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Tag: placebo effect

  • From Gastric Balloons to Fake Knee Surgeries: When the Fix Is an Illusion | NutritionFacts.org

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    Sham surgery trials have shown that some of our most popular surgeries are themselves shams.

    Intragastric balloons “arrived with much fanfare in the 1980s,” since they could be implanted into the stomach and inflated with air or water to fill much of the space. Unfortunately, surgical devices are often brought to the market before there is adequate evidence of effectiveness and safety, and the balloons were no exception.

    The “gastric bubble” had its bubble burst when a study at the Mayo Clinic found that 8 out of 10 balloons “spontaneously deflated,” which is potentially dangerous because they could pass into the intestines and cause an obstruction, as you can see below and at 0:40 in my video Is Gastric Balloon Surgery Safe and Effective for Weight Loss?.

    Before balloons deflated, however, they apparently caused gastric erosions in half the patients, damaging their stomach lining. The kicker is that, in terms of inducing weight loss, they didn’t even work when compared to diet and other behavior modification strategies. Eventually, intragastric balloons were pulled from the market. But now, balloons are back.

    After a 33-year hiatus, the U.S. Food and Drug Administration started approving a new slew of intragastric balloons in 2015, which immediately resulted in the placement of more than 5,000 devices. By then, the Sunshine Act had passed. It forced drug companies and the surgical and medical device industry to disclose any payments made to physicians, shining a disinfecting light on industry enticements. By now, most people know about the overly cozy financial relationships doctors can have with Big Pharma, but fewer may realize that surgeons can also get payments from the companies for the devices they use. The 100 top physician recipients of industry payments received an unbelievable $12 million from device companies in a single year. Yet outrageously, when they published papers, only a minority disclosed the blatant conflict of interest.

    The benefit of balloons over most types of bariatric surgery is that they’re reversible, but that doesn’t mean they’re benign. The FDA has released a series of advisories about the risks, which include death. But how could someone suffer a stomach perforation with a smooth, rounded object? By that smooth, rounded object causing the patient to vomit so much that they rupture their stomach and die. Nausea and vomiting are unsurprisingly “very common side effects,” affecting the majority of those who have balloons placed inside of them. Persistent vomiting likely also explains cases of life-threatening nutrient deficiencies after balloon implantation.

    Some complications, such as bowel obstruction, are due to the balloons deflating, but others, oddly enough, are due to the balloons suddenly overinflating, causing pain, vomiting, and abdominal distention, as you can see below and at 2:45 in my video.

    This issue was first noticed in breast implants, as documented in reports such as “The Phenomenon of the Spontaneously Autoinflating Breast Implant.” Out of nowhere, the implants can just start growing, increasing breast volume by an average of more than 50%. “It remains an underreported and poorly understood phenomenon,” one review noted. (Interestingly, breast implants were actually used as some of the first failed experimental intragastric balloons.)

    As with any medical decision, though, it’s all about risks versus benefits. Industry-funded trials display “notable weight loss,” but it’s hard to tease out the effect of the balloon on its own from the accompanying “supervised diet and lifestyle changes” prescribed in the studies. In drug trials, you can randomize study participants to sugar pills, but how do you eliminate the placebo effect of undergoing a procedure? Perform sham surgery.

    In 2002, a courageous study was published in The New England Journal of Medicine. The most common orthopedic surgery—arthroscopic surgery of the knee—was put to the test. Billions of dollars are spent on sticking scopes into knee joints and cutting away damaged tissue in osteoarthritis and knee injuries, but does that actually work? People suffering from knee pain were randomized to get the actual surgery versus a sham surgery, in which surgeons sliced into people’s knees and pretended to perform the procedure—even splashing saline—without actually treating the joint.

    The trial caused an uproar. How could anyone randomize people to get cut open for fake surgery? Professional medical associations questioned the ethics of the surgeons as well as “the sanity” of the patients who agreed to be part of the trial. Guess what happened? The surgical patients got better, but so did the placebo patients, as you can see below and at 4:42 in my video.

    The surgeries had no actual effect. Currently, rotator cuff shoulder surgery is facing the same crisis of confidence.

