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TitleThe Handbook of Clinically Tested Herbal Remedies
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Total Pages1503
Table of Contents
                            Pre-publication REVIEWS, COMMENTARIES, EVALUATIONS...
NOTES FOR PROFESSIONAL LIBRARIANS AND LIBRARY USERS
CONSERVATION AND PRESERVATION NOTES
Haworth Series in Evidence-Based Phytotherapy
Publication & Copyright Information
Table of Contents
About the Editor
Contributors
Preface
Acknowledgments
Editor's Note
PART I: FUNDAMENTALS OF HERBAL MEDICINE
Chapter 1  History and Regulation of Botanicals in the United States
Chapter 2  Product Definition Deficiences in Clinical Studies of Herbal Medicines
Chapter 3  Identifying and Characterizing Botanical Products
Chapter 4  Standardization of Botanical Preparations: What It Does and Does Not Tell Us
Chapter 5  The Importance and Difficulty in Determining the Bioavailability of Herbal Preparations
Chapter 6  "Borrowed Science" and "Phytoequivalence": Can Two Herbal Products Be Judged Equivalent?
Chapter 7  Determining Efficacy of Herbal Preparations
Chapter 8  Evaluating Safety of Herbal Preparations
Chapter 9  Conducting Clinical Trails on Herbal Dietary Supplements in North America: Commercialization, Confidence, and Conflicts
Chapter 10  Motives for Conducting Clincial Trails on Botanicals in Europe: A Focus on Germany
Chapter 11  Pharmacopoeias and Botanical Monographs
PART II: METHODS
Chapter 12  Methods of Product and Trail Inclusion and Evaluation
Chapter 13  Clinical Trail Reviewer's Guidance and Checklist
PART III: BOTANICAL PROFILES-- PRODUCT AND CLINICAL TRAIL INFORMATION
Artichoke
Bilberry
Black Cohosh
Boxwood
Cat's Claw
Chaste Tree
Cordyceps
Cranberry
Devil's Claw
Dragon's Blood Croton
Echinacea
Elderberry
Evening Primrose
Garlic
Ginger
Ginkgo
Ginseng
Pre-publication REVEIW, COMMENTARIES, EVALUATIONS...
NOTES FOR PROFESSIONAL LIBRARIANS AND LIBRARY USERS
CONSERVATION AND PRESERVATION NOTES
Haworth Series in Evidence-Based Phyotherapy
Publication and Copyright Information
Table of Contents
About the Editor
Editor's Note
PART III: BOTANICAL PROFILES--PRODUCT AND CLINICAL TRIAL INFORMATION
Grape Seed
Grass Pollen
Green Tea
Hawthorn
Horse Chestnut
Kava
Lemon Balm
Milk Thistle
Pygeum
Red Clover
Red Yeast Rice
Saw Palmetto
St. John's Wort
Valerian
HERBAL FORMULAS  2nd Wind™
Cystone®
Gastrim®
Geriforte®
Iberogast™
Padma®
Phytodolor™
Prostane®
Resistex™
Sinupret®
Appendix A  Products Listed By Manufacturer/Distributor
Appendix B  Manufacturer/Distributor Contact Information
Index
                        
Document Text Contents
Page 2

Marilyn Barrett, PhD
Editor

The Handbook
of Clinically Tested
Herbal Remedies

Volume 1

Pre-publication
REVIEWS,
COMMENTARIES,
EVALUATIONS . . .

“T he Handbook of Clinically TestedHerbal Remedies is an important
addition to the modern clinical litera-
ture on herbs.”

Adriane Fugh-Berman, MD
Associate Professor,
Department of Physiology
and Biophysics,
Georgetown University School
of Medicine

“This book is well written by expertsin their respective fields and for
the first time provides information on
specific botanical products that relate
to their therapeutic value. It should be
of great interest to students and practi-
tioners in any of the health sciences, to
manufacturers of botanical products, to
the lay public, to those in the media
who can rely on information in this
book to be authoritative, and to librar-
ies.”

Norman R. Farnsworth, PhD
UIC Distinguished Professor
and Research Professor
of Pharmacognosy, College of Pharmacy,
University of Illinois at Chicago

Page 751

Blinding adequate Yes

Placebo Yes
Drug comparison No

Site description 3 private practices

No. of subjects enrolled 227
No. of subjects completed 219
Sex Male and female
Age 31-65 years (mean: 48)

Inclusion criteria
Over 18 years of age, recommended for influenza vaccination.

Exclusion criteria
Already vaccinated for influenza; already taking ginseng; with granulocytes
<1,000 mm; hypersensitivity to ginseng; receiving any investigational agent
or antineoplastic chemotherapy; with underlying terminal diseases (e.g.,
AIDS) or liver disease; pregnant or nursing women; and subjects with severe
gastritis.

End points
Incidences of influenza/common cold were recorded at 2, 4, 8, 10, and 12
weeks. Natural killer activity (peripheral blood mononuclear cells) and anti-
body titers were measured before the trial and after 4, 8, and 12 weeks. Lab-
oratory safety parameters were measured before the trial and after 12
weeks. Adverse events were recorded every two weeks after the trial.

