It is time to protect patients from 'vile and cynical exploitation' by the alternative medicines industry, argues a cancer expert in this week's BMJ.
It is estimated that up to 80% of all patients with cancer take a complementary treatment or follow a dietary programme to help treat their cancer, writes Jonathan Waxman, Professor of Oncology at Imperial College London.
Yet the rationale for the use of many of these approaches is obtuse - one might even be tempted to write misleading, he says.
Indeed the claims made by companies to support the sales of such products may be overtly and malignly incorrect and, in many cases, the products may be doctored by chemicals borrowed from the conventional pharmaceutical industry. The reason that these products are accessible to patients is that they are not subject to the testing of pharmaceuticals because they are classified as food supplements.
So why do patients take alternative medicines" Why is science disregarded" How can it be that treatments that don't work are regarded as life saving"
Waxman believes that it is because the complementary therapists offer something that doctors cannot offer - hope. If you eat this, take that, avoid this, and really believe this then we can promise you sincerely that you will be cured.
And if the patient is not cured, it is the patient who has failed, not the alternative therapy. The patient has let down the alternative practitioner and disappointed his family who have encouraged his 'treatment.'
As well as the complementary medicines they take, many patients will have changed their diets in order to cure their cancers, says the author. But although there is a strong dietary basis to the development of cancer, once cancer has been diagnosed no change in diet will lead to any improvement in cancer outcomes, he writes.
Why do patients change their diet" For some it is a way of taking back some control of a situation that is entirely out of their control, says Waxman. For others it is because of the pressure put on them by families, friends or vested interest groups to 'go organic.'
"It's time for legislation to focus on a particularly vulnerable section of our society and do something to limit the exploitation of our patients," he says. Why not subject the alternative medicines industry to the level of scrutiny that defines pharmaceuticals"
"Reclassify these agents as drugs - for this is after all how they are marketed - and protect our patients from vile and cynical exploitation whose intellectual basis, at best, might be viewed as delusional. The current EU initiative to bring forward legislation on this matter is welcomed."
Contact: Emma Dickinson
BMJ-British Medical Journal
четверг, 20 октября 2011 г.
понедельник, 17 октября 2011 г.
Brief Training In Meditation May Help In Pain Management
Living with pain is stressful, but a surprisingly short investment of time in mental training can help you cope.
A new study examining the perception of pain and the effects of various mental training techniques has found that relatively short and simple mindfulness meditation training can have a significant positive effect on pain management.
Though pain research during the past decade has shown that extensive meditation training can have a positive effect in reducing a person's awareness and sensitivity to pain, the effort, time commitment, and financial obligations required has made the treatment not practical for many patients. Now, a new study by researchers at the University of North Carolina at Charlotte shows that a single hour of training spread out over a three day period can produce the same kind of analgesic effect.
The research appears in an article by UNC Charlotte psychologists Fadel Zeidan, Nakia S. Gordon, Junaid Merchant and Paula Goolkasian, in the current issue of The Journal of Pain.
"This study is the first study to demonstrate the efficacy of such a brief intervention on the perception of pain," noted Fadel Zeidan, a doctoral candidate in psychology at UNC Charlotte and the paper's lead author. "Not only did the meditation subjects feel less pain than the control group while meditating but they also experienced less pain sensitivity while not meditating."
Over the course of three experiments employing harmless electrical shocks administered in gradual increments, the researchers measured the effect of brief sessions of mindfulness meditation training on pain awareness measuring responses that were carefully calibrated to insure reporting accuracy. Subjects who received the meditation training were compared to controls and to groups using relaxation and distraction techniques. The researchers measured changes in the subjects' rating of pain at "low" and "high" levels during the different activities, and also changes in their general sensitivity to pain through the process of calibrating responses before the activities.
While the distraction activity - which used a rigorous math task to distract subjects from the effects of the stimulus - was effective in reducing the subject's perception of "high" pain, the meditation activity had an even stronger reducing effect on high pain, and reduced the perception of "low" pain levels as well.
Further, the meditation training appeared to have an effect that continued to influence the patients after the activity was concluded, resulting in a general lowering of pain sensitivity in the subjects - a result that indicated that the effect of the meditation was substantially different from the effect of the distraction activity.
The finding follows earlier research studies that found differences in pain awareness and other mental activities among long-time practitioners of mindfulness meditation techniques.
"We knew already that meditation has significant effects on pain perception in long-term practitioners whose brains seem to have been completely changed - we didn't know that you could do this in just three days, with just 20 minutes a day," Zeidan said.
In assessing the first experiment, the researchers were not terribly surprised to discover that meditation activity appeared to be affecting the experimental subjects' perception of pain because the researchers assumed that the change was mainly due to distraction, a well-known effect. However, subsequent findings began to indicate that the effect continued outside of the periods of meditation.
" When we re-calibrated their pain thresholds after the training had started and we found that they felt less pain, compared to the control subjects," Zeidan noted. "This was totally surprising because a change in general sensitivity was not part of our hypothesis at all.
"We were so surprised after the first experiment that we did two more. We thought that no one was going to listen to us because no one had done this before??¦ and we got a robust finding across the three experiments."
Zeidan stresses that the effect the researchers measured in the meditation subjects was a lessening of pain but not a lessening of sensation. The calibration results showed little change in the meditation subjects' sensitivity to the sensation of electricity, but a significant change in what level of shock was perceived to be painful.
"The short course of meditation was very effective on pain perception," Zeidan said. "We got a very high effect size for the periods when they were meditating.
"In fact, it was kind of freaky for me. I was ramping at 400-500 milliamps and their arms would be jolting back and forth because the current was stimulating a motor nerve. Yet they would still be asking, 'A 2?' ('2' being the level of electrical shock that designates low pain) It was really surprising," he said.
Zeidan suspects that the mindfulness training lessens the awareness of and sensitivity to pain because it trains subjects' brains to pay attention to sensations at the present moment rather than anticipating future pain or dwelling on the emotions caused by pain, and thus reduces anxiety.
"The mindfulness training taught them that distractions, feelings, emotions are momentary, don't require a label or judgment because the moment is already over," Zeidan noted. "With the meditation training they would acknowledge the pain, they realize what it is, but just let it go. They learn to bring their attention back to the present."
Though the results are in line with past findings regarding mindfulness practitioners, Zeidan says that the findings are important because they show that meditation is much easier to use for pain management than it was previously believed to be because a very short, simple course of training is all that is required in order to achieve a significant effect. Even self-administered training might be effective, according to Zeidan.
"What's neat here is that this is the briefest known way to promote a meditation state and yet it has an effect in pain management. People who want to make use of the technique might not need a meditation facilitator - they might be able to get the necessary training off the internet, " Zeidan said. "All you have to do is use your mind, change the way you look at the perception of pain and that, ultimately, might help alleviate the feeling of that pain."
The research was funded in part by a grant from the National Science Foundation. The article is available online in Pain, via sciencedirect.
A new study examining the perception of pain and the effects of various mental training techniques has found that relatively short and simple mindfulness meditation training can have a significant positive effect on pain management.
Though pain research during the past decade has shown that extensive meditation training can have a positive effect in reducing a person's awareness and sensitivity to pain, the effort, time commitment, and financial obligations required has made the treatment not practical for many patients. Now, a new study by researchers at the University of North Carolina at Charlotte shows that a single hour of training spread out over a three day period can produce the same kind of analgesic effect.
The research appears in an article by UNC Charlotte psychologists Fadel Zeidan, Nakia S. Gordon, Junaid Merchant and Paula Goolkasian, in the current issue of The Journal of Pain.
"This study is the first study to demonstrate the efficacy of such a brief intervention on the perception of pain," noted Fadel Zeidan, a doctoral candidate in psychology at UNC Charlotte and the paper's lead author. "Not only did the meditation subjects feel less pain than the control group while meditating but they also experienced less pain sensitivity while not meditating."
Over the course of three experiments employing harmless electrical shocks administered in gradual increments, the researchers measured the effect of brief sessions of mindfulness meditation training on pain awareness measuring responses that were carefully calibrated to insure reporting accuracy. Subjects who received the meditation training were compared to controls and to groups using relaxation and distraction techniques. The researchers measured changes in the subjects' rating of pain at "low" and "high" levels during the different activities, and also changes in their general sensitivity to pain through the process of calibrating responses before the activities.
While the distraction activity - which used a rigorous math task to distract subjects from the effects of the stimulus - was effective in reducing the subject's perception of "high" pain, the meditation activity had an even stronger reducing effect on high pain, and reduced the perception of "low" pain levels as well.
