Volume 10, Issue 3 (10-2022)
Jorjani Biomed J 2022, 10(3): 61-69 |
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Javadi-Pashaki N, Mehrabi H, Asdaghijahromi I, Taheri Otaghsara S M, Ghazanfari M J, Ghorbani Vajargah P, et al . Methodological and Ethical Challenges for the Implementation of Complementary and Alternative Medicine-Related Clinical Trials: Review of Reviews. Jorjani Biomed J 2022; 10 (3) :61-69
URL: http://goums.ac.ir/jorjanijournal/article-1-883-en.html
URL: http://goums.ac.ir/jorjanijournal/article-1-883-en.html
Nazila Javadi-Pashaki1 
, Hamidreza Mehrabi2 , Iman Asdaghijahromi3 , Seyedeh Mahjabin Taheri Otaghsara4 , Mohammad Javad Ghazanfari5 , Pooyan Ghorbani Vajargah6 , Amirabbas Mollaei6 , Atefeh Falakdami6 , Poorya Takasi6 , Aghil Mollaei7 , Hatef Mashhadi8 , Samad Karkhah 9
, Hamidreza Mehrabi2 , Iman Asdaghijahromi3 , Seyedeh Mahjabin Taheri Otaghsara4 , Mohammad Javad Ghazanfari5 , Pooyan Ghorbani Vajargah6 , Amirabbas Mollaei6 , Atefeh Falakdami6 , Poorya Takasi6 , Aghil Mollaei7 , Hatef Mashhadi8 , Samad Karkhah 9
1- 1. Social Determinants of Health Research Center (SDHRC), Guilan University of Medical Sciences, Rasht, Iran/ 2. Department of Nursing, Cardiovascular Diseases Research Center, School of Nursing and Midwifery, Guilan University of Medical Sciences, Rasht, Iran
2- Student Research Committee, School of Nursing and Midwifery, Guilan University of Medical Sciences, Rasht, Iran
3- Department of Anesthesiology, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran
4- Student Research Committee, Nasibeh School of Nursing and Midwifery, Mazandaran University of Medical Sciences, Sari, Iran
5- Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Kashan University of Medical Sciences, Kashan, Iran
6- Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Guilan University of Medical Sciences, Rasht, Iran
7- Department of Biostatistics, School of Health, Mazandaran University of Medical Sciences, Sari, Iran
8- Department of Geriatrics, School of Nursing and Midwifery, Kashan University of Medical Sciences, Kashan, Iran
9- 1. Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Guilan University of Medical Sciences, Rasht, Iran/ 2. Burn and Regenerative Medicine Research Center, Guilan University of Medical Sciences, Rasht, Iran ,sami.karkhah@yahoo.com
2- Student Research Committee, School of Nursing and Midwifery, Guilan University of Medical Sciences, Rasht, Iran
3- Department of Anesthesiology, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran
4- Student Research Committee, Nasibeh School of Nursing and Midwifery, Mazandaran University of Medical Sciences, Sari, Iran
5- Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Kashan University of Medical Sciences, Kashan, Iran
6- Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Guilan University of Medical Sciences, Rasht, Iran
7- Department of Biostatistics, School of Health, Mazandaran University of Medical Sciences, Sari, Iran
8- Department of Geriatrics, School of Nursing and Midwifery, Kashan University of Medical Sciences, Kashan, Iran
9- 1. Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Guilan University of Medical Sciences, Rasht, Iran/ 2. Burn and Regenerative Medicine Research Center, Guilan University of Medical Sciences, Rasht, Iran ,
Abstract: (3848 Views)
Background and Objectives: The implementation of Complementary and Alternative Medicine (CAM) has increased in recent decades. Due to the positive effects of CAM interventions, 5 to 74.8% of people use these treatments worldwide. However, implementing CAM-related clinical trials is associated with challenging issues. Failure to address these challenges can lead to poor quality of studies, publication of non-scientific findings, and ultimately disregard for human rights and ethics. This review aims to comprehensively review the literature focusing on methodological and ethical challenges for implementing CAM-related clinical trials.
Material and Methods: This review of reviews was conducted via international databases, including PubMed/MEDLINE, Web of Science, and Scopus using keywords extracted from medical subject headings such as “Methods”, “Methodological Study”, “Methodological Studies”, “Ethics”, “Complementary Therapies”, “Complementary Medicine”, “Alternative Medicine”, “Clinical Trial”, and “review” from the earliest to May 1, 2022.
