RSS-Feed abonnieren
DOI: 10.1055/s-0043-1770697
Evaluation of the Usefulness of Homoeopathic Mother Tincture Sarothamnus Scoparius in Managing Essential Hypertension
Funding None.
Abstract
Objective The objective of this study was to evaluate the effectiveness of homoeopathic mother tincture Sarothamnus scoparius in the management of essential hypertension.
Materials and Methods An open label, prospective, single arm, clinical trial was conducted on 35 participants recruited from outpatient department/inpatient department of a Govt. Homoeopathic Medical College and Hospital. All participants received Sarothamnus scoparius mother tincture, suffering from essential hypertension. The primary outcome was to evaluate the change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) every month for 3 months and the secondary outcome was to assess the QOL of the patient by using WHOQOL-BREF at baseline and after 3 months. The primary outcome and secondary outcome measures were analysed by repeated measure analysis of variance (ANOVA) and ‘Paired t-test’ respectively.
Result Twenty-nine participants completed the study and six participants dropped out. Intention-to-treat sample (n = 35) was analysed. There was statistically significant reduction in SBP (146.40 ± 7.65 to 128.00 ± 12.34) as well as DBP (88.80 ± 3.26 to 86.07 ± 3.307). Repeated measure ANOVA was performed to compare the changes in SBP as well as DBP at different time interval. In SBP, the result was statistically significant on all occasions (p = 0.000, at 95% confidence interval [CI]). In DBP, the result was also found statistically significant (p = 0.000, at 95% CI). However, the result was not statistically significant when DBP was compared at 1 month with 2nd and 3rd months (p = 1.000, at 95% CI); 2 months with 1 and 3 months (p = 1.000, 0.863 at 95% CI respectively); 2 months with 3 months (p = 0.518, at 95% CI); and 3 months with 1 and 2 months (p = 1.000, 0.863 at 95% CI respectively).
Paired t-test performed to measure the changes in WHOQOL-BREF score showed statistically significant (62.57 ± 10.81 to 96.07 ± 17.47; p = 0.000, at 95% CI).
Conclusion The study findings suggest that Sarothamnus scoparius mother tincture is beneficial in the management of essential hypertension as well as improving QOL. Randomised controlled trials are further warranted.
Keywords
hypertension - Sarothamnus scoparius - homoeopathy - systolic blood pressure - diastolic blood pressure - WHOQOL-BREFNote
This study was conducted at the OPD/IPD of R.B.T.S. Govt. Homoeopathic Medical College and Hospital, Muzaffarpur, Bihar, India.
Editor's Note
Though this study lacks in methodological rigor, by not addressing the confounders (LSM and DASH) still we decided to publish this paper because Spartium scoparium is a medicine less often used. This paper can be thought provoking and give an impetus to further research in exploring the role of this drug in Essential Hypertension by carrying out parallel arm randomized trial with one group receiving Placebo with LSM and the other Sarothamnus scoparius and LSM. Since Hypertension is a rampant non-communicable disease, with multiple ramifications, a better study design would definitely help develop a treatment algorithm for hypertension.
Ethical Approval
Ethical clearance was obtained from the Institutional Ethical Committee. Each patient was informed of the ethical issues related to the study through the informed consent form and was duly documented. Patients were instructed to report adverse events, either directly or over the phone. A specific protocol confirming to the Declaration of Helsinki[30] on human experimentation & Good Clinical Practice (GCP) in India[31] was designed for the study.
Trial Registration
The study protocol was approved by the Institutional Ethical Committee (IEC) vide Ref. No.- RBTS/ETHICS-35/2021, dated-23/06/2021 and thereafter registered prospectively in Clinical Trials Registry- India (CTRI) before initiation of the study (CTRI/2021/09/036584).
Publikationsverlauf
Artikel online veröffentlicht:
25. Juli 2023
© 2023. Thieme. All rights reserved.
Thieme Medical and Scientific Publishers Pvt. Ltd.
A-12, 2nd Floor, Sector 2, Noida-201301 UP, India