Subject: Long-term cholesterol-lowering effects of psyllium as an adjunct to Die

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Long-term cholesterol-lowering effects of psyllium as an

adjunc JoAnn Guest

May 30, 2006 14:08 PDT

 

Long-term cholesterol-lowering effects of psyllium as an

adjunct to diet therapy

 

Long-term cholesterol-lowering effects of psyllium as an adjunct to

diet therapy in the treatment of hypercholesterolemia1,2,3

James W Anderson, Michael H Davidson, Lawrence Blonde, W Virgil

Brown, W James Howard, Henry Ginsberg, Lisa D Allgood and Kurt W

Weingand

1 From the University of Kentucky and the Veterans Affairs Medical

Center, Lexington; the Chicago Center for Clinical Research; the

Ochsner Clinic, New Orleans; the Medlantic Research Institute,

Washington, DC; the Department of Medicine, College of Physicians

and Surgeons, Columbia University, New York; and The Procter &

Gamble Company, Cincinnati.

 

2 Supported by The Procter & Gamble Co.

 

3 Address reprint requests to JW Anderson, Veterans Affairs Medical

Center, Medical Services (111C), Leestown Road, Lexington, KY 40511.

E-mail: jwand-.

 

 

 

ABSTRACT

TOP

ABSTRACT

INTRODUCTION

SUBJECTS AND METHODS

RESULTS

DISCUSSION

REFERENCES

 

 

Background: Hypercholesterolemia is a major risk factor for coronary

heart disease and nutrition management is the initial therapeutic

approach.

 

Objective: This multicenter study evaluated the long-term

effectiveness of psyllium husk fiber as an adjunct to diet in the

treatment of persons with primary hypercholesterolemia.

 

Design: Men and women with hypercholesterolemia were recruited.

After following an American Heart Association Step I diet for 8 wk

(dietary adaptation phase), eligible subjects with serum LDL-

cholesterol concentrations between 3.36 and 4.91 mmol/L were

randomly assigned to receive either 5.1 g psyllium or a cellulose

placebo twice daily for 26 wk while continuing diet therapy.

 

Results: Serum total and LDL-cholesterol concentrations were 4.7%

and 6.7% lower in the psyllium group than in the placebo group after

24–26 wk (P < 0.001). Other outcome measures did not differ

significantly between groups.

 

Conclusions: Treatment with 5.1 g psyllium twice daily produces

significant net reductions in serum total and LDL-cholesterol

concentrations in men and women with primary hypercholesterolemia.

Psyllium therapy is an effective adjunct to diet therapy and may

provide an alternative to drug therapy for some patients.

 

 

Key Words: Psyllium • dietary fiber • hypercholesterolemia • total

cholesterol • LDL cholesterol • men • women

 

 

INTRODUCTION

TOP

ABSTRACT

INTRODUCTION

SUBJECTS AND METHODS

RESULTS

DISCUSSION

REFERENCES

 

 

Despite substantial medical progress in the past 2 decades, coronary

heart disease (CHD) remains a major health problem in most

industrialized countries (1). Elevated serum total and LDL-

cholesterol concentrations are powerful risk factors for CHD (2, 3),

with oxidation of LDL potentially playing a major role in

atherogenesis and development of CHD (4). Each 1% increase in the

serum cholesterol concentration results in a 2–3% increase in CHD

risk (5, 6). Furthermore, in primary and secondary prevention

trials, a reduction in total and LDL cholesterol concentrations

improved the function of the coronary endothelium (7, 8) and

decreased the risk of CHD (9).

 

The second report of the National Cholesterol Education Program

Adult Treatment Panel (ATP II) confirms diet therapy as the primary

intervention for lowering serum cholesterol concentrations; drug

therapy is reserved for persons at high risk of CHD who do not

respond adequately to diet (2). On the basis of the ATP II

guidelines, almost 30% of American adults require dietary

intervention for elevated serum cholesterol concentrations (10).

 

Consumption of viscous soluble fibers significantly lowers serum

total and LDL cholesterol concentrations (11, 12). Such fibers may

provide an alternative to drug therapy for some patients (13–15). Of

the viscous soluble fibers, psyllium husk fiber appears to be one of

the most effective (16, 17) with the least adverse effects (18).

Short-term placebo-controlled studies showed that consumption of 7–

10 g psyllium/d lowers serum total cholesterol concentrations 4–11%

and serum LDL cholesterol concentrations 6–18% below placebo control

concentrations (12–16, 19–24). The long-term effects of psyllium on

serum lipids have not been reported.

