After three weeks of treatment with probiotic bacteria, babies cried for an average of about a half-hour a day, while infants who received a placebo were still crying for an hour and a half daily. At the study's outset, babies in both groups were crying for five to six hours a day.

The cause of colic, traditionally defined as inconsolable crying for at least three hours a day, on at least three days in a week and lasting for at least three weeks, isn't clear. It affects up to 28 percent of babies under three months of age, according to lead author Dr. Francisco Savino of Regina Margherita Children Hospital in Turin, Italy.

Causes are "most likely multifactorial," Savino noted in an e-mail to Reuters Health, and may include social and psychological factors, as well as allergies to certain foods, including cow's milk. He added that recent research suggests that babies with colic have an abnormal balance of bacteria in their guts.

Savino and his team had previously tested the probiotic Lactobacillus reuteri against simethicone, the anti-gas remedy found in over-the-counter medications such as Gas-X, and found L. reuteri was much more effective in improving colicky symptoms. Another group of Italian researchers published a study last month that found L. reuteri was more helpful than placebo for treating constipation in babies.

In the current study, published in Pediatrics and funded by BioGaia AB of Stockholm (a company that makes probiotic infant drops for babies, among other products containing L. reuteri), the researchers compared the "good bacteria" to placebo.

Parents gave their babies five drops of the active probiotic, a suspension of freeze-dried L. reuteri in oil, or a placebo consisting of the same oil minus the bacteria, once a day a half-hour before feeding the baby in the morning. All of the infants were exclusively breastfed and mothers were asked to abstain from drinking cow's milk during the three week test. The study was double-blind, meaning neither the patients nor the researchers knew whether a participating baby was receiving active treatment or placebo.

At the beginning of the study, the 25 babies in the probiotic group were crying for 370 minutes a day, on average, compared to 300 minutes for the 21 babies in the placebo group, which wasn't a statistically significant difference, meaning it could have been due to chance.

On day 21, babies in the probiotic group averaged 35 minutes of crying a day, compared to 90 minutes for the placebo babies. Seven days into the study, 20 of the babies in the probiotic group had showed a response to treatment (defined as a 50 percent or greater reduction in crying time), compared to 8 of the placebo group; at 14 days, 24 of the probiotic babies and 13 of the placebo babies had responded; and at 21 days, 24 of the probiotic group had responded to treatment, compared to 15 of the placebo group.

The researchers also tested stool samples from the infants before and after treatment and confirmed an increase in the probiotic bacteria among the infants given the supplement; these babies also showed a reduction in the amount of Escherichia coli in their stool and less ammonia. Theories about the causes of colic include the possibility that an overabundance of E. coli in the intestines of colicky babies could produce excess gas.

The authors speculate that the probiotic might help babies by improving their gut function and calming intestinal nerves. They also note that the considerable decrease in crying time among the babies who received the placebo might be attributable to the mothers' milk-free diet or just growing out of the colicky stage, as most babies eventually do, during the study period.

After a pediatrician has examined a colicky child to rule out any underlying cause of disease and address any feeding problems, "our results suggest a potential role of L. reuteri as a new safe therapeutic approach to infantile colic," Savino said.

Omega-3 margarines fail to help in heart study

Sun Aug 29, 2010 4:24am EDT

By Ben Hirschler

STOCKHOLM (Reuters) - Giving patients with a history of heart attacks a margarine enriched with omega-3 oils in addition to standard drugs appears to make no difference to their chances of having a repeat attack.

A 40-month study of more than 4,800 patients showed taking low doses of omega-3 fatty acids in margarine did not significantly reduce rates of serious heart attacks and other cardiovascular events, Dutch researchers said on Sunday.

The finding raised questions about the benefits of omega-3, which has been shown in previous studies to make for healthier hearts. The margarines used in the study were developed for the researchers by food and consumer goods giant Unilever.

Doctors, however, are unlikely to rush to change clinical practice. Many already prescribe omega-3 fish oil capsules, including GlaxoSmithKline's Lovaza, to reduce triglycerides, a type of blood fat linked to clogged arteries.

"It will be viewed as a largely negative study and people who are enthusiasts for omega fatty acids will continue to be enthusiasts and people who are skeptics will continue to be skeptics," said Scott Wright of the Mayo Clinic in the United States, who was not involved in the research.

Daan Kromhout of Wageningen University, who led the study, told the European Society of Cardiology the lack of efficacy might reflect the good background drug treatment patients were receiving, with 85 percent on cholesterol-lowering statins, as well as blood pressure and blood-thinning tablets.

"We found the cardiovascular mortality rate in the study population was only half that expected, probably because of their excellent treatment," he said.

"This may also be why the rate of major cardiovascular events during follow-up was no lower in the fatty acid groups than in the placebo group."

All the men and women in the Dutch study were aged between 60 and 80 and had suffered a heart attack roughly four years previously.

They were randomly assigned use of one of four margarines on bread instead of their regular spread -- one containing no extra omega-3 fatty acids; one with 400 milligrams a day of extra eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA); one with 2 grams of alpha-linolenic acid (ALA); and one with a combination of EPA-DHA and ALA.

Fish like salmon, herring and sardine are a common source of EPA-DHA, while ALA is found in vegetables including soybeans, flax seeds and walnuts.

Despite the overall negative results, researchers did find there was a reduction in repeat heart attacks and other cardiovascular events in women who took ALA margarine, although this was not statistically significant. Diabetes patients also showed a possible benefit.

Unilever, whose margarine brands that contain omega-3 include Flora and I Can't Believe It's Not Butter, said the lack of benefit seen with EPA and DHA was surprising, considering the weight of evidence published to date.

"The results indicate that more investigation is required into the efficacy of vegetable omega 3, but do not question the current authoritative dietary recommendations and advices for omega 3 intakes on which our products are based," the company said in a statement.

The results of the study, which was supported by the Netherlands Heart Foundation, the National Institutes of Health, and Unilever, were also published in the New England Journal of Medicine.