Further, the meditation training appeared to have an effect that continued to influence the patients after the activity was concluded, resulting in a general lowering of pain sensitivity in the subjects - a result that indicated that the effect of the meditation was substantially different from the effect of the distraction activity.
The finding follows earlier research studies that found differences in pain awareness and other mental activities among long-time practitioners of mindfulness meditation techniques.
"We knew already that meditation has significant effects on pain perception in long-term practitioners whose brains seem to have been completely changed - we didn't know that you could do this in just three days, with just 20 minutes a day," Zeidan said.
In assessing the first experiment, the researchers were not terribly surprised to discover that meditation activity appeared to be affecting the experimental subjects' perception of pain because the researchers assumed that the change was mainly due to distraction, a well-known effect. However, subsequent findings began to indicate that the effect continued outside of the periods of meditation.
" When we re-calibrated their pain thresholds after the training had started and we found that they felt less pain, compared to the control subjects," Zeidan noted. "This was totally surprising because a change in general sensitivity was not part of our hypothesis at all.
"We were so surprised after the first experiment that we did two more. We thought that no one was going to listen to us because no one had done this before??¦ and we got a robust finding across the three experiments."
Zeidan stresses that the effect the researchers measured in the meditation subjects was a lessening of pain but not a lessening of sensation. The calibration results showed little change in the meditation subjects' sensitivity to the sensation of electricity, but a significant change in what level of shock was perceived to be painful.
"The short course of meditation was very effective on pain perception," Zeidan said. "We got a very high effect size for the periods when they were meditating.
"In fact, it was kind of freaky for me. I was ramping at 400-500 milliamps and their arms would be jolting back and forth because the current was stimulating a motor nerve. Yet they would still be asking, 'A 2?' ('2' being the level of electrical shock that designates low pain) It was really surprising," he said.
Zeidan suspects that the mindfulness training lessens the awareness of and sensitivity to pain because it trains subjects' brains to pay attention to sensations at the present moment rather than anticipating future pain or dwelling on the emotions caused by pain, and thus reduces anxiety.
"The mindfulness training taught them that distractions, feelings, emotions are momentary, don't require a label or judgment because the moment is already over," Zeidan noted. "With the meditation training they would acknowledge the pain, they realize what it is, but just let it go. They learn to bring their attention back to the present."
Though the results are in line with past findings regarding mindfulness practitioners, Zeidan says that the findings are important because they show that meditation is much easier to use for pain management than it was previously believed to be because a very short, simple course of training is all that is required in order to achieve a significant effect. Even self-administered training might be effective, according to Zeidan.
"What's neat here is that this is the briefest known way to promote a meditation state and yet it has an effect in pain management. People who want to make use of the technique might not need a meditation facilitator - they might be able to get the necessary training off the internet, " Zeidan said. "All you have to do is use your mind, change the way you look at the perception of pain and that, ultimately, might help alleviate the feeling of that pain."
The research was funded in part by a grant from the National Science Foundation. The article is available online in Pain, via sciencedirect.
пятница, 14 октября 2011 г.
More Americans Turn To Lower-Cost Alternative Meds, Especially Whites
The use of complementary and alternative medicine (CAM) therapies experienced a significant growth in the United States in the last decade, and a new analysis finds that CAM use becomes more likely when access to conventional care has been restricted.
"In both 2002 and 2007, having unmet needs in medical care, or delayed care due to cost, was associated with a higher chance of CAM use," said lead author Dejun Su, Ph.D. "Importantly, for Americans without health insurance, who cannot afford medical care, CAM might be their last and only resort."
Su is director of the South Texas Border Health Disparities Center at the University of Texas-Pan American. He and his colleagues analyzed data from the 2007 National Health Interview Survey. Based on interviews with more than 23,000 adults, the NHIS showed more pronounced growth in CAM use among whites than among racial and ethnic minorities. This increased an already existing white-minority gap in CAM use, Su said.
Without counting prayer for health purposes, 33 percent of whites report using at least one CAM therapy, while 31.8 percent of Asian Americans, 20.1 percent of African-Americans and 16.9 percent of Hispanics report using these therapies.
The use of CAM rose across all these populations between 2002 and 2007, but at different rates. The increase was highest among whites and Asian Americans, at 18.1 percent and 17.2 percent, respectively. Use among African-Americans increased only 6.6 percent. Use among Hispanics increased only 1.01 percent.
"So far, we know little about how the difference in CAM use has influenced racial and ethnic disparities in health and mortality," Su said. "Research is urgently needed to understand the effectiveness, side effects and interactions of CAM therapies with conventional medicine."
Richard Nahin, Ph.D., senior advisor for Scientific Coordination and Outreach at the National Center for Complementary and Alternative Medicine (NCCAM), says that this study provides clarity to some differences in the use of CAM by various populations. However, he said, the authors neglected to mention one, perhaps crucial, explanation for these differences.
"There is, in fact, some evidence to suggest that the 2007 NHIS underestimated CAM use among Hispanics and non-Hispanic blacks," Nahin said. "For instance, some CAM products for which minority groups report substantial use in small local or regional surveys were not included in the 2002 or 2007 NHIS."
Nahin, whose research on CAM contributed to the 2007 NHIS, said, "Understanding this possibility, NCCAM is redesigning the CAM supplement to the 2012 NHIS. They hope to better capture the use of various unconventional therapies more likely to be used by minority groups."
Su D, Li L. Trends in the use of complementary and alternative medicine in the United States. J Health Care Poor Underserved 22(1), 2011.
"In both 2002 and 2007, having unmet needs in medical care, or delayed care due to cost, was associated with a higher chance of CAM use," said lead author Dejun Su, Ph.D. "Importantly, for Americans without health insurance, who cannot afford medical care, CAM might be their last and only resort."
Su is director of the South Texas Border Health Disparities Center at the University of Texas-Pan American. He and his colleagues analyzed data from the 2007 National Health Interview Survey. Based on interviews with more than 23,000 adults, the NHIS showed more pronounced growth in CAM use among whites than among racial and ethnic minorities. This increased an already existing white-minority gap in CAM use, Su said.
Without counting prayer for health purposes, 33 percent of whites report using at least one CAM therapy, while 31.8 percent of Asian Americans, 20.1 percent of African-Americans and 16.9 percent of Hispanics report using these therapies.
The use of CAM rose across all these populations between 2002 and 2007, but at different rates. The increase was highest among whites and Asian Americans, at 18.1 percent and 17.2 percent, respectively. Use among African-Americans increased only 6.6 percent. Use among Hispanics increased only 1.01 percent.
"So far, we know little about how the difference in CAM use has influenced racial and ethnic disparities in health and mortality," Su said. "Research is urgently needed to understand the effectiveness, side effects and interactions of CAM therapies with conventional medicine."
Richard Nahin, Ph.D., senior advisor for Scientific Coordination and Outreach at the National Center for Complementary and Alternative Medicine (NCCAM), says that this study provides clarity to some differences in the use of CAM by various populations. However, he said, the authors neglected to mention one, perhaps crucial, explanation for these differences.
"There is, in fact, some evidence to suggest that the 2007 NHIS underestimated CAM use among Hispanics and non-Hispanic blacks," Nahin said. "For instance, some CAM products for which minority groups report substantial use in small local or regional surveys were not included in the 2002 or 2007 NHIS."
Nahin, whose research on CAM contributed to the 2007 NHIS, said, "Understanding this possibility, NCCAM is redesigning the CAM supplement to the 2012 NHIS. They hope to better capture the use of various unconventional therapies more likely to be used by minority groups."
Su D, Li L. Trends in the use of complementary and alternative medicine in the United States. J Health Care Poor Underserved 22(1), 2011.
вторник, 11 октября 2011 г.
Research Promotes Pro-Active Vitamin D Regimen In Patients With Osteoporosis
New data indicates an aggressive Vitamin D treatment plan should be considered when caring for all Osteoporosis patients. Doing so may help decrease their likelihood of developing Vitamin D deficiency. These findings will be presented at the American Association of Clinical Endocrinologists (AACE) 17th Annual Meeting & Clinical by Harinder Singh, MD on Friday, May 16th at the Walt Disney World Dolphin Resort in Orlando.
"Our research suggests that Vitamin D deficiency is quite prevalent in patients with Osteoporosis," Dr. Singh said. "Much more so than was originally believed."
Singh will present how his research showed an alarming rate of Vitamin D deficiency amongst patients being treated for Osteoporosis and furthermore, how it should be met with an "aggressive" treatment regimen.