 

The purpose of this multicenter study was to compare the long-term

effectiveness and safety of psyllium husk fiber with that of a

cellulose placebo as an adjunct to an American Heart Association

(AHA) Step I diet in the treatment of men and women with primary

hypercholesterolemia.

 

 

SUBJECTS AND METHODS

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ABSTRACT

INTRODUCTION

SUBJECTS AND METHODS

RESULTS

DISCUSSION

REFERENCES

 

 

Subjects

Men and women with hypercholesterolemia were recruited for study.

The protocol and consent form for the study were approved by the

institutional review boards at each study site and subjects gave

written, informed consent after the study procedures had been fully

explained to them. Eligible subjects were aged 21–70 y and were free

of significant organic disease. Persons who had had a myocardial

infarction or major surgery 6 mo before the study were excluded, as

were those with a history of phenylketonuria or allergies to

psyllium or aspartame. Women who became pregnant were excluded or

dropped from the study. Persons who had taken corticosteriods,

androgens, phenytoin, thyroid hormones, oral contraceptives,

antibiotics, fiber supplements, calcium supplements, or oral

hypolipidemic agents 3 mo before the study were also excluded.

 

Subjects were randomly assigned to the psyllium or placebo group

after the dietary adaptation phase if their serum LDL-cholesterol

concentrations were between 3.36 and 4.91 mmol/L, if their plasma

triacylglycerol concentrations were <4.52 mmol/L, and if their LDL

concentrations had stabilized within 0.65 mmol/L 2 wk before random

assignment. The study protocol specified that subjects maintain a

constant body weight (±5%), consume >75% of the test product they

received, and comply with the diet throughout the study. As the

primary analysis, we analyzed data from all subjects who were

randomly assigned to receive either placebo or psyllium (ie, an

intention-to-treat analysis). We also analyzed data for just those

subjects who completed the study (ie, evaluable subjects) for

comparison.

 

Study design

This double-blind, placebo-controlled, parallel, multicenter study

consisted of an 8-wk dietary adaptation phase (weeks -8 to -1)

followed by a 26-wk treatment phase (weeks 0–26). During the dietary

adaptation phase, subjects with primary hypercholesterolemia

received ongoing dietary counseling regarding an AHA Step I diet

(25, 26). Subjects who met the entry criteria at the end of the

dietary adaptation phase were then stratified by sex and randomly

assigned to the treatment or placebo group.

 

Subjects were randomly assigned to groups independently at each

study site in blocks of 5 (4 to the psyllium group and 1 to the

placebo group). The study was designed to have 250 subjects complete

the protocol, 200 in the psyllium group and 50 in the placebo group.

Power calculations were based on a two-sided risk of 0.05. On the

basis of the stated sample sizes and variance estimates from

previous studies, this study was designed to have 97% power to

detect a 5% difference in serum total cholesterol concentrations and

a 7% difference in serum LDL-cholesterol concentrations between

groups.

 

Subjects in the treatment group received 5.1 g psyllium husk twice

daily and subjects in the placebo group received 5.1 g

microcrystalline cellulose twice daily for 26 wk adjunctive to the

AHA Step I diet. Subjects returned at weeks -8, -4, -2, -1, 0, 4, 8,

12, 16, 20, 24, and 26 for serum lipid measurements and dietary

counseling.

 

Diets and test products

All subjects were instructed to consume an AHA Step I diet (26) at

enrollment and to continue that diet throughout the dietary

adaptation and treatment phases. The Step I diet provided 55% of

total energy as carbohydrate, 15% of energy as protein, <30% of

energy as fat, <10% of energy as saturated fatty acids, and <300 mg

cholesterol daily. Registered dietitians reviewed dietary

information and provided dietary counseling.

 

During the treatment phase, subjects in the psyllium group received

orange-flavored, sugar-free Metamucil (Procter & Gamble Co,

Cincinnati), whereas subjects in the placebo group received

microcrystalline cellulose, an insoluble fiber (Avicel PH-101; FMC

Corp, Philadelphia). Both groups received two 6.7-g packets daily;

each packet provided 5.1 g psyllium husk fiber or cellulose placebo.

The products were packaged in identical foil packets with identical

information and instructions. Both products were orange-flavored

powders that were similar in taste, texture, and appearance. The

subjects were instructed to mix each packet in 240 mL liquid and to

drink the mixture immediately before breakfast and dinner.

Compliance was monitored by interviewing the subjects and counting

unopened packets returned at each follow-up visit.

