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Psyllium husk has therapeutic effects in hyperlipidemia
INTRODUCTION
Despite substantial medical progress in the past two decades, coronary heart disease (CHD) remain the major health problem in most of the industrialized countries (Anderson et al; 2000). The disease remains a common cause of morbidity and mortality throughout the world. The incidence of CHD in Pakistan is as high as in the western world (Karira et al; 2000).
Elevated serums total and low density lipoprotein (LDL) Cholesterol concentrations are powerful risk factors for CHD, with oxidation of LDL potentially playing a major role in atherogenesis and development of CHD. Each 1 % increase in the serum cholesterol concentration results in 2-3% increase in CHD risk (Anderson et al; 2000). The levels below 200 mg/dl are classified as desirable blood cholesterol, those 200 to 239 mg/dl as borderline high blood cholesterol and those 240 mg/dl and above as high blood cholesterol. The cut point that defines high blood cholesterol (240 mg/dl) is a value above which risk of CHD rises steeply. The cut points recommended are uniform for adult men and women of all ages (Kostner GM; et al 1989). Regarding management of primary hyperlipidemia, diet restriction, bile acid resins, statins, clofibrate, Psyllium hydrophilic mucilloid and nicotinic acid play an important role(Timmis AD; 1991). Furthermore in primary and secondary prevential trials, a reduction in total and LDL cholesterol concentrations improved the function of the coronary endothelium and decreased the risk of CHD (Mayes, 1993). Consumption of soluble fibers significantly lowers serum total and LDL-Cholesterol concentration. Such fibers may provide an alternative to drug therapy. For some patients of the viscous soluble fibres, psyllium husk fibres appear to be one of the most effective, with the least adverse effects. Short term placebo controlled studies showed that consumption of 7-10 gm of Psyllium/day lowers serum total cholesterol concentration 4-11 % below placebo control concentration. (Edington, 1987).psyllium does not significantly affect blood pressure or levels of high-density cholesterol, triglycerides, serum glucose, or iron (Bell et al; 1989).
Psyllium is naturally occurring water-soluble gel forming fiber. It is common household remedy in Pakistan for constipation. Cholesterol lowering efficacy of diet can be considerably improved if a soluble fiber content of food is increased and this can be achieved by judicious selection of food or by supplementation with Psyllium (Memon, 2001, Spence et al; 1995).
PATIENTS AND METHODS
This study was conducted at department of Pharmacology and therapeutics, Basic Medical Sciences Institute, Jinnah Postgraduate Medical Centre, Karachi, from January to July 2002.Forty patients of primary hyperlipidemia were initially enrolled in this study, selected from ward and OPD of National Institute of Cardiovascular Diseases, Karachi. Newly diagnosed and untreated primary hyperlipidemic patients of either sex, age range from 17 to 70 years were randomly selected. Patients with diabetes mellitus, peptic ulcer, renal disease, hepatic disease, hypothyroidism and alcoholism were excluded from the study by available laboratory investigation, history and clinical examination. After explaining the limitations, written consent was obtained from all participants. The study period consisted of 90 days with fortnightly follow up visits. The required information such as name, age, sex, occupation, address, previous medication, date of follow up visit and laboratory investigations, etc of each patient was recorded on a proforma, especially designed for this study. Initially a detailed 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 husk (ISPAGHOL) 10 gm daily in three divided times 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. Drug compliance to the regimen was monitored by interview and counseling at each clinical visits. Serum LDL-cholesterol was calculated by Friedwald formula (LDL-Cholesterol = Total Cholesterol-(Triglycerides/5 +HDL-Cholesterol) described by Delong et al (1986) and Beamount et al (1970)11.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
Out of 40 patients, 38 completed the over all study period. Two patients withdrew from one group (Psyllium husk group) due to non-compliance of psyllium.They did complaint about metallic test after taking Psyllium husk. Tables 1, 2, and 3 are showing the results. When results were summed up and test parameters were compared, it was seen that, after 90 days of treatment with Psyllium husk, LDL-Cholesterol decreased from 159.72±5.70 mg/dl to 129.55±2.81 mg/dl, which is highly significant (P<0.001). The overall percentage change from day-0 to day-90 was -18.88, as shown in table no 1. In placebo group at day-0, LDL-Cholesterol level was 150.75±2.67 mg/dl, which decreased to 148.80±2.28 mg/dl, which is non-significant (P>0.05).The overall percentage decrease in the parameter was -1.29.The difference between mean values among placebo group and Niacin group is 17.59, which is highly significant (<0.001)
DISCUSSION
This study proves that significant changes occurred in serum LDL-Cholesterol as a result of administration of Psyllium husk for the period of three months.
