|Year : 2020 | Volume
| Issue : 1 | Page : 3-14
Effects of individualised homoeopathic intervention in Stage I essential hypertension: A single-blind, randomised, placebo-controlled trial
Roja Varanasi1, Raju Kolli2, Yogendra Rai3, Dubashi Ramesh4, R G. R. Kiranmayee4, G Ravi Chandra Reddy5, H Baig4, Tejaswini Patole6, Priyanka Srivastava1, Rupali Bhalaerao1, Anupriya Chaudhary1, Arvind Kumar1, V Sarathy2, GR Jayasri2, Garima Sachdeva3, Saurabh Kumar Jain3, Neha Sharma3, Sucharitha Amsole4, Amita Oinam6, Praveen Oberai1, Raj K Manchanda1
1 Central Council for Research in Homoeopathy, New Delhi, India
2 Homoeopathic Research Institute for Disabilities, Chennai, Tamil Nadu, India
3 Dr.D.P Rastogi Central Research Institute (H), Noida, Uttar Pradesh, India
4 Drug Standardization Unit (Homoeopathy), Hyderabad, Telangana, India
5 Clinic Research Unit (Homoeopathy), Tirupati, Andhra Pradesh, India
6 Regional Research Institute (Homoeopathy), Imphal, Manipur, India
|Date of Submission||06-Jan-2020|
|Date of Acceptance||17-Mar-2020|
|Date of Web Publication||9-Apr-2020|
Dr. Roja Varanasi
Central Council for Research in Homoeopathy, New Delhi
Source of Support: None, Conflict of Interest: None
Background: Hypertension (HTN) is a leading risk factor for death and disability and responsible for over 1.6 million deaths in India. Clinical case reports, observational studies and randomised controlled trials show the effects of homoeopathic medicine in HTN. Objectives: The results of this study will add to the evidence of effectiveness of individualised homoeopathic medicine in Stage I HTN. Methods: A single-blind, randomised, placebo-controlled trial was undertaken from October 2013 to March 2018. The primary outcome measure was to evaluate the change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) every month for 3 months. Of 2127 patients screened, 217 patients who fitted the inclusion criteria were randomised to receive either homoeopathic Q potencies (or LM potencies) plus lifestyle modification (LSM) =116 or placebo + LSM = 101. LSM included physical activity and diet as part of the treatment regimen. Analysis was by intention to treat. Results: Repeated-measure ANOVA between the groups showed statistically significant difference (Wilk lambda 0.85, F = 12.12, df = 213,P = 0.0001), in both SBP and DBP favouring Individualised Homoeopathy (IH) along with LSM. Post hoc independent t-test showed a significant mean reduction in SBP (mean difference 7.12 mm Hg, 95% confidence interval [CI] 4.72–9.53,P = 0.0001) and DBP (mean difference 5.76 mm Hg, 95% CI: 4.18–7.23,P = 0.0001) favouring Homoeopathy plus LSM group. Sulphur (n = 24), Natrum muriaticum (n = 21), Lycopodium (n = 16), Nux vomica (n = 12) and Phosphorus (n = 10) were the most useful medicines. Conclusion: IH in LM potency along with LSM was found effective over placebo along with LSM in the patients suffering from Stage I HTN. Further trials in rigorous setting are warranted.
Keywords: Homoeopathy, lifestyle modification, Stage I hypertension
|How to cite this article:|
Varanasi R, Kolli R, Rai Y, Ramesh D, Kiranmayee R G, Chandra Reddy G R, Baig H, Patole T, Srivastava P, Bhalaerao R, Chaudhary A, Kumar A, Sarathy V, Jayasri G R, Sachdeva G, Jain SK, Sharma N, Amsole S, Oinam A, Oberai P, Manchanda RK. Effects of individualised homoeopathic intervention in Stage I essential hypertension: A single-blind, randomised, placebo-controlled trial. Indian J Res Homoeopathy 2020;14:3-14
|How to cite this URL:|
Varanasi R, Kolli R, Rai Y, Ramesh D, Kiranmayee R G, Chandra Reddy G R, Baig H, Patole T, Srivastava P, Bhalaerao R, Chaudhary A, Kumar A, Sarathy V, Jayasri G R, Sachdeva G, Jain SK, Sharma N, Amsole S, Oinam A, Oberai P, Manchanda RK. Effects of individualised homoeopathic intervention in Stage I essential hypertension: A single-blind, randomised, placebo-controlled trial. Indian J Res Homoeopathy [serial online] 2020 [cited 2020 Sep 28];14:3-14. Available from: http://www.ijrh.org/text.asp?2020/14/1/3/282117
| Introdauction|| |
Hypertension (HTN) is an important worldwide public health challenge because of its role in the causation of coronary heart disease (CHD), stroke and other vascular complications,, to a population undergoing socioeconomic evolution. It is directly responsible for 57% of all stroke deaths and 24% of all CHD deaths in India.
