A review of Aconite (Vatsanabha) usage in Ayurvedic formulations: traditional views and their inferences

A review of Aconite (Vatsanabha) usage in Ayurvedic formulations: traditional views and their inferences Ayurveda formülasyonlarında İtboğan (Aconite)...
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A review of Aconite (Vatsanabha) usage in Ayurvedic formulations: traditional views and their inferences Ayurveda formülasyonlarında İtboğan (Aconite) bitkisi kullanımına dair bir derleme: geleneksel görüşler ve çıkarımlar Sanjeev Rastogi State Ayurvedic College, Lucknow, India. SUMMARY Ayurveda, a commonly practiced system of medicine in India, has its unique proposition to the concept of health and disease. At one end it identifies various material based properties which determine the pharmacological property of the drug used; on the other this also identifies various the psycho-physical composition of person to be treated as a factor which may influence the action profile of the drug under use. Vatsanabha (Aconite) finds its place in Ayurvedic materia medica since antiquity though with a clear caution before it is used. A deadly material can also be turned into a saviour or even the vise-versa depending upon the methods of use, Ayurveda explains. Ayurveda proposes a traditional purification technique to reduce the harmful effects associated with Vatsanabha. A willful or ignorance of the principles of Ayurveda, from the stage of drug manufacturing to the stage of consumption, is supposed to cause unpredictable drug responses which may result in adverse reactions as the one is reported in the review, or in under responses as is commonly accused. The review gives us opportunity to feel that a thoughtful understanding of Ayurvedic pharmacology, its clinical principles and limitations is required for its optimal utilization. We should therefore, be ready to get criticized for inconsistent theories if there are any, and should welcome with open heart for the principles which are proving their worth on scientific grounds. Key words: Vatsanabha, Aconite, adverse reactions, Ayurveda, purification ÖZET Hinditan’da tıpta yaygın olarak kullanılan bir sistem olan Ayurveda, sağlık ve hastalık anlayışında eşsiz bir konuma sahiptir. Ayurveda, bir yandan kullanılan ilaçların farmakolojik özelliğini belirleyen niteliklere dayalı çeşitli malzemeleri saptarken; diğer yandan kullanımdaki ilaçların etki profillerini etkileyebilen bir faktör olarak, uygulanmış bireylerin çeşitli psikolojik ve fiziksel niteliklerini saptar. Kullanımından once açık bir uyarı gerekmesine rağmen, Aconite antik çağlardan bu yana Ayurvedik tıbbi malzemeler içinde yerini bulmuştur. Ölümcül bir maddenin bir kurtarıcıya ya da kullanım metodlarına bağlı olarak tam tersine bile dönüştürülebileceğini Ayurveda açıklamaktadır. Ayurveda, Vatsanabha ile ilgili zararlı etkileri azaltmak için geleneksel bir arıtma tekniği önermektedir. Ayurveda’nın prensiplerine karşı ihmal ve kasıtlı yaklaşımlar; İlacın üretim aşamasından tüketim aşamasına kadar, bu derlemede rapor edilen konulardan biri olarak istenmeyen etkilerle sonuçlanabilen beklenmeyen ilaç cevaplarına neden olmasını gerektirmektedir veya sıklıkla suçlanan cevaplar altında olmalıdır. Bu derleme bize, Ayurvedik farmakolojiye karşı önyargısız bir anlayış fırsatı vermektedir. Ondan en etkin şekilde faydalanılması için klinik prensiplerinin ve sınırlandırmalarının bilinmesi gereklidir. Bu sebeple, varsa eğer, tutarsız teoriler için eleştirilmeye hazır olmalı ve bilimsel platformlarda değerini ispatlamakta olan prensipleri hoşgörüyle karşılamalıyız. Anahtar kelimler: Vatsanabha, Aconite, yan etkiler, Ayurveda, arıtma

Corresponding Author: Sanjeev Rastogi, State Ayurvedic College, Lucknow, India Email: [email protected]

Received Jun 29, 2011; accepted December 20, 2011 DOI 10.5455/spatula.20111220112858 Published online in ScopeMed (www.scopemed.org). Spatula DD. 2011; 1(4): 233-244.

