The Placebo Effect

The placebo effect and its polar opposite, the nasty nocebo

The placebo effect is defined as the measurable, observable, or subjectively felt improvement in health or behavior (such as pain or stress reduction) not attributable to a medication or invasive treatment that has been administered. It has been the study of innumerable scientists and scientific governmental or private projects; it forms an essential part of the criteria of approval by Food and Drug Administrations of the vast majority of countries and has been known and acknowledged for thousands of years. Basically, it means that if people believe that they are being treated their bodies react physiologically and psychologically to the belief bringing both measurable and perceived improvements, even a permanent cure. The contemporary western medical establishment started noticing after an anesthetist called Henry Beecher, during the Second World War, discovered after running out of painkillers that administering salt water injections to wounded troops by nurses actually reduced their pain significantly. He returned to his post in Harvard and initiated a scientific revolution. An excerpt from a med tech article in Wired, a scientific online magazine, titled “Placebos Are Getting More Effective. Drugmakers Are Desperate to Know Why” tells the story:

In a 1955 paper titled “The Powerful Placebo,” published in The Journal of the American Medical Association, Beecher described how the placebo effect had undermined the results of more than a dozen trials by causing improvement that was mistakenly attributed to the drugs being tested. He demonstrated that trial volunteers who got real medication were also subject to placebo effects; the act of taking a pill was itself somehow therapeutic, boosting the curative power of the medicine. Only by subtracting the improvement in a placebo control group could the actual value of the drug be calculated.

The article caused a sensation. By 1962, reeling from news of birth defects caused by a drug called thalidomide, Congress amended the Food, Drug, and Cosmetic Act, requiring trials to include enhanced safety testing and placebo control groups. Volunteers would be assigned randomly to receive either medicine or a sugar pill, and neither doctor nor patient would know the difference until the trial was over. Beecher’s double-blind, placebo-controlled, randomized clinical trial—or RCT—was enshrined as the gold standard of the emerging pharmaceutical industry. Today, to win FDA approval, a new medication must beat placebo in at least two authenticated trials.

Beecher’s prescription helped cure the medical establishment of outright quackery, but it had an insidious side effect. By casting placebo as the villain in RCTs, he ended up stigmatizing one of his most important discoveries. The fact that even dummy capsules can kick-start the body’s recovery engine became a problem for drug developers to overcome, rather than a phenomenon that could guide doctors toward a better understanding of the healing process and how to drive it most effectively.

In his eagerness to promote his template for clinical trials, Beecher also overreached by seeing the placebo effect at work in curing ailments like the common cold, which wane with no intervention at all. But the triumph of Beecher’s gold standard was a generation of safer medications that worked for nearly everyone. Anthracyclines don’t require an oncologist with a genial bedside manner to slow the growth of tumors.

source: www.wired.com

The article is all about drugs and their approval process and presents amazing information and statistics, all easily cross-referenced and verifiable:

From 2001 to 2006, the percentage of new products cut from development after Phase II clinical trials, when drugs are first tested against placebo, rose by 20 percent. The failure rate in more extensive Phase III trials increased by 11 percent, mainly due to surprisingly poor showings against placebo. Despite historic levels of industry investment in R&D, the US Food and Drug Administration approved only 19 first-of-their-kind remedies in 2007—the fewest since 1983—and just 24 in 2008. Half of all drugs that fail in late-stage trials drop out of the pipeline due to their inability to beat sugar pills.

The upshot is fewer new medicines available to ailing patients and more financial woes for the beleaguered pharmaceutical industry. Last November, a new type of gene therapy for Parkinson’s disease, championed by the Michael J. Fox Foundation, was abruptly withdrawn from Phase II trials after unexpectedly tanking against placebo. A stem-cell startup called Osiris Therapeutics got a drubbing on Wall Street in March, when it suspended trials of its pill for Crohn’s disease, an intestinal ailment, citing an “unusually high” response to placebo. Two days later, Eli Lilly broke off testing of a much-touted new drug for schizophrenia when volunteers showed double the expected level of placebo response.

It’s not only trials of new drugs that are crossing the futility boundary. Some products that have been on the market for decades, like Prozac, are faltering in more recent follow-up tests. In many cases, these are the compounds that, in the late ’90s, made Big Pharma more profitable than Big Oil. But if these same drugs were vetted now, the FDA might not approve some of them. Two comprehensive analyses of antidepressant trials have uncovered a dramatic increase in placebo response since the 1980s. One estimated that the so-called effect size (a measure of statistical significance) in placebo groups had nearly doubled over that time.

It’s not that the old meds are getting weaker, drug developers say. It’s as if the placebo effect is somehow getting stronger

Why is it getting stronger? According to well documented research presented in the publication, it is because of increasing awareness of the advances in modern medicine and the advertising and publication of effects by Big Pharma, other medical businesses and the media. The more people believe in the cure, the more it happens.