LDL- Cholesterol is reduced 18.8% in this period, which is highly significant (<0.001). Our study matches with the study of Anderson et al (1988) who observed almost same changes in LDL- Cholesterol of 26 male patients, treated with 3.4 gm of Psyllium thrice daily for eight weeks. Our study results are in contrast with the study results of Kris-Etherton et al (1999) who observed less percentile changes in lipid profile of hyperlipidemic patients. They observed that Psyllium decreased LDL- Cholesterol 10.2% in 70 male patients when treatment period was 4 weeks. This contrast may be due to increased sample size and lesser duration of treatment in their study. They even saw 1% increase in HDL-Cholesterol in placebo group but by Psyllium treatment HDL-Cholesterol was decreased upto 0.3%.They did not mention the mechanism by which placebo increased the HDL-Cholesterol and Psyllium has reduced it. They discussed various mechanisms by which Psyllium decreased cholesterol. One of the mechanisms was that Psyllium stimulated bile acid synthesis (7- ?-hydroxylase activity). Second mechanism was diversion of hepatic cholesterol for bile acid production. Effects of Psyllium on absorption of cholesterol and fat appeared minimal but may make a small contribution to cholesterol lowering. Additional mechanisms such as inhibition of hepatic cholesterol synthesis by propionate and secondary effects of slowing glucose absorption may also play a role.
REFERENCES
1. Anderson JW, Davidson MH, Blonde L, et al (2000).Long term cholesterol-lowering effects of Psyllium as an adjunct to diet therapy in the treatment of hypercholesterolemia.Am. J. Clin; 71: 1433-8.
2. Beamount JL, Carlson LA, Cooper GR (1970). Classification of hyperlipidemia. Bull. WHO; 43: 891-908.
3. Bell LP, Hectorne K, Reynolds H, Balm TK, Hunninghake DB (1989). Cholesterol lowering effects of Psyllium hydrophilic mucilloid. JAMA; 261; 3419-3423.
4. Delong DM, Delong ER, Wood PD, Lippel K, Rifkind BM (1986). A comparison of methods for the estimation of plasma low and very
5. Edington L, Geekie M, Carter R et al (1987). Effects of dietary cholesterol on plasma cholesterol concentration in subjects following reduced fat, high fiber diet. BMJ; 294: 333-336.
6. Karira KA, Shah SMA, Salahuddin et al (2000). Incidence of lipid disorders in offspring of patients with premature myocardial infarction. Medical Channel; 6: 9-12
7. Kostner GM, Gavish D, Leopold B, Bolzano K, Weintraub MS, Breslow JL (1989). HMG-CO A reductase inhibitors lower LDL cholesterol without reducing LP (a) levels.
8. Kris-Etherton PM, Pearson TA, Wan Y et al (1999). High mono-unsaturated fatty acids diet lower both plasma cholesterol and triglycerol concentration. Am. J. Clin. Nutr; 70: 1009-1015.
9. Mayes PA, (1993). Cholesterol synthesis, transport and excretion. In: Harper’s Biochemistry. Murray RK, Granner DK, Mayes PA, Rodwell VW. Eds. (23rd edition) Appleton and Lange, Connecticut,pp. 266-278.
10. Memon MA (2001). Efficacy, safety and tolerability of Psyllium hydrophilic mucilloid in mild to moderate hypercholesterolemia. Medical Channel; 7: 37-40.
11. Spence JD, Huff MW, Heidenheim P, et al (1995). Combination therapy with colestipol and Psyllium mucilloid in patients with hyperlipidemia. Ann. Intern. Med: 123; 493-499.
12. Timmis AD (1991). Early diagnosis of myocardial infarction. BMJ; 7: 309-310.
About the Author
Shah Murad,Professor, Pharmacology,Lahore Medical and Dental College, Lahore, pakistan
Muhsin Turab,Assistant Professor, Pharmacology, Hamdard College of Medicine & Dentistry, Karachi, Pakistan
Mehjabeen,Assistant Professor, Physiology,Hamdard College of Medicine & Dentistry, Karachi, Pakistan
M Ashraf Memon,Professor, Pharmacology, Sardar Ghulam Muhammad Mahar Medical College, Sukkur, Pakistan
Ghulam Rasool Bhurgari,Assistant Professor,Pharmacology, Muhammad Medical College, Mirpurkhas,Pakistan