An Experimental Non-Randomized Study of Rauwolfia Serpentina Mother Tincture on Essential Hypertension

 

Abstract

Background And Objectives

 At the present day, an elevated blood pressure level is recognized as the most important public health problem in the developed countries and essential hypertension is held responsible for more than 95% of the cases. It is common, asymptomatic and leads to lethal complications if left untreated. The “silent killer” as it is known, is gradually becoming a problem of enormous proportions in the developing world also. Hypertension is the most important modifiable risk factor for coronary heart disease(CHD), stroke, congestive heart failure, end-stage renal disease and peripheral vascular disease. According to literature review, Rauwolfia serpentina appears to be a safe and effective treatment for hypertension when used in appropriate low doses.

Materials And Method

To study the effect of Rauwolfia serpentina  mother tincture in the management of essential hypertension at the Out Patient Department   of R.V.S Homoeopathic medical college and hospital, Sulur, Coimbatore , Tamilnadu,  and Coimbatore Government Medical College and Hospital, Hopes,Avinashi road, Coimbatore,Tamil nadu, between February2022 and June2023.  The duration of the study is 17 months (12 months for the enrollment, 3 months for follow up and 2 months for data collection and data compilation). Screening and enrollment was continued for the first 12months followed by intervention and follow-up for the next 5months. 

Results And Interpretation

Out of 150 hypertensive patients assessed for the eligibility criteria, 80 were enrolled. A total of 2 dropouts and 59 were regular. During the seventeen months trial, all data were measured and analyzed at entry and after three months of the study by the  t test and ANOVA. 

Conclusion

At the end of the study it was found that Rauwolfia serpentina mother tincture was effective in treating patients suffering from essential hypertension.

Abbreviations SBP(Systolic Blood pressure), DBP(Diastolic Blood Pressure), CHD(Coronary Heart Disease), 

Introduction

“A man’s life may be said to be a gift of his blood pressure, just as Nile is a gift of the Egypt”. So said Sir William Osler, (1892) an icon of modern medicine and the man said to be the most influential physician in History. The pioneers in the study of arterial pressure, Reverend Stephen Hale, (1711) who made the first blood pressure measurement on animals and Scipione Riva Rocci, (1896) who invented the blood pressure cuff, were probably not aware of the full significance of their discoveries. It was only in the late 1950’s that the medical world became aware of the importance of high blood pressure as a precursor of complications commonly attributed to old age. At the present day, an elevated blood pressure level is recognized as the most important public health problem in the developed countries and essential hypertension is held responsible for more than 95 percentages of the cases. It is common, asymptomatic and leads to lethal complications if left untreated. The silent killer as it is known is gradually becoming a problem in enormous proportions in the developing world also. 

Hypertension is a global problem. In India, it is estimated to range from 4 to 8 percentages and the trend is increasing due to changes in life style. A recent report indicates that nearly 1 billion adults globally had hypertension in 2000 and this is predicted to increase to 1.56 billion by 2025. Although a single cause may not be identified, the general consensus is that various factors contribute to blood pressure elevation in essential hypertension. In these days of 70 hour work weeks, mobile phones, electronic mails, social medias and endless committee meetings, stress has become a prevalent part of people’s lives; therefore the effect of stress on blood pressure is of increasing relevance and importance. Although stress may not directly cause hypertension, it can lead to repeated blood pressure elevations, which eventually may lead to hypertension.

Hypertension is the most important modifiable risk factor for coronary heart disease (CHD), stroke, congestive heart failure, end stage renal disease and peripheral vascular disease. Therefore, health care professionals must identify and treat patients with hyper-tension, but also promote a healthy lifestyle and preventive strategies to decrease the prevalence of hypertension in the general population. Treatment of hypertension reduces the risk of stroke, coronary artery disease and congestive heart failure, as well as overall cardiovascular morbidity and mortality from cardiovascular causes. Therefore, antihypertensive therapy should be directed towards improving blood pressure control in hypertensive patients.

   Rauwolfia serpentina, satisfies all the criteria of a successful hypotensive agent formulated by Evans and Lounghnan (1939). Judging from the results, it has a definite place in the treatment of cases of high blood pressure. Reserpine, the principal alkaloid of Rauwolfia serpentina, is traditionally used for the treatment of hypertension and the first recorded reference to the application of Rauwolfia in case of human hypertension was in 1940. It has been observed that the roots of Rauwolfia serpentina have antihypertensive, sedative and hypnotic properties in experimental animals. Rauwolfia serpentina appears to be a safe and effective treatment for hypertension when used in appropriate low doses.

