|
| |
 |
|
| ORIGINAL ARTICLE |
|
| Year : 2022 | Volume
: 4
| Issue : 2 | Page : 71-76 |
|
Effect of herbal detoxification and reverse diet treatment on the mortality rate of CAD patients
Rohit Sane1, Rahul Mandole2, Gurudatta Amin3, Pravin Ghadigaonkar4, Suhas Dawkhar5
1 CEO, Madhavbaug Cardiac Care Clinics and Hospitals, India
2 Head of Department of Research and Development, Madhavbaug Cardiac Care Clinic and Hospital, Thane, Maharashtra, India
3 Chief Medical Officer, Madhavbaug Cardiac Care Clinic and Hospital, Thane, Maharashtra, India
4 Ayurveda Head Medical Operations, Madhavbaug Cardiac Care Clinic and Hospital, Thane, Maharashtra, India
5 Head of Medical Operations, Madhavbaug Cardiac Care Clinics and Hospitals, Mumbai, Maharashtra, India
| Date of Submission | 10-May-2022 |
| Date of Decision | 28-Jul-2022 |
| Date of Acceptance | 15-Nov-2022 |
| Date of Web Publication | 03-Jan-2023 |
Correspondence Address:
Dr. Rahul Mandole
201B, Madhavbaug, Bhoomi Velocity, Wagle Industrial Estate, Thane, Maharashtra
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/ACCJ.ACCJ_9_22
Background: Coronary Artery Disease (CAD) has metabolic disorders at its core etiology. Ayurvedic-based Panchkarma treatment has previously been reported to have reversed CAD-related conditions and improved the quality of life post-treatment. Objectives: The current study was designed to determine the effectiveness of Ayurvedic-based Panchkarma treatment as assessed by the mortality and rehospitalization rate. Methods: This was a multicenter cohort study carried out between August 2017 and August 2020 in India. The study enrolled known CAD patients (stable at rest). The study therapy included a three-step Panchkarma treatment and a low-calorie high-protein diet kit for 12 months and was monitored for up to 36 months. The hazard ratios for different risk factors including – age, body mass index (BMI), weight, diabetic status, and blood pressure were calculated using the Cox proportional hazards model and the actual number of deaths that occurred over the study period (24 months and 36 months) were recorded. Results: The study included 572 known CAD patients (78.67% of males and 21.33% of females) within the age group of 60.22 ± 10.89 years (mean ± standard deviation). Complete compliance to study therapy was recorded whereas ~15%–25% of patients were unable to follow the dietary modifications. The overall mortality rate was found to be 5.07%. BMI, weight, diabetes, and blood pressure were modified during the treatment which may have led low mortality rate. Statistically, age was the only risk factor that showed significance in determining overall survival. The total number of cases of rehospitalization during the study period was 52 (9.09%) patients. Conclusion: Our study concluded that the Panchakarma-based treatment is beneficial in reducing risk factors such as BMI, diabetes, and blood pressure in known CAD patients, thus lowering the mortality and rehospitalization rate posttreatment.
