How Effective is Madhavbaug Treatment?

How Effective is Madhavbaug Treatment?

About 1200 patients have been successfully treated at Madhavbaug in last 2 years.
Patients who have completed Madhavbaug treatment have climbed up mountains without any breathlessness.
A research paper has been presented on the treatment at Madhavbaug.
Here it is:

Research paper

An exploratory, single centric study to evaluate the changes in Exercise Tolerance by a therapy “ Sampurna Hridaya Shuddhikaran” in patients with Congestive Heart Failure.

Dr. Rohit Sane¹, Dr. Gurudatta²

¹Cardiopulmonary Wellness Manager, Madhavbaug Hospital; ²Associate Research Officer

ABSTRACT

Objective: To study the effect of Ayurvedic study procedure on exercise tolerance in patients of CCF.

Material & Methods: Study procedure was done in 6 sessions over duration of 6 days. Sample size was 30. Patients of CHF were enrolled. Exercise tolerance was measured by a six minute walk test before & after the procedure. Data was collected, analyzed & presented in table & graphs.

Results: In CHF patients after scheduled course of therapy we found significant improvements in exercise tolerance. The Six minute Walk test improved significantly (413±69 to 489±160).

Conclusion: Study procedure is effective in CHF patients and outcomes are almost similar to patients received 36 months cardiac rehabilitation program.

Key Words: Six Minute Walk test, Treadmill testing, Sampurna Hridaya Shuddhikaran, Chronic Heart Failure

INTRODUCTION:

Chronic Heart Failure due to Systolic dysfunction resulting from reduced Inotropy in case of Myocardial Infarction leads to reduced Cardiac Output. This generates Neurohumoral responses resulting in activation of Sympathetic system and secretion of ADH and ANP. Consequently the blood volume increases due to salt & water retention and vasoconstriction increasing the peripheral resistance.

A comprehensive Herbal therapy named Sampurna Hridaya Shuddhikaran (SHS) was planned to reverse the above Pathophysiology. This study was therapeutic confirmatory study to see effects of study procedure.

Rationale	Parts of Study procedure	Pathophysiology to be reversed
Reduce vascular Tone	Snehan {Oil massage}	Increased Sympathetic tone
Reduce salt and water retention	Swedan + Hriddhara {systemic+local thermal vasodilation} with moist steam	Sodium and Water retention
Increase Cardiac Contractility	Rectal infusion of cardiotonic Herb	Reduced Cardiac output

In the light of above data, objectives of the present study were to evaluate

1) To study the effect of study procedure i.e. Sampurna Hridaya Shuddhikaran on exercise tolerance in patients of Chronic Heart Failure

MATERIAL & METHODS:

Sample Size: According to inclusion & exclusion criteria 30 patients were randomly selected.

Out of 30 subjects 20 were male & 10 were female patients.

Inclusion Criteria:

· Male and female subjects aged between 17 to 80 yrs

• Patients diagnosed for CHF under NYHA class 1, 2, 3.
• Provides written informed consent and ready to stay at the study centre for 6 days.

Exclusion Criteria:

· Experienced an episode of Acute Myocardial Infarction within one month prior to screening

· LVEF <>

· K/C/O diabetes mellitus.

· Uncontrolled hypertension SBP ≥ 180 & DBP ≥ 110 mm of Hg

· Participated in another investigational study within 3 months before recruitment

· Any disorder or conditions of the subject that the investigator believes will contraindicate their inclusion in the study.

· Any other medical conditions/concomitant drugs that would confound the efficacy evaluation and would be unsafe

· Cardiac Patients with h/o severe psychiatric disorders or severe depression

· Cardiac patients with h/o severe cognitive disorders (memory, attention span, concentration);

· history of chronic drug abuse (alcohol, marijuana, cocaine, or opiates).

Study procedure:

Sampurna Hridaya Shuddhikaran {Study Procedure}, Duration: 1 ½ Hour

Parts:

1. Snehan: A Til oil centripetal massage in strokes directed toward the heart.

2. Swedan: An herbal moist steam bath to the whole body below the neck, using about 50          gms.of Terminalia Arjuna herb 

3. Hrid Dhara: we concentrated a warm herbal decoction of 50 gms. of T. Arjuna on the precordial area.

4. Hridya Basti: an herbal enema given very slowly so that everything gets absorbed through the rectal mucosa. For this we used a decoction from 10 gms. of Arjuna. The decoction was prepared in 1000 ml. of water that was boiled until the water evaporated to 100 ml. This was administered rectally.

This study procedure was done once in the whole day over 6 consecutive days.

