Efficacy of Homeopathy in Addition to a Multidisciplinary Intervention for Overweight or Obesity in Mexican Adolescents: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled TrialFunding None.
27 May 2019
14 August 2019
20 January 2020 (online)
Background Current recommendations for treating obesity in adolescence include a comprehensive approach (nutritional, behavioral, and exercise). Calcarea carbonica ostrearum (CCO) is a homeopathic medicine usually prescribed in obese individuals, but its effects on weight and body fat are not completely known.
Objective The aim of this study will be to evaluate the efficacy of homeopathic CCO, in addition to a multidisciplinary intervention (diet, motivational support, and exercise program), on body fat and weight in obese adolescents.
Methods/Design A randomized, placebo-controlled, double-blind, parallel-group, superiority trial with 3-month study duration will be undertaken. The study will be conducted in a public research hospital in Mexico City, Hospital Juárez de México, in the outpatient services of homeopathy and sports medicine. Eighty non-diabetic adolescents, 12 to 19 years old, who are overweight or obese, will be included. The primary outcome: change in body fat percentage at week 12. The secondary outcomes: change in mean total weight, total body mass index, fat mass index, waist–hip ratio, lean muscle mass, fasting glucose, insulin, insulin resistance, lipid profile, score of Center for Epidemiologic Studies Depression Scale Revised (CESD-R) and score of Screen for Child Anxiety-Related Emotional Disorders (SCARED) at week 12. Efficacy data will be analyzed in the intention-to-treat sample. To determine the difference in the outcomes between groups at baseline and week 12, data will be analyzed using Student's t-test.
Discussion This is the first randomized controlled trial aimed to determine the fat-reducing efficacy in obese adolescents of a homeopathic medicine, CCO, given in addition to a multidisciplinary intervention, compared with placebo plus the same intervention. It is an attempt to support scientific evidence in homeopathy for one of the most common chronic diseases, which causes high mortality due to its complications.
ClinicalTrials.gov Identifier: NCT03945396 https://clinicaltrials.gov/ct2/show/NCT03945396?term=homeopathy+for+obesity+in+Mexican+adolescents&rank=1
• Calcarea carbonica ostrearum (CCO) is a homeopathic medicine usually prescribed in obese individuals, but its effects on weight and body fat are not completely known.
• The aim of this randomized controlled trial is to evaluate the efficacy of CCO, given in addition to a multidisciplinary intervention (diet, exercise program, and motivational support), in reducing percentage of body fat.
• Eighty non-diabetic adolescents, 12 to 19 years old, who are overweight or obese, will be included.
• Primary outcome is the change in mean body fat percentage at week 12.
• Study participants will receive a comprehensive approach, including clinical evaluation, with assessment of severity of depression and anxiety, as well as anthropometric, and laboratory-derived measurements.
† Dr. Pilar Sánchez-Navarrete, who conceived the original design for this study, died on November 17, 2011.
