Homeopathic Treatment of Premenstrual Syndrome

Is Homeopathic Treatment a Placebo Treatment? - Homeopathic Treatment of Premenstrual Syndrome- A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial

The proposed study will focus on premenstrual syndrome (PMS) symptom alleviation for women diagnosed as suffering from the syndrome with the DRSP questionnaire.

The women will be treated with Homeopatic remedies. The improvement of PMS symptoms will be evaluated using the Daily Record of Severity of Problems questionnaire (DRSP). The questionnaire will be completed daily by women for 2 months prior to receiving the treatment and for 3 months following treatment with a single dose of the homeopathy treatment.

Study Overview

• Status: Unknown
• Conditions: Premenstrual Syndrome-PMS
• Intervention / Treatment: Drug: Natrum muriaticum 30C; Drug: Lachesis 30C; Drug: Sepia 30C; Drug: Nux vomica 30C; Drug: Pulsatilla 30C; Drug: Folliculinum 30C; Drug: Placebo Natrum muriaticum; Drug: Placebo Lachesis; Drug: Placebo Sepia; Drug: Placebo Nux vomica; Drug: Placebo pulsatilla; Drug: Placebo Folliculinum

Detailed Description

Premenstrual syndrome (PMS) is a set of physical, emotional and behavioral symptoms that occur during the week preceding menstruation and which alleviate when the menstrual flow begins. PMS affects millions of women during their reproductive years. Mild symptoms, which usually do not interfere with daily activities, are experienced occasionally by almost all ovulatory women. Between 8-30% of ovulatory women suffer from moderate to severe PMS symptoms, which may even require treatment. The more severe form of PMS, premenstrual dysphoric disorder is considered to affect up to 8% of ovulatory women. This severe form is associated with severe disruptions in work function, family, or social relationships. To date, therapeutic interventions are insufficient and ranges from stress reduction and lifestyle changing to hormonal therapies and the use of psychotropic medications. While traditional medications do not necessarily offer satisfactory alleviation of PMS symptoms homeopathy can offer a significant alleviation of PMS symptoms for an extended period of time.

The proposed study will focus on PMS symptom alleviation for women diagnosed as suffering from the syndrome with the DRSP questionnaire.

Five Homeopathic remedies (Natrum muriaticum, Lachesis, Sepia, Nux vomica and Pulsatilla ) will be used, in five different therapy groups. The women will be allocated to the groups according to their matching to the remedy according to Homeopathic principles. In each group the women will either be treated with the appropriate remedy or with a placebo remedy. Women who do not match any of these five groups will be allocated to a sixth group receiving either Folliculinum that is given as general indication for PMS in homeopathy or placebo.

The improvement of PMS symptoms will be evaluated using the Daily Record of Severity of Problems questionnaire at (DRSP). The questionnaire will be completed daily by women for 2 months prior to receiving the treatment and for 3 months following treatment with a single dose of the homeopathy treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age between 18 and 50 years.
• Suffers from the PMS, confirmed by the DRSP questionnaire, for at least one year
• Read and write in
• Signing the informed consent form

Exclusion Criteria:

• Comorbidity.
• Use of medications.
• Menstruation complains which do not correlate to the menstruation cycle.
• Inability to be in a daily contact with the experiment center (e.g., by phone, electronically).
• Participating in another clinical trial in the last 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1: Natrum muriaticum 30C; Natrum muriaticum 30C	Drug: Natrum muriaticum 30C; 3 globules of Natrum muriaticum applied once daily at days 7,8, and 9 after the start of the period.; Other Names: Active Natrum muriaticum
Active Comparator: 2: Lachesis 30C; Lachesis 30C	Drug: Lachesis 30C; 3 globules of Lachesis applied once daily at days 7,8, and 9 after the start of the period.; Other Names: Active Lachesis
Active Comparator: 3: Sepia 30C; Sepia 30C	Drug: Sepia 30C; 3 globules of Sepia applied once daily at days 7,8, and 9 after the start of the period.; Other Names: Active Sepia
Active Comparator: 4: Nux vomica 30C; Nux vomica 30C	Drug: Nux vomica 30C; 3 globules of Nux vomica applied once daily at days 7,8, and 9 after the start of the period.; Other Names: Active Nux vomica
Active Comparator: 5: Pulsatilla 30C; Pulsatilla 30C	Drug: Pulsatilla 30C; 3 globules of Pulsatilla applied once daily at days 7,8, and 9 after the start of the period.; Other Names: Active Pulsatilla
Active Comparator: 6 Folliculinum 30C; Folliculinum 30C	Drug: Folliculinum 30C; 3 globules of Folliculinum applied once daily at days 7,8, and 9 after the start of the period.; Other Names: Active Folliculinum
Placebo Comparator: 1: Placebo Natrum muriaticum; Placebo Natrum muriaticum	Drug: Placebo Natrum muriaticum; 3 globules of placebo Natrum muriaticum applied once daily at days 7,8, and 9 after the start of the period.
Placebo Comparator: 2: Placebo Lachesis; Placebo Lachesis	Drug: Placebo Lachesis; 3 globules of placebo Lachesis applied once daily at days 7,8, and 9 after the start of the period.
Placebo Comparator: 3: Placebo Sepia; Placebo Sepia	Drug: Placebo Sepia; 3 globules of placebo Sepia applied once daily at days 7,8, and 9 after the start of the period.
Placebo Comparator: 4: Placebo Nux vomica; Placebo Nux vomica	Drug: Placebo Nux vomica; 3 globules of placebo Nux vomica applied once daily at days 7,8, and 9 after the start of the period.
Placebo Comparator: 5: Placebo pulsatilla; Placebo pulsatilla	Drug: Placebo pulsatilla; 3 globules of placebo Pulsatilla applied once daily at days 7,8, and 9 after the start of the period.
Placebo Comparator: 6: Placebo Folliculinum; Placebo Folliculinum	Drug: Placebo Folliculinum; 3 globules of placebo Folliculinum applied once daily at days 7,8, and 9 after the start of the period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decrease in the average DRSP questionnaire scores during the 12 days prior to menstruation during three months following single dose homeopathy treatment as compared to the average DRSP questionnaire scores during the 12 days prior to menstruation during	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decreased work absence during the 3 months after therapy begin as compared to the 2 months prior to homeopathy treatment.		3 months
Change in the amount of painkillers taken by the patient during the 3 months after homeopathy treatment as compared to the amount of medications taken by the patient during 2 months prior to therapy begin.		3 months
Self-report of the efficiency of the homeopathy treatment.	The patient will indicate subjectivlly her filling after taking the homeopathic remedy	3 months
Side effects occurrence during therapy (e.g headaches, vomiting, nausea etc.)		3 months

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center
• Investigators: Principal Investigator: Menachem Oberbaum, MD, The Center for Inegrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: March 24, 2015
• First Posted (Estimate): March 30, 2015

Study Record Updates

• Last Update Posted (Estimate): March 30, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Menstruation Disturbances; Syndrome; Premenstrual Syndrome
• Other Study ID Numbers: PMS-14