INTRODUCTION Ayurveda is one of the oldest practicing medical systems prevailing to the Indian sub continent. Seeking its origin from the periods before Christ and through the ancient scripts of Vedas, Ayurveda survived through ages and is possibly one among few oldest living health care traditions still in practice [1]. Ayurveda has its unique vision into the science of disease and their management. Being an observational science deriving its principles through constant observation of the nature, Ayurveda is largely influenced by nature and her remedial potential. Ayurveda believes in a mind- body interaction behind the usual causation of the disease and eventually it looks into the remedies which can harmonize both of these components. One important principle of Ayurveda is the consideration of five elements as the primordial matter, responsible for the formation of every physical object in the universe. These five elements are sky, air, fire, water and earth sequenced in order of their density and their importance in physical formations. The living body is said to have the functions regulated as per the basic composition of these five elements, which are physiologically represented as Vata, Pitta and Kapha or tridosha in human body [2]. A harmonized status of the five elements and consequently of the three dosha is a basic prerequisite of arriving at health. “Any deficiency of these substances hence should be replenished, excess should be reduced and equity should be maintained” is the basic protocol of Ayurveda towards disease management in reference to its pathogenesis. Rasa (taste) is the physicobiological determinant, which lies between two poles of physical and biological existence represented by five elements and three dosha of Ayurveda (Table 1). At a simple level, the six Rasas are said to respond in a precise way to particular qualities, or “panchmahabhuta”, of plant material tasted [3]. Rasa as the representative of basic elements are possibly the most important pharmacological determinant of a material in Ayurveda. Similar taste may have a similar pharmacological property, this thought has come into the lime light recently [4] and asks for a more genuine introspection into the philosophy of Ayurveda. Treatment modalities utilized in Ayurveda are herbs in the form of mono or poly herbal formulations, diet advice, minerals and some physico-biological purificatory procedures named as Pancha-Karma (Five procedures). Selection of drug or a procedure for certain disease or condition in Ayurveda is depending upon

the etio-pathogenesis of the disease which explains and quantifies for the disharmonisation of basic elements in body and identification of the substances which can harmonize it back. Herbs are evaluated for their disease combating potential as per their Rasa (Taste), Guna (physical property), Virya (Physiological property), Vipaka (After taste) and Prabhava (special effect). Herbs with similar properties are often combined to enhance their therapeutic effects resulting in poly herbal preparations used in common practice.

Table 1. Interrelation of Mahabhuta, Rasa and Dosha Mahabhuta

Rasa

Dosha affiliation

Vayu, Akasha

Tikta (Pungent)

Pro Vata

Vayu, Prithvi

Kasaya (Astringent)

Pro Vata

Vayu, agni,

Katu (Bitter)

Pro Vata, Pro Pitta

Prithvi , Agni

Amla (Sour)

Pro Kapha, Pro Pitta

Jala , Agni

Lavana (Salt)

Pro Kapha, Pro Pitta

Prithvi, Jala

Madhur (sweet)

Pro Kapha

Traditional Chinese medicine (TCM) has much resemblance to Ayurvedic fundamentals and this similarity pleads for a homology between these two oldest living traditions of health care [5]. The resemblance is not only limited to their philosophy and approach to the health and disease but is also seen through their modalities. There are many common herbs used for similar indications in Ayurveda and TCM [6] History of Aconite Aconite is a commonly used drug in traditional medical practices world over. Its toxic properties were possibly first noticed and utilized by tribes to make their arrow and spear heads poisonous [7]. Word Aconite is derived from a Greek word Akoniton, which stands for spear or lancet .A paste of Aconite tuber, was utilized for this purpose. Aconite (Vatsanabha) found its place in Ayurvedic pharmacopia for centuries back with its first possible mention in Atharva veda [7, 8]. Ativisha, a non

poisonous variety of Aconite, was mentioned in Charaka samhita as a drug known for its digestive and antidiarrhoeal properties .Aconite finds its further mention in later works of Ayurveda as in Chakra dutta (1050 AD) and Sharangadhara Samhita (1363 AD) where this was identified as a medicine for fever, diarrhoea, indigestion, cough and as an aphroidisiac. Vatsanabha, the Ayurvedic synonym to Aconite has derived its name from sanskrit for the resemblance of its tuber to the umbilicus ( ) of a calf ( ). In TCM, Aconite is called and is indicated for cold induced joint pain, abdominal pain and fever. This is also used as an analgesic in anesthesia. Aconite has been recognized for its toxic effects by Ayurvedic as well as the TCM scriptures. A purification process of Aconite root which was supposed to reduce the toxic effect of the drug without compromising its pharmacological properties was thus described in many ancient Ayurvedic pharmacopoeia. A similar processing of Aconite root was also indicated in Chinese literature where a caution is also exerted for any use of unprocessed drug. In TCM, Aconite is advised to be used with caution in pregnancy and is told to be incompatible with Bulbus Fritilliariae, Rhizoma pinalliae, Rhizoma Bletillae, Radix Ampelopsis, Radix Trichosanthis, Fructus Trichosanthis [9]. Aconite has continued its use in Ayurveda and TCM practice as a dependable remedy for cold induced conditions including common cold, fever and respiratory tract infections (2). Despite of its toxic effects vividly mentioned in the ancient literature, its toxic manifestations are sparingly reported in clinical practice through the use of Aconite containing formulations. In India, these incidences are rarely reported, the cause may either be an under reporting or a lack of awareness about sysmptoms of toxicity or at the most, their negligible occurrence. Nevertheless, there are many incidences reported from around the world. As toxic manifestations of Aconite may affect cardiac rhythm to a fatal extent [10], this may require a prompt evaluation and correction. Use of Aconite in traditional medicine therefore needs a revalidation in view of its toxicity and pharmacological properties. Traditional description of Aconite (Vatsanabha) in Indian medicine ! "# Identification features of Vatsanabha described in various ancient Ayurvedic texts are following [1113].

