RESUMO
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.
Assuntos
Antidepressivos de Segunda Geração/uso terapêutico , Depressão/terapia , Fluoxetina/uso terapêutico , Materia Medica/uso terapêutico , Perimenopausa/psicologia , Pós-Menopausa/psicologia , Projetos de Pesquisa , Inibidores Seletivos de Recaptação de Serotonina/uso terapêutico , Análise de Variância , Antidepressivos de Segunda Geração/efeitos adversos , Protocolos Clínicos , Depressão/diagnóstico , Depressão/tratamento farmacológico , Depressão/psicologia , Método Duplo-Cego , Feminino , Fluoxetina/efeitos adversos , Hospitais Públicos , Humanos , Materia Medica/efeitos adversos , México , Medicina de Precisão , Escalas de Graduação Psiquiátrica , Inibidores Seletivos de Recaptação de Serotonina/efeitos adversos , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do TratamentoRESUMO
Mesotherapy has recently become an advertised method for the treatment of different types of alopecia despite the lack of any data regarding its efficacy and possible side effects. The substances injected into the scalp include "cocktails" of natural plant extracts, homoeopathic agents, vitamins, vasodilators, and drugs that may stimulate hair growth, such as finasteride and minoxidil. We report two cases of patchy alopecia that developed after mesotherapy for the treatment of androgenetic alopecia. In the first patient, alopecia developed after injections of the heparinoid vasodilator mesoglycan; the 3-month follow-up examination revealed a small residual area of cicatricial alopecia. The second patient developed reversible alopecia after multiple scalp injections of homeopathic agents. These cases underline the possible risks of mesotherapy as a therapeutic technique for hair loss.