- 1 Encuesta Nacional de Salud y Nutrición de Medio Camino. 2016 (ENSANUT MC 2016). Informe final de resultados. Available at: https://www.gob.mx/cms/uploads/attachment/file/209093/ENSANUT.pdf
- 2 Tirosh A, Shai I, Afek A. , et al. Adolescent BMI trajectory and risk of diabetes versus coronary disease. N Engl J Med 2011; 364: 1315-1325
- 3 Greydanus DE, Agana M, Kamboj MK. , et al. Pediatric obesity: current concepts. Dis Mon 2018; 64: 98-156
- 4 Khatib O. Noncommunicable diseases: risk factors and regional strategies for prevention and care. East Mediterr Health J 2004; 10: 778-788
- 5 Dabelea D, Mayer-Davis EJ, Saydah S. , et al; SEARCH for Diabetes in Youth Study. Prevalence of type 1 and type 2 diabetes among children and adolescents from 2001 to 2009. JAMA 2014; 311: 1778-1786
- 6 Rodríguez-Rodríguez E, Perea JM, López-Sobaler AM, Ortega RM. Obesidad, resistencia a la insulina y aumento de los niveles de adipoquinas: importancia de la dieta y el ejercicio físico. Nutr Hosp 2009; 24: 415-421
- 7 Laguna-Alcaráz AD, Mejía-Rodríguez O, Rendón-Paredes AL, Villa-Barajas R, Paniagua R. Impact of a comprehensive intervention to families with teenage sons with overweight and obesity in a primary care setting: a case report. Diabetes Metab Syndr 2017; 11: S195-S200
- 8 Muñoz HO. Programas integrados de salud (PREVENIMSS). Rev Med Inst Mex Seguro Soc 2016; 44: S1-S2
- 9 Steinberger J, Daniels SR, Eckel RH. , et al. Progress and challenges in metabolic syndrome in children and adolescents: a scientific statement from the American Heart Association Atherosclerosis, Hypertension, and Obesity in the Young Committee of the Council on Cardiovascular Disease in the Young; Council on Cardiovascular Nursing; and Council on Nutrition, Physical Activity, and Metabolism. Circulation 2009; 119: 628-647
- 10 Berge JM, Maclehose R, Loth KA, Eisenberg M, Bucchianeri MM, Neumark-Sztainer D. Parent conversations about healthful eating and weight: associations with adolescent disordered eating behaviors. JAMA Pediatr 2013; 167: 746-753
- 11 Anderson KL. A review of the prevention and medical management of childhood obesity. Child Adolesc Psychiatr Clin N Am 2018; 27: 63-76
- 12 Lee S, Bacha F, Hannon T, Kuk JL, Boesch C, Arslanian S. Effects of aerobic versus resistance exercise without caloric restriction on abdominal fat, intrahepatic lipid, and insulin sensitivity in obese adolescent boys: a randomized, controlled trial. Diabetes 2012; 61: 2787-2795
- 13 Miller WR, Rollnick S. Motivational Interviewing. Helping People Change. 3rd ed. New York, NY: The Guilford Press; 2013
- 14 Resnicow K, Harris D, Schwartz R. , et al. Can brief motivational interviewing in practice reduce child body mass index? Results of a 2-year randomized controlled trial. Presented at: Pediatric Academic Societies Annual Meeting, Vancouver, British Columbia, Canada; May 4, 2014
- 15 Golden NH, Schneider M, Wood C. ; Committee On Nutrition; Committee On Adolescence; Section On Obesity. Preventing obesity and eating disorders in adolescents. Pediatrics 2016; 138: e20161649
- 16 Jonas WB, Kaptchuk TJ, Linde K. A critical overview of homeopathy. Ann Intern Med 2003; 138: 393-399
- 17 Macías-Cortés Edel C, Llanes-González L, Aguilar-Faisal L, Asbun-Bojalil J. Individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP study): a randomized, double-dummy, double-blind, placebo-controlled trial. PLoS One 2015; 10: e0118440
- 18 Hahnemann S. Organon of Medicine. 6th ed. Translated by Dr. William Boericke. New Delhi: B Jain Publishers Pvt. Ltd; 1900
- 19 Monami M, Silverii A, Mannucci E. Alternative treatment or alternative to treatment? A systematic review of randomized trials on homeopathic preparations for diabetes and obesity. Acta Diabetol 2019; 56: 241-243
- 20 Denisova TG, Gerasimova LI, Pakhmutova NL, Mahesh S, Vithoulkas G. Individualized homeopathic therapy in a case of obesity, dysfunctional uterine bleeding, and autonomic dystonia. Am J Case Rep 2018; 19: 1474-1479