1. 2.

3. 4. 5. 6. 7. 8. 9.

(Vitex nigundo) like leaves. Tuber shape is like cow’s nipple ( ) or is like umbilicus of a calf ( ). Does not permit other plants to grow nearby ( ). Pale ( ) color tuber. Not bigger than 5 finger width ( ). Blue flowers ( ). Toxic properties in tuber ( ). Shrub ( ). Native to temperate climate ( Garhwal, Kashmir and Nepal)

$ # Traditionally, Aconite is classified into three varieties as per the color of its tuber. These are black, gray and pale. Among these, pale colored tuber variety is considered superior to others. [13] L. (Ranunculaceae) is a diverse genus with nearly 300 species worldwide, mostly in temperate and alpine regions of northern hemisphere [14]. Among them about 26 species and two varieties are common in India [15]. The rest are distributed in Japan, central Europe, East Asia, and Eastern and North- Western America. In India, the genus is restricted to the Himalayan region with a difference between the eastern and western zone varieties [16, 17]. 13 species of Aconitum have been identified for their drug value and trade in India under the name of Aconite [18]. Commercially available Aconite in Indian market seems to have a combination of these varieties which is evident from huge variation in alkaloid percentage from different samples collected from the market [19].Their toxicological and pharmacological properties are variable and range between completely non-toxic to highly toxic varieties. Following Species of Aconite are commonly known for their medicinal properties to Indian terrain [20]. Wall. Found in lower Himalayas and contain nontoxic alkaloid Atisine. ! Staph. Found at 10000-14000 ft height hilly terrain of Himalaya. It has bitter taste and causes a tingling sensation to tongue. Contain PseudoAconitene alkaloid, which is more toxic than Aconitene. ! " Wall. Highly toxic, used for local application in traditional medicine in the form of a paste in rheumatic conditions. This is the species, which was used for envenomation of spear and arrow by tribes.

Staph. Found at 7000-12000 ft height. Tuber is blackish brown in colour. Active alkaloid is Indaconitine, which is 9.7 times more active than aconitine. # Staph. Tuber is hard in consistency. Contain Aconitene and pseudoAconitene as main alkaloids. Staph. Found in Tibet and Sikkim. Toxic variety. Staph. Most common among the Aconite species common to Nepal, Sikkim and Eastern Himalayas. Highly toxic due to the presence of Bikhaconitine, which resembles to pseudoAconitene in properties. Jacq. Sweet in taste and is non toxic.Found in Kumayu and Garhwal region of lower Himalaya. Commercially available Aconite tuber in Indian market is a combination of various species except for the Aconitum heterophyllum, which is identified as Atis or Ativisha, a nontoxic variety of Aconite known for its different medicinal properties.

indicated in indigestion, hepato-spleenomegally, gout, respiratory tract infections and dyspnoea. This is also indicated for rheumatic conditions, fever, skin disease and anemia. Its local application is useful in snake, scorpion and rat bite conditions and also in various pain related conditions. A relation between the pharmacological properties of Vatsanabha and its clinical usage can be drawn as per the following table. (Table 2) (Figure1)

BOX 1. Properties of Vatsanabha Rasa- Katu, Tikta, Kashaya

Virya -Ushna Guna-Ruksha,Tikshana, Laghu,Vyavayi, Vikasi Karma-Reduces cold induced symptoms, improves digestion

Properties, Preparations and indications In Ayurvedic literature properties of Vatsanabha are discussed in detail including the identification of the good quality Vatsanabha, appropriate time of its collection, its pharmacological and toxic properties and methods to purify crude Vatsanabha to reduce its toxic properties without compromising to its medicinal properties [13]. % &' #$ " ! ( ( This should be about 5–7 finger width long, 1-2 finger width thick, should be thicker at its distal end and of pale in color. This should additionally be smooth from outside, heavy and fresh. ) * ! This should be collected during winter or in spring for this time the Vatsanabha root is ripe in its medicinal properties. This should be collected only after the ripening of fruits in the plant ($ ). " In Ayurvedic literature, following pharmacological properties are attributed to Vatsanabha (Box 1). +!& !" Ayurveda considers Vatsanabha as Rasayana (restorative) if used properly. This eliminates cold induced symptoms, improves digestion and is

Figure 1. Clinical application of Vatsanaba

!" !& !& ! A manual survey of Ayurvedic materia-medica identified good number of Aconite containing poly herbal and herbomineral preparations (Table 3).

