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Efficacy of individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP): study protocol for a randomized, double-dummy, double-blind, placebo-controlled trial.
Trials. 2013 Apr 23; 14:105.T

Abstract

BACKGROUND

The perimenopausal period refers to the interval when women's menstrual cycles become irregular and is characterized by an increased risk of depressive symptoms. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and postmenopausal women. Previous trials suggest that individualized homeopathic treatments improve depression. In classical homeopathy, an individually selected homeopathic remedy is prescribed after a complete case history of the patient. The aim of this study is to assess the efficacy and safety of the homeopathic individualized treatment versus placebo or fluoxetine in peri- and postmenopausal women with moderate to severe depression.

METHODS/DESIGN

A randomized, placebo-controlled, double-blind, double-dummy, three-arm trial with a six-week follow-up study was designed. The study will be conducted in a public research hospital in Mexico City (Juárez de México Hospital) in the outpatient service of homeopathy. One hundred eighty nine peri- and postmenopausal women diagnosed with major depression according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (moderate to severe intensity) will be included. The primary outcome is change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression after the fourth and sixth week of treatment. Secondary outcomes are: Beck Depression Inventory change in mean score, Greene's Scale change in mean score, response and remission rates and safety. Efficacy data will be analyzed in the intention-to-treat population. To determine differences in the primary and secondary outcomes among groups at baseline and weeks four and six, data will be analyzed by analysis of variance for independent measures with the Bonferroni post-hoc test.

DISCUSSION

This study is the first trial of classical homeopathy that will evaluate the efficacy of homeopathic individualized treatment using C-potencies versus placebo or fluoxetine in peri- and postmenopausal women with moderate to severe depression. It is an attempt to deal with the obstacles of homeopathic research due to the need for individual prescriptions in one of the most common psychiatric diseases.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT01635218.

Authors+Show Affiliations

Escuela Superior de Medicina, Instituto Politécnico Nacional, Ave, Plan de San Luis y Salvador Díaz Mirón, Casco de Santo Tomás, Distrito Federal CP 11340, Mexico. ecmc2008@hotmail.esNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

23782520

Citation

Macías-Cortés, Emma del Carmen, et al. "Efficacy of Individualized Homeopathic Treatment and Fluoxetine for Moderate to Severe Depression in Peri- and Postmenopausal Women (HOMDEP-MENOP): Study Protocol for a Randomized, Double-dummy, Double-blind, Placebo-controlled Trial." Trials, vol. 14, 2013, p. 105.
Macías-Cortés Edel C, Aguilar-Faisal L, Asbun-Bojalil J. Efficacy of individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP): study protocol for a randomized, double-dummy, double-blind, placebo-controlled trial. Trials. 2013;14:105.
Macías-Cortés, E. d. e. l. . C., Aguilar-Faisal, L., & Asbun-Bojalil, J. (2013). Efficacy of individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP): study protocol for a randomized, double-dummy, double-blind, placebo-controlled trial. Trials, 14, 105. https://doi.org/10.1186/1745-6215-14-105
Macías-Cortés Edel C, Aguilar-Faisal L, Asbun-Bojalil J. Efficacy of Individualized Homeopathic Treatment and Fluoxetine for Moderate to Severe Depression in Peri- and Postmenopausal Women (HOMDEP-MENOP): Study Protocol for a Randomized, Double-dummy, Double-blind, Placebo-controlled Trial. Trials. 2013 Apr 23;14:105. PubMed PMID: 23782520.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP): study protocol for a randomized, double-dummy, double-blind, placebo-controlled trial. AU - Macías-Cortés,Emma del Carmen, AU - Aguilar-Faisal,Leopoldo, AU - Asbun-Bojalil,Juan, Y1 - 2013/04/23/ PY - 2012/08/09/received PY - 2013/04/09/accepted PY - 2013/6/21/entrez PY - 2013/6/21/pubmed PY - 2013/10/18/medline SP - 105 EP - 105 JF - Trials JO - Trials VL - 14 N2 - BACKGROUND: The perimenopausal period refers to the interval when women's menstrual cycles become irregular and is characterized by an increased risk of depressive symptoms. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and postmenopausal women. Previous trials suggest that individualized homeopathic treatments improve depression. In classical homeopathy, an individually selected homeopathic remedy is prescribed after a complete case history of the patient. The aim of this study is to assess the efficacy and safety of the homeopathic individualized treatment versus placebo or fluoxetine in peri- and postmenopausal women with moderate to severe depression. METHODS/DESIGN: A randomized, placebo-controlled, double-blind, double-dummy, three-arm trial with a six-week follow-up study was designed. The study will be conducted in a public research hospital in Mexico City (Juárez de México Hospital) in the outpatient service of homeopathy. One hundred eighty nine peri- and postmenopausal women diagnosed with major depression according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (moderate to severe intensity) will be included. The primary outcome is change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression after the fourth and sixth week of treatment. Secondary outcomes are: Beck Depression Inventory change in mean score, Greene's Scale change in mean score, response and remission rates and safety. Efficacy data will be analyzed in the intention-to-treat population. To determine differences in the primary and secondary outcomes among groups at baseline and weeks four and six, data will be analyzed by analysis of variance for independent measures with the Bonferroni post-hoc test. DISCUSSION: This study is the first trial of classical homeopathy that will evaluate the efficacy of homeopathic individualized treatment using C-potencies versus placebo or fluoxetine in peri- and postmenopausal women with moderate to severe depression. It is an attempt to deal with the obstacles of homeopathic research due to the need for individual prescriptions in one of the most common psychiatric diseases. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01635218. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/23782520/Efficacy_of_individualized_homeopathic_treatment_and_fluoxetine_for_moderate_to_severe_depression_in_peri__and_postmenopausal_women__HOMDEP_MENOP_:_study_protocol_for_a_randomized_double_dummy_double_blind_placebo_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-14-105 DB - PRIME DP - Unbound Medicine ER -