Data Collection:

After receiving written informed consent from subjects screening was done. Following an initial assessment of individuals with CHF, subjects underwent a Six Minute Walk test to measure exercise tolerance. The American Thoracic societies Guidelines for Six Minute walk test were followed for indications and contraindications to 6MWT. Vitals and RPE (rate of perceived exertion) were reported at the end. Exercise tolerance time was determined by the total distance completed and RPE scale.

On admission to the study centre the subjects were assessed by a six minute walk test. The initial readings were noted down. All the 30 subjects were then given one sitting of the study procedure {SHS} every day. Heart rate, blood pressure monitoring was done everyday before and after the procedure. On the sixth day after completing the sixth sitting of study procedure Six minute walk test was repeated in all subjects.

Statistical Analysis:

Data on 6MWT, METS score & VO2 MAX score collected before & after study procedure. Data were analyzed by applying Paired t test.

Value of P less than 5% (P<>

RESULTS:

A Significant increase in 6 MWT was found in patients after study procedure. “Sampurna Hridaya Shuddhikaran” procedure was well tolerated by all 30 individuals with no adverse events during the 6 days study procedure. Changes for variables of exercise tolerance by study procedure are shown in Table 1.

Table 1. Outcomes for Exercise Tolerance ^µ

Outcome	CHF
	Mean±SD
	Pre-test	6 days
n=	30	30
Exercise Duration*	413±69	484±79
MET	2.96+0.33	3.30+0.38
VO2 MAX	10.37+1.60	11.56+1.33

SD Standard Deviation. ^¥ Exercise Tolerance measured in seconds.

Significant pre-post changes: ** p < .001 Denotes significance within-groups.

Exercise tolerance in all 30 individuals improved significantly with the SHS procedure (p<0.001).difference>+69 was improved to mean 6MWT 484­+79. P value is less than 0.001.

DISCUSSION

This study suggests that a significant improvement in exercise tolerance can occur in individuals with CHF following a 6 days Sampurna Hridaya Shudhikaran. Subjects showed significant increase in Walk Test, METS score & VO2 MAX score from pre to post-procedure. Our outcomes were in line with previous research studies involving outpatient intervention programs designed to increase the functional capacity (9) and Exercise Tolerance of individuals with CHF. As mentioned earlier, few studies are available comparing outcomes of individuals with CHF and post CABG following a cardiac rehabilitation program. However, one observational study similar to ours in sample size and study design found equal improvements between individuals with and without left ventricular dysfunction in the six-minute walk distance and quality of life scores (16). Such type of studies are necessary and indicates that individuals with CHF can be safely benefited from cardiac rehabilitation programme while learning lifestyle modifications that may improve overall health. Although there may not be complete restoration of pre-disease physical functioning levels in individuals with CHF, these initial increases, if sustained, may be meaningful in terms of the quality of a potentially prolonged life span.Individuals with CHF have plenty to gain from exercise, so it should be included in their treatment regimen

As Ayurvedic procedures are being used from long duration their safety in human being is established. No Adverse Event or Adverse Drug Reaction was found during the study duration period. We concentrated on therapeutic confirmatory trials of these efficacious procedures. In our procedure subject was given Snehana followed by Swedana. Swedana is expected to expel sodium and water. Cardiotonic herbs are introduced in patients intra rectally in decoction form which showed good outcomes.

We feel it is important to teach all individuals about their medications, the signs of angina, oxygen desaturation, and water retention to assist their own healthcare. To this point, clinicians should not be apprehensive about discussing appropriate regimens with the individual’s primary physician or specialist.

Phase III controlled parallel grouped randomized studies are needed to accurately assess the impact of study therapy on CHF morbidity and mortality rates, maintenance of functional capacity and quality of life. Currently, we are examining if these short-term outcomes can be sustained for a longer period of time in the individuals with CHF by increasing the duration between sittings. In conclusion, the data presented in this study may drag attention of cardiologists towards Samurna Hridaya Shudhikaran program for individuals with CHF, or with left ventricular dysfunction.

Conclusion

Study procedure is effective in CHF patients with significant changes in 6MWT readings. Study procedure can offer a new & promising approach in the long term management of CHF patients, because of its multifaceted actions. Since it can produce a better exercise tolerance, it is worthwhile to try it as adjunctive therapy.

Address for Correspondence: Dr. Rohit Sane, Madhav Bag Clinic, 3^rd floor, Navarang Shopping Complex, Near Alok Hotel, Dr. Ambedkar Chouk, Thane (west). Phone ; FAX:

Email: rohitmsane@gmail.com

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