Abstract
Introduction: Hyperlipidemia, either primary or secondary causes atherogenetic abnormalities leading to coronary artery disease, cardiac arrest and arrhythmias. Herbal therapy for prevention or cure of Hyperlipidemia is replacing allopathic medicine due to their bioequivalence and good compliance features. This study was conducted to compare hypolipidemic effects of Garlic and Nigella sativa.
Place of Study: Study was conducted at Jinnah Hospital Lahore from July 2013 to December 2013. Seventy-five hyperlipidemic patients were enrolled after being written consent, which was approved by Ethics committee of the hospital.
Grouping: They were divided in three equal groups comprising 25 patients in each group. Group-A was treated by Nigella Sativa, Group-B was advised to take Garlic 10 grams twice daily for two months. Group-C was on placebo.
Results: After two months therapy it was observed by statistical analysis that Nigella sativa decreased total cholesterol 12.4mg/dl, triglycerides 16.7mg/ dl, and LDL cholesterol 27.3mg/dl. HDL rise was 5.2mg/dl. Garlic decreased total cholesterol 17.9mg/dl, triglycerides 19.9mg/dl and LDL cholesterol 14.8mg/ dl. HDL cholesterol rise was 8.0mg/dl.
Conclusion: It was concluded from this study that there is little difference between hypolipidemic effects of two important and famous herbal medicines ie, Nigella sativa and Garlic.
Keywords: Herbal Remedies; Coronary Artery Disease; Cholesterol; Hyperlipidemia
Introduction
Coronary Artery Disease (CAD) and atherosclerosis are the leading causes of morbidity and mortality in the western as well as in developing countries of the world. Lowering cholesterol levels is known to be an effective preventive measure of atherosclerosis, reducing both coronary and all-cause mortality in patients with established coronary artery disease [1]. The effect of hypocholesterolemic therapy on primary prevention of atherosclerosis is still primary focus by researchers. So hypolipidemic drugs are still under research. Patient and doctor compliance of allopathic drugs is still major problem among various ethnic populations. Some cardiologists prefer allopathic hypolipidemic drugs and some are trying herbal hypolipidemic medications. Herbal medicines Garlic and Nigella sativa are getting popularity in western world as well as in east, due to their lesser adverse effects [2]. Garlic has been found to lower serum and liver cholesterol, inhibit platelet growth and reduce oxidative stress. The cholesterol-lowering effect of garlic is attributed to the bioavailability of allicin and its derivatives [3]. Garlic is one of the most popular herbal remedies and is steadily gaining interest in complementary and alternative medicine practice. There is a general belief that garlic is an effective and harmless mode of lowering cholesterol. This effect has not been linked to inhibition of HMG CoA reductase and is presumably due to a different mechanism of action. Garlic has also been attributed with other protective cardiovascular effects like antihypertensive, anti-inflammatory, beneficial effects on blood rheology and coagulability, some of which may be independent of its cholesterol-lowering effect [4-7]. Nigella sativa is a pretty herb, seeds of which are commonly known as kalonji. Its chemical composition is moisture 7.43%, ash 4.14%, fixed oil 37%, volatile oil 1.64%, albumin 8.2%, mucilage 1.9%, organic acid precipitated by copper 0.38%, metarabin 1.36%, melanthin 1.4%, cellulose 8.32%, sugar 2.75%, arabic acid 3.41% and other substances dissolved by soda 9.38% [8]. Nigella sativa seeds used as an herbal medicine has many effects including cholerectic activity. Kalonji seeds also help in lowering blood cholesterol, blood pressure. It increases bile excretion, which may play as hypolipidemic role in primary and secondary Hyperlipidemia [9]. Its different fractions (extracts) were used to observe its effects in whole blood clotting and plasma clot time. In vitro it significantly shortened both and bleeding time, partial thromboplastin time, prothrombin time and thrombin time in vivo it shortened bleeding time and partial thromboplastin time but prothrombin time and thrombin time remained unaffected [10]. Seeds of Nigella sativa are given with butter and milk to cure obstinate hiccup. Seeds are employed as a purgative. They are also useful in indigestion, loss of appetite, fever, diarrhea, and puerperal disease etc [7,8,11].
Patients and Methods
Research design, duration, sample size and place of work
The research work was single blind placebo-controlled, conducted at Jinnah Hospital, Lahore from July 2013 to December 2013. Seventy- five hyperlipidemic patients were selected for research work. Written consent was taken from all patients. Specific Performa was designed for the research work.
Selection of patients with inclusion and exclusion criteria
75 newly diagnosed primary hyperlipidemic patients were selected with age range from 18 to 70 years. Exclusion criteria were hypothyroidism, diabetes mellitus, alcohol addictive patients, peptic ulcer, any gastrointestinal upset, renal impairment, and any hepatic or cardiac problem.
Division/grouping of patients
All patients were divided in three groups (group-A, group-B, group-C), 25 in each group. Their baseline experimental data was taken and filed in specifically designed Performa, at start of taking medicine, like lipid profile, blood pressure and pulse rate. Twenty five patients of group-A were advised to take one tea spoon of Nigella sativa (Kalonji), twice daily, i.e.; one tea spoon after breakfast and one tea spoon after dinner. Twenty-five patients of group-B were advised to take Garlic 10 grams twice daily. Twenty five patients of group-C were provided placebo capsules, (containing grinded wheat), taking one capsule after breakfast and another before going to bed. All participants were advised to take these medicines for eight weeks. All participants were called every 2 weeks for follow up.
Method for measurement of lipid profile
Serum lipid profile (total cholesterol, HDL-cholesterol, triglyceride) as well as other biochemical parameters were determined after a 12 hour overnight fast by standard methods. LDL-cholesterol level was calculated according to the Friedewald’s formula. Psychological status was determined at the first and last visit by the following self-report questionnaires, all of which are considered sensitive and reliable.
Biostatistical analysis
Data were expressed as the mean ± Standard Deviation and “t” test was applied to determine statistical significance as the difference. A probability value of ‹0.05 was considered as non-significant and P‹0.001 was considered as highly significant change in the results when pre and post-treatment values were compared.
Results
When results were compiled and statistically analyzed by using SPSS New Version 5, it was observed that Nigella sativa and Garlic decreased total-cholesterol, LDL-cholesterol, triglycerides significantly and increased HDL-cholesterol significantly as compared to placebo treatment. Pre and post-treatment values/ results are shown in Table 1-3.
TC before treat: 269.13.72
After Treat: 256.77±2.41
Difference 12.4 %
P-value= <0.001
TG before treat: 208.68±2.81
After Treat: 191.94±2.90
16.70%
P-value= <0.001
LDL-C before treat:177.64±2.76
After Treat: 150.32±1.46
27.30%
P-value= <0.001
HDL-C before treat: 33.83±1.00
After Treat: 39.00±2.38
5.20%
P-value= <0.001
Table 1: Showing parameters values before and after treatment with their statistical significance in group A (Nigella Sativa).
TC before treat: 287.33±1.30
After Treat: 269.44±2.70
Difference 17.9 %
P-value= <0.001
TG before treat: 221.65±2.06
After Treat: 201.72±1.47
19.90%
P-value= <0.001
LDL-C before treat:203.17±2.01
After Treat: 188.42±1.00
14.80%
P-value= <0.001
HDL-C before treat: 33.17±2.91
After Treat: 41.15±1.98
8.00%
P-value= <0.001
Table 2: Showing parameters values before and after treatment with their statistical significance in group B (Garlic).
TC before treat: 254.61±1.02
After Treat:252.81±3.78
Difference 1.8 %
P-value= >0.05
TG before treat: 240.80±3.01
After Treat:241.70±2.44
0.90%
P-value= >0.05
LDL-C before treat:170.55±2.65
After Treat:170.10±1.77
0.50%
P-value= >0.05
HDL-C before treat: 34.43±2.87
After Treat:35.14±1.55
0.70%
P-value= >0.05
Key: P-value <0.01 stands for significant change, P-value >0.05 stands for non-significant change. All values are in mean and ± stands for standard error of mean. T-C: Serum Total Cholesterol; TG: Serum Triglycerides; LDL-C: Low Density Lipoprotein Cholesterol; HDL-C: High Density Lipoprotein Cholesterol. Treat stands for treatment. All parameters pre and post-treatment are measured in mg/dl.