Table 2. Ayurvedic Pharmacology of Aconite Properties Rasa

Guna

Differential properties Katu Tikta

Action Reduces Kapha Reduces Kapha

Pharmacological use Prokinesis Antipyresis

Kashaya

Reduces Kapha

Reduce mucous production

Ruksha Tikshana

Reduces Kapha Reduces Kapha

Reduce mucous production Mucolytic

Laghu Vyavayi

Reduces Kapha $

Reduces edema %

Vikasi Virya

Ushna

Adverse reactions

% Increases Pitta

Improved appetite

Reduces Kapha

Prokinesis

Reduces Vata

Analgesic

Table 3. Ayurvedic formulations containing Aconite (Vatsanabha) Name of the compound Agnikumara rasa Agnisandipana rasa Agnitundi Bati Ajirna kantaka rasa Amara sundari Bati Amrit Kala nidhi Rasa Ashvini Kumara rasa Aswakanchuki Rasa Ananda Bhairava rasa Betal rasa Durjala jeta rasa Gada murari Rasa Grihani Kapata rasa Grihani Gaja kesari Hinguleshvara Rasa Jvarankusha rasa Jaya Bati Kanaka sunder Rasa Kasturibhairava Rasa Kalari Rasa Kapha ketu Rasa Laxmi narayana rasa Mritunjaya Rasa Mrita sanjivani rasa Narayana jwarankusha rasa Pancha Vaktra rasa Pratap lankeshwara Rasa Panchamrita Rasa Ramabana rasa Shleshmakalanal rasa Shvasa kuthara rasa Shiva Tandava Rasa Shula kuthara rasa Sannipata bhirava rasa Sanjeevani Bati Tripur bhairava rasa Tribhuvan Kirti Rasa Vata gajankusha rasa Vatabh kesari rasa Visuchi vidhvansan rasa

Reference Book Bhaisajya Ratnavali Bhaisajya Ratnavali Bhaisajya Ratnavali Bhava Prakasha Yoga Chintamani Yoga Ratnakara Anupana Tarangini Sidha Yoga Samgriha Rasa Raj Sunder Rasa Sara Samgriha Yoga Ratnakara Rasa Tarangini Yoga Ratnakara Yoga Ratnakara Bhaishajya Ratnavali Bhaishajya Ratnavali Rasa Sara Samgriha Yoga Chintamani Sidha Yoga Samgriha Yoga Chintamani Rasa Tarangini Rasa Yoga Samgriha Rasa Tarangini Bhaisajya Ratnavali Yoga ratnakara RasaYogaSagar Yoga Ratnakara Rasa Ratna Sammuchaya Bhaisajya Ratnavali Rasendra SaraSamgriha Bhaisajya Ratnavali Rasa Tarangini Vrihad Nighantu Ratnakara Bhaisajya Ratnavali Sharangdhara Samhita Bhava Prakasha Yoga Ratnakara Rasendra Sar Samgriha Siddha Bhairava Bhaisajya Ratnavali

Indication Indigestion Indigestion Indigestion Indigestion Vata disease Indigestion, Fever Chronic diarrhea Respiratory tract infections, fever Fever, cough, diarrhea Malarial fever, Septicemia Disease caused by contaminated water as infective diarrhea, fever Inflammatory fever Chronic diarrhea Infective diarrhea Joint pain, Viral fever, Pain and fever Pain in abdomen Septicemia, Viral fever, Enteric fever Malarial fever Common cold, Cough,fever Chronic fever Chronic fever Rheumatic pain,Malarial fever Fever Septicaemia, Fever Puerparial fever Initial and chronic stage of tuberculosis Diarrhea, pain in abdomen Common cold Asthmatic bronchitis Septicaemia Indigestion Septicemia Common cold with fever, indigestion Fever Influenza, viral fever Sciatica, obesity, Vata disease Pneumonia Acute gastroenteritis