Research on the topics of Vitamin D and Osteoporosis will be a major highlight at this year's meeting. Two major sessions include "Osteoporosis: What's New and What's Next," where AACE Member Nelson Watts MD, FACP, MACE will discuss a possible once-a-year treatment for Osteoporosis. The other session, "Vitamin D Deficiency: A Near Universal Health Problem," will focus on how adequate vitamin D intake may help reduce the severity of chronic endocrine-related diseases.
Media Registration
About the AACE Annual Meeting
American Association of Clinical Endocrinologists
"Our research suggests that Vitamin D deficiency is quite prevalent in patients with Osteoporosis," Dr. Singh said. "Much more so than was originally believed."
Singh will present how his research showed an alarming rate of Vitamin D deficiency amongst patients being treated for Osteoporosis and furthermore, how it should be met with an "aggressive" treatment regimen.
Research on the topics of Vitamin D and Osteoporosis will be a major highlight at this year's meeting. Two major sessions include "Osteoporosis: What's New and What's Next," where AACE Member Nelson Watts MD, FACP, MACE will discuss a possible once-a-year treatment for Osteoporosis. The other session, "Vitamin D Deficiency: A Near Universal Health Problem," will focus on how adequate vitamin D intake may help reduce the severity of chronic endocrine-related diseases.
Media Registration
About the AACE Annual Meeting
American Association of Clinical Endocrinologists
суббота, 8 октября 2011 г.
Link Found Between Selenium Supplements And Increased Risk For Diabetes
A new analysis of data from a large national study found that people who took a 200 microgram selenium supplement each day for almost eight years had an increased risk of developing type 2 diabetes than those who took a placebo or dummy pill.
The data came from the Nutritional Prevention of Cancer Trial (NPC), a large randomized, multi-center, clinical trial from the eastern United States, designed to evaluate whether selenium supplements prevent skin cancer. In the study being published, researchers selected 1,202 participants who did not have diabetes when they were enrolled in the NPC Trial. Half received a 200 microgram selenium supplement and half received a placebo pill for an average of 7.7 years.
Saverio Stranges, MD, PhD, lead author of the study, says that the findings from this study suggest that selenium supplements do not prevent diabetes and that they might be harmful. "At this time, the evidence that people should take selenium supplements is extremely limited. We have observed an increased risk for diabetes over the long term in the group of participants who took selenium supplements."
Dr. Stranges is currently working at Warwick Medical School, UK, but previously worked at the State University of New York at Buffalo. Other authors of the article include Mary E. Reid, PhD, and James R. Marshall, PhD, researchers at the Roswell Park Cancer Institute in Buffalo.
Selenium is a naturally occurring trace mineral present in soil and foods. The body need selenium in minute amounts to aid in metabolism. Selenium supplements are widely promoted on the Internet for conditions ranging from cold sores and shingles to arthritis and multiple sclerosis. They are sold to prevent aging, enhance fertility, prevent cancer and get rid of toxic minerals such as mercury, lead and cadmium.
Selenium supplements have shown some promise in preventing prostate cancer. Because of selenium's antioxidant activities, some scientists feel it might be effective against diabetes.
In the current study, 58 out of 600 participants in the selenium group and 39 out of 602 participants in the placebo group developed type 2 diabetes. After 7.7 years of follow-up, the relative risk rate was approximately 50 percent higher among those randomly selected for the selenium group than among those randomly placed in the placebo group.
The results consistently showed higher risks of disease among participants receiving selenium across subgroups of baseline age, gender, and smoking status. However, the selenium supplements had no impact on the most overweight participants. The risk of developing diabetes tended to be higher in people who had higher blood selenium levels at the start of the study.
Dr. Stranges said, "No single study can provide the answer to a scientific question, but at this time, selenium supplementation does not appear to prevent type 2 diabetes, and it may increase risk of the disease. However, our understanding of the mechanisms whereby selenium would increase risk of diabetes is very limited at this time and this issue needs to be further explored. Nevertheless, I would not advise patients to take selenium supplements greater than those in multiple vitamins."
About 60 percent of Americans take multivitamin pills, many of which contain between 33 and 200 micrograms of selenium, in addition to the selenium taken in from food and the air. The RDA (recommended dietary allowance) for selenium varies by age. For people aged 14 and over, 55 micrograms per day is recommended for the body to function normally.
Dr. Stranges said that selenium levels in soil in United States are higher than the minimum needed to optimize metabolism, so people in the United States should not need to take selenium supplements greater than those in multivitamin supplements.
In an accompanying editorial, Eliseo Guallar, MD, DrPH, from Johns Hopkins University Bloomberg School of Public Health, says the article is "more bad news for supplements." He says that the NPC trial is the largest and longest experimental study available comparing selenium supplements to placebo, that selenium has a narrow therapeutic range and that at high levels, it can be toxic.
"What the U.S. public needs to know," Dr. Guallar says, "is that most people in the United States have adequate selenium in their diet. Moreover, taking selenium supplements on top of an adequate dietary intake may cause diabetes."
The study, "Effects of Long-Term Selenium Supplementation on the Incidence of Type 2 Diabetes," and the editorial, "Selenium and Diabetes: More Bad News for Supplements," is on the Web site of Annals of Internal Medicine (annals/) and in the Aug. 21, 2007, print edition of the journal.
Annals of Internal Medicine (annals/) is one of the most widely cited peer-reviewed medical journals in the world. The journal has been published for 80 years and accepts only seven percent of the original research studies submitted for publication. Annals of Internal Medicine is published by the American College of Physicians (acponline/), the largest medical specialty organization and the second-largest physician group in the United States. ACP members include 123,000 internal medicine physicians (internists), related subspecialists, and medical students. Internists specialize in the prevention, detection, and treatment of illness in adults.
1. Dr. Stranges: Clinical Sciences Research Institute, Warwick Medical School, University Hospital Coventry & Warwickshire, Clifford Bridge Road, Coventry CV2 2DX (UK)
2. Eliseo Guallar, MD, DrPH, department of epidemiology, Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University Bloomberg School of Public jhsph/communications/
The data came from the Nutritional Prevention of Cancer Trial (NPC), a large randomized, multi-center, clinical trial from the eastern United States, designed to evaluate whether selenium supplements prevent skin cancer. In the study being published, researchers selected 1,202 participants who did not have diabetes when they were enrolled in the NPC Trial. Half received a 200 microgram selenium supplement and half received a placebo pill for an average of 7.7 years.
Saverio Stranges, MD, PhD, lead author of the study, says that the findings from this study suggest that selenium supplements do not prevent diabetes and that they might be harmful. "At this time, the evidence that people should take selenium supplements is extremely limited. We have observed an increased risk for diabetes over the long term in the group of participants who took selenium supplements."
Dr. Stranges is currently working at Warwick Medical School, UK, but previously worked at the State University of New York at Buffalo. Other authors of the article include Mary E. Reid, PhD, and James R. Marshall, PhD, researchers at the Roswell Park Cancer Institute in Buffalo.
Selenium is a naturally occurring trace mineral present in soil and foods. The body need selenium in minute amounts to aid in metabolism. Selenium supplements are widely promoted on the Internet for conditions ranging from cold sores and shingles to arthritis and multiple sclerosis. They are sold to prevent aging, enhance fertility, prevent cancer and get rid of toxic minerals such as mercury, lead and cadmium.
Selenium supplements have shown some promise in preventing prostate cancer. Because of selenium's antioxidant activities, some scientists feel it might be effective against diabetes.
In the current study, 58 out of 600 participants in the selenium group and 39 out of 602 participants in the placebo group developed type 2 diabetes. After 7.7 years of follow-up, the relative risk rate was approximately 50 percent higher among those randomly selected for the selenium group than among those randomly placed in the placebo group.
The results consistently showed higher risks of disease among participants receiving selenium across subgroups of baseline age, gender, and smoking status. However, the selenium supplements had no impact on the most overweight participants. The risk of developing diabetes tended to be higher in people who had higher blood selenium levels at the start of the study.
Dr. Stranges said, "No single study can provide the answer to a scientific question, but at this time, selenium supplementation does not appear to prevent type 2 diabetes, and it may increase risk of the disease. However, our understanding of the mechanisms whereby selenium would increase risk of diabetes is very limited at this time and this issue needs to be further explored. Nevertheless, I would not advise patients to take selenium supplements greater than those in multiple vitamins."
About 60 percent of Americans take multivitamin pills, many of which contain between 33 and 200 micrograms of selenium, in addition to the selenium taken in from food and the air. The RDA (recommended dietary allowance) for selenium varies by age. For people aged 14 and over, 55 micrograms per day is recommended for the body to function normally.
Dr. Stranges said that selenium levels in soil in United States are higher than the minimum needed to optimize metabolism, so people in the United States should not need to take selenium supplements greater than those in multivitamin supplements.