- 21 Vilhena EC, Castilho EA. Homeopathic treatment of overweight and obesity in pregnant women with mental disorders: a double-blind, controlled clinical trial. Altern Ther Health Med 2016; 22: 14-22
- 22 Sampath S, Narasimhan A, Chinta R. , et al. Effect of homeopathic preparations of Syzygium jambolanum and Cephalandra indica on gastrocnemius muscle of high fat and high fructose-induced type-2 diabetic rats. Homeopathy 2013; 102: 160-171
- 23 To KLA, Fok YYY, Chong KCM, Lee YCJ, Yiu LSS. Individualized homeopathic treatment in addition to conventional treatment in type II diabetic patients in Hong Kong – a retrospective cohort study. Homeopathy 2017; 106: 79-86
- 24 Lathoud JA. Materia Medica. 1st ed. Argentina: Albatross; 2006
- 25 Demarque D, Jouanny J, Poitevin B, Saint-jean Y. Farmacología y material médica homeopática. Colección del Centro de Enseñanza y Desarrollo de la Homeopatía; 1997
- 26 Sánchez-Navarrete P, Ocharán-Hernández E, Ochoa-Bernal F, Macías-Cortés E. Calcarea carbonica ostrearum para la obesidad en adolescentes mexicanos. La Homeopatía de México 2016; 85: 7-22
- 27 Schulz KF, Altman DG, Moher D. ; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med 2010; 7: e1000251
- 28 Chan AW, Tetzlaff JM, Gøtzsche PC. , et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013; 346: e7586
- 29 Dean ME, Coulter MK, Fisher P, Jobst KA, Walach H. Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT. J Altern Complement Med 2007; 13: 19-23
- 30 Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/obesity/childhood/defining.html
- 31 Food and Agriculture Organization (FAO). Food-based dietary guidelines – Mexico. Available at: http://www.fao.org/nutrition/education/food-based-dietary-guidelines/regions/countries/mexico/es/
- 32 Guo Y, Bian J, Li Q. , et al. A 3-minute test of cardiorespiratory fitness for use in primary care clinics. PLoS One 2018; 13: e0201598
- 33 Mayo Clinic. Exercise intensity: How to measure it. Available at: https://www.mayoclinic.org/healthy-lifestyle/fitness/in-depth/exercise-intensity/art-20046887
- 34 Miller WR, Rollnick S. What makes it Motivational Interviewing? Presentation at the International Conference on Motivational Interviewing (ICMI). Stockholm, June 7, 2010. Available at: http://www.fhi.se/Documents/ICMI/Dokumentation/June--7/Plenary/Miller--june7--plenary.pdf
- 35 Center for Epidemiologic Studies Depression Scale Revised (CESD-R). Available at: https://cesd-r.com/cesdr/
- 36 Birmaher B, Brent DA, Chiappetta L, Bridge J, Monga S, Baugher M. Psychometric properties of the Screen for Child Anxiety Related Emotional Disorders (SCARED): a replication study. J Am Acad Child Adolesc Psychiatry 1999; 38: 1230-1236
- 37 Nemet D, Barkan S, Epstein Y, Friedland O, Kowen G, Eliakim A. Short- and long-term beneficial effects of a combined dietary-behavioral-physical activity intervention for the treatment of childhood obesity. Pediatrics 2005; 115: e443-e449
- 38 International Standards for Anthropometric Assessment. The International Society for the Advancement of Kinanthropometry 2001 . Available at: https://docplayer.net/25335980-International-standards-for-anthropometric-assessment.html
- 39 Ashwell M, Hsieh SD. Six reasons why the waist-to-height ratio is a rapid and effective global indicator for health risks of obesity and how its use could simplify the international public health message on obesity. Int J Food Sci Nutr 2005; 56: 303-307
- 40 Dantas F, Rampes H. Do homeopathic medicines provoke adverse effects? A systematic review. Br Homeopath J 2000; 89: S35-S38
- 41 Endrizzi C, Rossi E, Crudeli L, Garibaldi D. Harm in homeopathy: aggravations, adverse drug events or medication errors?. Homeopathy 2005; 94: 233-240
- 42 Díaz RG, Esparza-Romero J, Moya-Camarena SY, Robles-Sardín AE, Valencia ME. Lifestyle intervention in primary care settings improves obesity parameters among Mexican youth. J Am Diet Assoc 2010; 110: 285-290