As strong doubts emerge over the safety of a second popular arthritis pain medication, the federal government yesterday announced promising results of a study for another way to treat the common ailment -- acupuncture.
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In the largest, most rigorously designed clinical trial of the 2,000-year-old Chinese treatment, acupuncture was found to be a safe and effective complementary therapy to reduce pain and improve function among people with knee osteoarthritis, a chronic condition that affects 20 million Americans.
Results of the study -- funded by arms of the National Institutes of Health, including the National Center for Complementary and Alternative Medicine -- are being published today in the Annals of Internal Medicine.
"We tried to apply good science to an ancient therapy," said Dr. Stephen Straus, director of the 6-year-old national center, which is funding studies all over the country to look at a host of alternative treatments.
"Acupuncture is safe and effective in reducing pain and improving physical function."
The 570 people enrolled in the multicenter study continued on standard medical care therapy, including pain medication, while getting the acupuncture treatments.
The goal of the study was to see if acupuncture, which uses hair-thin needles inserted at specific body points, is safe and could be an adjunct to standard treatments.
"Just because acupuncture is 2,000 years old, it doesn't mean that it's magic," Straus said during a national teleconference about the study. "It alone or in combination with standard therapy doesn't suddenly convert an individual with osteoarthritis into an individual without osteoarthritis, but it does afford an added benefit and that is an important health goal."
Osteoarthritis is a chronic disease that results from a breakdown of cartilage in the joints, especially weight-bearing joints, causing painful bone-to-bone wear and tear.
Finding effective treatments for this condition is becoming more urgent as safety issues have arisen over two of the newest and most popular pain relief drugs, Vioxx and Celebrex, both so-called COX-2 inhibitors.
The drugmaker Merck & Co. pulled Vioxx off the market in September, and last week, Pfizer found an increased risk of heart attacks with patients taking high doses of its top-selling painkiller Celebrex. The National Cancer Institute, which was examining the use of Celebrex in two long-term cancer prevention trials, suspended the study.
Yesterday, the epidemic of bad news about the potential risks of popular anti-inflammatory medications expanded as federal officials announced that naproxen, a painkiller sold by prescription and also over the counter as Aleve, might increase people's risk of having a heart attack or stroke.
Researchers uncovered the potential problem with naproxen on Friday during a quick review of data from a large, ongoing three-year-old National Institutes of Health study. As part of that study, which has aimed to see if anti-inflammatory drugs can help delay the onset of Alzheimer's disease, 2,500 elderly people have been receiving regular doses of naproxen or Celebrex.
The Alzheimer's study review surprised officials by revealing a 50 percent increase in heart attacks or strokes among study participants taking naproxen compared with those who had been taking placebos.
NIH officials and study leaders decided to suspend both parts of the study as a "precautionary measure."
Not withstanding the safety issues, many elderly patients can't take pain medication, said Dr. Debra Weiner, a geriatrician and rheumatologist at the University of Pittsburgh Medical Center who is conducting other studies on acupuncture.
"A lot of people don't tolerate medication," said Weiner. "We have frail, older people who are on lots of other medications. A lot of the time pain medication interacts with other drugs. It's very complicated."
There is no scientific evidence at this point that acupuncture will help patients reduce pain medication or get off it altogether, but local practitioners have their own anecdotal accounts of this happening.
Dr. Donald Yoon, who practices in Monroeville, said about 30 percent of his acupuncture patients are seeking relief from knee osteoarthritis.
"Usually they come to my office as one of their last resorts," he said. "They have tried all kinds of pain medication, including narcotics. With this treatment they definitely decrease the amount of pain medication and improve most if not all of their function."
The popularity of acupuncture has grown steadily throughout the United States, fueled mostly by anecdotal accounts of its benefits. In 2002, an estimated 2.1 million U.S. adults received acupuncture treatments for a range of ailments. There are 450 practitioners in Pennsylvania, including about 25 in the immediate Pittsburgh area.
Acupuncturists say that inserting the needles corrects energy imbalances along the body's meridians that carry an energy flow called Qi (pronounced "chee").
Richard Nahin, senior adviser for scientific coordination and outreach for the National Center for Complementary and Alternative Medicine, acupuncture is believed to stimulate the central nervous system to release pain-dulling chemicals into the muscles, spinal cord and brain.
In the NIH study, participants 50 or older were randomly assigned to receive one of three treatments: acupuncture, sham acupuncture -- a procedure designed to prevent patients from being able to detect if needles are actually inserted at treatment points -- or participation in a control group that followed the Arthritis Foundation's self-help course for managing their condition.
The participants received 24 acupuncture treatments over 26 weeks. By week eight, those receiving the true acupuncture were showing significant increase in function, and by week 14, a significant decrease in pain.
Overall, those who received acupuncture had a 40 percent decrease in pain and 40 percent improvement in function.
Side effects may involve soreness or numbness around the needle insertion area, but no major problems were reported in this study, said the researchers, who were led by Dr. Brian Berman of the University of Maryland School of Medicine in Baltimore.
Alise Brown, 33, of Oakdale, has seen the benefits of acupuncture firsthand. She started treatments with Yoon after she was diagnosed with osteoarthritis of the knee, apparently caused by years of running and weight-training. She was taking Mobic, a prescription anti-inflammatory medicine, but didn't like the side effects and worried about long-term drug use.
After two weekly acupuncture treatments, she was able to get off the medication.
"I know it's very soon, but right now, I've had a positive response," Brown said. "I would never have believed how much better I feel from the acupuncture and being off the anti-inflammatory."
Like most patients, she pays out of pocket for the treatments. Most insurance companies don't cover the sessions, which average $50.
"In my heart, I know this is a very good alternative treatment in many arthritis cases," Yoon said. "Now the NIH gives you more scientific explanation and legitimacy of this procedure."