Psyllium Fibres To Reduce Risk Of Myocardial Infarction Biology Essay

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Patients and methods: Forty already diagnosed primary hyperlipidemic patients were selected from Cardiology OPD of Jinnah Hospital, Karachi, Pakistan. Exclusion criteria were patients suffering from hypothyroidism, renal dysfunction, any hepatic disease. Consent Performa was designed and got approval for the research from "Research Ethical Committee of Jinnah Postgraduate Medical Centre, Karachi". After explaining the limitations, consent was obtained from all study participants before they were enrolled in the study. They were divided in two groups, 20 patients were on Psyllium husk fibres, 10 gram daily in divided doses. And 20 patients were kept on placebo as control group. Lipid profile of all participants was estimated at day-0 and at day-90. All other vital functions of patients were also estimated and kept on record. They were advised to visit clinic fortnightly.

Results: When results compiled at the end of research study, it was observed that two patients discontinued taking drug given, due to metallic test of psyllium fibres. Psyllium decreased serum total cholesterol from 228.27±4.89 mg/dl to 199.22 ± 2.30 mg/dl, triglycerides from 169.27± 9.92 mg/dl to 164.5±8.56 mg/dl, LDL-Cholesterol from 159.72 ± 5.70 to 129.55± 2.81 mg/dl, and increased serum HDL-Cholesterol from 34.61±1.85 to 36.77±1.96 mg/dl in three months of treatment. Data were expressed as the mean ± SD and "t" test was applied to determine statistical significance of results. P- value lesser than 0.05 was the limit of significance. Results of all parameters of lipid profile were significant when paired't' test was applied for statistical analysis.

Conclusion: We concluded from the research study that psyllium is effective agent to maintain lipid profile parameters at normal limits in hyperlipidemic patients. And Normal limits of all lipid parameters play major role in prevention of atherosclerosis and MI.

Key words: Myocardial Infarction. Hyperlipidemia. Atherosclerosis. Psyllium fibres.

INTRODUCTION

Excess blood lipids except HDL-cholesterol are dangerous to health and human heart but elevation of LDL-cholesterol is particularly associated with risk of coronary artery disease risk.1 Moderately raised triglycerides or VLDL or remnants in the presence of low HDL-Cholesterol may also be atherogenic.2 Atherosclerosis, if not controlled and treated at early stage of its development may lead to myocardial infarction.3 Prevention and treatment of hyperlipidemia are the elimination or modification of risk factors, if possible, in conjunction with treatment of the specific lipid disorder.4 For treating primary hyperlipidemia, statins, fibric acids, nicotinic acid, bile acid binding resins including psyllium husk fibres are main drug groups used. For many years psyllium husk has been used as an agent for gastrointestinal disturbances but it has remarkable hypolipidemic effects too.5 Like other bile acid binding resins, psyllium fibres has similar mode of action. It binds with bile acids and decreases their absorption from intestine. This in turn stimulates the hepatic synthesis of bile acid from cholesterol and thus reducing the total and LDL-cholesterol level. It also probably decreases the reabsorption of cholesterol from intestine by decreasing the micelle formation. HDL-Cholesterol concentrations increase by about 0.5 mg/dl, when psyllium is added to the treatment regimen of patients who are already receiving statins or nicotinic acid.6 Various studies have proved remarkable effects on reducing risk of coronary artery disease by decreasing serum lipids which are responsible for development of atherogenesis7. In developed countries like UK and US, Lipid Research Clinics have been established to conduct research, starting from counseling on diet, exercise, and change in sedentary life style to medication and cardiovascular-related therapeutics8.

PATIENTS AND METHODS

As it was research study on humans, so consent Performa was formatted initially and got approval from 'Ethical Committee for Research, JPMC, Karachi, Pakistan. The study was conducted at 'LIPID RESEARCH CLINIC', Jinnah Hospital Karachi, Pakistan from January to July 2009. Forty patients of primary hyperlipidemia were initially recruited in this study, referred from OPD of Jinnah Hospital, Karachi, to this lipid research clinic on reques. Untreated primary hyperlipidemic male and female patients , age range from 21 to 65 years, were randomly selected. Patients with diabetes mellitus, peptic ulcer, renal disease, hepatic disease, hypothyroidism and alcoholism were excluded from the study by laboratory investigations, history and clinical examination. Written consent was obtained from all participants. The study period consisted of 3 months with fortnightly follow up visits. The required information like name, age, sex, occupation, address, previous medication, date of follow up visit and laboratory investigations, etc of each patient was recorded on a Performa. Initially medical history and physical examination of all patients were carried out. All the base line assessments were taken on the day of inclusion (Day-0) in the study and a similar assessment was taken on Day-90 of research design. After fulfilling the inclusion criteria patients were randomly divided into two groups, i.e.Drug-1(Psyllium husk 10gm/day) and Drug-2 (placebo capsules, containing equal amounts of partly grinded wheat) groups. Patients of drug-1 group were advised to take psyllium fibres 10 gm daily in three divided doses after or before each meal. Patients of drug-2 group were provided placebo capsules, i.e. one capsule, TID, after meal for 90 days. Patients were called every 2 weeks for follow up to check blood pressure, weight, pulse rate and general appearance of the individual. Serum total cholesterol and triglycerides were estimated by the enzymatic calorimetric Method.9 Serum LDL-Cholesterol was calculated by Friedwald formula (LDL-Cholesterol = Total Cholesterol-(Triglycerides/5 +HDL-Cholesterol).10 Serum HDL-cholesterol was determined by direct method, at day-0 and day-90. Data were expressed as the mean ± SD and "t" test was applied to determine statistical significance as the difference. A probability value of <0.05 was the limit of significance.

