Today, I discuss the safety and efficacy of some unconventional weight loss methods – everything from Botox and corsets to siphons and tapeworms.
A moderately obese person doing moderately intense physical activity, like biking or brisk walking, would burn off approximately 350 calories an hour, but most drinks, snacks, and other processed junk are consumed at a rate of about 70 calories per minute. Therefore, it only takes five minutes for someone to wipe out a whole hour of exercise.
Enter: the “AspireAssist siphon assembly.”
It’s a percutaneous gastrostomy device, meaning surgeons cut a hole in your stomach and tunnel a fistula out through your abdominal wall. So, after each meal you can attach a suctioning gadget to the hole and directly drain out your stomach contents. You could gorge on doughnuts, spew them out through the hole in your stomach, and then gorge again on more doughnuts. Have your cake, and eat it too…and three, and four times. It’s like bulimia—without the aftertaste!
Seems to me the quintessential American invention, straight from the land that brought you Jell-O salads, spray cheese, and deep-fried Snickers bars. Patients do lose weight, perhaps in part, perhaps, because the fistula may interfere with the relaxation of the stomach wall during a meal. The process also requires drinking lots of water and for food to be chewed thoroughly, both of which may help with weight loss in other ways by increasing hydration and slowing eating rate. Patients also started to make healthier choices to “avoid unpleasant-appearing gastric aspirate of unhealthy food choices.” The tubing is clear and evidently fried foods look particularly gross as they are pumped out.
All patients need to take supplemental potassium, since it’s sucked out in the stomach juices; otherwise, they risk becoming potassium deficient (a common complication in true bulimia), but most side effects are just minor wound complications. Serious adverse effects, like abdominal abscesses, are rare. The big selling point is that the siphon device “does not alter the anatomy of the gastrointestinal tract.” Seems like a low bar, but in today’s Wild West world of weight loss procedures, you can’t take anything for granted. Case in point: the “duodenal-jejunal bypass liner.”
Gastric bypass surgery works in part by cutting out part of the small intestine from the flow of food to prevent help the absorption of calories. Instead of major surgery, how about just dropping down a couple feet of plastic tubing to line the intestinal walls? The problem with the “EndoBarrier” is that it has to be anchored in the digestive tract. This is accomplished with ten barbed hooks that cause lacerations, accounting for the majority of the 891 adverse effects reported in 1,056 patients. That’s nearly 9 out of 10. Severe penetrating trauma, resulting in esophageal perforation or liver abscesses, is thankfully more rare (occurring in only about 1 in 27 patients).
Concern has been raised about the “palatability” of the AspireAssist stomach pump, but the most cringeworthy endoscopic procedure I ran across in my research was intestinal “resurfacing.” Why cover the inside of your intestines with plastic to prevent absorption when you can just “thermally ablate the superficial duodenal mucosa.” In other words, have your intestinal lining burned off. Or rather, “resurfaced.”
Surgeons have tried injecting botox into the stomach walls of obese individuals hoping it would partially paralyze their gastric muscles, slow stomach emptying, make people feel fuller longer, and lose weight. It didn’t work.
Researchers in Sweden tried randomizing people to wear corsets for 12 to 16 hours a day, seven days a week, for nine months. And it didn’t work. You can guess why—the study subjects just didn’t wear them. The corset was “perceived as uncomfortable.” Duh.
“Sanitized tapeworms” have evidently been widely advertised as a weight loss remedy since back in the early 1900s. The fact that living tapeworms have been discovered during bariatric surgery operations suggests infesting yourself with parasites may not be particularly effective either.