In an accompanying editorial, Eliseo Guallar, MD, DrPH, from Johns Hopkins University Bloomberg School of Public Health, says the article is "more bad news for supplements." He says that the NPC trial is the largest and longest experimental study available comparing selenium supplements to placebo, that selenium has a narrow therapeutic range and that at high levels, it can be toxic.
"What the U.S. public needs to know," Dr. Guallar says, "is that most people in the United States have adequate selenium in their diet. Moreover, taking selenium supplements on top of an adequate dietary intake may cause diabetes."
The study, "Effects of Long-Term Selenium Supplementation on the Incidence of Type 2 Diabetes," and the editorial, "Selenium and Diabetes: More Bad News for Supplements," is on the Web site of Annals of Internal Medicine (annals/) and in the Aug. 21, 2007, print edition of the journal.
Annals of Internal Medicine (annals/) is one of the most widely cited peer-reviewed medical journals in the world. The journal has been published for 80 years and accepts only seven percent of the original research studies submitted for publication. Annals of Internal Medicine is published by the American College of Physicians (acponline/), the largest medical specialty organization and the second-largest physician group in the United States. ACP members include 123,000 internal medicine physicians (internists), related subspecialists, and medical students. Internists specialize in the prevention, detection, and treatment of illness in adults.
1. Dr. Stranges: Clinical Sciences Research Institute, Warwick Medical School, University Hospital Coventry & Warwickshire, Clifford Bridge Road, Coventry CV2 2DX (UK)
2. Eliseo Guallar, MD, DrPH, department of epidemiology, Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University Bloomberg School of Public jhsph/communications/
среда, 5 октября 2011 г.
Antioxidants May Improve Chances Of Conceiving In Male Subfertility
Antioxidant supplements may benefit couples who have difficulty conceiving naturally, according to a new systematic review published today in The Cochrane Library. The review provides evidence from a small number of trials that suggest the partners of men who take antioxidants are more likely to become pregnant.
Male subfertility affects one in 20 men. Chemicals called reactive oxygen species (ROS) are said to cause damage to cells, and in particular sperm cells, which may result in lowered sperm counts and interfere with their ability to fertilise eggs. Antioxidants include natural and synthetic chemicals, including certain vitamins and minerals, which help to reduce the damage caused by ROS.
The review focused on 34 trials involving 2,876 couples undergoing assisted reproductive techniques such as in vitro fertilisation and sperm injections. Most men in the trials had low sperm counts or low sperm motility. The trials explored the use of many different types of oral antioxidants, including vitamin E, L-carnitine, zinc and magnesium.
Compared to controls, a couple was more likely to have a pregnancy or live birth if the man took antioxidants. However, these results are based on just 964 of the couples in the review for pregnancies and 214 couples for live births. Other trials tested the effects of antioxidants on sperm motility and concentration and showed mostly positive effects, although study group sizes were small.
"When trying to conceive as part of an assisted reproductive program, it may be advisable to encourage men to take oral antioxidant supplements to improve their partners' chances of becoming pregnant," said lead researcher Marian Showell, who works in Obstetrics and Gynaecology at the University of Auckland in Auckland, New Zealand. "However, these conclusions are currently based on limited evidence."
There were not enough data comparing different antioxidants to reach any conclusions about the relative effectiveness of supplements. "We need more head-to-comparisons to understand whether any one antioxidant is performing better than any other," said Showell.
Full citation: Showell MG, Brown J, Yazdani A, Stankiewicz MT, Hart RJ. Antioxidants for male subfertility. Cochrane Database of Systematic Reviews 2011, Issue 1. Art. No.: CD007411. DOI: 10.1002/14651858.CD007411.pub2
Article
Male subfertility affects one in 20 men. Chemicals called reactive oxygen species (ROS) are said to cause damage to cells, and in particular sperm cells, which may result in lowered sperm counts and interfere with their ability to fertilise eggs. Antioxidants include natural and synthetic chemicals, including certain vitamins and minerals, which help to reduce the damage caused by ROS.
The review focused on 34 trials involving 2,876 couples undergoing assisted reproductive techniques such as in vitro fertilisation and sperm injections. Most men in the trials had low sperm counts or low sperm motility. The trials explored the use of many different types of oral antioxidants, including vitamin E, L-carnitine, zinc and magnesium.
Compared to controls, a couple was more likely to have a pregnancy or live birth if the man took antioxidants. However, these results are based on just 964 of the couples in the review for pregnancies and 214 couples for live births. Other trials tested the effects of antioxidants on sperm motility and concentration and showed mostly positive effects, although study group sizes were small.
"When trying to conceive as part of an assisted reproductive program, it may be advisable to encourage men to take oral antioxidant supplements to improve their partners' chances of becoming pregnant," said lead researcher Marian Showell, who works in Obstetrics and Gynaecology at the University of Auckland in Auckland, New Zealand. "However, these conclusions are currently based on limited evidence."
There were not enough data comparing different antioxidants to reach any conclusions about the relative effectiveness of supplements. "We need more head-to-comparisons to understand whether any one antioxidant is performing better than any other," said Showell.
Full citation: Showell MG, Brown J, Yazdani A, Stankiewicz MT, Hart RJ. Antioxidants for male subfertility. Cochrane Database of Systematic Reviews 2011, Issue 1. Art. No.: CD007411. DOI: 10.1002/14651858.CD007411.pub2
Article
воскресенье, 2 октября 2011 г.
Efficacy Of Glucosamine And Chondroitin Sulfate May Depend On Level Of Osteoarthritis Pain
In a study published in the New England Journal of Medicine*, the popular dietary supplement combination of glucosamine plus chondroitin sulfate did not provide significant relief from osteoarthritis pain among all participants. However, a smaller subgroup of study participants with moderate-to-severe pain showed significant relief with the combined supplements. This research was funded by the National Center for Complementary and Alternative Medicine (NCCAM) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), components of the National Institutes of Health (NIH). Researchers led by rheumatologist Daniel O. Clegg, M.D., of the University of Utah, School of Medicine, Salt Lake City, conducted the 4-year study known as the Glucosamine/chondroitin Arthritis Intervention Trial (GAIT) at 16 sites across the United States.
"GAIT is another example of NIH's commitment to exploring the potential of complementary and alternative medicine to prevent and treat disease in a manner that is fair, unbiased, and scientifically rigorous," said Elias A. Zerhouni, M.D., NIH Director.
GAIT enrolled nearly 1,600 participants with documented osteoarthritis of the knee. Participants were randomly assigned to receive one of five treatments daily for 24 weeks: glucosamine alone (1500 mg), chondroitin sulfate alone (1200 mg), glucosamine and chondroitin sulfate combined (same doses), a placebo, or celecoxib (200 mg). Celecoxib is an FDA-approved drug for the management of osteoarthritis pain and served as a positive control for the study. (A positive control is a treatment that investigators expect participants to respond to in a predictable way; it helps validate study results.) A positive response to treatment was defined as a 20 percent or greater reduction in pain at week 24 compared to the start of the study.
The researchers found that participants taking celecoxib experienced statistically significant pain relief, as expected, versus placebo--about 70 percent of those taking celecoxib versus 60 percent taking placebo had a 20 percent or greater pain reduction. For all participants, there were no significant differences between the other treatments tested and placebo. However, for participants in the moderate-to-severe pain subgroup, glucosamine combined with chondroitin sulfate provided statistically significant pain relief compared to placebo--about 79 percent in this group had a 20 percent or greater pain reduction compared to 54 percent for placebo. In the subgroup of participants with mild pain, glucosamine and chondroitin sulfate together or alone did not provide statistically significant relief compared to placebo.
"This rigorous, large-scale study showed that the combination of glucosamine and chondroitin sulfate appeared to help people with moderate-to-severe pain from knee osteoarthritis, but not those with mild pain," said Stephen E. Straus, M.D., NCCAM Director. "It is important to study dietary supplements with well-designed research in order to find out what works and what does not."
"Because of the small size of the moderate-to-severe pain subgroup, the findings in this group for glucosamine plus chondroitin sulfate should be considered preliminary and need to be confirmed in a study designed for this purpose," said Dr. Clegg, Professor of Medicine and Chief of Rheumatology at the University of Utah, School of Medicine.