Keywords: Coronary artery disease, herbal detoxification, mortality rate, rehospitalization rate, reverse diet, risk factors
How to cite this article:
Sane R, Mandole R, Amin G, Ghadigaonkar P, Dawkhar S. Effect of herbal detoxification and reverse diet treatment on the mortality rate of CAD patients. Ann Clin Cardiol 2022;4:71-6 |
How to cite this URL:
Sane R, Mandole R, Amin G, Ghadigaonkar P, Dawkhar S. Effect of herbal detoxification and reverse diet treatment on the mortality rate of CAD patients. Ann Clin Cardiol [serial online] 2022 [cited 2023 Jun 4];4:71-6. Available from: http://www.onlineacc.org/text.asp?2022/4/2/71/366990 |
| Introduction | |  |
Diseases related to the circulatory systems such as coronary heart disease (CHD), coronary artery disease (CAD), and acute coronary syndrome belong to a group of a disease called cardiovascular diseases (CVDs).[1] Patients with myocardial infarction (MI) are at risk of developing CHD. Risk factors related to CHD include “hypertension (HTN), smoking, dyslipidemia, diabetes, and family history of CHD.”[2] Urban Indians between the age group of 20 and 39 years, have low physical activity and increased smoking habits which lead to CHD. On average, the first incidence of MI is seen at the age of 53 years.[3]
CVD-related mortality amounts to two-thirds of the deaths caused by noncommunicable diseases. Barefoot, et al. in 2011 believed that CAD patients' recovery depends on the age, functional status, and severity of the condition. Posttreatment, the patients' mental state also determines how well they respond to the treatment. Depressive symptoms may increase the chances of mortality and also affect the functional status of the patient.[4] It is predicted that CVD-related mortality will reach 23.4 million by 2030 with CVD affecting younger people, thus harming the workforce.[5]
Food and macronutrients play an important role in determining the mortality rate in CVD patients. Increased servings of sweetened sugar beverages can increase CVD mortality, whereas polyunsaturated fatty acids can reduce the risk. Alcohol consumption is also linked to an increase in mortality due to CVD. Thus, it is necessary to adhere to healthy food options to prevent the risk of CVD.[6]
Ayurveda-based Panchkarma treatment has proved to be beneficial in reducing body mass index (BMI), HbA1c levels, and blood pressure in CAD patients.[7],[8],[9] Thus, altering/reducing these risk factors can reduce the estimated mortality rate post-Panchkarma treatment.
Our study determines the effect of Panchakarma treatment after 2 and 3 years of follow-up to determine the rehospitalization and mortality rates of CAD patients.
| Methods | | |
Study design
This was an observational cohort study conducted from August 2017 to August 2020 on known CAD patients that were enrolled in 217 Madhavbaug Clinics across India.
Study population
Patients with a known case of CAD (diagnosed/confirmed using coronary angiography reports) who wanted to opt for an Ayurveda-based treatment were included in the study. The CAD patients included were stable CAD patients (the New York Heart Association class I-III) with no symptoms at rest. The patients were also suffering from other comorbidities, the history of which is shown in [Table 1]. Diabetes, HTN, and chronic heart failure were experienced by a major percentage of patients.
Study therapy
The study population was divided into three groups. The first group consisted of patients who continued the follow-up for 12 months, the second group for 24 months, and the third group for 36 months. Out of the 572 patients, 393 patients opted for the inclusion of the diet kit along with Panchkarma therapy in their treatment and 33 patients did not take the diet kit but followed a diet chart given by the doctors.
The Panchkarma treatment consisted of three procedures – centripetal oleation, thermal vasodilation, and per rectal herb decoction administration. The details of the therapy are mentioned in previous literature.[10] The treatment was given for a maximum of 12 months.
The diet kit has a preportioned food mix and easy-to-make meal options with an interesting menu to encourage the patient to eat healthily and on a timely basis. The diet consisted of a low-calorie diet with high oxygen radical absorbance capacity value for breakfast, lunch/dinner, and evening snacks. Adherence to diet was tracked using a digital platform (WhatsApp). Each patient shared photos every day of each meal (breakfast, lunch, mid-meal, and dinner). This was to ensure the patient is following the diet and if any rectifications are required, then they are done immediately. The patients were advised to perform routine exercises during the treatment.
Study evaluation
At the start of the treatment, the weight and height were measured to calculate the BMI, along with abdominal girth (ABG) and blood pressure. The patients' SPO2 levels were noted down to check their oxygen saturation levels due to the COVID pandemic. At 2 years/3 years of follow-up, the above parameters were checked and compared. The number of deaths and rehospitalization of the patients under the study were noted to plot the survival curves. The hazard ratios for CAD-related risk factors were calculated. The data of the patients who completed 1 year at the end of the study period were not included in the study.