 

Variables measured

Subjects underwent a complete physical examination at weeks -4 and

26 of the study and routine clinical chemistry, hematology, and

urinalysis evaluations at weeks -4, 0, and 26. At weeks -8, -4, -2,

and -1 of the dietary adaptation phase and weeks 0, 4, 8, 12, 16,

20, 24, and 26 of the treatment phase, serum lipids, body weight,

blood pressure, and heart rate were measured. Clinic visits occurred

in the morning after a minimum 12-h fast and subjects did not

consume the test products on these mornings.

 

Serum lipid profiles included enzymatic measurement of total

cholesterol, HDL-cholesterol, and triacylglycerol concentrations

(27). LDL-cholesterol concentrations were calculated from total and

HDL-cholesterol concentrations by using the Friedewald equation

(28). Because the equation has not been validated for

triacylglycerol concentrations >4.52 mmol/L, LDL cholesterol was not

calculated when triacylglycerol concentrations were >4.52 mmol/L.

 

Serum concentrations of apolipoproteins A-I (29) and B-100 (30) were

measured by radioimmunoassay at weeks 0 and 26. In addition to

derived values, serum LDL-cholesterol concentrations were also

measured at weeks 0 and 26 by using an ultracentrifugal ß-quantition

procedure (27). All serum lipid concentrations were determined at

PennMed Laboratories, Medlantic Research Institute, Washington, DC.

 

Adverse events related to the test products were solicited at each

clinic visit during the treatment phase. Subjects were asked an open-

ended question about the occurrence of any unusual symptoms or

events during the previous 4 wk. Subjects were also telephoned by

the investigator's staff at 4-wk intervals between clinic visits

(weeks 2, 6, 10, 14, 18, and 22) and asked about potential adverse

events and study compliance.

 

The subjects provided 3-d food records (2 weekdays and 1 weekend

day) at weeks -4, -2, 0, 8, 12, 16, 20, 24, and 26. A registered

dietitian reviewed all food records for completeness. Food records

from weeks -4, 0, 12, 20, and 24 were analyzed by the Nutrition

Coding Center of the University of Minnesota, Minneapolis, by using

the Nutrition Coding Center nutrient database for evaluation of

total energy, fat, fiber, and cholesterol intakes; the ratio of

polyunsaturated to saturated fat; and percentages of energy from

fat, protein, and carbohydrate.

 

Statistical analyses

Comparability of the psyllium and placebo groups at baseline was

determined by using a chi-square test for sex distribution and by

using analysis of variance and Wilcoxon rank-sum tests for baseline

height, weight, and lipid concentrations. Baseline values for serum

total, derived LDL, and HDL-cholesterol and plasma triacylglycerol

concentrations were defined as the average of values taken at weeks -

2, -1, and 0. Posttreatment values for these variables were defined

as the average of values taken at weeks 24 and 26. For serum

apolipoproteins and ß quantification of LDL cholesterol, values

taken at weeks 0 and 26 were compared.

 

Changes from baseline lipid concentrations and clinical laboratory

data, body weight, and dietary data were compared between groups by

using one-way analysis of variance. Changes were confirmed by using

Wilcoxon rank-sum tests, analysis of covariance with the baseline

value as a covariate, and analyses of the percentage change from

baseline. Each week in which measurements were taken, comparisons of

change from baseline were also made. Paired t tests, Wilcoxon rank-

sum tests, or both were used to assess the significance of changes

from baseline within groups. All analyses were performed by using

SAS (31). Significance was defined as P 0.05.

 

 

RESULTS

TOP

ABSTRACT

INTRODUCTION

SUBJECTS AND METHODS

RESULTS

DISCUSSION

REFERENCES

 

 

Of the 459 subjects who began the dietary adaptation phase, 248

qualified for assignment to a study group (51 to receive placebo and

197 to receive psyllium). Major reasons for disqualification for

random assignment were failure to meet the study's inclusion

criteria (n = 152), withdrawal of consent (n = 25), and loss to

follow-up (n = 23). Of the randomly assigned subjects, 200 (39 in

the placebo group and 161 in the psyllium group) completed the

entire study. Of those who completed the entire study, 163 subjects

(30 in the placebo group and 133 in the psyllium group) fully

complied with the study protocol. Compliance with the regimens was

excellent: the subjects consumed 93% of the psyllium and 95% of the

placebo.

