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Quelle: JAMA. 2002;287:1807-1814

 

US Studie weckt Zweifel: Ist Johanniskraut bei Depressionen möglicherweise  unwirksam?

Die Gabe von Hypericum perforatum (Johanniskraut) war bei unter einer mittelgradigen Depression leidenden Patienten nicht in der Lage,  bessere Therapiergebnisse als Placebo zu erzeugen.  

 

 

 


Effect of Hypericum perforatum (St
John's Wort) in Major Depressive Disorder

A Randomized Controlled Trial

Hypericum Depression Trial Study Group

Context Extracts of Hypericum perforatum (St John's
wort) are widely used for the treatment of depression of varying severity. Their efficacy in major depressive disorder, however, has not been conclusively
demonstrated.

Objective To test the efficacy and safety of a
well-characterized
H perforatum extract (LI-160) in major
depressive disorder.

Design and Setting Double-blind, randomized,
placebo-controlled trial conducted in 12 academic and, community psychiatric research clinics in the United ,States.

Participants Adult outpatients (n = 340) recruited
between December 1998 and June 2000 with major depression and a baseline total score on the Hamilton Depression Scale (HAM-D) of at least 20.

Interventions Patients were randomly assigned to
receive H perforatum, placebo, or sertraline (as an active comparator) for 8 weeks. Based on clinical response, the daily dose of H perforatum could range from 900 to 1500 mg and that of sertraline from 50 to 100 mg. Responders at week 8 could continue blinded treatment for another 18 weeks.

Main Outcome Measures Change in the HAM-D total
score from baseline to 8 weeks; rates of full response, determined by the HAM-D and Clinical Global Impressions (CGI) scores.

Results On the 2 primary outcome measures, neither
sertraline nor H perforatum was significantly different from placebo. The random regression parameter estimate for mean (SE) change in HAM-D total score from baseline to week 8 (with a greater decline indicating more
improvement) was –9.20 (0.67) (95% confidence interval
[CI], –10.51 to –7.89) for placebo vs –8.68 (0.68) (95% CI, –10.01 to –7.35) for H perforatum (P = .59) and –10.53 (0.72) (95% CI, –11.94 to –9.12) for sertraline (P = .18).Full response occurred in 31.9% of the placebo-treated patients vs 23.9% of the H perforatum–treated patients (P
= .21) and 24.8% of sertraline-treated patients (P = .26).
Sertraline was better than placebo on the CGI ,improvement scale (P = .02), which was a secondary ,measure in this study. Adverse-effect profiles for H perforatum and sertraline differed relative to placebo.

Conclusion This study fails to support the efficacy of H
perforatum in moderately severe major depression. The result may be due to low assay sensitivity of the trial, butthe complete absence of trends suggestive of efficacy for , H perforatum is noteworthy.

JAMA. 2002;287:1807-1814

View Full Text


Author/Article Information



Author Affiliations Coordinating Center, Duke
University Medical Center, and Duke Clinical Research
Institute. Jonathan R. T. Davidson, MD, Kishore M.
Gadde, MD, John A. Fairbank, PhD, K. Ranga Rama
Krishnan, MD, Robert M. Califf, MD, Cynthia Binanay,
BSN. Research Triangle Institute. Corette B. Parker,
DrPH, Norma Pugh, MS, Tyler D. Hartwell, PhD. National
Institute of Mental Health. Benedetto Vitiello, MD, Louise
Ritz, MBA, Joanne Severe, MS. Clinical Sites. Jonathan
O. Cole, MD (Harvard Medical School, McLean Hospital,
Belmont, Mass); Charles de Battista, MD (Stanford
University, Palo Alto, Calif); P. Murali Doraiswamy, MD
(Duke University Medical Center, Durham, NC); John P.
Feighner, MD (Feighner Research Institute, San Diego,
Calif); Paul Keck, MD (University of Cincinnati, Cincinnati,
Ohio); Jeffrey Kelsey, MD, PhD (Emory University Medical
School, Atlanta, Ga); Khae-Ming Lin, MD (University of
California, Los Angeles); Peter D. Londborg, MD (Summit
Research Network, Seattle, Wash); Charles B. Nemeroff,
MD, PhD (Emory University Medical School, Atlanta, Ga);
Alan F. Schatzberg, MD (Stanford University, Palo Alto,
Calif); David V. Sheehan, MD (University of South Florida,
Tampa); Ram K. Srivastava, MD (Eastside
Comprehensive Medical Services, New York, NY); Leslie
Taylor, MD (Dean Foundation and University of Wisconsin,
Madison); Madhukar H. Trivedi, MD (University of Texas
Southwestern Medical Center, Dallas); Richard H. Weisler,
MD (Duke University Medical Center, Durham, NC, and
private practice, Raleigh, NC).

