Vedic Health: Ayurveda and Evidence-Based Research

There are six types of evidences accepted in the literature.

1.            Pratyaksha: What is seen or observed directly. These are observational studies and accepted in the scientific community.

2.            Anumana or the evidence based on the inference of a defined hypothesis

3.            Upamana are the evidences based on analogies

4.            Arthapathi are the evidences, which are based on circumstantial evidence

5.            Anupalabdhi is an evidence based on the theory of negation

6.            Shabda is undisputed evidence as it is written in text books and taught to us

Let us take an example to further understand this.

Here is a statement “Neem or Azadirachta indica is a good antiseptic.”

1.             Pratakysha: I would look for any observational study.

2.             Anumana: I will look for any double-blind study in the literature

3.             Upamana: As per Ayurveda, any plant which is bitter in nature will have anti-pitta qualities

4.             Arthapati: Circumstantial evidence and

5.             Anupalabdhi is evidence by negation.

6.             Shabda: Would refer to Sushrut Samhita reference as gold standard.

An Ayurveda doctor will follow the Shabda evidence, but a modern medicine doctor would prefer Anumana as evidence. But both are accepted evidences.

Comments

·         Original (primary) research is based on data collected from individuals or clusters of individuals, with clusters defined by physician, clinic, geographic region, or other factors.

·         Within primary research, the hierarchy of evidence must be considered to minimize the risk of bias.

·         For studies evaluating therapy or harm, well-conducted randomized clinical trials are superior to observational studies, which are superior to unsystematic clinical observations

·         Questions regarding benefits (and harms) of an intervention are best answered with randomized controlled trials; whereas questions regarding risk factors for disease and prognosis are best answered with prospective cohort studies.

·         Systematic reviews and meta-analyses are best for answering single questions (e.g. the effectiveness of tight glucose control on microvascular complications of diabetes). They are more scientifically structured than traditional reviews, more open about how the authors attempted to find all relevant articles, judge the scientific quality of each study and weigh evidence from multiple studies with conflicting results. Systematic reviews pay particular attention to including all strong research, whether or not it has been published, to avoid publication bias (positive studies are preferentially published).

·         Summaries and guidelines represent the highest level of complexity. Ideally, guidelines are a synthesis of systematic reviews, original research, clinical expertise, and patient preferences. At their best, summaries and guidelines are a comprehensive synthesis of the best available evidence, from which the guidelines themselves follow. Guidelines should therefore be based on a critical appraisal of the relevant original research and systematic reviews. There are several examples of multiple guidelines on the same topic making contradictory recommendations

The accepted standards for guideline development include:

·         Rely on systematic reviews

·         Grade the quality of available evidence

·         Grade the strength of recommendations

·         Make an explicit connection between evidence and recommendations

Strength of the recommendation: A recommendation is a strong recommendation to do (or not do) something, where the benefits clearly outweigh the risks (or vice versa) for nearly all patients.

Grade 1 reflects a strong recommendation. A weak recommendation is made either when risks and benefits are more closely balanced or are more uncertain. Grade 2 reflects a weak recommendation.

Quality of evidence

Assessment of evidence quality in GRADE reflects confidence in the estimates of benefits, harms, and burdens.

GRADE can be implemented with either four levels of evidence quality or with three levels such that the "low" and "very low" categories are combined. The three levels use a letter (A, B, or C) for high-, moderate-, or low-/very low-quality evidence.

·         High-quality evidence typically comes from well-performed randomized controlled trials or other overwhelming evidence (such as well-executed observational studies with very large effects).

·         Moderate-quality evidence typically comes from randomized trials with important limitations or from other study designs with special strength.

·         Low-quality evidence typically comes from observational studies or from controlled trials with very serious limitations. Very low-quality evidence typically comes from non-systematic observations, biologic reasoning, or observational studies with serious limitations.

Based on the above we must come out with strength of evidence and quality of evidence for every Ayurveda treatment.

Let us review Azadirachta indica in Pubmed

·         There are 2467 studies on the subject.

·         There are over 138 mentions in headings.

