Opioids no more effective than placebo for acute back and neck pain

Opioid pain-relieving medicines are not more effective than a placebo in relieving acute back and neck pain and may even cause harm, according to a world-first trial led by the University of Sydney.

The researchers say this is proof that treatment guidelines should be updated to advise against the use of opioids for this purpose.

Over 577 million people worldwide experience low back and neck pain at any one time.

Despite a global push to reduce the use of opioids, in Australia approximately 40 to 70 percent of those who present with neck and back complaints are prescribed opioids for their pain.

The OPAL trial recruited close to 350 participants from 157 primary care and emergency department sites. Participants with acute-meaning sudden and generally short-term-back or neck pain were randomly allocated to a six-week course of a commonly prescribed opioid or a placebo.

Both groups also received standard care including advice to avoid bed rest and stay active. Participants were followed for 52 weeks.

The results of the trial are published in The Lancet today.

What did the study find?

• At six weeks, those who received opioids did not have better pain relief than those given the placebo.
• Quality of life and pain outcomes at long-term follow-up were better in the placebo group.
• Patients who received opioids were at a small but significantly higher risk of opioid misuse 12-months after their short course of medication.

The research team says that according to current back and neck pain guidelines opioids can be considered as a last resort if all other pharmacological options have failed, however, this study is evidence that opioids should not be recommended at all.

“We have clearly shown there is no benefit to prescribing an opioid for pain management in people with acute back or neck pain, and in fact, it could cause harm in the long-term even with only a short course of treatment,” said lead investigator Professor Christine Lin from Sydney Musculoskeletal Health, an initiative of the University of Sydney, Sydney Local Health District and Northern Sydney Local Health District

“Opioids should not be recommended for acute back and neck pain full stop.

“Not even when other drug treatments are not able to be prescribed or have not been effective for a patient.”

The study complements previous research into opioid use for chronic (long-term) low back pain which found a small treatment benefit, but increased risk of harm.

Global push to reduce opioid use

Reducing the overuse of opioids is a global health priority. Medical authorities around the world have cautioned that due to the significant risk of harm to individuals and society, opioids should only be used where there is evidence that the benefits outweigh the harms.

Co-author Professor Chris Maher said in recent years there has been a shift in focus from opioid to non-opioid treatments for low back pain, with a focus on physical and psychological therapies and simple analgesics such as anti-inflammatory medicines (called NSAIDs).

“This study is further evidence that the first line management of acute low back pain and neck pain should rely on reassurance and advice to stay active, and simple analgesics like non-steroidal anti-inflammatory drugs if necessary,” said Professor Maher, also of Sydney Musculoskeletal Health.  

Harm caused by opioid use

Professor Andrew McLachlan, Dean of Sydney Pharmacy School and co-investigator, said the Lancet study is important and should influence prescribing and dispensing of these medicines as Australia faces rising rates of opioid use.
According to Australia’s Therapeutic Goods Administration, every day in Australia nearly 150 hospitalisations and 14 emergency department admissions involve issues relating to opioid use, and three people die from the harm that results from prescription opioid use.

“The possible harmful effects of opioids are well known. They range from minor harms such as constipation and drowsiness to major harms such as dependence, addiction, overdose, and even unintentional death,” said Professor McLachlan.

“The findings from the OPAL trial further reinforce the need to reassess the use of opioid pain-relieving medicines as there is limited evidence of benefit and known significant risk of harm.”

The authors note some study limitations including data gaps due to participant attrition and issues with medication adherence consistent with other backpain drug trials. They suggest neither are likely to have impacted the main outcomes of the study.

The trial is a collaboration between the University of Sydney, The George Institute for Global Health, UNSW, St Vincent’s Hospital Sydney, Sydney Local Health District and Erasmus University Medical Center in the Netherlands.

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Vitamin D supplements may reduce risk of serious cardiovascular events in older people

Findings show monthly vitamin D may prevent heart attacks in over 60s

Vitamin D supplements may reduce the risk of major cardiovascular events such as heart attacks among people aged over 60, finds a clinical trial published by The BMJ today.

The researchers stress that the absolute risk difference was small, but say this is the largest trial of its kind to date, and further evaluation is warranted, particularly in people taking statins or other cardiovascular disease drugs.

Cardiovascular disease (CVD) is a general term for conditions affecting the heart or blood vessels and is one of the main causes of death globally. CVD events such as heart attacks and strokes are set to increase as populations continue to age and chronic diseases become more common.

Observational studies have consistently shown a link between vitamin D levels and CVD risk, but randomised controlled trials have found no evidence that vitamin D supplements prevent cardiovascular events, possibly due to differences in trial design that can affect results.

To address this uncertainty, researchers in Australia set out to investigate whether supplementing older adults with monthly doses of vitamin D alters the rate of major cardiovascular events.

Their D-Health Trial was carried out from 2014 to 2020 and involved 21,315 Australians aged 60-84 who randomly received one capsule of either 60,000 IU vitamin D (10,662 participants) or placebo (10,653 participants) taken orally at the beginning of each month for up to 5 years.

Participants with a history of high calcium levels (hypercalcemia), overactive thyroid (hyperparathyroidism), kidney stones, soft bones (osteomalacia), sarcoidosis, an inflammatory disease, or those already taking more than 500 IU/day vitamin D were excluded.

Data on hospital admissions and deaths were then used to identify major cardiovascular events, including heart attacks, strokes, and coronary revascularisation (treatment to restore normal blood flow to the heart).

