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Treating Osteoarthritis with Dietary Supplements-Part V

(3/11/13)- The U.S. Preventive Services Task Force recommended against the use of low or moderate doses of supplements containing both vitamin D and calcium, after concluding they don't work to prevent fractures and might increase the risk of kidney stones.

It said there was not enough clinical data to determine whether high doses, or those above 400 international units of vitamin D and 1,000 milligrams of calcium, are effective.

(2/3/12)- Researchers led by rheumatologist Daniel O. Clegg, M.D. of the University of Utah School of Medicine, conducted the 4-year primary GAIT study at 16 sites, that we referred to in our item dated 12/26/00 below.

The results were published in the February 22, 2006 edition of the New England Journal of Medicine. The results showed that the popular dietary supplement combination of glucosamine plus chondroitin sulfate did not provide significant relief from osteoarthritis pain among all participants.

A smaller subgroup of study participants with moderate-to-severe pain showed significant relief with the combined supplements.

(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"

by Allan Rubin and Harold Rubin, MS, ABD, CRC, guest lecturer

updated March 11, 2013

http://www.therubins.com

To e-mail: hrubin12@nyc.rr.com or allanrubin4@gmail.com

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