The Indian political leader Mahatma Gandhi was known to employ Rauwolfia, reportedly using the root to make a tea that he consumed in the evening to help relax after a busy, over-stimulated day. 

Objectives Of The Study

To scientifically validate  the effect of Rauwolfia serpentina  mother tincture in patients with essential hypertension using blood pressure values.

 

Materials And Methods

Reseach Methodology And Study Design

The study is an Experimental Non-Randomized study, conducted at the Out Patient Department  of R.V.S Homoeopathic medical college and hospital, sulur, Coimbatore,  Tamilnadu and Coimbatore Government Medical College and Hospital, Hopes,Avinashi road, Coimbatore,Tamil nadu , between February2022 and June2023.  The duration of the study was 17 months (12 months for the enrollment, 3months for follow up and 2 months for data collection and data compilation). Screening and enrollment was continued for the first 12months followed by intervention and follow-up for the next 5months. Clearance was obtained from the Ethical committee . Consequently, each participant was verbally explained about the study, with the help of the Patient Information sheet, and thereafter, a written consent in Tamil language was obtained from them. Hypertensive questionnaire is used for data collection. However they were free to withdraw from the study at any point in time.

For the study the patients were selected using Purposive sampling a non- randomized technique (i.e. patients with Essential hypertension) to allot  cases in Persons receiving Rauwolfia serpentina mother tincture (80 persons)

And their BP recordings on 45th day and 90th day were taken into consideration.

Descriptive statistics like mean and standard deviation were applied to get a basic idea about the effectiveness of the medicine. Paired t test was carried out to observe the significant change in BP level before and after medication at 45th day and 90th day. Repeated measure ANOVA was performed comparing data at baseline, at 45th day and at 90th day.

Sample Size

They were one hundred and fifty in number, including – males and females.

Inclusion Criteria:

• Persons willing to give written consent to participate in the study.
• Age group- Above 20 years and below 65 years.
• Sex – Both sexes are included.
• All socioeconomic status
• SBP-upper limit upto160mmof Hg & DBP-upper limit up to 100mm of Hg
• SBP-Lower limit up to 140mmof Hg & DBP Lower limit up to 90mm of Hg

Exclusion Criteria:

• Patients already receiving Anti-Hypertensive medicines.
• Complicated Hypertensive cases of CHD,CAD,Ventricular Hypertrophy, hepatic disorders, impaired renal function, Hyperlipidemia.
• Patients suffering from other systemic diseases.
• Secondary Hypertension.
• Pregnant women & Lactating mothers
• History of any other Medical or Surgical illness.
• SBP above 160mm of Hg & DBP above 100mm of Hg

Details Of Intervention

 Every patient included in this study was interrogated in detail from a homoeopathic perspective, Hypertension Questionnaire was used and the history and examination findings were recorded in a case record book.  

 Selection Of Tools

• Case record format

• Blood pressure values

  The hypertensive status of the study population was initially confirmed by taking the average of the measured blood pressure thrice on three separate occasions on both arms in a supine position during rest, using a mercury sphygmomanometer of standard cuff size, throughout the study. Every case was subjected to detailed screening by a specified eligibility criteria followed by recruitment in the trial. After recruitment, all were subjected to baseline assessments.

 The pre-entry laboratory investigations performed were as follows: 

Urine analysis for blood,protein and glucose, Blood analysis for urea, electrolytes, creatinine, Serum sodium, potassium, calcium.,Fasting blood glucose, Serum total cholesterol and HDL cholesterol, triglycerides(Lipid profile), 12 Lead ECG, Haematocrit and USG Abdomen.

A detailed case recording of each patient was done by the investigator as per the guidelines laid down by Hahnemann in organon of Medicine. 

 Any acute complaint arising during the follow-up was prescribed the indicated remedy as the prevailing symptomatology suggested. 

 Rauwolfia Serpentina Mother Tincture 

All the medicines used were manufactured by a Good Manufacturing Practice certified homoeopathic pharmaceutical company and were prepared strictly in adherence with the regulations /instructions of the homoeopathic pharmacopoeia of India. Medicines in mother tincture form were dispensed in Good Clinical Practice environment.  Rauwolfia serpentina mother tincture was administered in dosage of 15 drops of mother tincture in 30 ml of pure water in morning half an hour after food daily.  

