Day: 06/08/2016

Yoga Improves Sleep Quality in Cancer Survivors

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Cancer survivors who participated in a special yoga program reported better sleep quality and less reliance on sleep medication, according to the results of a study published in the Journal of Clinical Oncology.

Sleep problems and fatigue are among the most common problems experienced by cancer survivors, and can have a profound impact on quality of life. Sleep problems are very common during cancer treatment, but can persist even after treatment ends. In fact, 30 to 90 percent of cancer survivors report impaired sleep quality after treatment.

Yoga is a mind-body practice and form of exercise that may improve sleep among cancer survivors. In order to evaluate the impact of yoga on sleep, researchers conducted a randomized trial that included 410 cancer survivors with moderate to severe sleep disturbances that occurred two to 24 months after treatment. Participants were randomly assigned to standard care or standard care plus a 4-week yoga intervention called YOCAS® (Yoga for Cancer Survivors). The twice-weekly program included breathing exercises, 16 gentle yoga postures, and meditation. Participants attended two 75-minute sessions per week for four weeks.

Both groups showed improvement in overall sleep quality; however, the participants in the yoga group experienced greater improvement in sleep quality as well as sleep duration, sleep efficiency, sleep disturbances, su

bjective sleep quality, and daytime dysfunction. They reported greater sleep quality, less use of drugs for sleep, less fatigue, and better quality of life. In fact, participants in the yoga group decreased their use of sleep medication by 21 percent, whereas those in the control group increased their use by 5 percent.

The researchers concluded that yoga—and specifically the YOCAS program—could be a useful treatment for improving sleep quality and reducing the use of sleep medication among cancer survivors.

SIDE EFFECTS OF CANCER TREATMENT

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SIDE EFFECTS OF CANCER TREATMENT – INTRODUCTION

The treatment of a cancer may include the use of chemotherapy, radiation therapy, targeted therapy, surgery, or some combination of all of these or other therapeutic options. All of these treatment options are directed at killing or eradicating cancer cells. Unfortunately, cancer treatments may also damage normal, healthy cells that are not affected by the cancer. The result of this damage is a complication, or side effect, of treatment.

WHY DO SIDE EFFECTS OCCUR?

Side effects occur because most cancer treatments cannot distinguish between cancer cells and normal, healthy cells. For example, chemotherapy damages rapidly dividing cells, a hallmark trait of cancer cells. In the process, healthy cells that are also rapidly dividing, such as blood cells and the cells lining the mouth and GI tract are also damaged. Radiation therapy kills some healthy cells that are in the path of the radiation or near the cancer being treated. Newer radiation therapy techniques can reduce, but not eliminate this damage.

WHY ARE SIDE EFFECTS IMPORTANT?

Side effects of treatment cause inconvenience, discomfort, and occasionally even fatality to patients. Additionally, and perhaps more importantly, side effects may also prevent doctors from delivering the prescribed dose of therapy at the specific time and schedule of the treatment plan. This is extremely important to understand since the expected outcome from therapy is based on delivering treatment at the dose and schedule of the treatment plan. In other words, side effects not only cause discomfort and unpleasantness, but may also limit a patient’s ability to achieve the best outcome from treatment by preventing the delivery of therapy at its optimal dose and time. Fortunately, in the last 15 years there has been a great deal of progress in the development of treatments to help prevent and control the side effects of cancer treatment. These compounds have led to vast improvements in the management of symptoms associated with cancer treatment, allowed for greater accuracy and consistency concerning the administration of cancer treatment, and have made many cancer treatments more widely available to patients throughout the world.

COMMON SIDE EFFECTS

 

LESS COMMON SIDE EFFECTS

LONG TERM SIDE EFFECTS

Nutritional Needs during Cancer Treatment

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Although a given diet can­not prevent or cure can­cer, good nutrition can reduce disease risk as well as improve quality of life, immune function, healing, and even survival. That’s good news.

Practically speaking, this begs the questions: What is good nutrition? What should I eat, and what should I consume for the best benefit?

I’m not going to present a list of good or bad foods or do’s and don’ts because the best diet for anyone, but particularly in the context of cancer, is different from one person to the next—there’s no cookie-cutter answer. It is important to think about what your nutrition goals are, both in the present and over the long term, and consider big-picture best practices.

General Guidelines for Good Nutrition

Keeping in mind the importance of individual variability and needs, for most people an ideal diet has some common characteristics: it is mostly plant based, with the right amount of calories to maintain a healthy weight and lean body mass, and it includes a variety of whole vegetables and fruits and minimal added sugars. The American Cancer Society suggests limiting alcohol intake and mini­mizing red and processed meats. An ideal diet is sustainable, flexible, and long term—it’s a lifestyle. Following a balanced diet is not the same things as “going on a diet.”