Let us examine some interesting, once more fully verifiable facts, about the placebo effect. First of all, it is not restricted to humans. Placebo has been experimentally proven to also occur to dogs, cats and other animals. Pharmaceutical companies employ the same double blind procedures on Dogs when testing K9 medication as they do for human medications, using two groups, giving one group the medication and the other group a placebo. It turns out the Placebo phenomenon transcends the human/dog continuum because the placebo group reacts extremely positively to the drugs. New studies observing Siberian hamsters reveal that most animals have something similar to the placebo effect that kicks into gear depending on surroundings and available body energy. When the hamsters are made to believe it is winter time, their immune system goes into a more dormant state to preserve energy. In addition, the where we live, our cultural environment affects placebo. Pharmaceutical companies get wildly different results depending on whether they stage their trials in Germany, India, Africa or the US. Strangely, the placebo still works in many cases (but in most of them less effectively) even if you know it is a placebo, mainly because the method of administration and especially because the belief not only of the patient but also the therapist is crucial, as in the case of homeopathy, shamanic and other alternative practices. Nobody doubts that the effect is not only commonplace but also sizable, but everybody doubts everybody else´s methods. With so many variables and subjectivity in the tests, everything can be disputed. The average statistical placebo effect susceptibility is considered to be over 32%, depending on ailment, location and innumerable other subjective or objective factors. But also opinions on such a general measurement are conflicted. For example, it has been proven statistically that pill colors are crucial, depending on the illness they are supposed to treat. As for anti-depressants, every study agrees that their effect is more influenced by their perceived benefits (from 50%-80%) than its pharmacological effects.

“Placebo” actually literally means “I shall please,” from Latin, so it refers to the body acting to please the mind. Why is it so hard for us to investigate such serious phenomena and actually take advantage of them rather than disregard, ignore or even denounce? Read on my friend, all shall be revealed.

The way the placebo appears to work, is by emitting various hormones, and neurotransmitters such as dopamine, noradrenaline, serotonin, oxytocin, Gaba amino acids, cortisol and other chemicals from the brain which cause reactions by the body, and also by activating the immune system and other bodily resources. We could describe the placebo effect better as a reaction, automatically and subconsciously activating the body’s “endogenous health care system.” Its benefits are more easily measurable in analgesics and antidepressant usage, where their results are spectacular and in many cases better than active ingredients, but also in a huge list of ailments, ranging from Parkinson´s, multiple sclerosis and osteoarthritis to ulcers, psoriasis and allergies. Again, why wouldn´t such an effective treatment be widely exploited and used by everyone in the healing and treatment professions? Why would many (not all) scientists acknowledge it and look down on it at the same time?

Because placebo also raises a number of moral, legal, social and other concerns. The Sceptics Dictionary, skepdic.com, after acknowledging clear evidence that placebo exists and functions to relieve symptoms and even cure illnesses warns:
It then proceeds to pose the question: are placebos dangerous? The sceptics report:

The power of the placebo effect has led to an ethical dilemma. One should not deceive other people, but one should relieve the pain and suffering of one’s patients. Should one use deception to benefit one’s patients? Is it unethical for a doctor to knowingly prescribe a placebo without informing the patient? If informing the patient reduces the effectiveness of the placebo, is some sort of deception warranted in order to benefit the patient? Some doctors think it is justified to use a placebo in those types of cases where a strong placebo effect has been shown and where distress is an aggravating factor.  Others think it is always wrong to deceive the patient and that informed consent requires that the patient be told that a treatment is a placebo treatment. Others, especially complementary and alternative medicine (CAM) practitioners, don’t even want to know whether a treatment is a placebo or not. Their attitude is that as long as the treatment is effective, who cares if it a placebo? This attitude is changing, however, and it is now common to find defenders of CAM admit that CAM is placebo medicine and go on to claim that that’s why CAM is good medicine!

While it may be unethical to knowingly package, prescribe, or sell placebos as magical cures, the CAM folks seem to think they are ethical because they really believe in their chi, meridians, yin, yang, prana, vata, pitta, kapha, auras, chakras, energies, spirits, succussion, natural herbs, water with precise and selective memory, subluxations, cranial and vertebral manipulations, douches and irrigations, body maps, divinities, and various unobservable processes that allegedly carry out all sorts of magical analgesic and curative functions.