    When intragastric balloons were put to the test, sham-controlled trials showed that both older and newer devices sometimes fail to offer any weight-loss benefit. Even when they do work, the weight loss may be temporary because balloons are only allowed to stay in for six months (at which point the deflation risk gets too great). Why can’t you keep putting new ones in? That’s been tried; it failed to improve long-term weight outcomes. A sham-controlled trial showed that any effects of the balloon on appetite and satiety may vanish with time, perhaps as your body gets used to the new normal.

    What sham surgery trials have shown us is that some of our most popular surgeries are themselves shams. Doctors like to pride themselves on being men and women of science. For example, we rightly rail against the anti-vaccination movement. Many of us in medicine have been troubled by the political trend in which people “choose their own facts.” But when I read that some of these still-popular surgeries are not only useless but may actually make matters worse (for example, increasing the risk of progression to a total knee replacement), I can’t help but think we are hardly immune to our own versions of fake news and alternative facts.

    Doctor’s Note

    Next in this two-part series is Extreme Weight-Loss Devices.

    For more on bariatric surgery, check out related posts below.

    My book How Not to Diet is focused exclusively on sustainable weight loss. Borrow it from your local library or pick up a copy from your favorite bookseller. (All proceeds from my books are donated to charity.)

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    Michael Greger M.D. FACLM

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  • IBD and Cannabis  | NutritionFacts.org

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    Smoking cannabis may help with symptoms of inflammatory bowel disease (IBD) in the short term, but it may make the long-term prognosis worse.

    As this study asks, “Medical Marijuana: A Panacea or Scourge?” For 5,000 years, cannabis “has been used throughout the world medically, recreationally, and spiritually.” It was even prescribed by American physicians “for a plethora of indications” from the mid-19th century to the 1930s, a fact that’s often used by medical marijuana proponents as evidence justifying the modern medical applications.” But the field of old-timey medicine is “fraught with potions and herbal remedies,” not to mention bloodletting and other questionable and harmful remedies.

    Skeptics criticize the medical marijuana movement as the “‘medical excuse marijuana’ movement,” insinuating that children with epilepsy and the terminally ill are being “used as a ‘Trojan horse’ for the legalization of recreational cannabis use” or to peddle “outlandish claims” about “miracle cancer cures,” frustrating researchers in the field who just want to get at the science.

    For example, what about the therapeutic use of cannabis for inflammatory bowel diseases like Crohn’s disease and ulcerative colitis? Conventional therapies work mainly by suppressing the immune system to try to tamp down inflammation. “Given the limited therapy options and known adverse side effects with chronic use” from these drugs, people suffering from these diseases often need to have inflamed sections of their bowels removed surgically, so it’s clear why there’s so much interest in alternative approaches.

    About one in six IBD patients who use marijuana say it helps with their symptoms, so researchers decided to put it to the test. Thirteen patients with IBD were given a third of a pound of marijuana to smoke at their leisure over a period of three months, and they reported feeling significantly better with “reported improvement in general health perception, social functioning, ability to work, physical pain, and depression.” There wasn’t a control group, so it’s unknown if they would have improved anyway or what role the placebo effect may have played. It’s like some of the studies of cannabis used for pediatric epilepsy that had response rates exceeding 30 percent and a frequency cut in half in a third of the kids. Amazing results until you realize you can sometimes get similarly amazing responses from giving kids nothing but a sugar pill placebo, as seen below and at 2:21 in my video Friday Favorites: Cannabis for Inflammatory Bowel Disease (IBD). That’s why it’s critical to do randomized, double-blind, placebo-controlled trials, but there weren’t any on cannabis and IBD until 2013. 

    For 21 patients with Crohn’s disease, nothing seemed to help. So researchers randomized them to either smoke two joints a day of marijuana or a look-alike placebo. The results? Ninety percent of those in the cannabis group got better, compared to only 40 percent in the placebo group. Shown below and at 3:11 in my video is a graph of their symptom scores. As you can see, there was no big change in the placebo group over the two-month study, but the cannabis group cut their symptoms by about half. 

    The researchers acknowledge that long-term cannabis use is not without risks, but it may be a cakewalk compared to the potential adverse—and even life-threatening—side effects of some of the more powerful conventional therapies, so the study was heralded in a paper entitled “High Hope for Medical Marijuana in Digestive Disorders.”

    The study was funded by a medical marijuana advocacy organization, the main supplier in the country, in fact. So, expectations may have been placed on the participants about how much better they would feel—in other words, they may have been primed for the placebo effect. But the researchers controlled for that, right? Those getting the real cannabis did significantly better than those randomized to get the placebo. But the point of a placebo is that it is indistinguishable from the real thing, so the participants don’t know which group they’re in—the control group or the treatment group. How can that be accomplished with a psychoactive drug? It can’t, which is the problem. The researchers tried to hide which group participants were in by only recruiting patients who had never tried cannabis before in the hopes that they wouldn’t notice placebo pot, but, unsurprisingly, most of them did. So, we’re basically left with another unblinded study. The researchers asked a bunch of subjective questions, like “How are you feeling?” and those who pretty much knew they were taking the drug said they were feeling better.

    There were no significant changes in objective lab values, like CRP, a sign of inflammation, so perhaps the “cannabis may simply be masking symptoms without affecting intestinal inflammation.” Another indicator that it may not be affecting the course of the disease itself is how quickly the symptoms rebound. Two weeks after the study ended, those in the cannabis group were right back to where they started, as shown here (see week 10) and at 5:05 in my video. 

    So, “there was no difference in objective inflammatory markers to indicate disease modification. Given the rapid rebound…to pretreatment levels after the 2-week washout period, it seems more plausible that cannabis ameliorated the symptoms of Crohn’s disease, rather than actually modulating the disease.” That may be, but the symptoms are terrible. A reduction in pain is a reduction in pain. Indeed, “from the point of view of the patients, a marked symptomatic improvement and ability to resume normal life is not trivial, even if inflammation persists.” Of course, what if cannabis somehow makes the disease worse in the long run?

    A survey study published the following year found that cannabis provided the same immediate symptomatic relief but was associated with a worse disease prognosis over time. Patients with IBD reported that cannabis improved their pain, cramping, and diarrhea, but use for more than six months by Crohn’s patients appeared to be a strong predictor of them ending up in surgery; they had five times the odds of going under the knife. There are two possible explanations for this: It’s quite possible that the increased disease severity led to the cannabis use and not the other way around. The alternative explanation: “Cannabis use may worsen the prognosis of IBD, leading to greater surgeries and hospitalizations.”

    This is why we need prospective clinical trials where people are followed over time to see which came first. Until then, perhaps we should consider cannabis use for IBD as “potentially harmful.” Not just to err on the side of caution, but because there was a study on hepatitis C patients that found that daily cannabis use was associated with nearly seven times the odds of worse liver fibrosis, which is like scar tissue. If cannabis really does make fibrosis worse, that may explain why cannabis users with IBD may be more likely to require surgery. 

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    Michael Greger M.D. FACLM

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  • Statins and Muscle Pain Side Effects  | NutritionFacts.org

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    Why is the incidence of side effects from statins so low in clinical trials while appearing to be so high in the real world?

    “There is now overwhelming evidence to support reducing LDL-C (low-density lipoprotein cholesterol)”—so-called bad cholesterol—to reduce atherosclerotic cardiovascular disease (CVD),” the number one killer of men and women. So, why is adherence to cholesterol-lowering statin drug therapy such “a major challenge worldwide”? Researchers found “that the majority of studies reported that at least 40%, and as much as 80%, of patients did not comply fully with statin treatment recommendations.” Three-quarters of patients may flat out stop taking them, and almost 90 percent may discontinue treatment altogether.

    When asked why they stopped taking the pills, most “former statin users or discontinuers…cited muscle pain, a side effect, as the primary reason…” “SAMSs”—statin-associated muscle symptoms—“are by far the most prevalent and important adverse event, with up to 72% of all statin adverse events being muscle-related.” Taking coenzyme Q10 supplements as a treatment for statin-associated muscle symptoms was a good idea in theory, but they don’t appear to help. Normally, side-effect symptoms go away when you stop the drug but can sometimes linger for a year or more. There is “growing evidence that statin intolerance is predominantly psychosocial, not pharmacological.” Really? It may be mostly just in people’s heads?