Of course, there are always excep­tions. Cancer symptoms and treatment side effects may mean you have to adjust your diet. Here are some examples:

  • If you are experiencing acute di­arrhea, you would want to reduce fiber-rich vegetables and whole grains and instead choose white rice and plain toast.
  • If you have changes in taste that make it hard to drink plain water, which is important to stay hy­drated, try flavored seltzer or add cucumber or lemon to your water.
  • If you feel nauseated, it might be best to avoid hot foods or foods with strong odors and instead try cool, bland foods, as well as ginger tea.
  • Always ask to speak with a reg­istered dietitian or nutritionist if you have specific concerns.

Remember, do your best at any given point to eat healthfully without mak­ing yourself miserable or worrying that your food choices are hurting you. If you have had no appetite for days and have lost weight and then one day you crave chocolate-chip cookies, let yourself have them—and enjoy them.

Weight Gain or Loss Associated with Treatment

Unplanned weight loss and weight gain may occur during and after cancer treatment. These changes can

be related to the disease itself, behav­ioral changes, medications, and other factors. Some types of cancer are more associated with weight gain, others with weight loss. For example, about half of women who receive adjuvant treatment for breast cancer gain weight; women and men treated for head and neck cancer lose weight.

Either gaining or losing too much weight can be a problem. In the setting of breast cancer, for example, undesired weight gain may increase recurrence risk, other disease risk, and risk of death. On the flip side, excess unintentional weight loss and underweight are associated with poorer outcomes. Excess or insuffi­cient body weight can also compro­mise healing, immune function, and quality of life, including one’s mood, social well-being, and energy level.

If you gain excess weight during treatment, be assured that while losing weight is never easy, it is still possible. One of the best places to start is keeping a written food diary: this immediately increases your accountability and makes you more aware of your food choices. Portion control is also very important. I find that many people are not eating foods that are unhealthy—they’re just eating too much. Go slowly and eat mindfully. Your brain needs at least 20 minutes to recognize that your stomach is full. If you rush through a meal you’ll often end up overeating. Learn to read your body’s natural appetite and satiety cues; if you tend to eat when you’re not physically hungry—and we all do that sometimes—check in with what you really need and want. If you are very tired or stressed, for example, you would probably feel better by sitting down with a favorite book or calling a friend or going for a walk. Always have something you’re looking forward to beyond your next meal or snack.

On the other hand, if you have lost weight without wanting to, be patient with yourself. Sometimes it’s best to set an immediate goal of maintaining your current weight rather than putting pressure on your­self to regain. Increase your intake gradually, eating frequently in small amounts that don’t feel overwhelm­ing. Homemade shakes and smooth­ies can add calories without making you feel overfull. You might want to try a smoothie, for example, made with almond milk, cocoa, a banana, and honey. Commercial supplement drinks are also available. Try to choose foods that will give you some pleasure, and incorporate foods that are high in calories (don’t be afraid to have full-fat rather than low-fat versions of food).

Keep Calm and Carry On

Making good choices about nutrition can be an empowering step you can take during and after cancer treat­ment. If you need guidance about what the best choices are, given your unique needs, diagnosis, and treat­ment, speak with your care team.

Maternal influenza and birth outcomes: systematic review of comparative studies

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Abstract

Background

Although pregnant women are considered at high risk for severe influenza disease, comparative studies of maternal influenza and birth outcomes have not been comprehensively summarised.

Objective

To review comparative studies evaluating maternal influenza disease and birth outcomes.

Search strategy

We searched bibliographic databases from inception to December 2014.

Selection criteria

Studies of preterm birth, small-for-gestational-age (SGA) birth or fetal death, comparing women with and without clinical influenza illness or laboratory-confirmed influenza infection during pregnancy.

Data collection and analysis

Two reviewers independently abstracted data and assessed study quality.

Main results

Heterogeneity across 16 studies reporting preterm birth precluded meta-analysis. In a subgroup of the highest-quality studies, two reported significantly increased preterm birth (risk ratios (RR) from 2.4 to 4.0) following severe 2009 pandemic H1N1 (pH1N1) influenza illness, whereas those assessing mild-to-moderate pH1N1 or seasonal influenza found no association. Five studies of SGA birth showed no discernible patterns with respect to influenza disease severity (pooled odds ratio 1.24; 95% CI 0.96–1.59). Two fetal death studies were of sufficient quality and size to permit meaningful interpretation. Both reported an increased risk of fetal death following maternal pH1N1 disease (RR 1.9 for mild-to-moderate disease and 4.2 for severe disease).

Conclusions

Comparative studies of preterm birth, SGA birth and fetal death following maternal influenza disease are limited in number and quality. An association between severe pH1N1 disease and preterm birth and fetal death was reported by several studies; however, these limited data do not permit firm conclusions on the magnitude of any association.

Do pelvic floor muscle exercises reduce postpartum anal incontinence? A randomised controlled trial

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Abstract

Objective

To evaluate the effect of pelvic floor muscle exercises (PFME) for postpartum anal incontinence (AI).

Design

A parallel two-armed randomised controlled trial stratified on obstetrical anal sphincter injury with primary sphincter repair and hospital affinity.

Setting

Ano-rectal specialist out-patient clinics at two hospitals in Norway.

Population

One hundred and nine postpartum women with AI at baseline.

Methods

The intervention group received 6 months of individual physiotherapy-led PFME and the control group written information on PFME. Changes in St. Mark’s scores and predictors of post-intervention AI were assessed by independent samples t-tests and multiple linear regression analyses, respectively. The study was not blind.

Main outcome measures

The primary outcome measure was change in AI symptoms on the St. Mark’s score from baseline to post-intervention. Secondary outcome measures were manometry measures of anal sphincter length and strength, endoanal ultrasound (EAUS) defect score and voluntary pelvic floor muscle contraction.

Results

There was a significant difference in the reduction of St. Mark’s scores from baseline to post-intervention in favour of the PFME group (−2.1 versus −0.8 points, P = 0.040). No differences in secondary outcome measures were found between groups. Baseline St. Mark’s, PFME group affinity and EAUS defect score predicted post-intervention St. Mark’s score in the imputed intention-to-treat analyses. The analysis on un-imputed data showed that women performing weekly PFME improved their AI scores more than women in the control group did.

Conclusions

Our results indicate that individually adapted PFME reduces postpartum AI symptoms.

Tweetable abstract

Performing regular pelvic floor muscle exercises may be an effective treatment for postpartum anal incontinence.

DASH Diet Ranks Best for Sixth Time

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The DASH diet took the top spot overall for the sixth straight year in the U.S. News & World Report annual diet rankings, released January 5.

This year, the publication rated 38 diet plans in all — three more than in 2015 — with rankings based on reviews from a panel of experts. Two of the new additions ranked highly: the MIND diet, which focuses on boosting brain health, and the Fertility diet, which aims to help women conceive faster but has been shown to benefit others as well.

The rankings also added a new category, Best Diets for Fast Weight Loss. “We recognize dieters may have short-term weight goals and need options to accomplish that in a healthy way,” says Angela Haupt, a senior health editor at U.S. News.

DASH (dietary approaches to stop hypertension) was developed by the National Heart, Lung, and Blood Institute to help people prevent high blood pressure. The plan focuses on eating plenty of fruits, vegetables, and whole grains while lowering salt. Besides being named Best Diet Overall, DASH also got first place in the category of Best Diets for Healthy Eating.

Weight Watchers won first place in the Best Weight Loss Diets category. The Weight Watchers and Mayo Clinic plans tied for first place in the Best Commercial Weight Loss Diet category, with Jenny Craig coming in next.

The report and its experts take into account that ”people diet for different reasons,” Haupt says. Some are looking for short-term weight loss, others long term. One of the new contenders, as the name implies, aims to boost a woman’s odds of getting pregnant. Other people diet to improve their heart health, diabetes, or to lower their risks for those conditions.

The experts rated the plans into various categories. They included:

· Best Overall

· Best Weight Loss Diets

· Best Fast Weight Loss Diets

· Easiest Diets to Follow

· Best Diets for Healthy Eating

· Best Diets for Diabetes

· Best Diets for Heart Disease

· Best Plant-Based Diets

· Best Commercial Weight Loss Diets

For Best Overall, the MIND diet came in second after DASH, tying with TLC. MIND combines features of the DASH and Mediterranean plans, aiming to boost brain health. TLC stands for Therapeutic Lifestyle Changes and aims to lower cholesterol through diet, exercise, weight loss, and not smoking.
For fast weight loss, the HMR (Health Management Resources) and Biggest Loser plans tied for first place. HMR is a low-calorie plan that includes meal-replacement shakes and emphasizes plenty of fruits and vegetables. The Biggest Loser diet has you eat regular meals with lean protein, fruits, and vegetables, keep a food journal, and control your portions, along with physical activity.

For the Easiest to Follow category, Weight Watchers, Fertility, and MIND tied for first.

In the Best for Healthy Eating group, DASH came in first, followed by TLC and Mediterranean, a way of eating rather than a formal diet plan that emphasizes fruits, vegetables, whole grains, and moderate alcohol.

For those with diabetes, the Fertility diet, surprisingly, was first. The diet focuses on changes that are healthy for everyone, like cutting down on red meat and getting protein from nuts and vegetables. DASH and Biggest Loser tied for second place in this category.

For Best Diets for Heart Disease, Ornish, TLC, and DASH took the first three spots, respectively. The Ornish diet is very low-fat, with 10% of calories from fat, and it encourages exercise. It can be tailored to goals such as reversing heart disease or diabetes, or losing weight.