On entering the study, a participant's level of pain was assessed as either mild or moderate to severe using standard pain assessment tools and scales, such as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Of the 1,583 study participants, 78 percent were in the mild pain subgroup and the other 22 percent were in the moderate-to-severe pain subgroup. Level of pain was evaluated at weeks 4, 8, 16, and 24 using the WOMAC scale and other tools. In addition to taking their daily study treatment, participants could take up to 4000 mg of acetaminophen daily for pain, except for the 24 hours before they were assessed by study staff. The use of acetaminophen, however, was low, overall averaging fewer than two 500 mg tablets per day. Participants could not take other non-steroidal anti-inflammatory medicines or narcotic (opioid-based) pain relievers during the study.
"More than 20 million Americans have osteoarthritis, making it a frequent cause of physical disability among adults," said Stephen I. Katz, M.D., Ph.D., NIAMS Director. "We are excited to support studies looking at new treatment options that could improve the symptoms and quality of life of people with osteoarthritis."
GAIT was conducted under an Investigational New Drug application filed with the U.S. Food and Drug Administration. Thus, all of the products used in the study were subject to the FDA's pharmaceutical regulations and evaluated and manufactured by an FDA-licensed clinical research pharmacy center. The glucosamine and chondroitin sulfate used were tested for purity, potency, quality, and consistency among batches. Products were retested for stability throughout the study. The dosages selected were based on the prevailing doses in the scientific literature. Few side effects from any of the treatments were reported. Those reported were generally mild, such as upset stomach, and distributed evenly across the treatment groups.
"The GAIT team's goal was to assess whether glucosamine and chondroitin sulfate, which we saw our osteoarthritis patients using, provided pain relief," said Dr. Clegg. "I urge people with osteoarthritis to follow a comprehensive plan for managing their arthritis pain--eat right, exercise, lose excess weight, and talk to your physician about appropriate treatment options."
The GAIT team continues their research with a smaller study to see whether glucosamine and chondroitin sulfate can alter the progression of osteoarthritis, such as delaying the narrowing of the joint spaces. About one-half of the participants in the larger GAIT study were eligible to enroll in this ancillary study. The results are expected in about a year.
The National Center for Complementary and Alternative Medicine's mission is to explore complementary and alternative medical practices in the context of rigorous science, train CAM researchers, and disseminate authoritative information to the public and professionals. For additional information, call NCCAM's Clearinghouse toll free at 1-888-644-6226, or visit the NCCAM Web site at nccam.nih. NCCAM is 1 of 27 institutes and centers at the National Institutes of Health, the Federal focal point for medical research in the United States.
The National Institute of Arthritis and Musculoskeletal and Skin Diseases, a component of the National Institutes of Health, DHHS, supports research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases; the training of basic and clinical scientists to carry out this research; and the dissemination of information on research progress in these diseases. For additional information, call NIAMS's clearinghouse at (301) 495-4484 or visit NIAMS's Web site at niams.nih/.
*Clegg D, et al. Glucosamine, Chondroitin Sulfate, and the Two in Combination for Painful Knee Osteoarthritis. New England Journal of Medicine, 2006; 354:795-808.
The following is a companion Q&A document for the above release. It provides additional details about the GAIT trial.
Questions and Answers: NIH Glucosamine/chondroitin Arthritis Intervention Trial (GAIT)
ABOUT THE STUDY
* What is the Glucosamine/chondroitin Arthritis Intervention Trial (GAIT)?
* What was the purpose of the study?
* What was the basic design of the study?
* What did GAIT cost?
STUDY BACKGROUND
* What is osteoarthritis?
* What are glucosamine and chondroitin sulfate?
* What is celecoxib?
* What doses were used for the various treatments?
* Who provided the source materials for making the glucosamine and chondroitin sulfate products used in GAIT?
* Where did the other study products come from?
* Where was the study conducted?
KEY RESULTS
* What were the key results of the study?
* How many people participated in the study and who were they?
* Were there any side effects from the treatments?
CONSUMER INFORMATION AND NEXT STEPS
* Should people with osteoarthritis use glucosamine and chondroitin sulfate?
* Can U.S. consumers get the glucosamine and chondroitin sulfate products used in GAIT?
* Will the GAIT team continue to do research on glucosamine and chondroitin sulfate?
* For More Information
ABOUT THE STUDY
What is the Glucosamine/chondroitin Arthritis Intervention Trial (GAIT)? GAIT is the first, large-scale, multicenter clinical trial in the United States to test the effects of the dietary supplements glucosamine hydrochloride (glucosamine) and sodium chondroitin sulfate (chondroitin sulfate) for treatment of knee osteoarthritis. The study tested whether glucosamine and chondroitin sulfate used separately or in combination reduced pain in participants with knee osteoarthritis.
The University of Utah, School of Medicine coordinated this study, which was conducted at 16 rheumatology research centers across the United States. The National Center for Complementary and Alternative Medicine (NCCAM) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), two components of the National Institutes of Health (NIH), funded GAIT.
What was the purpose of the study?
Previous studies in the medical literature had conflicting results on the effectiveness of glucosamine and chondroitin sulfate as treatments for osteoarthritis. GAIT was designed to test the short-term (6 months) effectiveness of glucosamine and chondroitin sulfate in reducing pain in a large number of participants with knee osteoarthritis.
What was the basic design of the study?
In GAIT, participants were randomly assigned to one of five treatment groups: (1) glucosamine alone, (2) chondroitin sulfate alone, (3) glucosamine and chondroitin sulfate in combination, (4) celecoxib, or (5) a placebo (an inactive substance that looks like the study substance). Glucosamine and chondroitin sulfate and their combination were compared to a placebo to evaluate whether these substances significantly improve joint pain. Celecoxib, which is a prescription drug effective in managing osteoarthritis pain, was also compared to placebo to validate the study design.
To reduce the chance of biased results, the study was double-blinded--neither the researchers nor the participants knew which of the five treatment groups the participants were in. Participants received treatment for 24 weeks. Participants were evaluated at the start of the study and at weeks 4, 8, 16, and 24 and closely monitored for improvement of their symptoms as well as for any possible adverse reactions to the study agents. X-rays documented each participant's diagnosis of osteoarthritis. Participants were also stratified into two pain subgroups--mild pain 1,229 participants (78 percent) and moderate-to-severe pain 354 participants (22 percent).
The primary outcome of the study was defined as at least a 20 percent reduction in pain at 24 weeks. All participants had the option to use up to 4000 mg of acetaminophen, as needed, to control pain from osteoarthritis throughout the study, except for the 24 hours prior to having their knee assessed. Acetaminophen use was low: on average, participants used fewer than two 500 mg tablets per day.
What did GAIT cost?
The primary GAIT study cost just over $12.5 million.
STUDY BACKGROUND
What is osteoarthritis?
More than 20 million adults in the United States live with osteoarthritis--the most common type of arthritis. Osteoarthritis, also called degenerative joint disease, is caused by the breakdown of cartilage, which is the connective tissue that cushions the ends of bones within the joint. Osteoarthritis is characterized by pain, joint damage, and limited motion. The disease generally occurs late in life, and most commonly affects the hands and large weight-bearing joints, such as the knees. Age, female gender, and obesity are risk factors for this condition.
What are glucosamine and chondroitin sulfate?
Glucosamine and chondroitin sulfate are natural substances found in and around the cells of cartilage. Glucosamine is an amino sugar that the body produces and distributes in cartilage and other connective tissue and chondroitin sulfate is a complex carbohydrate that helps cartilage retain water. In the United States, glucosamine and chondroitin sulfate are sold as dietary supplements, which are regulated as foods rather than drugs.
What is celecoxib?
Celecoxib (brand name Celebrex) is a type of nonsteroidal anti-inflammatory drug (NSAID), called a COX-2 inhibitor. Like traditional NSAIDS, celecoxib blocks the COX-2 enzyme in the body that stimulates inflammation. Unlike traditional NSAIDS, however, celecoxib does not block the action of COX-1 enzyme, which is known to protect the stomach lining. As a result, celecoxib reduces joint pain and inflammation with reduced risk of gastrointestinal ulceration and bleeding. Recent reports have linked possible cardiovascular side effects to COX-2 inhibitors. Although GAIT was not designed to study the safety of celecoxib, participants were monitored for adverse events and no increase in such side effects was observed.
What doses were used for the various treatments?
The doses used in GAIT were based on the doses seen in the prevailing scientific literature.
* Glucosamine alone: 1500 mg daily given as 500 mg three times a day
* Chondroitin sulfate alone: 1200 mg daily given as 400 mg three times a day
* Glucosamine plus chondroitin sulfate combined: same doses--1500 mg and 1200 mg daily
* Celecoxib: 200 mg daily
* Acetaminophen: participants were allowed to take up to 4000 mg (500 mg tablets) per day to control pain, except for the 24 hours before pain was assessed.
Who provided the source materials for making the glucosamine and chondroitin sulfate products used in GAIT?
