Elderberry extract: The magic fix for influenza?

The Pediatric Insider

© 2017 Roy Benaroch, MD

A Facebook pal posted about using an elderberry extract to treat flu – apparently this stuff is flying off the shelves. Could it really help?

It’s certainly conceivable that a plant extract could have anti-viral or other health promoting properties. After all, plants battle with viruses, bacteria, and other microorganisms all the time. We know that there are tons of “natural” compounds right there in the plants we eat that are themselves pesticides or anti-microbials (in fact, there’s far more pesticide in a plant than is ever sprayed on a plant. Cool, huh?) There’s a certain plausibility that says some plants or plant exacts could help prevent or treat infections. There have also been a small number of in vitro studies of elderberry – that is, studies in a test tubes – that show some antimicrobial properties. And even one study in chimps!

But what we really want to know is whether elderberry can help fight flu in people. And to do that, we need a good study. A randomized controlled trial, to be precise, where some people with flu are given elderberry, and another group a placebo. And then let’s see how they do. Science!

In fact, one such trial was done about 20 years ago, by a team of researchers from Israel and Scandinavia. 80 adults from age 18 to 54 (no children) were candidates for inclusion, all with typical flu symptoms during the 1999 flu season, recruited from one of four health centers in Norway. 60 people participated in the study (it’s unclear how the 80 was whittled down to 60.) Half of the 60 were given a standardized elderberry extracted called “Sambucol”, made in Israel; the other half were given a syrup said to be identical in taste, but lacking actual elderberry. Both groups were told to take a tablespoon of their syrup four times a day for 5 days. No attempt was made to see if patients could guess whether they were in the placebo or elderberry group.

The patients judged how they felt on several scales of crumminess, rating their own aches and pains, degree of coughing, quality of sleep, and other measures each day. Their ratings at the beginning of the study were similar (which is good—that means the randomization didn’t put sicker people in unbalanced groups.) None of the patients had any important side effects.

The results – you can take a look at them in figure 1 – were impressive. The elderberry-takers quickly had a huge improvement in symptoms, and rated that they had almost no symptoms by day 4. Contrast with the placebo-takers, who really didn’t get back to feeling good until day 8. There are different ways to break down different symptoms in the text of the study, but the bottom line is that these authors found elderberry extract to be very effective at relieving the symptoms of flu.

I have some doubts. The results fail a kind of “sniff test” to me – they’re too good to be true. No one with flu has symptoms that disappear so quickly. And it shouldn’t have taken the control group 8 days to get better, even with no treatment at all. I wonder if the patients were truly blinded, or if they figured out their group assignment. I read a lot of studies, and these results show a huge effect size seldom seen with any intervention.

I also wonder what impact the funding source could have had – the study was funded by the maker of Sambucol, who also supplied the elderberry and placebo extracts. The study was performed in 1999 and published in 2004, and I cannot find any further human studies of any elderberry product to fight influenza since then.

So there you have it – that’s the evidence. A single, small, industry-paid-for study showing a remarkably positive effect of elderberry in treating influenza in adults. Color me skeptical. But I’ll also say that I don’t know of any down side to elderberry – as far as I can tell, it’s safe, and some people even like the taste. And other than fluids and ibuprofen, I don’t know of anything else that has a big impact on treating influenza. Is it worth a try? Sure. Let me know how it goes.

Goodbye, Flumist: Why science is important

The Pediatric Insider

© 2016 Roy Benaroch, MD

Yesterday the CDC announced that its Advisory Committee on Immunization Practices (ACIP) voted to stop recommending the nasal spray flu vaccine, Flumist, for anyone. Bottom line: it doesn’t work. Though their recommendation against the use of Flumist still has to be approved by the CDC director to make it “official”, it’s pretty much a done deal. The AAP’s president has already endorsed the announcement, too.

Bye, Flumist. We’ll miss the ease of use and the not-scaring-children part, but the data’s clear. The mist doesn’t work. There was a sliver of good news, though—we have solid surveillance data from last year re-confirming that the traditional flu shot does work, with an estimated effectiveness of 63% last year. That’s not outstanding, but it’s pretty good. From a public health point of view preventing 63% of influenza cases can have a huge impact. Remember: every case prevented is one fewer person out there spreading influenza. Effective vaccinations not only help the person who got the vaccine, but the whole family and community.