The average treatment duration was 5 years and more than 80% of participants reported taking at least 80% of the study tablets. 

During the trial, 1,336 participants experienced a major cardiovascular event (6.6% in the placebo group and 6% in the vitamin D group). 

The rate of major cardiovascular events was 9% lower in the vitamin D compared with the placebo group (equivalent to 5.8 fewer events per 1,000 participants).

The rate of heart attack was 19% lower and the rate of coronary revascularization was 11% lower in the vitamin D group, but there was no difference in the rate of stroke between the two groups. 

There was some indication of a stronger effect in those who were using statins or other cardiovascular drugs at the start of the trial, but the researchers say these results were not statistically significant.

Overall, the researchers calculate that 172 people would need to take monthly vitamin D supplements to prevent one major cardiovascular event.

The researchers acknowledge that there may be a small underestimate of events and say the findings may not apply to other populations, particularly those where a higher proportion of people are vitamin D deficient. However, this was a large trial with extremely high retention and adherence, and almost complete data on cardiovascular events and mortality outcomes.

As such, they say their findings suggest that vitamin D supplementation may reduce the risk of major cardiovascular events. “This protective effect could be more marked in those taking statins or other cardiovascular drugs at baseline,” they add, and they suggest further evaluation is needed to help to clarify this issue. 

“In the meantime, these findings suggest that conclusions that vitamin D supplementation does not alter risk of cardiovascular disease are premature,” they conclude.

Light or moderate alcohol consumption does not guard against diabetes, obesity

Study finds these associations are stronger in women

Peer-Reviewed Publication

THE ENDOCRINE SOCIETY

—People who have just one or two drinks per day are not protected against endocrine conditions such as obesity and type 2 diabetes, according to a new study published in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism.

Alcohol consumption is a significant public health concern because it is related to many medical conditions such as diabetes, obesity, liver conditions and heart disease. While it is widely accepted that excessive alcohol consumption causes a wide range of health issues, whether modest alcohol consumption has beneficial health effects remains controversial.

“Some research has indicated that moderate drinkers may be less likely to develop obesity or diabetes compared to non-drinkers and heavy drinkers. However, our study shows that even light-to-moderate alcohol consumption (no more than one standard drink per day) does not protect against obesity and type 2 diabetes in the general population,” said Tianyuan Lu, Ph.D., from McGill University in Québec, Canada. “We confirmed that heavy drinking could lead to increased measures of obesity (body mass index, waist-to-hip ratio, fat mass, etc.) as well as increased risk of type 2 diabetes.”

The researchers assessed self-reported alcohol intake data from 408,540 participants in the U.K. Biobank and found people who had more than 14 drinks per week had higher fat mass and a higher risk of obesity and type 2 diabetes.

These associations were stronger in women than in men. No data supported the association between moderate drinking and improved health outcomes in people drinking less than or equal to seven alcoholic beverages per week.

“We hope our research helps people understand the risks associated with drinking alcohol and that it informs future public health guidelines and recommendations related to alcohol use,” Lu said. “We want our work to encourage the general population to choose alternative healthier behaviors over drinking.”

Study identifies risk factors for early onset colorectal cancer in males

Presence of risk factors can identify younger men for whom early screening should be considered

Peer-Reviewed Publication

REGENSTRIEF INSTITUTE

 Colorectal cancer incidence and deaths are declining for individuals age 50 and older, but are increasing for those under 50.

A new study, led by researcher-clinician Thomas Imperiale, M.D., of the U.S. Department of Veterans Affairs, Regenstrief Institute and Indiana University School of Medicine, identifies seven risk factors for early onset colorectal cancer in males. The risk evaluation model the researchers developed may help 45- to 49-year-olds accept and adhere to new national screening recommendations and may also identify younger men for whom earlier screening should be considered.

“This study is important because it puts whether, and possibly how, to screen people who are younger than age 45 -- below the age for recommended colorectal cancer screening and have some of the risk factors we identify -- on the table for consideration for screening,” said Dr. Imperiale.

“We know that colon cancer at younger ages is on the rise, although the absolute risk is still much lower than even in the 45- to 54-year-old age group. Nonetheless, that doesn't mean that we shouldn't be trying to identify younger people at higher risk to screen them with some modality,” he said.

“Clinicians might have a discussion with a patient and say that although screening guidelines don't kick in until age 45 and you don't have a family history, you do have some risk factors. Might you consider a noninvasive screening test? It could be fecal occult blood testing or multi-target stool DNA testing. It doesn’t have to be a colonoscopy. For men younger than 45 who are at higher-than-average risk, doing some type of screening would seem to make sense.

“When our study started it wasn't clear whether the same set of risk factors for older folks would apply to those who were getting cancer at younger ages,” said Dr. Imperiale. “We found that while the weights assigned to some factors, such as family history and alcohol use, were about the same for men older and younger than 50, others, such as high body mass index (BMI) were risk factors for older but not younger men.”

The study of 600 individuals with non-hereditary colon or rectal cancer plus 2,400 control patients from VA medical centers across the U.S., used electronic health record data and national VA datasets to determine sociodemographic and lifestyle factors, family and personal medical history, physical measures, vital signs, medications and laboratory values for six to 18 months. All participants were male veterans between the ages of 35 and 49. A total of 65 percent were White and 30 percent were Black.

Initially identifying 15 variables associated with early onset colorectal cancer, the researchers subsequently condensed the prediction model to seven factors that provide similar precision and would be easier to use in clinical practice to estimate relative risk.