Source: www.skepdic.com

It then proceeds to pose the question: are placebos dangerous? The sceptics report:

While skeptics may reject faith, prayer and “alternative” medical practices such as bioharmonics, chiropractic, and homeopathy, such practices may not be without their salutary effects. Clearly, they can’t cure cancer or repair a punctured lung, and they might not even prolong life by giving hope and relieving distress as is sometimes thought. But administering placebo therapies does involve interacting with the patient in a caring, attentive way, and this can provide some measure of comfort. However, to those who say “what difference does it make why something works, as long as it seems to work” I reply that it is likely that there is something that works even better and might even be cheaper. Worse, some people might seek out an alternative healer for a serious disorder that isn’t affected by the CAM treatment but could be relieved or cured by scientific medicine. Furthermore, placebos may not always be beneficial or harmless. John Dodes notes: 

Patients can become dependent on nonscientific practitioners who employ placebo therapies. Such patients may be led to believe they’re suffering from imagined “reactive” hypoglycemia, nonexistent allergies and yeast infections, dental filling amalgam “toxicity,” or that they’re under the power of qi or extraterrestrials. And patients can be led to believe that diseases are only amenable to a specific type of treatment from a specific practitioner (The Mysterious Placebo by John E. Dodes, Skeptical Inquirer, Jan/Feb 1997).

In other words, the placebo can be an open door to malfeasance.  R. Barker Bausell speculates that since complementary and alternative medicine (CAM) practitioners’ greatest asset is their nourishment of hope (2007: 294), “such therapies may be engendering nothing more than the expectation that they will reduce pain by elaborate explanations, promises, and ceremonies” (p. 149). Packaging placebos is big business and is likely to get even bigger. The only thing that could slow down CAM atavism would be the sudden appearance of horrible side effects issuing from treatments like aura cleansings or homeopathic douches.

Astoundingly, evident results, sometimes more effective than when using powerful active ingredients, even raise discussions regarding making the use of placebo enhancement illegal in sports BECAUSE it works so well! The plot thickens! There are even worst consequences, namely the evil twin of the placebo, the nocebo. Just as our expectations of a drug’s effectiveness can enhance our reaction to a placebo, an expectation of side effects or dangers can cause us to experience them as well. One notable study documenting the effects of nocebo took place in Italy where both people with and without lactose intolerance took what they thought was lactose (it wasn’t). Sure enough forty-four percent of those with intolerance and a staggering twenty-six percent without it developed symptoms of gastrointestinal discomfort. As if tricking yourself into diarrhea and stomach cramps weren’t bad enough, imagine losing faith in your penis working because of what your doctor told you. The nocebo effect regrettably works on those taking real pharmaceuticals as well, as revealed by a study conducted on men taking Finasteride for their enlarged prostates. Half were told by the doctor that erectile dysfunction was a possible side effect and the other half were not. Of the group told about the side effect, forty-four percent reported erectile dysfunction compared to only fifteen percent of the group that had not been told. Furthermore, the nocebo effect is also deemed responsible for the effects of voodoo, brujeria and other practices where people can be made to suffer or even die.

Although the placebo effect has become more powerful over the years, as many studies indicate, and Big Business is taking note and advantage of the phenomenon while governments are trying to figure out how to regulate it and many scientists like Ted Kaptchuck of Harvard Medical School and others are investigating it, amazed at its power, complexity and significance, a big part of the medical establishment regards any use of it as quackery.

And there lies the crux of the arguments, caused by huge dollops of cognitive dissonance, paradoxical beliefs, that allow the separation and the looking dismissively down on a huge body of established, for half the population of the earth, knowledge and practices: “It is all the placebo effect, there is no real therapeutic value to any of it; It depends on the superstition and gullibility of the exploited subjects who need to leave this useless nonsense and go to a real doctor.” In most cases all of herbal medicine is discounted and attributed to the placebo effect and quackery, regardless of the existence of active ingredients in many traditional Chinese potions, widely recognized for their benefits and also used in western pharmaceuticals.

Accepting this argument, because it does not matter an iota to where we going with this, let us consider it. If the energetic does not have an importance, and all these important, consistently measurable reactions are all a thing of the mind, the beliefs of a person and a therapist in a cure creating the positive or negative reaction, if it is all the result of a placebo, SO WHAT? We look down on it because it works so well?

It is evident in everything we experience and observe around us; in the coaches who try to psyche up their athletes, in everything that you, my reader, and I, all of us feel inside us and see around us. It works and proves the level of interconnection and interdependence of our different layers and the importance of the next layer of functionality that we will examine, the philosophical, and the enormous significance of harmonious cooperation between all our levels, as we will explore below. Isn´t this the stated goal of all energy and “alternative” treatments and practices? Harmony between our parts, alignment, cooperation, wholeness? Why would oncologists disregard endocrinologists, urologists or cardiologists if we are all working towards the same ultimate goal, the only goal that is an end by itself: Our happiness, our health, our wellbeing?

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