MMD SUPRIYA

Original Research Utilization of Triphala by Ayurvedic physicians for management of obesity: a cross-sectional study Shital Giramkar1, Manasi Deshpande2, Supriya Bhalerao3 1 3 , Interactive Research School for Health Affairs (IRSHA) , Bharati Vidyapeeth Deemed to be University, Pune Satara Road, Pune-411043, Maharashtra,. 2 College of Ayurved, Bharati Vidyapeeth Deemed (to be) University, Dhankawadi, Pune-Satara Road, Pune411043. Corresponding author email: [email protected] Received at: Feb 09, 2023 || Accepted at: Dec 23, 2023 Abstract Obesity is a metabolic condition observed due to multiple causes. The current treatment modalities necessitate the need of safe and effective pharmacotherapy. Ayurvedic texts have recommended various anti-obesity drugs and formulations for obesity, of which Triphala is a top cited formulation. In the present study, documentation of Triphala utilization by Ayurvedic physicians was carried out. A survey was carried out in 86 Ayurvedic physicians from Pune city. They were asked for frequency of Triphala usage, its dose, dosage form, beneficial and adverse effects using a pre-designed questionnaire. Of 86 respondents, data from only 70 physicians was analyzable. Triphala was used by 66 physicians for obesity. The commonly used form was churna in a dose of 3-7 gm. Ayurvedic signs and symptoms formed major criteria for dose selection followed by conventional anthropometry. Our study revealed that Ayurvedic physicians commonly prescribe Triphala to their obese patients owing to its efficacy and safety. Keywords: adverse effects, Ayurpharmacoepidemiology, safety, tolerability How to cite this article Giramkar S, Deshpande M, Bhalerao S, Utilization of Triphala by Ayurvedic physicians for management of obesity: a crosssectional study, Annals Ayurvedic Med. 2023;12(4) 320-326, DOI. 10.5455/AAM. 142825 What is the unique contribution of this article in the field ? This article has highlighted the experiences of Ayurvedic physicians regarding efficacy and safety of Triphala for obesity management. Triphala, has been reported to be the commonest ingredient of most anti-obesity formulations. There was hardly any data available from the physicians perspective that was documented regarding Triphala. This article has concluded that Triphala is the preferred and commonly prescribed formulation by Ayurvedic physicians from Pune city for obesity management. It thus provides a crucial evidence regarding Triphala in treatment of obesity. Introduction Obesity is one of those clinical conditions, for which a highly desired safe and effective pharmacotherapy is needed. It is well reported that the reduction in weight will reduce the burden of non-communicable diseases as obesity is a major risk factor for almost all these diseases.1,2,3 The conventional treatment of obesity is imprudent. The current available options are not only less effective but also have add-on adverse effects.4,5,6 This situation needs to be considered in view of the steep increase in obesity prevalence.7,8,9 On the other hand, Ayurveda, the Traditional Indian Annals of Ayurvedic Medicine Vol-12 Issue-4 Oct.-Dec., 2023 320 Giramkar S. et.al. : Utilization of Triphala by Ayurvedic physicians.... System of Medicine, has described the disease obesity and its pharmacotherapy in great details. There are anecdotal reports demonstrating the efficacy of various Ayurvedic drugs and formulations in obesity. 10,11,12 Triphala, a poly-herbal formulation consisting of equiproportional mixture of three seeded fruits of Terminalia chebula Phyllanthus emblica and Terminalia bellerica, is the most recommended Ayurvedic formulation for obesity management. It is commonly prescribed/used medicine for promoting longevity and rejuvenation. Pharmacologically it is classified as tridoshnashak rasayana and describes it as strengthening, immune supporting, digestive, mild laxative, bowel tonic, purgative, carminative, expectorant, antispasmodic, and bronchodilator medicine with anti obesity properties.13-20 We have reported earlier that it is the most commonly available ingredient of marketed Ayurvedic/herbal antiobesity formulations.21 We have also shown its effect on body weight and composition in a well-designed clinical study.22 The present study was carried out to explore the utilization of Triphala by Ayurvedic physicians for obesity management, wherein we systematically documented the experiences of these physicians pertaining to efficacy and safety of Triphala. Methodology The study was initiated after obtaining permission from the Institutional Ethics Committee (Ref: BVDUCOA/EC/ 08). Written informed consent was also obtained from all the Ayurvedic physicians. It was conducted at randomly selected Ayurvedic hospitals & private clinics from Pune city over a period of 6 months (January 16–June 16). Since it was an exploratory study, no prior sample size calculation was done. We approached a total of 86 physicians during this period. The physicians were informed about the purpose and methodology of the study. To gather information precisely, a specially designed questionnaire was administered which consisted of the following 4 sections. 1. Demographic details of physicians: age, education, clinical experience 2. Usage of Triphala: Yes/No, if yes, percentage of obese patients in whom Triphala is prescribed. 3. Formulation details: composition, usage pattern (standalone/formulation), dosage form, dose, vehicle 4. Clinical findings: efficacy, ancillary benefits, safety, tolerability, rebound effect, global assessment by physicians These sections are summarized in Figure 1. Statistical analysis The frequency observed in case of different parameters is expressed as actual numbers. The rest of the data are presented as Mean ± SD. Results Out of total 86 physicians interviewed, the data collected from only 70 physicians was analyzable as they filled the questionnaire completely. Demographic details The mean age of the physicians was 37.62 ± 8.1 years. A maximum number of physicians (n=35) were MD (post graduates), 19 were BAMS (graduates) and 16 were PhD qualified. According to age, the participating physicians had varying years of clinical experience ranging from 1– 32 years. Usage of Triphala Of 70 physicians interviewed, 66 physicians were found to use Triphala for management of obesity in their clinics. The physicians prescribed Triphala to almost all obese patients attending their clinics. Formulation details Composition Annals of Ayurvedic Medicine Vol-12 Issue-4 Oct.-Dec., 2023 321 Giramkar S. et.al. : Utilization of Triphala by Ayurvedic physicians.... Efficacy Terminalia chebula, Terminalia bellerica and Phyllanthus emblica in proportion of 1:1:1 was preferred by maximum i.e. 50 out of 70 physicians. Eleven physicians were found to use it in 1:2:4 combination, while 3 physicians prescribed both the combinations followed by 1 physician, who used in 1:1:4 combination. The comprehended benefits of Triphala in obesity by 66 physicians were reduction in weight, decrease in circumferences, increased energy levels and improvement in lipid profile. Usage pattern Ancillary benefits Twelve physicians used Triphala individually/singly for obesity, while 27 physicians were found to use it as an ingredient of other formulations or in combination with other plants. Fifteen physicians were using it in both ways. The other regimens suggested were diet, exercise and medicines along with Triphala. The reported benefits of Triphala other than obesity were bowel regulation, improvement in vision, hair growth and quality of life. Dosage form Nineteen physicians recommended the traditionally prescribed churna (powder) form. Tablets/capsule and kwath (decoction) were less in use (8 physicians individually). Twenty two physicians were using all dosage forms of Triphala viz. churna, kwath and tablets. Dose The dose of churna used ranged from 3-7 gm. Twenty nine physicians were found to decide the dose of Triphala on the basis of Ayurvedic signs and symptoms while 15 used to decide it based on anthropometric parameters like weight and BMI. Four physicians were using one standard dose to all patients. The remaining 23 physicians did not comment on this question. Time of administration Thirty physicians preferred Triphala administration after meals followed by 16 preferring before food and 6 on empty stomach. Lukewarm water as vehicle was recommended by 38 physicians, honey by 5, and its combination by 15 along with ghee or cow urine. Clinical findings Safety The adverse events observed by 24 physicians during Triphala treatment were dryness of skin, constipation, addiction. No adverse event was observed by 18 physicians and 28 physicians didn’t answer. Tolerability According to 54 physicians, Triphala was well tolerated by patients while 8 observed non-tolerance of Triphala. Fifty two physicians answered that Triphala was readily consumable by patients while 6 answered not consumable and 10 gave no answer. Rebound effect Fifty physicians observed no rebound weight gain while 13 observed rebound weight gain after treatment. Global assessment The maximum rating given by physicians to Triphala for its anti-obesity efficacy was 6-8 on the visual analogue scale ranging from 1 – 10 with mean rating of 6.6. (Figure 2). Discussion The present study was carried out to document experiences pertaining to safety and efficacy of the formulation for management of obesity from Ayurvedic physicians systematically. We observed that out of 70 Annals of Ayurvedic Medicine Vol-12 Issue-4 Oct.-Dec., 2023 322 Giramkar S. et.al. : Utilization of Triphala by Ayurvedic physicians.... physicians approached by us, 66 physicians were using Triphala regularly in their clinics. For the management of obesity, the preferred combination of ingredient plants of Triphala is 1:1:1. Few physicians also mentioned use of Triphala in 1:2:4 proportion of the ingredients during the survey. It would thus be interesting to understand rationale behind these ratios and study them in detail further. The desired dosage form of Triphala was found to be churna (powder) which was prescribed with luke warm water or honey after meals. The physicians were found to select dose of Triphala for individual patient mainly on the basis of anthropometric measurements followed by reliance on Ayurvedic symptoms. Use of Triphala along with lifestyle modifications was a common trend among the physicians. This implies consideration of flexible dose studies and advice regarding lifestyle modification while evaluating the formulation in clinical studies. Majority of physicians mentioned reduction in weight and circumferences after administration of Triphala. The principles of Ayurveda suggest that improper functioning of gut is responsible for many diseases including obesity. Recently there are reports establishing link between gut microflora and obesity. According to Ayurveda, the major site of action of Triphala is gut.19,23-26 The physicians reported improved gut health as one of the ancillary benefits seen in their patients with Triphala treatment. It can be therefore hypothesized that Triphala may be acting through modulation of gut microflora. Interestingly, chebulic ellagitanins (present in Terminalia and Phyllanthus species) have shown degradation of gut microbiota metabolites in an in vitro study.26 In case of safety, dryness of skin and hair was reported as major adverse event by the physicians Although Triphala possesses laxative activity, some physicians had even observed constipation in few patients. Our results are contradicted with findings observed by Mukherjee et al., where they did not observe any adverse effects in participants treated with Triphala.27 The event could be due to chronic usage or host related factors like prakriti (body constitution) of the patient. After stopping Triphala treatment, maximum physicians observed no rebound weight gain in their patients which is in line with our earlier study. 28,22 The major limitation of obesity pharmacotherapy is rebound weight gain and hence irreversibility of reduced weight can prove an important feature to consider Triphala as potential anti-obesity drug. The global assessment of anti-obesity efficacy of Triphala by the physicians showed average rating of 6.6 on the scale of 0 to 10. Our study however has certain limitations. The sample size of 70 physicians is too small to generalize the results. Further, in depth interviews of physicians could have been a better option than questionnaire based survey. This might have revealed more information like rationale of use and mechanisms of action of Triphala, patients suffering any other co-morbidities apart from obesity, other strategies or medications used for obesity management. Such questions could have shed more light on the current practices and indications for Triphala with respect to obesity. However, our findings coupled with reported Ayurvedic literature adequately highlight wide utilization of Triphala by Ayurvedic physicians. Conclusion The data collected from 70 Ayurvedic physicians highlights acceptability of Triphala as an anti-obesity formulation. Acknowledgement We would like to acknowledge Jyotibala Banjare for her help in collecting data from physicians. We also thank all the physicians who participated in our study and facilitated data collection. References Annals of Ayurvedic Medicine Vol-12 Issue-4 Oct.-Dec., 2023 1. Available at https://www.who.int/news/item/1505-2014-world-health-statistics-2014. World Health Organization, World Health Statistics, Geneva, 2014.Last accessed on 3rd February, 2023. 323 Giramkar S. et.al. : Utilization of Triphala by Ayurvedic physicians.... 2. Mc Donald A, Bradshaw RA, Fontes F, Mendoza EA, Motta JA, et al. Prevalence of obesity in panama: some risk factors and associated diseases, BMC Public Health. 2015;15:1075. https://doi.org/10.1186/s12889-015-2397-7. 3. Banjare JB, Bhalerao SS. Obesity associated noncommunicable disease burden, Int J Health Allied Sci. 2016;5:81-87. doi: 10.4103/2278344X.180429. 4. Wadden TA, Webb VL, Moran CH, Bailer BA. Lifestyle modification for obesity: new developments in diet, physical activity and behavior therapy. Circulation. 2012;125(9): 1157-1170. doi: 10.1161/CIRCULATIONAHA. 111.039453. 5. Kang JG, Park CY. Anti-Obesity Drugs: A Review about Their Effects and Safety. Diabetes Metab J. 2012;36(1):13-25. doi: 10.4093/ dmj.2012.36.1.13. 6. Vetter ML, Faulconbridge LF, Webb VL, Wadden TA. Behavioral and pharmacologic therapies for obesity. Nat Rev Endocrinol. 2010;6(10) 578-588. doi: 10.1038/ nrendo.2010.121 7. 8. Mead E, Atkinson G, Richter B, Metzendorf MI, Baur L, Finer N. et al. Drug interventions for the treatment of obesity in children and adolescents. Cochrane Database Syst Rev. 2016;11(11):CD012436. doi: 10.1002/ 14651858.CD012436. Snow V, Barry P, Fitterman N, Qaseem A, Weiss K. Clinical Efficacy Assessment Subcommittee of the American College of Physicians. Pharmacologic and surgical management of obesity in primary care: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2005;142(7):52531. doi: 10.7326/0003-4819-142-7-200504050- Annals of Ayurvedic Medicine Vol-12 Issue-4 Oct.-Dec., 2023 00011. 9. Cooke D, Bloom S. The obesity pipeline: current strategies in the development of anti-obesity drugs. Nature Reviews Drug Discovery. 2006;5(11):919–931. doi: 10.1038/nrd2136. 10. Patwardhan B, Vaidya AD, Chorghade M, Joshi SP. Reverse pharmacology and systems approaches for drug discovery and development. Current Bioactive Compounds. 2008; 4(4):201212. 11. Balasubramani SP, Venkatasubramanian P, Kukkupuni SK, Patwardhan B. Plant-based Rasayana drugs from Ayurveda. Chinese journal of integrative medicine. 2011;17(2):88-94. doi: 10.1007/s11655-011-0659-5. 12. Sharma BS, Ota S, Khanduri S, Yadav B, Dua P, Ramkrishna KK, et al. Clinical safety of selected ayurvedic formulations in obesity and dyslipidemia, Journal of Research in Ayurvedic Sciences, 1(3) (2018) 142-149. doi:10.5005/jpjournals-10064-0016. 13. Agnivesa. Sharma RM, Dash B. Charaka Samhita: Text with English Translation & Critical Exposition Based on Cakrapani Datta’s Ayurveda dipika, 1st ed. Varanasi, India: Chowkhamba Sanskrit Series Office, 1976. 14. Baliga MS, Meera S, Mathai B, Rai MP, Pawar V, Palatty LP. Scientific validation of the ethnomedicinal properties of the Ayurvedic drug Triphala: A review. Chin J Integr Med;2012;18:946–954. doi: 10.1007/s11655012-1299-x. 15. Lu K, Chakroborty D, Sarkar C, Lu T, Xie Z, Liu Z, et al. Triphala and its active constituent chebulinic acid are natural inhibitors of vascular endothelial growth factor-a mediated angiogenesis. PLoS One. 2012;7(8):e43934. doi: 324 Giramkar S. et.al. : Utilization of Triphala by Ayurvedic physicians.... 10.1371/journal.pone.0043934. 16. Belapurkar P, Goyal P, Tiwari-Barua P. Immunomodulatory effects of triphala and its individual constituents: a review. Indian J Pharm Sci. 2014;76(6):467-75. 17. Lee HS, Won NH, Kim KH, Lee H, Jun W, Lee KW. Antioxidant effects of aqueous extract of Terminalia chebula in vivo and in vitro. Biol Pharm Bull. 2005;28(9):1639-44. doi: 10.1248/ bpb.28.1639. 18. Hamid KS, Ranjbar SH, Esfehani MM, Mohammad K, Larijani B, A systematic review of the antioxidant, anti-diabetic, and anti-obesity effects and safety of Triphala herbal formulation. Jounal of Medicinal Plants Research. 2013;7(14):831-844. doi:10.5897/JMPR12.352 19. Kamali SH, Khalaj AR, Hasani-Ranjbar S, Esfehani MM, Kamalinejad M, Soheil O, et al. Efficacy of ‘Itrifal Saghir’, a combination of three medicinal plants in the treatment of obesity; A randomized controlled trial. Daru. 2012;20(1):33. doi: 10.1186/2008-2231-20-33. 20. Kalaivani B, Vanithakumari G. Comparative study of triphala and trikatu on obesity induced oxidative stress in heart of albino rats, International Journal of Current Research. 2016;8(6):33051-33056. 21. Banjare J, Bhalerao S. A survey of marketed ayurvedic/herbal anti-obesity products. International Journal of Pharmacy and Pharmaceutical Sciences. 2016;8(8):384-386. 22. Salunke M, Banjare J, Bhalerao S. Effect of selected herbal formulations on anthropometry and body composition in overweight and obese individuals: A randomized, double blind, placebo-controlled study. Journal of Herbal Medicine. 2019;17(18):100298. doi:10.1016/ Annals of Ayurvedic Medicine Vol-12 Issue-4 Oct.-Dec., 2023 j.hermed.2019.100298 23. Peterson CT, Denniston K, Chopra D. Therapeutic Uses of Triphala in Ayurvedic Medicine. J Altern Complement Med. 2017;23(8):607-614. doi: 10.1089/ acm.2017.0083. 24. Beri K. Perspective: Stabilizing the Microbiome Skin-Gut-Brain Axis with Natural Plant Botanical Ingredients in Cosmetics. Cosmetics. 2018;5(37):1-8. https://doi.org/10.3390/ cosmetics5020037 25. Ley RE, Backhed F, Turnbaugh P, Lozupone CA, Knight RD, Gordon JI. Obesity alters gut microbial ecology. Proceedings of the National Academy of Sciences of the United States of America. 2005;102(31):11070-11075. https:// doi.org/10.1073/pnas.0504978102 26. Olennikov DN, Kashchenko NI, Chirikova NK. In Vitro Bioaccessibility, Human Gut Microbiota Metabolites and Hepatoprotective Potential of Chebulic Ellagitannins: A Case of Padma Hepaten® Formulation. Nutrients. 2015;7(10):8456-77. doi: 10.3390/nu7105406. 27. Mukherjee PK, Rai S, Bhattacharyya S, Debnath PK, Biswas TK, Jana U, et al. Clinical Study of ‘Triphala’ – A Well Known Phytomedicine from India. Iranian Journal of Pharmacology & Therapeutics. 2007;5(1):51-54. 28. Gupte P, Harke S, Deo V, Shrikhande BB, Mahajan M, Bhalerao S. A clinical study to evaluate the efficacy of Herbal Formulation for Obesity (HFO-02) in overweight individuals. J Ayurveda Integr Med. 2020;11(2):159-162. doi: 10.1016/j.jaim.2019.05.003. Source of Support : Nil Conflict of Interest : None 325 Giramkar S. et.al. : Utilization of Triphala by Ayurvedic physicians.... Annals of Ayurvedic Medicine Vol-12 Issue-4 Oct.-Dec., 2023 326