Results
The frequency of influenza or common cold between weeks 4 and 12 was 42
cases in the placebo group and 15 cases in the G115 group, the difference
being statistically highly significant (p < 0.001). Whereas antibody titers by
week 8 rose to an average of 171 units in the placebo group, they rose to an
average of 272 units in the G115 group (p < 0.0001). Natural killer activity
levels at weeks 8 and 12 were nearly twice as high in the G115 group as
compared to the placebo group (p < 0.0001).

Side effects
Of the eight adverse events reported for G115, four were insomnia, three
were gastrointestinal, and one was anxiety.

Authors’ comments
The results obtained from this study show that the standardized ginseng ex-
tract G115 Ginsana is able to improve the immune response in vivo in hu-
mans and can protect against influenza and the common cold.

Page 752

Reviewer’s comments
Well-conducted study showing that ginseng protects against influenza and
improves immune response. The randomization was inadequately de-
scribed. (3, 6)

Clinical Study: G115®

Extract name G115
Manufacturer Pharmaton S.A., Switzerland

Indication Bronchitis
Level of evidence III
Therapeutic benefit Yes

Bibliographic reference
Scaglione F, Cogo R, Cocuzza C, Arcidiancono M, Beretta A (1994).
Immunomodulatory effect of Panax ginseng C.A. Meyer (G115) on alveolar
macrophages from patients suffering with chronic bronchitis. International
Journal of Immunotherapy 10 (1): 21-24.

Trial design
Parallel.

Study duration 2 months
Dose 1 (100 mg G115) capsule every 12

hours
Route of administration Oral

Randomized Yes
Randomization adequate No
Blinding Single-blind
Blinding adequate No

Placebo Yes
Drug comparison No

Site description Single center

No. of subjects enrolled 40
No. of subjects completed Not given
Sex Male and female
Age Not given

Inclusion criteria
Smokers (less than 20 cigarettes per day) who suffered from chronic bron-
chitis.

Page 1502

vitamin E
and bilberry, 167, 181-183
and evening primrose, 397-399
with ginseng, 696-697
and grape seed, 769
versus garlic, 416, 477-478

vitamins
with ginseng. See Ginsana® Gold

Blend
versus ginseng, 720-721

Vitex agnus-castus. See chaste tree
Vitis vinifers. See grape seed
volatile oils, 42
vomiting

postoperative, and ginger, 499-500,
526, 528-539

as side effect
boxwood, 209
ginseng, 718, 725
saw palmetto, 1073
St. John’s wort, 1116, 1152

von Willebrand factor, 475-476
voucher specimens, 26-27, 31-32

Walgreens, 134
walking. See intermittent claudication
warfarin

and garlic, 424
and ginkgo, 565-566
and ginseng, 684
and natural coumarins, 87
and St. John’s wort, 1118

weakness
artichoke, 154
cordyceps, 257-258, 262-264
ginkgo, 613

Web sites
benefit claims, 8
on botanical research, 9
false advertising, 99
literature reviews, 74
for pharmacopoeias, 125
for product identification, 27
unfounded claims, 69
USP, 117-118

weight gain
garlic, 472
as side effect

black cohosh, 191
chaste tree, 237, 246

weight loss
evening primrose, 367, 394-396
and Garcinia cambogia, 15-16
garlic, 472
green tea, 789-790, 797-799
and milk thistle, 952-953
as side effect, and kava, 893

well-being. See also mood; quality of
life

garlic, 438, 441
valerian, 1204

white thorn. See hawthorn
WHO. See World Health Organization
whortleberry. See bilberry
wine grape. See grape seed
witch hazel, 27-28
Withania somnifera. See Geriforte®

withdrawal
from clinical trials, 72, 144
from valerian, 14, 1210

women. See also menopausal
symptoms; menstrual
disorders; premenstrual
syndrome

atherosclerosis in, 458-460
cardiovascular protection, 1014-1015,

1019, 1021-1025
insomnia in, 1227-1229
with lung cancer, 792-793
physical performance, 697-699, 702
with venous insufficiency, 847,

875-876
World Health Organization (WHO)

and adverse reactions, 80, 82
and pharmacopoeias, 116, 122,

123-124
WS 1490, 887, 912-913. See also kava
WS 1531, 277, 279, 286-288. See also

devil’s claw
WS 1540, 493, 497, 517-519. See also

ginger

Page 1503

WS 5570, 1104, 1106. See also St.
John’s wort, WS 5570 studies

WS 5572, 1104, 1110-1112. See also St.
John’s wort, WS 5572 studies

WS 5573, 1110. See also St. John’s
wort, WS 5573 studies

wujia, 16-18

xi yang shen. See ginseng
Xin Nao Jian, 803-804. See also green

tea; Tegreen®

Xue-zhi-kang, 1029, 1030, 1038-1040.
See also red yeast rice

xylene exposure, 939, 967-968
xylometazoline, 1354-1355

Ze 117TM, 112-113, 132, 1104, 1181-1189.
See also St. John’s wort

and digoxin, 1118, 1119-1120
ZE 339, 213, 215, 220-223
ZE 440, 233, 235, 251-253
ZE 91019, 1200, 1244-1247. See also

AllunaTM; valerian
Zea mays. See grass pollen
Zhitai, 1029, 1030, 1040-1042. See also

red yeast rice
zinc, 975
Zingiber officinale. See Gastrim®; ginger
Zintona®, 493, 496-497, 501-502,

508-517. See also ginger

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