(a )
According to the randomized, double-blind, reference-controlled
trial, patients who took 900 mg per day of a SJW extract known as
WS(R) 5570 (W. The paroxetine
patients reported 269 adverse effects compared to only 172 for those
on SJW.
"This trial can help resolve some of the confusion surrounding the
potential benefits of St.com
201-641-1911 x18

C.
Dr. Dave studied medicine at the University
of Sheffield, England, and completed an internal medicine residency in London.
Capobianco received his medical degree from New York Medical College in
Valhalla, N .

scharr appraised

The patients had been diagnosed to
have moderate to severe levels of major depression.(e)
A dietary supplement product of identical strength to WS(R) 5570
is available in health food stores in the United States under the
trade name Perika(R) (Nature's Way Products, Springville, UT). Efficacy of St.

MetaWorks(R) Inc. Executives to Discuss Evidence-Based Medicine's Impact on Clinical Drug Development at Annual DIA Meeting

org/docs/Events/Events_search_results.cfm?Region=1. By combining its expertise and
experience in systematic reviews and meta-analysis with diverse data sources
including its proprietary clinical trial database, MetaHub(TM), MetaWorks
delivers clinical evidence that drives sound decisions and supports key
messages.D. Dave served most recently as Associate Professor of Medicine at George
Washington University and Assistant Chief of Hematology at the VA Medical
Center in Washington, D.

pulmonary cochrane

The full
treatment period was for six weeks. John's wort (Hypericum perforatum ) is a traditionally used
herbal remedy for "melancholy" and related depressive states.(c) A highly
publicized trial in 2002 funded by the National Center for
Complementary and Alternative Medicine of the National Institutes of
Health concluded that a hypericin-standardized SJW preparation and the
popular prescription antidepressant drug sertraline (Zoloft(R),
Pfizer) were ineffective in treating patients with chronic moderate to
severe depression. John's wort) in major depressive disorder .
On June 26th from 1:00 to 4:30 p. Derived
from the systematic review of published clinical trials, EvidenceHub(TM)
permits the query, exporting, and analysis of clinical trial outcomes by

patient characteristics, treatment variables, and key efficacy and safety
outcomes.D.D. She studied
medicine at Morehouse School of Medicine in Atlanta and completed her OB/GYN
residency at Columbia Presbyterian Medical Center, Harlem Hospital, in New
York City. He is board certified in internal medicine,
hematology and medical oncology.

eboc infirmary

The trial results showed that the SJW actually produced a better
HAMD improvement than the pharmaceutical drug; patients in the SJW
group experienced a three-point greater decrease in the average HAMD
total score compared to the original scores (baseline ) than did those
taking paroxetine. The most frequently reported adverse effect for both
treatments was stomach upset, a fairly common side effect in many
clinical trials of this type. Cochrane
Database Syst Rev 2004; (4):CD000448.com Demonstration at Booths 1501 and 1503

MEDFORD, Mass., a premiere
provider of evidence-based medical information, today announced that two
corporate executives will present during the 41st annual Drug Information
Association (DIA) meeting in Washington, D. DIA's
mission is to serve and develop members by providing a neutral, global forum
that promotes the exchange of information critical to professional performance
and achievement.C., Quintiles
Transnational Corp.C.

weaknesses evidence

Health/Medical Writers

AUSTIN, Texas----A new clinical
study shows that a proprietary standardized extract of St. The study was published Friday,
February 11, in the British Medical Journal . If a patient did not
experience a measurable response after two weeks, the dose was
doubled.

Patients in the SJW group experienced significantly better
improvement as measured by the Hamilton Depression Rating Scale
(HAMD), an internationally accepted severity scale for depression.3 percent levels of total hypericins (LI 1370 aka
Jarsin 300, Lichtwer Pharma, Berlin, Germany). John's
wort extract WS(R) 5570 in major depression: a double-blind,
placebo-controlled trial.

