The Impact of Sira Vedha (Phlebotomy) at the Right Elbow Joint in the Treatment of Non-Alcoholic Fatty Liver Disease - A Research Report

ABSTRACT

Non-alcoholic fatty liver disease (NAFLD) affects 9%–53% of the Indian population. No Indian studies have examined Sira Vedha (phlebotomy) for NAFLD, although it has been studied for other conditions. Sushruta recommended Sira Vedha at the right elbow joint for liver diseases, but clinical evidence for its efficacy in NAFLD is lacking. This clinical trial aimed to generate evidence for Sira Vedha in NAFLD patients. One hundred eleven patients with Grade I/II NAFLD were randomly assigned to either a control group (diet and exercise) or an intervention group (Sira Vedha, diet, and exercise). Blood samples were collected for lipid profile and liver function tests before and after treatment. Results showed significant improvements in SGOT, SGPT, cholesterol, HDL, and triglyceride levels in the intervention group compared to the control group, supporting the efficacy of Sira Vedha in NAFLD treatment. This study highlights the need for clinical evidence to confirm traditional Ayurvedic practices.

INTRODUCTION

Non-alcoholic fatty liver disease (NAFLD) affects 9%–53% of the Indian population.[1] No Indian studies have examined Sira Vedha (phlebotomy) for NAFLD, though it has been studied for Gridhasi (sciatica), Vicharchika (eczema), and foot ulcers, with 27–100 ml of blood drawn over 3–4 sittings. Modern phlebotomy involves removing 250–500 ml of blood, with intervals of a week to a month. Sushruta recommended Sira Vedha at the right elbow joint for liver diseases,[2] but clinical evidence for its efficacy in NAFLD is lacking. Modern science supports phlebotomy for liver diseases, suggesting it reduces liver cell damage and improves liver enzymes.[3]

METHODOLOGY

In a randomized clinical trial, 111 patients with Non-alcoholic fatty liver disease (NAFLD) Grade I/II were assigned to either the control group (group A) with diet and moderate exercise (57 patients) or the intervention group (group B) with Sira Vedha (phlebotomy) at the right elbow joint, diet, and moderate exercise. Blood samples were collected for lipid profile and liver function tests (LFT) analysis. Group A received dietary modifications, while Group B underwent dietary modifications, and Sira Vedha underwent them three times over 15 days, with 65 cc of blood drawn each time. Hemoglobin levels were checked before each session to ensure safety. Blood samples were collected at enrollment and 60 days post-intervention. The trial was registered at CTRI/2020/04/024783 and approved by the Institutional Ethical Committee DMIMS (DU)/IEC/2018-19/7351.

Screening parameters

Clotting time, Bleeding time, Hemoglobin, Liver Function Test, Lipid profile, USG.

Assessment parameters

Liver Function Test, Lipid profile, Weight, B.M.I.

Population

Diagnosed non-alcoholic fatty liver disease (NAFLD) Grade 1 and 2.

Inclusion criteria

Participants in the study must provide written informed consent, have non-alcoholic fatty liver disease (Grade I and Grade II fatty liver), be between the ages of 20 and 50 years old, regardless of gender, and meet certain criteria. Screening parameters include clotting time of 8-15 minutes, bleeding time of 2-7 minutes, hemoglobin levels of ≥11 g/dL (Male), ≥10 g/dL (Female), AST (SGOT) of ≥40 units per liter of serum, ALT (SGPT) of ≥56 units per liter of serum, total cholesterol of ≥200 mg/dL, LDL of ≥130 mg/dL, triglycerides of ≥150 mg/dL, and USG of NAFLD Grade-I/II.

Exclusion criteria

The study excluded patients with contraindications for Sirvedha (Sushrut Sharir Sthan 8/3), including liver cancer, liver cirrhosis, HIV positive, HBsAg positive, terminal illness, pregnancy and lactation, accidental cases, anemias, hemophilia, thalassemia, poisoning, alcoholic liver diseases, eczema over the right elbow joint, skin diseases/allergies, and injury at the right elbow joint.