Statistical analysis
Kaplan–Meier survival curves were used to plot the life-table survival curve and the product-limit survival curve. Life-table survival curve help to identify the rate of survival based on the age of the patient and the product-limit survival curve compared the survival rate between the two genders. Hazard ratios for the risk factors related to CAD mortality were studied using the Cox proportional hazards model. The data were statistically analyzed using SAS software and parameters with a P < 0.05 were considered clinically significant.
| Results | | |
Study population
A total of 572 enrolled patients were screened and all were included in the study with 122 (21.33%) female and 450 (78.67%) male patients. Adult patients were observed in this study with females belonging to the age group of 60.10 ± 10.97 years (mean ± standard deviation) and males to the age group 60.22 ± 10.89 years.
Study therapy
The effect of the Panchakarma treatment was studied for 36 months of which 69.40% of patients continued the follow-up for 24 months and 29.37% of patients continued it till 36 months [Figure 1]. We considered the 24 and 36 months follow-up for our study. Diet compliance was achieved on an average of 70%–75%. If the patient was traveling or if no one can cook the food, only in such cases the patient has not adhered to the diet kit. | Figure 1: The period of follow-up carried out after the Panchkarma treatment
Click here to view |
Study evaluation
There was a significant reduction in the ABG and weight and thus the BMI of the patient, posttreatment. Visceral fat is a culprit in metabolic syndrome. Therefore, ABG is a preferred parameter then BMI, especially in metabolic disorders like CAD. The blood pressure was reduced and maintained at desired levels. The treatment helped to reduce the metabolic burden on the body of the patients [Table 2]. | Table 2: Change in laboratory investigations for patients from the 1st day to the latest day
Click here to view |
Out of the 572 patients under study, 426 patients were following the diet chart. Most of the patients followed the diet throughout treatment with only 6 (1.41%) of patients not complying with the diet [Table 3].
[Figure 2] represents the number of patients that have survived the study period with respect to the age of the patients. Based on the survival curve, we can observe that older patients are at a higher risk of not responding positively to the treatment as compared to younger patients. However, the percentage of patients censored is still high even for patients at 85 years of age suggesting that the treatment is beneficial in the survival of older patients as well. | Figure 2: Kaplan–Meier survival curves – life-table survival curve. The difference in the age group of censored is statistically insignificant; P = 0.3956 for the test of equality over strata using the logrank test
Click here to view |
The gender of the patient does not play a significant role in determining the mortality rate of the study population as both the genders – male (94.89%) and female (95.08%) show similar results [Figure 3]. | Figure 3: Kaplan–Meier survival curves – product-limit survival curve. In the above mentioned, 0 as a female and 1 as a male gender group. The difference in the gender group of censored is statistically insignificant; P = 0.7795 for the test of equality over strata using the log-rank test
Click here to view |
The mortality rate after 36 months of follow-up was 8.92% of 168 patients and after 24 months of follow-up was 3.52% of 397 patients. About 14.88% of patients were rehospitalized during the 36-month follow-up and 6.80% of patients during the 24-month follow-up [Table 4]. | Table 4: Comparison of mortality risk during the 1 year, 2 years, and 3 years
Click here to view |
The overall major cause of death was cardiac related which majorly occurred after 2 years of follow-up as compared to 3-year follow-up [Table 5].
Posttreatment, 52 patients needed rehospitalization due to several reasons as shown in [Table 6]. Heart problem was a major concern. Two patients opted for angioplasty after completing the treatment.
Based on [Table 7], we can observe that age being the only nonmodifiable factor, contributes to survival; however, the other risk factors can be modified with the treatment, thus contributing to a reduction in the mortality rate.
