All Posts tagged placebo

Placebos may work – even when the patient knows

For most of us, the “placebo effect” is synonymous with the power of positive thinking; it works because you believe you're taking a real drug. But a new study rattles this assumption.Researchers at Harvard Medical School's Osher Research Center and Beth Israel Deaconess Medical Center (BIDMC) have found that placebos work even when administered without the seemingly requisite deception.

Placebos—or dummy pills—are typically used in clinical trials as controls for potential new medications. Even though they contain no active ingredients, patients often respond to them. In fact, data on placebos is so compelling that many American physicians (one study estimates 50 percent) secretly give placebos to unsuspecting patients. Because such “deception” is ethically questionable, HMS associate professor of medicine Ted Kaptchuk teamed up with colleagues at BIDMC to explore whether or not the power of placebos can be harnessed honestly and respectfully.

To do this, 80 patients suffering from irritable bowel syndrome (IBS) were divided into two groups: one group, the controls, received no treatment, while the other group received a regimen of placebos—honestly described as “like sugar pills”—which they were instructed to take twice daily. “Not only did we make it absolutely clear that these pills had no active ingredient and were made from inert substances, but we actually had 'placebo' printed on the bottle,” says Kaptchuk. “We told the patients that they didn't have to even believe in the placebo effect. Just take the pills.”

For a three-week period, the patients were monitored. By the end of the trial, nearly twice as many patients treated with the placebo reported adequate symptom relief as compared to the control group (59 percent vs. 35 percent). Also, on other outcome measures, patients taking the placebo doubled their rates of improvement to a degree roughly equivalent to the effects of the most powerful IBS medications. “I didn't think it would work,” says senior author Anthony Lembo, HMS associate professor of medicine at BIDMC and an expert on IBS. “I felt awkward asking patients to literally take a placebo. But to my surprise, it seemed to work for many of them.”

The authors caution that this study is small and limited in scope and simply opens the door to the notion that placebos are effective even for the fully informed patient—a hypothesis that will need to be confirmed in larger trials. “Nevertheless,” says Kaptchuk, “these findings suggest that rather than mere positive thinking, there may be significant benefit to the very performance of medical ritual. I'm excited about studying this further. Placebo may work even if patients knows it is a placebo.”

This study was funded by the National Center for Complementary and Alternative Medicine and Osher Research Center, Harvard Medical School.

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Tomato juice helps stop osteoporosis

Tomatoes are rich in cell-protecting antioxidants. Antioxidants are known cancer-fighters, such as prostate and breast cancer. And now lycopene – one of the antioxidants found in tomatoes – is being linked to reduce risk of osteoporosis. Osteoporosis is a degenerative bone disease, usually developing in old age, especially in post-menopausal women.

But the new study at the University of Toronto in Canada, says drinking tomato juice may help stave off osteoporosis. Published in the journal Osteoporosis International, scientists claim consuming 30mg of lycopene from tomato juice (about two glasses) is enough to help prevent osteoporosis. For the research, experts restricted a group of post-menopausal women, ages 50 to 60, from consuming anything containing lycopene for one month, then the study participants were split into four groups for four months. Groups were given either a 15mg lycopene supplement, a glass of tomato juice naturally containing 15mg of lycopene, a gourmet tomato juice with 35mg of lycopene, or a placebo.

After four months, results showed supplementing with lycopene raised serum lycopene, compared to the placebo group. The women consuming lycopene had significantly increased antioxidant capacity, decreased oxidative stress, and decreased bone markers for osteoporosis.

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Denufosol improves Cystic Fibrosis in clinical trials

Cystic fibrosis is a genetic disease that causes a thick, sticky mucus to build up in the lungs and digestive tract. A clinical trial of a new drug called denufosol found that those given the medication for six months prevented some of the accumulation and improved performance on lung tests.

The Cystic Fibrosis Foundation estimates that about 30,000 children and adults in the United States have the condition that clogs the lungs and leads to life-threatening lung infections. The mucus also obstructs the pancreas and stops natural enzymes from helping the body break down and absorb food.

