The Effect of Individualised Homoeopathic Treatment Using the Grant Bentley Method in Premenstrual Syndrome

Premenstrual Syndrome Clinical Trial

Official title:

The Effect of Individualised Homoeopathic Treatment Using the Grant Bentley Method in Premenstrual Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481973
• Other study ID #: MoniqueChavannes200570791
• Status: Completed
• Phase: Phase 2
• First received: June 4, 2015
• Last updated: May 18, 2016
• Start date: September 2014
• Est. completion date: October 2015

Study information

• Verified date: May 2016
• Source: University of Johannesburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: National Health Research Ethics Council
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Females (aged 18-40) suffering from at least one PMS symptom from both of the following physical and psychological symptoms, for at least 3 consecutive menstrual cycles:

• Physical symptoms: headache, breast tenderness, abdominal bloating, food cravings and swelling of extremities

• Psychological symptoms: depression, anxiety, irritability, social withdrawal and memory changes;

• symptoms that are present from at least day 14 (2 weeks before menstruation) of the menstrual cycle, are relieved by day 4 of menstruation, and do not reoccur until after day 13 of the menstrual cycle; and

• if currently on the OCP, they must be using the same brand of medication for 3 consecutive months.

Exclusion Criteria:

• Females on any kind of chronic medication that may interfere with PMS symptoms such as medication for hyperthyroidism, hypothyroidism, diabetes mellitus and psychiatric disorders;

• are suffering from dysphoric disorder (a severe form of premenstrual syndrome);

• are on hormonal treatment (except OCP);

• have been pre-diagnosed with any anxiety or depression disorders; and/or

• have irregular menses.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premenstrual Syndrome
• Syndrome

Intervention

Other:
• Individualised Homoeopathic Remedy
Each participant is to receive an individualised homoeopathic remedy prescribed according to their characteristic symptoms.

Locations

Country	Name	City	State
South Africa	University of Johannesburg	Johannesburg	Gauteng

Sponsors (1)

Lead Sponsor	Collaborator
University of Johannesburg

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PMS symptom severity as measured by the PMS chart	The PMS chart will be conducted daily by each participant for 12 weeks.	12 weeks	No
Secondary	Changes in symptom severity as evaluated by researcher case notes	Case notes will be taken every 4 weeks in each consultation and will be used to collect qualitative data.	Every 4 weeks for 12 weeks	No