Thus, conclude that there is no evidence of an increasing or decreasing trend over time in the hazard ratio. Age is the only factor that contributes to survival.
| Discussion | | |
The study treatment was effective in reducing the short-term (24 months) mortality rate. It can be postulated that the mortality rate is associated with the burden of metabolic disorders along with the increase in age, whereas gender cannot be associated with mortality due to metabolic disorders. The treatment led to a reduction in the BMI levels and thus reduced the metabolic burden on the body of the patients. BMI is an indicator of the obesity level of an individual. Obesity is the cause of many diseases such as diabetes mellitus, HTN, and CVD.
A recent study reported by the European Society of Cardiology newly suggested grouping stable CAD patients under chronic coronary syndrome which will increase awareness of the progressive pathological nature of the disease, thereby leading to early prognosis and the use of various management strategies such as lifestyle modifications.[11] Earlier published literature also focuses on reducing obesity and inculcating healthy eating habits can potentially decrease adverse clinical outcomes and also reduce overall cardiovascular events and mortality.[12],[13],[14] A previous case study demonstrates the effect of basti (per rectal herb decoction administration), which is a part of Panchkarma, as an effective way of dealing with obesity.[15] By reducing the BMI, the average blood pressure of the study group was also reduced. A similar result was seen during a cross-sectional study carried out on Tangkhul Naga men in Northeast India where the survey led to the conclusion that change in BMI is directly proportional to change in systolic blood pressure and diastolic blood pressure.[16] Age is also a factor that is related to blood pressure and is considered its risk factor. A study conducted on 240 adults belonging to the Punjabi community also proves the positive correlation between BMI and blood pressure levels.[17]
The two nonmodifiable parameters that were considered for determining the mortality rate were age and gender. It was observed that the mortality rate was dependent on the age of the patient with older patients having a higher risk of death or rehospitalization. A similar result was observed in previous studies with patients suffering from ischemic heart disease.[18] Gender, however, does not show a significant effect on the mortality rate or the rate of rehospitalization.
A periodic comparison of the mortality rate shows that the number of deaths of patients was higher during the 36 months of follow-up as compared to that during the 24 months of follow-up. Similarly, the rate of rehospitalization was also higher during 36 months compared to after 24 months of follow-up.
The overall mortality rate of the entire study population was very low (5.07%) as compared to earlier studies (19.5%–33.3%, 12-month follow-up)[19] and this may be attributed to the study treatment provided. The Panchakarma and diet treatment reduced the modifiable risk factors such as BMI, diabetes, weight, and blood pressure of the study population, thus lowering the risk of mortality.
Limitation
The study did not have an age- and gender-matched control/placebo group to determine the difference between patients who received study treatment and those who did not. The current study timeline included a follow-up of 36 months thereby long-term mortality could not be predicted.
| Conclusion | | |
CAD patients of different age groups that underwent ayurvedic-based Panchakarma treatment and diet were able to reduce their overall weight, BMI, and blood pressure, thereby lowering the risk factors associated with CAD-related mortality and rehospitalization. The total mortality rate observed was low as the treatment lead to a decrease in the risk factors, thus increasing the survival rate of the patients.