* Glucosamine was donated in part by Ferro Pfanstiehl Laboratories, Inc., Waukegan, IL, through Wilke Resources
* Chondroitin sulfate was donated by Bioiberica, S.A., Barcelona, Spain
The study agents were manufactured by Albuquerque Veterans Affairs (VA) Cooperative Studies Program Clinical Research Pharmacy.
Where did the other study products come from?
* Acetaminophen was donated by McNeil Consumer and Specialty Pharmaceuticals, Fort Washington, PA
* Celecoxib was purchased from Pfizer
Where was the study conducted?
The University of Utah, School of Medicine, Salt Lake City, UT, served as the coordinating study center and oversaw the research and recruitment efforts of the 16 study centers. The study was led by Daniel O. Clegg, M.D., a Professor of Medicine and Chief of Rheumatology, Division of Rheumatology, University of Utah School of Medicine. The GAIT biostatistician was Domenic J. Reda, Ph.D., from the Hines VA Cooperative Studies Program, which served as the study data management and analysis center. The GAIT Clinical Research Pharmacist was Crystal L. Harris, Pharm.D., at the Albuquerque VA Cooperative Studies Program Clinical Research Pharmacy, which manufactured, packaged, distributed, and provided analytical testing of the study agents along with regulatory support for GAIT. The 16 study centers and their lead investigators were:
* University of Alabama at Birmingham, Birmingham, AL; Larry W. Moreland, M.D.
* University of Arizona, Tucson, AZ; David Yocum, M.D.
* Cedars-Sinai Medical Center, Los Angeles, CA; Michael Weisman, M.D.
* University of California Los Angeles, Los Angeles, CA; Daniel Furst, M.D.
* University of California San Francisco, San Francisco, CA; Nancy Lane, M.D.
* Northwestern University, Chicago, IL; Thomas J. Schnitzer, M.D.
* Indiana University, Indianapolis, IN; John Bradley, M.D.
* The Arthritis Research and Clinical Centers, Wichita, KS; Frederick Wolfe, M.D.
* University of Nebraska Medical Center, Omaha, NE; James O'Dell, M.D.
* Hospital for Joint Diseases, New York, NY; Clifton Bingham, III, M.D.
* Case Western Reserve University, Cleveland, OH; Michele Hooper, M.D.
* University of Pennsylvania, Philadelphia, PA; H. Ralph Schumacher, Jr., M.D.
* University of Pittsburgh, Pittsburgh, PA; Chester Oddis, M.D.
* Presbyterian Hospital of Dallas, Dallas, TX; John J. Cush, M.D.
* University of Utah, Salt Lake City, UT; Christopher G. Jackson, M.D.
* Virginia Mason Medical Center, Seattle, WA; Jerry Molitor, M.D.
KEY RESULTS
What were the key results of the study? Researchers found that:
* Participants taking the positive control, celecoxib, experienced statistically significant pain relief versus placebo--about 70 percent of those taking celecoxib had a 20 percent or greater reduction in pain versus about 60 percent for placebo.
* Overall, there were no significant differences between the other treatments tested and placebo.
* For a subset of participants with moderate-to-severe pain, glucosamine combined with chondroitin sulfate provided statistically significant pain relief compared to placebo--about 79 percent had a 20 percent or greater reduction in pain versus about 54 percent for placebo. According to the researchers, because of the small size of this subgroup these findings should be considered preliminary and need to be confirmed in further studies.
* For participants in the mild pain subset, glucosamine and chondroitin sulfate together or alone did not provide statistically significant pain relief.
How many people participated in the study and who were they?
A total of 1,583 people participated in the study. People age 40 or older with knee pain and documented x-ray evidence of osteoarthritis were eligible to participate. Participants could not have used glucosamine for 3 months and chondroitin sulfate for 6 months prior to entering the study. Participants were about 59 years of age, on average, and nearly two-thirds of participants were women. Of the 1,583 study participants 78 percent (1,229) were in the mild pain subgroup and 22 percent (354) were in the moderate-to-severe pain subgroup.
Were there any side effects from the treatments?
There were 77 reports of serious adverse effects during the study. Of those 77, only 3 were attributed to study treatments. Most side effects were mild, such as upset stomach, and were spread evenly across the different treatment groups. In addition, although GAIT was not designed to evaluate these risks, no change in glucose tolerance was seen for glucosamine nor was an increased incidence of cardiovascular events seen with celecoxib.
CONSUMER INFORMATION AND NEXT STEPS
Should people with osteoarthritis use glucosamine and chondroitin sulfate?
People with osteoarthritis should work with their health care provider to develop a comprehensive plan for managing their arthritis pain: eat right, exercise, lose excess weight, and use proven pain medications. If people have moderate-to-severe pain, they should talk with their health care provider about whether glucosamine plus chondroitin sulfate is an appropriate treatment option.
Can U.S. consumers get the glucosamine and chondroitin sulfate products used in GAIT?
Identical products may not be commercially available. GAIT was conducted under an Investigational New Drug application filed with the U.S. Food and Drug Administration (FDA). All of the products used in the study were developed for the study and subject to the FDA's pharmaceutical regulations. The products were evaluated and manufactured by the VA Cooperative Studies Program Clinical Research Pharmacy, an FDA-licensed clinical research pharmacy center. The glucosamine and chondroitin sulfate used were tested for purity, potency, quality, and consistency among batches. Products were retested for stability throughout the study.
Will the GAIT team continue to do research on glucosamine and chondroitin sulfate?
GAIT includes an ancillary study, which is still ongoing, that will assess whether glucosamine and chondroitin sulfate can reduce or halt the progression of knee osteoarthritis following additional treatment. About one-half of the participants enrolled in GAIT will be treated for an additional 18 months. As in the primary study, participants will not know to which treatment group they belong. Researchers will compare x-rays taken at the beginning of the study and after 1 and 2 years of treatment to identify changes in the knee joints as a result of treatment. Results are expected in about a year.
For More Information
NCCAM Clearinghouse
The NCCAM Clearinghouse provides information on CAM and NCCAM, including publications and searches of Federal databases of scientific and medical literature. The Clearinghouse does not provide medical advice, treatment recommendations, or referrals to practitioners.
Toll-free in the U.S.: 1-888-644-6226
International: 301-519-3153
TTY (for deaf and hard-of-hearing callers): 1-866-464-3615
Web site: mailto:nccam.nih
E-mail: infonccam.nih
National Institute of Arthritis and Musculoskeletal and Skin Diseases For information on rheumatic diseases such as osteoarthritis and diseases of the musculoskeletal and skin systems, contact the NIAMS Information Clearinghouse.
Toll-free in the U.S.: 1-877-22-NIAMS
Telephone: 301-495-4484
Web site: niams.nih/hi/index.htm
Address: NIAMS/National Institutes of Health
1 AMS Circle
Bethesda, MD 20892-3675
NIH Office of Dietary Supplements (ODS)
For scientific citations and abstracts on dietary supplements, visit the ODS Web site for access to the International Bibliographic Information on Dietary Supplements database.
Web site: ods.od.nih/
U.S. Food and Drug Administration
For information on dietary supplement labeling requirements and safety monitoring, order the FDA Guide to Dietary Supplements from the U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition.
Toll-free in the U.S.: 1-800-FDA-4010
Web site: cfsan.fda/
Contact: NCCAM Press Office
nccampressmail.nih
NIH/National Center for Complementary and Alternative Medicine
"GAIT is another example of NIH's commitment to exploring the potential of complementary and alternative medicine to prevent and treat disease in a manner that is fair, unbiased, and scientifically rigorous," said Elias A. Zerhouni, M.D., NIH Director.
GAIT enrolled nearly 1,600 participants with documented osteoarthritis of the knee. Participants were randomly assigned to receive one of five treatments daily for 24 weeks: glucosamine alone (1500 mg), chondroitin sulfate alone (1200 mg), glucosamine and chondroitin sulfate combined (same doses), a placebo, or celecoxib (200 mg). Celecoxib is an FDA-approved drug for the management of osteoarthritis pain and served as a positive control for the study. (A positive control is a treatment that investigators expect participants to respond to in a predictable way; it helps validate study results.) A positive response to treatment was defined as a 20 percent or greater reduction in pain at week 24 compared to the start of the study.
The researchers found that participants taking celecoxib experienced statistically significant pain relief, as expected, versus placebo--about 70 percent of those taking celecoxib versus 60 percent taking placebo had a 20 percent or greater pain reduction. For all participants, there were no significant differences between the other treatments tested and placebo. However, for participants in the moderate-to-severe pain subgroup, glucosamine combined with chondroitin sulfate provided statistically significant pain relief compared to placebo--about 79 percent in this group had a 20 percent or greater pain reduction compared to 54 percent for placebo. In the subgroup of participants with mild pain, glucosamine and chondroitin sulfate together or alone did not provide statistically significant relief compared to placebo.
