|Year : 2019 | Volume
| Issue : 1 | Page : 1-5
Evaluation of the effect of heart failure reversal therapy on the exercise capacity in patients with chronic heart failure and their association with comorbidities
Rohit Sane1, Gurudatta Amin2, Snehal Dongre3, Rahul Mandole4
1 Founder and Head, Department of Research and Development, Madhavbaug Hospital, Khopoli, Maharashtra, India
2 Chief Medical Officer, Clinical Operations, Madhavbaug Hospital, Khopoli, Maharashtra, India
3 Medical Head, Madhavbaug Hospital, Khopoli, Maharashtra, India
4 Senior Research Associate, Madhavbaug Hospital, Khopoli, Maharashtra, India
|Date of Web Publication||23-Apr-2019|
Dr. Rahul Mandole
Department of Research and Development, Madhavbaug Hospital, Khopoli, Maharashtra
Source of Support: None, Conflict of Interest: None
Background: New treatment modalities are needed to improve the aerobic capacity of patients with chronic heart failure (CHF) considering the increasing disease prevalence. This study was done to evaluate the effect of heart failure reversal therapy (HFRT) on exercise indices, namely VO2 max and metabolic equivalents (METs). Methodology: This retrospective study screened data of 147 patients who had visited Madhavbaug Clinics between July 2018 and December 2018. The mean VO2 max and METs on day 30 of HFRT initiation was compared with that at baseline. Regression analysis was used to calculate the odds for increase in VO2 max and METs by HFRT, in specific comorbidity. Results: Of the 64 patients who fit the study criteria, majority were males (n = 51) with mean age of 57.89 ± 8.14 years. The most common comorbidity was hypertension (n = 45) followed by diabetes mellitus (n = 36) and coronary artery disease (n = 27). Mean VO2 max and METs increased significantly at day 30 of HFRT initiation compared to the mean values on day 1 (P < 0.05). Odds for elevation in VO2 max and METs were maximum in patients with myocardial infarction (MI) (VO2 max: odds ratio [OR] = 4.95; confidence interval [CI] = 0.26–91.5. METs: OR = 3.46; CI = 0.18–65.54), ischemic heart disease (IHD) (VO2 max: OR = 2.85; CI = 0.32–24.7. METs: OR = 1.67; CI = 0.18–15.29), or obesity (VO2 max: OR = 2.57; CI = 0.29–22.4. METs: OR = 1.5; CI = 0.16–13.78). All odds were statistically insignificant (P > 0.05). Conclusion: HFRT leads to significant increase in the VO2 max and METs in CHF patients, indicating improved aerobic capacity. Odds for increased exercise indices with HFRT were maximum in CHF patients suffering from MI, IHD, and obesity.
Keywords: Aerobic capacity, alternative medicine, exercise indices, heart failure reversal therapy, metabolic equivalents
|How to cite this article:|
Sane R, Amin G, Dongre S, Mandole R. Evaluation of the effect of heart failure reversal therapy on the exercise capacity in patients with chronic heart failure and their association with comorbidities. Res Cardiovasc Med 2019;8:1-5
|How to cite this URL:|
Sane R, Amin G, Dongre S, Mandole R. Evaluation of the effect of heart failure reversal therapy on the exercise capacity in patients with chronic heart failure and their association with comorbidities. Res Cardiovasc Med [serial online] 2019 [cited 2019 Sep 20];8:1-5. Available from: http://www.rcvmonline.com/text.asp?2019/8/1/1/256883
| Introduction|| |
The World Health Organization has declared cardiovascular diseases (CVDs) to be the most important cause of morbidity as well as mortality globally. CVD has been a menace to the Indian population, affecting them in their productive midlife period, which is at least a decade before the European contemporaries. About 52% of the CVD deaths occur before the age of 70 years; in Western population, it is as low as 23%. The annual increase rate in the CVD prevalence of India has been found to be between 0.5 and 1.8 million.
Chronic heart failure (CHF) is one of the most common prevalent CVD, with an estimate of at least 26 million people affected by it globally. In India, 1.3 million to 4.6 million people are suffering from CHF, and this may be an underestimation. The treatment options for CHF comprise of various pharmacological agents such as angiotensin receptor blockers, beta blockers, angiotensin-converting enzyme inhibitors, vasodilators, and diuretics. However, majority of CHF patients require elaborate management due to comorbidities, elderly age, and reduced handling capabilities. Despite many recent advances in the treatment of CHF, the prognosis still has not become promising. Hence, there is a need for new treatment options which can add to the armamentarium for CHF management. This search is not limited to only allopathy and has brought researchers to the doorway of alternative medicine.
