Paracetamol no better than placebo for low back pain, study finds

Paracetamol, a painkiller universally recommended to treat people with acute low back pain, does not speed recovery or reduce pain from the condition, according to the results of a large trial published on Thursday.

A study published in The Lancet medical journal found that the popular pain medicine was no better than placebo, or dummy, pills for hastening recovery from acute bouts of low back pain or easing pain levels, function, sleep or quality of life.

Researchers said the findings challenge the universal endorsement of paracetamol as the first choice painkiller for lower back pain.

"We need to reconsider the universal recommendation to provide paracetamol as a first-line treatment," said Christopher Williams, who led the study at the University of Sydney in Australia.

Lower back pain is the leading cause of disability worldwide. In the United States alone, costs relating to the condition are estimated to be more than $100 billion a year.

Currently, every back pain treatment guideline in the world recommends paracetamol as the first-line analgesic and Williams said this was despite the fact that no previous studies have provided robust evidence that it works in this condition.

Tim Salomons, a pain expert at Britain's University of Reading whose own research has found that cognitive behavioral therapy could be used to treat chronic pain, said this latest study showed the challenge of treating the condition.

"It is vitally important we continuously challenge conventional wisdom about treating pain," he said in an emailed comment. "Even though paracetamol has a good safety profile, every drug has side effects. If the drug is not doing what it is being prescribed to do, pain patients might be better off without."

In Williams' trial, 1,652 people from Sydney with acute low back pain were randomly assigned to receive up to four weeks of paracetamol, either in regular doses three times a day, or as needed, or to receive placebos. All those involved received advice and reassurance and were followed up for three months.

The results showed no difference in the number of days to recovery between the treatment groups - with the average time to recovery coming out at 17 days for each of the groups given paracetamol, and at 16 days for the placebo group.

Paracetamol had no effect on short-term pain levels, disability, function, sleep quality, or quality of life, the researchers said, and the number of patients reporting negative side effects was similar in all groups.

Christine Lin, an associate professor at the George Institute for Global Health and the University of Sydney who also worked on the study, said the reasons for paracetamol failing to work for lower back pain were not well understood.

"While we have shown that paracetamol does not speed recovery from acute back pain, there is evidence that paracetamol works to relieve pain for a range of other conditions, such as headaches, some acute musculoskeletal conditions, tooth ache and for pain straight after surgery," she said in a statement about the findings.

"What this study indicates is that the mechanisms of back pain are likely to be different from other pain conditions, and this is an area that we need to study more."

Experts who were not directly involved praised the study but cautioned that guidelines should nevertheless not be changed on the basis of a single piece of research.

"More robust and consistent evidence, including verification of the results in other populations, is needed," Bart Koes and Wendy Enthoven from the Erasmus Medical Centre in the Netherlands wrote in a Lancet commentary.

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They also called for more studies on whether other simple analgesics could add extra benefits on top of giving advice and reassurance to patients.

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(Editing by Robin Pomeroy and Catherine Evans)

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Researchers practice living on Mars - without leaving Earth

For the past four months, a team of researchers have been living in a mockup Mars habitat on a Hawaiian volcano practicing isolated living on the Red Planet.

For the most part, expedition leader Casey Stedman and his five crewmates have stayed inside their 1,000-square foot (93-square meter) solar-powered dome, venturing out only for simulated spacewalks and doing so only when fully attired in mock spacesuits.

"I haven’t seen a tree, smelled the rain, heard a bird, or felt wind on my skin in four months,” Stedman wrote in a blog on Instagram. Stedman is a U.S. Air Force Reserve officer, graduate student at Embry-Riddle Aeronautical University Worldwide.

“We are simulating a long-duration mission on Mars, with a focus on crew psychology in isolation,” the crew said during an online interview with Reddit on Sunday.

Crewmembers, who include a NASA chemical engineer and a neuropsychologist at the Fort Wayne Neurological Center in Indiana, have been isolated from direct human contact and have been eating dehydrated and shelf-stabilized foods.

“We’ve basically been subsisting on mush. Flavorful mush, but mush nonetheless,” crewmember Ross Lockwood wrote on Instagram. Lockwood is finishing a doctorate in physics at the University of Alberta.

The habitat, which is outfitted with waterless composting toilets, is basically self-sustaining except for a water resupply and wastewater recovery every two- to three weeks.

Communications with the outside world have been time-delayed to match the 20-minute travel time of radio waves passing between Earth and Mars. In addition to a battery of daily psychological surveys, the researchers tend to science projects and other studies, including expeditions outside the habitat to scout Mars-like features on Hawaii's Mauna Loa volcano. The landscape is similar to a region on Mars known as Tharsis. For fun, there are movies, board games and exercise, Lockwood told Reddit.