The seven factors conveying higher-than-average risk for early onset colorectal cancer in males are:

• older age (within the 35- to 49-year-old age range)
• no regular use of non-steroidal anti-inflammatory drugs (such as aspirin or ibuprofen)
• no regular use of statins
• current alcohol use
• first or second degree relative with colorectal cancer
• a higher disease burden
• service-connection/copay variable – a marker for socio-economic status

“We don’t believe that any of these risk factors, with the exception of service-connection/copay variable, which we believe may be a proxy for income and/or socioeconomic status (and only an approximate one), are unique or specific to the veteran population,” said Dr. Imperiale.

He is currently analyzing data on risk factors for early onset colorectal cancer in female veterans. The risk of colorectal cancer is twice as high for men as for women in any age category.

“Risk Factors for Early Onset Sporadic Colorectal Cancer in Male Veterans” is published in the peer-reviewed journal Cancer Prevention Research.

That essential morning coffee may be a placebo

For many people, the day doesn’t start until their coffee mug is empty. Coffee is often thought to make you feel more alert, so people drink it to wake themselves up and improve their efficiency. Portuguese scientists studied coffee-drinkers to understand whether that wakefulness effect is dependent on the properties of caffeine, or whether it’s about the experience of drinking coffee.

“There is a common expectation that coffee increases alertness and psychomotor functioning,” said Prof Nuno Sousa of the University of Minho, corresponding author of the study in Frontiers in Behavioral Neuroscience and Field Chief Editor of the journal. “When you get to understand better the mechanisms underlying a biological phenomenon, you open pathways for exploring the factors that may modulate it and even the potential benefits of that mechanism.”

A caffeine kickstart

The scientists recruited people who drank a minimum of one cup of coffee per day and asked them to refrain from eating or drinking caffeinated beverages for at least three hours before the study. They interviewed the participants to collect sociodemographic data, and then did two brief functional MRI scans: one before and one 30 minutes after either taking caffeine or drinking a standardized cup of coffee. During the functional MRI scans, the participants were asked to relax and let their minds wander.

Because of the known neurochemical effects of drinking coffee, the scientists expected that the functional MRI scans would show that the people who drank coffee had higher integration of networks that are linked to the prefrontal cortex, associated with executive memory, and the default mode network, involved in introspection and self-reflection processes. They found that the connectivity of the default mode network was decreased both after drinking coffee and after taking caffeine, which indicates that consuming either caffeine or coffee made people more prepared to move from resting to working on tasks.

Waking up on the right side of the bed

However, drinking coffee also increased the connectivity in the higher visual network and the right executive control network - parts of the brain which are involved in working memory, cognitive control, and goal-directed behavior. This didn’t happen when participants only took caffeine. In other words, if you want to feel not just alert but ready to go, caffeine alone won’t do – you need to experience that cup of coffee.

“Acute coffee consumption decreased the functional connectivity between brain regions of the default mode network, a network that is associated with self-referential processes when participants are at rest,” said Dr Maria Picó-Pérez of Jaume I University, first author. “The functional connectivity was also decreased between the somatosensory/motor networks and the prefrontal cortex, while the connectivity in regions of the higher visual and the right executive control network was increased after drinking coffee. In simple words, the subjects were more ready for action and alert to external stimuli after having coffee.”

“Taking into account that some of the effects that we found were reproduced by caffeine, we could expect other caffeinated drinks to share some of the effects,” added Picó-Pérez. “However, others were specific for coffee drinking, driven by factors such as the particular smell and taste of the drink, or the psychological expectation associated with consuming that drink.”

The authors pointed out that it is possible that the experience of drinking coffee without caffeine could cause these benefits: this study could not differentiate the effects of the experience alone from the experience combined with the caffeine. There is also a hypothesis that the benefits coffee-drinkers claim could be due to the relief of withdrawal symptoms, which this study did not test.

“The changes in connectivity were studied during a resting-state sequence. Any association with psychological and cognitive processes is interpreted based on the common function ascribed to the regions and networks found, but it was not directly tested,” cautioned Sousa. “Moreover, there could be individual differences in the metabolism of caffeine among participants that would be interesting to explore in the future.”

Intermittent fasting and traditional calorie counting about equal for weight loss

A small randomized controlled trial found that time-restricted eating, also known as intermittent fasting, produced similar weight loss results to traditional calorie counting in a racially diverse population of adults with obesity. The study also showed that participants who engaged in 8-hour time restricted eating had improved insulin sensitivity compared to those in the control group who ate their calories any time over 10 or more hours a day. The study is published in Annals of Internal Medicine.

Obesity is a major health issue. Many traditional weight loss diets involve counting calories, which can be cumbersome and difficult to do well. Time-restricted eating, without calorie counting, has become a popular weight loss strategy because it is simple to do. Whether it’s effective in producing weight loss, especially beyond the short term, is unclear.

Researchers from the University of Illinois Chicago studied 90 adults with obesity from the Greater Chicago area to determine whether intermittent fasting or calorie restricted eating would be more effective for weight control and cardiometabolic risk reduction. Participants were randomly assigned to 1 of 3 groups: 8-hour time-restricted eating (eating from noon to 8:00 p.m. only, without calorie counting); calorie restriction (reduce 25% of their calories daily), or no change in calorie consumption, with eating taking place over 10 hours or more throughout the day. Both the time-restricted eating and calorie restriction groups met regularly with a dietician. Participants were not blinded. The authors found that participants who engaged in time-restricted eating ate 425 fewer calories per day than the control group and lost about 10 more pounds than the control group after one year. The calorie-restricted group ate 405 fewer calories per day and lost about 12 more pounds after one year. Participants showed high adherence to both interventions.

