|
 
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| REVIEW ARTICLE |
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| Year : 2019 | Volume
: 51
| Issue : 2 | Page : 63-67 |
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Call for global standards in clinical yoga trials
Atul Kumar Goyal
Department of Otolaryngology and Head & Neck Surgery (ENT), Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India
| Date of Submission | 31-May-2019 |
| Date of Decision | 17-Jul-2019 |
| Date of Acceptance | 26-Sep-2019 |
| Date of Web Publication | 09-Dec-2019 |
Correspondence Address:
Atul Kumar Goyal
Department of Otolaryngology and Head Neck Surgery (ENT), Post Graduate Institute of Medical Education and Research, Chandigarh - 160 012
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/ym.ym_12_19
Clinical yoga trials, which were conducted in medical research institutes, found to skew toward imposing positive health impacts. Several concerns related with the clinical yoga trials including the availability of exclusive ethical committee to review yoga research proposal, compensation to the poor patients, patient's actual will to participate in the study, yoga trainer qualification, insurance policy for patients if being harmed, standard yoga protocols (exercise, stretching, bending, meditation, music, timings, and duration), mode of training (self-practice by video or personal trainer), assessment of level of compliance, religious concerns, law and legislation have been neglected, not highlighted, or not well justified by most of the studies. The present article represents the grassroot level of experience of clinical yoga trials in medical research institutes and recommended that, until and unless the global standards for clinical yoga trials have not been introduced, for the safety of the patient, either yoga trials should not be allowed in medical and research institutes or all institutions should follow the standard study designs described in highly indexed standard journals.
Keywords: Ethics, health, medical, meditation, patients, yoga
How to cite this article:
Goyal AK. Call for global standards in clinical yoga trials. Yoga Mimamsa 2019;51:63-7 |
| Introduction | |  |
In the past, yoga was considered just a healthy way of living, but nowadays, it finds its way in patient care in the clinical scenario. Various medical research institutes have been exploring the role of yoga as an integrative and alternative medicine for various communicable and noncommunicable diseases (Goyal et al 2019; Saini, Goyal, & Jangra, 2019; Anand et al., 2018; Pal et al., 2017). As yoga is still an evolving field in medical research, standard guidelines are still lacking across the world, to monitor yoga clinical trials. That may lead to injuries to patients, primarily due to excessive efforts made by patients while performing asanas and by inadequately trained yoga instructors, and unknown medical preconditions (Fishman, Saltonstall, & Genis, 2009; Cramer, Ostermann, & Dobos, 2018). Clinical trials on yogic interventions have been found to lack patient's safety data (Cramer et al., 2018; Cramer, Lange, Klose, Paul, & Dobos, 2012; Cramer, Lauche, Langhorst, & Dobos, 2012), and these trials have been found to be biased towards classifying the adverse events as nonserious (Fishman et al., 2009; Cramer et al., 2018; Cramer, Lauche, Haller, & Dobos, 2013; Cramer, Lauche, Klose, Langhorst, & Dobos, 2013).
In a self-reported incident, the author observed that one group of researcher starts the yoga trial and researchers themselves start giving yoga training to the participants without being well trained and in the absence of certified yoga trainer supervision. As a result, one of the women encountered intense pain in the vertebral column during yoga. The pain was so severe that she had to be taken to the hospital immediately. Other participants who were performing yoga in the same session became so afraid that none of them came next day. The cause of pain to the woman was identified as the incorrect posture of yoga-asana. If one carefully analyzes the incident, such practices cause more damage than any good, to the society. The incident happened as there was no well-trained yoga teacher and no standard protocol was followed. Further, the woman did not get any compensation as there was no insurance policy. Apparently, the study was approved as there was no exclusive ethical committee. Due to such incidents, people lose faith in yoga and are reluctant to participate in such future studies. A lot of such incidents related to yoga studies are often unreported in final results.
