Premenstrual Syndrome Clinical Trial
Official title:
The Effect of Individualised Homoeopathic Treatment Using the Grant Bentley Method in Premenstrual Syndrome
Premenstrual syndrome (PMS) is related to the changes in the levels of hormones
predominately progesterone, oestrogen and prolactin, during the luteal phase of the
menstrual cycle. Both physical and psychological symptoms may occur from at least day 14 of
the menstruation cycle and cease by day 4 of menstruation. The symptoms may interfere with a
female's daily activities and have a negative impact well-being. There are a number of
conventional pharmacological drugs which are used in the treatment or alleviation of the
symptoms of PMS, however the drugs may have side effects and may negatively interact with
other medications. Research has shown that homoeopathy is beneficial in relieving or
decreasing the severity of PMS, however finding the individualised homoeopathic remedy can
be difficult. Grant Bentley developed a system that helps find the most suitable remedy for
each individual case. The Grant Bentley Method (GBM) uses homoeopathic case taking,
photographs of the facial features and repertorisation to determine the dominant miasmatic
group of the patient. This aids in the selection of specific homoeopathic remedy. There has
been no research to show the effect of the GBM on PMS.
This study aims to determine the effect of individualised homoeopathic treatment using the
GBM, on females with PMS by using case studies and a daily self-grading PMS chart.
The study is of an embedded mixed method design using the PMS chart and case studies and
will take place over 12 weeks at the University of Johannesburg (UJ) Health Centre. Using
purposive sampling, 10 female participants between the ages of 18 to 40 years will be
recruited by means of advertisements at the Homoeopathic Health Centre, campus gym and
female residences on the Doornfontein campus of the University of Johannesburg, as well as
various health shops, practices and gyms in the Auckland Park and Killarney areas, with the
relevant permission granted.
Each potential participant will be required to complete a screening questionnaire in order
to establish whether they are an appropriate candidate for this study. Once this is
confirmed, the researcher will explain the study to each participant. The participants will
be required to read the participant information form and sign the consent and medical
photograph consent forms. Participants will be informed that their photographs will be used
for facial analysis to assist in finding the most accurate remedy and will not be published.
Each participant's facial features will be hand-drawn by the researcher in order to aid
participant confidentiality.
Each participant will undergo a full homoeopathic consultation which will focus on her PMS
symptoms. In addition, 9 photos of their facial features will be taken with a digital camera
(Panasonic DMC-FZ5) for classification of their dominant miasmatic group. Thereafter, a
physical examination including vital signs and an abdominal and/or breast examination (if
indicated) will be conducted.
After the consultation, the participant will be asked to record their daily PMS symptoms,
for a period of 1 month, on the PMS chart (provided to them by the researcher) at home. The
first month will act as a baseline measurement as no treatment will be prescribed.
Additionally, the researcher will analyse and repertorise the participant's case in this
period. The participant will be grouped into their dominant miasmatic group and the
corresponding remedy will be selected, according to the principles of homoeopathy and GBM of
prescribing, for use in the following consultation. Remedy selections will be supervised by
a registered homoeopath.
The follow-up consultations will be conducted at weeks 4, 8 and 12, wherein participants
will hand in their completed PMS charts and undergo any relevant physical examinations. The
participant will then receive their individualised remedy, as determined by the researcher,
along with an explanation as to how to store and take the remedy. They will additionally
receive another PMS chart to complete over the following 4 weeks. Photographs may be retaken
to re-analysed the case if necessary as to ensure the correct selection of the remedy using
the GBM during the study.
Should the participant want further treatment at the completion of the study, they will be
appropriately referred to a registered homoeopath or to the UJ Homoeopathic Health Centre.
A positive result of this research would indicate the viability of the GBM as a useful tool
to aid in the individualised homoeopathic treatment and therefore aid in successful
prescribing in the treatment of PMS. Additionally, a positive result would indicate
homoeopathy as a potential treatment for PMS.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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