  The pharmacist was instructed to server Rauwolfia serpentine mother tincture to the indicated persons. All the participants were given additional instructions regarding the diet(DASH diet; i.e., Dietary Approach to Stop Hypertension) and regimen, keeping in mind their socioeconomic status and level of education. The usual measures included avoiding tobacco and alcohol, restricting salt and saturated fat in the daily diet, increasing fruit and fiber content in the diet, and encouragement to undertake more physical activity. These additional measures were advised to all the participants to minimize bias.

Follow Up Visits

 The follow up examination of the patient was usually done every 15 days up to 3 months. They were also asked to report even before the scheduled date, in the event of experiencing any troublesome symptom or serious illness. In addition, they were made aware of the necessity of being faithful to the follow up schedule. At each follow up the patients were evaluated in detail with special reference to changes in general well being, change in presenting symptoms and addition of new symptoms. In addition, the physical examination, including measurement of blood pressure, were repeated. During the follow up visits, the remedy was repeated . Likewise a change in remedy  also was considered only when essential, after careful evaluation of the follow up. If worsening of symptoms/BP readings occurs means the patients will be referred for standard care. 

Outcome Assessment Criteria 

The outcome measure is the systolic and diastolic blood pressure values measured using a sphygmomanometer at 45th day and 90th day . These were compared with the initial values, and the difference analyzed using statistical tests, to find the efficacy of the treatment.  

Descriptive statistics like mean and standard deviation is applied to assess the effectiveness of the medicine. Paired t test was carried out to assess the difference between before and after treatment effect on Blood pressure at 45th day and 90th day . Repeated measure ANOVA was performed comparing data at baseline, at 45th day and at 90th day.

Thus, cases where this lowering in systolic and diastolic BP was observed were ascribed as improved and the rest as not improved. 

 

Results

Out of 150 hypertensive patients assessed for the eligibility criteria, 80 were enrolled. A total of 2 dropouts and 59 were regular. During the seventeen months trial, all data were measured and analyzed at entry and after three months of the study by the t test and ANOVA. 

Descriptive statistics like mean and standard deviation are applied to assess the effectiveness of the medicine. After 45th day of medication in the mean SBP reduction was 14.57 mmHg and mean DBP reduction was 5.09 mm Hg with a standard deviation of SBP was 6.67 mmHg and standard deviation of DBP was 5.91 mmHg. 

Again after 3 months the mean SBP  reduction was 14.00 mmHg and mean DBP reduction was 13.05 mm Hg with a standard deviation of SBP was 6.55 mmHg and  standard deviation of DBP was 5.96 mmHg respectively.

Paired t test was carried out to assess the difference between before and after treatment effect on Blood pressure at 45th day and 90th day. The paired t test value after 45th day   for  SBP  is 19.74 and  DBP is 6.87 , After 90th day  the paired t test values in   SBP is 14.40  and DBP is12.354  

It also showed a significant difference in the blood pressure value at different stages

 

Figure 1 Graphical representation of Age Incidence

     Figure 2 Graphical representation of sex incidence

Discussion & Conclusion

Age incidence

In this study, it was observed that maximum incidence of Essential hypertension was observed in the age group 41-50 years (Figure 1) . This observation is similar to observation made in another study conducted in India (2012) where it was found in age group 41-50 years.

Sex incidence

It was observed that maximum cases of essential hypertension were in Female patients (Figure 2) (58%) as compared to male  (42%). This observation is similar to an observation made in another study conducted in India (2012) that incidences reported were more females as compared to males.

Family history

It has been observed that  (64%)  cases had no family history, followed by  (36%) with a positive family history of Hypertension which is in corroboration with other study conducted in India (2018).

Marital status

It was observed in the study that maximum cases of essential hypertension occurred in married individuals (84%) as compared to unmarried individual’s (16%). This observation is similar to observation made in other study conducted in India (2018)

Habitat

It has been observed that essential hypertension occurred in individuals residing in urban areas (80%) when compared to the individuals residing in rural areas  (20%) which is in correlation with other studies conducted in India (2018).

Risk factors

In this study maximum incidence of essential hypertension was observed in stressful individuals  (83%), Non –Vegetarians 

(71%), High salt intake (84%) and sedentary habits  ( 45%). Which is in corroboration with other studies conducted in India (2018).

Conclusion

At the end of study ,  through statistical analysis it is evident that   Rauwolfia serpentina mother tincture is effective in treating patients suffering from Essential Hypertension. 

 This study has proved that Rauwolfia serpentina mother tincture is having  power  both of reducing a blood pressure that is high and of maintaining it at the lowered value, It is  able to exhibit its  action consistently and in a high proportion of patients and it  is free of all toxic ill-effects. Rauwolfia serpentina appears to be a safe and effective treatment for Essential hypertension.

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