The present article aims to strongly contradict such studies and calls for protocols of global standards for clinical yoga trials in medical and research institutes. The present article represents grassroot level experience of yogic trials with the patients in clinical scenario and highlights crucial stakeholders and the lacunae which need to be taken into consideration while designing the guidelines of a global standard for clinical yoga trials.
| Institutional Ethics Committees | | |
Institutional ethics committees are the independent bodies which act as the first line of defense in patient's safety in research proposals which involve human participants. The ethics committees play a vital role in review, approval, and follow-up of the research proposal and have full authority to reject, modify, or stop the ongoing clinical trials if research is found to lack compliance to ethical standards (Gelling, 1999). Poor compliance with guidelines of the ethics committees can cause severe complications to the patients as previously reported by many studies (Rogers et al., 2019). Ethics committees are constituted by the members of both scientific and medical background along with individuals from the backgrounds of psychology, law, and social science and nonspecialists. The diverse interdisciplinary constitution of ethics committee makes it possible to assess the potential health risks, social and cultural aspects, and scientific and medical procedures of the proposed research work (Kadam & Karandikar, 2012).
In the most recent ethics guidelines issued by the Indian Council of Medical Research (ICMR), it is mentioned that the ethical committee must have an expert person of concerned field to review the proposal in terms of benefits and risks of the intervention (Mathur, 2017). However, in many medical and research institutes, most of the members of the ethics committee are clinicians with few researchers, and almost every ethical committee lacks experts in yoga. As a result, the ethical concerns of a proposed clinical yoga trials are well justified, but the core concern of the study, i.e., yoga, remains untouched. When the protocol approved by such ethical committees comes into actual practice at ground level, the study designs fall drastically. Another alternative in case where the yoga expert is lacking in the Institutional ethics committee, is to get the protocol reviewed by the outside expert. In one of the study conducted by Verma et al in 2019 (Verma, Shete, Kulkarni and Bhogal, 2019) to assess role of yoga in micronutrient absorption in school children, the study protocol is approved by the Institutional Ethics Committee as well as the Research Advisory Board of Kaivalyadhama Yoga Institute. It should be made compulsory to mention explicitly in committee constitution guidelines that if the ethical committee is supposed to review the research proposal related to yoga research, then there must be an expert of yoga in the committee; or else the protocol should be reviewed by an outside expert. Otherwise, permission to review yoga-related research should not be given to the ethics committee which lack such standards.
| Participant Information | | |
Patients have all rights to know about the details of the study in which they are supposed to participate and have full rights to decline from participating in the study in case they do not feel comfortable with the study procedures. However, in medical research institutes, during the recruitment procedure, it is a general practice to give patients information just enough to bias them to say yes to participate in the study. No importance is generally given to the patient's actual will to participate in the study. Macy (Macy, 2008) has reported that only 15% of individuals in America are actually interested in yoga. This could be even lower in a country like India, where individuals do not have resources enough to sustain their basic requirements. When information regarding yogic studies is provided to the patients, most of the patients tend to agree to participate just because they think that they will not get proper medical attention if they decline to participate or get better medical attention if they agree to participate. Both the cases represent the improper way to guide participants into the study. Over the long term, such practice has several ill consequences such as loss of patient follow-ups after completion of medical treatment. It is also the case many times that the participant's information sheet provided to the patients has inadequate information about the study procedures, and contact information regarding the higher authorities is also missing or incomplete in the sheet. To have information about the study procedure is the right of the participant and should be provided to him/her at the initiation of the recruitment process. The participant information sheet must include the information regarding the risk and benefits of yoga, nature of therapy, and potential theoretical orientation (Kamradt, 2017). If participants have doubt about the study, it should be explained by the researchers. The consent of participants should be taken considering moral values rather than as a formality. Studies which are unable to provide the required information to the patients should not be conducted.
