The Efficacy of Viburnum Opulus 3X in the Treatment of Primary Dysmenorrhea

Study Overview
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Brief Summary
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Dysmenorrhea (painful menstruation) is a common gynaecological disorder that is prevalent in more than 50% of women during their reproductive years. Primary dysmenorrhea describes cyclic uterine pain without any identifiable or underlying causes. Menstrual pain results as a consequence of endometrial ischemia, high levels of prostaglandins and other inflammatory mediators. Conventional treatment for primary dysmenorrhea consists of non-steroidal anti-inflammatory drugs and oral contraceptives, which may have adverse effects. Viburnum opulus (Cramp bark) is a homoeopathic remedy well indicated for the treatment of dysmenorrhea. While there are studies using Viburnum opulus in its herbal form, there is no research assessing its efficacy in the homoeopathic form. The aim of this study is to determine the efficacy of Viburnum opulus 3X in the treatment of primary dysmenorrhea as measured with the modified Short Form McGill pain questionnaire (SF-MPQ-2) and visual analogue scale (VAS) respectively.

Detailed Description
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This will be a double blind placebo controlled study, involving 30 female participants. The study will run for 3 months, over 3 menstrual cycles and shall be determined by the length of each participant menstrual cycle. The participants will be assessed over 3 menstrual events. Consultations will take place in a private setting at the Homoeopathic Health Centre at the Doornfontein campus, under the supervision of a registered homoeopath. Participants will be recruited by advertisements placed at the University of Johannesburg Health Centre located on the Doornfontein campus, with the relevant permission obtained. The researcher will explain the study to each participant as well as provide each participant with a consent form to sign, before they may take part in the study. Participants will be screened and a general physical examination will be conducted to asses each participant's general wellbeing. Each participant will be issued with a modified Short Form McGill questionnaire and the Visual Analogue Scale to complete. Participants will be instructed to complete the forms when they begin to experience the pain and cramping. No medication will be given at the initial consultation. During the second follow-up consultation the participants will return their completed forms given to them at the initial consultation. Each participant will be issued with a 50 ml bottle of the homoeopathic remedy or placebo and new forms (SF-MPQ-2 and VAS) to complete. Participants will be advised to take 10 drops of the remedy three times a day starting when they experience pain and cramping. The forms will additionally need to be completed during this time. The participants will be advised to stop the homoeopathic remedy when their pain and cramping has ceased. This process will be repeated at both the third and fourth consultations. During the final consultation participants will return the last forms to the researcher. The participants will measure their subjective satisfaction of the medicine on their pain by completing the five point treatment satisfaction scale. The data will be statistically analysed by the researcher with the aid of a statistician. This will be done using the non-parametric Friedmann test (to measure the differences within both groups) and the Mann-Whitney test (to measure the differences between the groups) as well as the repeated measures ANOVA. These tests will evaluate the change of severity of symptoms over time. The possible benefits for those participating in the study may include an improvement in their symptoms of primary dysmenorrhea. This study will contribute to the medical knowledge and efficacy of the clinical management of primary dysmenorrhea.

Official Title
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The Efficacy of Viburnum Opulus 3X in the Treatment of Primary Dysmenorrhea

Conditions
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Dysmenorrhea

Intervention / Treatment
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* Other: 20% Ethanol
* Other: Viburnum opulus 3X


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females between 18-35 years. Have a history of painful menstruation. Exclusion Criteria: Are on any form of hormonal contraceptives. Have intra uterine contraceptive devices. Have prediagnosed endometriosis, chronic pelvic inflammatory disease, uterine fibroids, polycystic ovarian syndrome or other known causes of secondary dysmenorrhea. Suffers from any serious chronic disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 20% Ethanol<br>20% ethanol containing no active ingredients. Ten drops will be taken three times daily when the pain and cramping of dysmenorrhea start, and should be stopped when the pain and cramping have ceased. | Other: 20% Ethanol<br>* Unmedicated 20% Ethanol<br>|
| Experimental: Viburnum opulus 3X<br>Viburnum opulus 3X in a vehicle of 20% ethanol. Ten drops will be taken three times daily when the pain and cramping of dysmenorrhea start, and should be stopped when the pain and cramping have ceased. | Other: Viburnum opulus 3X<br>* Viburnum opulus 3X in a vehicle of 20% ethanol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as measured by the Short Form McGill Pain Questionnaire (SF-MPQ-2) | The SF-MPQ-2 is a highly reliable and sensitive instrument used to asses and measure pain levels. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as measured by the Visual Analogue Scale (VAS) | The scale (VAS) is a validated and established tool used clinically to assess pain levels. | 3 months | 
| Patient satisfaction as measured by the 5-Point Treatment Satisfaction Scale | The 5-Point Treatment Satisfaction Scale is a reliable tool to assess patient satisfaction with the treatment provided. This will be conducted once at the final consultation. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary dysmenorrhea, Viburnum opulus 3X, Homoeopathic