|Year : 2019 | Volume
| Issue : 4 | Page : 89-93
Correlation between Change in Blood Pressure and V02max in Indian Patients of Ischemic Heart Disease after Ischemic Reversal Program Therapy
Rohit Sane1, Gurudatta Amin2, Snehal Dongre3, Rahul Mandole4
1 Founder & Head, Madhavbaug Hospital, Khopoli, Maharashtra, India
2 Chief Medical Officer, Department of Clinical Operations, Madhavbaug Hospital, Khopoli, Maharashtra, India
3 Medical Head, Madhavbaug Hospital, Khopoli, Maharashtra, India
4 Senior Research Associate, Department of Research and Development, Madhavbaug Hospital, Khopoli, Maharashtra, India
|Date of Submission||06-May-2019|
|Date of Decision||08-Jun-2019|
|Date of Acceptance||15-Dec-2019|
|Date of Web Publication||30-Jan-2020|
Madhavbaug Hospital, Khopoli, Maharashtra
Source of Support: None, Conflict of Interest: None
Background: The control of blood pressure (BP) is crucial in improving the outcomes of ischemic heart disease (IHD) patients. Ischemia Reversal Program (IRP) has been proved to improve the aerobic capacity of IHD patients, but further validation is needed. Methodology: This retrospective study used the data of 78 patients who had visited Madhavbaug Clinics between July and December 2018. The mean VO2max, systolic BP (SBP), and diastolic BP (DBP) with heart rate (HR) after day 30 of IRP completion was compared with that on day 1 of IRP initiation. These values were evaluated separately after classifying the patients as those being normotensive and those having either elevated BP or hypertension (HTN). Pearson's test was used to correlate the change in SBP or DBP with VO2max. Results: Majority of the patients were male (n = 54) with the mean age of 59.94 ± 9.46 years. Majority of the IHD patients had elevated BP or HTN (n = 56). The mean HR decrease in both, the normotensive group and the group with elevated BP/hypertensive patients, was found to be statistically significant at the follow-up (P < 0.05). The mean SBP (119.48 ± 12.26 mmHg vs. 135.29 ± 15.59 mmHg) and the mean DBP (77.41 ± 9.06 mmHg vs. 91.18 ± 8.86 mmHg) were significantly decreased in the hypertensive group of patients at the follow-up (P < 0.05). For the normotensive patients, they were maintained in the normal range (P > 0.05). The negative correlations of SBP (R = −0.12, P > 0.05) and DBP (R = −0.32, P < 0.05) changes with VO2maxchange were found. Conclusion: IRP increased the VO2maxand reduced the BP in IHD patients with elevated BP. The reduction in BP correlated with an increase in VO2maxin IHD patients.
Keywords: Blood pressure, ischemic heart disease, Ischemic Reversal Program, VO2max
|How to cite this article:|
Sane R, Amin G, Dongre S, Mandole R. Correlation between Change in Blood Pressure and V02max in Indian Patients of Ischemic Heart Disease after Ischemic Reversal Program Therapy. Res Cardiovasc Med 2019;8:89-93
|How to cite this URL:|
Sane R, Amin G, Dongre S, Mandole R. Correlation between Change in Blood Pressure and V02max in Indian Patients of Ischemic Heart Disease after Ischemic Reversal Program Therapy. Res Cardiovasc Med [serial online] 2019 [cited 2020 Feb 24];8:89-93. Available from: http://www.rcvmonline.com/text.asp?2019/8/4/89/277271
| Introduction|| |
Cardiovascular disorders can be considered as a global epidemic. While the cardiovascular mortality is on a decline in most of the developed Western countries, it is increasing in developing countries like India. It has been estimated that about three-fourth of the deaths associated with cardiovascular diseases are actually seen in developing countries. The rise in the cardiovascular mortality has been progressive in India over the past few decades, with 20.6% deaths in the year 1990, 24.3% in the year 2000, 27.5% in the year 2005, and 29.0% in the year 2013. The most important culprit for cardiovascular mortality is coronary heart disease (CHD), which is also known as ischemic heart disease (IHD). The increase in the IHD occurrence is due to various factors which include urbanization, industrialization as well as major lifestyle changes. It has been noted that the IHD prevalence in India has grown from 2% in the year 1960 to about 14% in 2013. IHD is now considered as one of the most common causes for the growing number of deaths due to cardiovascular disease in the country. This mortality rate is much higher than the global mean mortality rate due to IHD.
