Clinical development of dietary supplements: the perils of starting at phase III

Fitoterapia
Josh Berman

Abstract

Dietary supplements are in worldwide use particularly for diseases for which conventional agents are ineffective. Many of the diseases have subjective endpoints and variable natural histories which lead to large placebo effects. Phase III studies with their large resource requirements should not be undertaken until the commonly used dose of the dietary supplement has been evaluated vs placebo, and if necessary raised until specific efficacy is demonstrated, in phase II testing. If phase II tests precede phase III evaluation, a product destined to fail will not consume important resources, and the optimum dose of products destined to succeed can be identified.

References

Feb 9, 2002·Science·Predrag PetrovicMartin Ingvar
Apr 10, 2002·JAMA : the Journal of the American Medical Association·UNKNOWN Hypericum Depression Trial Study GroupRichard H Weisler
Nov 11, 2005·The Journal of Neuroscience : the Official Journal of the Society for Neuroscience·Fabrizio BenedettiJon-Kar Zubieta
Apr 9, 2008·BMJ : British Medical Journal·Ted J KaptchukAnthony J Lembo
Sep 11, 2009·Annals of Neurology·Petra KaufmannUNKNOWN QALS Study Group

❮ Previous
Next ❯

Citations

Jul 13, 2011·The Journals of Gerontology. Series A, Biological Sciences and Medical Sciences·James M SmoligaJoseph A Baur
Jan 10, 2020·FASEB Journal : Official Publication of the Federation of American Societies for Experimental Biology·Barbara C SorkinGuido F Pauli

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

Amyotrophic Lateral Sclerosis : Official Publication of the World Federation of Neurology Research Group on Motor Neuron Diseases
ALSUntangled Group
Journal of Cataract and Refractive Surgery
Elizabeth Yeu, Richard Grostern
BMJ : British Medical Journal
T Everett Julyan
Lancet
Alison Sally PoultonRalph Nanan
© 2021 Meta ULC. All rights reserved