Impact of Gastro-Hepatic Pack on Liver Functions in Patients with Type 2 Diabetes Mellitus—A Pilot Study

Abstract

Background:

Diabetes mellitus is a metabolic disease caused by an insufficient amount of insulin that is marked by persistently high blood sugar levels and is also associated with impaired liver function and liver abnormalities. The gastro-hepatic pack (GHP) is a hydrotherapeutic therapy used to treat a variety of diseases, including diabetes mellitus. Nevertheless, no study has reported the effect of GHP on liver function in people with type 2 diabetes mellitus (T2DM). Thus, the goal of this study was to evaluate the effect of GHP on liver functioning of participants with T2DM.

Materials and Methods:

Twenty patients with T2DM aged 40–70 years underwent GHP for 20 min a day, daily for 1 week. Assessments such as total protein, albumin, globulin, total bilirubin, serum glutamic pyruvic transaminase, serum glutamic-oxaloacetic transaminase, and alkaline phosphatase were taken before and after 1 week of intervention.

Results:

The results showed a significant increase in total protein (P < 0.001), albumin (P = 0.004), globulin (P < 0.001), and a significant reduction in total bilirubin (P = 0.015), serum glutamic pyruvic transaminase (P = 0.012), serum glutamic-oxaloacetic transaminase (P = 0.018), and alkaline phosphatase (P < 0.001) after 1 week of intervention.

Conclusion:

Twenty minutes of GHP, daily for a week was effective in improving liver functions of patients with T2DM.

Background

Type 2 diabetes mellitus (T2DM) is a group of metabolic disorders characterized by persistently high blood sugar levels due to irregularities in insulin function, production, or both. It is recognized as a complex, chronic condition influenced by an ongoing excess of energy intake, affecting the cardiovascular, renal, and metabolic systems. ¹ The International Diabetes Federation predicts a global increase in diabetes prevalence to 643 million by 2030 and 783 million by 2045, with India having the second-highest prevalence. ² According to the previous study, abnormal liver function tests were discovered in 33.3% of patients with T2DM, with raised serum glutamate pyruvate transaminase (SGPT) levels being the most common problem, occurring in 23.3% of instances. ³ Compared to 32% of healthy patients, 62.53% of diabetes subjects exhibited abnormal liver enzyme activity. ⁴ Previous research indicates that T2DM is linked to liver abnormalities like abnormally elevated hepatic enzymes, abnormal glycogen deposition, nonalcoholic fatty liver disease, fibrosis, cirrhosis, acute liver disease, and viral hepatitis. These complications can lead to severe and irreversible conditions such as nephropathy, retinopathy, vasculopathy, neuropathy, cardiovascular diseases, and hepatopathy. ⁵ Despite conventional management (i.e., pioglitazone improves liver enzyme levels in T2DM), many T2DM patients experience unstable plasma glucose levels due to oral hypoglycemic medications. Prolonged drug usage can lead to negative consequences such as hypoglycemia, hypokalemia, syncope, drowsiness, headache, hypersensitive reaction, nausea, vomiting, chest pain, peripheral edema, and cardiac failure. ¹ In this case, noninvasive, alternative approaches such as naturopathy are required to treat diabetes and enhance liver function. Hydrotherapy is a typical naturopathic treatment technique with the use of water in any form-water, ice, or steam—internally or externally to treat a range of ailments at various pressures, temperatures, times, and places. ⁶ One hydrotherapy treatment modality called the gastro-hepatic pack (GHP) combines hot and cold treatments, each of which has a different impact on blood flow, blood glucose tissue metabolism, inflammation, and edema. ⁷ GHP alone has been shown to lower blood sugar levels in T2DM ⁸ and GHP in addition to other naturopathy treatments has been shown to improve liver functions (i.e., aspartate aminotransaminase, alanine aminotransaminase, total bilirubin, direct bilirubin and indirect bilirubin) in a patient with hepatic cirrhosis with portal hypertension and ascites ⁹ without causing adverse effects. Nevertheless, no studies reported the effect of GHP on liver function in people with T2DM. Thus, the goal of this study was to evaluate the effect of GHP on liver functioning of participants with T2DM.

Materials and Methods

Study design

A single-group pre-test and post-test pilot study was conducted in 20 patients with T2DM. All participants underwent GHP for 20 min a day, daily for 1 week. Assessments were taken before and after 1 week of intervention (Fig. 1).

FIG. 1.

Trail profile.

Participants

A total of 20 patients with T2DM aged 58.75 ± 7.88 years were recruited from a medical college hospital, Chennai, India. Both male and female participants with known history of T2DM without complications aged between 40 and 70 years and willing to participate in the study were included. Participants with known history of type 1 diabetes mellitus, psychiatric illness, gestational diabetes mellitus, liver diseases, participants with hypersensitive skin, females during pregnancy, lactation, and menstruation were excluded.

Ethical consideration

The study was conducted at Government Yoga and Naturopathy Medical College and Hospital (GYNMCH), Chennai, India. Institutional ethics committee clearance was obtained from the GYNMCH (Ref. No.: RES/IEC-GYNMC/2016/102) before recruitment of the first subject. The study protocol was explained to the subjects, and signed informed consent was obtained from each participant.

Intervention

All participants underwent GHP as follows: participants were asked to lie in supine position. A hot fomentation (103°F–104°F) was placed anteriorly from the fourth rib to the umbilicus over the abdominal region. An ice bag (55°F–60°F) was then applied to the dorsal and lumbar spines on the lower back, covering the region of the lumbar vertebra (L2–L5) of the patient. Then, the bag was wrapped with cotton cloth (the innermost covering) and a woolen blanket (the outermost covering) for a duration of 20 min a day daily for 1 week. ⁸

Assessment

Liver function tests such as total protein, albumin, globulin, total bilirubin, SGPT, serum glutamic-oxaloacetic transaminase (SGOT), and alkaline phosphatase (ALP) were performed in a standard private laboratory before and after 1 week of intervention.