Older data, at one point, had shown that Flumist was as effective (or even more effective) than the flu shot. For a few years, the mist was even considered the “preferred product” for children, because it seemed to work better.  Last year, Flumist lost its “preferred” status when data emerged showing that it wasn’t looking as good as the shot. Now, enough newer data has accumulated to show that at least against the strains that have been circulating recently, Flumist doesn’t work at all.

There’s going to be a scramble (again!) this year to ensure an adequate supply of injectable flu vaccine. I don’t know if MedImmune will suspend the Flumist program, or if they’ll still try to sell their product – but I am sure that there are a lot of docs out there scrambling this morning, trying to cancel Flumist pre-orders and increase our orders for alternatives. In the long run, that will be better for everyone. In the short run, it’s a problem. Families ought to plan to get their flu shots as early as possible this year, before they run out.

Science isn’t a set of answers, or a body of knowledge etched on a stone somewhere. It is a method of arriving at the truth, involving repeated observations and the continuous re-assessment of data. Estimates of vaccine effectiveness (and safety) are initially based on licensing studies, but they’re then adjusted by real-world data that continues to be collected, year after year. We should always make the best decision we can, based on the best data, even if that means we have to sometimes admit we’ve made a mistake, or that we have to change our minds. That’s not a weakness of science or medicine – that’s a strength. We can’t always promise to get it right, but we’ll keep studying and learning and trying to do it better.

A cold, the flu, or sinusitis? Part 3: Myths

The Pediatric Insider

© 2015 Roy Benaroch, MD

You might not like to hear it, but the truth is….

 

Nothing really works well to treat these things

Colds, flus, and sinusitis all share some things in common—and the most important one is that just about all of us get these, and they make us miserable, and we want them to go away. Billions are spent on all sorts of things to treat these conditions, both from pharmaceutical companies and from companies that make supplements and other alternative-health nostrums. We’ll try just about anything. But if clinical studies reliably show that just about nothing really helps, why do we keep buying them?

I think the most important factor is simple human nature, and the way that symptoms change. If you have a cold, the symptoms get better and worse throughout the day—so if you take medicine or supplement XX when you feel really bad, the natural ups and downs average out, and you’ll feel better. But: you would have felt better anyway! Still, human nature, you took the magic beans (that you paid for), then you felt better, so there must be a connection, right?

That happens at the end of an illness, too. Let’s say you’ve had a cold for 6 days, and you go to the local get-me-some-drugs at the QuickieClinic. You get some antibiotics, and a few days later you start to feel better. Boom, QED, there’s all the proof you need. (BTW, docs are pretty much just as bad about giving out unnecessary antibiotics, too.) But: you were going to get better anyway.

Think about this, it’s really important: many symptoms occur like a mountain, with an up and a down. If you try therapy at the top, when you’re feeling bad, you will feel better. But that doesn’t mean that the therapy was why the mountain went downhill.

 

Flu shots work

The effectiveness of flu vaccines varies from year to year, but typically runs ~ 50-75% — that’s pretty good, really, for a health intervention (it’s much better than, say, the effectiveness of taking a cholesterol-lowering drug to prevent a heart attack. And some people take those every day for years.) It does mean, though, that in a family with say four people who’ve gotten flu vaccine, one child may not be well protected. That’s why it’s important for the whole family to get it.

Also: flu vaccines only prevent the flu. They don’t prevent colds. And they take 3 weeks or so to “kick in” – you don’t get instant protection.

 

Flu shots cannot cause the flu

No. They can’t, and they don’t. They can sometimes cause a little fever or achiness, but that is not the flu—and anyone who’s actually had the flu will tell you that these mild symptoms after a flu vaccine are pretty much nothing. Sometimes, right after a flu vaccine, someone does get the flu—that’s because we’re giving flu vaccines during flu season, and if you don’t get it in advance it can’t protect you. The vaccines take about 3 weeks to work. If you catch influenza right after getting the flu vaccine that’s called “bad luck” or “bad planning”, not “bad vaccine.”

