Clinical Study on Homeopathy in Hypertension

Dr Arun Prasad K P

“A man’s life may be said to be a gift of his blood pressure, just as Egypt is a gift of the Nile”. So said Sir William Osler, an icon of modern medicine and the man said to be the most influential physician in history.

Sir Osler may be indeed right, as arterial pressure is essential for sustaining life, the most important factor which ensures that the circulation of blood reaches all the tissues in our body. At the same time, an elevated blood pressure can be most inimical to life, if persisting over a period of time.

The pioneers in the study of arterial pressure, Reverend Stephen Hale, who made the first blood pressure measurement on animals, and Scipione Riva Rocci, 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% of the cases. It is common, asymptomatic, and lead 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.

The practitioners of the allopathic system of medicine have tried to combat this malady by trying to develop drugs designed to reduce the high arterial pressure. Over the years they have been successful in developing drugs with profound blood pressure lowering capabilities, but the magnitude of the problem at the community level has remained. The reasons for this are many, including the adverse effect of drugs and relatively higher cost of treatment, but the absence of a holistic view of disease is probably the most important. As with other conditions, the inclination is to treat the “results” of disease. This ultimately proves less successful, and is also detrimental to the health of the patient.

The homoeopathic physician on the other hand, considers disease as a disturbance of the life force, made known to him only through signs and symptoms. He understands that the patient is sick prior to the localization of disease. The hypertension, like other diagnoses, is considered only as a part of the whole. The homoeopathic approach also does not have the other drawbacks seen with the allopathic system, like adverse effect of drugs and high cost of treatment. Thus it is potentially suitable to deal with the problem of essential hypertension, especially in a developing country like India.

Unfortunately there is little information regarding the management of hypertension in homoeopathic literature. Many of the classical therapeutic text books and materia medicae do not mention the condition at all. This is possibly due to the lack of awareness about hypertension during the earlier days of homoeopathy. Clinical studies on the effectiveness of homoeopathic medicines in hypertension also has been few. Off the studies published, most have tried to evaluate the action of “specific” drugs rather than use an individualized approach.

All these factors, have encouraged me to take up this study on the efficacy of homoeopathic medicines in the management of essential hypertension. It is hoped that useful information will be gained both on the entity of essential hypertension, as well as the homoeopathic approach to its management.

Essential Hypertension: Homoeopathic research
Documented research on the efficacy of homoeopathic medicines on the management of essential hypertension are very few. Most of the published work has not focused on an individualized approach to treatment.
The remedies administered has been mostly those with a reputation for effectiveness in cases of hypertension.
Bignamini et al. examined73 the effect of Baryta carbonica 15C in 34 elderly hypertensive subjects. Overall the trial result did not show a significant effect of the medicine , compared to placebo. But an interesting observation was that the patients who exhibited symptoms of Baryta carbonica, had a considerable reduction in blood pressure.

A study74 conducted by Dr. Farokh J. Master has shown a decided improvement in the treatment group. Here the medicines used were Adrenalinum, Eel serum and Baryta muriatica.
At present the Central Council for Research in Homoeopathy in India is conducting a study on hypertension in its unit in Hyderabad, the results of which are awaited.

Materials and Methods
The material for this study comprised of patients with essential hypertension, registered for treatment in the out patient department of Govt. Homoeopathic medical college, Thiruvananthapuram. Keeping the aims and objectives in mind, and to help in drawing valid conclusions from the study, the following inclusion and exclusion criteria were followed

Inclusion criteria
” Diagnosis of essential hypertension – History, examination and routine investigations show no evidence of secondary causes
” Age group – patients within 35 – 65 years of age
” Sex – Both sexes included
” Cases falling into low and medium risk groups after risk stratification

Exclusion criteria
” Diagnosis uncertain or findings from the history, physical examination or routine investigations arouse suspicion of a secondary cause for the hypertension
” Cases falling into the very high risk group after risk stratification
” Isolated systolic hypertension
” Cases with wide fluctuations of blood pressure
” Cases with serious illnesses or conditions affecting function of different organs or systems – e.g. hepatic disorders, impaired renal function, pregnancy etc.

Population under study
The study population was comprised of cases of essential hypertension registered at the Govt. Homoeopathic Medical College, Trivandrum, during the period 1997 – 2000. They included patients who wanted treatment for their hypertension and those in whom a raised blood pressure was discovered during the examination in the various out patient departments.

