“I am doing very well, and I am very healthy. The vulvodynia symptoms have never come back. Also,my stomach (gastrointestinal discomfort) has gotten much, much better. I don’t really have random pain anymore, now I just have to be watchful and careful of my diet and my exercise, which are all great things!” —A five-year follow-up report from a 28-year-old woman who had previously suffered from severe vulvodynia (pelvic floor pain).
Numerous clients and students have reported that implementing self-healing strategies–common sense suggestions often known as “grandmother’s therapy”—significantly improves their health and find that their symptoms decreased or disappeared (Peper et al, 2014). These educational self-healing approaches are based upon a holistic perspective aimed to reduce physical, emotional and lifestyle patterns that interfere with healing and to increase those life patterns that support healing. This may mean learning diaphragmatic breathing, doing work that give you meaning and energy, alternating between excitation and regeneration, and living a life congruent with our evolutionary past.
If you experience discomfort/symptoms and worry about your health/well-being, do the following:
- See your health professional for diagnosis and treatment suggestions.
- Ask what are the benefits and risks of treatment.
- Ask what would happen if you if you first implemented self-healing strategies before beginning the recommended and sometimes invasive treatment?
- Investigate how you could be affecting your self-healing potential such as:
- Lack of sleep
- Too much sugar, processed foods, coffee, alcohol, etc.
- Lack of exercise
- Limited social support
- Ongoing anger, resentment, frustration, and worry
- Lack of hope and purpose
- Implement self-healing strategies and lifestyle changes to support your healing response. In many cases, you may experience positive changes within three weeks. Obviously, if you feel worse, stop and reassess. Keep a log and monitor what you do so that you can record changes.
This self-healing process has often been labeled or dismissed as the “placebo effect;” however, the placebo effect is the body’s natural self-healing response (Peper & Harvey, 2017). It is impressive that many people report feeling better when they take charge and become active participants in their own healing process. A process that empowers and supports hope and healing. When participants change their life patterns, they often feel better. Their health worries and concerns become reminders/cues to initiate positive action such as:
- Practicing self-healing techniques throughout the day (e.g., diaphragmatic breathing, self-healing imagery, meditation, and relaxation)
- Eating organic foods and eliminating processed foods
- Incorporating daily exercise and movement activities
- Accepting what is and resolving resentment, anger and fear
- Taking time to regenerate
- Resolving stress
- Focusing on what you like to do
- Be loving to yourself and others
For suggestions of what to do, explore some of the following blogs that describe self-healing practices that participants implemented to improve or eliminate their symptoms.
Hot flashes and premenstrual symptoms https://peperperspective.com/2015/02/18/reduce-hot-flashes-and-premenstrual-symptoms-with-breathing/
Internet addiction https://peperperspective.com/2018/02/10/digital-addiction/
Irritable bowel syndrome (IBS) https://peperperspective.com/2017/06/23/healing-irritable-bowel-syndrome-with-diaphragmatic-breathing/
Math and test anxiety https://peperperspective.com/2018/07/03/do-better-in-math-dont-slouch-be-tall/
Trichotillomania (hair pulling) https://peperperspective.com/2015/03/07/interrupt-chained-behaviors-overcome-smoking-eczema-and-hair-pulling/
Peper, E., Lin, I-M, Harvey, R., Gilbert, M., Gubbala, P., Ratkovich, A., & Fletcher, F. (2014). Transforming chained behaviors: Case studies of overcoming smoking, eczema and hair pulling (trichotillomania). Biofeedback, 42(4), 154-160.
When randomized controlled studies of pharmaceuticals or surgery find that the treatment is no more effective than the placebo, the authors conclude that surgery or drugs have no therapeutic value (Moseley et al, 2002; Jonas et al, 2015). Even though the patients may have gotten better, the researchers often do not explore questions such as, why did some of the patients improve just with the placebo treatment; what are the components of the placebo process; and, how can clinicians integrate placebo components into their practice to enhance the body’s own natural healing response.
To explore these topics further, listen to Shankar Vedantam’s outstanding podcast, A Dramatic Cure, from the NPR program, Hidden Brain-A conversation about life’s unseen patterns. Also, read the background materials on the website https://www.npr.org/2019/04/29/718227789/all-the-worlds-a-stage-including-the-doctor-s-office
Placebo effects can be a powerful healing strategy as demonstrated by numerous research studies that have persuasively explored the central features of the placebo effect. The research has found that the more dramatic and impressive the procedure, the more powerful the placebo effect. For example, branded medicine with brightly colored packaging is more effective than generic medicine in plain boxes, an injection of a saline or sugar solution is more effective than taking a sugar pill, and placebo surgery is more effective than simply receiving an injection (Branthwaite & Cooper, 1981; Colloca & Benedetti, 2005). For a detailed exploration of placebo, nocebo and the important role of active placebo, see the blog, How effective is treatment? The importance of active placebos.
To see the effect of the placebo in action, watch the well-known British stage hypnotist and illusionist, Derren Brown’s video, Fear and Faith (https://www.youtube.com/watch?v=hfDlfhHVvTY). He magically weaves together a narrative that addresses the powerful influences of the natural, physical, and clinical environment and language used during a ‘therapeutic’ interaction. He shows how the influences of role modeling, the words that increase hope, trust and social compliance, and other covert factors promote healing. It uses the cover of a drug trial to convince various members of the public to overcome their fears using a placebo medicine called “Rumyodin” (which is a made-up name of a fake pharmaceutical) and demonstrates that the limits of experience are the limits of your belief.
This blog post serves as a reminder to ask ourselves as educators and therapists, ‘what can I do to include placebo enhancing components into my practice so that my clinical and educational outcomes are more effective?’ Explore ways to optimize your clinical environment, language use during ‘therapeutic’ interactions, and role modeling to increase hope, trust and social compliance and thereby optimize your clients’ own natural healing response.
Jonas, W. B., Crawford, C., Colloca, L. , et al.(2015). To what extent are surgery and invasive procedures effective beyond a placebo response? A systematic review with meta-analysis of randomised, sham controlled trials. BMJ Open, 5: e009655. doi:10.1136/ bmjopen-2015-009655
*I thank Richard Harvey, PhD., for his constructive feedback and James Fadiman, PhD., for reminding me to reframe the term placebo into “the body’s natural healing response.”
This blog describes a structured imagery that evokes past memories of joy and health and integrates them into a relaxation practice to support healing. First, a look at the logic for the practice and then the process of creating your own personal imagery script. A sample audio file is included as a model for creating your MP3 file. The blog is adapted from Peper, E., Gibney, K.H. & Holt. C. (2002). Make Health Happen: Training Yourself to Create Wellness. Dubuque, IA: Kendall-Hunt.
“I enjoyed regressing back into my childhood, remembered playing in the rain, making paper sailboats with my brother…. Placing my fingers in a bowl of water and stroking a paper sailboat enabled me to participate in the total experience… I felt tingling sensations all over my body, like tiny bundles of energy exploding inside of me. By the end of the week the simple word “rain” could induce these sensations inside my whole being.”–Student
Daydreaming! We all know how to do it. When we daydream, we feel, sense, hear, and taste our daydream—the image becomes tangible, as if we are living it. A well-developed relaxation image can also include colors, scents, sounds, flavors, temperature, and so forth. Evoking a past memory image of wholeness may contribute significant to healing, as illustrated in Pavlov’s experience with controlled conditioning and with self-healing.