Data analysis

Data were checked for normality using the Shapiro–Wilk test. Based on the distribution of the data, paired samples t-test and Wilcoxon singed rank test were used for analysis by statistical package for the social sciences, version 16.

Results

Twenty T2DM participants who fulfilled the eligibility criteria were recruited for the study. The demographic data of the participants are provided in Table 1. Results showed a significant increase in total protein (P < 0.001), albumin (P = 0.004), globulin (P < 0.001), and a significant reduction in total bilirubin (P = 0.015), SGPT (P = 0.012), SGOT (P = 0.018), and ALP (P < 0.001) after 1 week of intervention (Table 2).

Table 1.

Demographic Details of the Study

Parameters	Study group (n = 20)
Age (years)	58.75 ± 7.88
Weight (kg)	65.50 ± 4.70
Gender	Male: 12; female: 8
Body mass index (kg/m2)	26.19 ± 1.38

All values are in mean ± standard deviation except gender.

Table 2.

Pre-Test and Post-Test Assessments of the Study Group (n = 20)

Parameters	Pre-test	Post-test	t/z value	P value
Total protein (g/dL)	6.72 ± 0.85	7.24 ± 0.53	t = 5.238	<0.001**
Albumin (g/dL)	4.10 ± 0.42	4.32 ± 0.26	t = 3.253	0.004 *
Globulin (g/dL)	2.62 ± 0.81	2.92 ± 0.56	t = 4.348	<0.001**
Total bilirubin (mg/dL)	0.87 ± 0.26	0.80 ± 0.22	t = 2.676	0.015 *
SGPT (IU/L)	51.70 ± 14.37	48.90 ± 13.87	z = 2.511	0.012 *
SGOT (IU/L)	52.45 ± 14.13	49.80 ± 11.97	z = 2.362	0.018 *
ALP (IU/L)	201.55 ± 98.40	186.35 ± 90.59	z = 3.661	<0.001**

All values are in mean ± standard deviation. t = paired samples t-test; z = Wilcoxon signed-rank test.

^*P < 0.01; ^**P < 0.001.

SGPT, serum glutamic pyruvic transaminase; SGOT, serum glutamic oxaloacetic transaminase; ALP, alkaline phosphatase.

Discussion

The results showed a significant increase in total protein, albumin, and globulin and a significant reduction in total bilirubin, SGPT, SGOT, and ALP in the post-test assessments compared with pre-test assessments. This suggests that 20 min of GHP is effective in enhancing liver functions in T2DM. Although this is a pilot study, these results are encouraging and suggest GHP could be considered as a potentially effective complementary therapy for improving liver functions in T2DM.

According to naturopathy, there is only one cause of disease and only one way to cure the disease, i.e., violation of nature (physical, mental, or behavioral) is the cause of disease, and returning to nature is the only way to cure the disease. A basic principle of naturopathy is that “the body heals itself” when you assist and facilitate it through treating patients holistically with natural substances like water (hydrotherapy), mud (mud therapy), etc. ¹⁰

A previous study on the effects of yoga and naturopathy on liver function tests in a patient with hepatic cirrhosis showed an improvement in liver function tests (i.e., decreased total bilirubin, SGPT, SGOT, and ALP and elevated serum albumin levels), ⁹ which is correlated with the results of the current study. Literature suggests that GHP is useful in enhancing the effectiveness of abdominal organs, including the liver, and its functions by reducing hepatic congestion. ¹¹ Hyperglycemia-induced oxidative stress can cause tissue damage and disrupt protein, carbohydrate, and lipid metabolism in the liver, an organ that is sensitive to insulin. Elevated oxidative stress leads to abnormal liver enzyme production and an inflammatory cascade. ⁵ Hot application of GHP increases skin and underlying tissue activity and metabolism. Conversely, cold application causes contraction of cutaneous blood vessels, lowering the temperature of the applied parts. This compensatory vasodilatation in the deeper vascular system increases blood flow to tissues underlying the site of exposure, increasing metabolic rate to maintain a constant deep tissue temperature. GHP may also increase blood flow to abdominal organs (liver), facilitate glucose metabolism, and decrease oxidative stress through thermoregulatory changes. ⁸ Likewise, heat treatment enhances mitochondrial efficiency, organization, gene expression, transport, protein folding, and localization through the mitochondrial heat shock response, leading to compensatory increases in hepatic proteins and genes and reduced mitochondrial reactive oxygen species (ROS) production. ¹² Studies have indicated that cryotherapy can decrease oxidative stress by raising the ferric reducing ability of plasma (FRAP) and total antioxidant status (TAS). ¹³ Therefore, the potential mechanisms underlying the improvement in liver functions under GHP may include a number of factors, including decreased production of ROS by the mitochondria, decreased oxidative stress caused by hyperglycemia by enhancing TAS and FRAP, enhanced mitochondrial efficiency, protein folding, metabolism, and blood flow to the liver. Strength of the study: This study provides a new report on the impact of GHP on liver functions in patients with T2DM. The participants did not mention any adverse effects during the study period. Limitations of the study: Despite encouraging results, the smaller sample size, lack of sample size calculation, a control group, and a long-term intervention are limiting the scope of this study. Therefore, to validate the effect of GHP on liver function in T2DM and comprehend its underlying mechanism, a randomized controlled trial with a larger sample size and long-term follow-up are recommended.

Conclusions

One week of GHP might be considered as an effective complementary therapy in improving liver function in patients with T2DM. However, a lack of control group in the current study, recommend further randomized controlled trials to warrant the results of this study.