Climacteric Clinical Trial : the Use of Complementary Therapy and Hormonal Replacement

Summary

The alternative and complementary therapies are being gradually included in the Brazilian Health Unique System (SUS), as it is foreseen in the National Politics of Integrative and Complementary Practices in Brazil . However, though this thematic is also included in the National Agenda of Research Priorities concerning Health, published studies concerning this matter are quite scarce. The World Health Organization (WHO) indicated that it is a big challenge to effect the following studies: cost-effectiveness, as well as safety, efficiency and the quality of such practices. WHO also pointed out the clinical situations where they could be applied and that is why this investigation we are undertaken is fully justified.

Annoying signs and symptoms which come along with the climacteric period, especially anxiety, insomnia and hot flushes, change women´s life quality and their affective, social and business relationships as well. Consequently, this can generate sadness, depression and isolation.

Many women cannot undergo hormonal replacement, for several reasons: or they have some illnesses which reject hormones, or due to hypersensitiveness reactions or even economical difficulties. Also, the cost-effectiveness ratio between conventional therapy of hormonal replacement and complementary therapies which compose this study are not known yet .

The complementary therapies proposed in this study concern non-invasive methods, of low cost, which justify being researched in order to verify the potential of those annoying signs alleviation.

Conditions

• Climacteric

Interventions

OTHER

flower therapy

Each woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms.

OTHER

therapeutic touch

Each woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms.

OTHER

auricular therapy

Each woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms.

DRUG

Hormones

Estradiol 1 mg and a drospirenone 2mg/day (3 months)

Sponsors & Collaborators

• University of Sao Paulo

  collaborator OTHER

• Sociedade Hospital Samaritano

  lead OTHER

Principal Investigators

• Eliseth R Leão, PhD · Hospital Samaritano

• Maria Julia P Silva, PhD · University of Sao Paulo

• Léia Sales, MscN · University of Sao Paulo

• Ivaldo da Silva, PhD · Tocogynecological Department of São Paulo Federal University

• Maria C Martinez, PhD · Hospital Samaritano

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-07-31

Primary Completion

2008-12-31

Completion

2009-11-30

Countries

• Brazil

Study Locations