The authors of an accompanying editorial from the Anschutz Health and Wellness Center and Division of General Internal Medicine, University of Colorado School of Medicine say that access to dieticians likely helped participants in the restricted eating group make healthier food choices. They believe the results of this study can help guide clinical decision-making partially by taking individual preferences into consideration, rather than just choosing a diet that may be more effective. They emphasize that the results of this study highlight the substantial individual variability in weight loss using these interventions, and that further research is needed to determine who would most benefit from each of these interventions

Carotene-rich diet linked to lower fat levels in arteries

 

A high level of carotenes in the blood is linked with a lower degree of atherosclerosis in the arteries and thus a lower risk of cardiovascular diseases. These are the conclusions of a new study by a team of researchers from IDIBAPS and the UOC, published as open access in Clinical Nutrition.

The work was headed by Gemma Chiva Blanch, of the IDIBAPS Translational research in diabetes, lipids and obesity group, led by Josep Vidal. Chiva Blanch also forms part of the CIBEROBN research centre and is an associate professor and researcher at the Faculty of Health Sciences of the Universitat Oberta de Catalunya (UOC).

 

Atherosclerosis and cardiac risk 

Atherosclerosis is the build-up of fat, generally the LDL or "bad" type of cholesterol, on the inner walls of the blood vessels. This build-up, in the form of atherosclerotic plaques, causes a narrowing of the vessel's internal diameter, thereby hindering the blood's circulation.

Furthermore, these plaques can rupture and form clots that obstruct the blood flow, which can lead to myocardial infarctions (heart attacks), when the blood doesn't reach the heart, or ischaemic strokes, when it doesn't reach the brain.

 

The role of carotenes

It's no secret that diet plays a key role in cardiovascular diseases. Carotenes are bioactive compounds found in yellow, orange and green fruits and vegetables, such as carrots, spinach, lettuce, tomatoes, sweet potatoes, broccoli, cantaloupes, bell peppers, mangoes, papayas, apricots, loquats and pumpkins. Carotenes are potentially capable of checking atherosclerosis. "However, the studies carried out to date have not been conclusive and it even appears that, when administered as a supplement, they have a prejudicial effect," explained Chiva Blanch.

The article looked at 200 people aged between 50 and 70 forming part of the DIABIMCAP cohort and recruited by the IDIBAPS Primary healthcare transversal research group, led by Antoni Sisó Almirall. The volunteers taking part in the study were analysed with regard to two parameters: the concentration of carotenes in the blood and, by means of ultrasound imaging, the presence of atherosclerotic plaques in the carotid artery.

"The study concludes that the greater the concentration of carotenes in the blood, the lesser the atherosclerotic burden, particularly in women. […] So, we can confirm that a diet rich in fruit and vegetables and thus in carotenes lowers the risk of suffering from cardiovascular diseases," said Chiva Blanch.

DASH diet ranks as the American Heart Association’s top heart-healthy eating style

An American Heart Association scientific statement assessed and scored the heart healthiness of popular dietary patterns, and the DASH Diet – developed in part at Pennington Biomedical Research Center – received a perfect score as the top heart-healthy eating plan.

“Pennington Biomedical has a long history and association with the DASH Diet,” said Dr. John Kirwan, Pennington Biomedical Executive Director. “Pioneering Pennington Biomedical researchers Dr. George Bray, Dr. Donna Ryan and Dr. Catherine Champagne were among the lead developers of the diet, as part of the DASH Diet Collaborative Research Group, along with Brigham and Women’s Hospital; Duke Hypertension Center and the Sarah W. Stedman Nutrition and Metabolism Center; and Johns Hopkins Medical Institutions.”

The successful Dietary Approaches to Stop Hypertension, or DASH, Diet study results were published in a 1997 New England Journal of Medicine publication, which has been cited by other researchers about 6,000 times since original publication.

“The DASH Diet is a great choice because it is proven to help those with a history of heart disease or people with diabetes, but it is really a diet plan for everyone because it is easy to follow, and it can work for anyone in the family,” said Dr. Champagne professor and registered dietitian nutritionist at Pennington Biomedical.

The statement, published in the association’s flagship, peer-reviewed journal Circulation, rates how well popular dietary patterns align with the American Heart Association’s Dietary Guidance. The guidance includes key features of a dietary pattern to improve cardiometabolic health, which emphasizes limiting unhealthy fats and reducing the consumption of excess carbohydrates. This balance optimizes both cardiovascular and general metabolic health and limits the risks of other health conditions such as Type 2 diabetes and risk factors such as obesity that may result from excess consumption of carbohydrates, particularly processed carbohydrates and sugar sweetened beverages.

The new scientific statement is the first to analyze how closely popular dietary patterns adhere to those features, and the guidance is focused on being adaptable to individual budgets as well as personal and cultural preferences.

“The number of different, popular dietary patterns has proliferated in recent years, and the amount of misinformation about them on social media has reached critical levels,” said Christopher D. Gardner, chair of the writing committee for the new scientific statement and the Rehnborg Farquhar Professor of Medicine at Stanford University. “The public — and even many health care professionals — may rightfully be confused about heart healthy eating, and they may feel that they don’t have the time or the training to evaluate the different diets. We hope this statement serves as a tool for clinicians and the public to understand which diets promote good cardiometabolic health.”