Cystic fibrosis is caused by a genetic mutation that disrupts the cystic fibrosis transmembrane regulator (CFTR) protein, an ion channel. Denufosol tetrasodium inhalation solution works by correcting ion transport in patients to enhance airway hydration and mucus clearance by increasing chloride secretion, inhibiting sodium absorption and increasing ciliary beat frequency.

Frank J. Accurso MD of the University of Colorado and colleagues included about 350 children with cystic fibrosis aged five and older in the study called TIGER-1, The Transport of Ions to Generate Epithelial Rehydration. All had a forced expiratory volume (FEV1) at least 75% of normal, indicating normal to mildly impaired lung function characteristic of early cystic fibrosis.

The patients were randomized to receive either 60 milligrams of inhaled denufosol three times daily or a matching placebo for 24 weeks. This was followed by another 24-week open-label safety extension phase.

The patients on the new medication had increase in FEV1 of 0.048 L, approximately 2% over baseline. In addition, the researchers found further lung improvement by 0.115L by the end of the open-label phase. The placebo group, when switched over to denofusol in the open-label phase, also improved by a mean 0.078 L in FEV1.

Big improvements weren't expected, says Accurso, because the drug is primarily designed to prevent or delay loss of lung function rather than act as a rescue therapy.

Denufosol appeared to be safe without serious adverse events or impaired growth of the young patients, suggesting it could be suitable as an early intervention. Intervention for cystic fibrosis early in its course has the potential to delay or prevent progressive changes that lead to irreversible airflow obstructions, the researchers say in their study published in the American Journal of Respiratory and Critical Care Medicine.

A second phase III trial, which is called TIGER-2, is ongoing which will incorporate a longer placebo-controlled treatment phase. Inspire Pharmaceuticals is targeting a potential US commercial launch of the drug for 2012, pending FDA approval.

Source reference:
Accurso FJ, et al “Denufosol Tetrasodium in Patients with Cystic Fibrosis and Normal to Mildly Impaired Lung Function” Am J Respir Crit Care Med 2011.

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“Good” bacteria helps kids with irritable bowel syndrome

Good bacteria
About 10 to 15 percent of children experience recurrent abdominal pain, the researchers said. The pain can be due to irritable bowel syndrome — which is usually relieved by defecation — or can be “functional abdominal pain,” which is not explained by another disease. While LGG has been tested before in children with abdominal pain, the studies were small and showed mixed results. The new study, which involved 141 children with irritable bowel syndrome or functional abdominal pain, was conducted in Italy between 2004 and 2008. Researchers gave the kids either the probiotic or a placebo for eight weeks. Neither the doctors nor the patients were aware which treatment they received.

Following the treatment, the patients were followed up for another 8 weeks. During the treatment and follow-up, the severity and frequency of abdominal pain decreased for both groups, but the probiotic group experienced a more drastic reduction. For instance, after 12 weeks, patients who took the probiotic reported experiencing, on average, 1.1 episodes of pain per week, compared with 3.7 weekly episodes before the treatment. Those who took the placebo reported experiencing 2.2 pain episodes per week, compared with 3.5 episodes initially.

And a greater percentage of parents of children who took the probiotic reported that their children experienced a decline in pain,compared with those whose kids took the placebo. Among kids who took the probiotic, it was mostly children with irritable bowel syndrome who showed improvements, the researchers said.

Why does it work?
The results suggest LGG may be specifically beneficial for those with irritable bowel syndrome, the researchers said. It's possible that children with irritable bowel syndrome have an imbalance of good and bad bacteria in their guts, which contributes to the pain, and the probiotics relieves pain by restoring the proper balance, Francavilla said. Probiotics have also been suggested to reduce inflammation in the gut, as well as stimulate the release of analgesic substances that relieve pain. The researchers noted they cannot be sure whether the beneficial effects will last for more than a few weeks after treatment is stopped.

The results were published in the journal Pediatrics.

