ABS 7 Bitter Herbs Clinical Study to Fight
Diabetes and Cholesterol

ABSTRACT

A prospective randomized study was done comparing the herbal food supplement (ABS Herbs) and Statin (Simvastatin) in a group of 300 patients who had blood cholesterol 240mg/dl or more aged 30 to 65 years old. One hundred fifty patients were randomized to be given a herbal medicine (ABS Herbs) with a drop out rate of 19.33%.  Likewise, another one hundred fifty patients were given statin (simvastatin) with a drop out rate of 22%.  Patients were followed-up for a period of 12 weeks and cholesterol monitoring done every 4 weeks.  After 12 weeks, both shoed a significant decrease of blood cholesterol.  The decline in ABS Herbs was 43.90% and 51.09 in simvastatin with no statistical difference between the two (p-value is .060).  It was concluded that Active Bitter Supplement Herbs is safe and effective in lowering blood cholesterol.

INTRODUCTION

            In recent years, there has been a keen revival of interest in herbal medicine.  This movement has acquired a deep significance, considering the economic level of our people and the rising cost of medical treatment and medicine.  This interest has been accentuated by the policy of the government to improve the quality of life of our patients.  Treatment of dyslipidemia is an important aspect to an individual to decrease the risk factor for atherosclerotic cardio vascular diseases.

            In the USA alone, a nation with by no means the worst CVD burden, almost 6 million people have one or more types of CVD according to current estimates. 1 Statistics have shown that the probability at birth of eventually dying from major CVD in the USA is 47% compared with 22% for cancer, 3% for accidents, 2% for diabetes and 0.&% for HIV. 1

            In the Philippines, two out of the 10 leading causes of disease are cardiovascular in nature which are hypertension and diseases of the heart with a combined prevalence rate of 363.7 per 100,000 population.  Hypertension rate more than doubled (from 135.3 to 278.6) during the past two years. 2  This reflects the gradual transition of our country’s development to a developed one with its attendant life style change of the population.

            Active Bitter Supplement Herbs capsule combines the potency and strength of seven amazing herbs from the Philippines, known for their potency and remarkable healing effects.  Together, the herbs perform multiple tasks such as ridding the body of harmful toxins.

            An important aspect in the management off dyslipidemia is the administration of effective and safe lipid lowering agents.  In this regards, we want to determine the effectiveness and safety of
ABS Herbs in dyslipidemia because of the promising lipid lowering activity of ABS Herbs.  We compared ABS Herbs with Statin (Simvastatin) in the management of patient with dyslipidemia.

MATERIALS AND METHODS

            This is a prospective cohort study on three hundred Filipinos with dyslipidemia.  In a two month period, October 2002 to November 2002, screening was done among residents of Nueva Vizcaya, Philippines.  Venous blood was extracted to determine the presence of abnormal cholesterol level after adequate fasting.  Included in the study are patients 30 to 65 years of age with total cholesterol of 240 mg/dl or more.  Each, was randomly assigned to receive either Active Bitter Supplement Herbs capsule or Statin (Simvastatin).  Excluded in the study were patients known to have hypersensitivity reaction to drugs, those who are pregnant or nursing, those who are already taking anti-cholesterol drug and those patients who suffered stroke.  Informed consent was obtained from each patient before enrollment in the study.

            Active Bitter Supplement Herbs of two (2) capsules single dose were given daily to be taken after breakfast to the one hundred fifty patients.  Likewise, Simvastatin 20 mg to be taken at bedtime was also given to another one hundred fifty patients.  All patients were followed up for a period of twelve (12) weeks.  Outpatient visits were scheduled every two weeks to evaluate for occurrences of side effects.

            Specimen of venous blood are extracted every four (4) weeks of treatment.  Blood are examined promptly for blood cholesterol using the biochromatic photometer system.  Daily quality control assay is done.  Statistical analysis was performed using independent t-test.

            Active Bitter Supplement Herbs capsules combines seven herbs namely:  Momordica charantia (Bitter melon),  Andrographis paniculata (King of Bitter), Curcumae longa (Turmeric), Corchorus Capsularis (Saluyot), Mentha arvensis (Peppermeint), Vitex negundo (Lagundi), Moringa oleifera (Malunggay).