RESULTS

Data were analyzed using paired and unpaired t-tests, with results represented as mean ± standard deviation (SD). A P value < 0.05 indicated significance. SPSS version 17.0 and Microsoft Excel were used for analysis. Out of 120 recruited patients, 111 completed the study; 9 dropped out due to COVID-19. Control Group (A) had 21 males and 36 females, while Intervention Group (B) had 19 males and 37 females [Table 1].

Table 1.

Before and after treatment- mean and SD

Investigation parameters	Before			After
	Control	External Control	Intervention	Control	External Control	Intervention
SGOT (Serum Glutamic Oxaloacetic Transaminase)/AST (Aspartate Aminotransferase)	47.59±7.11	47.0±20.6	48.57±6.74	41.63±6.54	38.8±14.2	25.29±5.93
Serum glutamic pyruvic transaminase (SGPT)/ALT (Alanine transaminase)	69.08±10.69	63.5±30.6	70.55±10.71	61.74±9.18	49.7±18.2	36.24±11.16
Serum Total Cholesterol	243.42±21.31	181.47±46.33	244.41±21.59	217.71±17.42	177.61±46.33	149.81±10.71
High-density lipoprotein (HDL)	34.42±3.86	38.61±11.58	34.5±38.9	42.07±3.99	38.61±11.58	53±4.08
Serum Triglyceride	205.21±56.81	150.44±53.10	209±54.33	158.28±46.25	150.44±79.65	142.33±35.78

COMMENTS

• 1) Inference: In the intervention group, there was a significant effect of Sira Vedha on SGOT, SGPT, Sr. Cholesterol, HDL, and Sr. Triglyceride, suggesting that Siravedha was found more effective as compared to the control group.

  Justification: Dietary and lifestyle changes, such as increased physical activity or moderate exercise, are the first-line treatments for reducing liver fat and inflammation and improving metabolic profile. Numerous studies have investigated phlebotomy’s role in improving metabolic markers, for example, insulin resistance, lipid profile, and liver enzymes in NAFLD patients.[4]

• 2) Inference: In the interventional group, there was a significant effect of Sira Vedha on SGOT, SGPT, Sr. Cholesterol, HDL, and Sr. Triglyceride, which was found to be more effective as compared to external control.

  Justification: Non-alcoholic fatty liver disease (NAFLD) affects 9%–53% of the Indian population.[1] No Indian studies have examined Sira Vedha (phlebotomy) for NAFLD, although Sushruta recommended it for liver diseases.[2] This trial aimed to generate evidence for Sira Vedha in NAFLD patients. One hundred eleven patients with Grade I/II NAFLD were randomly assigned to a control group (diet and exercise) or an intervention group (Sira Vedha, diet, and exercise). Results showed significant improvements in liver function and lipid profiles in the intervention group, supporting Sira Vedha’s efficacy.[5]

  Inference: After comparing baseline data with endpoint values in all the groups, physical, biochemical, and hematological parameters were found to be statistically significant.

  Justification: NAFLD is linked to unhealthy lifestyles, such as excess calorie intake, poor diet, and lack of exercise. Diet and lifestyle changes, like moderate exercise, are first-line treatments to reduce liver fat and inflammation, improving the metabolic profile and lowering cardiac and liver disorder risks.[6] Sira Vedha (phlebotomy) has hepato-protective, hypolipidemic, and anti-obesity effects, supporting its use in NAFLD treatment.[7]

  Inference: The Sira Vedha is found more effective in patients of NAFLD having Pitta-Kapha, Kapha-Pitta, and Kapha-Vata predominant Prakriti as compared to the control group.

  Justification: Siravedha is predominantly indicated in clinical conditions with Pitta, Rakta, and Kaphaja disorders and Pitta or Kapha disorders associated with Vata Dosha. Siravedha helps remove the Avarana of Pitta and Kapha Dosha and induces Vatanulomana by pacifying Vata Prakopa due to Kapha and Pitta Avarana. Indirectly, it cures the Vata along with symptoms of Pitta and Kapha dosha.[8] Hence, Sira Vedha is found more effective in Pitta-Kapha, Kapha-Pitta, Kapha-Vata predominant Prakriti.

• 3) Limitation of the study: Secondary data (external control group) was employed to compare with the interventional group.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.