Table 3: Showing parameters values before and after treatment with their statistical significance in group C (Placebo).
Discussion
Among numerous genetic and lifestyle parameters, dyslipidemia is one of the most prominent risk factors for CAD. In the past decade, lowering LDL cholesterol (LDL-c), serum total cholesterol, serum triglycerides and increasing High Density Lipoprotein cholesterol (HDL-c) has been the major target in cardiovascular protection strategies. This approach has proven to be beneficial and effective in both primary and secondary prevention of Cardiovascular Disease (CVD). When analyzed biostatistically in this study the serum total cholesterol, triglycerides and serum low-density lipoprotein cholesterol were decreased and high-density lipoprotein cholesterol was increased significantly when compared with placebo group. These results suggest that nigella sativa and Garlic has a protective role in atherosclerosis and that is due to their hypolipidemic activity by different mechanisms. In our observations two months therapy by Nigella sativa decreased total cholesterol 12.4%, triglycerides 16.7%, LDL-cholesterol 27.3% and increased HDL-cholesterol 5.2% when pre and post treatment values were compared. All these changes are highly significant when analyzed statistically. These results match with results of study conducted by Cross DE et al. [12]. They observed 10.11%, 15.00%, 22.90% decreased in total cholesterol, triglycerides and LDL-cholesterol respectively. They proved 7.91% increase in HDL-cholesterol. Their results support our results. Botsoglou NA et al. [13] described that herbal medications have more than one or two mechanism to balance plasma lipids in hyperlipidemic patients. LE PM et al. [14] have explained one important mechanism of action of Nigella sativa that oil of these seeds inhibits enterohepatic circulation causing biosynthesis of bile acids instead of cholesterol by hepatocytes. EI Dakhakhani M et al. [15] observed that Nigella sativa reduces LDL-cholesterol lesser than HMG CoA-reductase inhibitors statins. They proved reduction in LDL-cholesterol only 10.75% when one tea spoon of Nigella sativa oil was used in 16 hyperlipidemic patients for four months. Their results are in contrast with our results. Reason for this mismatch in results may be less concentration of NS oil used in small number of patients, although they used it for four months. In our results, Garlic reduced 17.9%, 19.9%, 14.8% total cholesterol, Triglycerides and LDL-cholesterol respectively. HDL-cholesterol increased from 33.17±2.91mg/dl to 41.15±1.98mg/dl. In percentage, it was 8.0% increase. These results match with results of research work conducted by Raeesi M et al. [16] who proved almost same change in serum total cholesterol, triglycerides and HDL-cholesterol but in their results LDL-cholesterol reduction was much less than our results ie; only 7.3%. They explained that LDL-cholesterol is important for consideration of development of atherosclerosis, CAD leading to cardiac arrhythmias and heart attack. Our results for reduction in LDL-cholesterol and boosting of HDL-cholesterol matches with results obtained by Islam MS and Choi H [17] who proved 13.00% reduction in LDL-cholesterol and 7.81% increase in HDL-cholesterol by Garlic use for 3 months in 26 hyperlipidemic patients. Kim YJ et al. [18] proved no significant change in HDL-cholesterol when 5 grams of Garlic was used in 10 secondary hyperlipidemic patients for 10 days. So much change in results may be due to less amount of Garlic, lesser sample size and duration of intake of the selected herbal medication used in their research work.
Conclusion and Recommendation
It was concluded from this research study that when hypolipidemic features of herbal medications are compared, their results are usually same. Patient compliance of herbal medications is good in our ethnic background. We recommend that research on hypolipidemic herbs/plants should be expanded and be supported by concerned government departments in our country.
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