarvaDosha Prashamana drugs. Amritha (Tinospora cordifolia) is Jwaraghna, Deepana, Vata and Kapha Hara, Rasayana, Medhya, Trishna Nigraha, Daha Prashamana. It has excellent Rasayana property which enables the body to synthesis Uttama Rasa Dhatu, thus may be helpful in reducing Dhatukshaya prevalent in Amavata. It has shown anti- inflammatory, immuno-modulatory, anti pyretic,anti oxident and analgesic property in several studies. These facts explain the remarkable results shown by this preparation in such a short time. Signs of inflammation in joints such as redness, warmth, swelling etc , as well as constitutional symptoms showed considerable improvement at the end of the trial.

Although the main presenting feature in Amavata is inflammation of synovial joints, there are multiple constitutional and GIT symptoms which are present in most patients. However, their incidence and intensity depends upon preponderance of their causative pathological factors i .e. Ama , Vata or both. It was observed that the trial drug had an early and prompt relief in Ama relatedGIT symptoms such as Aruchi, Apaka, Asya-Vairasya etc. Another observation made was that the drug is more effective in relieving Jadyata in comparison to Shula. It is interesting fact to note that all the constituent herbs of Shatyadi Kwatha ara Vatahara. Then what may be the cause of this delayed action of trial drug on symptoms related to Vata….?

According to Vagabhatta, Ama causes obstruction in Srotansi trapping Vata. This trapped Vata cannot move in Srotansi, leading to a condition of Anila-Mudhata . This Mudha Vata can be pacified only when obstruction in Srotansi is removed by Amapachana chikitsa. This explains relatively late action of trial drug on vata. Once Ama is digested, Vata-Hara action of trial drug become apparent. It was observed that degree of stress is directly proportional to the chronicity and severity of the disease in RA patients. Among the eight patients with third degree( severe) emotional stress six had terminal stage disease, whereas among nine cases with mild disease five had no emotional stress. Madhava also mentions presence of Utsaha Hani (depression ) indicating low mental esteem in Amavata patients. Several symptoms indicating involvement of Manas and Sanjavahi Srotasa, such as Bhrama,Murchha etc. The trial drug reduced the incidence of these symptoms which may be attributed to Medhya action of Guduchi and Vacha.

Although, the study period was short, trial drug showed promising results in improving muscular status of the patient. There was a statistically significant increase in mean weight of the patients at the end of the trial. Ama Rasa Dhatu impairs Dhatu Nirmana and Poshana resulting in Dhatu Kshaya. By virtue of its Deepana Pachana action trial drug ensures formation of Shuddha Adi RasaDhatu subsequently improving Dhatu Nirmana and Poshana. The Deepana Pachana action also improves appetite and digestion. Some constituents of trial drug such as Guduchi, Shati are Tikt Paushtika (bitter nutrients) which improve nutrition. These drugs are very rich in micronutrients. Shunthi contains several vitamins such as folate, niacine, pyridoxine, vit c , minerals such as copper, iron, calcium,magnesium, manganese, phosphorus ,zinc etc(source USDA National Nutrient Database). Haritaki has fairly good amount of vit c, minerals such as selenium,manganese, iron, copper, several amino acids such as glutamic acid, aspartic acid, arginine,lysine, proline etc . It is found to be highly nutritious. Thus the trial drug improves the DhatuNirmana and Poshana in multiple ways. This was reflected in mean hemoglobin levels of the patients which increased significantly after the trial though no additional hematinic was supplemented along with trial drug.

CONCLUSIONS :

Shatyadi Kashaya is an excellent Deepana Pachana preparation for Amavata which shows prompt and early action on Ama related symptoms of Amavata. It is very effective in alleviating stiffness. However, if pain is dominating symptom then some additional Shula Hara drug can be prescribed as drug has a delayed action on Vata. The drug helps in Dhatu Nirmana and Poshana resulting in increased muscle mass, body weight and hemoglobin levels. Due to presence of Medhya Rasayana in it the trial drug showed good results in stress related symptoms of Amavata. Out of 52 patients 4 patients didn't show any improvement at the end of the three months. Major improvement was seen in 18 cases and minor improvement in 26 cases. Although the trial drug was able to achieve complete remission in 4 cases, it would be advisable to give it as part of recommended combination therapy for Amavata by Chakradutta. Considering the outcome of the trial it can be asserted that Shatyadi kashaya must be given as a Deepana Pachana and Vyadhihara Kashaya in Amavata patients along with the other therapeutic measures.