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This is late news (Nov last year), but the boss thought its still worth posting as it was quite a noteworthy study:
Press release from the American College of Rheumatology: GLUCOSAMINE AND CHONDROITIN SULFATE MAY BE USEFUL FOR PATIENTS WITH MODERATE TO SEVERE PAIN FROM KNEE OSTEOARTHRITIS
Quote:
SAN DIEGO, CALIFORNIA – Glucosamine and chondroitin sulfate may be an effective combination in reducing pain associated with osteoarthritis of the knee, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in San Diego, California.
Glucosamine is an amino sugar naturally produced by the body and widely distributed to the connective tissues, including cartilage. The body also produces chondroitin sulfate, a complex carbohydrate molecule which, among its other roles, helps retain water in cartilage. Over the past 25 years, oral glucosamine and chondroitin sulfate, derived from animal products, have become popular dietary supplements with patients attempting to combat the cartilage wear and tear associated with osteoarthritis. The precise biologic mechanisms that enable oral supplements to emulate the body's natural products, however, remain undefined.
GAIT (The Glucosamine/Chondroitin Arthritis Intervention Trial) funded by the National Institutes of Health, was designed to rigorously assess the effectiveness and safety of these supplements when taken separately or in combination. Almost 1,600 patients with painful knee osteoarthritis were recruited from 16 U.S. academic rheumatology centers for the study. The patients, who had experienced significant knee pain for more than six months and had x-ray evidence of knee osteoarthritis, were evaluated at the beginning of the study, and at weeks 4, 8, 16 and 24. Each was randomly assigned to receive glucosamine hydrochloride, sodium chondroitin sulfate, both supplements, celecoxib, or placebo therapy and allowed up to 4,000 mg daily of acetaminophen. The primary outcome measure was a 20 percent improvement in knee pain by week 24.
“As expected, celecoxib improved knee pain in patients with osteoarthritis. For the study as a whole, the supplements were not shown to be effective; however, an exploratory analysis suggested that the combination of glucosamine and chondroitin sulfate might be effective in osteoarthritis patients who had moderate to severe knee pain,” stated Daniel O. Clegg, MD, Chief, Division of Rheumatology, University of Utah School of Medicine, Salt Lake City, Utah. Adverse events that were seen in GAIT were generally mild and evenly distributed across all groups. Dr. Clegg continued, “Given the results of this study, patients might want to discuss treatment options with their physicians.”
Here is the conference abstract: The Efficacy of Glucosamine and Chondroitin Sulfate in Patients with Painful Knee Osteoarthritis (OA): The Glucosamine/chondroitin Arthritis Intervention Trial (GAIT)
Daniel O. Clegg 1, Domenic J. Reda 2, Crystal L. Harris 3, Marguerite A. Klein 4, for the GAIT Investigators. 1 University of Utah, Salt Lake City, UT; 2 VACSP, Hines, IL; 3 VACSP, Albuquerque, NM; 4 NCCAM/NIH, Bethesda, MD
Quote:
PURPOSE: Glucosamine (G) and chondroitin sulfate (CS) are widely promoted to “reduce joint pain and provide support for healthy cartilage and joint function.” GAIT was designed to rigorously assess the efficacy and safety of these agents alone and in combination. G and CS were required to meet pharmaceutical standards as GAIT was conducted under an Investigational New Drug application.
METHODS: Patients were =40 years of age with knee pain (WOMAC Pain 125-400 mm) of at least 6 months duration and x-ray evidence of knee OA [Kellgren-Lawrence (KL) Grades 2 or 3]. Patients were randomly assigned double-blind to placebo (P); G(Glucosamine HCl 500 mg) tid; Sodium CS 400 mg tid; G+CS at the above doses tid; or celecoxib (CE) 200 mg daily. All patients were allowed up to 4000 mg daily of acetaminophen (APAP) as rescue analgesia, except within 24 hours of study visits. Allocation was stratified by Center and by WOMAC Pain severity (125-300mm and 301-400mm). Patients were evaluated at baseline and weeks 4, 8, 16 and 24. The primary outcome measure was a 20% improvement from baseline in WOMAC Pain at week 24. Adverse events were documented at each visit. Analysis was based on intention-to-treat.
RESULTS: 3238 patients were screened at 16 US academic rheumatology centers. 1583 were randomized and 1258 (80%) completed the study. Baseline characteristics were: mean age 58.6 years, BMI 31.7 kg/m 2 , OA symptoms 10 years, 64% female, summed mean WOMAC Pain 236±73mm (206mm for 125-300mm stratum, 341mm for 301-400mm stratum), 59% KL Grade 2, and 78% were in the 125-300mm WOMAC Pain stratum and were evenly distributed across all arms.
