Monday, December 3, 2012

Essay 1



The Placebo Effect

The human brain is a phenomenal muscle. It is the root of every individual and how each person reacts to not only the people around them but also how humans react to themselves both mentally and physically. The brain has the ability to protect people when they are scared, forget memories that are hurtful and even cure them when they are sick. So if the human brain is so powerful why do placebos work for some people and not others? Are placebos an effective treatment and is there any evidence that they actually work? When is it appropriate to use a placebo in lieu of a medication that works?  Doctors have been trying to come to an agreement for years now on whether or not placebos are useful. One of the biggest concerns is there is no way to control a placebo in a clinical trial.
There are many factors involved when it comes to studying the effects of a placebo. First is the patient a good candidate and open to the idea of a placebo? How can the FDA control placebos when there are no guidelines. For example the ingredients in a placebo are rarely disclosed so each type of placebo is very different. Is there a way to create a control?
The biggest obstacle for doctors and scientists is finding a good candidate for placebos. Because so much of what humans can do and overcome is compelled by the human brain it is nearly impossible to test placebos. Author Bagley from Newsweek wrote an article called Placebo Nation: Just Believe. In it he compares placebos to the magic feather of Dumbo the flying elephant (Owens 817). Dumbo didn’t need the feather to fly it simply gave him the confidence to do it. Medication can be very similar. There are many times when the public doesn’t need medicine to fight off an illness just something to trick the body into feeling better. Instead of being happy that our bodies can fight off illness completely on its own the majority of people are outraged when they discover that the medicine prescribed to them was nothing short of expensive magic feathers.
New studies have shown that placebos are physiologically measurable with condition specific pathways. With these new studies also comes new testing. In the past doctors conducting a clinical trial that involves placebos would have the daunting task of finding the right candidate for placebo testing. This effort was largely abandoned because of inconsistent results. “The widespread conclusion was there was no reliable individual difference factor at work in placebo responding that has been a major stumbling black for placebo theorist for decades,” (Owens 818). One of the things that doctors have discovered throughout their research is the wrong person for placebos. Any patient with negative expectations for treatment effectiveness, be it a placebo or actual medication, has a much less likely success rate than those with a drive to be well again. These groups of people are known as “nocebos.” An individual with a placebo-prone personality will only create a placebo effect in the presence of positive beliefs and companionship. These naturally vary from one situation to the next. Even a person that is prone to the placebo effect can become a nocebo based on the individuals around them.
In the article The Quantification of Placebo Effects Within a General Model of Health Care Outcomes explains a study completed at three research sites (The University of Washington Medical Center, the Neurology Center of Fairfax, VA and the Multiple Sclerosis Association of America, Cherry Hill, NJ). These three facilities recruited candidates with MS through flyers, mailing and word of mouth. The three sites were able to take on 117 test subjects. Subjects were randomly assigned to either the “treatment first” or “placebo first” upon arrival to the study. At the end of the study the placebo responders “were more confident that the sham treatment was the active device compared to those who didn’t respond,” (819 Owens). This study did not only have the expected outcome but gave placebo theorist exactly what they were looking for. “Positive expectancy is an essential factor in understanding placebo effects,” (Owens 819).          Since placebos are such a questionable form of treatment it is difficult to know when there is a definite need for them and when doctors are simply testing their effects. It is general knowledge that there is no cure for the common cold. Research has shown that placebos make up 85% of the efficiency of cough medications. The advertising and packaging alone for these medications begin to get patients brains working toward feeling better without even taking the medicine. The physiological effects of cough medicine are initiated by the physical properties of the medicine such as color, taste, smell and texture. The placebo effect consists of several components; natural recovery, regression of cough response, effects of sweetness, voluntary control and effects of the expectancy of the treatment (Eccles 55).
There have been many positive things that have come from placebos being used in clinical trial for the common cold. It used to be that the active ingredient codeine was the standard prescription for colds. Placebo controlled clinical trial have shown that there is a lack of efficiency in codeine and placebos have better effects and no addictive side effects. Many over the counter brands add the bitter taste that the public is used to tasting to cough syrup to make them feel like they are taking a more effective treatment. In fact the active codeine in cough syrup had little, if any specific pharmaceutical effect on the cough.
            In order to understand why placebos work there must be an explanation as to how they work. The placebo effect for a cold has three major working properties. Ron Eccles explains why placebos have such a high success rate in cough medicines in his article Importance of Placebo Effect in Cough Clinical Trials The taste of the cough medicine triggers the mouth to salivate more therefore opening airway secretion and allowing to irritation in the throat to begin to heal itself. The bitter sweetness in the medication also numbs the throat to a degree and the patient is then not thinking about the cold as much. Many ancient cultures used honey when they were suffering from a cold. The honey would coat their throat and has medicinal qualities as well. One of the biggest hurdles these people had to overcome was the quality of medical attention they were able to provide for their people. Not only did homey help alleviate the coughing symptom, but it never goes bad. And the biggest argument for a placebo working is the sensory effect such as taste and smell. Some of the main ingredients in cough syrups are sugar, honey and spicy substances such as capisum, or bitter substances such as lemon. These ingredients cause reflex salvation and promote secretion in the airway (55).
            There are very few people in this world that would complain about placebos in cough medication. When it comes to the common cold most people are happy to feel better and move on without a runny nose or sore throat. But what about patients that suffers from more severe illnesses such as cancer or mental illnesses such as depression?
Many cancer patients are plagued with rough side effects from chemotherapy such as nausea, vomiting and a major decline in energy. There is no proven medication on the market to completely relieve patients of these symptoms but it is not an uncommon practice for doctors to prescribe a sugar pill to counteract these side effects. Many of these doctors have to pick and chose who they are going to prescribe these placebos to because the patient has to be open to feeling better. They must have a positive outlook for their recovery or the sugar pill will never work.
A doctor by the name of William Potter was intrigued by placebos and took on the task of testing placebos with mental illnesses such as depression. The idea behind his research was to better understand how a placebo could work if the patient was starting their treatment as more of a nocebo candidate. Potter discovered that the majority of patients suffering from depression seamed to get healthier simply with doctors empathy than the pill itself. Since the 1980’s, “two comprehensive analyses of anti-depressant trials have uncovered a dramatic increase in placebo response” (33). In a study conducted in Chicago in 2007 almost half the doctors polled admitted that they knowing prescribed medications that were either completely ineffective or a very low dose of an effective medication to evoke a placebo effect (Silberman 41).

