Effect of Homeopathy, Acupuncture or Anthroposophic Medicine in Women's Quality of Life

Federal University of Minas Gerais

Status: Unknown

Conditions: Premenstrual Tension; Muscular Diseases; Hot Flashes; Depression; Anxiety

Treatments: Other: World Health Organization Quality of Life Bref Questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT02504515

22858113.9.0000.5149

Details and patient eligibility

About

Patients will be randomly assigned to two separate groups. Both patient groups will be evaluated using the WHOQOL-BREF questionaire. Evaluations will be carried out just before the study begins and at intervals of six months during a period of one year for a total of three evaluations. Group one will be made up of patients who will begin homeopathy or acupuncture or anthroposophic medicine treatment and patients from group two will start homeopathy or acupuncture or anthroposophic medicine six months after the beginning of the study. Each one of these three research branches will be done independently (Homeopathy versus control; Acupuncture versus control; Anthroposophic Medicine versus control). Conventional medical treatment will be available for all patients in both groups. A data sheet will be filled out on each patient with data as to age, education level, marital status and the patient's own perception of their health status. During the interviews the interviewer will have no influence whatsoever over the respondents' answers. Integrative/complementary or traditional medicine doctors do not participate in the research and will not be informed about which patients are participating in this project, and as such the research will be blinded for these doctors. Minitab software, version 16, was used for sample calculation through the module Power and Sample Size. Sample calculation option for paired t-tests before and after intervention demonstrated the need to randomize 906 patients: 450 patients for homeopathy branch (225 patients in the homeopathy group and 225 patients in the control group), 228 patients for acupuncture branch (114 patients in the acupuncture group and 114 patients in the control group), and 228 patients for anthroposophic medicine branch (114 patients in the anthroposophic medicine group and 114 patients in the control group).

Enrollment: 906 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women over 18 years of age
• Patients with chronic diseases

Exclusion criteria

• Women below 18 years of age
• Previous treatment with homeopathy (for homeopathy versus control branch)
• Previous treatment with acupuncture (for acupuncture versus control branch)
• Previous treatment with anthroposophic medicine (for anthroposophic medicine versus control branch)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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906 participants in 6 patient groups

Homeopathy

Active Comparator group

Treatment:

Other: World Health Organization Quality of Life Bref Questionnaire

Allopathy homeopathy control

Active Comparator group

Treatment:

Other: World Health Organization Quality of Life Bref Questionnaire

Acupuncture

Active Comparator group

Treatment:

Other: World Health Organization Quality of Life Bref Questionnaire

Allopathy acupuncture control

Active Comparator group

Treatment:

Other: World Health Organization Quality of Life Bref Questionnaire

Anthroposophic medicine

Active Comparator group

Treatment:

Other: World Health Organization Quality of Life Bref Questionnaire

Allopathy anthroposophy control

Active Comparator group

Treatment:

Other: World Health Organization Quality of Life Bref Questionnaire