소아청소년 단순 비만에 대한 한약 및 약물 중재 임상시험 등록 현황 분석 - WHO ICTRP를 중심으로 -
The Analysis of Registration Status of Herbal Medicine and Medication Interventional Clinical Trials for Simple Obesity in Children and Adolescents -Focused on WHO ICTRP
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초록
Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.
Abstract
Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.
참고문헌 (44)
- Jebeile H, "Obesity in children and adolescents : epidemiology, causes, assessment, and management", Lancet Diabetes Endocrinol, 10(5), pp.351~365 (2022)
- Kim JH, "Overview of pediatric obesity : diagnosis, epidemiology, and significance", J Korean Med Assoc, 64(6), pp.401~409 (2021)
- Kim BY, "Quick reference guideline for obesity 2020", pp.32~36 (2020), Korean Society of the Study of Obesity Publishing Co
- Oh MS, "Factors associated with advanced bone age in overweight and obese children", Pediatr Gastroenterol Hepatol Nutr, 23(1), pp.89~97 (2020)
- Lee SY, "Pharmacologic and surgical therapies for childhood and adolescent obesity", Korean J Fam Med, 25(8), pp.579~584 (2004)
- "New guidelines for treating childhood obesity include medications and surgery for first time" (2023)[URL]
- Gaikwad S, "American academy of pediatrics, 2023 : guideline for the evaluation and treatment of children and adolescents with obesity", Indian Pediatr, 60(9), pp.759~761 (2023)
- Flory J, "Metformin in 2019", JAMA, 321(19), pp.1926~1927 (2019)
- Wajid I, "Topiramate(Topamax) : evolving role in weight reduction management : a narrative review", Life(Basel), 13(9), pp.1~12 (2023)
- Lonneman DJ Jr, "Phentermine", topiramate extended-release capsules(qsymia)for weight loss, 2013, pp.38(8), 446~452
- Coghill DR, "A systematic review of the safety of lisdexamfetamine dimesylate", CNS Drug, 28(6), pp.497~511 (2014)
- Singh G, "Wegovy(semaglutide) : a new weight loss drug for chronic weight management", J Investig Med, 70(1), pp.5~13 (2022)
- Taylor JR, "Lorcaserin for weight management", Diabetes Metab Syndr Obes, 6, pp.209~216 (2013)
- Mahase E, "Weight loss pill praised as"holy grail"is withdrawn from US market over cancer link", BMJ, 368, pp.m705~ (2020)
- Czernichow S, "Withdrawal of sibutramine for weight loss : where does this leave clinicians?", Obes Facts, 3(3), pp.155~156 (2010)
- Nauck MA, "GLP-1 receptor agonists in the treatment of type 2 diabetes-state-ofthe-art", Mol Metab, 46, pp.1~18 (2021)
- McCormack SJ, "Metabolic effects of oxytocin", Endocr Rev, 41(2), pp.121~145 (2020)
- "Guidelines for pharmaceutical clinical trial statistics" (2016)[URL]
- Choi JT, "Quality improvement is the key challenge in multinational clinical trials", Korean J Clin Oncol, 1(2), pp.27~29 (2005)
- "Basic textbooks for those involved in clinical trials" (2012)[URL]
- Pu R, "Effects of metformin in obesity treatment in different populations : a meta-analysis", Ther Adv Endocrinol Metab, 11, pp.1~12 (2020)
- Bonnet F, "Understanding and overcoming metformin gastrointestinal intolerance", Diabetes Obes Metab, 19(4), pp.473~481 (2017)
- Kim HG, "Screening of herbal medicines for synergistic effects of metformin and herbal extracts combination in raw 264.7 cells", J Korean Med Obes Res, 14(1), pp.13~23 (2014)
- Kim JB, "A traditional herbal formula, hyangsa-pyeongwi san, improves quality of life of the patient with functional dyspepsia : randomized double-blinded controlled trial", J Ethnopharmacol, 151(1), pp.279~286 (2014)
- Kim A, "A narrative review : phentermine and topiramate for the treatment of pediatric obesity", Adolesc Health Med Ther, 14, pp.125~140 (2023)
- Lee SY, "The use of weight loss medication in Korea : an analysis of prescriptions voluntarily posted online", Health Insur Rev Assess Service Res, 3(2), pp.182~195 (2023)
- Chakhtoura M, "Pharmacotherapy of obesity : an update on the available medications and drugs under investigation", EClinicalMedicine, 58, pp.101882~ (2023)
- Zhang P, "The efficacy and safety of liraglutide in the obese, non-diabetic individuals : a systematic review and meta-analysis", Afr Health Sci, 19(3), pp.2591~2599 (2019)
- Buse JB, "Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes : a randomised, open-label study", Lancet, 381(9861), pp.117~124 (2013)
- Madsbad S, "Review of head-to-head comparisons of glucagon-like peptide-1 receptor agonists", Diabetes Obes Metab, 18(4), pp.317~332 (2016)
- Lee B, "Comparative effectiveness of East Asian traditional medicine for childhood simple obesity : a systematic review and network meta-analysis", Int J Environ Res Public Health, 19(20), pp.1~19 (2022)
- Shim SB, "The current state of registration of interventional clinical trials for children and adolescents with precocious puberty", J Pediatr Korean Med, 36(3), pp.1~18 (2022)
- Kim OJ, "Bioethics and protection of personal information in experimental studies", Korean J Epidemiol, 29(1), pp.1~12 (2007)
- Ki M, "Recruitment of study participants, randomization and blindness in clinical trial", Korean J Clin Oncol, 2, pp.68~73 (2007)
- Kelly AS, "Phentermine", topiramate for the treatment of adolescent obesity, 2022, pp.1(6), ~
- Hsia DS, "A randomized, double-blind, placebo-controlled, pharmacokinetic and pharmacodynamic study of a fixed-dose combination of phentermine", topiramate in adolescents with obesity, 2020, pp.22(4), 480~491
- Warnakulasuriya LS, "Metformin in the management of childhood obesity : a randomized control trial", Child Obes, 14(8), pp.553~565 (2018)
- Fox CK, "Meal replacements followed by topiramate for the treatment of adolescent severe obesity : a pilot randomized controlled trial", Obesity(Silver Spring), 24(12), pp.2553~2561 (2016)
- Berkowitz RI, "Effects of sibutramine treatment in obese adolescents : a randomized trial", Ann Intern Med, 145(2), pp.81~90 (2006)
- Wilson DM, "Metformin extended release treatment of adolescent obesity : a 48-week randomized, double-blind, placebo-controlled trial with 48-week follow-up", Arch Pediatr Adolesc Med, 164(2), pp.116~123 (2010)
- Kelly AS, "A randomized, controlled trial of liraglutide for adolescents with obesity", N Engl J Med, 382(22), pp.2117~2128 (2020)
- Stenlid R, "Adolescents with obesity treated with exenatide maintain endogenous glp-1, reduce dpp-4, and improve glycemic control", Front Endocrinol(Lausanne), 14, pp.1293093~ (2023)
- Weghuber D, "A 6-month randomized, double-blind, placebo-controlled trial of weekly exenatide in adolescents with obesity", Pediatr Obes, 15(7), pp.e12624~ (2020)
- Danne T, "Liraglutide in an adolescent population with obesity : a randomized, double-blind, placebo-controlled 5-week trial to assess safety, tolerability, and pharmacokinetics of liraglutide in adolescents aged 12-17 years", J Pediatr, 181, pp.146~153 (2017)