Clinical trial NCT02402049: Homeopathic Treatment of Premenstrual Syndrome
Official title: Is Homeopathic Treatment a Placebo Treatment? - Homeopathic Treatment of Premenstrual Syndrome- A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Premenstrual Syndrome-PMS
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 3 months
Secondary outcomes:
measure: Decreased work absence during the 3 months after therapy begin as compared to the 2 months prior to homeopathy treatment.
timeFrame: 3 months
measure: 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.
timeFrame: 3 months
measure: Self-report of the efficiency of the homeopathy treatment.
timeFrame: 3 months
measure: Side effects occurrence during therapy (e.g headaches, vomiting, nausea etc.)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: The Center for Inegrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel
name: Menachem Oberbaum, MD
role: PRINCIPAL_INVESTIGATOR
References: