Are Sugar Pills Better than Antidepressant Drugs?

Do Antidepressant Drugs Really Work.jpg

We've learned that exercise compares favorably to antidepressant medications as a first-line treatment for mild to moderate depression (in my video Exercise vs. Drugs for Depression). But how much is that really saying? How effective are antidepressant drugs in the first place?

A recent meta-analysis sparked huge scientific and public controversy by stating that the placebo effect can explain the apparent clinical benefits of antidepressants. But aren't there thousands of clinical trials providing compelling evidence for antidepressant effectiveness? If a meta-analysis compiles together all the best published research, how could it say they don't work much better than sugar pills?

The key word is "published."

What if a drug company decided only to publish studies that showed a positive effect, but quietly shelved and concealed any studies showing the drug didn't work? If you didn't know any better, you'd look at the published medical literature and think "Wow, this drug is great." And what if all the drug companies did that? To find out if this was the case, researchers applied to the FDA under the Freedom of Information Act to get access to the published and unpublished studies submitted by pharmaceutical companies, and what they found was shocking.

According to the published literature, the results of nearly all the trials of antidepressants were positive, meaning they worked. In contrast, FDA analysis of the trial data showed only roughly half of the trials had positive results. In other words, about half the studies showed the drugs didn't work. Thus, when published and unpublished data are combined, they fail to show a clinically significant advantage for antidepressant medication over a sugar pill. Not publishing negative results undermines evidence-based medicine and puts millions of patients at risk for using ineffective or unsafe drugs, and this was the case with these antidepressant drugs.

These revelations hit first in 2008. Prozac, Serzone, Paxil and Effexor worked, but so did sugar pills, and the difference between the drug and placebo was small. That was 2008. Where were we by 2014? Analyses of the published data and the unpublished data that were hidden by drug companies reveals that most (if not all) of the benefits of antidepressants are due to the placebo effect. And what's even worse, Freedom of Information Act documents show the FDA knew about it but made an explicit decision to keep this information from the public and from prescribing physicians.

How could drug companies get away with this?

The pharmaceutical industry is considered the most profitable and politically influential industry in the United States, and mental illness can be thought of as the drug industry's golden goose: incurable, common, long term and involving multiple medications. Antidepressant medications are prescribed to 8.7 percent of the U.S. population. It's a multi-billion dollar market.

To summarize, there is a strong therapeutic response to antidepressant medication; it's just that the response to placebo is almost as strong. Indeed, antidepressants offer substantial benefits to millions of people suffering from depression, and to cast them as ineffective is inaccurate. Just because they may not work better than fake pills doesn't mean they don't work. It's like homeopathy--just because it doesn't work better than the sugar pills, doesn't mean that homeopathy doesn't work. The placebo effect is real and powerful.

In one psychopharmacology journal, a psychiatrist funded by the Prozac company defends the drugs stating, "A key issue is disregarded by the naysaying critics. If the patient is benefiting from antidepressant treatment does it matter whether this is being achieved via drug or placebo effects?"

Of course it matters!

Among the side effects of antidepressants are: sexual dysfunction in up to three quarters of people, long-term weight gain, insomnia, nausea and diarrhea. About one in five show withdrawal symptoms when they try to quit. And perhaps more tragically, the drugs may make people more likely to become depressed in the future. Let me say that again: People are more likely to become depressed after treatment by antidepressants than after treatment by other means - including placebo.

So if doctors are willing to give patients placebo-equivalent treatments, maybe it'd be better for them to just lie to patients and give them actual sugar pills. Yes, that involves deception, but isn't that preferable than deception with a side of side effects? See more on this in my video Do Antidepressant Drugs Really Work?

If different treatments are equally effective, then choice should be based on risk and harm, and of all of the available treatments, antidepressant drugs may be among the riskiest and most harmful. If they are to be used at all, it should be as a last resort, when depression is extremely severe and all other treatment alternatives have been tried and failed.

Antidepressants may not work better than placebo for mild and moderate depression, but for very severe depression, the drugs do beat out sugar pills. But that's just a small fraction of the people taking these drugs. That means that the vast majority of depressed patients--as many as nine out of ten--are being prescribed medications that have negligible benefits to them.

