The Efficacy of Viburnum Opulus 3X in the Treatment of Primary Dysmenorrhea
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      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: 
      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.
    

Intervention name(s): 20% Ethanol; Viburnum opulus 3X
Intervention type(s): Other; Other
Intervention description(s): Unmedicated 20% Ethanol; Viburnum opulus 3X in a vehicle of 20% ethanol.
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Primary dysmenorrhea; Viburnum opulus 3X; Homoeopathic