RESULTS

After completion of study it was observed that when used psyllium fibres in 18 hyperlipidemic patients for the period of 3 months, mean total serum cholesterol decreased from 228.2±4.8 mg/dl on day-0 to 199.2±2.3 mg/dl on day-90. This reduction in total cholesterol was highly significant (P <0.001) when levels on day-0 and those on day-90 were compared. The average percentage reduction in total cholesterol was −12.7%. Two patients out of 20, discontinued taking psyllium due to its metallic taste. The mean serum triglycerides level of 18 patients treated with psyllium fibres was 169.2±9.9 mg/dl on day-0 which reduced to 164.5±8.5 mg/dl on day-90. These differences were highly significant (P <0.001) when levels on day-0 and those on day-90 were compared statistically. The percentage change between day-0 to day-90 was −2.81. In 18 primary hyperlipidemic patients, when started treatment with psyllium husk, their mean serum LDL-C level at day-0 was 159.7±5.7 mg/dl. This level reduced to 129.5±2.8 mg/dl at day-90. When compared between day-0 to day-90, this change was highly significant (P <0.001). The percentage change was -18.88. In 18 patients treated with psyllium husk, the mean HDL-C at day-0 was 34.6±1.8 mg/dl, which increased to 36.7±1.9 mg/dl on day-90. The result was highly significant (P <0.001) when values were compared at day-0 to day-90. The percentage increase in HDL-C from day-0 to day-90 was +6.24. In placebo group serum total cholesterol reduced from 215.95±2.47 mg/dl to 208.70±5.38 mg/dl, triglycerides reduced from 148.45±4.80 mg/dl to 146.20±4.20 mg/dl, LDL-cholesterol reduced from 150.75±2.67 mg/dl to 148.80± 2.28 mg/dl. HDL-cholesterol raised from 35.50±1.13 mg/dl to 35.75±1.07 mg/dl in three months of treatment period. All results of placebo group are non-significant when analyzed statistically. Results of all parameters are shown in table 1, 2 and 3.

TABLE NO: 1

Changes in lipid profile in psyllium husk group of patients (n=18)

Parameter

At day-0

At day-90

% Change

T-C

TG

LDL-C

HDL-C

228.27±4.89

169.27±9.92

159.72±5.70

34.61±1.85

199.22±2.30

164.50±8.56

129.55±2.81

36.77±1.96

-12.72

-2.81

-18.88

+6.24

Key:

± indicates standard error of mean

(-) indicates decrease in percentage

(+) indicates increase in percentage

T-C stands for total cholesterol

TG stands for triglycerides

LDL-C stands for low density lipoprotein cholesterol

HDL-C stands for high density lipoprotein cholesterol

All observations are measured in mg/dl

Figures in parentheses indicate number of patients

TABLE NO: 2

Changes in lipid profile of patients on placebo group (n=20)

Parameter

At day-0

At day-90

% Change

T-C

TG

LDL-C

HDL-C

215.95±2.47

148.45±4.80

150.75±2.67

35.50±1.13

208.70±5.38

146.20±4.20

148.80±2.28

35.75±1.07

-3.35

-1.51

-1.29

+0.70

Key:

± indicates standard error of mean

(-) indicates decrease in percentage

(+) indicates increase in percentage

TC stands for total cholesterol

TG stands for triglycerids

LDL-C stands for low density lipoprotein cholesterol

HDL-C stands for high density lipoprotein cholesterol

All observations are measured in mg/dl

Figures in parentheses indicate number of patients

TABLE NO: 3

Comparison of changes in lipid profile parameters between placebo and psyllium group of patients in 90 days of treatment.