Acknowledgment
The authors would like to thank Ms. Harshita Gupta and Ms. PallaviMohe of the Madhavbaug R and D department for contributing to data collection and analysis, Ms. Reshma Fernandes for writing assistance, and Ms. Poonam Pawar for additional editorial support.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
| References | | |
| 1. | Sanchis-Gomar F, Perez-Quilis C, Leischik R, Lucia A. Epidemiology of coronary heart disease and acute coronary syndrome. Ann Transl Med 2016;4:256.  |
| 2. | Canto JG, Kiefe CI, Rogers WJ, Peterson ED, Frederick PD, French WJ, et al. Number of coronary heart disease risk factors and mortality in patients with first myocardial infarction. JAMA 2011;306:2120-7. |
| 3. | Sharma M, Ganguly NK. Premature coronary artery disease in Indians and its associated risk factors. Vasc Health Risk Manag 2005;1:217-25. |
| 4. | Barefoot JC, Brummett BH, Williams RB, Siegler IC, Helms MJ, Boyle SH, et al. Recovery expectations and long-term prognosis of patients with coronary heart disease. Arch Intern Med 2011;171:929-35. |
| 5. | Cassar A, Holmes DR Jr., Rihal CS, Gersh BJ. Chronic coronary artery disease: Diagnosis and management. Mayo Clin Proc 2009;84:1130-46. |
| 6. | Anand SS, Hawkes C, de Souza RJ, Mente A, Dehghan M, Nugent R, et al. Food consumption and its impact on cardiovascular disease: Importance of solutions focused on the globalized food system: A report from the workshop convened by the World heart federation. J Am Coll Cardiol 2015;66:1590-614. |
| 7. | Sinha K, Gaikwad S, Prabhakar M, Ba L. Critical review on role of panchakarma in sthaulya with special reference to obesity. Int J Res Ayurved Pharm 2017;8:4-7. |
| 8. | Nirmal H, Dharmarajan P, Bhatted S, Meena R. Role of panchakarma in the management of Madhumeha with W.S.R. To diabetes mellitus a case study. World J Pharm Res 2019;8:6. |
| 9. | Shukla G, Bhatted SK, Dave AR, Shukla VD. Efficacy of virechana and basti karma with shamana therapy in the management of essential hypertension: A comparative study. Ayu 2013;34:70-6. [ PUBMED] [Full text] |
| 10. | Sane R, Wadekar A, Shinde K, Furia H, Priyanka Upadhyay RM. Understanding the role of Ayurveda based ischemia reversal program and low carbohydrate diet in reduction of risk of heart disease. Asian J Cardiol Res 2019;2:1-8. |
| 11. | Hussain S, Al-Rashed M, Rajan R, Al-Jarallah M, Brady PA, Soman B, et al. Chronic coronary syndrome: A review of the literature. Ann Clin Cardiol 2021;3:3-7. [Full text] |
| 12. | Pack QR, Rodriguez-Escudero JP, Thomas RJ, Ades PA, West CP, Somers VK, et al. The prognostic importance of weight loss in coronary artery disease: A systematic review and meta-analysis. Mayo Clin Proc 2014;89:1368-77. |
| 13. | Freeman AM, Morris PB, Barnard N, Esselstyn CB, Ros E, Agatston A, et al. Trending cardiovascular nutrition controversies. J Am Coll Cardiol 2017;69:1172-87. |
| 14. | Khan SS, Ning H, Wilkins JT, Allen N, Carnethon M, Berry JD, et al. Association of body mass index with lifetime risk of cardiovascular disease and compression of morbidity. JAMA Cardiol 2018;3:280-7. |
| 15. | Bhattarai A, Sunil Kushwah, Mangal G. Panchakarma intervention in the management of Obesity: A case study. AYUHOM 2018;5:45-50. |
| 16. | Mungreiphy NK, Kapoor S, Sinha R. Association between BMI, Blood Pressure, and Age: Study among Tangkhul Naga Tribal Males of Northeast India. J Anthropol 2011;11:748147. https://doi.org/10.1155/2011/748147. |
| 17. | Dua S, Bhuker M, Sharma P, Dhall M, Kapoor S. Body mass index relates to blood pressure among adults. N Am J Med Sci 2014;6:89-95. |
| 18. | Nowbar AN, Gitto M, Howard JP, Francis DP, Al-Lamee R. Mortality from ischemic heart disease. Circ Cardiovasc Qual Outcomes 2019;12:e005375. |
| 19. | Truong HH, Victor MV, Imad MA, Kobalava ZD, Parvathy UT, Al-Zakwani I. Mortality and morbidity associated with type 2 myocardial infarction: A single-center study. Ann Clin Cardiol 2020;2:70-9. [Full text] |
[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]
|
Search Pubmed for