(c) Linde K, Ramirez G, Mulrow C, Pauls A, Weidenhammer W,
Melchart D.
JAMA 2002;287:1807-14. Ross and Reynolds will discuss how evidence-based medicine -- the
application of currently available best evidence to clinical research -- can
be incorporated into drug-development processes, ranging from early-phase
clinical trials through post-launch activities, to optimize decision-making.m.diahome., and Harish Dave, M., Vice President, Medical Affairs.

ebm pharmacology

In some clinical outcomes,
including the primary efficacy endpoint (a decrease of the depression
scale score), WS 5570 was superior to the pharmaceutical
antidepressant . The improvement in the SJW patients was considered
clinically significant: there was a responder rate (50% improvement on
HAMD) of 70% for the SJW patients versus 60% for those on paroxetine
and a remission rate (HAMD equal or less than 10) of 50% for SJW
versus 35% for paroxetine. John's wort ," said Mark Blumenthal, founder
and executive director of the nonprofit American Botanical Council .org

References

(a) Szegedi A, Kohnen R, Dienel A, Kieser M., June 26 to 30, 2005. We look forward to discussing how
evidence-based resources can enhance drug development. to noon, Dr . She conducted her clinical practice in a variety of settings in
the Washington, D. Oh has therapeutic experience in
critical care, trauma, general medicine, cardiovascular and respiratory
disease . Zadeikis comes to Quintiles from Ortho-McNeil Pharmaceuticals, where
she served as Medical Director of Infectious Disease Research. Lukes
Medical Center in Chicago.

adequate infirmary

John's wort. * June 26 -30, 2005, Washington, D. In addition, they will identify
opportunities for these tools to help determine optimal clinical trial sample
size, identify trial endpoints, predict efficacy and safety outcomes , and
determine new indications. Reynolds will also discuss
"Evaluation of Risk Minimization Action Plans (RiskMAPs)" as part of a
clinical safety and pharmacovigilance panel discussion on risk management .
MetaWorks(R), Inc., and Lori Stone,
M., in Research Triangle Park,
N.D.

augment ebm

St.diahome.C.

, and completed residencies in neurology at UC-Irvine and
psychiatry at UC-San Diego.

chalmers scharr

Further, in the secondary efficacy measures
(other standard depression scales including the clinical global
impression ), SJW was rated superior. Both WS 5570 and WS 5572 are standardized to SJW's hyperforin
(another of the compounds in SJW) content at levels of 3-5 percent.

(e) Linde K, Mulrow CD."
Dr .
Her expertise covers a wide range of neurological conditions, including
stroke, migraine, Parkinson 's disease, multiple sclerosis, peripheral
neuropathy, epilepsy and Alzheimer's disease.

ebm weaknesses

Regarding the safety aspects of the trial, the SJW produced
significantly fewer adverse side effects than the drug. In 1996 the British Medical Journal
published a meta-analysis of 23 previously published clinical trials
on the hypericin-standardized SJW extract (hypericin is one of the
compounds in SJW) concluding that the SJW was safe and effective in
treating mild to moderate forms of major depression.
Most other clinical trials on SJW have utilized an SJW extract
standardized to 0.
SJW has recently received public attention because of its ability
to interact with a variety of pharmaceutical drugs , lowering their
levels and effectiveness.

(d) Hypericum Depression Trial Study Group. Convention Center

* EvidenceHub. MetaWorks
will also be exhibiting at the conference at booths 1501 and 1503 and
demonstrating its proprietary EvidenceHub.
Sethi, President and CEO of MetaWorks . For further information, please visit
http://www., office; Marc Capobianco, M., in the Parsippany , N. Capobianco joins Quintiles from the University of California at San
Diego, where he was Assistant Clinical Professor in the Department of
Psychiatry and Associate Medical Director for the Affiliated Research
Institute. She received her medical degree
from the State University of New York at Stony Brook, where she also completed
her internship in internal medicine. Dr. She is board certified in infectious disease and internal
medicine.

evidence chalmers

John's wort): randomized, controlled, double-blind,
non-inferiority trial versus paroxetine.
"The life sciences industry is increasingly exploring more cost-effective
and expeditious methods for bringing new products to market," said Shubh L. For more information, visit
http://www.metaworksinc., and Neddie Zadeikis, M. Blackburne has over 10 years of clinical experience in reproductive
health and is board certified in obstetrics and gynecology .
He completed his medical oncology-hematology fellowship at the National
Institutes of Health (NIH) and George Washington University in addition to
post-doctoral research training in molecular biology, gene regulation and gene
therapy at the NIH. She received her medical degree at Rush Medical College in Chicago
and completed an infectious disease residency at Rush-Presbyterian-St.

crg netting

The trial took place in various centers in Germany on patients
from the ages of 18 to 70 during the years 2000 to 2003.(b)
St.(d) A follow-up meta-analysis confirms that SJW
preparations are more effective than placebo in mild to moderate
depression. For conference details, visit
http://www. Dr.

