Herbal Alternatives for Menopause Symptoms (HALT Study)

September 12, 2005 updated by: Kaiser Permanente

Herbal Alternatives for Menopause Symptoms: A Randomized Trial

Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms.

The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Hormone replacement therapy (HT: estrogen and progestin) remains the treatment of choice for women with vasomotor symptoms, and long-term HT has been recommended for prevention purposes. The demand for alternatives to HT, and the availability and use of over-the-counter products including dietary phytoestrogen supplements, and naturopathic medicines has grown dramatically. Few of these products have faced the rigors of randomized trials and none have been tested to evaluate their effects on long-term outcomes.

The purpose of this 4-year, randomized controlled trial is to evaluate the efficacy and safety of three alternative approaches utilizing phytoestrogens to treat vasomotor symptoms in peri- and postmenopausal women. The treatments were chosen because of the scientific evidence supporting a possible benefit, the availability of products with adequate quality control, their frequency of use in naturopathic medicine, and our ability to blind participants to the intervention. The 5 proposed treatment arms are: 1) conjugated equine estrogen with or without medroxyprogesterone acetate in women with or without an intact uterus respectively; 2) a single herbal product, black cohosh; 3) a multibotanical preparation; 4) a combination regimen that includes the same multibotanical preparation plus soy diet counseling; and 5) placebo. Our primary aim is to compare the effects of three alternative treatments, HRT and placebo on the frequency and intensity of vasomotor symptoms measured by The Wiklund Menopause Symptom Checklist and a daily Vasomotor Symptom Diary. Our secondary aims are to compare the effects of three alternative treatments, HRT and placebo on: 1) vaginal cytology (vaginal maturation index); 2) serum lipids (total cholesterol, HDL and LDL cholesterol, triglycerides); 3) bone mineral density (hip and spine dual energy x-ray absorptiometry scan); 4) glucose metabolism (insulin, fasting blood glucose); and 5) coagulation factors (fibrinogen, PAI-1).

Our hypotheses are that compared to placebo, the three alternative treatments tested in this proposal will; reduce frequency of hot flashes and night sweats, improve vaginal maturation and decrease vagina atrophy as measured by maturation index, lower total cholesterol and LDL with no effect on HDL, reduce the rate of decline in bone mineral density (BMD), and have no effect on glucose metabolism or clotting factors.

To accomplish our specific aims we will: 1) recruit and randomize approximately peri- and post-women to one of 5 treatment arms for one year; 2) collect measurements of primary and secondary outcomes at baseline, 3, 6, and 12 months; and 3) compare changes in outcomes in the groups taking alternative treatments to those in the HRT and placebo groups.

Study Type

Interventional

Enrollment

351

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98101-1448
        • Group Health Cooperative, Center for Health Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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
  • age 45 - 55
  • peri- or post-menopausal
  • moderate to severe vasomotor symptoms
  • normal thyroid stimulating hormone
  • proof of normal mammogram within past 2 years

Exclusion Criteria:

  • use of HT or oral contraceptives within past 3 months
  • use of herbs or alternative or complementary medicines for vasomotor symptoms within past 1 month
  • medical history of contraindications to HT
  • bone mineral density greater than 2 standard deviations below age specific mean
  • bilateral oophorectomy
  • current use of tamoxifen, raloxifene, bisphosphonates, cholesterol-lowering medications, prescription blood-thinners, or oral steroids
  • pregnant or planning to become pregnant
  • allergy to soybeans or soy protein
  • unable to swallow pills
  • current participation in another investigational drug trial
  • intention to move out of area in the next 12 months
  • non-compliance with procedures involved in screening and run-in trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Self report daily diary of frequency and intensity of vasomotor symptoms at BL, 3, 6 and 12 months.
Wiklund Menopause Symptom Checklist at BL, 3, 6 and 12 months.

Secondary Outcome Measures

Outcome Measure
Vaginal cytology (vaginal maturation index)at BL, 3 and 12 months.
Serum lipids (total cholesterol, HDL and LDL cholesterol, triglycerides) at BL, 3, 6, and 12 months.
Bone mineral density (hip and spine dual energy x-ray absorptiometry scan) at BL, 6 and 12 months.
Glucose metabolism (insulin, fasting blood glucose) at BL, 3, 6, and 12 months.
Coagulation factors (fibrinogen, PAI-1) at BL, 3, 6, and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

National Institute on Aging (NIA)
National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Katherine M Newton, PhD, Group Health Cooperative, Center for Health Studies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Study Completion

September 1, 2004

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 15, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 15, 2005

Last Update Submitted That Met QC Criteria

September 12, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AG017057 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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