THE POWER OF CONDITIONING
Most of us are probably familiar with the classical conditioning experiment of the famous Russian physiologist, Ivan Pavlov, who taught dogs to salivate on cue when they heard a bell ring—even when no food was provided. Pavlov accomplished this by giving the dogs food immediately after ringing a bell. Eventually, the dogs became conditioned to expect the food with the bell and simply hearing the bell ring would induce salivation (shown in Figure 1).
Figure 1. The process of classical conditioning. (Figure adapted from: https://opentextbc.ca/introductiontopsychology/chapter/7-1-learning-by-association-classical-conditioning/)
The conditioning effects of imagery can have an effect on health as well as physiology as reflected in an anecdote told by Theodore Melnechuk about Ivan Pavlov. As an old man, he became quite ill with heart disease and his doctors had no hope of curing him. They took his family aside and told them that the end was near. Pavlov himself, however, was not disheartened. He asked the nurse who was caring for him to bring him a bowl of warm water with a little dirt or mud in it. All day, as he lay in bed, he dabbled one hand in the water, with a dreamy, faraway look on his face. His family was quite sure that he had taken leave of his wits and would die soon. However, the next morning he announced that he felt fine, ate a large breakfast, and sat out in the sun awhile. By the end of the day, when the doctor came to check on him, there was no trace of the heart condition. When asked to explain what he had done, he said that he had reasoned that if he could recall a time when he was completely carefree and happy, it might have some healing benefit for him. As a young boy, he used to spend his summers playing with his friends in a shallow swimming hole in a nearby river. The memory of the warm, slightly muddy water was delightful to him. With his knowledge of the power of conditioned stimuli, he reasoned that having a physical reminder of that water might help him evoke that experience and those blissful feelings, and bring some of those memories into the present time. Using this strategy, he harnessed positive memory and the associated emotions that evoked the associated body changes to bring about his healing.
We all performs many conditioned behaviors every day. Some of these behaviors can have implications for our health and wellness. There may be aspects of allergic reactions that are conditioned. For example, the literature reports that a woman who was allergic to roses developed a severe allergic reaction to a very realistic-looking paper rose, even though she was not allergic to paper. Her body reacted as if the paper rose was real. (Mackenzie, 1886; Vits et al, 2011).
Conditioning can also affect our immune system. When rats were injected with a powerful immune-suppressing drug, while being fed saccharin-flavored water, their immune function showed an immediate drop. After the drug and saccharine water were paired a number of times, the rats were then given just the saccharin water and a harmless injection of salt water. Their immune cells responded exactly as if they had received the drug! The reverse ability, increasing immune cell function, has been shown to be influenced through conditioning (Ader, Cohen & Felten, 1995; Ader and Cohen, 1993).
Belief can also play a role in these scenarios. Bernie Siegel, MD,(2011) has recounted the story of a woman scheduled for chemotherapy who was first given a saline solution, and cautioned that it could cause hair loss. Although this is an unlikely result of a saline injection, given her belief, her hair fell out.
Actions, thoughts, and images affect our physiology.
We often anticipate, react, and form conclusions with incomplete information. Thoughts and images affect our physiology and even our immune system. Re-evoking a positive memory and living in that memory could potentially improve your health. In a remarkable study by a Harvard psychologist, Ellen Langer, eight men in their 70s lived together for one week, recreating aspects of the world that they had experienced more than 20 years earlier. They were instructed to act as they had in 1959, while the control group was instructed to focus entirely on the present time.
In the experimental group, all the physical cues were reminiscent of the culture twenty years earlier. Black and white television and magazines were from 1959. There were no mirrors to remind them of their current age—only photos on the wall of their younger selves. After a week in which the participants acted as if they were younger and the cues around them evoked their younger selves, 63% of the experimental group had improved their cognitive performance as compared with 44% of the control group. Among participants in the experimental group, even their physical health had improved. Independent raters who looked at the before and after pictures of these participants rated their appearance a little younger than the photos taken before the experiment (Langer, 2009; Grierson, 2014; Friedman, 2015). It is possible that by acting and thinking younger, we actually stay younger!
The limits of our belief are the limits of our experience. This concept underlies the remarkable power of placebo. If one believes a drug or a procedure is helpful, that can have a powerful healing effect (Peper & Harvey, 2017; also see the blog, How effective is treatment? The importance of active placebos).
CREATE YOUR OWN VISUALIZATION
Begin by remembering a time when you felt happy, healthy, and whole. Draw inspiration from Pavlov, who evoked happy memories from his childhood, apparently dramatically changing his health. To develop your personal visualization, set aside the time to recreate a healing memory. Remember a time in your life when you felt healthy and joyous (possibly from your childhood). For some, this might be time in nature or with your family or with friends.
Once you remember the event, re-experience it as if you were there right now. Evoke as many senses as possible. Think of the memory and any associations such as an old teddy bear, a shell from the beach, a favorite song, a certain perfume or some other tangible aspect of the experience. The goal is to recreate the experience as if it was current reality. Olfactory and gustatory cues can be especially powerful. If possible include the actual objects and cues associated with that memory—articles, pictures, music, songs, fragrances, or even food.
Sounds, scents, or touching and objects from that era of your life can deepen your ability to recreate and experience the quality of that memory—to actually be in the memory. These sensory reminders will help to evoke the memory and increase the felt experience. You might find it helpful to review Ellen Langer’s experiment, recreating an environment from twenty years earlier. The actual cues will deepen the experience, just as aromas often evoke specific memories and emotions.
The underlying principle is that memories are associated with conditioned stimuli that evoke the physiological state(s) in the body present when the memory was created.
Once you have created a vivid memory that engenders a sense of wholeness, develop a detailed description of your memory to help you evoke that experience. (For some, the memory calls up a timeless setting—relaxing on a warm beach, sitting in front of the fire on a winter evening, or sailing on a calm day. For others, the sense of trust may be associated with a specific person—someone you love—being with your grandmother, helping your mother bake a cake, or going fishing with your dad.). As you recreate the experience, engage all your senses (images, fragrance, tastes, textures, sounds, kinetics). Stay in your image: see it, smell it, taste it, touch it, hear it, be it and allow the experience to deepen.
Begin by writing up your imagery. Then record the introduction the structured relaxation and follow it with a description that evokes the memory as an MP3 audiofile. Use the following three-step process to create the script for your personal relaxation.
- Describe a time in your past when you felt joy, peace, love, or a sense of integration and wholeness.
- Identify the specific cues or stimuli associated with that memory.
- Write out a detailed description that will evoke your personal memory.
CREATING YOUR AUDIO FILE
In this approach, there are three components to your script: first, a relaxation practice to ease you into your visualization, then the visualization of your memory, closing with a brief script that brings you back into the present moment.
Begin the recording with progressive relaxation—use your favorite process for relaxing, or apply the script included here.
Generally tense the muscles for about 5 to 8 seconds and let go for 15 to 20 seconds as indicated by the …. While tightening and relaxing the muscles, sense the muscle sensations with passive attention. Tense only the muscles that you are instructed to tighten and continue to breathe while tensing and relaxing the muscles. If your attention wanders, gently bring it back to feeling the sensations in the specific muscles that you are instructed to tighten or relax.