According to the National Family Health Survey (NFHS) 4-National fact sheet, the prevalence of hypertension is more widespread in male (13.6 %) than female (8.8%) population and also it is higher in case of urban subjects than the rural counterparts. There is significant difference in HTN in rural and urban population. Anchala et al., in their study, determined that the overall prevalence of HTN in India is 29.8%, which is significantly different between rural (27.6%) and urban (33.8%) population. The increasing prevalence of HTN is attributed to population growth, ageing and behavioural risk factors such as unhealthy diet, harmful use of alcohol, lack of physical activity, excess weight and exposure to persistent stress. Global urbanisation, sedentary lifestyle, stress at workplace, lack of physical activity and social support lead to increased anxiety and uncertainty and finally to chronic mental and emotional stress. Psychological stress is also proposed as a significant factor contributing to the development of HTN.
The primary goal of therapy for HTN should be effective control of BP to prevent, reverse or delay the progression of complications and thus reduce the overall risk of an individual without adversely affecting the quality of life. Patients can be categorised into different risk groups based on their risk factors. In low-risk patients, it is suggested to institute lifestyle modification (LSM) and observe BP for 2–3 months, before deciding whether to initiate drug therapy. The treatment of HTN is multidisciplinary in nature and is based on drug and non-drug strategies, and the latter are managed and supported by LSMs. LSM in hypertensive patients shows 60% goal achievement in BP, and this modification seems to be important especially for the young, male and obese patients.,
Researchers are facing challenges in fundamental, clinical research in terms of fulfilment of the responsibility of treatment, cardiac failure, obesity, end-stage renal disease and atherosclerosis. The anti-hypertensives prescribed to control the BP though useful for few days/months, long-term use is questionable due to its side effects. Joshi et al. in their review paper have enlisted side effects of anti-hypertensive drugs, such as dizziness, ankle swelling, headache, fatigue, chest discomfort and cough. Olowofela and Isah  in their cross-sectional study listed 27 symptoms attributed to the use of anti-hypertensives. The most important symptoms being frequency of micturition, poor erection, headache, reduced sexual urge, insomnia, weakness, nightmares (bad dreams), coughing, fatigue/little initiative, swollen ankles/oedema, muscular cramp/myalgia, dizziness upon standing up, palpitation and warm feeling/flushes in the face.
According to the statistics by the WHO, Homoeopathy is the second most useful healthcare system in the world. There are several medicines enlisted , in homoeopathic literature for managing elevated BP. In all the studies reported, LSM was an integral part of the management. Preclinical study  with homoeopathic medicine Rauwolfia serpentina (0c, 30c and 6c) indicated its efficacy to reduce systolic BP (SBP) in deoxycorticosterone acetate salt-induced hypertensive rat and also modulate serum clinical parameters and renal antioxidant defences. The case reports, observational studies ,,, and randomised controlled trial (RCT) published using Homoeopathy in HTN have shown some positive effects in managing it. Baig et al. showed significant reduction in both SBP and diastolic BP (DBP) and reduction in dosage of conventional medicine. Similar results were also found in a study in their by Lakhera et al. Saha et al. in their RCT included patients with all stages of HTN and used different potencies, mother tinctures with significant reduction in BP. The former study lacked scientific rigour, and in the latter study, population included all the stages of HTN with different types of homoeopathic drugs, such as potencies, mother tinctures. The analysis of sample with individual stage which was insufficient might have reduced power and distorted inference. A descriptive study by Patel, exploring the effect of psychological conflicts on HTN and role of Homoeopathy, showed that intrapersonal conflicts, such as suppressed anger/hostile impulses or sudden outburst of anger towards persons/things and unacceptable dependency, were the few of HTN symptoms in most patients seeking homoeopathic treatment. Natrum muriaticum, Lycopodium, Ferrum metalicum, Kali bichromicum, Silicea and Calcarea carbonica were found effective in cases of essential HTN and resolving conflicts.
