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#homeopathy 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

RESEARCH ARTICLE #homeopathy

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 Emma del Carmen Macías-Cortés1,2*, Lidia Llanes-González3, Leopoldo Aguilar-Faisal1, Juan Asbun-Bojalil1
1
División de Estudios de Posgrado, Escuela Superior de Medicina, Instituto Politécnico Nacional, Distrito
Federal, México,
2
Consulta Externa de Homeopatía, Hospital Juárez de México, Secretaría de Salud,
Distrito Federal, México,
3
Unidad de Salud Mental, Hospital Juárez de México, Secretaría de Salud, Distrito
Federal, México
*
ecmc2008@hotmail.es
Abstract
Background
Perimenopausal period refers to the interval when women’s menstrual cycles become irreg-
ular and is characterized by an increased risk of depression. Use of homeopathy to treat de-
pression is widespread but there is a lack of clinical trials about its efficacy in depression in
peri- and postmenopausal women. The aim of this study was to assess efficacy and safety
of individualized homeopathic treatment
versus
placebo and fluoxetine
versus
placebo in
peri- and postmenopausal women with moderate to severe depression.
Methods/Design
A randomized, placebo-controlled, double-blind, double-dummy, superiority, three-arm trial
with a 6 week follow-up study was conducted. The study was performed in a public research
hospital in Mexico City in the outpatient service of homeopathy. One hundred thirty-three
peri- and postmenopausal women diagnosed with major depression according to DSM-IV
(moderate to severe intensity) were included. The outcomes were: change in the mean total
score among groups on the 17-item Hamilton Rating Scale for Depression, Beck Depres-
sion Inventory and Greene Scale, after 6 weeks of treatment, response and remission
rates, and safety. Efficacy data were analyzed in the intention-to-treat population (ANOVA
with Bonferroni
post-hoc
test).
PLOS ONE | DOI:10.1371/journal.pone.0118440 March 13, 2015
1/24
OPENACCESS
Citation:
Macías-Cortés EdC, Llanes-González L,
Aguilar-Faisal L, Asbun-Bojalil J (2015) 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 10(3): e0118440. doi:10.1371/
journal.pone.0118440
Academic Editor:
Yiru Fang, Shanghai Mental
Health Center, Shanghai Jiao Tong University School
of Medicine, CHINA
Received:
September 18, 2014
Accepted:
January 13, 2015
Published:
March 13, 2015
Copyright:
© 2015 Macías-Cortés et al. This is an
open access article distributed under the terms of the
Creative Commons Attribution License
, which permits
unrestricted use, distribution, and reproduction in any
medium, provided the original author and source are
credited.
Data Availability Statement:
Data are available upon request to the Research and Ethics Committee
of National Homeopathic Hospital, Mexico City [Dr.
Gustavo Aguilar-Velázquez (
gav5799@gmail.com

Results
After a 6-week treatment, homeopathic group was more effective than placebo by 5 points
in Hamilton Scale. Response rate was 54.5% and remission rate, 15.9%. There was a sig-
nificant difference among groups in response rate definition only, but not in remission rate.
Fluoxetine-placebo difference was 3.2 points. No differences were observed among groups
in the Beck Depression Inventory. Homeopathic group was superior to placebo in Greene
Climacteric Scale (8.6 points). Fluoxetine was not different from placebo in Greene Climac-
teric Scale.
Conclusion
Homeopathy and fluoxetine are effective and safe antidepressants for climacteric women.
Homeopathy and fluoxetine were significantly different from placebo in response definition
only. Homeopathy, but not fluoxetine, improves menopausal symptoms scored by Greene
Climacteric Scale.
Trial Registration
ClinicalTrials.gov
NCT01635218
Protocol Publication
http://www.trialsjournal.com/content/14/1/105
.
https://www.hri-research.org/wp-content/uploads/2015/03/Mac%C3%ADas-Cort%C3%A9s-2015-Depression-menopause.pdf

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