    “Statins have developed a bad reputation with the public, a phenomenon driven largely by proliferation on the Internet of bizarre and unscientific but seemingly persuasive criticism of these drugs.” “Does Googling lead to statin intolerance?” But people have stopped taking statins for decades before there even was an Internet. What kinds of data have doctors suggested that patients are falsely “misattribut[ing] normal aches and pains to be statin side effects”?

    Well, if you take people who claim to have statin-related muscle pain and randomize them back and forth between statins and an identical-looking placebo in three-week blocks, they can’t tell whether they’re getting the real drug or the sugar pill. The problem with that study, though, is that it may take months not only to develop statin-induced muscle pain, but months before it goes away, so no wonder three weeks on and three weeks off may not be long enough for the participants to discern which is which.

    However, these data are more convincing: Ten thousand people were randomized to a statin or a sugar pill for a few years, but so many more people were dying in the sugar pill group that the study had to be stopped prematurely. So then everyone was offered the statin, and the researchers noted that there was “no excess of reports of muscle-related AEs” (adverse effects) among patients assigned to the statin over those assigned to the placebo. But when the placebo phase was over and the people knew they were on a statin, they went on to report more muscle side effects than those who knew they weren’t taking the statin. “These analyses illustrate the so-called nocebo effect,” which is akin to the opposite of the placebo effect.

    Placebo effects are positive consequences falsely attributed to a treatment, whereas nocebo effects are negative consequences falsely attributed to a treatment, as was evidently seen here. There was an excess rate of muscle-related adverse effects reported only when patients and their doctors were aware that statin therapy was being used, and not when its use was concealed. The researchers hope “these results will help assure both physicians and patients that most AEs associated with statins are not causally related to use of the drug and should help counter…exaggerated claims about statin-related side effects.”

    These are the kinds of results from “placebo-controlled randomised trials [that] have shown definitively that almost all of the symptomatic adverse events that are attributed to statin therapy in routine practice are not actually caused by it (ie, they represent misattribution.)” Now, “only a few patients will believe that their SAMS are of psychogenic origin” and just in their head, but their denial may have “deadly consequences.” Indeed, “discontinuing statin treatment may be a life-threatening mistake.”

    Below and at 4:46 in my video How Common Are Muscle Side Effects from Statins?, you can see the mortality of those who stopped their statins after having a possible adverse reaction compared to those who stuck with them. This translates into about “1 excess death for every 83 patients who discontinued treatment” within a four-year period. So, when there are media reports about statin side effects and people stop taking them, this could “result in thousands of fatal and disabling heart attacks and strokes, which would otherwise have been avoided. Seldom in the history of modern therapeutics have the substantial proven benefits of a treatment been compromised to such an extent by serious misrepresentations of the evidence for its safety.” But is it a misrepresentation to suggest “that statin therapy causes side-effects in up to one fifth of patients”? That is what is seen in clinical practice; between 10 to 25 percent of patients placed on statins complain of muscle problems. However, because we don’t see anywhere near those kinds of numbers in controlled trials, patients are accused of being confused. Why is the incidence of side effects from statins so low in clinical trials while appearing to be so high in the real world? 

    Take this meta-analysis of clinical trials, for example: It found muscle problems not in 1 in 5 patients, but only 1 in 2,000. Should everyone over a certain age be on statins? Not surprisingly, every one of those trials was funded by statin manufacturers themselves. So, for example, “how could the statin RCTs [randomized controlled trials] miss detecting mild statin-related muscle adverse side effects such as myalgia [muscle pain]? By not asking. A review of 44 statin RCTs reveals that only 1 directly asked about muscle-related adverse effects.” So, are the vast majority of side effects just being missed in all these trials, or are the vast majority of side effects seen in clinical practice just a figment of patients’ imagination? The bottom line is we don’t know, but there is certainly an urgent need to figure it out.

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    Michael Greger M.D. FACLM

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