Hahnemann, the father of Homoeopathy, aimed at achieving ‘a rapid, gentle and permanent restoration of the health', which seemed to him easier to achieve with his last dynamisation method, known as 50 millesimal, Quinquagintamillesimal (Q potencies) or LM potencies, in which the medicine is diluted ≈ 50,000 times at each step (potency) of the dynamising process. These potencies can be repeated more often with ease and are thus suitable for chronic diseases. There are no trials which estimated the effects of homoeopathic Q potencies in Stage I HTN.
This single-blind, randomised, placebo-controlled trial was carried out on the population suffering from Stage I essential HTN as per the Joint National Committee criteria 7. The aim of this trial was to determine whether individualised Homoeopathy (IH) along with LSM could produce any significant hypotensive effect different from placebo along with LSM in patients suffering from Stage I essential HTN. Single-blind design was adopted to prevent the subject bias towards the treatment arms. However, keeping in view the individualised nature of homoeopathic prescription, investigators were not blinded. We hypothesised that there might (alternative; Ha) or might not be (null; H0) any significant difference between the groups receiving IH plus LSM and placebo plus LSM.
| Methods|| |
This was a single-blind, randomised, placebo-controlled trial conducted at five centres: Dr D. P. Rastogi Central Research Institute (H), Noida; Drug Standardization Unit (H), Hyderabad; Regional Research Institute (H), Imphal; Homoeopathic Research Institute for Disabilities (earlier Clinical Research Unit (H)), Chennai and Clinical Research Unit (H), Tirupati, under Central Council for Research in Homoeopathy, from October 2013 to March 2018. The study protocol was approved by the 17th Meeting of Institutional Ethical Committee dated 14th August 2013 and was registered in the Clinical Trials Registry – India (CTRI/2018/08/015228 dated 07th August 2018 – retrospectively). It was conducted according to the standards of Good Clinical Practice of India, and all procedures were in accordance with the ethical standards of the responsible committee on human experimentation and with the Helsinki Declaration of 1975, as revised in 2013. Five homoeopathic physicians with more than 20 years of homoeopathic practice, having a degree to practice Homoeopathy from a government-recognised institution, participated in the study as investigators and responsible for the prescription of homoeopathic medicines. Study staff such as senior research fellows who also had institutional qualification as per the regulations of the Government of India assisted the investigators in conduct of the study.
Patients aged between 30 and 60 years, both genders, suffering from Stage I essential HTN (SBP 140–159 mmHg; DBP 90–99 mmHg), who were not on any anti-hypertensive medicines and willing to participate in the study were included.
Patients who had established secondary HTN of known aetiology, such as renal disease, pheochromocytoma or Cushing's syndrome, known diabetics, history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect or known cases of cardiac diseases, any systemic illness (consumptive disease, autoimmune disease, cancer, hepatic disease, renal disease, hypothyroidism) or clinical features suggestive of systemic illness, i.e., liver function test, kidney function test above normal range, patients receiving any drugs known to affect BP or medical treatments that can influence the BP, having a history of alcohol or drug abuse, i.e., excessive alcohol intake, who are taking 60 mL in case of males and 30 mL in case of female each day for the last 1 year, women who are taking contraceptive pills, pregnancy and lactating mother, unable or unwilling to give informed consent were excluded.
All the patients enrolled were subjected to detailed case-taking as per the homoeopathic principles to avoid bias in the treatment effects.
Patients were prescribed IH in 50 millesimal potency as per the homoeopathic principles for 90 days customised to each patient which started with 0/1 potency, followed by the next higher potency, serially, as per need of the case. Each dose was directed to be taken orally. The investigator or the pharmacist on instruction from the investigator dispensed the medicine/placebo as follows: one globule (poppy seed size) of the desired potency was dissolved in 120 mL of distilled water, containing 2.4 mL (2% v/v) of dispensing alcohol, premixed in it, followed by 10 uniformly forceful downward strokes given against the bottom of the phial. Each patient was advised to give 10 uniformly forceful downward strokes to the bottle with the hand on a hard surface and to take three tea spoonful (15 mL) of this solution and mix it in eight tea spoonful (40 mL) of water in a clean glass after stirring the solution for each dose of medicine taken. One teaspoonful (5 mL) of this solution constitutes one dose which was administered once daily. If any change was triggered after administration (improvement/deterioration), change of remedy followed homoeopathic principles.
