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And Dose-Dependent Effect of Psyllium on Serum Lipids in Mild-To-Moderate Hypercholesterolemia: a Meta-Analysis of Controlled Clinical Trials

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And Dose-Dependent Effect of Psyllium on Serum Lipids in Mild-To-Moderate Hypercholesterolemia: a Meta-Analysis of Controlled Clinical Trials European Journal of Clinical Nutrition (2009) 63, 821–827 & 2009 Macmillan Publishers Limited All rights reserved 0954-3007/09 $32.00 www.nature.com/ejcn ORIGINAL ARTICLE Time- and dose-dependent effect of psyllium on serum lipids in mild-to-moderate hypercholesterolemia: a meta-analysis of controlled clinical trials Z-h Wei1, H Wang1, X-y Chen, B-s Wang, Z-x Rong, B-s Wang, B-h Su and H-z Chen Department of Pharmacology and Biostatistics, Institute of Medical Sciences, Shanghai Jiaotong University School of Medicine, Shanghai, China Objectives: Evidences from randomized clinical trials and meta-analysis have claimed an association between the use of soluble dietary fiber from psyllium and a cholesterol-lowering effect. However, there is still uncertainty as to the dose–response relationship and its long-term lipid-lowering efficacy. This meta-analysis was primarily conducted to address the dose–response relationship between psyllium and serum cholesterol level and time-dependent effect of psyllium in mild-to-moderate hypercholesterolemic subjects. Methods: Twenty-one studies, which enrolled a total of 1030 and 687 subjects receiving psyllium or placebo, respectively, were included in the meta-analysis. The studies were randomized placebo-controlled trials, double blinded or open label, on subjects with mild-to-moderate hypercholesterolemia. The dose of psyllium was between 3.0 and 20.4 g per day and intervention period was more than 2 weeks. Any type of diet background was permitted. Diet lead-in period was between 0 and 8 weeks. Results: Compared with placebo, consumption of psyllium lowered serum total cholesterol by 0.375 mmol/l (95% CI: 0.257– 0.494 mmol/l), and LDL cholesterol by 0.278 mmol/l (95% CI: 0.213–0.312 mmol/l). With random-effect meta-regression, a significant dose–response relationship were found between doses (3–20.4 g/day) and total cholesterol or LDL cholesterol changes. Regression model of total cholesterol was À0.0222 þ 0.2061 Â log (dose þ 1), and that of LDL cholesterol was 0.0485 þ 0.1390 Â log (dose þ 1). There was a time effect of psyllium on total cholesterol (equation: 6.3640–0.0316 Â treatment period) and on LDL cholesterol (equation: 4.3134–0.0162 Â treatment period), suggesting that psyllium reduced serum total cholesterol more quickly than LDL cholesterol. Conclusions: Psyllium could produce dose- and time-dependent serum cholesterol-lowering effect in mild and moderate hypercholesterolemic patients and would be useful as an adjunct to dietary therapy for the treatment of hypercholesterolemia. European Journal of Clinical Nutrition (2009) 63, 821–827; doi:10.1038/ejcn.2008.49; published online 5 November 2008 Keywords: hypercholesterolemia; total cholesterol; LDL cholesterol; meta-analysis; randomized controlled trials Introduction (Petchetti et al., 2007). It has been speculated that a deficiency of soluble fibers in the Western diet might be In recent years, there has been growing interest in the use of contributing to the epidemics of coronary heart disease dietary fibers in health maintenance and disease prevention (CHD), diabetes mellitus and colonic cancer. Hypercholes- terolemia has been identified as a prominent independent risk factor in the development of CHD. Soluble fibers, Correspondence: Professor H-z Chen, Department of Pharmacology and including those from psyllium husk, have been shown to Biostatistics, Institute of Medical Sciences, Shanghai Jiaotong University School augment the cholesterol-lowering effects of a low-fat diet in of Medicine, 200025, Shanghai, China. persons with hypercholesterolemia. Increasing dietary fiber E-mail: [email protected] has been recommended as a safe and practical approach for 1These authors contributed equally to this work. Received 27 December 2007; revised 21 August 2008; accepted 18 cholesterol reduction (NCEP ATPIII, 2001 and Brunner et al., September 2008; published online 5 November 2008 2007). Time- and dose-dependent effect of psyllium on serum lipids Z-h Wei et al 822 Psyllium is one of the highest sources of soluble mucilagi- terms psyllium or dietary fiber and blood lipids to identify nous dietary fiber derived from seed husk of Plantago psyllium, the clinical trials involving psyllium from 1966 to August an annual plant grown in Mediterranean region, India, China 2005. In addition, FDA document, published reviews, and other regions. It is mainly marketed in two forms, an reference lists from clinical trials and conference abstracts over-the-counter bulk-forming laxative under the trade name were also examined. Metamucil and psyllium-enriched health