Ayurvedic physicians recommend the usage of conventional drugs in the acute phase of heart failure. For management of the chronic stage of heart failure, use of Panchakarma therapy (a 5-step process for providing internal body purification) is advocated by these physicians as an add-on to the conventional allopathic medications. Heart failure reversal therapy (HFRT) is a blend of Panchakarma practice along with herbal treatment. The techniques used in Panchakarma are Snehana (external oleation), Hridaydhara (concoction-dripping therapy), Swedana (passive heat transfer), and Basti (per-rectal drug administration). There are some clinical studies which suggest that HFRT can be an effective add-on therapy in CHF patients., However, none of the studies have assessed the effect of HFRT on the exercise indices, which are important indicators for the aerobic capacity of an individual, in association with other common comorbidities such as hypertension (HTN) and diabetes mellitus (DM) among others. This study was planned to evaluate the effect of HFRT on the exercise indices, namely VO2 max and metabolic equivalents (METs), in CHF patients. It was also planned to assess the odds of positive response with HFRT in association with common comorbidities in the CHF patients.
| Methodology|| |
This retrospective study was conducted between July 2018 and December 2018. We identified the data of patients who had visited the Madhavbaug clinics in the Indian state of Maharashtra, suffering from CHF. The data of patients who had been administered HFRT with minimum 1 sitting per week over a span of 30 days (±5 days) were considered. Cases were identified, and data were evaluated from the medical records of Madhavbau g clinics for the specified study period. The selection was based on the availability of complete relevant baseline data (day 1 of HFRT) as well as the day-30 data of the patients. The information about comorbidities, if any, was also noted down.
The HFRT is a blend of Panchakarma and allied therapies. HFRT uses different decoctions as well as oils and is made up of a 4-step procedure, as described in [Table 1].
On day 1 of HFRT, the patients underwent cardiac stress testing, based on the modified Bruce protocol. The maximum workload was evaluated in terms of METs, which signifies a practical and simple method for asserting the energy expense of physical activities, in terms of multiples of the resting metabolic rate. The METs data were noted for the patients who fit the screening criteria of the retrospective analysis. This MET was multiplied by 3.5 to give peak VO2 max, which is the same as the maximal aerobic capacity (MAC). This process was repeated on day 30 from the first HFRT administered to the patient, to calculate VO2 max.
Data were entered and coded in Microsoft Excel chart. GraphPad Instat V3.0 software (San Diego, California, GraphPad Software) was used to analyze the entered data. Categorical data were represented in the numerical form whereas the continuous data were expressed as the mean ± standard deviation. The paired t-test was used to analyze the statistical difference between baseline values and 30th day after the HFRT initiation. The association between the comorbidities with increase in the VO2 max as well as with the METs values was assessed using Chi-square analysis as well as regression analysis.
| Results|| |
One hundred and forty-seven patients who visited the Madhavbaug clinics during the study period were screened for the availability of relevant data. Sixty-four patients were found with VO2 max and METs data available, and data of these patients were included in the study for analysis [Flowchart 1]. The demographic details revealed that majority of the CHF patients were males (n = 51, 79.68%). The mean age of the CHF patients was found to be 57.89 ± 8.14 years, with a median age of 58 years (range: 42–75 years). The mean baseline weight was 72.21 ± 14.39 kilograms and mean height of 1.62 ± 0.07 meters [Table 2].
The CHF patients were found to be suffering from various comorbidities, enlisted in [Table 3]. Among these, the most common comorbidity was HTN which was seen in 45 patients, followed by DM (36 patients) and coronary artery disease (CAD) (27 patients). The other comorbidities noted down were ischemic heart disease (IHD), myocardial infarction (MI), hypothyroidism, and obesity.
On evaluating the VO2 max in the patients, it was found that there was an increase in the parameter in 54 out of 64 patients (84.38%) at day 30 of HFRT as compared to day 1. Similarly, 55 patients (85.93%) showed increased METs at day 30 of HFRT initiation in comparison to day 1 [Table 4].