Selection of sample
The hypertensive status of the study population was initially confirmed after measuring the blood pressure twice on two separate occasions. The blood pressure was measured using a mercury sphygmomanometer of standard cuff size, with the subject in the sitting position, after 5 minutes rest.

The patients whose hypertensive status was confirmed was subjected to a preliminary enquiry and examination to exclude causes of secondary hypertension. They also underwent laboratory investigations, which included a blood count, urine for protein, glucose and blood, blood urea and serum creatinine, serum cholesterol, random blood glucose, chest X-ray, and an electrocardiogram.

Further their blood pressure was graded and different risk factors analyzed to assess the overall cardiovascular risk in individual cases. For this purpose the criteria laid down by the WHO-ISH was followed.
The patients who finally got through the various inclusion and exclusion criteria, formed the study sample. They were twenty in number, including – males and – females.

Study design
The study consisted of subjecting patients with essential hypertension to homoeopathic treatment and assessing the efficacy by comparing the systolic and diastolic blood pressures before and after the period of study.
The feasibility of a placebo-controlled study was examined, but was rejected because of ethical and logistical reasons. It was decided to conduct a clinical trial without a placebo control, with the understanding that a placebo controlled trial may be attempted in the future if the results from the current trial is encouraging.

Period of study
The cases were followed up for three months, from the date of the first prescription. The study period was fixed considering the importance of assessing the efficacy of treatment within a reasonable time frame. This is especially so in the case of essential hypertension, with its known risks of prolonged uncontrolled blood pressure. It also helps in comparing the results with conventional treatment, which is known to show improvement in blood pressure within a short period of time.

Treatment intervention
Case taking and analysis
Every patient included in this study was interrogated in detail from a homoeopathic perspective, and the history and examination findings were recorded in a case record book.
In all the cases, a detailed analysis and evaluation of the symptoms were done, before erecting a totality. An examination of the miasmatic basis of the symptoms was also carried out to understand the different miasmatic influences in each case. Further they were repertorized with Synthesis repertory (Synthesis: Repertorium Homoeopathicum Syntheticum ed. 7.1 by Schroyens F, published by Homoeopathic Medical Publishers, London, Published in India by B Jain Publishers (P) Ltd.). In certain cases, other repertories were also consulted.

Remedy selection
The final differentiation of the remedies were made after reference to the different materia medicae, and a remedy matching the totality was chosen, taking care that it also corresponded to the predominant miasmatic influence in the case. In some cases, especially where characteristic symptomatology was lacking, remedy selection was influenced by factors like causation, keynotes, marked modalities etc.

Potency and dose
The potency selection depended on the individual case. Different factors like, the degree of similarity, presence of reversible or irreversible pathological changes, clear or vague image of sickness, and the general vitality of the patient etc were considered for selection of the appropriate potency. When there was no clear trend towards either a higher or lower potency, a medium potency was chosen, usually the 30th .
The drugs selected were given in a single dose (in sugar of milk), along with placebo in the form of blank tablets. They were advised to take the remedy at night before going to bed, and the placebo in most cases were to be taken in the morning and evening.

Additional measures
The patients on anti-hypertensive drugs were asked to reduce the dosage gradually and then stop, corresponding to the pace of improvement.
All the patients were given instructions regarding diet and regimen, keeping in mind their socioeconomic status and level of education. The usual measures included avoiding coffee, smoking, alcohol or other substances having a medicinal nature. They were also advised to restrict salt and fat in their daily diet and were encouraged to undertake more physical activity.

Follow up visits
The follow up examination of the patient were usually made at 2-3 week intervals. 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, was repeated.
During the follow up visits, the remedy was repeated only when necessary, in the same potency or with a change in potency. Likewise a change in remedy also was considered only when essential, after careful evaluation of the follow up. In cases where both were not necessary, only placebo was prescribed, in the form of sugar of milk powders and blank tablets.

Outcome measures
The primary outcome measure is the systolic and diastolic blood pressure values after the period of the study. These were compared with the initial values, and the difference analyzed using statistical tests, to find the efficacy or otherwise of the treatment.
Secondary outcome measures include change in grade of hypertension before and after treatment, and change in other symptoms associated with hypertension.