Corresponding Author and Reprints: Jonathan R. T.
Davidson, MD, Duke University Medical Center, Box
3812, Durham, NC 27710 (e-mail:
jonathan.davidson@duke.edu).

Financial Disclosures: Dr Davidson holds stock in
Pfizer, American Home Products, GlaxoSmithKline,
Procter and Gamble, and Triangle Pharmaceuticals; has
received speaker fees from Solvay, Pfizer,
GlaxoSmithKline, Wyeth-Ayerst, Lichtwer, and the
American Psychiatric Association; has been a scientific
advisor to Allergan, Solvay, Pfizer, GlaxoSmithKline,
Forest Pharmaceuticals Inc, Eli Lilly, Ancile, Roche,
Novartis, and Organon; has received research support
from the National Institute of Mental Health (NIMH), Pfizer,
Solvay, Eli Lilly, GlaxoSmithKline, Wyeth-Ayerst, Organon,
Forest Pharmaceuticals Inc, PureWorld, Allergan, and
Nutrition 21; has received drugs for studies from Eli Lilly,
Schwabe, Nutrition 21, PureWorld Botanicals, and Pfizer;
and has received royalties from MultiHealth Systems Inc,
Guilford Publications, and the American Psychiatric
Association. Dr Keck has been a consultant for and
received grant support from Pfizer. Dr Kelsey has received
research support from Abbott Laboratories, Bristol-Myers
Squibb, Cyberonics, Eli Lilly, Forest Pharmaceuticals Inc,
GlaxoSmithKline, Merck, Mitsubishi, Organon, Pfizer,
Pharmacia-Upjohn, Sanofi, Solvay, and Wyeth-Ayerst; has
been a member of the speakers bureau for Abbott
Laboratories, Bristol-Myers Squibb, Forest
Pharmaceuticals Inc, GlaxoSmithKline, Pfizer,
Pharmacia-Upjohn, Solvay, and Wyeth-Ayerst; and has
been a consultant for Eli Lilly, Skila Inc, and Wyeth-Ayerst.
Dr Nemeroff has been a consultant for Abbott
Laboratories, Acadia Pharmaceuticals, AstraZeneca,
Bristol-Myers Squibb, Cypress Biosciences, Forest
Laboratories, Janssen Pharmaceuticals, Eli Lilly, Merck,
Neurocrine Biosciences, Organon, Otsuka,
Pharmacia-Upjohn, Sanofi, GlaxoSmithKline, Somerset,
Vela Pharmaceuticals, and Wyeth-Ayerst; has received
grant support from Abbott Laboratories, AstraZeneca,
Bristol-Myers Squibb, Forest Laboratories, Janssen
Pharmaceuticals, Eli Lilly, National Alliance for Research
on Schizophrenia and Depression, National Institute of
Mental Health, Organon, Pfizer, Pharmacia-Upjohn,
GlaxoSmithKline, Solvay, the Stanley Foundation and
National Alliance of the Mentally Ill, and Wyeth-Ayerst; and
has served on the speakers bureau of Abbott
Laboratories, AstraZeneca, Bristol-Myers Squibb, Forest
Laboratories, Janssen Pharmaceutica, Eli Lilly, Organon,
Pfizer, Pharmacia-Upjohn, GlaxoSmithKline, and
Wyeth-Ayerst. Dr Weisler has received grant support for,
served on the speakers bureau of, consulted for, and owns
stock in Pfizer. Dr Schatzberg has served as a consultant
to Eli Lilly, GlaxoSmithKline, Wyeth-Ayerst, Forest
Laboratories, Organon, Solvay, and Pfizer. Dr Trivedi has
received grant support from Abbott Laboratories, Akzo
Nobel, Bayer, Bristol-Myers Squibb, Eli Lilly, Forest
Laboratories, GlaxoSmithKline, Janssen Pharmaceutica,
Johnson and Johnson, NIMH, Mead Johnson,
Parke-Davis, Pfizer, Pharmacia-Upjohn, and
Wyeth-Ayerst. Dr de Battista has served on the speakers
bureau of Abbott Laboratories, Bristol-Myers Squibb,
Cephalon, Eli Lilly, Forest Laboratories, GlaxoSmithKline,
Organon, Pharmacia-Upjohn, Pfizer, and Wyeth-Ayerst;
has received grants or research support from
Bristol-Myers Squibb, Cephalon, Eli Lilly, NARSAD, NIMH,
Nancy Pritzker Network, Pharmacia-Upjohn,
GlaxoSmithKline, and Wyeth-Ayerst; has been a consultant
for Bristol-Myers Squibb, Corcept Therapeutics Inc, Eli
Lilly, GlaxoSmithKline, and Wyeth-Ayerst; and is a major
stockholder in Corcept Therapeutics Inc. Dr Krishnan has
received grant support from Eisai, Novartis, Pfizer, and
Forest Laboratories and has served as a consultant to
Abbott Laboratories, American Home Products,
GlaxoSmithKline, Merck, Organon, Pfizer, Vela
Pharmaceuticals, and Synaptic. Dr Doraiswamy has
received research grants, honoraria, or both from Pfizer,
Merck, GlaxoSmithKline, Johnson and Johnson,
Wyeth-Ayerst, Organon, Forest Laboratories, and Eli Lilly
and has received research support from NIMH.