Too many doctors quickly decide upon a depression diagnosis without necessarily listening to what the patient has to say and end up putting them on antidepressants without considering alternatives. And fortunately, there are effective alternatives. Physical exercise, for example can have lasting effects, and if that turns out to also be a placebo effect, it is at least a placebo with an enviable list of side effects. Whereas side effects of antidepressants include things like sexual dysfunction and insomnia, side effects of exercise include enhanced libido, better sleep, decreased body fat, improved muscle tone and a longer life.


There are other ways meta-analyses can be misleading. See The Saturated Fat Studies: Buttering Up the Public and The Saturated Fat Studies: Set Up to Fail.

More on the ethical challenges facing doctors and whether or not to prescribe sugar pills in The Lie That Heals: Should Doctors Give Placebos?

I've used the Freedom of Information Act myself to get access to behind the scenes industry shenanigans. See, for example, what I found out about the egg industry in Who Says Eggs Aren't Healthy or Safe? and Eggs and Cholesterol: Patently False and Misleading Claims.

This isn't the only case of the medical profession overselling the benefits of drugs. See How Smoking in 1956 is Like Eating in 2016, The Actual Benefit of Diet vs. Drugs and Why Prevention is Worth a Ton of Cure (though if you're worried about your mood they might make you even more depressed!)

In health,

Michael Greger, M.D.

PS: If you haven't yet, you can subscribe to my free videos here and watch my live, year-in-review presentations:

Image Credit: GraphicStock. This image has been modified.

Original Link

Are Sugar Pills Better than Antidepressant Drugs?

Do Antidepressant Drugs Really Work.jpg

We've learned that exercise compares favorably to antidepressant medications as a first-line treatment for mild to moderate depression (in my video Exercise vs. Drugs for Depression). But how much is that really saying? How effective are antidepressant drugs in the first place?

A recent meta-analysis sparked huge scientific and public controversy by stating that the placebo effect can explain the apparent clinical benefits of antidepressants. But aren't there thousands of clinical trials providing compelling evidence for antidepressant effectiveness? If a meta-analysis compiles together all the best published research, how could it say they don't work much better than sugar pills?

The key word is "published."

What if a drug company decided only to publish studies that showed a positive effect, but quietly shelved and concealed any studies showing the drug didn't work? If you didn't know any better, you'd look at the published medical literature and think "Wow, this drug is great." And what if all the drug companies did that? To find out if this was the case, researchers applied to the FDA under the Freedom of Information Act to get access to the published and unpublished studies submitted by pharmaceutical companies, and what they found was shocking.

According to the published literature, the results of nearly all the trials of antidepressants were positive, meaning they worked. In contrast, FDA analysis of the trial data showed only roughly half of the trials had positive results. In other words, about half the studies showed the drugs didn't work. Thus, when published and unpublished data are combined, they fail to show a clinically significant advantage for antidepressant medication over a sugar pill. Not publishing negative results undermines evidence-based medicine and puts millions of patients at risk for using ineffective or unsafe drugs, and this was the case with these antidepressant drugs.

These revelations hit first in 2008. Prozac, Serzone, Paxil and Effexor worked, but so did sugar pills, and the difference between the drug and placebo was small. That was 2008. Where were we by 2014? Analyses of the published data and the unpublished data that were hidden by drug companies reveals that most (if not all) of the benefits of antidepressants are due to the placebo effect. And what's even worse, Freedom of Information Act documents show the FDA knew about it but made an explicit decision to keep this information from the public and from prescribing physicians.

How could drug companies get away with this?

The pharmaceutical industry is considered the most profitable and politically influential industry in the United States, and mental illness can be thought of as the drug industry's golden goose: incurable, common, long term and involving multiple medications. Antidepressant medications are prescribed to 8.7 percent of the U.S. population. It's a multi-billion dollar market.

To summarize, there is a strong therapeutic response to antidepressant medication; it's just that the response to placebo is almost as strong. Indeed, antidepressants offer substantial benefits to millions of people suffering from depression, and to cast them as ineffective is inaccurate. Just because they may not work better than fake pills doesn't mean they don't work. It's like homeopathy--just because it doesn't work better than the sugar pills, doesn't mean that homeopathy doesn't work. The placebo effect is real and powerful.