One of the commonly known factors which has a massive influence on the incidence as well as the progression of CHD is the magnitude of hypertension (HTN) in the patients. Left ventricular hypertrophy, which is a common complication associated with HTN, leads to a decline of the “coronary reserve,” and this causes a rise in the myocardial oxygen demand. Both these mechanisms have been found to contribute to myocardial ischemia. It is important to highlight that the management of HTN reduces significantly the number of fatal as well as nonfatal cardiovascular events which occur in patients suffering from CHD.
Ayurveda is the Indian traditional type of medicine that has been studied and applied by various physicians to manage various types of acute as well as chronic diseases. Panchakarma along with allied therapies is used by the Ayurvedic physicians to manage these patients. One such integrative modality used for the management of IHD patients is the Ischemia Reversal Program (IRP) Kit. This IRP kit comprises an amalgamation of Snehana (centripetal oleation), Swedana (thermal vasodilation) as well as Basti (perrectal drug administration) for giving relief to IHD patients. A recently published scientific article recognized the efficacy of IRP in IHD patients, based on the induced improvement in the aerobic capacity of these patients. Further validation is needed to give more evidence on the impact of IRP on aerobic capacity variables, such as VO2max. Furthermore, the impact of this novel treatment modality on the raised blood pressure (BP) in IHD patients has not been assessed. Hence, it was decided to evaluate the effect of IRP on the systolic BP (SBP) and the diastolic BP (DBP) along with the heart rate (HR) in IHD patients having an elevated BP or hypertensive patients. We also thought of analyzing the change in the VO2maxof these patients by cardiac stress testing, and this change was correlated with the BP change.
| Methodology|| |
This observational study was planned for evaluating the IHD patients between the period July 2018 and December 2018. The data of patients who had visited the Madhavbaug Clinics and were diagnosed of having positive inducible ischemia by the stress test were considered for the study. The data of only those patients were considered who had been administered the IRP kit treatment with a minimum of five sittings, irrespective of the concomitant medication. These patients were called for follow-up after 30 days of the last IRP sitting. The cases were screened and identified, and the data were retrospectively analyzed from the records of Madhavbaug Clinics. The selection was based on the accessibility of the complete relevant baseline data (day 1 of IRP) and follow-up data (day 30 after IRP completion) of the IHD patients.
The IRP is a 3-step procedure which combines Panchakarma along with allied therapies. IRP utilizes various types of decoctions which have been mentioned in [Table 1]. Snehana or external oleation is a 30–35 min procedure which includes oil-based decoction, directed toward the IHD patients by external massage. This massage technique utilizes upward or centripetal strokes toward the heart's direction. Swedana or passive heat therapy is a 10–20 min technique that involves lying down of the IHD patients in the supine position inside a sudation box, with their head lying outside the box. Dashmoola (group of ten herbs) temperature steam not more than 40° is passed uninterruptedly for 10–15 min. After the treatment process is over, patients are directed to relax for about 3–4 min. Basti is the final process which involves the administration of perrectal herbal drugs for a period of 15 min to the IHD patients using extracts of Tribulusterrestris,Curcumalonga, and Emblicaofficinalis decoction.
