The Effect of a Homoeopathic Complex on Blood Pressure in Refractory Hypertension

This study is a six week, double-blind, placebo-controlled pilot study. Thirty participants, aged 35 to 60 years, who have been previously diagnosed by their healthcare provider with refractory hypertension, will be recruited by means of purposive sampling. Adverts will be placed at the University of Johannesburg (UJ) Doornfontein campus and the Soweto satellite clinic Nanga Vutshilo Community Centre. Potential participants that respond to the advert will attend an initial consultation and will be requested to sign a Participant Information and Consent Form once they agree to participate in the study. The medical history and physical examination (including vital signs, fundoscopic exam, cardiovascular exam, respiratory exam and urinalysis) will be recorded on a Case Form. Blood pressure (BP) readings will be taken on each arm with a manual BP cuff, according to standard operating procedures, on the first three consecutive days to confirm inclusion into the study. Individuals with secondary organ damage from hypertension will be excluded from the study. Those participants that qualify for the study will be placed into two groups. One group will receive a 50ml bottle of the homoeopathic complex and the other group a 50ml bottle of placebo. Participants will receive an Intake Diary, to be completed daily, recording compliance and any adverse symptoms or aggravations that may be experienced. Follow-up consultations will take place every 7 days and participants will be requested to bring with their medication bottles for further assessment of compliance; BP readings will be recorded on a data collection form. All participants will be given the Dietary Approaches to Stop Hypertension (DASH) eating plan at the end of the study to help control their hypertension. Additionally, participants will be given an information leaflet to give to their healthcare provider, detailing the study. Data will be analysed using the non-parametric methods: inter-group analysis will be conducted using SPSS v18 with the Mann-Whitney U-test; intra-group analysis will be done using the Friedman and the Wilcoxon-Signed Ranks tests. A possible outcome of this study is that the homoeopathic complex will have a normalizing effect on BP readings compared to placebo. Regardless of the outcome, this study will contribute to our knowledge on the use of homoeopathic complex remedies in the treatment and management of refractory hypertension.