| Yoga Instructor | | |
It has been reported that there is an increase in the number of yoga trainers by 30% in urban areas of India after the first first International day of Yoga in June 2015 (Telles et al., 2017). Most of the yoga trainers (39.2%) have not even done a degree course from college but just obtained education up to high school level (Telles et al., 2017). How such yoga trainers could understand the complex physical, physiological, and spiritual science behind yoga? Moreover, around 54.4% of trainers acquired yoga training for less than one year (Telles et al., 2017). How could an individual become perfect in yoga to trainer level in less than one year? In a study conducted by Kamradt in 2017, it has been recommended that psychotherapist should be the one who will provide the yoga training to psychiatric patients. Present article contradict that statement and recommends that instructors who provide yoga training should be qualified personal at least up to postgraduate level from a well-known Government-recognized institute with at least 2 years of experience of yoga and should be state-level winner in yoga competitions. Only a qualified instructor can explain the patients that they should avoid extreme practices such as headstand, lotus position, and forceful breathing and can guide them to practice only simple stretching and bending exercises at the beginning level.
Apart from this, if one looks deeply into the science of yoga, it consists of four parts, namely stretching-bending, yoga-asana, pranayama, and meditation. Master degree in yoga is recommended because it is necessary to understand the basic human anatomy and physiology to train patients for stretching-bending and yoga-asana. Experience is recommended because no one can become perfect in pranayama and meditation in a few days; it is a spiritual aspect which gives its true essence after lots of patience and practice. As all patients have disease-specific physical limitations, the yoga instructor, besides having all the above-said merits, should be exposed to the clinical scenario under the supervision of a medical professional (Cramer, Krucoff, & Dobos, 2013). Taking an example, bending postures may not be a problem for a healthy person, patients with glaucoma should avoid inversions and patients with compromised bone and other musculoskeletal disorders should avoid forceful or competitive yoga practices. Unless a yoga instructor has been trained in patient- and disease-specific manner, he/she should not be allowed by the authorities to give training sessions to patients.
Even after having the common disease, the group of patients, in which yoga has to be administrated in the clinical scenario, always consists of high heterogeneity in terms of culture, religion, socioeconomic status, mental setup, and social approach. When an inadequately trained yoga trainer conducts the yoga session, it generally results in potential conflicts and dissatisfaction among participants as the trainer is unable to provide a satisfactory decision to the whole group due to lack of proper knowledge. In one of the reported cases, when the issue of how to control sexual desire arose, the yoga trainer simply responded to follow “brahmacharya.” Theoretically asserting the value of the statement, it should resolve the problem, but practically individuals ignore this response due to the complexity of human experience (Parker, 2008). Hence, such kind of discussions never yield a satisfactory outcome until the yoga trainer is an expert. Apart from behavioral and psychological complications, there has been a report of physical injuries to the participants due to uncertified yoga trainers. One study has revealed that a yoga trainer broke the wrist of a participant during adjusting her for a posture (Parker, 2008). Therefore, it is necessary for yoga research, especially in a clinical scenario, to have a certified yoga trainer who has been adequately trained from a professional institute. Research proposal which lacks compliance with such an approach should be immediately rejected for the sake of patient's safety.
| Participation Compensation | | |
Patients who are undergoing treatment from tertiary care medical research institutes often face a substantial illness such as cancer, coronary heart disease, and stroke. They are already under financial burden due to the cost of treatment, medicines, traveling, and short-term stay. In addition, most of these patients are from below poverty line and are dependents as they are not earning anything due to the course of illness. Yoga causes additional financial burden on them as in certain cases, the therapist may also charge the patient for yoga sessions (Kamradt, 2017). In personal experience of author, financial burden is imposed on patients due to purchase of yoga mats, daily traveling cost to the yoga class, additional cost for the food, and cost in terms of human resources as patients who are old or severely ill need to be dependent on someone to take them to daily yoga class. The dependent individual in this way also becomes financially depleted due to the travel cost and the time invested.