The BP of the IHD patients was assessed at the baseline before starting the first IRP session. By the protocol followed at the Madhavbaug Clinics, the SBP and the DBP are assessed in the sitting position with proper support given to the back and arm of the patients. The blinded physicians act as the observers of BP, who are trained to view the sphygmomanometers in a straight line while measuring the BP. The cuff of the sphygmomanometer is positioned on the bare upper arm of either side, over the brachial artery. The stethoscope is put in the antecubital space just beneath the cuff, and the bell side is utilized by the physicians to assess the pressure accurately. The Korotkoff sounds are heard accurately, and the SBP plus DBP was clearly noted in the case record files.
The BP categories recommended by the American Heart Association were followed to classify patients based on their BP. Patients were classified as having elevated BP if the SBP was between 120 and 129 mmHg and diastolic of <80 mmHg. The patient was said to have HTN (Stage 1 or Stage 2) if the SBP was above 130 mmHg or the DBP was above 80 mmHg.
On day 1 of IRP, cardiac stress testing was performed by the modified Bruce protocol. The maximum work load was calculated and this was multiplied by 3.5 to present the peak VO2max. This same procedure was done after 30 days of IRP treatment completion. The mean change in the VO2maxwas calculated and this change was correlated with the both, the mean SBP change as well as the mean DBP change, in patients having raised BP.
The data were entered into a Microsoft Excel Spreadsheet, and the GraphPad Instat V3.0 software (San Diego, GraphPad Software, California) was utilized for the data analysis. Categorical data were noted down in the numerical form, while the continuous data were noted down as mean ± standard deviation. The mean SBP, DBP, and HR values were evaluated separately after classifying the patients as those being normotensive and those having either elevated BP or HTN. Paired t-test was used to assess the statistical difference between the values at the baseline and on the 30th day after the treatment. P< 0.05 was considered stastistically significant.
| Results|| |
The data of 78 patients were found to be appropriate for the study after screening process. The mean age of the IHD patients was found to be 59.94 ± 9.46 years, having a median age of 60 years. Most of the patients enrolled were male (69.23%) [Table 2]. On noting the comorbidities of the patients, it was found that majority of the IHD patients had HTN (71.79%).
|Table 2: Demographic details of patients with ischemic heart disease (n=78)|
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On evaluating the overall mean change in the HR, SBP, and the DBP, there was a significantdecrease seen in all the parameters at the end of 30 days post-IRP treatment [Table 3].
|Table 3: Change in vascular parameters in all patients treated with ischemia Reversal Program (n=78)|
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Fifty-six of the 78 patients were found to be suffering from either elevated BP or HTN, while 22 patients were found to be normotensive. The mean HR change in both, the normotensive group and the group with elevated BP/hypertensive patients, was found to be statistically significant at the follow-up in comparison to the baseline (P < 0.05). The mean SBP and the mean DBP were found to be significantly decreased in the hypertensive group of patients at the follow-up (P < 0.05). For the normotensive patients, there was no statistically significant decrease in the two BP parameters, and the BP was maintained in the normal range (P > 0.05) [Table 4].
|Table 4: Change in vascular parameters in hypertensive and nonhypertensive patients treated with Ischemia Reversal Program|
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The mean change in the VO2maxwas found to be 5.86 ± 5.2 ml/min/kg. On calculating the correlation between the change in SBP and change in VO2max, the correlation coefficient (R) was found to be − 0.12 (P = 0.42), indicating nonsignificant negative correlation between the two compared values. Similarly, the DBP change correlated negatively with the VO2maxchange in the patients having elevated BP, and this change was found to be statistically significant (R = −0.32, P< 0.05). [Figure 1] and [Figure 2] give a graphical representation of the linear correlation.