 

Green snot means sinusitis

No, green snot means it’s been sitting around up your nose (you’ll often notice this overnight), and your white cells are busy fighting off the viral infection. Good for your white cells. Go blow your nose, and stop looking at the color—it doesn’t matter what shade it is.

 

Flu tests are needed to diagnose flu

Commercially available flu tests aren’t very good—they give a lot of false negatives (a negative test even in the setting of flu), and some false positives (a positive test in a person without flu.) Many health care facilities don’t even use them. A flu test can be helpful, sometimes, if I’m on the fence about a diagnosis, but they’re really just not very reliable to help make decisions about treatment.

 

Cold weather causes colds

Colds are caused by viruses, one of many from families called “rhinovirus” and “coronavirus” and others. They’re not caused by cold weather. BUT there is a germ of truth here: cold air in the nose can make it more likely that these viruses can be transmitted. Grandma may have been right!

 

I’m sure there are other myths, feel free to add your own in the comments!

 

The whole series:

A cold, the flu, or sinusitis? Part 1: Symptoms and Diagnosis

A cold, the flu, or sinusitis? Part 2: Treatment

A cold, the flu, or sinusitis? Part 3: Myths

A cold, the flu, or sinusitis? Part 2: Treatment

The Pediatric Insider

© 2015 Roy Benaroch, MD

The previous post was about the symptoms of colds, the flu, and sinus infections—they’re not the same. This time, we’ll cover their treatment. And, surprise, it turns out that treating all of these is pretty much the same.

The most important part of treatment is rest and comfort. Get more sleep, and stay out of school or work until feeling better. That helps you and your children recover, and hopefully prevents the spread of illness. Drink more fluids, and have some soup.

To treat aches and pains, use acetaminophen or ibuprofen. It’s better to use these around-the-clock for a few days rather than just when symptoms become bad—these medicines are better at preventing pain and fever than treating pain and fever.

Treating nasal congestion is all about drainage. Use a humidifier and/or nasal saline spray. If your child is old enough, sometimes OTC decongestants given orally or as a nasal spray can help some, but they’re certainly not miracle drugs.

Coughs are annoying, but they’re there for a purpose: to get mucus up and out. If a cough is bothering your child, one of the best treatments is ordinary honey (for age 12 months and up.) Older children can sometimes benefit from OTC cough suppressants, but, again, they don’t work great. If your child has asthma, it’s probably a good idea to start up rescue medications during a cough.

There are a few more-specific treatments, depending on the diagnosis. If it’s influenza, a specific anti-viral medication (usually Tamiflu) can help some if started within the first 24-48 hours of symptoms. But the benefits of this medicine are modest at best. Tamiflu does not prevent serious complications, and only reduces symptoms by a little bit. Most people with influenza won’t notice any huge improvement with Tamiflu.

Sinusitis is typically treated with antibiotics, though even then the benefits of antibiotics are often over-stated. Studies looking at populations of both children and adults, comparing active antibiotics versus placebos, have shown really limited benefits to using antibiotics to treat sinusitis, at least ordinary, uncomplicated cases. And, of course, these same studies show that people taking antibiotics are much more likely to experience side effects and adverse reactions than those taking placebos.

The good news is that whatever you do, you’re going to get better. Whether it’s a cold, the flu, or sinusitis, symptoms will get better with or without treatment—though you’re going to be feeling sick for a while. If that’s the case, why does it seem like Tamiflu, antibiotics, OTC supplements, and all sorts of other things “work”? Next up, Part 3: Myths.

 

The whole series:

A cold, the flu, or sinusitis? Part 1: Symptoms and Diagnosis

A cold, the flu, or sinusitis? Part 2: Treatment

A cold, the flu, or sinusitis? Part 3: Myths

Some bad news about flu this year

The Pediatric Insider

© 2014 Roy Benaroch, MD

We could be in for a rough influenza winter.

First, data just released from the CDC shows that a lot of the flu circulating in the USA isn’t a good match for the strains in this year’s flu vaccines. About 82% of flu since autumn is a type A H3N2, one that historically has been associated with more-severe illness. Of those, only about half are closely related to the A/Texas/50/2012 strain that was chosen in February to be included in the vaccine. Unfortunately, current methods of vaccine production take a long time, and manufacturers have to commit early—months ahead of time—to what will be included in the vaccines. In February, when the World Health Organization made their recommendations for the Northern Hemisphere 2014-2015 flu vaccine, they chose the H3N2 that was then in circulation. Since then, it’s “drifted”, or changed, to a related but non-identical type.

