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 Trial

Emma Macías-Cortés; Saraí Arellano-Álvarez; Sandra Vega-Monroy; Violeta Vera-Pérez; Lidia Llanes-González; Pilar Sánchez-Navarrete; Dolores Enciso-González

doi:10.1055/s-0039-1697927

Homeopathy, Table of Contents

Homeopathy 2020; 109(02): 087-096
DOI: 10.1055/s-0039-1697927

Original Research Article

The Faculty of Homeopathy

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 Trial

Emma Macías-Cortés

¹Servicio de Consulta Externa de Homeopatía, Hospital Juárez de México, Secretaría de Salud, Alcaldía Gustavo A. Madero, Mexico City, Mexico

,

Saraí Arellano-Álvarez

²Servicio de Medicina del Deporte, Hospital Juárez de México, Secretaría de Salud, Alcaldía Gustavo A. Madero, Mexico City, Mexico

,

Sandra Vega-Monroy

³Servicio de Nutrición, Hospital Juárez de México, Secretaría de Salud, Alcaldía Gustavo A. Madero, Mexico City, Mexico

,

Violeta Vera-Pérez

⁴Servicio de Terapia Familiar, Hospital Juárez de México, Secretaría de Salud, Alcaldía Gustavo A. Madero, Mexico City, Mexico

,

Lidia Llanes-González

⁵Unidad de Salud Mental Comunitaria, Hospital Juárez de México, Secretaría de Salud, Alcaldía Gustavo A. Madero, Mexico City, Mexico

,

Pilar Sánchez-Navarrete^†

⁶Jefatura de Consulta Externa, Hospital Nacional Homeopático, Secretaría de Salud, Alcaldía Cuauhtémoc, Mexico City, Mexico

,

Dolores Enciso-González

²Servicio de Medicina del Deporte, Hospital Juárez de México, Secretaría de Salud, Alcaldía Gustavo A. Madero, Mexico City, Mexico

› Author Affiliations

Abstract

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

Keywords

overweight - obesity - adolescents - homeopathy - Calcarea carbonica ostrearum

Full Text

References

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