|Figure 1: Correlation between systolic blood pressure change and VO2maxchange in ischemic heart disease patients . R = −0.12, considered mildly negative correlation by Pearson's correlation test|
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|Figure 2: Correlation between diastolic blood pressure change and VO2maxchange in ischemic heart disease patients. R = −0.32, considered strong negative correlation by Pearson's correlation test|
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| Discussion|| |
HTN is an important factor which plays a crucial role in the progression of IHD. HTN is associated with endothelial dysfunction, remodeling of the coronary arteries as well as elevated resistance at the microvascular level, all leading to a reduction of coronary reserve. Coronary blood flow is increased in hypertensive patients having left ventricular hypertrophy compared with hypertensives without hypertrophy or normotensive patients. The importance of BP control in IHD patients can be established from the fact that the efforts to control SBP in the IHD patients in the USA have led to a significant decrease in the IHD-related mortality. Some of the antihypertensive medications such as beta-blockers, angiotensin-converting enzyme inhibitors, and angiotensin receptor blockers have been indicated for HTN in IHD patients, but their usage is contraindicated in various conditions such as asthma, heart blocks, pregnancy, bilateral renal stenosis, and dehydration. An increase in the HR, especially by vasodilator agents used in IHD, leads to an increase in the cardiac contractility, thereby leading to elevated myocardial oxygen demand and aggravating ischemia. Hence, there is a need for modalities which can be safely used to control HTN in IHD patients. IRP has been found to provide benefit to the IHD patient based on the aerobic capacity, but its effect on the BP parameters has not been assessed. Hence, this study was conducted to evaluate the impact of IRP on the BP as well as the HR in IHD patients having elevated BP.
In this study, of 78 patients, 56 patients were found to have an elevated SBP or DBP, according to the criteria mentioned by the American Heart Association. This shows that majority of the IHD patients are probably associated with the elevated BP. In all the patients irrespective of the BP, the mean HR was found to be significantly decreased after IRP treatment, indicating a possible lowering of the myocardial contractility by IRP. This may inevitably decrease the myocardial oxygen demand and thus prevent ischemia aggravation. In this study, a significant decrease (P < 0.05) in the mean SBP and mean DBP was noted, specifically in the hypertensive group of IHD patients. This is a positive finding as the BP is decreased significantly in hypertensive patients, without affecting the BP in the patients who are normotensive. This impact of IRP may help in controlling the progression of IHD and help in decreasing the probable IHD-related mortality. The mean change in VO2maxwas found to be positive, with a mean significant increase noted. The negative correlation between SBP and DBP change with VO2maxchange indicates that the decrease in the BP was associated with an increase in the VO2maxchange. This correlation was significant with DBP (P < 0.05), but the correlation with SBP was not statistically significant (P > 0.05). A bigger sample size is probably needed to find the significance of these findings.
The various IRP components involved in the management of CHD are Snehana,Swedana, and Basti. The amalgamation of these processes seems to work together to improve the vascular parameters in IHD patients. It has been hypothesized that Snehana, which involves massage and external oleation, leads to a decrease in the sympathetic activity, ultimately lowering the vascular tone and leading to a decrease in the HR. Swedana, which involves the application of passive heat therapy, leads to sweating in the IHD patients which may cause peripheral vasodilation and decrease in the systemic vascular resistance. This ultimately leads to a reduction in the SBP as well as an improvement in the aerobic capacity. A rise of body temperature due to the passive heating also gives rise to the cutaneous vascular conductance, causing an elevation in the systemic conductance and ultimate improvement inVO2max. According to a published research, Basti plays a role in causing moderation of the immune responses by modulating the release of various pro-inflammatory cytokines and the T-cell functions. Hence, the IRP may be contributing to the control in the vascular as well as the aerobic parameters in multiple ways, thereby promising to be an efficient adjunct to the standard allopathic medications in improving the outcomes of IHD patients.
The study had a few limitations. The study did not follow the IHD patients over the long term; hence, the actual impact of IRP over a longer period was not evaluated. The study was conducted in patients from Western India. Future studies including IHD patients from various parts of the country will help in creating more robust evidence related to the impact of IRP management.
| Conclusion|| |
IRP helps in improving the VO2maxand reducing the HR, SBP as well as the DBP in IHD patients having concomitant elevated BP. The reduction in both SBP and DBP was correlated with an increase in the VO2maxin IHD patients.
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Conflicts of interest
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