First, find a comfortable position for relaxation… To fully relax your face, squeeze your eyes shut tight, press your lips and teeth together, and wrinkle up your nose… feel the tightness in your whole face… Now let it go completely and relax… Allow your face to soften, feel the eyes sinking in their sockets, and your breath to flow effortlessly in and out…
Tense both arms by making fists, and extend them straight ahead, while continuing to breathe deeply… study the tension… Now relax and let your arms drop as if you were a rag doll… To relax your shoulders, hunch them toward your ears and tighten your neck, while keeping the rest of your body loose and relaxed… Continue to breathe easily… Allow your shoulders to drop… Feel the weight of your arms… Feel the relaxation flowing from your shoulders, down your arms into your hands and out your fingers…
Now your stomach. Then let go and relax… Arch your back and feel the tightness in the back. Let go and relax….Allow your body to sink comfortably into the surface on which you are resting… Finally, tighten your butt, thighs, calves, and feet by pressing your heels down into the surface where you are lying, curling your toes and squeezing your knees together… Feel the tension as you continue to breathe, keeping your upper body relaxed… Now let go and relax… Allow relaxation to flow through your legs… Be aware of the sensations of letting go…
Feel the deepening relaxation, the calmness and the serenity… Feel each exhalation flowing down and through your arms, chest, and legs… Let the feelings of relaxation and heaviness deepen as you relax more… Notice the developing sense of inner peace… a calm indifference to external events… Let the feelings of relaxation, calmness, and serenity deepen for a few minutes. After a few minutes, evoke your memory of wholeness.
Insert your imagery script here.
Finish with the brief closing script
Allow yourself to just stay in this special place all your own… and know that you can return to this peaceful sanctuary any time you choose to do so. When you are ready to release the imagery, take a deep breath, gently stretch your body, and open your eyes.
Record these this whole script on your cell phone as an MP3 file.
When you record, it often takes a few tries before the pacing is correct. You may find it helpful to listen to the following audio file as a model for to create your own.
LISTENING TO YOUR VISUALIZATION
Create a sanctuary for yourself by turning off your cellphone, adjusting the heat to a comfortable temperature, and ensuring that you will have uninterrupted quiet time for 20 to 30 minutes. Loosen any constricting clothing or jewelry, your glasses, and so on. Settle into a comfortable chair, bed, or setting where you can easily relax. Enjoy letting yourself drift into and relive the memory experience.
Many participants report that this practice is an exceptionally relaxing and nurturing experience, one that supports regeneration. You’ll probably find that the more you practice, the more the relaxation deepens. You may find it helpful to keep notes and observe how you feel after each practice. Although it may feel strange to listen to your own voice, most people find that after a while it becomes more comfortable. After listening to it for a few times, you may want to rerecord the script. Finally, generalize this practice by smiling and evoking the memory scene as much as you desire during the day.
Additional strategies to enhance the relaxation
- Have a massage or take a warm shower or soak and then do the practice. Compare your level of relaxation afterwards to the result of using the audio alone.
- Practice gentle stretches to loosen tight muscles or “shake out” your arms and legs just before doing your relaxation practice.
- Draw or paint the relaxing image or actually go to the location where your memory occurred (if possible) and do your practice. Or practice outdoors in the most relaxing place you can find. Nature can be a great healer.
- Create an atmosphere that helps to evoke and augment your relaxation image (e.g., play background music or use fragrances that you associated with the image).
- Inability to evoke a memory of wholeness. When this occurs, it is as if one draws a blank. This is common, especially if one has experienced abuse or feels depressed. In that case, use the image presented in the script or make one up and create a totally imaginary peaceful image.
- Positive memories of wholeness evoke a bitter/sweet feeling. This occurs when images of wholeness include a loved one who has passed on or who is no longer in your life. On the one hand, this may call up strongly positive feelings, but it may evoke a sense of loss and sadness. If this occurs, simply chose a different memory or create a different script. Let the memory of loss go. Accept your experience and your feelings as much as possible, and know that at least you have been loved. For your image, it may be easier to focus on a natural setting you love—one you associate with peace and tranquility.
- Lack of experience with places in nature. Some people have only urban experiences and find nature alien. See what comes up for you. Does your favorite memory as a city kid recall a day of freedom on your bike or skateboarding, or an afternoon with your playmates? Perhaps you have treasured memories as a teen or an adult of long walks in the city or time spent with close friends. You also have the option of creating new images such as sitting by a fireplace, in a walled garden, or some other scene of peace and safety.
- Difficulty using progressive relaxation. If you’re having trouble isolating a muscle: touch it, stroke it with your hands, and then tense it fully (without strain) and feel the tension in your hands; feel the difference with your hands as you let go of the tension. Or, you may tighten only as much as is needed to feel the tension.
- The desire to stay in the imagery and not wanting to return to reality. If the imagery is much more pleasant than the present, use this process as a stimulus to reorganize your life and set new goals and priorities.
Ader, R. & Cohen, N. (1993). Psychoneuroimmunology, Conditioning,_and_Stress. Annual Review of Psychology, 44(1), 53-85.
Ader, R., Cohen, N. and Felten, D. (1995) Psychoneuroimmunology: Interactions between the Nervous System and the Immune System. The Lancet, 345, 99-103.
Grierson, B. (2014). What if age is nothing more than a mind-set? New York Times Magazine. October 22.
Langer, E. (2009). Counterclockwise: Mindful Health and the Power of Possibility . New York: Ballantine Books.
McKenzie, J. (1886). The production of the so-called rose effect by means of an artificial rose, with remarks and historical notes. Am. J. Med. Sci. 91, 45–57
Peper, E., Gibney, K.H. & Holt. C. (2002). Make Health Happen: Training Yourself to Create Wellness . Dubuque, IA: Kendall-Hunt. ISBN-13: 978-0787293314
Peper, E. & Harvey, R. (2017). The fallacy of placebo controlled clinical trials: Are positive outcomes the result of indirect treatment side effects? NeuroRegulation. 4(3–4), 102–113. doi:10.15540/nr.4.3-4.102
Siegel, B. (2011, May). Remarkable recoveries. Retrieved from: http://berniesiegelmd.com/resources/articles/remarkable-recoveries/
The purpose of this blog is to share what I have learned from a cascade of medical errors that happen much more commonly than surgeons, hospitals, or health care providers acknowledge and is the third leading cause of death in the US (Makary, M.A. & Daniel, M., 2016). My goal here is to provide a few simple recommendations to reduce these errors.
It is now two years since my own surgery—double hernia repair by laparoscopy. The recovery predicted by my surgeon, “In a week you can go swimming again,” turned out to be totally incorrect.
Six weeks after the surgery, I was still lugging a Foley catheter with a leg collection bag that drained my bladder. I had swelling due to blood clots in the abdominal area around my belly button, severe abdominal cramping, and at times, overwhelming spasms. For six weeks my throat was hoarse following the intubation. Instead of swimming, hiking, walking, working, and making love with my wife, I was totally incapacitated, unable to work, travel, or exercise. I had to lie down every few hours to reduce the pain and the spasms.
Instead of going to Japan for a research project, I had to cancel my trip. Rather than teaching my class at the University, I had another faculty member teach for me. I am a fairly athletic guy—I swim several times a week, bike the Berkeley hills, and hiked. Yet after the surgery, I avoided even walking in order to minimize the pain. I moved about as if I were crippled. Now two years later, I finally feel healthy again.
How come my experiences were not what the surgeon promised?
All those who cared for me during this journey were compassionate individuals, committed to doing their best, including the emergency staff, the nurses, my two primary physicians, my surgeon, and my urologist. However, given the personal, professional, and economic cost to me and my family, I feel it is important to assess where things went wrong. The research literature makes it clear that my experience was by no means unique, so I have summarized some of the most important factors that contributed to these unexpected complications, following “simple arthroscopic surgery.”
- Underestimating the risk. Although the surgeon suggested that the operation would be very low risk with no complications, the published research data does not support his optimistic statement and misrepresented the actual risk. Complications for laparoscopic surgery range from 15% to as high as 38% or higher, depending on the age of the patient and how well they do with general anesthesia (Vigneswaran et al, 2015; Neumayer et al, 2004; Perugini & Callery, 2001). Experienced surgeons who have done more than 250 laparoscopic surgeries have a lower complication rate. However, a 2011 Cochran review points out that there is theoretically a higher risk that intra-abdominal organs will be injured during a laparoscopic procedure (Sauerland, 2011). In addition, bilateral laparoscopic hernia repair has significantly higher risk than single sided laparoscopic hernia repair for post-operative urinary retention (Blair et al, 2016). My experience is not an outlier–it is more common.
- Inappropriate post-operative procedures. In my case I was released directly after waking up from general anesthesia without checking to determine whether I could urinate or not. The medical staff and facility should never have released me, since older males have a 30% or higher probability that urinary retention will occur after general anesthesia. However, it was a Friday afternoon and the staff probably wanted to go home since the facility closes at 5:30 pm. This landed me in the Emergency Room.
- Medical negligence. In my case the surgeon recommended that I have my bladder in the emergency room emptied and then go home. That was not sufficient, and my body still was not working properly, requiring a second visit to the ER and the insertion of a Foley catheter. Following the second ER visit, the surgeon removed the catheter in his office in the late afternoon and did not check to determine whether I could urinate or not. This resulted in a third ER visit.
- Medical error. On my third visit to the emergency room, the nurse made the error of inflating the Foley catheter balloon when it was in the urethra (rather than the bladder) which caused tearing and bleeding of the urethra and possible irritation to the prostate.
- Drawbacks of the ER as the primary resource for post-surgical care. Care is not scheduled for the patient’s needs, but rather based on a triage system. In my case I had to wait sometimes two hours or more until a catheter could be inserted. The wait kept increasing the urine volume which expanded and irritated the bladder further.
- A medical system that does not track treatment outcomes. Without good follow-up and long-term data, no one is accountable or responsible.
- A reimbursement system that rewards lower up-front costs. The system favors quick outpatient surgeries without factoring in the long-term costs and harm of the type I experienced.
Assuming the best and not planning for the worst.
Can I trust the health care provider’s statement that the procedure is low risk and that the recovery will go smoothly?
The typical outcome of a medical procedure or surgery may be significantly worse than generally reported by hospitals or medical staff. In many cases there is no systematic follow-up nor data on outcomes and complications, thus no one knows the actual risks.
In the United States medical error results in at least 98,000 unnecessary deaths each year and 1,000,000 excess injuries (Weingart et al, 2000; Khon et al, 2000). The Institute of Medicine reported in 2012 that one-third of hospitalized patients are harmed during their stay (Ferguson, 2012; Institute of Medicine, 2012).
One should also be intelligently skeptical about positive claims for any specific study—it is important to know whether the study has been replicated with other populations and not just a particular group of patients.
To quote Dr. Marcia Angell (2009), the first woman editor of the highly respected New England Journal of Medicine, “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”
The evidence for many procedures and medications is surprisingly limited
- Research studies frequently select specific subsets of patients. They may exclude many patients who have other co-morbidities.
- Clinical trials may demonstrate statistical significance without providing clinically meaningful results. For example, between 2009 and 2013 all most all cancer drugs that were approved for treatment in Europe showed upon follow-up no clear evidence that they improved survival or quality of life for patients (Davis et al, 2017; Kim & Prasad, 2015).
- Pharmaceuticals are tested only against a passive placebo. In some cases, the patient’s positive response may actually be the placebo effect, due to physical sensations induced by the medication or its side effects, thus inspiring hope that the drug is working (Peper and Harvey, 2017).
- Negative side effects are significantly underreported. The data depend on self-report by both the patient and the health care provider.
Many published studies on the positive clinical outcome of pharmaceuticals are suspect. As Dr. Richard Horton (2015), Editor-in-Chief of The Lancet, wrote in 2015, “A lot of what is published is incorrect … much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness.”
Most studies, including those on surgery, lack long-term follow-up.
The apparent short-term benefits may be not beneficial in the long term or may even be harmful. For example, doctors and patients are convinced that SSRIs (serotonin re-uptake inhibitors—antidepressants such as Paxil and Prozac) are beneficial, with resulting global sales in 2011 of $11.9 billion. However, when all the research data were pooled, metanalysis showed that these drugs are no more effective than placebo for the treatment of mild to moderate depression and increase suicides significantly among young adults (Fournier et all, 2010; Kirsch, 2014).
Consider long-term follow-up in my case: the surgeon will report a successful surgery, despite the fact that it took me almost two years to recover fully. (I did not die during surgery and left in seemingly good shape.). Although I called him numerous times for medical guidance during my complications, the outpatient surgical facility will report no complications since I was not transferred from that facility during the surgery to a hospital for continuing care. My insurance carrier that paid the majority of the medical bills recorded the invoices as separate unrelated events: one surgery/one bill, but three separate bills for the emergency room, an additional visit to my primary care physician to check my abdomen when my surgeon did not return my call, and the ongoing invoices from the urologist. They all reported success because the iatrogenic events were not linked to the initial procedure in the data base.
In my case, following surgery, I had to go to the emergency room on three separate occasions due to post-operative urinary retention, placing me at risk of permanent detrusor muscle damage. For more than 18 months, I was under the care of a urologist.
Over the past two years, my symptoms have included gastrointestinal inflammation, spasms, and abdominal bulging, which are only now disappearing. Even my posture has changed. I am now working to reverse the automatic flexing at the hips and leaning forward which I covertly learned to reduce the abdominal discomfort. This level of discomfort and dysfunction are new to me. Reading the research on laparoscopy, I realized that excessive internal bruising, large hematomas, and internal adhesions are fairly common with this type of surgery. However, soft tissue injuries are difficult to confirm with imaging techniques.
My complications were also a direct result of inappropriate post-surgical recommendations and treatment. The symptoms were further compounded by faulty patient discharge procedures performed by the outpatient surgical facility. Since this was my first general anesthesia, I had no idea that I would be one of the people whose outcome were not what the surgeon had predicted. Thus, hope for the best, but plan for the worst.
SCHEDULING MEDICAL PROCEDURES
The following are recommendations may help reduce post-surgical or medical procedure complications.
- Schedule elective medical procedures or surgery early the morning and in the middle of the week. Do not schedule procedures on Mondays, Fridays, or in the afternoon. Procedures performed in the afternoon have significant increase in complications and errors. Anesthesia complications, for example, are four times higher in the afternoon than in the morning (Wright et al, 2006). Our biological rhythms affect our ability to attend and focus. In the morning most people are able to concentrate better than in the afternoon (Pink, 2018).
- Avoid weekends. Procedures performed on weekends (as compared to those done in the middle of the week) increase the risk of complications or dying. For example, babies born on the weekend have a 9.2% higher infant mortality than those born during the week, while those born on Tuesdays have the lowest death rate (Palmer et al, 2015). It is possible that on Mondays medical staff are recovering from weekend binging, while on Fridays they are tired and looking forward to the weekend? If elective procedures are done on a Friday and complications arise, the emergency room is the only option, as the medical staff may not be available over the weekend. In my case the procedure was done on a Friday, and I left the surgical outpatient facility at 2 pm. When complications occurred, it was after 5:30 pm—phone support from the advice nurse and the surgeon on call were my only option until the following Monday. Thus, I had to go the emergency room late Friday evening and again the next evening because of urinary retention, with a long delay in a busy waiting room. Since, I wasn’t bleeding or having a heart attack, that meant I had to wait, wait and wait, which significantly aggravated my specific problem.