·         There are 92 RCTs.

·         There are 308 systemic reviews

·         There are 30 observational studies

The conclusion that can be drawn is that from modern medicine point of view, Azadirachta indica will have Grade 1A scientific evidence that it has medicinal properties.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

More than 150 cases of scrub typhus in Mizoram: Revisiting scrub typhus

At least 150 people have been diagnosed with the scrub typhus disease at Thenzawl town in Serchhip district, Mizoram health department officials said on Wednesday. The officials said that the scrub typhus outbreak began in November 2018, as reported by NDTV.

Scrub typhus, also known as tsutsugamushi disease or Bush typhus, presents as an acute febrile illness.

Here are few salient points about scrub typhus.

·         Scrub typhus is a mite-borne infectious disease caused by Orientia tsutsugamushi (previously called Rickettsia tsutsugamushi).

·         It is a gram-negative coccobacillus.

·         Scrub typhus may begin insidiously with headache, anorexia, and malaise, or start abruptly with chills and fever. As the illness evolves, most patients develop high fever, worsening of headache severity, and myalgias. An eschar or rash may develop in a subset of patients.

·         The severity of infection can range from mild symptoms and signs to multiorgan failure.

·         Elderly patients and those with delays in therapy are more likely to develop complications.

·         Scrub typhus may cause spontaneous abortions in pregnant women.

·         Diagnostic methods for confirmation of O. tsutsugamushi infection include serology, biopsy, culture and polymerase chain reaction (PCR).

·         The differential diagnosis of scrub typhus includes malaria, dengue, leptospirosis and other rickettsial diseases.

·         Doxycycline shortens the clinical illness and the incidence of relapse of infection.

·         Azithromycin is an alternative drug to treat scrub typhus, which has an acceptable safety profile in pregnant women.

·         Chemoprophylaxis with doxycycline is effective when used by nonimmune individuals living or working in areas in which scrub typhus is endemic.

·         Insect repellants and miticides are highly effective when applied to both clothing and skin.

·         Permethrin and benzyl benzoate are also useful agents when applied to clothing and bedding.

Scrub typhus is a re-emerging zoonotic disease in India. It is endemic in the country and is especially prevalent in the sub-Himalayan belt, from Jammu to Nagaland.

Suspect scrub typhus in all cases of fever around that area. 

Doxycycline is the empirical antibiotic of choice in cases of fever with scrub typhus as differential diagnosis.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Wheat belly: Why is wheat the culprit?

More than 37% of Indians have belly obesity, which is defined as abdominal circumference > 80 cm in women and > 90 cm in men.

The reason for this is the every day consumption of wheat in diet. Wheat is a part of staple diet, particularly in North India. Traditionally Indians have been asked to do one wheat fast a week, extra wheat fast on the day of Ekadashi and nine-day wheat fast every three months during Navratras.

Why is wheat the culprit? Wheat contains amylopectin A, gliadin and gluten.

Amylopectin A is a chemical unique to wheat. It is a trigger of small LDL particles. When wheat is removed from the diet, these small LDL levels reduce by 90%.

Gliadin is a protein, which stimulates appetite. Eating wheat increases the average person’s calorie intake by 400 calories a day. Gliadin also has opiate-like properties, which make it “addictive”.

Gluten is inflammatory to the gut.

But wheat was a part of diet earlier also. Wheat eating patterns changed in the 70s and 80s, when newer techniques came to be used to increase yield, including hybridization. It was bred to be shorter and sturdier and also to have more gliadin. The wheat that is available today and what we eat today is not the wheat that was eaten many, many years ago.

Corn starch, rice starch, tapioca starch or potato starch are the four basic ingredients of gluten-free products. These dried, powdered starches increase the blood sugar even higher.

According to Dr Tom O’Bryan, an international expert on wheat and wheat-related disorders, for every one person who has intestinal manifestations of wheat sensitivity, there are 8 who don’t have any GI symptoms. No human has the capability to breakdown wheat. But, whether wheat causes a problem for them depends on whether they have crossed the line of tolerance. The inflammatory mechanisms begin once all tolerance is lost, which trigger the immune system resulting in an autoimmune disease. Females are three times more likely to develop autoimmune celiac disease than males.