 

Baseline characteristics of subjects in the placebo and psyllium

groups are shown in Table 1. The groups were well-matched for sex,

age, height, and weight. Baseline and final dietary intakes of the

psyllium and placebo groups are shown in Table 2. Subjects in the

psyllium group had significantly higher mean cholesterol intakes at

baseline than did those in the placebo group. Otherwise, dietary

intakes of the groups did not differ significantly throughout the

study. Subjects' body weights were also similar between groups;

there were no significant differences between groups and no

significant change from baseline within groups at any clinic visit.

 

 

 

 

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TABLE 1. Baseline demographic characteristics of subjects in the

psyllium and placebo groups1

 

 

 

 

 

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TABLE 2. Daily dietary intakes of subjects in the psyllium and

placebo groups1

 

 

 

During the dietary adaptation phase, average serum total and LDL-

cholesterol concentrations of the 248 subjects decreased 3.9% and

4.4%, respectively, from study entry (week -8 compared with baseline

values). The placebo and psyllium groups had similar baseline lipid

concentrations; there were no significant differences in serum

total, LDL, or HDL-cholesterol; apolipoprotein; or triacylglycerol

concentrations between groups. No significant differences in change

from baseline between groups were found for serum HDL-cholesterol,

apolipoprotein, or triacylglycerol concentrations at any point

during the study.

During the treatment phase, mean serum total cholesterol

concentrations decreased an additional 2.1% in the psyllium group

but increased 2.6% in the placebo group compared with baseline

concentrations (Table 3). Mean serum LDL-cholesterol concentrations

decreased an additional 2.9% with psyllium but increased 3.9% with

placebo. Thus, the change in serum total and LDL-cholesterol

concentrations (baseline compared with final) was significantly

different between groups. Serum total and LDL-cholesterol

concentrations were 4.7% and 6.7% (P < 0.001) lower, respectively,

in the psyllium group than in the placebo group after 6 mo of

treatment.

 

 

 

 

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TABLE 3. Serum lipid responses of subjects in the psyllium and

placebo groups

 

 

 

The importance of diet therapy during the initial dietary adaptation

phase and the additional hypolipidemic effects of psyllium compared

with placebo during the treatment phase are shown in Figure 1. The

greatest reductions in serum total and LDL-cholesterol

concentrations occurred at week 4 of the study in both the psyllium

and placebo groups. Significant differences between groups in

percentage change from baseline in serum total cholesterol

concentrations occurred at weeks 8, 12, 20, 24, and 26 of the study.

Significant differences in percentage change from baseline in serum

LDL cholesterol occurred at weeks 4, 8, 16, 20, 24, and 26.

 

 

 

 

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FIGURE 1. Mean (±SEM) percentage change from baseline (weeks -

2, -

1, and 0) in serum lipid concentrations during treatment with diet

alone (weeks -8 to -1) followed by diet plus placebo (...........)

or psyllium (————) (weeks 0–26) in all subjects who received a test

product. *, , Significantly different from placebo group: *P <

0.01, P < 0.05, P < 0.001.

 

 

 

 

No significant interactions of sex and treatment were found for any

of the lipid variables measured. Mean serum total and LDL-

cholesterol concentrations decreased in men and women in response to

psyllium treatment and increased in response to placebo.

Data from the 163 subjects who completed the entire study in full

compliance with all study protocol criteria (ie, evaluable subjects)

were also analyzed. Results in this more strictly controlled sample

closely paralleled the results that included all treated subjects.

For these 163 fully compliant subjects, serum total and LDL-

cholesterol concentrations were 4.6% (P < 0.02) and 6.2% (P < 0.02)

lower, respectively, in the psyllium group than in the placebo

group. No other significant differences between groups were noted

for any of the variables measured.

 

There were no significant differences in the incidence of adverse

events between groups. No serious adverse events related to

treatment were reported in either group. Mild gastrointestinal

effects, such as flatus, bloating, indigestion, nausea, heartburn,

diarrhea, and constipation, were reported by 26% of subjects taking

psyllium and 31% of subjects taking placebo.

 

 

DISCUSSION

TOP

ABSTRACT

INTRODUCTION

SUBJECTS AND METHODS

RESULTS

DISCUSSION

REFERENCES

 

 

The lipid reductions observed over 24–26 wk in this multicenter

study were similar to those in previous, smaller, placebo-controlled

studies of shorter duration. Sprecher et al (13) reported that total

and LDL-cholesterol concentrations were lower (net differences of

3.5% and 5.1%, respectively) in the psyllium group than in the

placebo group after 8 wk of treatment (5.1 g twice daily) in

subjects consuming a low-fat diet. In other studies with an 8-wk AHA

Step I diet lead-in phase, total and LDL-cholesterol concentrations

were 4.8% and 8.2% lower, respectively (15), and 4.3% and 8.8%

lower, respectively (19), in subjects who received psyllium (10.2

g/d) for an additional 8 wk than in subjects who received placebo.