Results: In general, challenging issues for the implementation of CAM-related clinical trials can be divided into two categories: 1) methodological and 2) ethical. Methodological challenges included: Risk of bias, Lack of knowledge of researchers, and Blinding. On the other hand, ethical challenges in clinical trial studies are divided into two categories: patients' rights and placebo use.
Conclusion: Overall, the present study emphasizes the need for special attention to the quality of CAM-related clinical trials. Also, this study can pioneer the introduction of critical challenging issues in CAM-related clinical trials and provide appropriate suggestions for researchers to solve these issues in future studies.
Material and Methods: This review of reviews was conducted via international databases, including PubMed/MEDLINE, Web of Science, and Scopus using keywords extracted from medical subject headings such as “Methods”, “Methodological Study”, “Methodological Studies”, “Ethics”, “Complementary Therapies”, “Complementary Medicine”, “Alternative Medicine”, “Clinical Trial”, and “review” from the earliest to May 1, 2022.
Results: In general, challenging issues for the implementation of CAM-related clinical trials can be divided into two categories: 1) methodological and 2) ethical. Methodological challenges included: Risk of bias, Lack of knowledge of researchers, and Blinding. On the other hand, ethical challenges in clinical trial studies are divided into two categories: patients' rights and placebo use.
Conclusion: Overall, the present study emphasizes the need for special attention to the quality of CAM-related clinical trials. Also, this study can pioneer the introduction of critical challenging issues in CAM-related clinical trials and provide appropriate suggestions for researchers to solve these issues in future studies.
Type of Article: Review Article |
Subject:
General medicine
Received: 2022/01/24 | Accepted: 2022/09/10 | Published: 2022/10/2
Received: 2022/01/24 | Accepted: 2022/09/10 | Published: 2022/10/2
References
1. Patel SJ, Kemper KJ, Kitzmiller JP. Physician perspectives on education, training, and implementation of complementary and alternative medicine. Advances in medical education and practice. 2017;8:499. [DOI] [PMID] [PMCID] [Google Scholar]
2. Ghazanfari MJ, Karkhah S, Zeydi AE, Mortazavi H, Tabatabaee A, Adib-Hajbaghery M. A Systematic Review of Potentially Effective Nonpharmacological Interventions for Reducing Fatigue among Iranian Patients Who Receive Hemodialysis. Complementary medicine research. 2021:1-11. [view at publisher] [DOI] [PMID] [Google Scholar]
3. de Moraes Mello Boccolini P, Siqueira Boccolini C. Prevalence of complementary and alternative medicine (CAM) use in Brazil. BMC complementary medicine and therapies. 2020;20(1):1-10. [DOI] [PMID] [PMCID] [Google Scholar]
4. Firkins R, Eisfeld H, Keinki C, Buentzel J, Hochhaus A, Schmidt T, et al. The use of complementary and alternative medicine by patients in routine care and the risk of interactions. Journal of cancer research and clinical oncology. 2018;144(3):551-7. [DOI] [PMID] [Google Scholar]
5. James PB, Wardle J, Steel A, Adams J. Traditional, complementary and alternative medicine use in Sub-Saharan Africa: a systematic review. BMJ global health. 2018;3(5):e000895. [DOI] [PMID] [PMCID] [Google Scholar]
6. Buckner C, Lafrenie R, Dénommée J, Caswell J, Want D. Complementary and alternative medicine use in patients before and after a cancer diagnosis. Current Oncology. 2018;25(4):275-81. [DOI] [PMID] [PMCID] [Google Scholar]
7. Hon KL, Bao YM, Chan KC, Chau KW, Chen R-S, Cheok KTG, et al. Determinants for asthma control, quality of life and use of complementary and alternative medicine in asthmatic pediatric patients in four cities. World Journal of Pediatrics. 2018;14(5):482-91. [DOI] [PMID] [Google Scholar]
8. Ng JY, Parakh ND. A systematic review and quality assessment of complementary and alternative medicine recommendations in insomnia clinical practice guidelines. BMC complementary medicine and therapies. 2021;21(1):1-11. [DOI] [PMID] [PMCID] [Google Scholar]