Earlier, the term gluten sensitivity was used, but now wheat sensitivity is used as wheat has several components other than gluten, which may be a problem.

All people are wheat sensitive to some degree, so wheat can be called an inflammatory diet.

The defense mechanisms vary between individuals; while some may react to it, some may overcome it, until they cross the line of tolerance.

If after eating wheat, you get discomfort, you should get yourself tested or try a wheat elimination diet.

About 50% of wheat-sensitive people also cross react with corn and dairy. Hence, a wheat elimination diet has no wheat of any type, no sugar, no corns/grains and no dairy products. Eliminate these from your diet for three weeks and observe the change. Then eat a pizza on day 22. If you notice any worsening effect, then you are wheat sensitive.

If you are sensitive, omit wheat in the diet.

So, is rice safe? Rice does not increase the blood sugar levels to the extent that wheat does; rice also does not contain amylopectin A or gliadin.

To know more about this, attend the International Symposium on Wheat Related Disorders at India Habitat Centre, New Delhi from January 12-13, 2019.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Law on Euthanasia in India

Life and death as concepts have invited many a thinker, philosopher, writer and physician to define or describe them. Swami Vivekananda expects one to understand that life is the lamp that is constantly burning out and further suggests that if one wants to have life, one has to die every moment for it. One may like to compare life with constant restless moment spent in fear of extinction of a valued vapour; and another may sincerely believe that it is beyond any conceivable metaphor.  Death is complicated and life is a phenomenon which possibly intends to keep away from negatives that try to attack the virtue and vigour of life from any arena. In spite of all the statements, references and utterances, be it mystical, philosophical or psychological, the fact remains, at least on the basis of conceptual majority, that people love to live – whether at eighty or eighteen – and do not, in actuality, intend to treat life like an ―autumn leaf.

The perception is not always the same at every stage. There comes a phase in life when the spring of life is frozen, the rain of circulation becomes dry, the movement of body becomes motionless, the rainbow of life becomes colourless and the word life, which one calls a dance in space and time becomes still and blurred and the inevitable death comes near to hold it as an octopus gripping firmly with its tentacles so that the person shall rise up never.

The ancient Greet philosopher, Epicurus, has said, although in a different context:-

Why should I fear death?

If I am, then death is not.

If death is, then I am not.

Why should I fear that which can only exist when I do not?

But there is a fallacy in the said proposition. It is because mere existence does not amount to presence. And sometimes there is a feebleness of feeling of presence in semi-reality state when the idea of conceptual identity is lost, quality of life is sunk and the sanctity of life is destroyed and such destruction is denial of real living.

The society at large feels that a patient should be treated till he breathes his last breath.

Every doctor is supposed to take a specific oath that he will make every attempt to save the life of the patient whom he/she is treating and who is under his/her treatment. This oath, thus, puts a moral and professional duty upon a doctor to do everything possible, till the last attempt, to save the life of a patient.

The Medical Council of India (MCI) Code of Ethics Regulations rejects Euthanasia (deliberately ending a patient’s life at his or her own request or at the request of close relatives).  “6.7 Euthanasia: Practicing euthanasia shall constitute unethical conduct. However, on specific occasion, the question of withdrawing supporting devices to sustain cardio-pulmonary function even after brain death, shall be decided only by a team of doctors and not merely by the treating physician alone. A team of doctors shall declare withdrawal of support system. Such team shall consist of the doctor in charge of the patient, Chief Medical Officer / Medical Officer in charge of the hospital and a doctor nominated by the in-charge of the hospital from the hospital staff or in accordance with the provisions of the Transplantation of Human Organ Act, 1994.”

While MCI Code of Ethics rejects euthanasia, it does not talk about physician-assisted-suicide (where a physician deliberately enables a patient to end his or her life by prescribing or providing medical substances with the sole intent of causing death. But practically it is included in the same as both acts are contrary to the ethics of medicine and the role of the physician.

