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

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.

Study Overview

• Status: Unknown
• Conditions: Climacteric
• Intervention / Treatment: Drug: Hormones; Other: flower therapy; Other: therapeutic touch; Other: auricular therapy

• Study Type: Interventional
• Enrollment (Anticipated): 278
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01232-010
    • Hospital Samaritano
  • São Paulo, Brazil, 01232-010
    • Nursing School of University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female
• Recruited and registered in local of the study
• They should present the signs and symptoms checked - insomnia, anxiety and hot flushes, they felt at the beginning of the climacteric
• They should not be under hormonal replacement or even should have stopped their use more than 90 days

Exclusion criteria:

• women who undergo a hysterectomy surgery
• women using hormonal therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hormone	Drug: Hormones; Estradiol 1 mg and a drospirenone 2mg/day (3 months)
Experimental: flower therapy	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.
Experimental: therapeutic touch	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.
Experimental: auriculotherapy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
annoying signs and climacteric symptoms	pre and post intervention

Collaborators and Investigators

• Sponsor: Sociedade Hospital Samaritano
• Collaborators: University of Sao Paulo
• Investigators: Study Director: Eliseth R Leão, PhD, Hospital Samaritano; Study Director: Maria Julia P Silva, PhD, University of Sao Paulo; Principal Investigator: Léia Sales, MscN, University of Sao Paulo; Principal Investigator: Ivaldo da Silva, PhD, Tocogynecological Department of São Paulo Federal University; Principal Investigator: Maria C Martinez, PhD, Hospital Samaritano

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Anticipated): December 1, 2008
• Study Completion (Anticipated): November 1, 2009

Study Registration Dates

• First Submitted: January 23, 2008
• First Submitted That Met QC Criteria: February 15, 2008
• First Posted (Estimate): February 18, 2008

Study Record Updates

• Last Update Posted (Estimate): September 22, 2009
• Last Update Submitted That Met QC Criteria: September 18, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: complementary therapy; climacteric; hormonal replacement therapy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: SHS 18/07