Treating Osteoarthritis with Dietary Supplements-Part V
(5/11/05)- The results of two large studies of elderly women in Scotland and England indicated that taking calcium and Vitamin D does not prevent fractures in older people who have broken a bone or who have osteoporosis. The results of the studies were published in The Lancet and the British medical journal BMJ.
Writing in The Lancet the authors report, " Our trial indicates that routine supplementation with calcium and Vitamin D3, either alone, or in combination, is not effective in prevention of further fractures in people who have had a recent low-trauma fracture". Just people older than 79, a majority of them being women with previous bone injuries were included in the studies.
About 10 million American older than 50 develop osteoporosis each year, and 1.5 million break bones because of it. The larger of the two studies followed more than 5,000 Scots who had broken bones in the last decade. They were separated into four groups with the subjects receiving large doses of calcium, vitamin D, a combination of the two or a placebo.
After several years, the researchers found that all four groups had roughly the same number of fractures, mostly to the hip. Recently scientists have been working on increasing bone density and improving bone fracture healing speed through various electric stimulation processes.
(12/26/00)-The following as taken from a press release from the National Institute of Health dated December 11, 2000:
"The first U.S. multicenter study to investigate
glucosamine and chondroitin, two dietary supplements widely
marketed in the United States as effective natural remedies for
osteoarthritis (OA), is about to begin. In September 1999, the
National Center for Complementary and Alternative Medicine
(NCCAM) in collaboration with the National Institute of Arthritis
and Musculosketal and Skin Diseases (NIAMS) announced a contract
award to the University of Utah to determine conclusively whether
glucosamine or chondroitin are more effective than placebos for
treating knee pain associated with OA. The study is now enrolling
participants.
This study, totaling $14 million will also determine whether the
combination of these two substances is more effective than
glucosamine or chondroitin alone. Only a few rather small studies
have been published in the worldwide literature, to-date,"
according to Stephen E. Straus, M.D., NCCAM Director. "Those
short-term, controlled clinical trials suggested that,
glucosamine is effective in relieving pain and increasing range
of motion in patients with osteoarthritis. This major new study
will provide compelling answers about the safety and
effectiveness of glucosamine and/or chondroitin, to the nearly 40
million Americans who suffer with osteoarthritis," Dr.
Straus added.
Since the contract was awarded, protocol development has been
completed so that the study -- now called the
Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT), will
proceed. The study investigators held a "kick-off"
meeting September 27-29, 2000.
The ambitious study will be a 24 week, placebo-controlled,
parallel, double blind, five-arm clinical trial. A total of 1588
individuals will be enrolled in the study at thirteen clinical
centers. The efficacy of glucosamine alone, chondroitin alone,
and the combination of glucosamine and chondroitin will be
compared to placebo in treating knee pain of osteoarthritis (OA).
Moreover, in order to verify that the study is able to detect
significant treatment effects, celecoxib -- an established
effective conventional treatment for OA will also be compared to
placebo. Patients will be able to take acetaminophen if they
experience severe pain.
The study will be conducted in three phases. Phase I of the study
has already been completed. This phase involved refining the
study design, hiring personnel, developing operating policies and
procedures, testing the electronic data entry system, obtaining
local Institute Review Board (IRB) approvals and securing the
Investigational New Drug (IND) exemption for the study from the
Food and Drug Administration. Phase II is the enrollment and
treatment phase, which will take approximately 33 months. During
this phase patients will be recruited and evaluated, study data
will be checked for errors and completeness, and reports will be
prepared on patient recruitment, the status of data collection,
and quality control. Phase III is expected to last 6 months,
which will include data clean-up, analysis and preparation of the
final report due in March 2005.
To thoroughly evaluate whether these substances impact the
progression of knee OA, an additional study or
"sub-study" has been added to the primary GAIT trial.
In this sub-study, approximately one-half of patients enrolled in
the primary GAIT trial will receive blinded treatment (whereby
patients do not know the specific treatment they receive) for an
additional eighteen months. Specially positioned knee radiographs
will be obtained at the beginning of the study and after one and
two years of treatment. These films will be compared and
evaluated for any structural change among the five groups.