Medicines were obtained from SBL Pvt. Ltd., a Good Manufacturing Practice-certified firm. Single individualised medicine was prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional features, repertorisation as and when required and due consultation with Materia Medica. Dose was also individualised and was based on homoeopaths’ judgment of susceptibility and treatment experience.
Patients randomised to the control group received placebo for the duration of the study (90 days). It constituted un-medicated poppy-sized sugar globules impregnated with dispensing alcohol. Mode of dispensing of the placebo was similar to that of the medicine. Any change triggered after administration (improvement) was followed by placebo only.
Patients of both the groups were advised for physical activity and dietary modification on daily basis from baseline till 3 months.
Patients who were involved in physical labour or who had to walk or cycle for >30 min/day or performed exercises regularly were asked to continue their routine activities. Patients engaged in sedentary or light physical activity, as assessed in the initial interview, were advised and regularly motivated to walk briskly for at least 30 min each day.
Diet modification for each participant included Dietary Approaches to Stop Hypertension (DASH) diet (reduction in total calories, refined carbohydrates and fats, not to exceed 20 g/day) and inclusion of fibre-rich foods (whole grains, legumes, vegetables and fruits) customised according to their region and culture., All participants were strongly encouraged to avoid alcohol and to stop smoking if they did so.
- To determine the mean change in SBP and DBP from baseline at every month for 3 months from baseline as per the routine method.
- Per cent of patients meeting the goal BP of SBP ≤135 mmHg and DBP ≤85 mmHg in patients of both the groups
- To assess adverse events if any in both the groups.
Evaluation of blood pressure, diet and physical activity
Measurement of blood pressure
Measurement of SBP and DBP at baseline and thereafter every month for 3 months was done using the routine method as described in Bates’ Guide to Physical Examination and History Taking. BP was measured in sitting position by investigators/study staff. The patients were instructed to avoid smoking or drinking caffeinated beverages for 30 min before the BP is measured. Before taking the BP, the patient was asked to sit quietly for at least 5 min in a chair with feet on the floor, rather than on the examining table. Three readings from both the arms were taken at an interval of 5 min. Then, the average of the three readings was calculated. The value obtained was considered for the inclusion of the patient into the study. Symptoms related to BP including headache, dizziness, ringing/buzzing in ears, rapid heart rate, and chest tightness and other signs were recorded using a questionnaire.
Physical activity was assessed as per the Physical Activity Scoring System developed by Ramachandran et al. The physical activity score was assessed every month for 3 months. The patient was adherent to or not adherent was assessed every 30 days for 90 days.
Diet was advised as per the region on a structured format, and adherence was assessed on diet adherence scale  every 30 days for 90 days.
Based on previous study by Baig et al., and keeping the lowest margin, it was assumed that the reduction in the SBP from baseline to 3 months shall be 10 ± 5 mmHg (mean ± standard deviation) in PL + LSM group; and keeping an additional absolute reduction of 20% more due by adding of IH with 95% confidence level and 80% power, 120 evaluable patients in each group were required. Keeping the drop out of 20%, the total sample size was 294 patients.
All the patients included in the study were randomised to either IH + LSM or placebo + LSM. Participants are simple randomised in a 1:1 ratio. The investigator assigned the patient to one of the intervention groups using simple randomisation techniques, i.e., the patients with odd enrolment numbers were given IH + LSM and patients with even numbers were given PL + LSM. The assigned groups were maintained throughout the study.