- Schedule medical procedures at least one or two weeks before any holiday. Do not schedule surgery just before or during holidays. Medical staff also take holidays and may not available. In my case, I scheduled the procedure the Friday before Thanksgiving because I thought I would have a week of recovery during my Thanksgiving break from teaching. This meant that medical staff were less available and more involved in their holiday planning.
- Schedule procedures so that you are released early in the day. This can allow you to return to the facility in case complications arise. I was released at 2 pm and the complications did not occur until early evening. The facility was closed, so the only option was the ER. When possible, schedule medical procedures or surgery in a facility that is able to provide post-operative care after 5 pm.
- Do not schedule elective procedures during the month of July in an academic teaching hospital. During this month mortality increases and efficiency of care decreases because of the end of the academic year and subsequent changeover to new personnel (Young et al, 2011). Medical school graduates with limited clinical experience begin their residencies and experienced house staff are replaced with new trainees. This is known as the July effect in the U.S. and Killing season in the United Kingdom. During the month of July in any given year, fatal medication errors, for example, increase by 10% at teaching hospitals, but not at neighboring hospitals which do not experience this turnover in medical personnel (Phillips & Barker, 2010).
- Have procedures performed at a medical facility in which the health care professional has no financial interest—take economics out of the equation. When health care practitioners have financial interest in a facility, they tend to order more tests and procedures than health care providers who have no financial interests (Bishop et al, 2010). In my case the surgeon had a financial interest in the outpatient surgical facility where I received surgery. Had I had the operation across the street in the hospital where the surgeon also operates, I probably would not have been released early, avoiding the problems in follow-up care.
STRATEGIES TO OPTIMIZE OUTCOMES AND HEALTH
Organize your support system. Assume that recovery could be more difficult then promised.
Before your procedure, ask family members, friends, and neighbors to be prepared to help. If you did not need them, thank them for their willingness to help. In my case I did not plan for complications, thus my wife was my entire support system, especially for the first three weeks when I was unable to do anything except rest and cope. I was very fortunate to have numerous family, friends, and colleagues who offered their expertise to help me understand what was going on and who assumed my responsibilities when needed.
- Bring an advocate to your appointments. Have your advocate/friend keep notes and ask questions, especially if the health care provider is a respected authority and you are suffering, exhausted, and/or anxious. Record any detailed instructions you must follow at home as a video or audio file on your cell phone or write them down (be sure to ask the health provider for permission). Under stress one may not be able to fully process instructions from the health care provider.
- Make a list of questions and concerns before seeing your health care provider. Talk to your partner and close friends and ask them if there are questions or concerns that you should raise with your provider.
- Ask for more information when tests or procedures are proposed (Robin, 1984).
- Why do you recommend this particular test/procedure/intervention for me and what are the major benefits?
- What are the risks and how often do they occur, in your experience and in the research literature?
- What will you do if the treatment is not successful?
- Ask your provider if there is anything that you should or should not do to promote healing. As much as possible, ask for advice on specific efforts you can make. General statements without instructions such as, “Relax” or “Don’t worry,” are not helpful unless the practitioner teaches you specific skills to relax or to interrupt worrisome thoughts. Many health professionals do not have the time to teach you these types of skills. In many cases the provider may not be able to recommend documented peer-reviewed self-care strategies. Often they imply—and they can be correct—that the specific medical treatment is the only thing that will make you better. In my case I did not find any alternative procedures that would reverse a hernia, although there may be habitual postural and movement patterns that could possibly prevent the occurrence of a hernia (Bowman, 2016). Being totally dependent upon the medical procedure may leave you feeling powerless, helpless, and prone to worry. In most cases there are things you can do to optimize self- healing.
- Think outside the box. Explore other forms of self-care that could enhance your healing. Initiate self-care action instead of waiting passively. By taking the initiative, you gain a sense of control, which tends to enhance your immune system and healing potential. Do anything that may be helpful, as long as it is not harmful. In my case, future medical options to resolve urinary retention could include additional medications or even surgery. Researching the medical literature, there were a number of studies showing that certain herbs in traditional Chinese medicine and Ayurveda medicine could help to reduce prostate inflammation and possibly promote healing. Thus, I began taking three different herbal substances for which there was documented scientific literature. I also was prescribed herbal tea to sooth the bladder. Additionally, I reduced my sugar and caffeine intake to lower the risk of bladder irritation and infection.
- Collaborate with your health care provider. Let your provider know the other approaches you are using. Report any interventions such as vitamins, herbs, Chinese medicine. Ask if they know of any harm that could occur. In most cases there is no harm. The health care professional may just think it is a waste of time and money. However, if you find it helpful, if it gives you control, if it makes you less anxious, and if it is not harmful, it may be beneficial. What do you have to lose?
- Assume that all the health care professionals are committed to improving your health to the best of their ability. Yet at times professionals are now so specialized that they focus only on their own discipline and not the whole person. In their quest to treat the specific problem, they may lose sight of other important aspects of care. Thus, hope for the best, but plan for the worst.
PREPARING FOR SURGERY
Assume that the clinical staff will predict a more positive outcome than that reported in the medical literature. In most cases, especially in the United States, there is no systematic follow-up data since many post-surgical complications are resolved at another location. In addition, many studies are funded by medical companies which have a vested interest and report only the positive outcomes. The companies tend not to investigate for negative side-affects, especially if the iatrogenic effects occur weeks, months, or years after the procedure. This has also been observed in the pharmaceutical companies sponsoring studies for new medications.
Generally, when independent researchers investigated medical procedures they found the complication rate three-fold higher than the medical staff reported. For example, for endoscopic procedures such colonoscopies, doctors reported only 31 complications from 6,383 outpatient upper endoscopies and 11,632 outpatient colonoscopies. The actual rate was 134 trips to the emergency room and 76 hospitalizations. This discrepancy occurred because the only incidents reported involved patients who went back to their own doctors. It did not capture those patients who sought help at other locations or hospitals (Leffler et al, 2010).
The data are even worse for patients who are hospitalized; in the U.S. 20% of patients who leave the hospital return within a month while in England, 7% of those leaving the hospital return within a month (Krumholz, 2013).
- Ask about possible complications that could arise, the symptoms, and what the physician would do if they occurred. Do not assume the health professional will have the time to explain or know all the possible complications. In my case when the surgeon removed the catheter at 4 pm during my second emergency room visit, I had to ask, “What would happen if I still cannot urinate?” Again, the emergency room was the only answer. However, I know now that he could have taught me simple self-catherization which would have eliminated the long waiting in the emergency room, the excessive stretching of the bladder and the subsequent emergency room medical error on my third visit to the ER. It would also have reduced the medical costs by a thousand-fold.
- Get a second opinion. In my case, the surgeon came highly recommended, is very experienced, and has done many hernia repairs. I trusted his judgement that I needed a bilateral hernia repair although I only felt the bulging in the right inguinal area and did not feel bulging or sensations in the left inguinal area. Despite my feeling of trust, I should have asked for a second independent opinion just to be sure. In many moments of despair when suffering the significant complications, I even started to wonder if the bilateral laparoscopic surgical repair was really necessary or just done to increase the income of the surgeon and the outpatient surgical facility in which he had a financial interest. My surgery resulted in large hematomas, irritation of internal organs, and possible damage to the GI track. This type of complication did not occur for a close friend who had a single-sided hernia repair by the same surgeon in a hospital where the surgeon had no financial interests.