About Quintiles
Quintiles helps improve healthcare worldwide by providing a broad range of
professional services, information and partnering solutions to the
pharmaceutical, biotechnology and healthcare industries. For more
information visit the company's Web site at http://www.

systematic scharr

Numerous
clinical trials have demonstrated the overall effectiveness and safety
of various SJW preparations . British Medical
Journal 2005, BMJ Online First., MetaWorks(R) Inc.
jboyce@cpronline.

It seeks to augment medical traditions not yet subjected to adequate evaluation with findings based on the application of the scientific method.

geriatrics anesthesiology

Effect of Hypericum
perforatum (St.
They will also discuss how evidence-based tools such as systematic
literature reviews can lead to a better understanding of disease
characteristics and progression, alternative treatments, and safety/efficacy
characteristics of competitor drugs.
As part of the conference, MetaWorks will demonstrate its proprietary
EvidenceHub (TM) database, which now encompasses multiple therapeutic
categories, including oncology, cardiology , and rheumatoid arthritis.
Dr.

evidence bets

John's wort should first
consult with a qualified healthcare practitioner to determine if the
herb might interact with their drugs."

About the American Botanical Council

Established in 1988, the American Botanical Council (ABC) is the
leading nonprofit, member-based international organization working to
educate consumers, healthcare professionals , researchers, educators,
industry, and the media on the safe and effective use of medicinal
plants .J. He has participated in a number of industry-sponsored clinical
trials, and he is board certified in both psychiatry and neurology.Y. Stone, a board-certified neurologist, joins Quintiles from the Centre
for Health Care in San Diego, where she was President of the Medical Group.C. Headquartered near
Research Triangle Park, North Carolina, Quintiles has offices in 50 countries
and is the world 's leading pharmaceutical services organization.

bets appraised

herbalgram.
On June 28th from 10:30 a.

CONTACT:
Jaime Boyce
CPR Strategic Marketing Communications for MetaWorks(R) Inc . Physicians Expand Expertise in CNS, Oncology, Women's Health, Infectious
Disease, Trauma

RESEARCH TRIANGLE PARK, N.
"We're very pleased to have these six physicians join Quintiles, adding
their experience to what was an already impressive staff of therapeutic
experts," said David Frakes, M."
"The addition of these six experts bolsters our strength in major
therapeutic areas," said Paul Spreen, Vice President, Sales, Clinical
Development Services, Americas. Army as an active duty
medical officer in Germany and Kosovo.
Dr.

anesthesiology obstetrics

The panel will review key risk-management components, including assessment,
intervention , communication, and evaluation, and outline pre- and post-
marketing approaches to each component .S.com .

EBM tools include, but are not limited to, randomized controlled trials, systematic reviews (of a series of trials) and meta-analyses.

weaknesses netting

John's wort
(SJW) was as effective as a common prescription antidepressant drug in
reducing symptoms of depression.
"Most of the clinical trials show that several types of St. ABC is located on a 2.5 acre site in Austin, Texas where it
publishes HerbalGram , a peer-reviewed journal. John's wort for depression -- an overview and
meta-analysis of randomized clinical trials. today announced that its Medical and Scientific Services
organization has hired six more physicians for their medical expertise., office.

systematic obstetrics

Paroxetine
is a prescription antidepressant drug in the class known as SSRI's
(selective serotonin reuptake inhibitors). Blumenthal noted, "The American Botanical
Council recommends that consumers who are taking conventional drugs
and who also might be considering using St.
MetaWorks' clients utilize evidence derived from existing published
medical information to support regulatory submissions, clinical trial
planning, and marketing claims.org., in the San Diego office; Richard Oh, M. He received his medical degree from the University of Pittsburgh
School of Medicine and completed a residency in Family and Community Medicine
at Womack Army Medical Center at Fort Bragg, N.