All the statistics was performed using IBM SPSS Statistics for Windows, version 20 (IBM Corp., Armonk, N.Y., USA). The principal analyses of primary and secondary outcomes employed the “intent-to-treat” approach. The overall significance level of the primary outcome was explorative. The last observations were carried forward to fill the missing values. Nature of data was assessed applying normality test at baseline. All the data were tested for normal distribution, i.e., Kolmogorov–Smirnov tests were used to analyse the normality of the data distribution. Thereafter, baseline characteristics were compared between the two treatment groups using parametric and non-parametric tests as per the nature of the variable. Standard errors for inferences with 95% confidence intervals (CIs) are presented. A repeated-measure ANOVA was used to show the repeated difference between the groups for 3 months. Resulting P values for treatment-group effects are considered explorative, and P > 0.05 was considered statistically significant.
| Results|| |
Of 2127 patients screened, 1910 patients were excluded and 217 were enrolled for the study (IH + LSM: 116; PL + LSM: 101) from October 2013 to December 2017. The reasons for exclusion were as follows: BP not in the inclusion range (56%); patients on anti-hypertensive medications (16%); patients’ age does not meet the criteria (8%); patients not willing for the study (6%). 23 participants in each group dropped out. The flow of patients in the study is given in [Figure 1]. Baseline demographic characteristics, clinical indices and pathological–biochemical parameters were comparable between the groups [Table 1].
The percentage of participants who adhered to physical activity was IH + LSM: 81% and PL + LSM: 77.2%. Similarly, the percentage of participants who adhered to diet was IH + LSM: 83.6% and PL + LSM: 84.2%. Chi-square test for association showed no significant difference for both the parameters, i.e., physical activity (χ2 = 0.47, P = 0.49) and diet (χ2 = 0.47, P = 0.49).
Repeated-measure ANOVA between the groups showed statistically significant difference, in both SBP (Wilk lambda 0.85, F = 12.12, df = 213, P = 0.0001) and DBP (Wilk lambda 0.85, F = 12.12, df = 213, P = 0.0001) favouring IH + LSM. Post hoc independent t-test showed a significant mean reduction in SBP (mean difference 7.12, 95% CI 4.72–9.53, P = 0.0001) and DBP (mean difference 5.76, 95% CI: 4.18–7.23, P = 0.0001) favouring the IH + LSM group [Table 2]. [Figure 2] shows the decreasing trend of SBP and DBP values at different time points with 95% error bars.
|Figure 2: Systolic blood pressure and diastolic blood pressure at different months over 3 months|
Click here to view
The secondary outcome [Table 2] for achieving the goal by SBP ≤135 and DBP ≤85 was also determined. It was observed that 35.3% (n = 41) of patients achieved the goal in IH + LSM group and 12.8% (n = 13) in PL + LSM group. There was relative risk of 0.74 (95% CI 0.63–0.86; P = 0.001). Number needed to treat (benefit) was 4.45 (95% CI 2.9–8.8) to bring SBP/DBP less than 135/85 mm of Hg in one patient by IH + LSM.
Homoeopathic prescription follows holistic approach; the medicines prescribed for presenting complaints along with HTN were Sulphur (n = 24), Natrum muriaticum (n = 21), Lycopodium (n = 16), Nux vomica (n = 12), Phosphorus (n = 10), Arsenicum album (n = 8), and Calcarea carbonica (n = 7), Pulsatilla (n = 5), Sepia (n = 4), Lachesis (n = 2), Argentum nitricum (n = 2), Aconite (n = 2), Silicea (n = 1), Belladonna (n = 1) and Rhus toxicodendron (n = 1). No change of prescription was done during the 3 months of treatment. The most useful medicines which were prescribed in 10 or more patients are given in [Table 3]. There were no adverse events reported during the study period.
The clinical symptoms presented by the patients and sought treatment are given in [Table 4]. 68.8% of complaints were rheumatological (knees pain, back pain and neck stiffness), while 49.8% neurological/mental (burning of extremities, vertigo, headache, numbness, weak memory, irritability and anxiety). There was a strong association of homoeopathic medicines and improvement of clinical symptoms too. 68% of 73 patients reported improvement in their rheumatological complaints compared to only 34.3% of 70 patients in placebo group (χ2 16.7; P = 0.0001). Similarly, 72.4% of patients with neurological complaints/mental complaints reported improvement in homoeopathic group compared to only 34% in placebo group (χ2 = 15.98; P = 0.0001). Further sleepless also improved in 54.5% of 11 patients in homoeopathic group compared to 15.4% of 13 patients in placebo group (χ2 = 4.11; P = 0.04). The association was insignificant in symptoms related to cardiac (palpitation), respiratory (breathing difficulties), gynaecological (irregular menses) and dermatological (pruritus).