The response rate for CE (70.1%) was higher than the response rate for P (60.1%) in the primary outcome analysis of all patients (p=0.008). In the 301-400 mm WOMAC pain stratum, the response rate for G+CS (79.2%) was higher than P (54.3%) (p=0.002). Secondary outcomes in the 301-400 mm stratum, including 50% WOMAC Pain response, WOMAC Stiffness, WOMAC Function, HAQ, patient assessments, and use of rescue APAP all demonstrated changes consistent with the primary outcome. Adverse events were generally mild and evenly distributed among the groups.
CONCLUSIONS : Combination G+CS is effective in treating moderate to severe knee pain due to OA. The lack of response in patients with mild pain may be due to a floor effect, limiting ability to detect response. All study agents were well tolerated.
Here is a different take on the same study just released from Associated Press: Study: Supplements Fail to Ease Arthritis
February 23, 2006 02:00:33 AM PST
Quote:
When researchers set out to test whether two nutritional supplements helped relieve arthritis pain, many were hopeful that a clear-cut answer would emerge about the popular yet unproven alternative treatment.
Previous smaller studies suggested the supplements — glucosamine and chondroitin sulfate — were effective at treating aching joints. But many of the studies were flawed or paid for by the supplement makers.
The latest study, funded by the National Institutes of Health and published in Thursday's New England Journal of Medicine, found the supplements overall did little to ease osteoarthritis, the most common form of arthritis.
But patients who had more severe knee throbbing seemed to show some improvement.
"We still have a bit of a conundrum," said Dr. Tim McAlindon, a Tufts University rheumatologist who had no role in the research.
Osteoarthritis afflicts more than 20 million Americans and that number is expected to double in the next two decades as baby boomers age. Osteoarthritis is a degenerative joint disease that affects the knees, hips, back and the small joints in the fingers.
Based on the findings, people with severe arthritis should talk to their doctors about trying the supplements short-term to see if they work, said rheumatologist Dr. Daniel Clegg of the University of Utah, who led the study.
Worldwide sales of glucosamine and chondroitin topped $1.7 billion last year, according to the Nutrition Business Journal, which tracks supplements.
The supplements — made from animal cartilage and shellfish — have had even wider appeal amid safety concerns over certain painkillers, including the blockbuster arthritis drug Vioxx, which was pulled from the market in 2004.
At least 5 million Americans use the two supplements either alone or together, government figures show. President Bush used to take the supplements to relieve stiffness in his joints, but no longer uses them.
The supplements showed no serious side effects during the government's six-month study, considered the largest and most rigorous test of the two supplements to date. But the scientists didn't address the safety of longer-term use.
The arthritis research is the third major study in a year to find no overall benefit from some of the most popular nutritional supplements. Recently, research showed the herb saw palmetto didn't reduce symptoms of an enlarged prostate, and last year a study indicated echinacea didn't prevent or treat colds.
Unlike drugs, such supplements are loosely regulated, and their makers don't have to prove the products are safe or effective.
Irene Schwartzburt, a retired teacher from Plainview, N.Y., said she plans to keep using the supplements. The 72-year-old said the remedies relieved the "sticking pain" in her right knee when painkillers failed.
"I want to stay active," she said. "The supplements work for me so why not continue with them?"
In the government study, 1,583 patients with arthritis knee pain received one of five treatments: either glucosamine or chondroitin, a combination of both, the painkiller Celebrex or dummy pills. Neither the doctors nor patients knew which treatment was given.
After six months, patients filled out a questionnaire to determine how many felt a 20 percent reduction in pain. Researchers found the supplements when taken alone or together were no more effective than dummy pills at pain relief.
Sixty percent who took the dummy medication had reduced pain compared with 64 percent who took glucosamine, 65 percent who took chondroitin and 67 percent who took the combo pills. These differences were so small that they could have occurred by chance alone.
The drug Celebrex did reduce pain — 70 percent reported improvement — affirming the study's validity. However, the drug is being studied to see if it's safe for people at risk of heart problems.
Of the 354 people with moderate to severe pain, 79 percent who took both supplements reported relief compared with 54 percent who took the dummy pills and 69 percent who took Celebrex.
In a journal editorial, Dr. Marc Hochberg of the University of Maryland noted the study's limitations: a high dropout rate (20 percent) and a whopping 60 percent who said the dummy pills made them feel better — double the usual placebo effect. Hochberg has received consulting fees from Pfizer Inc., which makes Celebrex, and Merck & Co., which made Vioxx.
Clegg and 10 other researchers in the study reported receiving fees or grant support from Pfizer or McNeil Consumer & Specialty Pharmaceuticals, which makes Tylenol.
The Council for Responsible Nutrition, which represents dietary supplement makers, said it was pleased about the positive findings in the severe arthritis group.
For what its worth. Glucosamine (bought from the pet shop) is the only things that is keeping my elderly German Shepherd dog on her feet. If we stop giving it to her she starts falling around with her legs giving in. A few hours after recommencing she was walking again.