Statistical tests
Statistical tests were used only for the main outcome measure. For the purpose of this study, the statistical analyses were conducted separately for systolic and diastolic blood pressure values, using the paired t test. The test helps to establish whether the changes observed before and after treatment were significant or not.
The same test was also used to estimate any difference in the changes observed in systolic and diastolic values, to understand specific effects if any.

Observation & Discussion
A total of twenty cases were selected for this study. Out of the many cases screened, only those, which passed all the inclusion and exclusion criteria were selected. Some of the cases were excluded, as subsequent measurements of blood pressure showed a fall in blood pressure into the normotensive range.
Some were rejected after analysis of the risk factors showed that they fall in the very high-risk category, due to very high blood pressure, complications like coronary artery disease, or concomitant illness like diabetes mellitus. Only one case was excluded due to the clinical suspicion of a secondary cause(hypothyroidism) for the hypertension.

Limitations of the study
A. Small sample size
Due to the small sample size, it would be difficult to generalize the results from this study
B. Duration of the study
The study duration was three months, and hence the study does not reflect the efficacy of homoeopathic treatment in the long term.
C. Lack of placebo control
The role of the placebo affect of treatment if any, cannot be assessed in the absence of placebo control.
D. Age & sex distribution
Although a wide age group was selected for the study, most of the cases are in the 55-65 years age group. In the sex distribution also there is predominance of the female sex. Both of these factors may possibly confound the results obtained
E. Selection criteria
Most of the hypertensive complications and concomitant illnesses are excluded from this study, and one cannot assume the efficacy of homoeopathic treatment in such cases. Such cases may also warrant the use of many partially proved or smaller remedies, and the efficacy of such remedies has not been assessed in this study.

Summary & Conclusion
Essential Hypertension is a major health problem, especially in the developing countries. It is a key risk factor for important cardiovascular diseases like coronary heart disease and stroke, both of which account for a good proportion of the deaths worldwide.
Conventional anti-hypertensive treatment, while effective in reducing the blood pressure, has its own draw backs. Non compliance with the treatment regimen is a major problem. The asymptomatic nature of the illness, adverse effects of drugs and high cost of treatment has resulted in the “rule of halves”, where less than half the hypertensive population is adequately treated.
In this scenario, Homoeopathy has a lot of potential to help in reducing the proportion of the hypertensive population in the community, and thereby make a contribution in reducing overall cardiovascular mortality levels. The holistic nature of homoeopathy is ideally suited for this, as even the practitioners of allopathic medicine are realizing the fallacy in treating the blood pressure or other risk factors in isolation. The cheaper cost of treatment also makes it a more attractive option at the community level.
The present study was primarily aimed at determining the effectiveness of the homoeopathic approach in the management of essential hypertension. An attempt was also made to find out if possible, remedies which are more useful in treating the condition. To achieve these aims, twenty cases of essential hypertension were subjected to three months of homoeopathic treatment, and the change in blood pressure levels before and after treatment were evaluated.

The study has shown that homoeopathic medicines have a positive effect on the hypertensive status of the patients in the study sample . The efficacy is demonstrated by the results of the statistical analyses (p < .001for both diastolic and systolic levels ), which show that the pretreatment and post treatment levels of blood pressure are indeed, different. An analysis of the change in grade of hypertension before and after treatment has also shown that thirteen cases or 65% have changed from a higher to a lower grade of hypertension. The group which responded the most to treatment was patients in grade II hypertension with 72.7 % showing change to a lower grade. Finally, an analysis of the cardiovascular risk profile before and after treatment has also demonstrated a reduction in the percentage of cases in the higher risk groups.

The remedies used in this study were essentially prescribed based on the chronic totality. Due to the relatively small size of the sample, no single remedy could be identified as clearly more efficacious than the others. However, remedies like Natrum mur, Calcarea carb, Kali carb and Sepia were found to be effective in more cases than others. China and Carcinosinum were found to be effective in one case each, though both are not mentioned in the general repertories under the rubric for hypertension. The potencies used also has varied, and no single potency was found to have a superior effect.

Bearing in mind the limitations of the study, It would be premature to draw absolute conclusions about the effect of homoeopathic medicines in the management of essential hypertension. But the results of this study are certainly encouraging, and warrants further studies with more stringent criteria. Such a study, with a good sample size, will also help in evaluating the relative efficacy of various medicines in the treatment of essential hypertension.

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Dr Arun Prasad K.P. BHMS,MD(Hom)
Department of Materia Medica
Govt. Homeopathic Medical College. Calicut. Kerala
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