The mean VO2 max at day 30 of HFRT initiation was significantly higher as compared to the mean value on day 1 (P < 0.05). Similarly, there was an increase in the mean METs on day 30 of HFRT initiation in comparison to day 1 [Table 5].
On calculating the association between an increase in VO2 max and the comorbidities by regression analysis, the odds ratio (OR) was maximum in CHF patients having MI as a comorbidity (OR: 4.95). The other comorbidities having an OR >1 included IHD, obesity, DM, and HTN. All these findings were not statistically significant (P > 0.05) [Table 6].
|Table 6: Association between common comorbidities with increase in VO2 max at follow-up (n=64)|
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On calculating the association between an increase in the METs value and the comorbidities by regression analysis, the OR was maximum in CHF patients having MI (OR: 3.46), similar to the finding for VO2 max change. The other comorbidities having an OR >1 included IHD and obesity. The odds for increased METs were not related to other comorbidities such as CAD, HTN, and DM as the OR was below 1 for these cases. All these findings were not found to be statistically significant (P > 0.05) [Table 7].
|Table 7: Association between common comorbidities with increase in metabolic equivalents value at follow-up (n=64)|
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| Discussion|| |
In the general population, the capacity for executing aerobic exercise depends on the heart's ability to increase its output for the exercising muscles along with the capacity of the muscles to use oxygen from the blood which is delivered. An important feature of CHF is the decreased ability of performing aerobic exercise. The decreased aerobic capacity is due to the inadequate blood supply to the skeletal muscles, secondary to the compromised cardiac output., CHF patients may be able to attain <50% of the cardiac output which can be maximally achieved by healthy people at the peak of exercise. The exercise indices which are commonly measured to evaluate the aerobic capacity of an individual are VO2 max and MET. Functional capacity is the capability of an individual to execute his/her routine activities which involve physical exertion. VO2 max, also called MAC, implies the maximum rate of oxygen consumption calculated during exercise. It is the most widely acknowledged indicator of aerobic fitness. A decrease in the VO2 max is symbolic of a reduction in the cardiorespiratory function and vice versa.
A MET is the metabolic rate at rest and symbolizes the quantity of oxygen which is consumed. It represents the energy spending of physical activities, measured as a multiple of the resting metabolic rate. In case of exercise testing, as the intensity of exercise is steadily increased, the surges in intensity from stage-to-stage are typically at least by 1–2 METs in normal individuals. However, the increase is insignificant in functionally compromised individuals, like those suffering from CHF. Like VO2 max, any increase in the MET is indicative of improvement in the cardiorespiratory function and exercise capacity.
In this study, the effect of HFRT on the exercise capacity was evaluated based on the changes in the VO2 max and MET at the end of 30 days of HFRT initiation. Nearly, 84.38% of the patients showed an increase in the VO2 max while 85.93% of the patients showed an elevation in the MET value at day 30. The mean VO2 max and METs levels were significantly increased at day 30 as compared to the mean values at day 1. This shows that HFRT improved the exercise capacity of majority of the CHF patients and elevated the mean indices of aerobic capacity. On calculating the association between the various comorbidities and elevation in VO2 max, ORs was found to be >1 in CHF patients suffering from MI (OR: 4.95), IHD (OR: 2.85), obesity (OR: 2.57), DM (OR: 2.18), and HTN (OR: 1.18). This shows that HFRT may be helpful in improving the exercise capacity in CHF patients who are suffering from other comorbidities such as MI, IHD, obesity, DM, and HTN. The population of CHF patients suffering from comorbidities is high, and hence, this finding holds importance.
An increase in the workload proportionately elevates the consumption of oxygen by the left ventricle, both in normal individuals as well as in those suffering from CHF. The work efficiency of heart is unable to increase proportionately. This causes a disproportionate elevation in the energy uptake, and hence, a decrease in left ventricular function is seen. There is also evidence that the vasodilatory capacity is impaired in patients with CHF, leading to a compromise in the ability of the peripheral vasculature to increase the skeletal muscle blood supply secondary to exercise.Snehana is supposed to reduce the sympathetic activity of the body, which may reduce the vascular tone and increase the capacity of peripheral vasculature to dilate, thus improving the aerobic capacity. Swedana also causes sweating and leads to peripheral vasodilation, which causes a reduction in the systemic vascular resistance. In addition, research suggests that aerobic capacity of an individual bears an inverse relationship with the inflammatory response. There is evidence to suggest that Basti regulates the release of pro-inflammatory cytokines and inhibits an inflammatory response, which may be contributing to the improved exercise capacity due to HFRT.Hridaydhara provides relaxation to the patient physically as well as mentally, which may be contributory to the attenuation of the sympathetic activity.