In the review, the DASH-style eating pattern received a perfect score by meeting all of the association’s guidance. These eating patterns are low in salt, added sugar, alcohol, tropical oils and processed foods, and rich in non-starchy vegetables, fruits, whole grains and legumes. Protein tends to be mostly from plant sources (such as legumes, beans or nuts), along with fish or seafood, lean poultry and meats, and low-fat or fat-free dairy products.

For more information, visit https://www.ahajournals.org/doi/10.1161/CIR.0000000000001146.

Lifestyle intervention promoting whole-food, plant-predominant eating pattern can achieve type 2 diabetes remission

A lifestyle-based treatment intervention promoting adherence to a whole-food, plant-predominant eating pattern and integrated into routine care can successfully achieve type 2 diabetes remission, according to a research study published in the American Journal of Lifestyle Medicine.

The case series determined that a sample of 59 patients from a cardiac wellness program, who also had type 2 diabetes, achieved significant improvements in blood glucose control, and in 37 percent of cases, full remission of their diabetes. The patients were treated with a low-fat, whole-food, plant-predominant dietary pattern while also receiving standard medical treatment at a wellness center in Virginia. Improvements in glucose control were accompanied by significant reductions in BMI.

Previous studies have demonstrated that whole-food, plant-predominant eating patterns can improve diabetes outcomes but that research primarily involved substantial calorie restriction, often relying on liquid meal replacements, or fasting. This study, published in collaboration with the American College of Lifestyle Medicine (ACLM), is unique in its assessment of remission as a primary outcome and contributes novel information on the feasibility of achieving remission simply by eating healthy food.

“The prevalence of diabetes is growing, as is recognition in the health care community that diet as the primary intervention can achieve lasting remission in individuals with type 2 diabetes,” said Gunadhar Panigrahi, MD, FACC, DipABLM, the first author of the study. “This case series further supports the effectiveness of a whole-food, plant-predominant eating pattern as a primary intervention to achieve remission as well as the need for increased education for both clinicians and patients on the successful application of lifestyle medicine principles and dietary interventions in everyday medical practice.”

Researchers reviewed electronic health records of patients treated at the wellness clinic between 2007 and 2021 to identify those who adopted a whole-food, plant-predominant eating pattern and achieved meaningful improvements in HbA1c or blood glucose control, as well as remission of type 2 diabetes. Data points were extracted from the periods immediately before the lifestyle intervention and the most recent post intervention.

The study used the 2022 consensus definition of remission published by ACLM of HbA1c less than 6.5% for at least three months without surgery, devices, or active pharmacologic therapy to lower blood glucose. That expert consensus statement was endorsed by the American Association of Clinical Endocrinology, supported by the Academy of Nutrition and Dietetics and co-sponsored by the Endocrine Society.

The mean age of the patients was 71.5 years and ranged in age from 41 to 89 years. Twenty-two of the 59 patients met the criteria for type 2 diabetes remission.  The study also reported an average de-escalation of  glucose-lowering medications among patients following lifestyle change. The reduction in glucose-lowering medications was consistent with that mentioned in a recent qualitative case series that provided the first published examples of protocols to help guide clinical decision making on when and how to deprescribe medications following lifestyle intervention. Medication deprescribing is a process that is supervised by a physician when a medication is no longer benefiting a patient.

The study highlighted that many patients did not first self-select into a lifestyle medicine treatment program for type 2 diabetes, but were rather educated on the merits of a whole-food, plant-predominant dietary pattern and regular physical activity as part of their routine care at the wellness center.

“There is a perception that many patients may not accept the idea of adopting a whole-food, plant predominant eating pattern but there is a growing abundance of research that in fact shows adherence to a plant-predominant dietary pattern is feasible, and even enjoyable,” said Micaela Karlsen, ACLM Senior Director of Research. “Although full remission may not be possible for every patient, our research shows that every patient deserves to know that it may be possible through the adopting of appropriately dosed therapeutic lifestyle change.”

Future research should measure the proportion of patients in typical medical practices who are willing to consider lifestyle changes as part of routine treatment and examine the factors leading to successful implementation of a plant-predominant dietary intervention, the authors said.

 

RSV is a serious heath threat, but the public knows little about it

 

Reports and Proceedings

ANNENBERG PUBLIC POLICY CENTER OF THE UNIVERSITY OF PENNSYLVANIA

 

IMAGE: THE PERCENTAGE OF PEOPLE WHO WOULD RECOMMEND AN FDA-APPROVED RSV VACCINE TO PREGNANT PEOPLE AND ADULTS 65 AND OLDER. SOURCE: ANNENBERG PUBLIC POLICY CENTER'S ASAPH SURVEY JUNE 2023. view more 

CREDIT: ANNENBERG PUBLIC POLICY CENTER

PHILADELPHIA – As the Centers for Disease Control and Prevention (CDC) determines whether to approve a vaccine against RSV for adults 60 and older, a new survey from the Annenberg Public Policy Center finds that the American public is ill-informed about the virus, unfamiliar with its most common symptoms, and more hesitant to recommend the vaccine to pregnant people than to older adults.