geriatrics evidence

St. John's Wort as Effective as Popular Prescription Anti-Depressant; New Trial Demonstrates Herb's Benefit and Safety Compared to Paroxetine

A reference -controlled trial is different than a
placebo-controlled trial where some of the patients take a placebo (a
dose with no active ingredient) as a control to test the effect of the
herb or drug being studied . In that double-blind, randomized,
placebo-controlled trial conducted on 375 subjects, 900 mg per day of
the same SJW extract (WS 5570) showed more benefit for depressed
patients than did the placebo. Acute treatment of
moderate to severe depression with hypericum extract WS(R)
5570 (St .C.C.com database portal. The company's 1997 designation as an
Evidence-based Practice Center by the Agency for Healthcare Research and
Quality (AHRQ) established MetaWorks as a reliable and expert resource for
evidence-based medical information.

Quintiles Adds Six Therapeutic Experts to Staff

bets obstetrics

, Susan Ross, MD, MetaWorks' Chief
Scientific Officer and co-founder, and Matthew Reynolds , PhD, Senior Director
of Risk Management and Safety Services, will discuss "Evidence-based Medicine
Throughout the Clinical Drug Development Process."
Drs. is a recognized healthcare consulting company focused
in clinical drug development and commercialization within the pharmaceutical,
biotechnology , and healthcare industries.
Dr.

pulmonary evidence

In a reference-controlled trial, the
substance being tested is compared directly to a known active
material, in this case, the FDA-approved prescription antidepressant
drug, paroxetine.
In the study, 251 patients were randomized to receive either 900
mg/day of WS 5570 or 20 mg/day of paroxetine."
The results of this trial are consistent with a previously
published larger trial in France.com.

About the Drug Information Association
With more than 2,000 members worldwide, the Drug Information Association
(DIA) is the premier member-driven organization encompassing the full
continuum of disciplines in the pharmaceutical and related industries.
Dr.

netting eboc

John's
wort extracts produce clinically measurable and significant benefits.
Marketed for helping to create a positive mood, this product (known as
WS(R) 5572) contains the same patented , standardized extract as WS
5570.

(b) Lecrubier Y, Clerc G, Didi R, Kieser M.m." The tutorial session is
designed for life sciences professionals in all phases of clinical trial
design, epidemiology , biostatistics, regulatory affairs, medical affairs, and
outcomes research.

About MetaWorks , Inc.D.D. "I think
our customers recognize the importance of therapeutic expertise, and I'm
confident that's why they keep coming back to Quintiles. "As Quintiles experiences significant growth
in a global market focused on patient well-being, it's important to acquire
talent that understands the need for proper study design and safety
reporting., area, including Kaiser, and has experience as a clinical
investigator. Dr. She completed her residency in neurology
and a fellowship in electromyography /neuromuscular disease at the University
of California at San Diego.

infirmary summarises

Schwabe, Karlsruhe, Germany) had as much benefit as the
pharmaceutical drug paroxetine (Paxil(R), GlaxoSmithKline). More
information is available at www. BMJ 1996;
313(7052):253-8. "Many companies, however, have just
begun to discover that they can more economically address scientific questions
in clinical development by accessing existing evidence rather than conducting
their own costly, time-consuming studies.
The physicians are Rose Blackburne, M. At the VA, he designed and conducted several
clinical research studies. He also served in the U.

Evidence-based Medicine (EBM) is an approach that encourages the employment of the best available clinical evidence from systematic research for use in clinical practice.

infirmary augment

ABC is also the
publisher of The ABC Clinical Guide to Herbs, a continuing education
and reference book, which contains extensive monographs on the safety
and efficacy of 29 popular herbs , including St. American Journal of Psychiatry
2002; 159(8):1361-1366. St John's wort for depression .
The DIA meeting will feature more than 20 content-area tracks and 300
discussions by leading biotechnology, pharmaceutical, and regulatory
professionals.D., who are
in Quintiles' Rockville , Md. Oh served most recently as hospitalist physician at Johnston Memorial
Hospital in North Carolina . She also has
worked as a clinical investigator in private practice and in Medical Affairs
at Roche Labs, Inc.quintiles.