Re: Glucosamine / Chondroitin in Osteoarthritis - the definitive study
I have some patients swear by it, others ask me if its helpful. From the above study I stil don't know much about it. Drugs are complex issue as even the medical profession knows little and trusts what ever is going...
millionairs in drug industry can fudge studies as much as they wish- I'll trust a healthy preventative Orgainc diet before I'll trust a drug study, sorry. Exercise for healthy joints, too ofcourse. The rest you just accommodate with orthotic devices which I understand alot more about how they actually function.
Re: Glucosamine / Chondroitin in Osteoarthritis - the definitive study
Generally the dose is 1000mg of the glucosamine component. Some high potency tablets are made 1500mg and again some patients have been advised to take 2000mg.
Then there is the dosage / price per tablet . Some are 1 a day and others can be 2 at each meal. I like the 1 a day option.
Be aware there is glucosamine sulfate and glucosamine hydrochloride. Obviously people allergic to sulfonamides won't want to take the sulfate one.
And... most forms are derived from shark cartiledge, so no good for those allergic to seafoods.
But quiz the health food store or do a google and find out more.
Re: Glucosamine / Chondroitin in Osteoarthritis - the definitive study
Hold your horses, Nelly.
Glucosamine is made from glucose and an amine added. That is amonia less a hydrogen atom. It occurs in everyone and as far as I know everthing mammalian.
The big debate lies in the stabilising group, ie. sulphate vs. the hydrorochloride.
If ones looks at all the papers, the hydrochloride comes a distant second on the asorbance scale. It is chraper but the studies show it to have a more random absorbance 11-78% versus a 80+ with the sulphate.
I have never read that a sulphate group is resopnsible for a sulphite (read allergy) group. Different kettle of fish, but willing to learn.
AS for dose, 1500 mg per day is the only dose. Anymore or any less is useless, taken for a minimum of three months, or possibly 6 months, before saying it is no good.
For added results add the shark cartilage.
Remember this is for the knee.
There should be major data withn three months on all other joints in a study for people with OA.
I must add that the GOD's speak for pain relief, but 30% of all people with OA have NO Pain!
Who knows those who experince a dramatic relief (taking the pills) are not going through one of those periods when the pain is better (central Control)/(burn out as in rheumatoid arthritis)/ versus actual benefits of the pills.
Having said that, there is MRI evidence that the combined pill taking makes the body attempt to make new cartilage in the knee.
Summary
Long-term follow-up studies on the effects of glucosamine preparations are still awaited. At present, only short-term results are available. They are known to relieve pain and decrease the rate of joint space narrowing clinically in osteoarthritis of knee, whilst the side effects are less when compared to the anti-inflammatory drugs and even placebos. It is probably safe – but there is no good evidence that it works. It would be ideal to have a medication that is a normal constituent of the human cartilage, which modifies the natural history of the disease. It is possible that long-term clinical studies with glucosamine may result in modifications to the indications for joint surgery or the time patients can live with osteoarthritis before developing substantial disability.
Background: The effectiveness of glucosamine sulfate as a symptom and disease modifier for osteoarthritis is still under debate.
Objective: To assess whether glucosamine sulfate has an effect on the symptoms and structural progression of hip osteoarthritis during 2 years of treatment.
Design: Randomized, controlled trial.
Setting: Primary care in the Netherlands.
Patients: 222 patients with hip osteoarthritis who were recruited by their general practitioner. Patients were eligible if they met the American College of Rheumatology clinical criteria for hip osteoarthritis.
Intervention: 2 years of treatment with 1500 mg of oral glucosamine sulfate or placebo once daily.
Measurements: Primary outcome measures were Western Ontario and McMaster Universities (WOMAC) pain and function subscales over 24 months and joint space narrowing after 24 months. The main secondary outcome measures were WOMAC pain, function, and stiffness after 3, 12, and 24 months.
Results: At baseline, both groups were similar in demographic and clinical variables. Overall, WOMAC pain did not differ (mean difference [glucosamine sulfate minus placebo], –1.54 [95% CI, –5.43 to 2.36]), nor did WOMAC function (mean difference, –2.01 [CI, –5.38 to 1.36]). Joint space narrowing also did not differ after 24 months (mean difference, –0.029 [CI, –0.122 to 0.064]). Only 1 of the sensitivity analyses, based on extreme assumptions regarding missing assessments due to total hip replacement, provided results consistent with a glucosamine effect.
Limitations: Twenty patients had total hip replacement during the trial. Half of the patients had a Kellgren and Lawrence score of 1.
Conclusion: Glucosamine sulfate was no better than placebo in reducing symptoms and progression of hip osteoarthritis.
Am I to understand that 30% of your patients w/ OA of the knee who are taking 1500 mg G/C combination have NO PAIN?
With all due respect (if this is what you are saying) I find this very unlikely.
I would be very willing to go on record as saying that there is no treatment out there that renders 30% of patients suffering from OS of the knee total pain relief.
Steve
__________________
DrSArbes
Fellow American College of Foot & Ankle Surgeons
Board Certified Foot & Ankle Surgery, ABPS
Green Bay, Wisconsin, USA
Glucosamine / Chondroitin in Osteoarthritis - the definitive study
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