The Mediterranean Diet, Flexitarian (avoiding meat most of the time), and Ornish plans took top spots for Best Plant-Based Diets.

At the Bottom

Meanwhile, the Whole30 diet — a 30-day program that prohibits legumes, grains, dairy, alcohol, added sugar, and processed food — ranked at the bottom of the list.

“The Whole30 program is extremely restrictive,” Haupt says. “…there’s no ‘cheating’ — not even a splash of milk in your coffee. Our health experts say that restriction is unnecessary and potentially unhealthy.”

Melissa Hartwig, co-creator of the Whole30, says the diet is “designed as a 30-day ‘reset,’ not a 365-day lifestyle or even a diet. …The point is to use those 30 days to eliminate foods that can cause digestive and inflammatory issues, and then re-introduce certain food groups one at a time to identify which ones make someone feel badly, so they can make informed choices for themselves going forward. Regardless of the results of any one survey, we believe eating real, whole foods, including [a] wide variety of vegetables and heart-healthy fats, is always a good thing.”

Independent Perspectives

“The list of best diets matches what we as [dietitians] RD’s recommend — choose diet plans that are sustainable, flexible, and enjoyable,” says Connie Diekman, RD, director of university nutrition at Washington University in St. Louis. “Weight loss is just one part of a healthy weight. Keeping weight off is the important part. And the top diets here make healthy eating sustainable.”

Quick-fix eating plans, she says, are not about “achieving a healthier muscle-to-fat ratio. They are about fitting into a dress or winning a bet — not health promoting.” She says the list is ”a good reminder to focus on the real goal, lowering body fat while building lean mass.”

It’s also a reminder that there’s no one perfect diet, says Jennifer Arussi, RD, a dietitian in Los Angeles who also reviewed the report. She is not surprised that the DASH diet got the top spot. “This research-based diet clearly demonstrates its ability to significantly reduce blood pressure with the added benefit of reducing the risk of heart disease and stroke.”

Two other plans that got high marks, HMR and Weight Watchers, she says, both emphasize group support and attendance, and both these things ”have been shown in the literature to predict and accelerate weight loss,” Arussi says.

How to Use the Rankings

The hope, Haupt says, is to ”put the tools out there, to help [people] choose a diet that is right for them, taking into account their personal tendencies and preferences.”

She says people should read the report and details about plans to find a good fit.

“A fair number exclude alcohol completely,” she says. So, ”if you like your nightly drink, you are not going to stick with it.”

Mediterranean Diet May Help Reduce Women’s Hip-Fracture Risk

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Following a Mediterranean-style diet may reduce the risk for hip fractures among postmenopausal women, a new analysis from the Women’s Health Initiative suggests.

The findings were published online March 28 in JAMA Internal Medicine by Bernhard Haring, MD, a clinical fellow in the department of medicine at the University of Würzburg, Germany, and colleagues.

The Mediterranean dietary pattern emphasizes the consumption of fruits, vegetables, fish, nuts, legumes, whole grains, and monounsaturated fat, with avoidance of red and processed meats. In the study, women in the highest quintile for adherence to this diet pattern, compared with the lowest quintile, were significantly less likely to experience a hip fracture over a follow-up period of about 16 years, although overall fracture rates didn’t differ.

Adherence to other healthful dietary patterns aligning with the 2010 US Dietary Guidelines and with the Dietary Approaches to Stop Hypertension (DASH) diet also were associated with a lower hip-fracture risk, although they did not achieve statistical significance.

“The average woman should follow a healthy lifestyle, which includes adopting a healthy dietary pattern, [such as] a Mediterranean dietary pattern, and being physically active. To this point, unfortunately, the US as well as other healthcare systems largely ignore nutrition and lifestyle measures in favor of pharmacology,” Dr Haring told Medscape Medical News.

Indeed, in an accompanying editorial, nutrition expert Walter C Willett, MD, chair of the department of nutrition at Harvard’s TH Chan School of Public Health, Boston, Massachusetts, noted that the “wealth of evidence” linking the Mediterranean diet to cardiovascular benefits led the 2015 US Dietary Guidelines Committee to recommend it, along with “healthy American and vegan dietary patterns based on similar elements” for widespread adoption.

“Integration of the Mediterranean diet and related dietary patterns into medical practice, hospitals, schools, and other institutions has the potential to improve well-being,” writes Dr Willett.

Healthful Diets and Fracture Risk

The Women’s Health Initiative enrolled over 90,000 postmenopausal women aged 50 to 79 years between 1993 and 1998 at 40 US clinical centers. Haring and colleagues looked at nutrient and food intake derived from self-report through questionnaires. They were scored for adherence to the Mediterranean dietary pattern, as well as to three others: The 2010 US Dietary Guidelines, assessed by the “Healthy Eating Index 2010”; a modified version of that called the “Alternative Healthy Eating Index 2010,” which accounts for type of fat, form of carbohydrate, and source of protein; and the DASH diet, which emphasizes lowering sodium content along with the other healthful patterns.
All four diets generally emphasize intake of fruits, vegetables, whole grains, and plant sources of protein and deemphasize refined starch, sugar, and red meat.

During a median follow-up of 15.9 years, a total of 2121 cases of hip fracture were documented and 28,718 cases of total fractures were self-reported. After adjustment for confounders including age, race/ethnicity, body mass index, smoking status, physical activity, physical function score, number of chronic medical conditions, and use of hormone therapy and bisphosphonates, women scoring in the highest quintile for Mediterranean diet adherence had a lower risk for hip fractures, with hazard ratio (HR) 0.80, absolute risk reduction 0.29%, and number needed to treat of 342. No association was seen for the diet and total fractures (HR, 1.01).

Higher adherence to the Healthy Eating Index 2010 and to the DASH diet also tended to be inversely related to hip fracture risk (HRs, 0.87 and 0.89, respectively), although these did not achieve statistical significance and, like the Mediterranean Diet, were not associated with total fractures. There was also no significant relationship between adherence to the alternative Healthy Eating Index 2010 and hip or total fractures (HR, 0.94).

The lack of an association with total fractures might be explained by the wide heterogeneity of fracture types in the analysis, Dr Haring told Medscape Medical News.

More Than One Reason to Go Mediterranean

Dr Willett cited a concern about the current study, that residual confounding is likely due to error introduced by assessing physical activity with via questionnaire and only at a single time point. Had physical activity been assessed better, he speculated, the results for dietary intake and hip fractures might have been nonsignificant.

Nonetheless, he writes, “At a minimum the present findings provide assurance that widely recommended eating patterns do not increase the risk of fractures, even though some of these patterns do not emphasize the intake of dairy foods.”

Dr Haring told Medscape Medical News that he agrees with Dr Willett regarding the caveats, adding, “In any case, given the known benefits of a Mediterranean-type diet — eg, prevention of cardiovascular disease — integration of the Mediterranean diet and related dietary patterns is of great public-health importance.”

ADHD Medication May Boost Kids’ Arrhythmia Risk

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The stimulant methylphenidate (multiple brands), which is commonly used to treat attention-deficit/hyperactivity disorder (ADHD), appears to increase the risk for arrhythmias, particularly in children and young people with congenital heart disease, new research shows.

Investigators at the University of South Australia, in Adelaide, found that methylphenidate increases the risk for arrhythmias by more than 60% overall and that the risk more than triples for individuals with congenital heart disease.

Study investigator Nicole Pratt, PhD, told Medscape Medical News that although these events are rare, “parents and clinicians should be aware of the potential for cardiac adverse effects.

“Children on these medicines should have their blood pressure and heart rate monitored to help mitigate potential risk. Health professionals also need to consider the risk-benefit balance in children with prior history of heart disease or children on medicines that can affect the QT interval, particularly where symptoms of ADHD are mild,” she added.

The research was published online May 31 in the BMJ.

Generalizeable?

To explore potential links between methylphenidate use in children and young people and cardiovascular events, the researchers examined data from the South Korean national health insurance claims database for the period 2008-2011.

They used a self-controlled case series design for the study, in which they identified all patients aged 17 years or younger for whom at least one ADHD diagnosis had been recorded. All patients had been receiving methylphenidate and had had an incident cardiovascular disease event. Cardiovascular events were defined as arrhythmias, hypertension, myocardial infarction, ischemic stroke, and heart failure.
The team then compared the occurrence of cardiovascular events before and after exposure to methylphenidate with such occurrence during methylphenidate exposure. Risk periods were classified as being of 1-3 days, 4-7 days, 8-14 days, 15-28 days, 29–56 days, and longer than 56 days after the start of treatment with methylphenidate.

The investigators identified 1224 individuals who experienced a cardiovascular event. These events included 864 cases of arrhythmia, 396 cases of hypertension, 52 cases of myocardial infarction, 67 cases of ischemic stroke, and 44 cases of heart failure.

The mean duration of methylphenidate exposure was 0.5 years for all events except heart failure, for which the mean duration of exposure was 0.3 years. The median age at first exposure was 11 to 13 years. The median age at first event was 11 to 13 years.

Across all risk periods, there was a significantly increased risk for arrhythmia, at an adjusted incidence rate ratio of 1.61, rising to 2.01 during days 1-3 after initial exposure. The increased risk was no longer significant after 56 days from the start of treatment.

Subgroup analysis revealed that the risk for arrhythmia was higher in patients with congenital heart disease than in those without, at an incidence rate ratio of 3.49 vs 1.34.

There was no overall increased risk for hypertension, myocardial infarction, stroke, or heart failure associated with methylphenidate exposure. However, there was an increased risk for hypertension on days 4-7 after exposure, and there was an increased risk for myocardial infarction for days 8-14, 15-28, and 29-56 days after exposure.

 Dr Pratt noted that the strength of the study was its within-person design, “which effectively controls for underlying factors that may influence the result.”

However, she acknowledged that the results may not be generalizable to other patient populations and that there could be factors not examined in the study that might have modified risk.

“It will be important to replicate these findings in other populations and to understand the risk factors that place children at increased risk of harm. This information will help clinicians and parents weigh up the risks against the benefits of treatment, particularly in mild cases of ADHD,” she said.

Conflicting Evidence

In an accompanying editorial, John W. Jackson, ScD, research fellow, Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, notes that there has been “conflicting evidence” concerning the cardiac safety of stimulants such as methylphenidate.

He points out that the current findings are apparently at odds with those of recent cohort studies using US Medicaid and private health insurance databases. These studies did not find an increase in rates of cardiovascular events, regardless of whether or not patients had preexisting cardiovascular disease.

However, Dr Jackson notes that this reflects differences in the populations studied and that the current population had a higher risk for cardiovascular events at baseline.

Speaking to Medscape Medical News, he explained that it is both a question of “who” and of “when.”

“The current study is really looking at a high-risk population, [and] it appears that early on after starting therapy is the period of risk that we’re most concerned about.” He noted that the evidence from this study pertains to patients with a high risk for cardiovascular disease to begin with, “because that was the type of population that this study design selected,” he said.

He said the study “underscores the need to consider the severity of ADHD symptoms and the option of nonstimulants for children with high cardiovascular risk, to avoid uses that are entirely off label, and to closely monitor patients for whom stimulants are critical for their well-being and development.”

High-Fat Mediterranean Diet Does Not Lead to Weight Gain

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Following a Mediterranean diet that is not calorie restricted and is high in healthy fats from olive oil or nuts does not cause weight gain over 5 years compared with a low-fat diet, according to results from the Spanish PREvención con DIeta MEDiterránea (PREDIMED) randomized controlled trial.

“These results have practical implications, because the fear of weight gain from high­fat foods need no longer be an obstacle to adherence to a dietary pattern such as the Mediterranean diet, which is known to provide much clinical and metabolic benefit,” write Ramon Estruch, MD, PhD, from CIBER OBN-University, Barcelona, Spain, and colleagues.

“They are also relevant for public health, because they lend support to not restricting intake of healthy fats in advice for bodyweight maintenance and overall cardiometabolic health, as acknowledged by the Dietary Guidelines for Americans 2015 Advisory Committee,” they add.

The study was published online June 6 in Lancet Diabetes & Endocrinology.

The study is the first randomized trial to evaluate the long-term effects of an unrestricted-calorie Mediterranean diet on weight and waist circumference.

Much evidence has linked a Mediterranean-style diet high in vegetable fats like nuts and olive oil to decreased all-cause mortality, cardiovascular disease, and cancer.

For the past 40 years, however, standard dietary advice for preventing or treating obesity has called for calorie restriction and increased physical activity, with a persistent belief that high fat intake promotes weight gain. Such recommendations, however, have not necessarily taken into account the different types of fat. Nonetheless, certain scientific societies — including the World Health Organization[0] — continue to advise limiting fat in the diet.
The idea that all dietary fat is unhealthy has led many Americans to curb their fat consumption, often at the expense of eating empty calories from processed foods high in sugar, salt, and carbohydrates. The demonizing of all fat, though, has failed to stem the tide of the diabetes and obesity epidemic.

The PREDIMED randomized controlled trial took place in primary care centers connected to 11 hospitals in Spain between 2003 and 2010. It included 4282 women aged 60 to 80 years and 3165 men aged 55 to 80 years with either type 2 diabetes or three or more cardiovascular risk factors. All patients were asymptomatic and more than 90% were overweight or obese at baseline. They had a mean age of 67 years; 97% were of white European ethnicity.

Researchers randomly assigned participants to an unrestricted-calorie Mediterranean diet with extra-virgin olive oil (n = 2543), an unrestricted-calorie Mediterranean diet with nuts (n = 2454), or a low-fat control diet (n=2450). Trained dieticians gave dietary advice to all three groups. Participants were not advised to restrict calories or increase physical activity.

Participants received free polyphenol-rich extra-virgin olive oil and nuts (walnuts, almonds, or hazelnuts). Results showed good adherence in the olive oil and nut groups, based on self-reported questionnaires, and blood and urine samples in a random subgroup.

Five-year results showed that total fat increased in the two Mediterranean diet groups. Both Mediterranean diet groups actually had a slight increase in fat consumption — from 40% to 41.8% in the olive oil group and 40.4% to 42.2% in the nut group (P < .0001 for all) — while their consumption of protein and carbohydrate decreased (P < .001).

