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

Study Overview
=================
Brief Summary
-----------------
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).

Official Title
-----------------
Evaluating Treatment With Homeopathy, Acupuncture, and Anthroposophic Medicine in Improving the Quality of Life for Women Treated at the Public Unified Healthcare System

Conditions
-----------------
Anxiety, Depression, Premenstrual Tension, Hot Flashes, Muscular Diseases

Intervention / Treatment
-----------------
* Other: World Health Organization Quality of Life Bref Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Homeopathy<br> | Other: World Health Organization Quality of Life Bref Questionnaire<br>* The World Health Organization Bref (WHOQOL-BREF) questionnaire will be applied in three different moments: Baseline, after 6 months, and after 12 months. The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.<br>|
| Active Comparator: Allopathy homeopathy control<br> | Other: World Health Organization Quality of Life Bref Questionnaire<br>* The World Health Organization Bref (WHOQOL-BREF) questionnaire will be applied in three different moments: Baseline, after 6 months, and after 12 months. The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.<br>|
| Active Comparator: Acupuncture<br> | Other: World Health Organization Quality of Life Bref Questionnaire<br>* The World Health Organization Bref (WHOQOL-BREF) questionnaire will be applied in three different moments: Baseline, after 6 months, and after 12 months. The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.<br>|
| Active Comparator: Allopathy acupuncture control<br> | Other: World Health Organization Quality of Life Bref Questionnaire<br>* The World Health Organization Bref (WHOQOL-BREF) questionnaire will be applied in three different moments: Baseline, after 6 months, and after 12 months. The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.<br>|
| Active Comparator: Anthroposophic medicine<br> | Other: World Health Organization Quality of Life Bref Questionnaire<br>* The World Health Organization Bref (WHOQOL-BREF) questionnaire will be applied in three different moments: Baseline, after 6 months, and after 12 months. The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.<br>|
| Active Comparator: Allopathy anthroposophy control<br> | Other: World Health Organization Quality of Life Bref Questionnaire<br>* The World Health Organization Bref (WHOQOL-BREF) questionnaire will be applied in three different moments: Baseline, after 6 months, and after 12 months. The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | six months |