Is extra strength tylenol good for arthritis pain

If you're one of an estimated 27 million Americans with osteoarthritis, you might think it makes sense to try Tylenol 8 Hour Arthritis Pain caplets to relieve your aching hips or knees.

But a new study by Swiss scientists concludes that acetaminophen, the generic name for Tylenol, doesn't work much better than a sugar pill in treating hip or knee pain from osteoarthritis (Europeans refer to the drug by a different name: paracetamol).

This isn't the first study of its kind to raise questions about the effectiveness of acetaminophen--often the first pain reliever prescribed to osteoarthritis patients--although its authors say it is the biggest. In 2015, researchers from Tufts and Brown universities reached a similar conclusion, that among the common treatments for knee osteoarthritis, only acetaminophen had no benefit.

Both the 2015 study and the new study were meta-analyses, in which scientists scoured the scientific literature for relevant research and then pooled the findings. In the new study, scientists ended up with 74 clinical trials with a total of nearly 60,000 osteoarthritis patients who had been randomly assigned to different treatment groups. Some of the trials compared varying doses of the same drug, while others compared a drug to a placebo, or sugar pill.

Besides acetaminophen, the clinical trials tested seven non-steroidal anti-inflammatory drugs, or NSAIDs: naproxen (Aleve), ibuprofen (Advil), celecoxib (Celebrex), lumiracoxib (Prexige) rofecoxib (Vioxx), diclofenac (Voltaren) and etoricoxib (Arcoxia). The researchers found that 150 milligrams a day of diclofenac was the most effective for short-term pain relief. Close behind were 60 milligrams a day of etoricoxib and 25 milligrams a day of rofecoxib.

In the United States, about two-thirds of osteoarthritis patients are prescribed NSAIDs, the authors of the new study write, but you might not be familiar with some of the ones included in their analysis.

For example, forget trying to find Merck's etoricoxib at your local drugstore. In 2007, a Food and Drug Administration advisory committee voted 20-1 (see the meeting transcript, starting at the bottom of page 50) against recommending approval of the drug because of cardiovascular safety concerns. The agency followed the committee's advice, although Arcoxia is on the market in dozens of other countries.

You won't find lumiracoxib or rofecoxib at the pharmacy, either. In 2007 (clearly not a good year for NSAIDs), the FDA issued a "not approvable letter" for lumiracoxib, and Canada and Australia told Novartis to pull the drug off the market because of reports linking it to liver problems (it is still available in a handful of countries). And in 2004, Merck voluntarily pulled the blockbuster rofecoxib, better known as Vioxx, off the market in the United States and approximately 80 other countries in which it was sold. An ongoing long-term study had found an increased risk of heart attack and stroke in patients on the drug  compared to those on a placebo. By the time Merck halted sales, Vioxx had been on the U.S. market for five years, and 2 million Americans were taking it.

The Vioxx debacle spurred the FDA to pay closer attention to the safety of NSAIDs. In 2015, the FDA strengthened an existing label warning on all of them except aspirin. The warning pertains to an increased risk of a heart attack or stroke, which can occur as early as the first few weeks of use and appears to be greater at higher doses, according to the FDA. Different NSAIDs might carry higher or lower risks of cardiovascular problems, but it's not yet possible to identify them, the agency says.

"Although our findings suggest that some NSAIDs have a clinically relevant treatment effect on osteoarthritis pain, their benefit has to be weighed against their potential harmful effects," the authors of the new study, published Thursday in The Lancet, wrote. They noted that previous research suggested that diclofenac in particular raised the risk of dying from a heart attack or stroke but carried a relatively low risk of bleeding in the digestive tract, a complication seen with older NSAIDs, including aspirin. Naproxen, on the other hand, doesn't seem to increase cardiovascular risk, but it substantially raises the risk of bleeding in the digestive tract, the scientists wrote.

If acetaminophen isn't effective in treating their pain, why do so many osteoarthritis patients take it for that reason? Several factors probably play a role, Dr. Sven Trelle, the lead author of the new study, told me in an email. Acetaminophen is marketed for arthritis pain, and if people think something is going to help relieve their aches, it often does. That's known as the placebo effect. In addition, Trelle said, osteoarthritis patients and their doctors view long-term acetaminophen use as safer than long-term NSAID use, because the former is thought to be easier on the heart and digestive tract than the latter.

But while sugar pills can trigger the placebo effect, acetaminophen is no sugar pill, emphasized Trelle, co-director of the clinical trials unit at the University of Bern in Switzerland. It is "a pharmacologic substance with potential side effects" that outweigh any perceived benefit in treating arthritis pain, he said. In fact, the FDA has cautioned that taking too much acetaminophen, which is found in a multitude of over-the-counter and prescription remedies, can cause serious liver damage.

Dr. Garrett FitzGerald, a professor of medicine and systems pharmacology and translational therapeutics at the University of Pennsylvania, called Trelle's study "an impressive survey of trials of NSAIDs in an attempt to assess their comparative efficacy."

Comparing pain-relievers' effect on pain and mobility in osteoarthritis patients is tricky because of the high rates of the placebo effect, FitzGerald told me. Plus, he said, clinical trials comparing the newer NSAIDs, the so-called coxibs, to older NSAIDs have focused on safety and "judiciously avoided" assessing the drugs' relative effectiveness. However, FitzGerald called it "encouraging" that the studies comparing different doses of the same NSAID found higher doses to be more effective, suggesting that more than the placebo effect was at play.

In an accompanying commentary, four pharmacologists from the University of Bordeaux in France called the finding that acetaminophen doesn't seem to confer any benefit at any dose Trelle's "most remarkable result."

"This finding is not entirely unexpected," the French scientists added. Acetaminophen "has been on the market for as long as most of us remember. Its efficacy has never been properly established or quantified in chronic diseases and is probably not as great as many would believe. It's safety is also questioned, not just in overdose. Is recommending it as the universal first-line analgesic in osteoarthritis still tenable?"

On the other hand, the commentary authors wrote, clinical trials, in which osteoporosis patients typically take NSAIDs for weeks or months at a time, might overstate the drugs' risks. In the real world, the French scientists noted, patients take the pain-relievers only when they have flare-ups.

A spokeswoman for Tylenol maker McNeil Consumer Healthcare, a division of Johnson & Johnson, said the company questioned Trelle's conclusion about acetaminophen.

"We disagree with the authors' interpretation of this meta-analysis and believe acetaminophen remains an important pain relief option for millions of consumers, particularly those with certain conditions for which...NSAIDs may not be appropriate," Jodie Wertheim said in a prepared statement. Those conditions include cardiovascular disease, digestive tract bleeding and kidney disease, Wertheim said.

"The safety and efficacy profile of acetaminophen is supported by more than 150 studies over the past 50 years," she said, "and we are committed to furthering research and education to ensure consumers can make informed choices about their medications based on individual health needs."

The problem, FitzGerald said, is a lack of scientific evidence to guide osteoarthritis patients in making that choice. For now, they must rely mostly on trial and error to pick which medication is most likely to relieve their pain with the fewest side effects.

"Patients often say that one NSAID works particularly well for them," FitzGerald said. "Is this true, and if so, why?"

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