All three groups lost a small amount of weight. Over 5 years, the olive oil group lost the most weight (0.88 kg), followed by the low-fat control group (0.60 kg), and then the nut group (0.40 kg). Multivariable analyses adjusted for 12 potential confounders showed that the difference in weight change at 5 years was significant only for the olive oil group vs control group (P = .044).

Likewise, all three groups had a slight increase in average waist circumference, but the increase was smaller for the Mediterranean diet groups (low-fat control group, 1.2 cm; olive oil group, 0.85 cm; nut group, 0.37 cm). Multivariable analyses adjusted for 12 potential confounders showed that the difference in change in weight circumference at 5 years was significant for both the olive oil and nut groups vs the control group (P = .048 and .006, respectively).

In a linked comment, Dariush Mozaffarian, MD, DrPH, from the Friedman School of Nutrition Science and Policy at Tufts University, Boston, Massachusetts, writes that these results provide “further robust evidence that liberally adding healthy foods to the diet, including high-fat choices such as nuts and extra-virgin olive oil, does not increase weight gain.”

“These important findings should be heralded around the world,” he asserts, while calling for the revision of dietary guidelines.

Decades of dietary advice have ignored food quality and the different effects of specific fatty acids, he pointed out.

By emphasizing calorie and fat restriction, such advice has produced “paradoxical warnings and caveats about eating healthy, high-fat foods” and fostered the proliferation of low-fat foods — often high in sugar and carbohydrates— in the US diet.

“[M]odern scientific evidence supports an emphasis on eating more calories from fruits, nuts, vegetables, beans, fish, yoghurt, phenolic-rich vegetable oils, and minimally processed whole grains; and fewer calories from highly processed foods rich in starch, sugar, salt, or trans-fat. We ignore this evidence — including these results from the PREDIMED trial — at our own peril,” he concludes.

New Data on CGRP Monoclonal Antibodies for Migraine Prevention

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New phase 2 data on the investigational calcitonin gene-related peptide (CGRP) monoclonal antibodies show significant efficacy in preventing migraine attacks with no major safety signals.

Phase 2 data for three different anti-CGRP drugs from Amgen (AMG 334), Teva Pharmaceuticals (TEV-48125), and Eli Lilly & Co (LY2951742) were presented here at the American Headache Society (AHS) 57th Annual Scientific Meeting by representatives from the three companies.

A fourth company, Alder Pharmaceuticals, is also developing an anti-CGRP agent but didn’t present data at this meeting. All four companies are planning to move their agents into phase 3 trials.

The drugs — administered as once-monthly injections — act by blocking CGRP, a vasodilator, without causing vasoconstriction. The Amgen product blocks the receptor for CGRP, while the other three are directed against the ligand itself. Lilly is developing its product for cluster headache as well as for migraine prophylaxis.

“They’re a new class to treat migraine preventatively,” AHS president Lawrence C. Newman, MD, professor of neurology at Icahn School of Medicine at Mount Sinai and director of The Headache Institute at Mount Sinai-Roosevelt Hospital, New York, told Medscape Medical News.. “We’re excited because there hasn’t been a new medicine designed specifically to prevent migraine in over 50 years.”

Session moderator Robert Shapiro, MD, PhD, professor in the Department of Neurological Sciences at the University of Vermont, Burlington, told Medscape Medical News, “to have a new category developed specifically for migraine and to have them all show in these early-phase studies significant efficacy and at the same time not have significant signals that there’s a serious adverse events is very encouraging…. This is not something we’ve experienced since 15 to 20 years ago when the triptans were rolling out.”

However, Dr Shapiro, who serves on the independent data monitoring committee for the Lilly drug, cautioned that these early studies are still too small and of short duration — none have data beyond 1 year — to fully establish efficacy and safety. “Any time there’s a new molecular entity, one has to be highly vigilant for safety concerns to emerge.”

Indeed, Thomas N. Ward, MD, professor of neurology at the Geisel School of Medicine, Dartmouth College, Lebanon, New Hampshire, and editor-in-chief of the AHS journal Headache: The Journal of Head and Face Pain, pointed out that CGRP is widely distributed throughout the body — in the kidney, lungs, eyes, liver, and gastrointestinal tract — as well as the brain.
“Could [the drugs] have a long-term effect on intraocular pressure, or renal function, or pulmonary function? CGRP is in your body for a reason and if you perturb it long enough, perhaps some people could accommodate well, but perhaps some people with underlying mild disease might not,” Dr Ward said. “It’s not really till you get to phase 3, with big, randomized, double-blind, placebo-controlled studies that you can really answer those questions.”

He pointed to previous experience with a related investigational drug that had generated similar excitement, Merck’s CGRP antagonist telcagepant. The company halted development in 2011 after liver toxicity was seen in a phase 3 study. “So far the [current agents] look safer…but things can appear that you weren’t expecting,” Dr Ward cautioned.