Parameter

Baseline

Post Treatment

P Value

Baseline

Post Treatment

P Value

% Difference

in groups

T-C

TG

LDL-C

HDL-C

215.95

±2.47

148.45

±4.80

150.75

±2.67

35.50

±1.13

208.70

±5.38

146.20

±4.20

148.80

±2.28

35.75

±1.07

<0.05

>0.05

>0.05

>0.05

228.27

±4.89

169.27

±9.92

159.72

±5.70

34.61

±1.85

199.22

±2.30

164.50

±8.56

129.55

±2.81

36.77

±1.96

<0.001

<0.001

<0.001

<0.001

9.37

1.30

17.59

5.54

PLACEBO GROUP (n=20) PSYLLIUM HUSK GROUP (n=18)

Key: (± indicates standard error of mean, T-C stands for total cholesterol, TG stands for triglycerides, LDL-C stands for low-density lipoproteins, HDL-C stands for high-density lipoproteins, P Value >0.05 indicates non significant, P Value <0.001 indicates highly significant, Figures in parentheses indicate number of patients)

DISCUSSION

In three months research study on use of psyllium fibres, statistical analysis proved that psyllium fibers reduced triglycerides 2.81%, LDL-cholesterol 18.88% and serum total cholesterol 12. 72%. High density lipoprotein cholesterol was increased 6.24%.

These results match with the study of Guido MA Van Rosendaal et al11 who observed almost same changes in lipid profile of 31 hyperlipidemic patients, treated with 6 gram of psyllium thrice daily for ten weeks. Results also match with the study of Blackwood et al12 in all parameters of lipid profile. In their study change in high density lipoprotein cholesterol was higher than ours. This difference may be due to genetic variation in patients suffering from primary hyperlipidemia. Different type of primary hyperlipidemia could respond in different manners with different drug regimen and duration of the treatment. Results of the study also match with results of Jenkins DJ et al13, in which 57 primary hyperlipidemic patients were treated by psyllium husk fibers 12 gram daily in divided doses for the period of 8 weeks. In their observation triglycerides reduction was −7.12%, LDL-C was reduced to −10.31%. HDL-cholesterol raised upto +5.11%. Another study was conducted by McCrindle BW et al14 on placebo controlled trials, in which 19 male primary hyperlipidemic patients of either sex were treated with six gram psyllium husk fibers in divided doses, thrice daily for the period of three months. Results of the trial almost match with our results. In their results total-cholesterol reduction was 15.71%, triglycerides reduced from 171.12±7.77 mg/dl to 161±3.23 mg/dl (P value <0.001). In percentage it was −3.7%. Observed low density lipoprotein cholesterol and very low density lipoprotein cholesterol reduction was −17.93% and −10.29%, respectively. Our study is in contrast with the study of Sanchez-Bayle M et al15 who observed more changes in serum total cholesterol. It was -19.11%. Only change in low density lipoprotein cholesterol match with our study. They did not mention the mode of action of psyllium to reduce cholesterol. One of the agreed upon mechanisms is that psyllium stimulate bile acid synthesis through 7α-hydroxylase activity. Another mode of action of psyllium fibers to reduce cholesterol is diversion of hepatic cholesterol synthesis to bile acid production. Effect of psyllium on absorption of cholesterol and fat appeared minimal but it is small contribution to cholesterol lowering effect. Other mode of actions of psyllium to reduce cholesterol synthesis such as inhibition of hepatic cholesterol synthesis by propionate and secondary effects of slowing glucose absorption from gastrointestinal tract may also contribute. Results of study conducted by Stoy DB et al16 are in contrast with our results. They used ispaghula fibers in twenty nine primary hyperlipidemic patients of both genders, i.e; male and female with age range from twenty eight to sixty years for the period of one month. They used psyllium husk fibers 12 gram daily, in divided doses with step I diet. They observed that psyllium husk has reduced low density lipoprotein cholesterol 19.99%, serum total cholesterol 19.00%, triglycerides 6.96%, and increased HDL-cholesterol 4.30%. These results are in contrast with our research work observations. The obvious reason for this contrast is step I diet, which was strictly followed by their patients recruited for this research especially on payment. They were stayed at Lipid Research Centre. Approach to conduct research work on nutrition and nutritional related works should be monitored separately like Stoy DB et al did at their Lipid Research Centre. Results of our study are in contrast with research work results of Tanstad S and Ose L17 who observed much more increase in high density lipoprotein cholesterol and very less decreased levels of plasma total, low density lipoprotein cholesterol, and triglycerides. They observed 9.11% increase levels of HDL-C. Total cholesterol, LDL-C and triglycerides reduced −21.23%, −19.90%, and −7.00% respectively. This difference may be due to change in sample size and period of drug administration. In their study, sample size was 200 hyperlipidemic patients who used psyllium fibers five gram twice daily for the period of one eight months. Statistically recommended sample size of patients, design of research study, controlled directions for follow up, counseling on psyllium husk intake and so the good compliance of the drug to be used may change the results of research.

CONCLUSION

Finally it was concluded from the research study that use of psyllium fibres reduce the risk of development of atherosclerosis and myocardial infarction by reducing serum total cholesterol, low density lipoprotein cholesterol, triglycerides, and increasing high density lipoprotein cholesterol.

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