What this means is that the current vaccine is well-matched to only about 40% of circulating flu. The vaccine will probably offer some protection against the other 60%– illness will be milder and shorter—but a lot of people who got their flu vaccines are still going to get the flu, and spread the flu. Now, some protection is still better than none, so I’d still go and get that flu vaccine now if you haven’t gotten it already. An imperfect (or, honestly, far-less-than-perfect) flu vaccine is better than none. But it isn’t looking good this year.

And it gets worse. It’s becoming increasingly clear that Tamiflu, the anti-viral medication we rely on to help treat influenza, doesn’t work very well. As summarized by the Cochrane Collaboration earlier this year, studies show that Tamiflu is only modestly effective in reducing the length of influenza illness, and may be only slightly effective at reducing complications. If it does work for treatment of flu, it works best when started very early in the course of the illness. The FDA labeling calls for it to be started within 48 hours, but honestly it seems to barely work if started that late. Better to get it started within 24, or even better, 12 or 6 or 2 hours.

In practice, Tamiflu really doesn’t seem to do much of anything for most of the flu patients seen in hospitals and doctor’s offices, because we usually see patients too late. It does have a role in helping family members at risk for flu. They can start it immediately, at the first symptoms, and will probably get more benefit.

Tamiflu can also be used as a prophylactic, or preventive, agent in people exposed to flu with no symptoms, though again, the benefits are modest at best. Crunching the numbers, we probably have to treat about 33 people on average for just one person to benefit from prophylaxis. That’s not very good, especially considering that all 33 people will have to pay for it and risk the side effects.

And Tamiflu does have some significant side effects. Nausea and vomiting are quite common, but the scarier reactions are depression, hallucinations, and psychosis. Neuropsychiatric side effects are most common in people of Japanese ancestry.

So: the flu vaccine, this year, will probably offer only modest benefits. And Tamiflu really has very limited usefulness. It looks like we’d better prepare for a rough winter, and keep in mind some of the old-fashioned ways to keep from getting the flu:

• Stay away from sick people.
• If you’re sick, stay home.
• Keep your mucus to yourself—sneeze into your elbow, or better yet into a tissue. And then wash your hands.
• Don’t touch your own face. Flu virus on your hands doesn’t make you sick until you help it get into your body by touching your eyes, nose, or mouth.
• Wash or sanitize your hands frequently, and especially before touching your face or eating.

Infection Report 3: The single biggest infectious health risk is preventable

The Pediatric Insider

© 2014 Roy Benaroch, MD

Here’s what people are dying of in the United States, in order: heart disease, cancer, chronic lung disease (mostly COPD, usually among smokers), stroke, accidents, Alzheimer disease, diabetes. And at number 8, the first infectious cause of death on the list: influenza and pneumonia, about 54,000 deaths a year.

(By the way, at least some cancers are infectious diseases, and two of those we can prevent with vaccinations. But let’s focus on influenza and pneumonia here.)

The most common fatal complication of influenza is pneumonia, so it can be difficult to tease out how many of those 54,000 “pneumonia and influenza” deaths were caused by influenza. Influenza also contributes to death by many of the other causes (it is the final straw in many patients with COPD or other health problems.) It’s likely that influenza viral infections are the proximal cause of about 36,000 deaths a year in the United States.

Unlike Ebola, influenza spreads rapidly in a community. Influenza virus can be spread by sneezing or coughing, or even better by mucus left on surfaces and doorknobs. Also, unlike Ebola, people with influenza become infectious a day or so before they’re obviously sick.

There are simple steps you can take to prevent contracting and spreading influenza. Most importantly, people with influenza symptoms shouldn’t go to school or work. Keep your mucus to yourself, as much as you can, by sneezing into tissues and using hand sanitizer to clean your hands. Remember, influenza virus gets from place to place on hands—once deposited somewhere, it doesn’t jump up and fly around. You have to touch it, then touch your own face, to get sick from influenza virus.