In a similar study with the longest treatment period reported in the

literature thus far (16 wk of psyllium therapy after an 8-wk AHA

Step I diet lead-in phase), net decreases in total and LDL-

cholesterol concentrations of 5.6% and 8.6% were reported (14).

Similar to the results of other studies (19, 32), no significant

interactions of sex and treatment were found in the present study

for any of the lipid variables measured. Thus, psyllium use by men

and women can sustain serum lipid benefits for up to 6 mo.

 

The low energy intakes reported by subjects in both the psyllium and

placebo groups in this study suggest that subjects in both groups

underreported food intakes. Underreporting of food intakes was

documented in previous clinical studies (33). Because mean energy

intakes of the groups did not differ significantly at any time

during the study, the reporting bias was probably similar in both

groups.

 

The mechanism of action of psyllium's hypocholesterolemic effects

has not been fully elucidated. Psyllium was shown to stimulate bile

acid synthesis (7 -hydroxylase activity) in animal models (34, 35)

and in humans (20). The diversion of hepatic cholesterol for bile

acid production has long been established as a mechanism for

reducing serum cholesterol. Psyllium's effect on the absorption of

cholesterol (20, 36) and fat (37) appears minimal but may make a

small contribution to cholesterol lowering. Additional mechanisms,

such as inhibition of hepatic cholesterol synthesis by propionate

(38) and secondary effects of slowing glucose absorption (39), may

also play a role.

 

Other soluble fiber sources, such as guar gum (40), locust bean gum

(41), pectin (42), oat bran (43), and legumes (44), have also been

reported to decrease serum total and LDL-cholesterol concentrations.

However, the practical uses for many of these fibers are limited by

a lack of palatable forms (21). In a study in which the effects of

10 different fibers were compared in rats, psyllium-fed rats had the

lowest serum and liver cholesterol concentrations (17).

 

Psyllium has long been used as a bulk laxative with a good safety

record. Although rare, allergic reactions to psyllium have been

reported in persons with prior exposure to psyllium from

manufacturing or bulk dispensing (45). The lack of significant

effects of long-term psyllium treatment on hematology, serum

chemistry, urinalysis, and routine clinical laboratory results; on

coagulation; or on vitamin and mineral status in the present study

and in another long-term study indicates the safety of this fiber

source (46).

 

On the basis of ATP II guidelines (2), 32% of men and 27% of women

in the United States have undesirably high serum cholesterol

concentrations (10). The ATP II guidelines advocate stepwise

reductions in fat, saturated fat, and cholesterol as the primary

therapy for high total and LDL-cholesterol concentrations; drug

therapy is reserved for persons at high risk of CHD or for those who

do not respond adequately to diet (2).

 

Although psyllium therapy does not replace diet therapy for persons

with high serum cholesterol concentrations, it offers an additional

dietary tool. The results of this study show that psyllium can play

an important role in maintaining diet-induced reductions in serum

total and LDL-cholesterol concentrations. For some people, psyllium

therapy may also be a safe, acceptable, and effective alternative to

drug therapy. For example, if a person is trying to reduce his or

her LDL-cholesterol concentration to 3.36 mmol/L through dietary

modification but can achieve a reduction to only 3.62 mmol/L, the

addition of psyllium to the regimen could help the person to attain

his or her goal and eliminate the need for drug therapy.

 

In this study, dietary change and long-term use of a standard dose

of psyllium (5.1 g twice daily) resulted in 5% lower serum total

cholesterol concentrations and 7% lower LDL-cholesterol

concentrations than did dietary changes and placebo. Because every

1% reduction in serum total cholesterol concentration results in a 2–

3% reduction in risk of CHD, dietary change plus psyllium therapy

could potentially reduce CHD risk 10–15% more than diet therapy

alone in people with hypercholesterolemia (6).

 

 

 

ACKNOWLEDGMENTS

 

We acknowledge the expert technical writing skills of Nancy

Gustafson.

 

 

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ABSTRACT

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RESULTS

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Received for publication August 25, 1999. Accepted for publication

November 5, 1999.

 

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JoAnn Guest

mrsjo-

www.geocities.com/mrsjoguest/Diets