| Discussion|| |
HTN is one of the major risk factors for cardiovascular event. This multicentric, single-blind, randomised, placebo-controlled trial conducted at five centres resulted in significant reduction in SBP and DBP with IH and LSM compared to placebo and LSM in patients suffering from Stage I HTN (absolute mean difference 7.12; 95% CI 4.7–9.5; P = 0.0001). 35% of patients in IH + LSM groups reached the goal of SBP/DBP ≤135/≤85 mmHg compared to 12.8% in PL + LSM group. Thus, there was 26% relative risk reduction in IH + LSM group. In this study, a strong association of improvement was also observed in Homoeopathy group compared to placebo group. The clinical symptoms related to rheumatological disorders, neurological/mental disorders and sleeplessness were prominent.
Baig et al. study comprised of patients with all stages of HTN showed 14 mmHg reduction in SBP and 11 mmHg reduction in DBP with homoeopathy intervention as add on or stand alone. However, this study included the patients of Stage I HTN only with systematic motivation for LSM. Saha et al., in their study, inferred that the mean BP reduction was 26.6 mmHg. The authors included patients of all stages of HTN. In both the studies, medicines prescribed included mother tinctures, homoeopathic dilutions in Q potencies and centesimal potencies. However, the present study streamlined the medicines using Q potencies only. The greater advantage of Q potencies is that the medicines can be given serially and continuously and they are highly dynamic with power increasing succinctly with each serial dilution.
The various challenges faced by the investigators during the trial were large number of screening (n = 2127) to get cases of Stage I HTN as per the inclusion criteria. For each one case to be enrolled, 10 patients had to be screened. In one centre, of 746 cases screened, none of the cases was found fit for inclusion. Due to large number of screening and achieving the targeted sample (n = 294), duration of enrolment period was required to be extended for 3 years. For hands-on training and identifying the ground-level difficulties, the investigators were instructed for initiating the study as single-blind trial. After a meaningful enrolment, an interim analysis was conducted with significant results. Thereafter, the enrolment was stopped with sample achievement of 217 patients. Further, with a placebo arm due to ethical reasons and risk factors, follow-up period was restricted to 3 months only.
The study has limitations too. This study was conceptualised and planned for a double-blind, placebo-controlled trial with ambulatory BP measurement as one of the primary outcomes. However, single-blind trial could be conducted. Thus, blinding subjects to treatment group may protect against the expectation bias, thereby enhancing the internal validity of the findings, which provides benefit to the research. However, the experimenter bias cannot be ignored. The ambulatory BP instrument requires hospital admission for monitoring of 24 h BP or the patient had to be given the instrument to be used at home. Both the methods were not feasible with the current study set-up. Therefore, this was not achieved in this study. Studies with pragmatic approach and double-blind design with infusion of real-time practice inclusive of all the stages of HTN can be the best option to reduce the long enrolment period with increase in long-time follow-up for better appraisal of homoeopathic treatment. Further, the clinical symptoms were analysed as a dichotomous variable of improved and not improved. In future studies, patient reported outcome measures such as measure your outcome profile may also be incorporated to bring robustness to the study findings.
Keeping in view nature of the disease, multiple risk factors and side effects of conventional drugs, the results of this study can be utilised in Stage I HTN so that the patients with low risk can be effectively managed with Homoeopathy along with LSM. As per the findings of Mahmoudian  and Patel, future research designs with homoeopathic intervention may also document in-depth psychological perspective to establish connection of Homoeopathy with psychology in patients suffering from HTN along with standard outcome measures/endpoints  for establishing causal relationship.
| Conclusion|| |
The study highlights the positive role of Homoeopathy in LM potency along with LSM for managing Stage I HTN. Along with reduction in BP, there was significant improvement in different symptoms. Further, pragmatic, double-blind studies in different settings and designs are required to substantiate the generated evidence.
We acknowledge the contribution of Dr R. M. Pandey, Head of Department, Biostatistics, AIIMS, for guiding in determining the sample size. The patients who participated in this study are also acknowledged.
Financial support and sponsorship
Central Council for Research in Homoeopathy, New Delhi, under Ministry of AYUSH, Government of India, supported the study.
Conflicts of interest
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4]