9. Ng JY, Dhawan T, Dogadova E, Taghi-Zada Z, Vacca A, Wieland LS, et al. Operational definition of complementary, alternative, and integrative medicine derived from a systematic search. BMC complementary medicine and therapies. 2022;22(1):1-39. [DOI] [PMID] [PMCID] [Google Scholar]
10. Odegard BR, Ferguson MR, Naja F, Ayoub J, Banna J. A qualitative investigation of the perceptions of complementary and alternative medicine among adults in Hawaiʻi. BMC complementary medicine and therapies. 2022;22(1):1-9. [DOI] [PMID] [PMCID] [Google Scholar]
11. Lindquist R, Tracy MF, Snyder M. Complementary & alternative therapies in nursing: Springer Publishing Company; 2018. [DOI] [Google Scholar]
12. Wang C, Preisser J, Chung Y, Li K. Complementary and alternative medicine use among children with mental health issues: Results from the National Health Interview Survey. BMC complementary and alternative medicine. 2018;18(1):1-17. [DOI] [PMID] [PMCID] [Google Scholar]
13. Barcan R. Complementary and alternative medicine: bodies, therapies, senses: Routledge; 2020. [DOI] [Google Scholar]
14. Lindquist R, Tracy MF, Snyder M. Complementary and alternative therapies in nursing: Springer Publishing Company; 2018. [DOI] [Google Scholar]
15. Ghaedi F, Dehghan M, Salari M, Sheikhrabori A. Complementary and alternative medicines: usage and its determinant factors among outpatients in Southeast of Iran. Journal of evidence-based complementary & alternative medicine. 2017;22(2):210-5. [DOI] [PMID] [PMCID] [Google Scholar]
16. Lee JA, Sasaki Y, Arai I, Go H-Y, Park S, Yukawa K, et al. An assessment of the use of complementary and alternative medicine by Korean people using an adapted version of the standardized international questionnaire (I-CAM-QK): a cross-sectional study of an internet survey. BMC complementary and alternative medicine. 2018;18(1):1-11. [DOI] [PMID] [PMCID] [Google Scholar]
17. Kiran C, Akdeniz M, Kavukcu E. Evaluation of Attitudes and Using About Complementary and Alternative Medicine of People Aged 18 and Older In Antalya. [Google Scholar]
18. Kalantar Motamedi MH, Abouie A, Hafezi-Nejad N, Saadat S, Rahimi-Movaghar A, Motevalian A, et al. Prevalence and Costs of Complementary and Alternative Medicine among Traumatic Patients in Iran: A Nationwide Population-based Study. Iranian journal of public health. 2018;47(10):1558-66. [Google Scholar]
19. Motamedi MHK, Abouie A, Hafezi-Nejad N, Saadat S, Rahimi-Movaghar A, Motevalian A, et al. Prevalence and costs of complementary and alternative medicine among traumatic patients in Iran: a nationwide population-based study. Iranian Journal of Public Health. 2018;47(10):1558. [Google Scholar]
20. Hlubocky FJ, Ratain MJ, Wen M, Daugherty CK. Complementary and alternative medicine among advanced cancer patients enrolled on phase I trials: a study of prognosis, quality of life, and preferences for decision making. Journal of Clinical Oncology. 2007;25(5):548-54. [view at publisher] [DOI] [PMID] [Google Scholar]
21. Albabtain H, Alwhaibi M, Alburaikan K, Asiri Y. Quality of life and complementary and alternative medicine use among women with breast cancer. Saudi pharmaceutical journal. 2018;26(3):416-21. [DOI] [PMID] [PMCID] [Google Scholar]
22. Dikmen HA, Terzioglu F. Effects of reflexology and progressive muscle relaxation on pain, fatigue, and quality of life during chemotherapy in gynecologic cancer patients. Pain Management Nursing. 2019;20(1):47-53. [DOI] [PMID] [Google Scholar]
23. Xu G, Lei H, Zhou Y, Huang L, Tian H, Zhou Z, et al. Acupuncture for Quality of Life of Patients with Defecation Dysfunction after Sphincter Preserving Surgery for Rectal Cancer: A Systematic Review. Evidence-Based Complementary and Alternative Medicine. 2021;2021. [view at publisher] [DOI] [PMID] [PMCID] [Google Scholar]
24. Hack CC, Hackl J, Hüttner NB, Langemann H, Schwitulla J, Dietzel-Drentwett S, et al. Self-reported improvement in side effects and quality of life with integrative medicine in breast cancer patients. Integrative cancer therapies. 2018;17(3):941-51. [DOI] [PMID] [PMCID] [Google Scholar]
25. Sajadi M, Davodabady F, Ebrahimi-Monfared M. The effect of foot reflexology on fatigue, sleep quality and anxiety in patients with multiple sclerosis: a randomized controlled trial. Archives of Neuroscience. 2020;7(3). [DOI] [Google Scholar]