RESULTS

            In the ABS group there were one hundred twenty one patients who finished the study.  The drop out rate is 19.33%.  There were 34.67% males and 65.33% females.  The mean age is 47.94 (range 30-65).  In the simvastatin group,  there were one hundred seventeen patients who finished the study.  The drop out rate is 22%.  There were 44% males and 56% females.  The mean age is 47.34 (range 30-65). Table 1

Table 1:  Sample Size ad Gender Distribution

The initial mean cholesterol level in ABS group is 307.84 while in the Simvastatin group the mean initial blood cholesterol is 307.0658.  the difference between the mean blood cholesterol levels after 12 weeks of treatment is insignificant (p-value is 0.060)  FIGURE 1.  the percent decrease of blood cholesterol level for ABS is 20.59% after 4 weeks, 22.26% after 8 weeks and 43.90% after 12 weeks of treatment.  The percent decrease of blood cholesterol levels for Simvastatin is 35.45% after 4 weeks, 36.36% after 8 weeks, and 51.09% after 12 weeks of treatment.  The difference between the percent decrease of blood cholesterol in ABS and Simvastatin is 7.19% which is statistically insignificant after 12 weeks.

BLOOD CHOLESTEROL LEVELS BETWEEN
ABS and SIMVASTATIN

Figure 1:  Mean Cholesterol Levels Before and After Treatments

No serous side effects were observed with either regiment.  Three patients who received ABS had transient constipation but relieved after two weeks of therapy.  Five patients who took Simvastatin complained of flatulence but were tolerable and mild.  No drug withdrawal due to side effects.

DISCUSSION

            Accumulation of cholesterol in the arterial wall is the pathologic lesion in atherosclerosis.  Continuous accumulation of fatty materials will significantly reduce blood flow once the obstruction reached 50-75% of the lumen diameter.  There are risk factors which can be modified.  Namely smoking raised blood pressure and dyslipidemia. 3 Dyslipidemia is shown to be the most strongly associated to the development of atherosclerosis.  Institution of anti-cholesterol regiment under this circumstance can decrease prevalence of cardio-vascular event.  Facts have shown that reduction in total cholesterol results in a reduction of cardio-vascular events.  A recent meta analysis of 38 trials, 4  has shown that for every 10% reduction in total cholesterol, coronary heart disease mortality was reduced by 15% and total mortality by 11%.

            The body obtains cholesterol by synthesis in the liver and derived from the dietary fat we eat. The lipid lowering therapies on cholesterol are the nicotinic acid, fibrate acid, resins and statins.  Nicotinic acid reduces the hepatic production of VLDL and LDL and increases HDL synthesis.  Fibrate accelerate VLDL catabolism via stimulation of lipase activity and decrease lipoprotein and cholesterol synthesis in the liver.  Resins binds and inactivate bile acids in  the intestines thereby blocking the digestion and absorption of cholesterol in the body.  Statins are competitive inhibitors of key enzyme in the metabolic pathway of cholesterol synthesis.

            The efficacy of Simvastatin (Statin) in reducing blood cholesterol level as a competitive inhibitor of hydroxymethylglutamate Co-enzyme A is well documented and is the drug of first choice for treating dyslipidemia. 5-7

            Medicinal herbs generally work in two ways.  First, they provide nutrients and elements that the body requires to carry out its basic processes.   Secondly, they add agents which would not otherwise be found in the body, but which stimulate, relax, strengthen, or “fine tune” the body’s processes and abilities. 8  Active Bitter Supplement works in the same way. 

            The result of the study suggests that ABS in comparison to Simvastatin given to patients with dyslipidemia is comparable in terms of effectiveness.  Bitter supplements work by activating the gastric secretions of acids and other digestive enzymes.  This increases the nerve tone of the muscles in the entire digestive tract and improves blood circulation thus enabling the body to utilize foods, absorb nutrients, and eliminate wastes more effectively.  8  Moringa has additional nutritive value as provided by Fuglie 10 which basically provide fibrate, resins and nicotinic acid, amino acids and minerals to lower blood cholesterol.  The Momordica preliminary chemical investigation shows that it contains chlorophyll and reins. 11  King of bitters was discovered by the researchers at the Chinese Academy of Preventive Medicines that administering andrographis to patients after angioplasty appeared to dramatically reduce the risk of re-stenosis by inhibiting formation of new plaque. 12  Turmeric also is a protection against heart disease.  Lowers high blood cholesterol levels and prevents blood clots that can lead to heart attack and stroke. 12  The seven active components of ABS Bitter Herbs affect the digestive system and the liver which are the metabolic pathways of cholesterol.

CONCLUSION

            Our results establish that ABS Bitter Herbs can be a substitute to treat dyslipidemia, considering its safety and effectiveness.  It is also purely natural and ecologically sound for the body and the environment.  It is a promising food supplement, however, further experience and study for long term results are required before it can be advocated as a replacement for the treatment of dyslipidemia.

REFERENCES

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