It is also the scenario in medical research institutes of India that patients have to bear all the costs of medical diagnosis and laboratory testing even if such test is actually not specific to the patient's disease. In most of the yoga research proposals, the researchers only demand the consumables and staff salaries, but no funds are demanded for the patients benefits. Although it is the rule in medical institutes that patients should not be exploited to do medical tests for research purpose, there is no actual practice of this as it is mentioned in proposal that tests will be for the patient's own medical benefits. There is a need to put an end to this. Only the disease-specific cost of medical tests should be borne by the patients, and the cost of rest of the investigations conducted for research purpose should be borne by the researchers. Lack of such fairness imparts financial burden on patients. With such practices, the patient also becomes confused because when he/she consults other doctors, who is unaware of the research plan, inform the patients that these investigations were not required at all. This leads to the loss of faith of patients in their doctors. Compensation to the patients participating in yoga research should be made compulsory from researchers' side, at least for the patients and may or may not for the dependent, to provide traveling allowance, daily allowance, and yoga mats to the patients.
| Insurance Policy | | |
According to a survey conducted by Fishman et al., in 2009, the most common injuries were found to occur in spine, shoulders, and joints. In a systemic review conducted by Cramer et al., in 2013 by analyzing 35 case studies and 2 case series, it was reported that yoga can have an adverse effect and can even cause death. Among the total cases, 35.5% of cases have reported damage to the musculoskeletal system, 18.4% of the cases have reported injuries to the nervous system, and 11.8% of the cases have reported damage to the eyes. Among all these cases, only 19.7% of the cases reached complete recovery; 11.3% of cases were able to recover only partially; in 1.3% of cases, the recovery was completely compromised, and even death occurred in another 1.3% of cases. If such cases are analyzed carefully, one could find the need of insurance policies for the patients who are participating in the yoga research. As discussed earlier, there is a huge financial burden on patients, and if they get injured, the situation becomes bad to worst. A participant comes selflessly to support the research, but instead of gaining any benefits, he/she gets more troubles. Therefore, it is recommended that insurance policies should be in place to compensate patients if they get injured during yoga training.
| Religious Concerns | | |
According to Article 25 of the Indian constitution, every citizen of the country has the fundamental right to freedom of religion. Every citizen has free will to worship, profess, and practice the religion he/she wants (Mustafa & Sohi, 2017). However, in clinical yoga trials, lots of religious conflicts occur. When considering Brahmakumaris Rajyoga which involves strict lifestyle pattern and worship of their guru “Brahma,” they have their own way of celebrating all the festivals, both religious and cultural, which do not resemble celebration traditions of other religions. The same is the concern with the Art of living Sudarshan Kriya, which also has its own religious culture and focuses on following their guru. Similar things are there with Osho meditation and Radha Soami meditation. In a way, yoga is itself a religion (Jain, 2012). Individuals, in India, are rarely interested in following a new guru and generally show resistance for such religious yoga (Büssing, Hedtstück, Khalsa, Ostermann, & Heusser, 2012; Middleton, Andrade, Moonaz, Muhammad, & Wallen, 2015).
Problems tend to occur when a research design proposes a method of randomization for the recruitment of patients, and participant disagrees to join a particular group of trial which involve religious yoga practices, but is comfortable to join traditional Hatha yoga or control group. Now, the researcher has two choices: either he/she can eliminate this patient or assign the patient to other groups. If the researcher follows the first case, lots of patients are lost, and it becomes impossible to achieve the proposed sample size in yoga group; however, if the researcher follows the latter case, sample size of control group rises exponentially while yoga group gets deprived of appropriate sample size, which leads to high effect size. Moreover, in either case, the randomization is not appropriately followed. If researchers imply that the religious part will be eliminated from yoga practice in the clinical trials, then the core concept of yoga, i.e., spirituality is not properly followed (Middleton et al., 2015). Moreover, the individual who is comfortable with the spiritual concept of yoga tends to show more positive results than those who have resistance against that in the same group (MacDonald, 2013). This spiritual biases lead to high standard deviation within the group.