"This rigorous, large-scale study showed that the combination of glucosamine and chondroitin sulfate appeared to help people with moderate-to-severe pain from knee osteoarthritis, but not those with mild pain," said Stephen E. Straus, M.D., NCCAM Director. "It is important to study dietary supplements with well-designed research in order to find out what works and what does not."
"Because of the small size of the moderate-to-severe pain subgroup, the findings in this group for glucosamine plus chondroitin sulfate should be considered preliminary and need to be confirmed in a study designed for this purpose," said Dr. Clegg, Professor of Medicine and Chief of Rheumatology at the University of Utah, School of Medicine.
On entering the study, a participant's level of pain was assessed as either mild or moderate to severe using standard pain assessment tools and scales, such as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Of the 1,583 study participants, 78 percent were in the mild pain subgroup and the other 22 percent were in the moderate-to-severe pain subgroup. Level of pain was evaluated at weeks 4, 8, 16, and 24 using the WOMAC scale and other tools. In addition to taking their daily study treatment, participants could take up to 4000 mg of acetaminophen daily for pain, except for the 24 hours before they were assessed by study staff. The use of acetaminophen, however, was low, overall averaging fewer than two 500 mg tablets per day. Participants could not take other non-steroidal anti-inflammatory medicines or narcotic (opioid-based) pain relievers during the study.
"More than 20 million Americans have osteoarthritis, making it a frequent cause of physical disability among adults," said Stephen I. Katz, M.D., Ph.D., NIAMS Director. "We are excited to support studies looking at new treatment options that could improve the symptoms and quality of life of people with osteoarthritis."
GAIT was conducted under an Investigational New Drug application filed with the U.S. Food and Drug Administration. Thus, all of the products used in the study were subject to the FDA's pharmaceutical regulations and evaluated and manufactured by an FDA-licensed clinical research pharmacy center. The glucosamine and chondroitin sulfate used were tested for purity, potency, quality, and consistency among batches. Products were retested for stability throughout the study. The dosages selected were based on the prevailing doses in the scientific literature. Few side effects from any of the treatments were reported. Those reported were generally mild, such as upset stomach, and distributed evenly across the treatment groups.
"The GAIT team's goal was to assess whether glucosamine and chondroitin sulfate, which we saw our osteoarthritis patients using, provided pain relief," said Dr. Clegg. "I urge people with osteoarthritis to follow a comprehensive plan for managing their arthritis pain--eat right, exercise, lose excess weight, and talk to your physician about appropriate treatment options."
The GAIT team continues their research with a smaller study to see whether glucosamine and chondroitin sulfate can alter the progression of osteoarthritis, such as delaying the narrowing of the joint spaces. About one-half of the participants in the larger GAIT study were eligible to enroll in this ancillary study. The results are expected in about a year.
The National Center for Complementary and Alternative Medicine's mission is to explore complementary and alternative medical practices in the context of rigorous science, train CAM researchers, and disseminate authoritative information to the public and professionals. For additional information, call NCCAM's Clearinghouse toll free at 1-888-644-6226, or visit the NCCAM Web site at nccam.nih. NCCAM is 1 of 27 institutes and centers at the National Institutes of Health, the Federal focal point for medical research in the United States.
The National Institute of Arthritis and Musculoskeletal and Skin Diseases, a component of the National Institutes of Health, DHHS, supports research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases; the training of basic and clinical scientists to carry out this research; and the dissemination of information on research progress in these diseases. For additional information, call NIAMS's clearinghouse at (301) 495-4484 or visit NIAMS's Web site at niams.nih/.
*Clegg D, et al. Glucosamine, Chondroitin Sulfate, and the Two in Combination for Painful Knee Osteoarthritis. New England Journal of Medicine, 2006; 354:795-808.
The following is a companion Q&A document for the above release. It provides additional details about the GAIT trial.
Questions and Answers: NIH Glucosamine/chondroitin Arthritis Intervention Trial (GAIT)
ABOUT THE STUDY
* What is the Glucosamine/chondroitin Arthritis Intervention Trial (GAIT)?
* What was the purpose of the study?
* What was the basic design of the study?
* What did GAIT cost?
STUDY BACKGROUND
* What is osteoarthritis?
* What are glucosamine and chondroitin sulfate?
* What is celecoxib?
* What doses were used for the various treatments?
* Who provided the source materials for making the glucosamine and chondroitin sulfate products used in GAIT?
* Where did the other study products come from?
* Where was the study conducted?
KEY RESULTS
* What were the key results of the study?
* How many people participated in the study and who were they?
* Were there any side effects from the treatments?
CONSUMER INFORMATION AND NEXT STEPS
* Should people with osteoarthritis use glucosamine and chondroitin sulfate?
* Can U.S. consumers get the glucosamine and chondroitin sulfate products used in GAIT?
* Will the GAIT team continue to do research on glucosamine and chondroitin sulfate?
* For More Information
ABOUT THE STUDY
What is the Glucosamine/chondroitin Arthritis Intervention Trial (GAIT)? GAIT is the first, large-scale, multicenter clinical trial in the United States to test the effects of the dietary supplements glucosamine hydrochloride (glucosamine) and sodium chondroitin sulfate (chondroitin sulfate) for treatment of knee osteoarthritis. The study tested whether glucosamine and chondroitin sulfate used separately or in combination reduced pain in participants with knee osteoarthritis.
The University of Utah, School of Medicine coordinated this study, which was conducted at 16 rheumatology research centers across the United States. The National Center for Complementary and Alternative Medicine (NCCAM) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), two components of the National Institutes of Health (NIH), funded GAIT.
What was the purpose of the study?
Previous studies in the medical literature had conflicting results on the effectiveness of glucosamine and chondroitin sulfate as treatments for osteoarthritis. GAIT was designed to test the short-term (6 months) effectiveness of glucosamine and chondroitin sulfate in reducing pain in a large number of participants with knee osteoarthritis.
What was the basic design of the study?
In GAIT, participants were randomly assigned to one of five treatment groups: (1) glucosamine alone, (2) chondroitin sulfate alone, (3) glucosamine and chondroitin sulfate in combination, (4) celecoxib, or (5) a placebo (an inactive substance that looks like the study substance). Glucosamine and chondroitin sulfate and their combination were compared to a placebo to evaluate whether these substances significantly improve joint pain. Celecoxib, which is a prescription drug effective in managing osteoarthritis pain, was also compared to placebo to validate the study design.
To reduce the chance of biased results, the study was double-blinded--neither the researchers nor the participants knew which of the five treatment groups the participants were in. Participants received treatment for 24 weeks. Participants were evaluated at the start of the study and at weeks 4, 8, 16, and 24 and closely monitored for improvement of their symptoms as well as for any possible adverse reactions to the study agents. X-rays documented each participant's diagnosis of osteoarthritis. Participants were also stratified into two pain subgroups--mild pain 1,229 participants (78 percent) and moderate-to-severe pain 354 participants (22 percent).
The primary outcome of the study was defined as at least a 20 percent reduction in pain at 24 weeks. All participants had the option to use up to 4000 mg of acetaminophen, as needed, to control pain from osteoarthritis throughout the study, except for the 24 hours prior to having their knee assessed. Acetaminophen use was low: on average, participants used fewer than two 500 mg tablets per day.
What did GAIT cost?
The primary GAIT study cost just over $12.5 million.
STUDY BACKGROUND
What is osteoarthritis?
More than 20 million adults in the United States live with osteoarthritis--the most common type of arthritis. Osteoarthritis, also called degenerative joint disease, is caused by the breakdown of cartilage, which is the connective tissue that cushions the ends of bones within the joint. Osteoarthritis is characterized by pain, joint damage, and limited motion. The disease generally occurs late in life, and most commonly affects the hands and large weight-bearing joints, such as the knees. Age, female gender, and obesity are risk factors for this condition.
What are glucosamine and chondroitin sulfate?
Glucosamine and chondroitin sulfate are natural substances found in and around the cells of cartilage. Glucosamine is an amino sugar that the body produces and distributes in cartilage and other connective tissue and chondroitin sulfate is a complex carbohydrate that helps cartilage retain water. In the United States, glucosamine and chondroitin sulfate are sold as dietary supplements, which are regulated as foods rather than drugs.
What is celecoxib?