Medical scientists have been, relentlessly and continuously, experimenting and researching to find out better tools for not only curing the disease with which human beings suffer from time to time, noble attempt is to ensure that human life is prolonged and in the process of enhancing the expectancy of life, ailments and sufferings therefrom are reduced to the minimal. There is, thus, a fervent attempt to impress the quality of life.

It is this very advancement in the medical science which creates dilemma at that juncture when, in common perception, life of a person has virtually become unlivable but the medical doctors, bound by their Hippocratic Oath and medical ethics want to still spare efforts in the hope that there may still be a chance, even if it is very remote, to bring even such a person back to life.

The Hippocratic Oath taken by a doctor and the MCI Code of Ethics may make him feel that there has been a failure on his part and sometimes also make him feel scared of various laws. There can be allegations against him for negligence or criminal culpability.

No physician should be forced to participate in euthanasia or assisted suicide, nor should any physician be obliged to make referrals to this end. However, the right to decline medical treatment is a basic right of the patient.  

The physician does not act unethically in respecting the patient’s wish to decline medical treatment, even if such a wish may result in the patient’s death by allowing the natural dying process to unfold in the course of terminal phases of sickness.

A doctor has a crucial role to play in such situations as there is a very thin line between this ethical and unethical act.

Remember it is the patient who has a right to deny the treatment and not the relatives. However, the patient must be in his or her sound state of mind to take any such decision.

There is a distinction between the administration of lethal injection or certain medicines to cause painless death and non-administration of certain treatment which can prolong the life in cases where the process of dying that has commenced is not reversible or withdrawal of the treatment that has been given to the patient because of the absolute absence of possibility of saving the life. To explicate, the first part relates to an overt act whereas the second one would come within the sphere of informed consent and authorized omission. The omission of such a nature will not invite any criminal liability if such action is guided by certain safeguards. The concept is based on non-prolongation of life where there is no cure for the state the patient is in and he, under no circumstances, would have liked to have such a degrading state.

In the landmark judgment Common Cause versus Union of India, 2018 (5) SCC 1, the Hon’ble 4-Judge Constitution Bench of the Supreme Court held that Euthanasia is basically an intentional premature termination of another person‘s life either by direct intervention (active euthanasia) or by withholding life-prolonging measures and resources (passive euthanasia) either at the express or implied request of that person (voluntary euthanasia) or in the absence of such approval/consent (non-voluntary euthanasia).

Active euthanasia also includes physician-assisted suicide, where the injection or drugs are supplied by the physician, but the act of administration is undertaken by the patient himself. Active euthanasia is not permissible in most countries.

Passive euthanasia is when medical practitioners do not provide life-sustaining treatment (i.e. treatment necessary to keep a patient alive) or remove patients from life sustaining treatment. This could include disconnecting life support machines or feeding tubes or not carrying out life-saving operations or providing life extending drugs. In such cases, the omission by the medical practitioner is not treated as the cause of death; instead, the patient is understood to have died because of his underlying condition.

Further, in Gian Kaur versus State of Punjab, (1996) 2 SCC 648, the Hon’ble Constitution Bench  of Apex Court expounded that the word "life" in Article 21 has been construed as life with human dignity and it takes within its ambit the "right to die with dignity" being part of the "right to live with dignity". As part of the right to die with dignity in case of a dying man who is terminally ill or in a persistent vegetative state, only passive euthanasia would come within the ambit of Article 21 and not the one which would fall within the description of activeeuthanasia in which positive steps are taken either by the treating physician or some other person. That is because the right to die with dignity is an intrinsic facet of Article 21.

In Aruna Ramachandra Shanbaug versus Union of India, 2011 (15) SCC480, Hon’ble Supreme Court has observed that autonomy means the right to self-determination where the informed patient has a right to choose the manner of his treatment. To be autonomous the patient should be competent to make decisions and choices. In the event that he is incompetent to make choices, his wishes expressed in advance in the form of a Living Will, or the wishes of surrogates acting on his behalf (substituted judgment) are to be respected.