“We don't have a lot of spare time, but I count work as part of the fun as well. Planning EVAs (spacewalks), preparing food, even chores - these are all enjoyable activities,” he said.

The operational part of the Hawaii Space Exploration Analog and Simulation mission, known as Hi-SEAS 2, wraps up on Friday, but it will take months to synthesize all the findings.

The point of the project is to create guidelines for future missions to Mars, the long-term goal of the U.S. human space program.

“Hopefully, when we send humans to Mars, we will have done enough missions like HI-SEAS that we'll remember to bring the really important stuff, like extra toilet paper,” mission support team member Gary Strawn said on Reddit.

The simulation, which is funded by NASA and overseen by the University of Hawaii, began on March 28.

(Editing by Bernard Orr)

Keryx drug improves phosphorus, iron in kidney patients: trial

A pivotal trial of Keryx Biopharmaceuticals Inc's experimental drug Zerenex showed that it improved levels of serum phosphorus and iron in patients on kidney dialysis, according to results published on Thursday.

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The trial involved 441 patients, according to the Journal of the American Society of Nephrology, which published the results.

Over the four-week efficacy assessment period, mean serum phosphorus for Zerenex patients dropped by 2.2 milligrams per deciliter compared with placebo patients, the trial showed.

Most patients with kidney disease that requires dialysis need chronic treatment with phosphate-binding agents to lower and maintain serum phosphorus at acceptable levels.

The study found that, if approved, Zerenex would be the only phosphate binder that also increases iron stores, reducing the need for other drugs to treat anemia.

Side effects experienced by patients treated with Zerenex included diarrhea, nausea, vomiting and constipation. Serious adverse events were reported in 39.1 percent of the Zerenex patients and 49 percent of patients in the control group.

The U.S. Food and Drug Administration, which earlier this year cited manufacturing information as the reason for a three-month extension of its review of Zerenex, is expected to decide by Sept. 7 whether to approve the drug.

(Reporting by Deena Beasley; Editing by Jan Paschal)

Scientists to excavate Wyoming cave with trove of Ice Age fossils

Scientists will begin excavation early next week of an ancient Wyoming sinkhole containing a rare bounty of fossil remains of prehistoric animals, such as mammoths and dire wolves, preserved in unusually good condition, researchers said on Thursday.

   The two-week dig, set to begin next Monday under the direction of Des Moines University paleontologist Julie Meachen, marks the first exploration of Natural Trap Cave in north-central Wyoming since its initial discovery in the 1970s.

At that time, scientists found that the 85-foot-deep cavern formed a natural repository for a rich fossil record that may date back as far as 100,000 years, but a full-scale expedition into the sinkhole has not previously been attempted.

  The cave, formed by the collapse of limestone bedrock at the base of the Bighorn Mountains, became a tomb for thousands of ancient mammals that stumbled into the 15-foot-wide mouth of the sinkhole, then concealed by vegetation, and plunged to their deaths.

  Conditions in the underground chasm, which widens to 120 feet at its base, are cold and damp, offering a degree of preservation for fossils generally associated only with those found frozen in ice in Siberia and the Arctic, Meachen said.

  "They fell into a refrigerator," she said of animals such as camels, American lions, cheetahs, woolly mammoths and short-faced bears.

  Meachen will lead a team of international scientists as they rappel from the outer rim of the cave's opening – covered for decades by a metal grate installed by federal land managers – to the depths below, where they will load fossils into buckets to be hoisted to the surface.

  Analysis of recovered fossils is expected to provide new insights into the climate, diets and genetic diversity of North American mammals that disappeared during the Ice Age extinction of more than 10,000 years ago.

   Meachen said there may also be an opportunity to draw inferences tied to an emerging theory that the mass extinction was linked more to overhunting by humans, whose appearance in North America coincided with a die-off long thought to be influenced mostly by climate.

  Meachen said she had trained at a rock-climbing gym for the descent and the more arduous ascent, also by rope, but remained leery of entries and exits from the cave.

  "I'm scared out of my wits," she said.

(Reporting by Laura Zuckerman from Salmon, Idaho; Editing by Curtis Skinner, Steve Gorman and Clarence Fernandez)

Bayer says Nexavar fails in breast cancer study

German drugmaker Bayer said a Phase III trial of cancer drug Nexavar in patients with advanced breast cancer did not meet its primary endpoint of delaying the progression of the disease.

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The study, called Resilience, evaluated Nexavar in combination with chemotherapeutic agent capecitabine, in women with HER2-negative breast cancer.

Oral drug Nexavar, which Bayer is developing jointly with Amgen, is approved for use against certain types of liver, kidney and thyroid cancer.