foods (Singh, 2007). Psyllium is considered to be useful as an adjunct to dietary therapy (step 1 or step 2 American Heart Association (AHA) Trial selection diet) in the treatment of patients with mild-to-moderate For inclusion in the meta-analysis, studies had to meet hypercholesterolemia. The earliest clinical study (Garvin the following criteria: (1) Trials were conducted on et al., 1965) in a non-placebo-controlled pattern suggested human adults for the treatment of mild-to-moderate hyper- a significant cholesterol-lowering effect of psyllium cholesterolemia, not secondary to any recognized cause; (Metamucil). Then the first double-blind, placebo-controlled (2) they were controlled and had either a randomized trial of psyllium was performed and it showed its effectiveness crossover or a parallel design; (3) they provided lipid in mild-to-moderate hypercholesterolemia (Anderson et al., changes in the treatment and control groups to permit 1988). Subsequently, numerous clinical trials have investi- the calculation of the treatment effect; (4) they had a gated the treatment effect of psyllium as an adjunct to minimum intervention period of 2 weeks; (5) they had a low- dietary modification. There was a universal feeling in all these fat diet or controlled usual diet background. Disagreements investigators that psyllium was a hypocholesterolemic agent. regarding criteria for admission to meta-analysis were However, most of these studies were poorly designed and only resolved by discussion and consensus. In all 22 of 39 studies enrolled a small number of patients; thus the results should were selected for special review. Two studies (Stoy et al., be considered inconclusive. In 1997, Olson et al.(1997) 1993; Spence et al., 1995), which met above criteria, were conducted a meta-analysis involving 404 subjects with mild- excluded because they did not provide enough data to to-moderate hypercholesterolemia and found a beneficial compute the effect size and one (Wolever et al., 1994) was effect of psyllium-enriched cereal products on blood total excluded because subjects in the study were already cholesterol and low-density lipoprotein (LDL) cholesterol. represented in another published study by the same group. Psyllium in a form other than cereal (for example, crackers, As two research reports (Sprecher et al., 1993; Jenkins et al., bulk laxative) was not included in this study. More recently, 1997) involved two sub-groups, the data were treated as two Brown et al. (1999) performed another meta-analysis to separate studies. quantify the cholesterol-lowering effect of major dietary fibers including pectin, oat bran, guar gum and psyllium and found that various soluble fibers reduced total and LDL cholesterol Data extraction by similar amounts, but the effect was small within the Data were extracted from the published reports by two practical range of intake. The latest meta-analysis, conducted independent reviewers and disagreements resolved by dis- on individuals with mild-to-moderate hypercholesterolemia, cussion with the third reviewer. For each trial, the followings demonstrated that psyllium supplementation could signifi- were documented: country of origin, study population, cantly lower serum total and LDL cholesterol concentrations number and type of subjects, initial cholesterol concentra- in subjects consuming a low-fat diet (Anderson et al., 2000a). tion, type of psyllium preparation and used dose regimen, Despite the wealth of information that is available on the nature of control group, background diet, method of association between the consumption of soluble dietary fiber allocation, extent of blinding, study design (parallel or from psyllium and a cholesterol-lowering effect, the dose– crossover), treatment length, method of analysis, laboratory response relationship and its long-term lipid-lowering method used to measure lipid levels, withdrawal and efficacy have not been defined. Thus it was of great interest so on. to conduct a meta-analysis with more updated evidence to precisely determine the effect size of psyllium on decreasing serum lipids and explore the dose–response relationship and Meta-analysis long-term effects of psyllium on serum total cholesterol and The value of total cholesterol, LDL cholesterol, high density LDL cholesterol levels in individuals with mild-to-moderate lipoprotein (HDL) cholesterol and triglycerides were hypercholesterolemia. presented in units of mmol/l. Results reported in mg/dl were converted to mmol/l. For studies with parallel group designs, lipid-lowering effect size was calculated Materials and methods by subtracting the mean change in the control group from that in the treatment group. The mean change was mean Identification of previous studies baseline subtracted by mean end point value. For crossover A computerized literature search was conducted on the studies, the effect size was represented by the difference MEDLINE, EMBASE,
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