Herbal Remedy Deemed Safe and Seemingly Effective in Heart Failure (fwd)

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Herbal Remedy Deemed Safe and Seemingly Effective in Heart Failure

By Gever, Staff Writer, MedPage Today

Published: January 23, 2008

Reviewed by Zalman S. Agus, MD; Emeritus Professor

University of Pennsylvania School of Medicine.

Action Points

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* Explain to patients who ask that the study

found evidence for safety and significant benefit

to heart failure patients from hawthorn extract.

* Point out that the study was a meta-analysis of

existing studies and it excluded a large trial

with equivocal efficacy results.

* Explain that patients with heart failure should

discuss potential treatments, including

over-the-counter herbal medicines, with a

physician before starting them.

EXETER, England, Jan. 23 -- Hawthorn extract is

safe and has significant benefits for patients

with congestive heart failure, according to a

meta-analysis here.

Data from 14 randomized placebo-controlled trials

involving 1,110 patients indicated that the

herbal remedy significantly improved maximal

workload, exercise tolerance, pressure-heart rate

product, and symptoms such as shortness of breath

and fatigue, reported Max Pittler, M.D., Ph.D.,

of the University of Exeter, and colleagues in a

Cochrane review.

In most of the trials, patients were taking

conventional cardiac medications such as

diuretics, ACE inhibitors, and calcium

antagonists along with the study medications.

Concomitant medications were not mentioned in the

other studies.

As a result, Dr. Pittler and colleagues wrote, it

cannot be concluded definitively that the herbal

remedy alone accounted for the results. On the

other hand, it appears that hawthorn extract can

be combined safely with conventional heart drugs.

The Cochrane analysis did not include results

from SPICE, a large placebo-controlled trial

presented at a major cardiology meeting last year

that found equivocal benefits at best for

hawthorn extract.

That still-unpublished study involved more than

twice as many patients as all the trials included

in the Cochrane study. SPICE found no difference

after two years of treatment in a composite

endpoint of cardiac events, including death,

nonfatal myocardial infarction, and heart failure

progression.

Dr. Pittler and colleagues included only studies

published in medical journals through June 2006,

thereby excluding the SPICE results.

Extracts made from leaves, flowers, and fruits of

hawthorn, a shrub with the Latin name Crataegus

laevigata, and also known as whitethorn, are a

staple of alternative and complementary medicine.

Hawthorn extract has been touted as a treatment

for heart failure and hypertension.

Most of the trials included in the Cochrane

analysi,s as well as SPICE, used a standardized

product called WS-1442, with the others studying

another product known as LI132. Doses ranged from

160 mg to 1,800 mg daily.

Maximal workload was the most frequent outcome

measure used in the 14 included studies. Pooled

data from trials involving 380 patients showed

that hawthorn extract increased maximal workload

by a weighted mean difference of 5.35 watts (95%

CI: 0.71 to 10.00, P<0.02).

For pressure-heart rate product, pooled data from

five trials and 264 patients found a weighted

mean decrease of -19.22 mm Hg/min (95% CI: -30.46

to -7.98).

Exercise tolerance improved by a weighted mean

difference of 122.76 watt-min (95% CI: 32.74 to

212.78) in trials involving 98 patients.

Two studies with 239 patients found a weighted

mean decrease of -5.47 points (95% CI: -8.68 to

-2.26) in dyspnea and fatigue scores.

Only one trial, involving 113 patients, tested

for six-minute walk distance. It found no

significant difference.

Dr. Pittler and colleagues sought data on

mortality and cardiac events, but the included

trials reported no analyzable data for these

outcomes.

The most common adverse events with hawthorn

extracts were dizziness and gastrointestinal

complaints, both of which affected fewer than 10

patients in the included trials.

The researchers noted that post-marketing

surveillance studies not included in their formal

analysis also have found low rates for adverse

effects. One study of 3,664 patients reported

event rates of 1.3%.

" Our results suggest that, compared with placebo,

hawthorn extract increases the maximal workload

in patients with chronic heart failure, " Dr.

Pittler and colleagues wrote. " This conclusion,

however, is based on small numbers of studies and

patients. Nevertheless, the secondary outcome

measures support the findings and suggest that

hawthorn extract is superior to placebo as an

adjunctive treatment for patients with chronic

heart failure. "

They added that future investigations are needed

to determine whether hawthorn extract treatment

affects the prognosis of heart failure.

They pointed out that, as with any systematic

review, they may have excluded some relevant

studies. Methodologies and degree of rigor varied

among the included trials as well, the

researchers said.

Gregg Fonarow, M.D., director of UCLA's heart

failure program, said he agreed with Dr. Pittler

and his group that hawthorn extract is safe for

heart failure patients. He said the review " does

indeed demonstrate that it is not a harmful

therapy. "

But he disputed the group's conclusion that

hawthorn is superior to placebo, citing the SPICE

results reported last March at the American

College of Cardiology's annual meeting in New

Orleans.

That study, conducted mainly in eastern Europe,

tested WS-1442 against placebo in 2,618 heart

failure patients. Holubarsch, M.D.,

of Median Kliniken Hospitals in Bad Krozingen,

Germany, reported no difference after two years

of treatment in the primary outcome measure. It

was a composite of cardiac events including

death, nonfatal myocardial infarction, and heart

failure progression.

Significant reductions in relative risk for

cardiac death in patients receiving hawthorn

extract were seen at six and 18 months, but not

at 12 or 24 months, according to the report.

Dr. Fonarow said these results impressed him more

than the Cochrane review. He said hawthorn " is

not particularly helpful " and would not recommend

it for patients.

" It's naturally attractive to think there is

something over the counter or naturally occurring

that may help improve outcome. Unfortunately,

we've not been able to identify that so far, " he

said.

The review was funded by the Videns-og

forsknings-center for alternativ behandling

(Denmark).

No financial conflicts of interest were reported.

Primary source: Cochrane Database of Systematic Reviews

Source reference:

Pittler M, et al " Hawthorn extract for treating

chronic heart failure " Cochrane Database of

Systematic Reviews 2008; Issue 1: DOI:

10.1002/14651858.CD005312.pub2.

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© 2004-2008 MedPage Today, LLC. .

http://www.medpagetoday.com/Geriatrics/CHF/tb/8077?pfc=101 & spc=222

1. The Cochrane review found significant

benefit from hawthorn extract in terms of

mortality and cardiac events. True or False?

a. True

b. False

Dr. Pittler and colleagues looked for data on

mortality and cardiac events, but the included

trials reported no analyzable data for these

outcomes.

2. How many patients participated in the 14

trials included in the Cochrane analysis?

a. 810

b. 1,110

Data from 14 randomized, placebo-controlled trials involved 1,110 patients.

c. 2,650

d. 3,660

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