Study details are expected to be presented at an upcoming scientific conference.

(Reporting by Ludwig Burger; Editing by Kirsti Knolle)

Evidence suggests babies in womb start learning earlier than thought: study

Babies in the womb show evidence of learning by their 34th week, three weeks earlier than previously thought, new research has found.

"It really pushed the envelope" in terms of how early babies begin to learn, lead researcher Charlene Krueger, associate professor at the University of Florida's College of Nursing, said on Thursday.

The study, published in the journal Infant Behavior and Development, followed 32 women from their 28th through 38th weeks of pregnancy in an investigation to pinpoint when the ability to learn emerges.

Krueger had the women repeat three times out loud a set 15-second nursery rhyme, and do it twice a day for six weeks. The selected rhyme was previously unknown to the mothers.

The fetuses’ heart rates were monitored at 32, 33 and 34 weeks as they listened to a recording of a female stranger recite the rhyme.

By the 34th week, Krueger said, the heart rates of the tested fetuses showed an overall slight decline while listening to the recording, compared with a control group of fetuses whose heart rates slightly accelerated while listening to a recording of a new nursery rhyme.

Krueger said a decelerating heartbeat has long been associated with a fetus recognizing something familiar, compared with an accelerated heartbeat response to a novel sound or experience.

"We cautiously concluded, because it was not statistically significant, that learning emerged by 34 weeks gestational age," she said.

At that point, the mothers stopped reciting the rhyme to their babies who were tested again at 36 and 38 weeks.

"At 38 weeks we confidently concluded the fetus could remember the rhythm of that nursery rhyme, which was four weeks after the mother stopped reciting the rhyme," Krueger said.

"The deeper and more prolonged response (at 38 weeks), the more confident I felt that learning had gone on," she said.

Krueger said the findings have implications for the care of pre-term babies in neonatal units. She said she next wants to experiment with placing recordings of the mothers’ voices in the babies’ cribs so they will benefit from positive impacts of their mothers’ voices.

“What it really shows is how sophisticated the interaction is between a mother and her infant,” she said.

(Editing by David Adams and Matthew Lewis)

Researchers practice living on Mars - without leaving Earth

For the past four months, a team of researchers have been living in a mockup Mars habitat on a Hawaiian volcano practicing isolated living on the Red Planet.

For the most part, expedition leader Casey Stedman and his five crewmates have stayed inside their 1,000-square foot (93-square meter) solar-powered dome, venturing out only for simulated spacewalks and doing so only when fully attired in mock spacesuits.

"I haven’t seen a tree, smelled the rain, heard a bird, or felt wind on my skin in four months,” Stedman wrote in a blog on Instagram. Stedman is a U.S. Air Force Reserve officer, graduate student at Embry-Riddle Aeronautical University Worldwide.

“We are simulating a long-duration mission on Mars, with a focus on crew psychology in isolation,” the crew said during an online interview with Reddit on Sunday.

Crewmembers, who include a NASA chemical engineer and a neuropsychologist at the Fort Wayne Neurological Center in Indiana, have been isolated from direct human contact and have been eating dehydrated and shelf-stabilized foods.

“We’ve basically been subsisting on mush. Flavorful mush, but mush nonetheless,” crewmember Ross Lockwood wrote on Instagram. Lockwood is finishing a doctorate in physics at the University of Alberta.

The habitat, which is outfitted with waterless composting toilets, is basically self-sustaining except for a water resupply and wastewater recovery every two- to three weeks.

Communications with the outside world have been time-delayed to match the 20-minute travel time of radio waves passing between Earth and Mars. In addition to a battery of daily psychological surveys, the researchers tend to science projects and other studies, including expeditions outside the habitat to scout Mars-like features on Hawaii's Mauna Loa volcano. The landscape is similar to a region on Mars known as Tharsis. For fun, there are movies, board games and exercise, Lockwood told Reddit.

“We don't have a lot of spare time, but I count work as part of the fun as well. Planning EVAs (spacewalks), preparing food, even chores - these are all enjoyable activities,” he said.

The operational part of the Hawaii Space Exploration Analog and Simulation mission, known as Hi-SEAS 2, wraps up on Friday, but it will take months to synthesize all the findings.

The point of the project is to create guidelines for future missions to Mars, the long-term goal of the U.S. human space program.

“Hopefully, when we send humans to Mars, we will have done enough missions like HI-SEAS that we'll remember to bring the really important stuff, like extra toilet paper,” mission support team member Gary Strawn said on Reddit.

The simulation, which is funded by NASA and overseen by the University of Hawaii, began on March 28.

(Editing by Bernard Orr)