- Request medical personnel who are highly experienced in the intervention. Mortality and complications rates are significantly lower for practitioners who have done the procedure at least 250 times.
- Don’t assume the worst but be prepared for the worst. Ask your health care provider about the various side effects of surgery, including the worst things that could happen, and then develop a pre-emptive plan.
The most common problems associated with surgery and general anesthesia include:
- Urinary retention. Following general anesthesia, neural enervation to the bladder and gastrointestinal tract are often affected. The general risk for postoperative urinary retention (POUR) for all types of surgeries ranges from 7% to 52% (Tammela et al, 1986; Petros et al, 1990; Petros et al, 1991; Gonullu et al, 1993; Tammela, 1995). For patients who have surgery for hernia repair 24.4% will experience postoperative urinary retention (Keita et al, 2005)—one in four. The risk for older males is even higher (Blair et al, 2017). Do not leave the medical unit until you have urinated or have a Foley catheter inserted with a leg bag and appropriate follow-up managed by a urologist. In my case, neither the surgeon nor the outpatient hospital checked to determine whether I could urinate—they just discharged me the moment I was conscious. Discharging a patient who has had general anesthesia without checking to determine whether they can urinate goes against all medical guidelines and standard hospital policies and constitutes malpractice. As this was my first surgery, I had no idea that urinary retention could occur. Thus, I did not recognize the symptoms nor did the advice nurse or the surgeon when called for advice before I checked into the emergency room.
- Expect constipation and plan to eat a high roughage diet that supports bowel movements. In case bowel function is slow in resuming, you may want to have on hand simple over-the-counter supplements such as magnesium capsules, psyllium husks, and aloe vera juice or gel, all available at any health food store. Liquid magnesium citrate (GoLytely® solution available at drug stores), can be useful, but tends to be a little stressful to take. Check these over-the-counter supplements with your provider to avoid supplement-drug interaction.
- Infection. Many patients pickup hospital-induced infections (nosocomial infections). In my case, I after four weeks with a Foley catheter, I got a mild bladder infection and had to control it with antibiotics. While in the hospital, avoid direct physical contact with other patients and staff, wash and rewash your hands. Remember medical staff tend are less attentive and wash their hands 10% less in the afternoons than in morning. Ask the medical staff to thoroughly wash their hands before they examine you. If you do get an infection, contact your medical provider immediately.
- Pace yourself. Assume that recovery could be slower than promised. Although your body may appear to be healed, in many cases your vitality could be significantly reduced for a number of months, and you will probably feel much more fatigued in the evening. The recovery from general anesthesia has been compared to recovery from a head-on car collision.
- Identify your support system in case you cannot take care of yourself initially. Organize family and friends to help you. In my case, for the first two weeks I did not have the energy to do anything for myself—the overwhelming abdominal spasms and the three episodes in the ER had drained my energy. I was very lucky that I had my family and friends to help me. For the first few weeks I was so distracted by the pain and discomfort that I did not drive or take care of myself.
- Have a plan in case you need to go to the Emergency Room in the evening. Know its location and have someone who can take you.
- Assume that you will probably have an extensive wait in the ER unless you are desperately ill. Do not try to “tough it out.” Be totally honest about your level of pain, so you can get the best possible care. In my case, I had horrible abdominal pain and spasms with urinary retention, but still acted as if I were okay. When the admitting nurse asked me how I felt, I rated my discomfort as a 5 on a scale from 0 to 10. In my mind I compared the pain with that I had experienced after a skiing accident, which was much worse. What I had forgotten was that the ER is triage system, so I had to wait and wait and wait, which was phenomenally uncomfortable.
- In the ER, ask which medical specialist can follow up with you if further issues develop. A general hospital usually has specialists on call. In my case, if I had requested care from a specialist, I would have been treated directly by a urologist. I would not have had to follow the advice of the surgeon who said, “When you go to Emergency Room, have them empty the bladder and then go home.” Almost all urologists would have recommended keeping the Foley catheter in for a few days to allow the side effects of the anesthesia and the trauma caused by the bladder expansion to ameliorate and then test whether urination was possible.
- Have a medical advocate with you at all times who can observe that the procedures are done correctly. There is a four-fold increase in errors during the evenings and nights as compared to the morning. The more medical staff is multi-tasking, the more likely they will make errors. Have the medical personnel explain any procedure before they perform it—why and how they will do the procedure and what you will experience. You also need to know if they are experienced in that particular procedure? If the answers do not make sense, stop them and ask for another staff member.
- In the ER, record the instructions on your phone. Have medical staff explain and demonstrate to you and your support person what you will need to do at home. Then repeat the instructions back to them to be certain you have it right.
- Remind yourself that errors can occur. In my case, during the third ER visit for urinary retention, the nurse delayed the anchoring of the catheter and it had slipped down into the urethra. As she began to pump, I could feel my urethra tearing and I alerted her to stop. This was immediately followed by another procedural error on her part, so I had to again alert her to stop, which she finally did. All this occurred at 1 am in the morning. As the patient, I had to take charge at a time when I was totally exhausted. As the nurse retreated, I was left sitting on the gurney waiting for someone to come and follow-up. I waited and waited and when I finally stood up, the catheter dropped out and I began bleeding.
Lesson learned: hope for the best but prepare for the worst. In my situation, after eight weeks and numerous visits to the urologist, he removed the catheter. He did this at 8:30 in the morning. This way I could go home and in case something happened, I could go back to his office for further care. Before leaving the office, I planned for the worst. I asked what would happen if I could not urinate later in the evening and requested that he give me a few catheters, so if problems developed, I could catheterize myself.
The urologist gave me the catheters and explained how to use them, although I did not actually practice on myself. Still, I felt better prepared. During the day, I become more and more optimistic because I had no problems; however, at 2 am I woke up unable to urinate. For the next hour, I felt very anxious about inserting the catheter, since I had never done it myself. Finally, my discomfort overcame my anxiety. To my surprise, it was easy. After waiting a few minutes, I removed the catheter and went to bed feeling much more comfortable. The next morning after breakfast and a cup of coffee, I found that my body was working fine without the catheter.
Had I not planned for the worst, I would have once again gone to the Emergency Room and probably waited for hours, risking a repeat of tremendous discomfort and irritation. This simple planning reduced my medical cost more than a thousand-fold from $1700 for the emergency room to $2 for some single-use catheters.
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 I think my family, friends and colleagues (Karen Peper, Norihiro Muramatsu, Richard Harvey, David Wise, Annette Booiman, Lance Nagel and many others) who generously supported me during this journey.
Adapted by Erik Peper and Richard Harvey from: Peper, E. & Harvey, R. (2017). The fallacy of the placebo-controlled clinical trials: Are positive outcomes the result of “indirect” treatment effects? NeuroRegulation, 4(3–4), 102–113. http://dx.doi.org/10.15540/nr.4.3-4.102
How come some drugs or medical procedures are initially acclaimed to be beneficial and later ineffective or harmful and withdrawn from the market?