Apart from a researcher point of view, if we analyze from a patient's point of view, many religions do not allow yoga practice as it is considered to be in conflict with their religion. Jain in 2012 mentioned that Christians should not practice yoga, which is Hindu, and yoga is in conflict with Christian doctrine, and an obstacle on the path to salvation. Similar statements were mentioned in a work published by Nicholson in 2013. Another case study reported by Middleton et al. from Baltimore in 2015 revealed that when a Catholic female was recruited in clinical yoga trial for rheumatoid arthritis, she refused to attend the classes (absent from the next day) because she felt that religious beliefs of yoga were being imposed on her. Similar events happen every day in India but have not been reported in the final results. Therefore, it is recommended that the yoga trials which involve religious concern should not be conducted in medical research institutes so that religious harmony of patients does not get hurt.
| Law and Legislation | | |
Ernst (MacDonald, 2013) has pointed out that the rules which apply to general medical scenario should apply to yoga trials but at present stage, clinical yoga trials are largely unregulated in terms of use of non-standard procedures, false health claims, misuse of the 'Doctor' title by non-medically trained clinicians and failure to monitor and report adverse effects (Mustafa & Sohi, 2017). Only 11–20% of patients who practiced yoga reported to refer from a healthcare professional or an oriental medicine physician (Mustafa & Sohi, 2017) and more than 50% patients reported not to consult their physician before starting yoga because patients assume either that their physician does not need to know, or they will not support the yoga (Eisenberg et al., 2001). There tends to be a risk of harm for the patients in such cases as yoga is not advised by medical professionals. Recently, the National Medical Commission Bill, passed by the Government of India in 2019 (NMC Bill, 2019), has opened the way for the yoga community who wish to make yoga therapy a licensable therapeutic profession. With the implementation of such policies, explicit rules of professional conduct and licensing statutes should be designed that define and limit yoga therapy practice, and civil litigation for violations of ethical conduct (Parker, 2008). Yoga community views yoga as inherently less risky and believe that there is no need to create strict rule of conduct as there is no prescription of drugs or surgery involved (Parker, 2008). But without the strict law, there will be no accountability when a yoga trainer actions result in harm to patient (Parker, 2008). Moreover, simple rules of conduct fails to provide the precise guidance to yoga therapists in ambiguous and complex situations (Parker, 2008). Therefore, it is recommended that yoga training should be allowed only to be only given by the certified yoga trainer after getting patient referred by a certified physician for the same. Clinicians should also conduct the regular interval follow ups to stay updated with the risk and benefits as yoga is still an emerging field which needs to be monitored carefully.
| Conclusion | | |
In clinical yoga trials, there is considerable lack of standards in terms of ethical considerations, participant information, certified yoga trainers, participant compensation, insurance policies, religious concerns, law and legislation. Therefore, it is recommended that until and unless the global standards for clinical yoga trials are not introduced for the safety of the patient, all medical and research institutions should follow the standard study designs described in highly indexed standard journals.
Acknowledgments
The author highly acknowledges all the colleagues who reviewed the present work.
Financial support and sponsorship
The work in the present article is financially supported by the Junior Research Fellowship (JRF) provided by ICMR, New Delhi, India (Grant No. 3/13/JRF – 2015/HRD).
Conflicts of interest
The author declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Compliance with ethical standards
This article does not contain any studies with human participants or animals performed by author.
Methodology and search strategy
References for this review were identified through searches of PubMed for articles published from 1999 to current year by the use of the terms “yoga,” “meditation,” “clinical trial,” and “standards.” Relevant articles published were identified through searches in the authors' files, in Google Scholar, ResearchGate, and Springer Online Archives Collection. Articles resulting from these searches and relevant references cited in those articles were reviewed. Articles published in a language other than English were not included in the present review.
Bibliography, grammar, and plagiarism
The references were inserted using EndNote software version X9 (Thomson Reuters, Toronto, Canada). Language and grammar were checked by Grammarly software version 6.6 (Grammarly, Inc., San Francisco, California, United States). Plagiarism was checked with the help of Turnitin plagiarism detection service (Webster St., California). Present work was proofread by professional agency (doc navigator©, Chandigarh).[27]
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