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Vitamin D Might Fight Colds

“However,” the researcher said, “there is a lack of clinical studies of the effect of vitamin D supplementation for preventing respiratory infections.”

For the current study, Laaksi's team randomly assigned 164 male military recruits to take either 400 international units (IU) of vitamin D or inactive placebo pills every day for six months — from October to March, covering the months when people's vitamin D stores typically decline and when respiratory infections typically peak.

At the end of the study, the researchers found no clear difference between the two groups in the average number of days missed from duty due to a respiratory infection — which included bronchitis, sinus infections, pneumonia, ear infections and sore throat.

On average, men who took vitamin D missed about two days from duty because of a respiratory infection, compared with three days in the placebo group. That difference was not significant in statistical terms.

However, men in the vitamin D group were more likely to have no days missed from work due to a respiratory illness.

Overall, 51 percent remained “healthy” throughout the six-month study, versus 36 percent of the placebo group, the researchers report.

The findings, Laaksi said, offer “some evidence” of a benefit from vitamin D against respiratory infections.

Still, the extent of the benefit was not clear. While recruits in the vitamin group were more likely to have no days missed from duty, they were no less likely to report having cold-like symptoms at some point during the study period.

Moreover, recent studies on the usefulness of vitamin D for warding off respiratory ills have come to conflicting conclusions.

A study of Japanese schoolchildren published earlier this year found that those given 1,200 IU of vitamin D each day during cold and flu season were less likely to contract influenza A. Of 167 children given the supplement, 18 developed the flu, compared with 31 of 167 children given placebo pills.

On the other hand, a recent study of 162 adults found that those who took 2,000 IU of vitamin D everyday for 12 weeks were no less likely to develop respiratory infections than those given placebo pills.

Laaksi said that larger clinical trials looking at different doses of vitamin D are still needed before the vitamin can be recommended for curbing the risk of respiratory infections.

In the U.S., health officials recommend that adults up to the age of 50 get 200 IU of vitamin D each day, while older adults should get 400 to 600 IU. The upper limit is currently set at 2,000 IU per day; higher intakes may raise the risks of side effects.

Symptoms of vitamin D toxicity are often vague and include nausea, vomiting, constipation, poor appetite and weight loss. Excessive vitamin D in the blood can also raise blood pressure or trigger heart rhythm abnormalities.

Some researchers believe that people need more vitamin D than is currently recommended, and that intakes above 2,000 IU per day are safe. However, exactly what the optimal vitamin D intake might be remains under debate.

Food sources of vitamin D include milk, breakfast cereals and orange juice fortified with vitamin D, as well as some fatty fish, like salmon and mackerel. Experts generally recommend vitamin pills for people who do not get enough of the vitamin from food.

SOURCE: Journal of Infectious Diseases

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Vitamin E May Decrease Pulmonary Disease

Ms. Agler and colleagues reviewed data compiled by the Women's Health Study, a multi-year, long-term effort ending in 2004 that focused on the effects of aspirin and vitamin E in the prevention of cardiovascular disease and cancer in nearly 40,000 women aged 45 years and older. Study participants were randomized to receive either 600 mg of vitamin E or a placebo every other day during the course of the research.

Although fewer women taking vitamin E developed COPD, Ms. Agler noted the supplements appeared to have no effect on asthma, and women taking vitamin E supplements were diagnosed with asthma at about the same rate as women taking placebo pills. Importantly, Ms. Agler noted the decreased risk of COPD in women who were given vitamin E was the same for smokers as for non-smokers.

Ms. Agler said further research will explore the way vitamin E affects the lung tissue and function, and will assess the effects of vitamin E supplements on lung diseases in men. “If results of this study are borne out by further research, clinicians may recommend that women take vitamin E supplements to prevent COPD,” Ms. Agler noted. “Remember that vitamin E supplements are known to have detrimental effects in some people; for example vitamin E supplementation increased risk of congestive heart failure in cardiovascular disease patients. Broader recommendations would need to balance both benefits and risks. “

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