How come some patients with a cancer diagnosis experience symptom remission after receiving a placebo medication? Take the case of Mr. Wright. Several decades ago Dr. Klopher (1957) described Mr. Wright as a patient who had a generalized and far advanced malignancy in the form of a lymphosarcoma with an estimated life expectancy of less than two weeks. Following the diagnosis Mr. Wright read a newspaper article about a promising experimental cancer medication called Krebiozen and requested that he receive the latest treatment. Soon after receiving the drug, Mr. Wright had a complete remission of cancer symptoms with no signs of the deadly tumor. For over two months after receiving the new promising drug, Krebiozen, Mr. Wright engaged in a normal life and was even able to fly his own plane at 12,000 feet. After a promising introduction to the medication, Mr. Wright subsequently read another newspaper article which proved the new medication to be a useless, inert preparation. Confused and demoralized, the results of the wonder drug did not last and his symptoms returned. When the final AMA announcement was published “Nationwide tests show Krebiozen to be a worthless drug in treatment of cancer,” his symptoms became acute and he died within two days (Klopher, 1957).
The term placebo loosely translates as ‘I shall please you’ can be contrasted with the term nocebo which loosely translates as ‘I shall harm you’ when referring to exposure to a sham medication, treatment or procedure that results a positive outcome (placebo response), or a negative outcome (nocebo response), respectively. The responses a person has reflect a complex interaction between many processes. For example, when studying a placebo or nocebo response we measure internal psychological processes, measured in terms of a person’s self-reported attitudes, beliefs, cognitions and emotions; behavioral processes, measured overtly by observations of a person’s actions; and, physiological processes, measured more or less directly with instruments such as heart rate monitors, or biochemical analyses. Most relevant is that a person’s beliefs about the placebo (or nocebo) medication, treatment or procedure leads to predictable positive (or negative) behaviors and physiological benefits or harms.
The case of Mr. Wright illustrates that we may underestimate the positive power of the placebo or, the negative power of the nocebo, where Mr. Wright’s belief about the medication’s benefits first interacted in a positive way (placebo) with his behaviors (e.g. engaging in daily activities including flying an airplane) as well as his physiology (e.g. cancer remission) and unfortunately later, in a negative way (nocebo) interacting with his physiology (e.g. cancer return) contributing to his death.
The placebo response can be very powerful and healing. For example, watch the very dramatic demonstration of how the placebo response can be optimized in Derren Brown’s BBC video Fear and Faith Placebo https://www.youtube.com/watch?v=y2XHDLuBZSw).
Placebo and nocebo effects are found in all therapeutic transactions when the communications between therapist and patient reflect embedded beliefs about the treatment. For example, patients have faith in clinician’s knowledge and belief that a prescribed medication is going to be effective at treating their symptoms, which then reinforces the patient’s belief in the medication, increasing indirect, embedded placebo effects, above and beyond any direct effects from the medication. The indirect effects of placebo responses have been most studied with medications; however, placebo effects are also studied in non-drug therapies. The research on placebo effects has demonstrated time and time again that when patients expect that the drug, surgery, or other therapeutic technique to be beneficial, then the patients tend to benefit more from the treatment.
The expectancy that the treatment will be effective at reducing symptoms is overtly, and covertly communicated by the health care professional during patient interactions, as well as by drug companies through direct to consumer advertising, and social media. The implied message is that the drug or procedure will improve symptoms, recovery or improve quality of life. On the other hand, if you do not do take the drug or do the procedure, your health will be compromised. For example, if you have high cholesterol, then take a statin drug to prevent the consequences of high cholesterol such as a heart attack or stroke. The implied message is that if you do not take it, you will die significantly sooner. Statins lower the risk for heart attacks; however, the benefits may be over stated. For people without prior heart disease, 60 people will have to take statins for 5 years to prevent 1 heart attack and 268 people to prevent 1 stroke. During the same time period 1 in 10 will experience muscle damage and 1 in 50 develop diabetes (theNNT, 2017 November).
If placebo and nocebo can have significant effects on medical outcome, how do you know if the treatment benefits are due to the direct effects of a drug or procedure or due to any indirect placebo effects or a combination of both?
The randomized controlled trial (RCT) is considered the gold standard method to determine the effectiveness of a drug or procedure. The ideal study would be a double blind, randomized, placebo controlled clinical trial in which neither the practitioner nor the patient would know who is getting what condition. For example, blinding implies the placebo group would receive a pill that appears identical to a ‘real’ pill, except the placebo has pharmacological ingredients. Similarly, a patient may receive an ‘exploratory’ surgery in which anesthesia is given and the skin is cut however the no further actual internal surgery occurs because the surgeon determined further internal surgery was unnecessary. Although, it is not possible to perform a double blind surgery study, the patient may be totally unaware whether an internal surgery had occurred.
Peper and Harvey (2017) point out that the positive findings of an ‘effective’ treatment are not always the results of the direct effects of medications and may be more attributable to indirect placebo responses. For example, patients may attribute the ‘effectiveness’ of the treatment to their experience of ‘non-directed’ treatment side effects that include: the post-surgical discomfort which signals to the patient that the procedure was successful, or a dry mouth and constipation that were caused by the antidepressant medication, which signals to the person that the trial medication or procedure-related medication is working (Bell, Rear, Cunningham, Dawnay, & Yellon, 2014; Stewart-Williams & Podd, 2004).
Just imagine the how pain can evoke totally different reactions. If you recently had a heart attack and then later experienced pain and cramping in the chest, you automatically may feel terrified as you could interpret the pain as another heart attack. The fear response to the pain may increase pathology and inhibit healing (a nocebo response). On the other hand, after bypass surgery, you may also experience severe pain when you move your chest. In this case, you interpret the pain as a sign that the bypass surgery was successful, which then reduces fear and reinforces the belief that you have survived a life threatening situation and will continue healing (placebo response).
Many research studies employ a placebo control, however what is less typical is a double-blind study using an ‘active’ placebo (Enck, Bingel, Schedlowski, & Rief, 2013). Less than 0.5% of all placebo studies include an active placebo group. (Shader, 2017; Jensen et al, 2017).
Unfortunately, a typical ‘placebo controlled’ study design is problematic for distinguishing the direct from any indirect (covert) placebo effects that occur within the study as shown in Figure 1.
Figure 1. Normal (passive) placebo control group controls and experimental group. What is not assessed are placebo benefits induced by the medication/treatment induced side effects.
With a passive placebo, there is no way to know if the observed benefits are from the medication/medical procedure, or from the placebo/self-healing response triggered by the medication/medical procedure (or both combined, or neither the placebo or medical procedure). The best way to know if the treatment is actually beneficial is to use an ‘active’ placebo instead of a passive placebo.
An active placebo builds on a patient’s attributions about a medication or medical procedure. For example, a patient may be told by a clinician that feeling any side effects such as insomnia, a racing heart or, experiencing a warm flushing feeling will let them know the medication is working, so the patient becomes conditioned to expect the medication is working when they feel or experience side effects. Whereas a passive (inert) placebo such as a sugar pill will have effects that are extremely subtly felt or experienced, an active placebo will have effects that are more overtly felt or experienced. Examples of active placebos include administering low doses of caffeine or niacin that have effects which may be felt internally however which do not have the same effects as the medication. When a patient is told they may have side effects from the medication that include felt changes in heart rate or a flushing feeling, the patient attributes the changes they feel to a medication they believe will bring about benefits, even though the changes are rightfully attributed to the caffeine or niacin in the active placebo.
An active placebo triggers observed and felt body changes which do not affect the actual illness. For surgical procedures, an ‘active’ placebo control would be a sham/mock surgery in which the patient would undergo the same medical procedure (e.g. external surgery incision) without continuing some internal surgical procedure (Jonas et al, 2015). In numerous cases of accepted surgery, such as the Vineberg procedure (Vineburg & Miller, 1951) for angina, or arthroscopic knee surgery for treating osteoarthritis, the clinical benefits of a sham/mock surgery were just as successful as the actual surgery. Similar studies suggest the clinical benefits were solely (or primarily) due directly to the placebo response (Beecher, 1961; Cobb et al, 1959; Moseley et al, 2002).