Celecoxib (brand name Celebrex) is a type of nonsteroidal anti-inflammatory drug (NSAID), called a COX-2 inhibitor. Like traditional NSAIDS, celecoxib blocks the COX-2 enzyme in the body that stimulates inflammation. Unlike traditional NSAIDS, however, celecoxib does not block the action of COX-1 enzyme, which is known to protect the stomach lining. As a result, celecoxib reduces joint pain and inflammation with reduced risk of gastrointestinal ulceration and bleeding. Recent reports have linked possible cardiovascular side effects to COX-2 inhibitors. Although GAIT was not designed to study the safety of celecoxib, participants were monitored for adverse events and no increase in such side effects was observed.
What doses were used for the various treatments?
The doses used in GAIT were based on the doses seen in the prevailing scientific literature.
* Glucosamine alone: 1500 mg daily given as 500 mg three times a day
* Chondroitin sulfate alone: 1200 mg daily given as 400 mg three times a day
* Glucosamine plus chondroitin sulfate combined: same doses--1500 mg and 1200 mg daily
* Celecoxib: 200 mg daily
* Acetaminophen: participants were allowed to take up to 4000 mg (500 mg tablets) per day to control pain, except for the 24 hours before pain was assessed.
Who provided the source materials for making the glucosamine and chondroitin sulfate products used in GAIT?
* Glucosamine was donated in part by Ferro Pfanstiehl Laboratories, Inc., Waukegan, IL, through Wilke Resources
* Chondroitin sulfate was donated by Bioiberica, S.A., Barcelona, Spain
The study agents were manufactured by Albuquerque Veterans Affairs (VA) Cooperative Studies Program Clinical Research Pharmacy.
Where did the other study products come from?
* Acetaminophen was donated by McNeil Consumer and Specialty Pharmaceuticals, Fort Washington, PA
* Celecoxib was purchased from Pfizer
Where was the study conducted?
The University of Utah, School of Medicine, Salt Lake City, UT, served as the coordinating study center and oversaw the research and recruitment efforts of the 16 study centers. The study was led by Daniel O. Clegg, M.D., a Professor of Medicine and Chief of Rheumatology, Division of Rheumatology, University of Utah School of Medicine. The GAIT biostatistician was Domenic J. Reda, Ph.D., from the Hines VA Cooperative Studies Program, which served as the study data management and analysis center. The GAIT Clinical Research Pharmacist was Crystal L. Harris, Pharm.D., at the Albuquerque VA Cooperative Studies Program Clinical Research Pharmacy, which manufactured, packaged, distributed, and provided analytical testing of the study agents along with regulatory support for GAIT. The 16 study centers and their lead investigators were:
* University of Alabama at Birmingham, Birmingham, AL; Larry W. Moreland, M.D.
* University of Arizona, Tucson, AZ; David Yocum, M.D.
* Cedars-Sinai Medical Center, Los Angeles, CA; Michael Weisman, M.D.
* University of California Los Angeles, Los Angeles, CA; Daniel Furst, M.D.
* University of California San Francisco, San Francisco, CA; Nancy Lane, M.D.
* Northwestern University, Chicago, IL; Thomas J. Schnitzer, M.D.
* Indiana University, Indianapolis, IN; John Bradley, M.D.
* The Arthritis Research and Clinical Centers, Wichita, KS; Frederick Wolfe, M.D.
* University of Nebraska Medical Center, Omaha, NE; James O'Dell, M.D.
* Hospital for Joint Diseases, New York, NY; Clifton Bingham, III, M.D.
* Case Western Reserve University, Cleveland, OH; Michele Hooper, M.D.
* University of Pennsylvania, Philadelphia, PA; H. Ralph Schumacher, Jr., M.D.
* University of Pittsburgh, Pittsburgh, PA; Chester Oddis, M.D.
* Presbyterian Hospital of Dallas, Dallas, TX; John J. Cush, M.D.
* University of Utah, Salt Lake City, UT; Christopher G. Jackson, M.D.
* Virginia Mason Medical Center, Seattle, WA; Jerry Molitor, M.D.
KEY RESULTS
What were the key results of the study? Researchers found that:
* Participants taking the positive control, celecoxib, experienced statistically significant pain relief versus placebo--about 70 percent of those taking celecoxib had a 20 percent or greater reduction in pain versus about 60 percent for placebo.
* Overall, there were no significant differences between the other treatments tested and placebo.
* For a subset of participants with moderate-to-severe pain, glucosamine combined with chondroitin sulfate provided statistically significant pain relief compared to placebo--about 79 percent had a 20 percent or greater reduction in pain versus about 54 percent for placebo. According to the researchers, because of the small size of this subgroup these findings should be considered preliminary and need to be confirmed in further studies.
* For participants in the mild pain subset, glucosamine and chondroitin sulfate together or alone did not provide statistically significant pain relief.
How many people participated in the study and who were they?
A total of 1,583 people participated in the study. People age 40 or older with knee pain and documented x-ray evidence of osteoarthritis were eligible to participate. Participants could not have used glucosamine for 3 months and chondroitin sulfate for 6 months prior to entering the study. Participants were about 59 years of age, on average, and nearly two-thirds of participants were women. Of the 1,583 study participants 78 percent (1,229) were in the mild pain subgroup and 22 percent (354) were in the moderate-to-severe pain subgroup.
Were there any side effects from the treatments?
There were 77 reports of serious adverse effects during the study. Of those 77, only 3 were attributed to study treatments. Most side effects were mild, such as upset stomach, and were spread evenly across the different treatment groups. In addition, although GAIT was not designed to evaluate these risks, no change in glucose tolerance was seen for glucosamine nor was an increased incidence of cardiovascular events seen with celecoxib.
CONSUMER INFORMATION AND NEXT STEPS
Should people with osteoarthritis use glucosamine and chondroitin sulfate?
People with osteoarthritis should work with their health care provider to develop a comprehensive plan for managing their arthritis pain: eat right, exercise, lose excess weight, and use proven pain medications. If people have moderate-to-severe pain, they should talk with their health care provider about whether glucosamine plus chondroitin sulfate is an appropriate treatment option.
Can U.S. consumers get the glucosamine and chondroitin sulfate products used in GAIT?
Identical products may not be commercially available. GAIT was conducted under an Investigational New Drug application filed with the U.S. Food and Drug Administration (FDA). All of the products used in the study were developed for the study and subject to the FDA's pharmaceutical regulations. The products were evaluated and manufactured by the VA Cooperative Studies Program Clinical Research Pharmacy, an FDA-licensed clinical research pharmacy center. The glucosamine and chondroitin sulfate used were tested for purity, potency, quality, and consistency among batches. Products were retested for stability throughout the study.
Will the GAIT team continue to do research on glucosamine and chondroitin sulfate?
GAIT includes an ancillary study, which is still ongoing, that will assess whether glucosamine and chondroitin sulfate can reduce or halt the progression of knee osteoarthritis following additional treatment. About one-half of the participants enrolled in GAIT will be treated for an additional 18 months. As in the primary study, participants will not know to which treatment group they belong. Researchers will compare x-rays taken at the beginning of the study and after 1 and 2 years of treatment to identify changes in the knee joints as a result of treatment. Results are expected in about a year.
For More Information
NCCAM Clearinghouse
The NCCAM Clearinghouse provides information on CAM and NCCAM, including publications and searches of Federal databases of scientific and medical literature. The Clearinghouse does not provide medical advice, treatment recommendations, or referrals to practitioners.
Toll-free in the U.S.: 1-888-644-6226
International: 301-519-3153
TTY (for deaf and hard-of-hearing callers): 1-866-464-3615
Web site: mailto:nccam.nih
E-mail: infonccam.nih
National Institute of Arthritis and Musculoskeletal and Skin Diseases For information on rheumatic diseases such as osteoarthritis and diseases of the musculoskeletal and skin systems, contact the NIAMS Information Clearinghouse.
Toll-free in the U.S.: 1-877-22-NIAMS
Telephone: 301-495-4484
Web site: niams.nih/hi/index.htm
Address: NIAMS/National Institutes of Health
1 AMS Circle
Bethesda, MD 20892-3675
NIH Office of Dietary Supplements (ODS)
For scientific citations and abstracts on dietary supplements, visit the ODS Web site for access to the International Bibliographic Information on Dietary Supplements database.
Web site: ods.od.nih/
U.S. Food and Drug Administration
For information on dietary supplement labeling requirements and safety monitoring, order the FDA Guide to Dietary Supplements from the U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition.
Toll-free in the U.S.: 1-800-FDA-4010
Web site: cfsan.fda/
Contact: NCCAM Press Office
nccampressmail.nih
NIH/National Center for Complementary and Alternative Medicine
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