Worldwide, RSV is the leading cause of lower respiratory tract infections in babies. Though its symptoms are typically mild, the highly contagious RSV, or respiratory syncytial virus, can cause serious illness, hospitalization, and even death among infants and the elderly. By the age of 2, nearly all children get sick from RSV, which was one of three illnesses – with the flu and Covid-19 – contributing to last winter’s “tripledemic” that overwhelmed some health care facilities. The CDC estimates that 58,000 to 80,000 children under age 5 are hospitalized annually because of it.

After decades of research, scientists have developed vaccines against RSV. In May, the Food and Drug Administration (FDA) approved two RSV vaccines for older adults, and this summer is likely to approve a maternal RSV vaccine for pregnant people to pass antibodies on to fetuses to prevent RSV in infants from birth up to at least six months of age.

The survey of more than 1,600 adults finds that less than half of Americans (49%) were likely to recommend the vaccine against RSV, if approved by the FDA, to a pregnant friend or family member. By contrast, most Americans (63%) would recommend a vaccine against RSV to a friend or family member aged 65 or older. (When the survey was fielded, the FDA had already approved the vaccine for adults 60 and older, although the shots were not yet available.)

“Those who recall the stress that the tripledemic placed on the nation’s hospitals last fall will understand why older individuals and those who are pregnant should discuss the advisability of RSV vaccination with their health care providers,” said Kathleen Hall Jamieson, director of the Annenberg Public Policy Center (APPC) of the University of Pennsylvania and director of the study.  

APPC’s Annenberg Science and Public Health Knowledge survey

The survey data come from the 11th wave of a nationally representative panel of 1,601 U.S. adults, first empaneled in April 2021, conducted for the Annenberg Public Policy Center by SSRS, an independent market research company. This wave of the Annenberg Science and Public Health Knowledge (ASAPH) survey was fielded May 31-June 6, 2023, and has a margin of sampling error (MOE) of ± 3.3 percentage points at the 95% confidence level.

Download the topline and the methodology.

Data from earlier waves on Covid-19, society’s “return to normal,” vaccination, monkeypox, the seasonal flu, health misinformation, and related topics can be found here.

Underestimating the prevalence of RSV – but awareness of potential severity

A quarter of the public (27%) expresses worry about contracting or having a family member contract RSV, less than the one-third (33%) who were worried in our January survey, which was conducted during the tripledemic. The decrease in concern is not surprising given that RSV circulates during the fall and winter, and there was media coverage of the surge of cases last winter that, combined with flu and Covid-19 cases, filled some hospitals.

The prevalence of this common illness is vastly underestimated by the public. Only 22% in the current survey say they know children who have had RSV – and among these respondents, over half say they have known just one child or two children who have had it. Asked how many children contract RSV before the age of two, 2% of respondents say, “virtually all.” According to the CDC, “Almost all children will have had an RSV infection by their second birthday.”

But among the people who say they know children who have had RSV, its potential severity is clear. Among these respondents, over half (54%) say the illness was somewhat or very serious. “Most children with cold-like symptoms are not tested for RSV, but when a child becomes severely ill, it’s more likely that child will undergo diagnostic testing,” Jamieson said. While RSV can cause severe illnesses such as bronchiolitis and pneumonia, the CDC says it usually causes mild, cold-like symptoms – like runny nose, coughing, sneezing, fever, wheezing, and decreased appetite – and is often mistaken for cold or flu.

This does not mean, however, that some do not experience serious illness. Among 100 babies under the age of six months who get RSV, 1 to 2 may require hospitalization, the CDC says. Although RSV-associated deaths are “uncommon” in the United States, they nonetheless do occur at an estimated rate of 100 to 500 per year for children under five, according to the CDC. Worldwide deaths of children under 5 years old attributable to RSV exceed 100,000 annually.

Far fewer people say they know older adults who have had RSV. Only 6% of those surveyed say they know someone age 65 or older who has had RSV. Among this group of respondents, most (71%) say they know one or two people who have had it and most (72%) say the infection was somewhat or very serious. The CDC reports that among adults 65 and older, there are 60,000 to 160,000 hospitalizations per year from RSV, and 6,000 to 10,000 deaths.

For more information, see these Q&As on the RSV maternal vaccine and RSV vaccines for older adults from FactCheck.org, a project of APPC.

Great uncertainty about RSV

Only small segments of the American public correctly answer questions about RSV. Most people say they are not sure. The survey found that:

• Symptoms: Less than 1 in 5 people (18%) know it’s more accurate to say that RSV usually produces mild, cold-like symptoms than serious difficulties in breathing (38%). And 44% say they are not sure.

• Persistence: Less than 1 in 5 people (17%) know it’s more accurate to say that RSV is able to survive for many hours on hard surfaces such as table or crib rails than to say RSV can’t survive for many hours on these hard surfaces (9%). Most people (75%) say they are not sure.

• Reoccurrence: Less than 4 in 10 people (38%) know it’s more accurate to say that once a person contracts RSV, they can get it again. Only 2% incorrectly believe it’s more accurate to say that you can’t get RSV again, but 60% say they are not sure.

• Spreading the virus: Just over 4 in 10 people (42%) know it’s more accurate to say it is possible to have and spread RSV before showing symptoms than to say it is not possible (3%). But over half of those surveyed (54%) are not sure.

• Vaccine for older adults: Just 13% knew at the time the survey was fielded about the existence of an FDA-approved vaccine against RSV for older adults, while 18% said there was not an FDA-approved vaccine. Nearly 7 in 10 people (69%) said they were not sure. (The FDA approved one RSV vaccine for adults 60 and older on May 3, 2023, and the second one on May 31, the beginning of the survey period. A CDC committee of experts known as ACIP is meeting today on whether the CDC should recommend those vaccines and, if so, for what ages.)