Results of a 1-year open-label extension of a 12-week randomized, double-blind, placebo-controlled, phase 2 study of AMG 334 for the prevention of episodic migraine were presented by Robert Lenz, MD, from the Department of Global Development at Amgen.

A total 483 patients with migraines on 4 to 14 days per month at baseline were randomly assigned to a once-monthly injection of placebo (n = 160 patients) or AMG 334 in doses of 7 mg (n = 108), 21 mg (n = 108), or 70 mg (n = 107). Most (80.5%) were female, with a mean age of 41 years.

The primary endpoint, a statistically significant change from baseline in monthly migraine days at week 12, was achieved with the 70-mg dose, with an average reduction of 3.4 days compared with 2.28 with placebo. Responses to lower doses were not statistically significant.

After the 12-week double-blind part of the trial, the 70-mg dose was given to all the study patients open-label. At 1 year, they had an average 4.9-day reduction in migraine days per month, down from 8.7 days at baseline, with no difference between those who had previously received the drug or placebo.

Also at 1 year, 62% of the patients achieved greater than a 50% reduction in monthly migraine days, 38% achieved greater than a 75% reduction, and 19% achieved a 100% reduction.

Adverse events occurred in about half of the drug and placebo groups and serious adverse events in less than 1% overall.

Events leading to discontinuation occurred in 2.8% with 70 mg vs 1.3% with placebo. Injection site pain or other problems occurred in less than 2% in all groups.

TEV-48125

Marcelo E. Bigal, MD, PhD, vice president of clinical development at Teva and formerly the chief medical officer at Labrys Biologics, where TEV-48125 was developed, presented the data for a randomized, double-blind, double-dummy, placebo-controlled, multidose, parallel-group study of once-monthly injections of the drug in patients with 8 to 14 days of migraine per month.

Patients could also take triptans and other acute migraine drugs for up to 14 days, but no more than 4 days per month of opioids or barbiturates were permitted.

A total 297 patients were randomly assigned to 225 mg or 675 mg of TEV-48125 or to placebo once monthly for 3 months.

For both doses, there was more than a 6-day decrease in the number of monthly migraine days, a highly significant difference from baseline (P < .0001) and also superior to placebo at months 1 and 2 (P< .001). Results were similar for the secondary endpoint of decrease in headache days (P < .001).

The proportions experiencing at least 50% improvement during the study were 59% with the 675-mg dose and 53% for the 225-mg dose, compared with 28% for placebo (P < .001). More than 75% improvement was seen in 31%, 34%, and 11%, respectively (P < .001).

Tolerability was similar to that seen with placebo, and no treatment-related serious adverse events occurred.

LY2951742

Phase 2b data on efficacy and safety for LY2951742 in a randomized, double-blind, placebo-controlled, dose-ranging study were presented by Aaron Schacht, global brand development leader for Lilly’s pain portfolio. Study participants had 4 to 14 migraine headache days and at least two attacks per month.

Subcutaneous injections of LY2951742 doses of 5 mg (n = 68), 50 mg (n = 68), 120 mg (n = 70), 300 mg (n = 67), or placebo (n = 137) were given once every 28 days for 12 weeks.

All four doses were numerically superior to placebo for the change from baseline in migraine headache days, although only the 120-mg dose achieved statistical significance in the last 28-day period of the 12-week treatment phase (P = .004).

Also statistically significant were the proportions achieving responses of at least 50% (P = .038), 75% (P= .003), and 100% (P = .038).

Treatment-emergent adverse events occurring in 5% or more of patients in any LY2951742 group and seen more often than in the placebo group included injection site pain, upper respiratory tract infection, nasopharyngitis, dysmenorrhea in women, and nausea. None of these occurred in more than 15% in any group.

Lilly is enrolling patients for phase 3 trials of LY2951742 for both chronic and episodic cluster headache and has received fast-track designation from the US Food and Drug Administration for cluster headache, Schacht said.

Awaiting Phase 3

Dr Shapiro noted that it’s also too early to be able to determine whether there are significant differences among the four anti-CGRP drugs, including whether the different target for the Amgen drug makes any difference in efficacy or safety.

“It’s way too soon on the basis of phase 2 trials to make significant comparisons between these agents,” he said. “It really requires larger numbers in phase 3 trials and sorting out inclusion/exclusion criteria…. All of them have positive data, and some have extraordinary signals for subsets of patients, but we can’t yet draw conclusions.”

However, Dr Ward noted, “If this class of medications pans out, it’s almost essentially the holy grail of prevention for migraine because we wouldn’t have a lot of side effects that we have with our current medications, such as weight gain, hair loss, or cognitive abnormalities. It might allow people to live a relatively normal life.”