Geography also played a major role in placebos and depression. It is not surprising that Americans had the highest percentage of taking to antidepressants. The idea that a pill would make one feel better was not very farfetched for a culture that is surrounded with the notion of instant gratification. It was found that color also effects the way people react to a placebo, for example a light blue pill (blue is considered a stress relieving color) were far more effective that an angry red pill (Silberman 37).
            It is safe to say that placebos defiantly have a place in the medical field. Placebos work, maybe not for the population as a whole but there is enough proof that there is no reason they should not be used as a form of healing. Now for the big question, can the FDA regulate what placebos are made of and if so how?
            As placebos became more commonly tested in clinical trials the more doctors discovered that the human brain had the ability to control so much of a person’s healing. From 2001 to 2006 20% of new drugs being tested were cut after they were put against placebos. Over half of new medications are dropped because they can’t beat the sugar pills. Steve Silberman writes, “It’s not that old drugs are getting weaker, it’s as if the placebo effect is getting stronger” (33).
            In the past there have been control treatments for nondrug interventions such as sham surgery, sham acupuncture or even sham procedures. So if there is a control for these wouldn’t a placebo fall under the same category, sham medicine? In the article What’s in Placebos: Who Knows? six colleagues come together and try to determine an answer. “No substances are known to be physiologically inert, and no regulations guide placebo composition” (532).
These colleagues collaborated using four major medical journals, The New England Journal of Medicine, JAMA, The Lancet and Annals of Internal Medicine. Within these journals they discovered 176 eligible studies. In eight of these studies both pills and injections were used and in one study both injection and intranasal spray were utilized to administer the placebo. There were a total of 86 studies using pills, 65 studies of injection and 26 studies using other treatment methods. In all 176 studies the placebo ingredients were seldom disclosed and were particularly rare of pill based studies. What these colleagues were able to conclude was that “disclosure of the actual (chemical) differences between the placebo and test drug is not required,” (Howick et al 534).
As a result of placebos not being regulated by the FDA there are those of the mindset that the use of placebos should be few and far between. Vanessa Clifford writes, “The use of placebos in clinical trials can only be justified ethically when no proven active treatment is available as a comparison, and conversely when a proven active treatment exists, the use of placebos is unethical” (361). For Clifford the issue is not whether or not placebos work but when it is ethical to use them or not. Her argument is that so many medical patients spend a lot of money for health care and it is not right for them to be given “medicine.” Even in clinical trials there is a flaw for testing placebos. Clifford not only believes placebos should only be used when there are no options for medication but the same goes for clinical trials as well. She believes placebos should only be introduced in a clinical trial when there is no proven effect treatment for the condition (363).
When placebos were first introduced into the medical field they were used for managing or pleasing a patient when the diagnosis was uncertain or there was no specific treatment available. Other doctors and scientist have recently debunked this thesis. In 2001 a Cochrane review showed that placebos worked their magic best when the patient was in pain or was heavily open to suggestion.
As one generation of medical professionals retire and a new younger generation begins to take their places the way placebos are tested is changing. When placebos were first being studied the majority of their use was to make patients believe they were being treated properly. This however was before the days of informed consent and medical professionals didn’t have to give their patients full disclosure (Clifford 363). Many drug makers are embracing the power of the placebo effect and have the drive to understand it better. They are learning the mechanics behind it so they can design trials that help doctors understand the difference between the medicine itself and the body’s innate ability to heal itself.
It has been proven time and again that placebos can work. The difficultly that comes with a placebos is how much they actually work. There are some people who psychiatrically are better suited for a placebo while others have either made peace with their illness or have no drive to get better. There is also proof that cough medicine is nothing more than a placebo. There is no cure for the common cold yet most people have some sort of cold remedy in their medicine cabinet. It is clear that placebos work, they make a huge part of western medicine and while the use of them is in need of some perfecting they do help people for the better not for the worst.


Works Cited

Clifford V. The Placebo Mystique: Implications for Clinical Trial Methodology. Journal Of Pediatrics & Child Health [serial online]. June 2011; 47(6): 361-366. Print.

Eccles R. Importance of Placebo Effect in Cough Clinical Trials. Lung [serial online]. February 2, 2010; 188:53-61. Print.

Jeremy Howick, et al. “What’s in Placebos: Who Knows? Analysis of Randomized Controlled Trials.” Annals of Internal Medicine 153.8 (2010): 532-W. 189 Health Source: Nursing/Academic Edition. Print.

Owens, Justine E., and Martha Menard. “The Quantification of Placebo Effects Within a General Model of Health Care Outcomes.”  Journal of Alternative & Complementary Medicine 17.9 (2011):817-821. Health Source: Nursing/Academic Edition. Print.

Silberman Steve, “The Placebo Problem.” 20 Best American Science Writings 2010 31-44. Print.

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