To persuasively demonstrate that a treatment or therapeutic procedure is effective it should incorporate a study design using an active placebo arm as shown in Figure 2.Figure 2. Active placebo control group controls for the normal placebo benefits plus those placebo benefits induced by the medication/treatment induced side effects.
Some treatments may be less effective then claimed because they were not compared to an active placebo, which could be one of the reasons why so many medical and psychological studies cannot be replicated. The absence of ‘active’ placebo controls may also be a factor explaining why some respected authorities have expressed some doubt about published scientific medical research results. Following are two quotes that illustrate such skepticism.
“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of the New England Journal of Medicine” —Dr. Marcia Angell, longtime Editor in Chief of the New England Medical Journal (Angell, 2009).
There are a variety of questions to ask before agreeing on a procedure or before taking medication
A quick way to ask whether a medication or medical treatment effectiveness is the result of placebo components is to ask the following questions:
- Have there been successful self-care or behavioral approaches beyond surgical or pharmaceutical treatments that have demonstrated effectiveness? When successful treatments are reported, then questions are raised whether pharmaceutical or surgical outcomes are also attributable to the result of placebo effects. On the other hand, if there a no successful self-care approaches, then the benefits may be more due to the direct therapeutic effect of a surgical procedure or medication.
- Has the procedure been compared to an active placebo control? If not, then to what extent it is possible that the results of the surgical or pharmaceutical therapy could be attributed to a placebo response instead of directly to the medication or surgery?
- What are the long term benefits and complication rates of the medication, treatment or procedure? When benefits are low and risks of the procedure are high, explore the risks associated with ‘watchful waiting’ (Colloca, Pine, Ernst, Miller & Grillon, 2016; Thomas et al, 2014; Taleb, 2012).
Unfortunately, most clinical studies that includes pharmaceuticals and/or surgery do not test their medication, surgery against an ‘active’ placebo. Whenever possible, enquire whether an active placebo was used to determine the degree of effectiveness of the proposed treatment or procedure. Fortunately, the design of ‘active’ placebo-controlled studies is very possible for anyone interested in comparing the effectiveness of medications, treatments and procedures in various settings, from hospitals and clinics to university classrooms and individual homes.
In summary, the benefits of the treatment must significantly outweigh any risks of negative treatment side effects. Short-term treatment benefits need to be balanced by any long-term benefits. Unfortunately, short-term benefits may lead to significant, long-term harm such as in the use of some medications (e.g. sleep medications, opioid pain killers) that result in chronic dependency and which lead to a significant increase in morbidity and mortality of many kinds. We suggest that more medications and other procedures are tested against an active placebo to investigate whether the medication or procedure is actually effective.
For a detailed analysis and discussion of placebo and the importance of active placebo see our article, Peper, E. & Harvey, R. (2017). The fallacy of the placebo-controlled clinical trials: Are positive outcomes the result of “indirect” treatment effects? NeuroRegulation, 4(3–4), 102–113. http://dx.doi.org/10.15540/nr.4.3-4.102
Angell M. Drug companies and doctors: A story of corruption. January 15, 2009. The New York Review of Books 56. Available: http://www.nybooks.com/articles/archives/2009/jan/15/drug-companies-doctorsa-story-of-corruption/. Accessed 24, November, 2016.
Beecher, H. K. (1961). Surgery as placebo: A quantitative study ofbias. JAMA, 176(13), 1102–1107. http://dx.doi.org/10.1001/jama.1961.63040260007008
Bell, R. M., Rear, R., Cunningham, J., Dawnay, A., & Yellon, D. M. (2014). Effect of remote ischaemic conditioning on contrast-induced nephropathy in patients undergoing elective coronary angiography (ERICCIN): rationale and study design of a randomised single-centre, double-blind placebo-controlled trial. Clinical Research in Cardiology, 103(3), 203-209. http://dx.doi.org/10.1007/s00392-013-0637-3
Cobb, L. A., Thomas, G. I., Dillard, D. H., Merendino, K. A., & Bruce, R. A. (1959). An evaluation of internal-mammary-artery ligation by a double-blind technic. New England Journal of Medicine, 260(22), 1115–1118. http://dx.doi.org/10.1056/NEJM195905282602204
Colloca, L., Pine, D. S., Ernst, M., Miller, F. G., & Grillon, C. (2016). Vasopressin boosts placebo analgesic effects in women: A randomized trial. Biological Psychiatry, 79(10), 794–802. http://dx.doi.org/10.1016/j.biopsych.2015.07.019
Derren Brown’s BBC video Fear and Faith Placebo https://www.youtube.com/watch?v=y2XHDLuBZSw
Enck, P., Bingel, U., Schedlowski, M., & Rief, W. (2013). The placebo response in medicine: minimize, maximize or personalize?. Nature reviews Drug discovery, 12(3), 191-204. http://dx.doi.org/10.1038/nrd3923
Horton, R. (2015). Offline: What is medicine’s 5 sigma. The Lancet, 385(9976), 1380. http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736%2815%2960696-1.pdf
Jensen, J. S., Bielefeldt, A. Ø., & Hróbjartsson, A. (2017). Active placebo control groups of pharmacological interventions were rarely used but merited serious consideration: A methodological overview. Journal of Clinical Epidemiology. https://doi.org/10.1016/j.jclinepi.2017.03.001
Jonas, W. B., Crawford, C., Colloca, L., Kaptchuk, T. J., Moseley, B., Miller, F. G., & Meissner, K. (2015). To what extent are surgery and invasive procedures effective beyond a placebo response? A systematic review with meta-analysis of randomised, sham controlled trials. BMJ open, 5(12), e009655. http://dx.doi.org/10.1136/bmjopen-2015-009655
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Moseley, J. B., O’Malley, K., Petersen, N. J., Menke, T. J., Brody, B. A., Kuykendall, D. H., … Wray, N. P. (2002). A controlled trial of arthroscopic surgery for osteoarthritis of the knee. The New England Journal of Medicine. 347(2), 81–88. http://dx.doi.org/10.1056 /NEJMoa013259
Peper, E. & Harvey, R. (2017). The fallacy of the placebo-controlled clinical trials: Are positive outcomes the result of “indirect” treatment effects? NeuroRegulation, 4(3–4), 102–113. http://dx.doi.org/10.15540/nr.4.3-4.102
Stewart-Williams, S., & Podd, J. (2004). The placebo effect: dissolving the expectancy versus conditioning debate. Psychological bulletin, 130(2), 324. http://dx.doi.org/10.1037/0033-2909.130.2.324
TheNNT (2017, November). http://www.thennt.com/nnt/statins-for-heart-disease-prevention-without-prior-heart-disease/
Thomas, R., Williams, M., Sharma, H., Chaudry, A., & Bellamy, P. (2014). A double-blind, placebo-controlled randomised trial evaluating the effect of a polyphenol-rich whole food supplement on PSA progression in men with prostate cancer—the UK NCRN Pomi-T study. Prostate Cancer and Prostatic Diseases, 17(2), 180–186. http://dx.doi.org/10.1038/pcan.2014.6
Vineberg, A., & Miller, G. (1951). Treatment of coronary insufficiency. Canadian Medical Association Journal, 64(3), 204. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1821866/pdf/canmedaj00654-0019.pdf