Among these, many have continued their use as dependable remedies in current Ayurvedic practice [2]. Owing to pharmacological properties of Aconite as is understood in Ayurveda, it is used in common cold and associated fever, gastrointestinal conditions including abdomen pain and cold induced diarrhea. The usual recommended dose for Ayurvedic rasa preparation (preparations containing metals and mercury) ranges between 50-100 mg a day. Just to ensure safety, the preparations containing Aconite are advised to be started from even more lower dose. Safety concerns about the use of Aconite (Vatsanabha) in ancient and contemporary literature Toxic properties of Aconite are well recognized in Ayurveda as most of the ancient texts containing details about the Aconite preparations are also added with cautions and special methods of treatment to Aconite tuber before it is internally used. Specific codes of its use and contra indications are also described at length [13]. TCM has also advocated for some pretreatment of Aconite tuber before its use as medicine [21]. Similar to Indian medicine, TCM also note that improperly treated Aconite may lead to adverse reactions because of its toxic properties [9]. ! * ! &" ! # & Three traditional methods for purification of Aconite are described in Ayurveda. [13] $ A properly collected Vatsanabha tuber should be broken into small pieces and dipped in a stone or earthen vessel containing cow urine. The vessel is to be kept under sun for three days with a change of urine every morning. After three days take the Aconite out from the vessel, peel off its skin and make it dry under the sun. This is the best textual way to purify Aconite. Small pieces of Aconite are to be kept in a cloth bag and this bag is to be boiled through a vessel called & (suspended boiling apparatus) (Fig.2.) containing cow milk. A 3-6 hour boiling through this way can purify Aconite. ' As is done in second method, Goat milk is used instead of cow milk. Through this way also, Aconite can be purified. Detoxifying capacity of these purificatory methods employed for the purification of Aconite is studied and has claimed for a superiority of purified Aconite on its crude counterpart when used

internally for medicinal purpose [23-25]. These studies however do not explain for the cause of using various ingredients in purification and also do not explain for a reason of superiority between any one of the mentioned methods. Breaking of Vatsanabha tuber into small pieces increases the penetrability of any liquid where it is dipped. Cow urine being acidic in nature, may help in reducing the effect of toxic alkaloids to a therapeutic minimum. There is possibility that these toxic ingredients may be dissolved and ooze out in solution for which a urine solution is advised to be changed every morning. Keeping the dipped drug in sun or boiling may help in dissolution of water-soluble toxic substances into the resulting solution. This explanation however is only a hypothesis unless validated scientifically. A summary of these 3 methods is presented in figure 3.

Figure 2. &

(suspended boiling apparatus)

Figure 3. Ayurvedic methods of Vatsanabha (Aconite) purification

) , ** " * ! " & " ( & ! & Toxic effects of Vatsanabha are well noted in Ayurvedic texts. It is warned for over dosing or crude use. This may cause burning sensation (& ), Syncope (% ), bradycadia or cardiac arrest (( ) as its toxic manifestation. This may even be fatal and so is recommended to be used only in proper dose and after proper purification [13]. #

- !& !" * " * ! Ayurvedic texts also describe a specific methodology for adoption while using Aconite. This is recommended to be used in winter and spring season .Use of Katu, Amla and Lavana (taste which may aggravate Pitta), oil, afternoon nap, exposure to sun and heat is advised to be avoided during the period of Aconite use (Table 4). During this period cow milk, rice, wheat, cold water and sweet taste food should preferably be taken.

- ! !& !" Aconite is contraindicated in summer and rainy season. This is also contraindicated in chronic diseases, in Pitta predominant people, and in people at extreme of ages (infants and elderly). State of pregnancy and state of dehydration also comes under the contraindications. This should also not to be used locally at vital (% ) places (Table 5). TCM also identifies contraindication to the use of Aconite. Additionally this also identifies some herbs which are incompatible with Aconite if used simultaneously [9]. Adverse drug reaction reporting (ADR) of Aconite A Pub med and Google scholar search for the articles published between 1985 and 2006 revealed many adverse reporting from the use of Aconite throughout the globe. In most of these reports, Aconite was found consumed either as a part of some TCM preparation, self-medication, accidental intake or suicidal intake (Box 2).