26. Dilekçi E, Özkuk K, Kaki B. Effect of balneotherapy on pain and fatigue in elderly with knee osteoarthritis receiving physical therapy: a randomized trial. International Journal of Biometeorology. 2019;63(12):1555-68. [DOI] [PMID] [Google Scholar]
27. Takahashi N, Kasahara S, Yabuki S. Development and implementation of an inpatient multidisciplinary pain management program for patients with intractable chronic musculoskeletal pain in Japan: preliminary report. Journal of pain research. 2018;11:201. [DOI] [PMID] [PMCID] [Google Scholar]
28. Ayati MH, Pourabbasi A, Namazi N, Zargaran A, Kheiry Z, Kazemi AH, et al. The necessity for integrating traditional, complementary, and alternative medicine into medical education curricula in Iran. Journal of integrative medicine. 2019;17(4):296-301. [DOI] [PMID] [Google Scholar]
29. Jung S-Y, Kang JW, Kim T-H. Monitoring in clinical trials of complementary and alternative medicine. Integrative medicine research. 2021;10(2):100666. [DOI] [PMID] [PMCID] [Google Scholar]
30. Jung S-Y, Kang JW, Kim T-H. Monitoring in clinical trials of complementary and alternative medicine. Integrative medicine research. 2020:100666. [DOI] [PMID] [PMCID] [Google Scholar]
31. Brantingham PJ, Valasik M, Mohler GO. Does predictive policing lead to biased arrests? Results from a randomized controlled trial. Statistics and public policy. 2018;5(1):1-6. [DOI] [Google Scholar]
32. Krauss A. Why all randomised controlled trials produce biased results. Annals of medicine. 2018;50(4):312-22. [DOI] [PMID] [Google Scholar]
33. du V. Florey C, Yule B, Fogg A, Napier A, Orbell S, Cuschieri A. A randomized trial of immediate discharge of surgical patients to general practice. Journal of Public Health. 1994;16(4):455-64. [DOI] [PMID] [Google Scholar]
34. Vickers A. Methodological issues in complementary and alternative medicine research: a personal reflection on 10 years of debate in the United Kingdom. The Journal of Alternative and Complementary Medicine. 1996;2(4):515-24. [DOI] [PMID] [Google Scholar]
35. Probst P, Zaschke S, Heger P, Harnoss JC, Hüttner FJ, Mihaljevic AL, et al. Evidence-based recommendations for blinding in surgical trials. Langenbeck's Archives of Surgery. 2019;404(3):273-84. [DOI] [PMID] [Google Scholar]
36. Goldstein CE, Weijer C, Brehaut JC, Fergusson DA, Grimshaw JM, Horn AR, et al. Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation. BMC medical ethics. 2018;19(1):1-10. [DOI] [PMID] [PMCID] [Google Scholar]
37. Corlett RT. Trouble with the gray literature. Biotropica. 2011;43(1):3-5. [DOI] [Google Scholar]
38. Adib-Hajbaghery M, Nabizadeh-Gharghozar Z, Nasirpour P. Bias in clinical trials into the effects of complementary and alternative medicine therapies on hemodialysis patients. Journal of family medicine and primary care. 2019;8(7):2179. [DOI] [PMID] [PMCID] [Google Scholar]
39. Mohammady M, Toghian Chaharsougi N, Abdoli S. Risk of bias in randomized controlled trials published in Iranian nursing and midwifery journals in 2010. Iranian Journal of Epidemiology. 2014;9(3):24-36. [view at publisher] [Google Scholar]
40. Katz N, Dworkin RH, North R, Thomson S, Eldabe S, Hayek SM, et al. Research design considerations for randomized controlled trials of spinal cord stimulation for pain: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials/Institute of Neuromodulation/International Neuromodulation Society recommendations. Pain. 2021;162(7):1935. [DOI] [PMID] [PMCID] [Google Scholar]
41. Louis TA, Shapiro SH. Critical issues in the conduct and interpretation of clinical trials. Annual review of public health. 1983;4(1):25-46. [DOI] [PMID] [Google Scholar]
42. Zhang J, Zhang Z-M. The Challenges of Ethical Review in Clinical Research of Traditional Chinese Medicine. Evidence-Based Complementary and Alternative Medicine. 2021;2021. [DOI] [PMID] [PMCID] [Google Scholar]
43. Huanhuan C, Li M, Wang M, Roder D, Olver I. Challenges for ethics committees in biomedical research governance: illustrations from China and Australia. Journal of Medical Ethics and History of Medicine. 2021;14. [DOI] [PMID] [PMCID] [Google Scholar]
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