Two-year clinical efficacy and safety data will also be
collected. This sub-study is jointly funded by NCCAM and NIAMS.
Daniel O. Clegg, M.D, Professor of Medicine and Chief of the
Division of Rheumatology, University of Utah School of Medicine,
will direct the coordinating center, which will oversee the
research, patient recruitment, and data collection efforts of
thirteen study centers across the country.
The participating 13 study centers and contact numbers for study
coordinators are as follows:
--University of Alabama at Birmingham, Birmingham AL (Larry W.
Moreland, M.D.)
Melinda Robertson (205) 934-7423
--Cedars-Sinai Medical Center, Los Angeles, CA (Michael Weisman,
M.D.)
Carol Joseph (310) 358-5757
--University of California, San Francisco, San Francisco, CA
(Nancy Lane, M.D.)
Rosita Stuart-Thiessen (415) 206-8644
--Indiana University, Indianapolis, IN (John Bradley, M.D.)
Heather Countryman (317) 278-0555
--Arthritis Research Center Foundation, Wichita, KS (Frederick
Wolfe, M.D.)
Nancy Flowers (315) 263-2125
--Hospital For Joint Diseases, New York, NY (Clifton Bingham,
III, M.D.)
Vivian Abellana (212) 598-6650
--Case Western Reserve University, Cleveland, OH (Michele Hooper,
M.D.)
Traci Tomaro (216) 844-5253
--University of Pennsylvania, Philadelphia, PA (H. Ralph
Schumacher, Jr., M.D.)
Allison Van Dyke (215) 823-4480
--Arthritis Consultation Center at Presbyterian Hospital of
Dallas, Dallas, TX (John Cush, M.D.)
Emma Barnboym (214) 345-8067
--University of Pittsburgh, Pittsburgh, PA (Susan Manzi, M.D.)
Michele Pauli (412) 692-4269
--University of Utah, Salt Lake City, UT (Christopher Jackson,
M.D.)
Sheldon Smith (801) 581-4911
--Virginia Mason Research Center, Seattle, WA (Daniel Furst,
M.D.)
Eching Voon (206) 223-6836 extension 2
--University of Nebraska Medical Center, Omaha, NE (James O'Dell,
M.D.)
Gail Paulsen (402) 559-4873
The Biostatistical Center is located at the VA Hospital, Hines,
IL (Domenic Reda, M.S.), and The Pharmacy Center at
the VA Medical Center, Albuquerque, NM (Carol Fye, R.Ph., M.S.)
will also be involved in the study.
The glucosamine hydrochloride used in this study is manufactured
by Pfanstiehl Laboratories located in Waukegan, IL and donated by
Wilke Resources. The chondroitin sulfate is manufactured and
donated by Bioiberica, S.A. located in Barcelona, Spain.
Open-label acetaminophen 500mg capsules, donated by McNeil
Consumer Healthcare, will also be provided to each center.
For information regarding patient recruitment, please contact the
study center closest to you.
The National Center for Complementary and Alternative Medicine
(NCCAM) is dedicated to exploring complementary and alternative
medical (CAM) practices in the context of rigorous science;
training CAM researchers and disseminating authorative
information. For additional information about NCCAM, please visit
our website at
http://nccam.nih.gov."
Please See: Herbs and Dietary
Supplements-St. John's Wort-Part I
St. John’s Wort -Herbs and Dietary
Supplements-Part II-Ephedra
Phytomedicine or Herbalist-What is It?-Part
III
Herbal Medicine and Botanical Supplements
Caveat-Part IV
St John's Wort: Does It Help Treat
Depression-Part VI
Herbal Products: Use With Caution-Part
VII
Kava: Safety Alert-Part VIII
Herbal Usage for Hormone Replacement Therapy-Part
IX
Latest Research Questions the
Effectiveness of Herbal Supplements-Part X
FOR AN INFORMATIVE AND PERSONAL ARTICLE ON PRACTICAL SUGGESTIONS WHEN SELECTING A NURSING HOME SEE OUR ARTICLE "How to Select a Nursing Home"
Dated May 11, 2005
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