Table 4.Specific don’ts for patients using Aconite Activities/edibles to be avoided Katu, Amla, Lavana diet

Possible reasons for avoidance

Box 2. Possible modes of adverse reactions to Aconite

May aggravate Pitta, can potentiate adverse reaction

TCM preparation

Oil

May aggravate Pitta, can potentiate adverse reaction

Ayurvedic preparation

Afternoon Nap

Increases Kapha

Exposure to sun and heat

May aggravate Pitta, can potentiate adverse reaction

Self-medication Accidental intake Suicidal intake

Table 5. Contra indications to Aconite use Contra indications In summer and rainy season In chronic disease

Possible reasons for contra indication Natural aggravation of Vata and Pitta Requirement of prolonged medication

Pitta predominant people

Potentiation of Pitta aggravating property

Infants

Unpredictability and fast action

Elderly

Unpredictability and fast action

Pregnancy Dehydration Physical exhaustion At vital points (% )

May harm to fetus Poor vital status Poor vital status Local irritation

Reports of Aconite adversities from Ayurvedic drug intake were only minimal and suggesting for their under reporting. References for Aconite research in Ayurveda were also looked into specific indexes made for Indian medicine. An Annotated bibliography of Indian medicine developed by Barkhuis publishing and Groningen university library was one such reference index for Indian medicine updated up to April 2006.A search for Aconite in this index could not find any adverse reporting of Aconite from Indian medicine [22]. Superiority of Ayurvedic purifications methods (Samskara) employed for purification of crude Aconite to make it medicinally usable has also been experimentally explored in some studies [23-25] These studies ,though not answering to why? and

how? related to the subject, but are able to raise a concern for looking into deeper details of the procedures adopted. Superiority of detoxifying procedures upon crude drug can also be presumed as a possible reason for minimal adverse reactions of Aconite usage in the form of Ayurvedic drugs however lack of awareness in adverse drug reporting among Ayurvedic physicians, poor understanding of Ayurvedic formulations at conventional toxicological centers and lack of uniform standards in Ayurvedic drug manufacturing questions this inference )-. ! A treatment with heat, water and vinegar is done in TCM to reduce the toxic effect of alkaloids from Aconite [21]. Many cases of poisoning with Aconite containing preparations like and have occurred in China and Hong Kong. One study at a Hong Kong hospital between 1989 and 1991 identified eight patients with signs of poisoning from Aconite [26]. Aconite poisoning is probably the most common cause of cardiac toxicity among people taking traditional Chinese medicine. Its clinical presentation typically includes numbness and parasthesia beginning in the mouth and spreading to the limbs as well as dizziness, nausea, vomiting, sweating and palpitation. The conscious state may be reduced. In severe poisoning, hypotensive sustained ventricular tachy arrhythmia may develop. This may be complicated with acidosis and hypokalemia. [27]. In a referral hospital at Hong Kong, out of 20 referred patients for drug adverse reactions between 2000–2002, Aconite poisoning accounted in 2 cases [28]. A systemic review done to identify adverse effects of herbal components in various preparations identified some serious cardiovascular adverse effects as arrhythmias, arteritis, chest pain, congestive heart failure, hypertension, hypotension, myocardial infarction, over-anticoagulation, pericarditis and death. The problems were basically found to be related to toxic herbal ingredients, adulteration and contamination of herbal medicinal products, and herb-drug interactions. Aconite is identified as a key component in many of these preparations causing adverse reactions [10]. # & ! Tab. 3 shows the list of common preparations of Ayurveda containing Vatsanabha as one of their main ingredients. Among them, many are commonly used proprietary preparations for common ailments like cold, fever and body aches [2]. Very few case reports regarding the adverse effects of Vatsanabha have been reported from India [29-31] and most of

them were isolated cases where cardiotoxic effects of Vatsanabha [32, 33] have brought the case into the notice. * & !/ & ! ! 0 /" & ! 0 These cases of Aconite poisoning are due to the unsupervised consumption of unprocessed and crude Aconite in a dose not recommended medically. Isolated cases of this poisoning have been reported sparingly where Aconite, in its crude form, is consumed with different intentions. A case of Aconite consumption through homemade capsules in order to self-medicate was reported from US with sinusal bradycardia, polymorphic and bigeminal ventricular extrasystole as the main features. A toxicokinetic study in the same case has revealed first order kinetics of its alkaloid elimination [34]. Deliberate consumption of Aconite with suicidal intentions has also been reported occasionally [35, 36]. Aconite alkaloids are postulated to be biotransformed, and their hydrolysis products are excreted time-dependently to the urine. The urine is found to be a useful material to identify the toxicants in the case of Aconite intoxication [37]. ADR reporting: a tool for further progress A 30-year male presenting with severe prostration, perspiration, vomiting and headache was brought in a hospital at Lucknow. The symptoms were having acute onset and initiated with giddiness followed by headache, vomiting and prostration. The physical examination revealed bradycardia (P/R 42/mt) and mild elevation of blood pressure (136/94 mm of Hg). ECG has revealed sinus bradycardia. There were no specific finding in abdomen during examination and other systemic examination also remained normal. An enquiry about the incidence has given following details. He was suffering from common cold for past 2-3 days and had taken some Ayurvedic medicine for the same just few hours before the onset of symptoms. Beside this, there was no other significant history of any preceding illness. An enquiry has also been done for seeing the possibility of food poisoning, deliberate intoxication, suicidal attempt, subarechnoid hemorrhage or any cardiac ailment as the possible cause of prostration and bradycardia but could not be established. ) * and ' were identified as the Ayurvedic drugs consumed before the incidence. Bhallataka (Semicarpus anacardiacum) and Vatsanabha (Aconitum ferox) were found as the key ingredients in )