• Vaccine for pregnant people: Just 1 in 5 people (20%) knew when the survey was fielded that there was not an FDA-approved vaccine against RSV for those who are pregnant to benefit their newborns, while 7% thought there was one. Nearly three-quarters of those surveyed (73%) were not sure. “However,” Jamieson noted, “since an FDA advisory panel had recommended approval at that point, we would expect a high level of uncertainty about whether or not an FDA-approved vaccine existed.”

• Vaccine for infants and children: About 1 in 5 people (19%) know there is currently not an FDA-approved vaccine against RSV for infants and children in the United States, while 11% say incorrectly that there is one and 70% are not sure.

Fewer than half recognize the symptoms of RSV

Fewer than half of those surveyed recognized some of the most common symptoms of RSV (respondents were asked to select all that applied):

• Wheezing: 46% know this is a symptom
• Runny nose: 38% know this is a symptom
• Pauses in breathing: 33% know this is a symptom
• Decreased activity: 32% know this is a symptom
• Decreased appetite: 29% know this is a symptom

Very few people incorrectly selected non-respiratory symptoms as associated with RSV:

• Jaundiced skin: 5% incorrectly say this is a symptom of RSV
• Spontaneous bruising: 2% incorrectly say this is a symptom of RSV
• Bleeding gums: 2% incorrectly say this is a symptom of RSV

Laser therapy is most effective treatment for tinnitus, study finds

 

Brazilian researchers compared the therapies used most frequently for tinnitus, which affects some 750 million worldwide

Peer-Reviewed Publication

FUNDAÇÃO DE AMPARO À PESQUISA DO ESTADO DE SÃO PAULO

Low-level laser therapy and associated photobiomodulation is the most effective of the known treatments for tinnitus, according to a study comparing the main therapies in current use, conducted by Brazilian scientists affiliated with the Optics and Photonics Research Center (CEPOF). The study is reported in an article published in the Journal of Personalized Medicine.

CEPOF is a Research, Innovation and Dissemination Center (RIDC) funded by FAPESP and hosted at the University of São Paulo’s São Carlos Institute of Physics (IFSC-USP) in Brazil.

Some 750 million people suffer from tinnitus worldwide, according to a European study that analyzed five decades of patient data. Often described as ringing or hissing in the ears, it is considered a symptom rather than a disease but is unpleasant and in some cases incapacitating. Its known causes can range from a buildup of earwax and insufficient peripheral irrigation in the inner ear to brain damage and bruxism. There are no standard treatments or drugs approved by the United States Food and Drug Administration (FDA).

“Tinnitus is a very widespread symptom throughout the general population. It’s treated with a vast number of methods, from ear lavage to local anesthetics, anti-depressants, anti-histamines, anti-psychotics and sedatives, with different results,” said Vitor Hugo Panhóca, a researcher at CEPOF. “After finding articles in the scientific literature that presented consistent laser therapy outcomes, we decided to compare the main treatments and pursue more responses to the problem.”

During a four-week period, Panhóca and his team tested alternative and complementary treatments for idiopathic (with no apparent cause) and refractory tinnitus on more than 100 men and women aged 18-65, divided randomly into ten groups. The treatments tested were laser acupuncture, flunarizine dihydrochloride, Ginkgo biloba (a medicinal plant), and low-level laser stimulation of the internal auditory canal or meatus (transmeatal stimulation), on its own and combined with vacuum therapy, ultrasound, G. biloba or flunarizine dihydrochloride.

The patients were submitted to eight twice-per-week treatment sessions. They were clinically assessed before treatment began, after the eighth session and a fortnight later, using a “tinnitus handicap inventory questionnaire” with a total of 25 questions. A functional subscale comprised 11 questions on mental, social, occupational and physical limitations due to tinnitus. 

The best outcomes were observed in patients treated with laser acupuncture alone and transmeatal low-power laser stimulation alone. In the latter case, they improved even more when irradiation time was increased from 6 minutes to 15 minutes. Combinations of laser therapy with vacuum therapy or G. biloba, laser acupuncture alone, and flunarizine dihydrochloride alone also had lasting therapeutic effects. 

“The positive effects include anti-inflammatory action and relaxation. We believe laser therapy can increase peripheral irrigation, which may be the main cause of the problem in many cases, as well as stimulating inner ear cell proliferation and collagen production,” Panhóca said.

New protocols

While the CEPOF study is not the only one to show that laser therapy can improve the condition of tinnitus patients, it paves the way to creation of a protocol for use by dentists, ear, nose and throat specialists, speech therapists and other medical practitioners who have such patients, as the number of sessions and intensity of the treatment vary greatly in the literature.

“Understanding how successful therapies work will help us focus on the most productive approaches in forthcoming studies. This is part of the learning curve when you innovate in health treatments like this,” Panhóca said, adding that it is also necessary to investigate the long-term effects of laser therapy.

: The U.S. Preventive Services Task Force (USPSTF) recommends screening for anxiety disorders and depression

 : The U.S. Preventive Services Task Force (USPSTF) recommends screening for anxiety disorders in adults, including pregnant and postpartum persons. The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for anxiety disorders in older adults. Anxiety disorders are commonly occurring mental health conditions. They are often unrecognized in primary care settings and substantial delays in treatment initiation occur. 