In one psychopharmacology journal, a psychiatrist funded by the Prozac company defends the drugs stating, "A key issue is disregarded by the naysaying critics. If the patient is benefiting from antidepressant treatment does it matter whether this is being achieved via drug or placebo effects?"

Of course it matters!

Among the side effects of antidepressants are: sexual dysfunction in up to three quarters of people, long-term weight gain, insomnia, nausea and diarrhea. About one in five show withdrawal symptoms when they try to quit. And perhaps more tragically, the drugs may make people more likely to become depressed in the future. Let me say that again: People are more likely to become depressed after treatment by antidepressants than after treatment by other means - including placebo.

So if doctors are willing to give patients placebo-equivalent treatments, maybe it'd be better for them to just lie to patients and give them actual sugar pills. Yes, that involves deception, but isn't that preferable than deception with a side of side effects? See more on this in my video Do Antidepressant Drugs Really Work?

If different treatments are equally effective, then choice should be based on risk and harm, and of all of the available treatments, antidepressant drugs may be among the riskiest and most harmful. If they are to be used at all, it should be as a last resort, when depression is extremely severe and all other treatment alternatives have been tried and failed.

Antidepressants may not work better than placebo for mild and moderate depression, but for very severe depression, the drugs do beat out sugar pills. But that's just a small fraction of the people taking these drugs. That means that the vast majority of depressed patients--as many as nine out of ten--are being prescribed medications that have negligible benefits to them.

Too many doctors quickly decide upon a depression diagnosis without necessarily listening to what the patient has to say and end up putting them on antidepressants without considering alternatives. And fortunately, there are effective alternatives. Physical exercise, for example can have lasting effects, and if that turns out to also be a placebo effect, it is at least a placebo with an enviable list of side effects. Whereas side effects of antidepressants include things like sexual dysfunction and insomnia, side effects of exercise include enhanced libido, better sleep, decreased body fat, improved muscle tone and a longer life.


There are other ways meta-analyses can be misleading. See The Saturated Fat Studies: Buttering Up the Public and The Saturated Fat Studies: Set Up to Fail.

More on the ethical challenges facing doctors and whether or not to prescribe sugar pills in The Lie That Heals: Should Doctors Give Placebos?

I've used the Freedom of Information Act myself to get access to behind the scenes industry shenanigans. See, for example, what I found out about the egg industry in Who Says Eggs Aren't Healthy or Safe? and Eggs and Cholesterol: Patently False and Misleading Claims.

This isn't the only case of the medical profession overselling the benefits of drugs. See How Smoking in 1956 is Like Eating in 2016, The Actual Benefit of Diet vs. Drugs and Why Prevention is Worth a Ton of Cure (though if you're worried about your mood they might make you even more depressed!)

In health,

Michael Greger, M.D.

PS: If you haven't yet, you can subscribe to my free videos here and watch my live, year-in-review presentations:

Image Credit: GraphicStock. This image has been modified.

Original Link

Flaxseeds for Diabetes

 

 

 

 

 

 

 

 

Drug companies hope to capitalize on the fact that the consumption of certain plants appears to lower the risk of diabetes by isolating these plants’ active components for use and sale as pharmacological agents. Though not as profitable, why don’t we just eat the plants themselves?

One plant in particular that’s now been tested is flax. We’ve known for 20 years that having ground flax in your stomach can blunt the blood sugar spike from a meal, but it’s never been tested in diabetics–until now. World Health Organization researchers published an open-label study on the effect of flax seed powder supplementation in the management of diabetes.

Diabetic subjects took a tablespoon of ground flax seeds every day for a month, and, compared to the control group, experienced a significant drop in fasting blood sugars, triglycerides, and cholesterol, as well as the most important thing, a drop in A1C level. If one’s sugars are already well controlled, though, there may be no additional benefit.

How does flax help control blood sugars? Flaxseeds may improve insulin sensitivity in glucose intolerant people. After 12 weeks of flax, researchers found a small but significant drop in insulin resistance, perhaps related to the drop in oxidant stress due to the antioxidant qualities of flaxseeds.