and Vatsanabha in ' + [38]. The patient was not having any history of allergic reaction to any of the drugs ayurvedic or allopathic, consumed so far.Ayurvedic drugs consumed this time have not been consumed by him for any other illness before. These drugs were found to be manufactured and dispensed by a hospital associated dispensary. It was presumed as a case of ADR from Vatasanabha due to its possible over dosing as two preparation consumed at the same time were containing Aconite. Naranjo’s algorithm has favored to this cause and effect relationship [39]. Patient improved gradually after stopping all the drugs consumed previously. Vomiting stopped after 8 hours and the blood pressure normalized then after. After 24 hours of hospital admission he was taken out of the ICU as his blood pressure and heart rate normalized. There was no headache or vomiting. The hematological and biochemical investigations done to identify any other pathology as the cause of the symptoms could not reveal any specific finding. The patient was discharged on the consequent day with a caution for any unsupervised intake of Ayurvedic preparations. This case is possibly the first reported case from India where a suspected vatasanbha adverse reaction is reported after consumption of some ayurvedic drugs.

DISCUSSION Vatsanabha is one of the most dependable herbs of Ayurvedic formulary which is used in cold and febrile conditions. The compounds containing Vatsanabha are included under the list of essential Ayurvedic medicines for ayurvedic dispensaries run under centrally sponsored schemes of Govt. of India This enlistment further endorses to its importance [40]. A sample of Vatsanabha in Indian market is a heterogeneous mixture of many species [19] with a variable toxicity. Aconitine is a group of highly toxic alkaloids, available in many species of Aconite and act as analgesic, diuretic and diaphoretic. For these alkaloids Aconite acts as a deadly poison. The symptoms of Aconite poisoning are tingling and numbness in tongue and mouth, parasthesia, nausea, vomiting, epigastric pain, dyspnoea, irregular pulse and syncope. Vatsanabha is cautioned before its internal use through out the Ayurvedic literatures. This is advised only to be used with caution, with proper purification and in right conditions and to the right patients. This

is mainly used in Vata Kapha disorders (Figure 1) and is contraindicated in conditions with aggravated Pitta (Table 5). This is contraindicated in Pitta psychosomatic composition people, in old and tender ages, in pregnancy, during summer, and along with food and behavior, which may aggravate heat of the body [12]. Improperly processed Vatsanabha is suggested as cardio depressive. Its purification is done by dipping the tubers in cow urine for 3-4 days and after washing them, steaming in cow milk for 6 hours. Processing of herbs has been claimed as to reduce the harmful effects of some drug and to potentiate its beneficial effects. A detail observation of making of tribhuvan kirti rasa gives little support to this claim though requires further evaluation. The ingredients of this preparation are processed through the extracts of Tulsi (, ), Ardraka ( !! ) and Dhatura (& ) [38]. Among these, Dhatura contain natural alkaloids with anticholinergic actions. These alkaloids are rapidly absorbed through GI tract and can block the inhibitory vagal impulse to SA node [41]. This is postulated that this may help in counteracting any remained cardiodepressive action of Aconite. The case report suggests that the symptoms originated in case study were presumably either due to the concomitant use of two preparations containing Aconite, which eventually has doubled the dose consumed, or due to improper processing of the either of drug. Improper selection of the drug can also be attributed as a distant cause of the event from Ayurvedic point of view. In the presented case the patient was objectively found to be of Pitta constitution where the preparations like Vatasnabha and Bhallataka are usually contraindicated. This interpretation however requires further enquiry. The review primarily suggests that Ayurvedic principles are required to be more honestly evaluated and investigated before their dismissal as being the non-scientific ones. With more advances in scientific medicine, initially unnoticed principles of Ayurveda are gaining grounds to be explored more thoroughly [3, 42]. Ayurveda has a well documented system of drug formulary and also a unique system of its approach to disease diagnosis and management. To explore it fully, these approaches are required to be thoroughly adopted however with an open mind and with a rationale vision. Taking a clue from the review of Vatsanabha descriptions in Ayurveda and from the case report, this can easily be interpreted that current model of ayurvedic practice in India needs thorough revision. Proper selection of the drug and its good manufacturing practice makes the one