Author Contributions: As primary investigator of the
study, Dr Davidson had full access to all data and takes
responsibility for the integrity of the data and accuracy of
the data analysis.

Study concept and design: Davidson, Hartwell, Fairbank,
Vitiello, Kelsey, Nemeroff, Weisler, Srivastava, Califf,
Trivedi, Londborg, Krishnan, Gadde, Taylor, Cole,
Doraiswamy.

Acquisition of data: Davidson, Parker, Fairbank, Ritz,
Keck, Kelsey, Nemeroff, Weisler, Binanay, Trivedi, de
Battista, Londborg, Gadde, Feighner, Taylor, Cole,
Doraiswamy, Sheehan, Lin.

Analysis and interpretation of data: Davidson, Pugh,
Parker, Fairbank, Vitiello, Severe, Nemeroff, Schatzberg,
Califf, Londborg, Krishnan, Gadde.

Drafting of the manuscript: Davidson, Parker, Vitiello,
Severe, Nemeroff, Srivastava, Trivedi, de Battista, Gadde.

Critical revision of the manuscript for important
intellectual content: Davidson, Hartwell, Pugh, Parker,
Fairbank, Vitiello, Ritz, Keck, Kelsey, Nemeroff, Weisler,
Srivastava, Schatzberg, Binanay, Califf, Trivedi, Londborg,
Krishnan, Gadde, Feighner, Taylor, Cole, Doraiswamy,
Sheehan, Lin.

Statistical expertise: Hartwell, Pugh, Parker.

Obtained funding: Davidson, Hartwell, Fairbank,
Nemeroff, Califf.

Administrative, technical, or material support: Davidson,
Parker, Fairbank, Vitiello, Ritz, Severe, Keck, Kelsey,
Nemeroff, Weisler, Schatzberg, Binanay, Califf, Trivedi, de
Battista, Londborg, Krishnan, Gadde, Taylor, Cole,
Doraiswamy, Sheehan, Lin.

Study supervision: Vitiello, Weisler, Srivastava,
Schatzberg, Binanay, Trivedi, Londborg, Gadde, Feighner,
Cole, Lin.

Funding/Support: The research was supported by
contract N01MH70007 from the National Center for
Complementary and Alternative Medicine and the National
Institute of Mental Health to Duke University Medical
Center (Dr Davidson). Study medications were donated by
Lichtwer Pharma and Pfizer.

Acknowledgment: We acknowledge the guidance of the
following members of the study scientific advisory board:
Joseph Betz, PhD (US Food and Drug Administration,
Rockville, Md), Jacques Bradwejn, MD (University of
Ottawa, Ontario, Canada), Samuel Gershon, MD
(University of Pittsburgh Medical Center, Pittsburgh, Pa),
Robert Golden, MD (University of North Carolina, Chapel
Hill), Jeffrey A. Lieberman, MD (University of North
Carolina, Chapel Hill), Lydia Lewis (National Depressive
and Manic-Depressive Association, Chicago, Ill), John E.
Overall, PhD (University of Texas Health Sciences Center,
Houston), and Richard Shader, MD (Tufts University,
Boston, Mass). We are also indebted to Miriam Gibbon,
MSW, and Janet Williams, DSW (Columbia University
Biometrics Unit, New York, NY), Marguerite Evans, MS
(National Center for Complementary and Alternative
Medicine, Bethesda, Md), William Harlan, MD (National
Institutes of Health, Bethesda, Md), Grayson Norquist, MD
(National Institute of Mental Health, Bethesda, Md),
Patricia Gibbons (National Institute of Mental Health),
Geoffrey Chung, PhD (National Institutes of Health),
Christine Swanson, PhD (National Institutes of Health
Office of Dietary Supplements, Bethesda, Md), Deborah
Roth, MSPH, Judith Kramer, MD, Rebecca Arias, BS, and
Isa Lamerton, BA (Duke Clinical Research Institute,
Durham, NC); Donna Medeiros, BS, Jim Wright, Jr, BA,
and Deborah McFadden, MBA (Research Triangle
Institute, Research Triangle Park, NC); and the National
Institute of Mental Health data and safety monitoring board.
The original protocol was designed by the National
Institutes of Health Office of Complementary and
Alternative Medicine and was subsequently adapted
according to input from the investigators, scientific
advisors, and data and safety monitoring board. Conduct
of the study, analysis of data, and approval of the
manuscript were undertaken with participation between
the investigators, the National Institutes of Health, and the
scientific advisors by means of conference calls and
meetings.

 

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