Speaking of disgusting strategies, how about disgust itself? A study entitled “Harnessing the power of disgust: a randomized trial to reduce high-calorie food appeal through implicit priming” tried using subliminal messages to ruin people’s appetite. Immediately before images of healthy foods, researchers showed people happy images like a group of kittens in a 20-millisecond flash. That’s too quick to consciously register, but the hope was to plant a positive imprint on the brain. Before images of high-calorie foods like ice cream though, they instead flashed scenes of a “cockroach on a slice of pizza, vomit in an unclean lavatory, a burn wound…” Apparently, it worked! Subjects subsequently reported a reduced desire to eat high-calorie foods, though this wasn’t tested directly. The researchers conclude subliminal revulsion might be a “successful tactic to combat the onslaught of food cues that promote unhealthy eating.”
The rest of the world looks on bemused by American machinations, penning commentaries like “A view from across the pond…Don’t let them eat cake!” A paper in the journal Obesity Surgery entitled “What are the Yanks doing?” reviewed the U.S. experience with “implantable gastric stimulation,” inserting electrodes into the muscular layer of the stomach wall. When that didn’t work, we tried “colon electrical stimulation.”
Even more shocking were studies like “Repetitive electric brain stimulation reduces food intake in humans.” Though placing deep brain electrodes is considered a “complication-prone operation,” scientists have long pondered whether “placing an electrode somewhere in the brain could make people eat less.” Holes were drilled through the skulls of five obese individuals, and wires were pushed into their brains for “electro-stimulatory exploration.” Once they poked around and found spots where they were able to elicit “convincing hunger responses,” they sent enough juice in to fry out “electro-coagulatory lesions.” It seemed to work in cats and monkeys, but the researchers found that burning holes in people’s brains “did not produce weight loss in obese humans.” Thankfully, as I aim to explain in my book How Not to Diet, healthy sustainable weight loss isn’t brain surgery.
In our next story, we look at how sham surgery trials have shown us that some of our most popular surgeries are themselves shams.
“Intragastric balloons” arrived with much fanfare in the 1980s––balloons that could be implanted into the stomach and inflated with air or water to fill up much of the space. Sadly, surgical devices are often brought to the market before there is adequate evidence of safety and effectiveness, 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, as they could pass into the intestines and cause an obstruction), but not before causing gastric erosions in half the patients, damaging the stomach lining. The kicker is that in terms of inducing weight loss, it didn’t even work. Eventually, it was pulled from the market, but now, balloons are back.
After a 33-year hiatus, the FDA started approving a new slew of intragastric balloons in 2015, immediately resulting in more than 5,000 placements. By then, the Sunshine Act had passed, which forced drug companies and the surgical and medical device industry to disclose any payments they were making to physicians to shine 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 recipients of industry payments received an unbelievable 12 million dollars 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 that include patient deaths. Wait. How could someone suffer a stomach perforation with a smooth rounded object? By causing the patient to puke so much they rupture their stomach and die. That’s how. 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 balloon deflating, but others, oddly enough, are due to the balloons suddenly overinflating, causing pain, vomiting, and abdominal distention. This was first noticed in breast implants, as documented in reports such as “The phenomenon of the spontaneously auto-inflating breast implant.” Out of nowhere, the implants just start growing, increasing breast volume by an average of more than 50 percent. “[I]t remains,” one review noted, “an underreported and poorly understood phenomenon.” (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 alone from the accompanying supervised diet and lifestyle changes prescribed along with them in the studies. In drug trials, you can randomize subjects 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 sticking scopes into knee joints and cutting away damaged tissue in osteoarthritis and knee injuries. But does it actually work? Knee pain sufferers were randomized to get the actual surgery versus a sham surgery in which they actually sliced into people’s knees and pretended to perform the procedure, complete with splashing saline, but never actually did anything within the joint.
The trial caused an uproar. How could you 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. But guess…what…happened? Sure, the surgical patients got better, but so did the placebo patients. 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 show 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 just keep putting new ones in? That’s been tried, and 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. We rightly rail, for example, against the anti-vaccination movement. Many of us in medicine have been troubled by the political trend of people “choosing their own facts.” But when I read that some of these still-popular surgeries are not only useless but may actually make things 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.