The U.S. Preventive Services Task Force (USPSTF) recommends screening for depression in the adult population, including pregnant and postpartum persons and older adults. The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for suicide risk in the adult population, including pregnant and postpartum persons and older adults. Major depressive disorder (MDD), a common mental disorder in the U.S., may have substantial impact on the lives of affected individuals. If left untreated, MDD can interfere with daily functioning and can also be associated with an increased risk of cardiovascular events, exacerbation of comorbid conditions, or increased mortality.

The USPSTF routinely makes recommendations about the effectiveness of preventive care services and this is a new USPSTF recommendation.

Eating larger meals earlier improves metabolic health

Eating more of one’s daily calories earlier in the day may counter weight gain, improve blood sugar fluctuations, and reduce the time that blood sugar is above normal levels, a new study suggests.

“This type of feeding, through its effect on blood sugar, may prevent those with prediabetes or obesity from progressing to type 2 diabetes,” said study lead author Joanne H. Bruno, MD, PhD, an endocrinology fellow at NYU Langone Health.

Presented at the Endocrine Society’s annual meeting on June 15, the new report evaluated early time-restricted feeding (eTRF), which involves restricting calories to the first eight hours of the day. Previous studies have found this form of intermittent fasting may improve cardiometabolic health and blood sugar levels. However, the team wanted to determine whether these improvements are related to weight loss or the fasting strategy.

Led by researchers at NYU Grossman School of Medicine, the work is the first to evaluate the effects of early time-restricted feeding on glycemia and inflammation independent of weight loss.

For their study, the researchers compared eTRF (80 percent of calories consumed before 1PM) to a usual feeding pattern (50 percent of calories consumed after 4PM) among ten participants with prediabetes and obesity.

The patients were randomized to eTRF or usual feeding patterns for the first seven days and were changed over to the alternative arm for the next 7 days. Food was provided to meet the patients’ caloric needs for weight maintenance to determine the weight-independent effects of this strategy. Patients wore continuous glucose (blood sugar) monitors throughout the study.

“We decreased the time these individuals were having high blood sugar levels with just one week of eTRF feeding,” said study senior author Jose O. Aleman, MD, PhD, assistant professor in the Department of Medicine, Division of Endocrinology, Diabetes, & Metabolism at NYU Grossman School of Medicine. “The findings show that eating a majority of one’s calories earlier in the day reduces the time that the blood sugar is elevated, thereby improving metabolic health.”  

Dr. Aleman and colleagues discovered the participants’ weights were stable throughout the study. Early time-restricted feeding led to a decreased mean amplitude of glycemic excursion and decreased time above range (blood glucose > 140mg/dL) compared to the usual eating pattern group. The time in range was similar between the eTRF and usual feeding pattern group.

“Based on this data, eTRF may be a helpful dietary strategy for diabetes prevention,” concluded Dr. Bruno. “Further studies are needed to understand the true overall benefit of these intervention strategies.”

Dietary supplementation shown to improve nutrition biomarkers in study of older men

 

A six-month study of healthy older men demonstrated that daily multivitamin/multimineral supplementation had a positive effect on key nutrition biomarkers.

The research led by Oregon State University’s Tory Hagen and Alexander Michels also showed that the changes in nutrition status could have direct connections to cellular function, measured by the oxygen consumption of the study participants’ blood cells.

The findings, published in the journal Nutrients, suggest that supplementation may be a key tool to help people stay healthier as they age.

“Many older adults take a multivitamin, thinking it will help them stay healthy,” said Michels, a research associate at OSU’s Linus Pauling Institute. “However, previous studies have shown mixed results when it comes to multivitamins and disease risk. We wanted to know why there was so much uncertainty. Is it possible that multivitamins aren’t as effective at changing nutrition biomarkers in older adults?”

The research group, which included eight OSU scientists, recruited 35 healthy men age 68 or greater for the double-blind study – half received a Centrum Silver supplement, the other half received a placebo, and participants did not know what they were receiving. None of the participants was allowed to take other supplements during the study, except for vitamin D if it was prescribed by their doctor.

“Our tests showed that many of these older men were not obtaining the optimal levels of several vitamins when the study started,” said Hagen, principal investigator and Helen P. Rumbel Professor for Healthy Aging Research at the Linus Pauling Institute. “So there certainly was room for improvement.”

After the six-month trial, differences in the supplement and placebo groups became apparent. While those taking the multivitamin showed improved biomarkers of nutrition, those on the placebo did not.

“Several of the participants assigned to the placebo group had blood nutrition biomarkers fall during the study,” said Hagen, who is also a professor of biochemistry and biophysics at OSU. “It suggests that food alone was not enough to keep their vitamin and carotenoid levels up.”

Carotenoids are yellow, orange and red pigments synthesized by plants, and they play multiple roles in human health. Some carotenoids like beta-carotene can provide the body with an extra source of vitamin A.

Although the researchers did not measure disease risk, they did test white blood cells, part of the body’s immune system.

“We were amazed to find that the men who took the placebo showed reduction in cellular oxygen consumption,” Hagen added, noting that oxygen consumption is an indicator of cell function. “This was not observed in men who took the multivitamin, suggesting a connection between vitamin status and white blood cell function that we are eager to explore further.”

The researchers believe the study is the beginning of a new era for multivitamin research.

“Our evidence indicates that many older men could benefit from a daily multivitamin, but the response did vary from individual to individual,” Michels said. “Knowing who benefits the most and why will be key for multivitamin trials that evaluate disease risk in the future.”