Feasibility of using a semi standardised prognostic protocol in homeopathic treatment for premenstrual syndrome/symptoms: pilot study for a pragmatic randomised trial

A future pragmatic randomised trial could evaluate the effectiveness of
homeopathic treatment for premenstrual syndrome/symptoms.

In research on individual homeopathy we face some specific challenges.
Homeopathic treatment is individually targeted treatment and a complex
intervention. In clinical research it would be convenient to limit the number
of possible homeopathic prescriptions and minimise inter-rater variability. We
also need to improve treatment results after first homeopathic precriptions. We
intend to achieve these goals with a semi standardised homeopathic prognostic
protocol for PMS, targeting on larger, responsive subgroups.

1. We will explore the feasibility of homeopathic treatment with a semi
standardised homeopathic prognostic treatment protocol for PMS in daily
homeopathic practice.

2. We will evaluate the prognostic validity of using a semi standardised
prognostic protocol for homeopathic treatment of premenstrual
syndrome/symptoms.

In phase 1 of the pilot study, an expert panel designs a patient questionnaire
and diagnostic algorithm for homeopathic treatment of premenstrual
syndrome/symptoms. They do this by Delphi procedures and focus group meetings.

In phase 2 we explore the feasibility of using the semi-standardised
homeopathic prognostic protocol for premenstrual syndrome/symptoms in
homeopathic practice. Patients with premenstrual syndrome/symptoms will be
treated by homeopathic doctors, who use the semi standard protocol to decide
about the prescription.

After intake and consent the patients keep a PMS diary during two months. The
diary is needed to diagnose PMS/premenstrual symptoms. We also use this diary
score as a baseline parameter.

After inclusion, the patient fills in the questionnaire for homeopathic
treatment of PMS, with predictive characterisitics, prior to the first
consultation. The history taking and examination is done as usual in
homeopathic practice. The doctor selects a homeopathic medicine after the usual
analysis of the case. Next he/she consults the diagnositc algorithm and selects
one out of eleven homeopathic pre-selected medicines, according to the outcome
of the algorithm. However, when the chracteristics of the patient don't match
with one of the medicines, the doctor prescribes a homeopathic medicine as
usual.

Follow up consultations will be planned after 1,2,3,5,7 and 9 months. The
patient will keep the PMS diary during two periods of three months: 1,2,3 and
7,8,9.
Before every follow up consultation the patients fills in a score about change
of complaints and general health.

We will compare the medicine prescription with one of the pre-selected
medicines after applying the algorithm with medicine prescription in the usual
way. We will also compare the proportion of agreement/disagreement of the
doctors first choice and the outcome of the algorithm. We will ask the opinion
of the doctors about working with the protocol. We will aso evalaute the use of
the questionnaire by patients.

Also, we will evaluate the predictive validity of the prognostic protocol. We
will correlate results of treatment with the pre-selected medicines derived
from the algorithm, as well as results of treatment with medicines otherwise
prescribed, with patient-perceived changes of symptoms and well being.
We will assess the coverage of the protocol (what % of the women with PMS can
we treat with one of the selected medicines?) and evaluate characteristics of
subgroups of women who do or do not react well to homeopathic treatment.
We will explore the feasibility of conducting a future larger pragmatic
randomised trial, comparing homeopathic treatment for PMS-patients with usual
care, using the semi standardised protocol.

The extra burden is low. The patient fills in several questionnaires and has
one to three extra consultations. Treatment is otherwise as usual in
homeopathic practice.
There are no risks.

After intake and informed consent the patient keeps a diary to record PMS
symptoms during two months.
After inclusion the patient fills in a patient questionnaire for homeopathic
treatment.
There is a short evaluation form for this questionnaire. During homeopathic
treatment she has a first consultation (1- 1 1/2 hours is usual in homeopathic
practice). Follow up consultation will be at 1,2,3,5,7,9 months. The follow up
consultations will take one half hour to three quarters of an hour, as usual.
The PMS diary will also be kept during the following treatment months:
1,2,3,7,8,9.
Before every follow up consultation the patints records change of complaints
and well being seperately, on a 9 point Likert scale.