Thus, all adults with the capacity to consent have the common law right to refuse medical treatment and the right of self - determination. Doctors would be bound by the choice of self-determination made by the patient who is terminally ill and undergoing a prolonged medical treatment or is surviving on life support, subject to being satisfied that the illness of the patient is incurable and there is no hope of his being cured.

In “Common Cause versus Union of India, 2018 (5) SCC 1 the Constitution Bench of Hon’ble Supreme Court held that Advance Medical Directive would serve as a fruitful means to facilitate the fructification of the sacrosanct right to life with dignity. The said directive will dispel many a doubt at the relevant time of need during the course of treatment of the patient. That apart, it will strengthen the mind of the treating doctors as they will be in a position to ensure, after being satisfied, that they are acting in a lawful manner. However, Advance Medical Directive cannot operate in abstraction. The Hon’ble Court in the said judgment has enumerated various safeguards and procedure of advance medical derivatives and also in cases where there is no advance medical derivatives which will remain enforced till Parliament makes a law on Advance Medical Derivatives. 

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Using the Smartphone to monitor heart rate: This is the future

Smartphones have become an integral part of our daily life now, so much so that a world without smartphones now seems inconceivable.

As technology has evolved, the use of phones has undergone a revolution. Each new version of the smartphone is equipped with better and often some mind-boggling features. Physical keypads have made way for touch screen. You can video chat with someone anywhere in the world. All you need is an internet connection on your smartphone. Apps like Google Assistant make it possible to interact with the phone through natural voice. Phones today, therefore, can perform many more functions beyond just making calls.

Apple has now taken a step ahead leaving a trail for the future with two new features in Apple Watch Series 4.

An ECG app on Apple Watch Series 4 is now available. As the first direct-to-consumer product, it helps people to take an ECG right from their wrist, whenever they experience symptoms such as rapid or missed heart beat and also share the data with their doctors.

The irregular rhythm notification feature on Apple Watch can now also monitor heart rhythms in the background and send a notification if an irregular heart rhythm is detected on five rhythm checks over a minimum of 65 minutes

According to a news release from Apple, “New electrodes built into the back crystal and Digital Crown on Apple Watch Series 4 work together with the ECG app to enable customers to take an ECG similar to a single-lead reading. To take an ECG recording at any time or following an irregular rhythm notification, users launch the new ECG app on Apple Watch Series 4 and hold their finger on the Digital Crown. As the user touches the Digital Crown, the circuit is completed and electrical signals across their heart are measured. After 30 seconds, the heart rhythm is classified as either AFib, sinus rhythm or inconclusive. All recordings, their associated classifications and any noted symptoms are stored securely in the Health app on iPhone. Users can share a PDF of the results with physicians”.

Rhythm classification from a 12-lead ECG by a cardiologist was compared to the rhythm classification of a simultaneously collected ECG from the ECG app in around 600 participants. The ECG app on Apple Watch showed 98.3% sensitivity in classifying AFib and 99.6% specificity in classifying sinus rhythm in classifiable recordings; 87.8% of recordings could be classified by the ECG app.

In a sub-study of the Apple Heart Study, which included participants that received an irregular rhythm notification on their Apple Watch while simultaneously wearing an ECG patch, 80% showed AF on the ECG patch and 98% showed AF or other clinically relevant arrhythmias. With over 400,000 participants, the Apple Heart Study was the largest screening study on atrial fibrillation ever conducted, also making it one of the largest cardiovascular trials to date.

The ECG App and the irregular heart rhythm notification have been provided De Novo classification by the US FDA. They are available as part of a free update to watch OS 5.1.2.

Health care today has shifted from being ‘paternalistic’ to ‘patient-centric’. The patient now wants to be a part of decision making. He has literally all information related to his illness at his fingertips because he has a smartphone.  

Technology has again empowered patients, who can use the App to monitor themselves for signs of AF and be alerted about the event right at the time it is occurring.

It’s a promising tool indeed, yet it needs to be used cautiously.

(Source: Medscape, Apple News)

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA