A Systematic Review of the Safety and Efficacy of Ayurveda Interventions for Hepatitis: A Protocol for Systematic Review
Amrish P Dedge, Tushar K Mandal, Manohar S Gundeti, Laxman W Bhurake, Shyam G Kale, Parth P Dave
Hepatitis, Systematic review,Ayurveda
Citation Information :
Dedge AP, Mandal TK, Gundeti MS, Bhurake LW, Kale SG, Dave PP. A Systematic Review of the Safety and Efficacy of Ayurveda Interventions for Hepatitis: A Protocol for Systematic Review. J Res Ayurvedic Sci 2019; 3 (1):1-5.
Introduction: A systematic review is planned to investigate the safety and efficacy of Ayurveda interventions for hepatitis through analyzing published clinical research work.
Materials and methods: We shall conduct a systematic review published clinical work for Ayurveda interventions for hepatitis. Electronic search of following databases will be performed: PubMed, AYUSH Research Portal, Digital Helpline for Ayurveda Research Articles (DHARA), Google Scholar, the Cochrane Library (the Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials (CENTRAL), and the Cochrane Methodology Register) without any restriction of publication year. Hand search, snowballing of studies will also be performed to fetch complete available literature. The selection of the studies, data abstraction, and validations will be performed independently by two teams of researchers. A conclusion will be derived from the consensus of the complete review team. Study selection will follow the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines and study quality will be assessed by the CONSORT checklist for randomized controlled trials (RCTs), transparent reporting of evaluations with nonrandomized designs (TREND) checklist for nonrandomized controlled trials (NRCTs), and CONSORT extension for pilot and feasibility studies for pilot studies. Risk of bias assessment will be performed with the help of the Cochrane risk-of-bias tool for randomized trials (RoB2) tool for RCTs and risk of bias in nonrandomised studies of interventions (ROBINS-I) tool for NRCTs. If sufficient and appropriate data are available, a meta-analysis will be conducted. Subgroup analysis and sensitivity analysis will be performed if found to be necessary and feasible.
Dissemination: The systematic review will be published in a peer-reviewed journal. The review will also be disseminated electronically and in print. The review will be updated to inform and guide healthcare practice and policy.
Trial registration number: PROSPERO 2019: CRD42019103115.
WHO Global Hepatitis Report 2017. Available from: https://apps.who.int/iris/bitstream/handle/10665/255016/9789241565455-eng.pdf?sequence=1.
National Ayush Morbidity And Standardized Terminologies Electronic Portal (NAMASTE - PORTAL), Ministry of AYUSH, Govt of India, New Delhi.
Tripathi B. Charak Samhita of Agnivesha, Chikitsa Sthana, Ch. 13, Ver. 16–18. Varanasi: Choukhamba Publication; 2004.
Bhatt N, Deshpande M, Namewar P, et al. A review of classical, proprietary and patented Ayurved products and their ingredients in liver/spleen diseases. Int J Pharm Sci Res 2018;9(10):4056–4070.
Valvi AR, Mouriya N, Athawale RB, et al. Hepatoprotective Ayurvedic plants – a review. J Complement Integr Med 2016;13(3):207–215. DOI: 10.1515/jcim-2015-0110. Available from: https://www.degruyter.com/view/j/jcim.2016.13.issue-3/jcim-2015-0110/jcim-2015-0110.xml.
Chua LS. Review on liver inflammation and antiinflammatory activity of andrographis paniculata for hepatoprotection. Phytother Res 2014;28(11):1589–1598. DOI: 10.1002/ptr.5193.
Ilyas U, Katare DP, Aeri V, et al. A review on hepatoprotective and immunomodulatory herbal plants. Pharmacogn Rev 2016;10(19): 66–70. DOI: 10.4103/0973-7847.176544.
Raval PR, Raval RM. Treatment of infective hepatitis: where biomedicine has no answers, Ayurveda has!! Anc Sci Life 2016;35(3):176–179. DOI: 10.4103/0257-7941.179861.
Saper RB, Kales SN, Paquin J, et al. Heavy metal content of ayurvedic herbal medicine products. JAMA 2004;292(23):2868–2873. DOI: 10.1001/jama.292.23.2868.
Devarbhavi H. Ayurvedic and herbal medicine-induced liver injury: it is time to wake up and take notice. Indian J Gastroenterol 2018;37(1):5–7. DOI: 10.1007/s12664-018-0820-6.
Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ 2009;339:b2700. DOI: 10.1136/bmj.b2700.
Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomized trials. BMJ 2010;340:c869. DOI: 10.1136/bmj.c869.
Des Jarlais DC, Lyles C, Crepaz N, et al. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. Am J Public Health 2004;94(3):361–366. DOI: 10.2105/AJPH.94.3.361.
Eldridge SM, Chan CL, Campbell MJ, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ 2016;355:i5239. DOI: 10.1136/bmj.i5239.
Higgins JPT, Altman DG, Sterne JAC. Chapter 8: assessing risk of bias in included studies. In: Higgins JPT, Green S, ed. Cochrane handbook for systematic reviews of interventions. Version 5.1.0 (updated March 2011). The Cochrane Collaboration; 2011. Available from: http://www.cochrane-handbook.org.
Sterne JA, Hernán MA, Reeves BC, et al. ROBINS-I: a tool for assessing risk of bias in non-randomized studies of interventions. BMJ 2016;355:i4919. DOI: 10.1136/bmj.i4919.
Deeks JJ, Higgins JPT, Altman DG. Chapter 9: analysing data and undertaking meta-analyses. In: Higgins JPT, Green S, ed. Cochrane handbook for systematic reviews of interventions. Version 5.1.0 (updated March 2011). The Cochrane Collaboration; 2011. Available from http://www.cochrane-handbook.org.
Sterne JAC, Egger M, Moher D. Chapter 10: addressing reporting biases. In: Higgins JPT, Green S, ed. Cochrane handbook for systematic reviews of interventions. Version 5.1.0 (updated March 2011). The Cochrane Collaboration; 2011. Available from: http://www.cochrane-handbook.org.
Egger M, Davey Smith G, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315(7109):629–634. DOI: 10.1136/bmj.315.7109.629.
Dijkers M. Introducing GRADE: a systematic approach to rating evidence in systematic reviews and to guideline development. KT Update 2013;1(5):1–9.