half of the success of a therapy where as a correct diagnosis and the patient selection makes the other half. In the present case the adverse effects was possibly due to the over dosing of Vatsanabha because of simultaneous administration of two compounds containing the similar herb and also possibly because of wrong selection of the patient. The case argues for putting more attention to the standard practice of Ayurveda and also brings forth a need of better understanding of ayurvedic formulary by the conventional physicians in India who may get a chance encounter to deal with the patient having adverse reactions erupting out of some ayurvedic drug consumption. Studies have shown superiority of processed Ayurvedic preparations than unprocessed and crude preparations [25] and this should also be noted that a herb, unless is processed in the way as stated in Ayurvedic scripts and is taken in the way and doses as advised, should not be labeled as Ayurvedic therapy and any failure or advantage of this approach should not also be accounted to the credibility of Ayurveda.

CONCLUSIONS There is a lay belief about the safety assurance of herbal drugs [43]. This belief has played an important role in popularization of these medicines among the masses. These drugs are either consumed for the health promotive purpose on over the counter (OTC) basis or are prescribed for some specific ailments [44]. In both of these conditions, the intake of herbal medicine often coexists with other therapies may be operating at the same time for the same person. This is a very common condition in India where people self medicate them selves with popular Ayurvedic herbs through some homemade or OTC preparations and also seek conventional therapy help at the same time. This has created some unique situations where a number of medical systems operating concomitantly in a given condition and the good or the bad effects upon the patient can not be clearly attributed to some specific system of medicine. What may lead to an adverse reaction in Ayurveda? Many drugs utilized in Ayurvedic pharmacopia are having toxic effects and various measures have been advocated to reduce these effects when these herbs are required to be used as a medicine. Adverse reactions from Ayurvedic drugs may be because of many reasons where adulteration, misidentification,

improper processing, wrong prescriptions and over dosing are accounted as the major ones [45, 46]. Role of physician and pharmacy in minimization and handling of adverse events Adverse reactions, in general are under reported and less entertained in documentations. For traditional medicine, the situation is even poorer [4749]. As the Ayurvedic drugs are commonly used form of prescriptions in India, their potential of causing adverse reaction is also higher and warrants for a proper identification and reporting. Vatsanabha (Aconite), a common ingredient of Ayurvedic anticold and anti febrile preparation may lead to some undesired consequences which may even be fatal if not taken care for. Proper awareness, availability of screening methods and proper reporting to disseminate the knowledge are the tools to up bring the herbal medicine into the mainstream and to make it more responsive. Ayurvedic physicians are also required to be more informed about the proper use of Ayurvedic preparations. They should also be well acquainted with the tools for earliest identification of untoward events and its proper management in the case of its existence. Ayurvedic principles are required to be more seriously evaluated and investigated before their dismissal as being the non-scientific ones. As was seen in the case reported, the adverse effects were apparently due to the over dosing of Vatsanabha because of simultaneous administration of two compounds containing Aconite and also possibly because of non observation of do’s and don’ts associated with Aconite prescription. Current practice model of Ayurveda is required to be modified in accordance of the observations. Studies have shown superiority of processed Ayurvedic preparations than unprocessed and crude preparations. A uniform code of quality production of Ayurvedic drugs would be the key to lead further. Unless this is assured, any failure or advantage of compromised approach, which is not in accordance to the principles of Ayurveda, should not be accounted to the credibility of Ayurveda. Proposals for Vatsanabha use in present scene As the review suggests, Vatsanabha is a dependable part of many ayurvedic preparations.This should however be used with caution, after proper purification, in the dosage determined as per the age and weight of the patient, after proper screening of the patient and with proper explanation of do’s and dont’s associated with Vatsanabha use. The contraindications associated with its use should be

carefully observed. The patient should also be warned for any untoward effects of Vatsanabha and should be suggested to report immediately in case of any unwell feeling. They may additionally be given a telephonic access to report any adverse reaction. The packing of the drug containing Vatsanabha should have a clear mention about the ingredients and its possible adversities. This can be mentioned on the lebel of the pack as well as on the insert of the pack. Ayurvedic physicians should be made more informed about its proper use and simultaneously, allopathic physicians should also be made aware of possible reactions of common Ayurvedic drugs and their management in case of their reporting in modern hospitals. The researches should also be promoted to identify the effect of purificatory methods as described in Ayurveda and a standard practice of these procedures should be adopted in manufacturing of herbal drugs containing toxic elements.

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