The study profiled in my 3-min video Flaxseed vs. Diabetes showing a tablespoon of daily ground flax seeds for a month appears to improve fasting blood sugars, triglycerides, cholesterol, and hemoglobin A1c levels in diabetics was a non-blinded, non-randomized small study. If it was some drug they were testing, I’d never prescribe it based on this one study, but this isn’t a drug. It’s just flaxseeds. There are just good side effects, so even if this study was a fluke or fraud, flaxseeds have other benefits. In the worst case scenario the seed would still end up benefiting patients who aren’t quite ready or able to reverse their diabetes completely with a plant-based diet.

Flaxseeds are calorically dense, but even adding a half cup of ground flax a day may not lead to weight gain. When 4 tablespoons a day were tested for 3 months the flax group ended up with a slimmer waist than the flaxseed oil or control group. Because of the potential of raw flax seeds to interfere with thyroid function at high doses, though, I would only recommend 2 tablespoons a day. And I would not recommend flaxseed supplementation during pregnancy.

The flaxseed study reminds me of the Prunes vs. Metamucil for Constipation one, or any of those talking about various foods that may control blood sugar (Amla Versus Diabetes), weight (Fat Burning Via Flavonoids), cholesterol (Dried Apples Versus Cholesterol), or sexual dysfunction (Watermelon as Treatment for Erectile Dysfunction). Yes, these foods may help, but why not get at the root of the problem and try to reverse the condition altogether with a healthier diet overall?

The three best books on reversing type 2 diabetes with diet are Defeating Diabetes, co-authored by my favorite dietician, Brenda Davis, and from two of my medical mentors: Dr. Neal Barnard’s Program To Reverse Diabetes Now and Dr. Joel Fuhrman’s The End of Diabetes.

-Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live year-in-review presentations Uprooting the Leading Causes of Death and More Than an Apple a Day.

Image credit: Jill A. Brown / Flickr

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The Best Nutrition Bar

There are a variety of healthier fruit and nut bars on the market now that boast dried fruit as a primary ingredient. Dried fruit is calorically dense, though. Should we be concerned that eating such bars may make us fat?

You may have noticed in the conclusion of the fig study I covered in Best Dried Fruit for Cholesterol that adding 14 figs to people’s daily diets did not lead to significant weight gain.

Wait a second.

That’s 300 calories of figs a day. Over 5 weeks that’s 10,000 calories. How did 10,000 calories disappear into thin air? Figs are so satiating and packed with fiber that even without trying people just end up eating less of other foods throughout the day. I get full just thinking about eating 14 figs!

Was that study just a fluke? Let’s look at the other new studies I covered. What about adding three quarters of a cup of dried apples to our diet every day for a year? Two hundred extra calories a day, but no significant change in weight. Two hundred extra calories of prunes a day for a year? No significant change in weight and same thing with a month of a daily 300 calorie load of dates.

In general, the 5-10% of Americans that average a tablespoon or more of dried fruit a day tend to be less overweight, less obese, and have a slimmer waist with less abdominal obesity. They tended to eat more, but weighed less.  Similar findings were found for those that eat nuts and nut butters, lower body mass index, slimmer waist, and significantly less excess weight and obesity. See my video Nuts and Obesity: The Weight of Evidence. The various mechanisms are summarized in Solving the Mystery of the Missing Calories and explored further in a four-video series:

What if you put dried fruit and nuts together? What would be the effect of adding daily fruit and nut bars on top of one’s regular diet for two months? Researchers took about a hundred folks who were overweight and randomized them into two groups. Half ate their regular diet, and the other half ate their regular diet plus two fruit and nut bars a day, totaling an extra 340 calories. But these weren’t candy calories; these were largely whole plant food calories, dried fruits and nuts.

Two daily fruit and nut bars for two months did not cause weight gain. And they had additional sugar in them (they were KIND brand bars). Maybe that may be why the participants’ cholesterol didn’t get better despite the nuts, which should have helped. I highlight some brands in my 3-min video Do Fruit & Nut Bars Cause Weight Gain? with no added sugar, but it’s even cheaper to just concoct one’s own trail mix and eat dried fruits and nuts on their own.

-Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live year-in-review presentations Uprooting the Leading Causes of Death and More Than an Apple a Day.

Image credit: miriamwilcox / Wikimedia Commons

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