One more step that we all need to take: make sure you and your family get influenza vaccinations! The vaccine is terrifically safe, and it works well most of the time to  reduce the transmission, rate, and severity of influenza. Taken as part of an overall influenza prevention scheme, vaccination is an essential step.

The CDC recommends influenza vaccinations for all of us, everyone over six months of age. That’s because the more people get the vaccine, the more all of us are protected. It doesn’t work 100% of the time, and young babies and people with some health conditions can’t be vaccinated—so it’s up to the rest of us to keep vaccination rates high, to protect everyone. One lesson is clear from the current media hysteria over Ebola, Enterovirus D68, and other new infections: we’re all in this together. Influenza is one infection that we’ve got the tools to beat.

Tomorrow: more new infections that are making the headlines.

More info:

Flu myths

CDC comprehensive flu info

Pregnant women should get influenza vaccines to protect their babies and themselves

The Pediatric Insider

© 2014 Roy Benaroch, MD

The kids are heading back to school, and my zucchini vines are withered—that means summer’s almost over, and we’re heading back into flu season. This year, I’m going to try my best to convince as many of you as possible to get yourselves and your children vaccinated.

Why? Because I don’t like to see people suffer and die. We’ve got a good, safe, effective way to prevent influenza—and the more people vaccinated, the better it works. There are very few medical contraindications, and the CDC recommends that everyone aged 6 months and over get the vaccine each year. That helps protect us all.

Today I’m going to focus at the beginning of the life cycle, with pregnancy. We’ve known for a long time that pregnant women are especially prone to complications and death from influenza infection, and ACOG (The American Congress of Obstetricians and Gynecologists) has recommended since 2010 that women receive a dose of injected influenza vaccine during pregnancy. Uptake has been poor, in part because of lingering safety concerns.

There have been several recent studies that provide solid reassurance about the safety and effectiveness of influenza vaccines during pregnancy. In 2013, the New England Journal published a study from Norway that looked at 117,347 pregnancies—vaccinated moms were less likely to get influenza, and less likely to have their babies die. Another study, BMJ 2012, looked at about 55,000 pregnancies in Denmark, showing no increased risk of birth defects, preterm birth, or fetal growth problems after vaccination. That same Danish group published a second study from their data set showing no increased risk of fetal death. The Danish studies looked rigorously for adverse reactions, finding no support for any significant problems, though these studies were not designed to look at the effectiveness of the vaccines.

The effectiveness of these vaccines has already been demonstrated, both to protect mom and to protect baby. Pregnant women ought to make the safe choice: get vaccinated against influenza. It’s the right thing to do for you, and the right thing to do for your baby.

Does the influenza vaccine work? A small observational study

The Pediatric Insider

© 2014 Roy Benaroch, MD

Flu season is in full swing here, and I’m seeing dozens of feverish, miserable kids a week. Since it started early this year, maybe that means influenza will burn out and be over soon—but maybe not. Some years we get a “double dip” as a second strain of flu moves through town.

Influenza does a very good job of working its way through our communities each year. The symptoms of flu, including runny nose and cough, make transmission of infected mucus almost guaranteed.  And the virus itself, already very contagious, changes over time– so neither natural infection nor immunizations provide reliable lasting protection.

Though far from perfect, influenza vaccinations should be an important part of your family’s flu prevention strategy. Their effectiveness varies from year to year, but is probably overall in the range of 50-70%. Not great, but if even half of the cases of flu could be prevented, that’s a whole lot less misery, and far fewer people continuing to spread infection. Remember: for every case of influenza prevented, that’s fewer exposures for the rest of us.

I get asked a lot: how’s this year’s vaccine doing? Does it work? So a few days ago I collected data from my practice. I copied out the log book we keep of flu tests from 12-18-2013 to 12-24-2013—this is a list of all of the rapid flu tests we did in one of my two offices, the names of the patients and the results of the tests. Then I went back through their charts to see if they had been fully vaccinated against influenza this year.

Here’s the data, raw, in a “2×2 contingency table”:

	Vaccine Yes	Vaccine No	total
Flu test POS	2	14	16
Flu test NEG	9	9	18
Totals	11	23	34

I’m not going to go into big-time statistics with this—I’m not pretending that this was a full-scale, professional study. This was just a convenience sample of kids who had flu tests done in my office over a few days in December. But what it does show is striking:

• If you had a flu vaccine, your chance of testing positive for influenza was about 20%.
• If you didn’t have a flu vaccine, your chance of testing positive for flu was 60%– three times the risk.