Our study did have some limitations. This retrospective study considered data of 30 days, and long-term effects were not studied. Future studies with a bigger sample size over multiple centers will also aid in generating robust evidence.
| Conclusion|| |
HFRT improved the exercise capacity in CHF patients by increasing the VO2 max as well as the METs. There was greater propensity to improve the exercise capacity in CHF patients suffering from other comorbidities such as MI, IHD, obesity, DM, and HTN.
The authors thank the study participants and their families, without whom this study would not have been accomplished.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Nag T, Ghosh A. Cardiovascular disease risk factors in Asian Indian population: A systematic review. J Cardiovasc Dis Res 2013;4:222-8.
Rigolli M, Whalley GA. Heart failure with preserved ejection fraction. J Geriatr Cardiol 2013;10:369-76.
Savarese G, Lund LH. Global public health burden of heart failure. Card Fail Rev 2017;3:7-11.
Huffman MD, Prabhakaran D. Heart failure: Epidemiology and prevention in India. Natl Med J India 2010;23:283-8.
Hilal-Dandan R, Brunton L, Goodman L. Goodman and Gilman's Manual of Pharmacology and Therapeutics. New York: Mcgraw-Hill; 2014.
Sane R, Aklujkar A, Patil A, Mandole R. Effect of heart failure reversal treatment as add-on therapy in patients with chronic heart failure: A randomized, open-label study. Indian Heart J 2017;69:299-304.
Mandole R, Sane R. A retrospective cohort to study the mortality and survival rate amongst chronic heart failure (CHF) patients after Ayurvedic Sampurna Hriday Shudhikaran (SHS) therapy. J Clin Exp Cardiol 2015;6:4.
Sane R, Hanchate M. Effect of the Sampurna Hriday Shuddhikaran (SHS) model in heart failure patients in India: A prospective study. Br J Med Med Res 2014;4:564.
Nanayakkara S, Kaye DM. Management of heart failure with preserved ejection fraction: A review. Clin Ther 2015;37:2186-98.
Jetté M, Sidney K, Blümchen G. Metabolic equivalents (METS) in exercise testing, exercise prescription, and evaluation of functional capacity. Clin Cardiol 1990;13:555-65.
Wilson JR, Martin JL, Schwartz D, Ferraro N. Exercise intolerance in patients with chronic heart failure: Role of impaired nutritive flow to skeletal muscle. Circulation 1984;69:1079-87.
Sullivan MJ, Cobb FR. Central hemodynamic response to exercise in patients with chronic heart failure. Chest 1992;101:340S-6S.
Arena R, Myers J, Williams MA, Gulati M, Kligfield P, Balady GJ, et al.
Assessment of functional capacity in clinical and research settings: A scientific statement from the American Heart Association Committee on Exercise, Rehabilitation, and Prevention of the Council on Clinical Cardiology and the Council on Cardiovascular Nursing. Circulation 2007;116:329-43.
Lombardo TA, Rose L, Taeschler M, Tuluy S, Bing RJ. The effect of exercise on coronary blood flow, myocardial oxygen consumption and cardiac efficiency in man. Circulation 1953;7:71-8.
Piña IL, Apstein CS, Balady GJ, Belardinelli R, Chaitman BR, Duscha BD, et al.
Exercise and heart failure: A statement from the American Heart Association Committee on Exercise, Rehabilitation, and Prevention. Circulation 2003;107:1210-25.
Rosado-Pérez J, Mendoza-Núñez VM. Relationship between aerobic capacity with oxidative stress and inflammation biomarkers in the blood of older Mexican Urban-Dwelling population. Dose Response 2018;16:1559325818773000.
Thatte U, Chiplunkar S, Bhalerao S, Kulkarni A, Ghungralkar R, Panchal F, et al.
Immunological & metabolic responses to a therapeutic course of Basti in obesity. Indian J Med Res 2015;142:53-62.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]