For you statistics types, I did plug these numbers into a web-based statistics package, and based on the Chi-Square calculation for a 2×2 contingency table the difference was statistically significant with p<0.05. However: I’m not 100% sure I did that right. I’m not swearing by my statistical chops here. Anyone out there with a good statistics background: if you want to chew on the data, please do, and post in the comments what you’ve determined.

Now, to be honest, there are some big-time caveats to this “study.” We didn’t systematically test people based on certain criteria. Each doc decided who to test, and it’s possible that some of my docs would be more or less likely to test people depending on whether they had had a flu vaccine. The test itself isn’t perfect—though a positive test is quite reliable, it’s possible that a negative flu test misses up to even 50% of true flu cases. The study wasn’t a randomized clinical trial- whether or not each child was vaccinated was up to the parents, and could have been influenced by their individual child’s risks of influenza exposure. And I didn’t look at the timing of the vaccines that were given—it’s possible that some kids in the “Vaccine YES” column received their vaccines too late in the season to be effective, and should have been counted as “Vaccine NO.” Furthermore: I only had access to my own records. Some of the “Vaccine NO” children could have gotten flu vaccines elsewhere.

Still: from this small sample, it looks like flu vaccines were strongly effective at preventing influenza in children at my practice.

More on preventing and treating influenza

Yet more evidence for the safety and effectiveness of vaccines

The Pediatric Insider

© 2013 Roy Benaroch, MD

Item #1: A study of about a million (!) girls in Sweden and Denmark showed no serious side effects, none at all, after administration of the HPV vaccine.

Item #2: Another study, looking at children vaccinated against influenza from 2010-2012, showed a 77% reduction in life threatening flu illness.

Item #3: From JAMA Pediatrics, a study showing that among children 3-36 months of age, those who hadn’t received their routine vaccines had 18 times the risk of pertussis compared to fully vaccinated children.

What do these studies have in common? They’ve all been published within the last few weeks, and they’re good, solid science. They’ll also be ignored by the hardcore anti-vaccine crowd, for whom no amount of evidence matters one bit. They’ve made up their minds, and they have no interest in what scientists or doctors or anyone else has to say—unless you already agree with them.

Jonathan Swift said, “It is useless to attempt to reason a man out of a thing he was never reasoned into.” People who have come to their antivaccine views out of hysteria and fear have not used reason. And I don’t think there is much hope to convince them of anything.

But the vast majority of vaccine-questioning parents aren’t like that. They want good, reliable information to help them make their decisions. Studies like these continue to be published, hundreds of them a year. As more evidence accumulates, the safety and effectiveness of vaccines continues to be reinforced. We’re learning more and more about the immune system and how to protect ourselves, and newer vaccines have been very effective. That’s great news for those of us who want to do what’s best to protect our children, or families, and our communities.

Influenza is here

The leaves are changing, there’s a nip in the air, and I’m making plans to steal my kids’ Reese’s tonight. And to make Halloween just a little scarier: we’ve got our first case of influenza, right here in Atlanta!

I don’t know if this will be a mild, moderate, or severe flu season—but even in the mildest years, we’re going to see a lot of miserable kids and families in our office, and a handful of really sick, hospitalized children. While nothing can give you 100% protection, one of the best ways to help keep your kids, yourself, and your neighborhoods healthy is for all of us to get the flu vaccine. It’s not too late! Go, now, get vaccines for your family to protect yourselves. Do the safe thing.

If you do get the flu—the aches, the fever, the misery—stay home. The best treatment is rest and fluids and maybe acetaminophen or ibuprofen. Anti-viral medications like Tamiflu are expensive, nauseating, and not very effective. Still, for high-risk cases it’s the best we’ve got.

You know what they say: an ounce of prevention is worth a pound of Tamiflu. Or something like that. Go get your vaccine!

Previously:

How to transmit influenza to your friends and enemies

Preventing and treating influenza

The CDC’s influenza page, including links to maps showing current influenza activity nationwide