In a world of turmoil, it is often challenging to think that tomorrow can be different and better. Yet, each day is an opportunity to accept whatever happened in the past and look forward to the unfolding present. So often, we anticipate that the future will be the same or worse especially if we feel depressed, suffer from ongoing pain, chronic illness, family or work stress, etc. At those moments, we forget that yesterday’s memories may contribute to how we experience and interpret the future. Most of us do not know what the future will bring, thus be open to new opportunities for growth and well-being. For the New Year, adapt a daily ritual that I learned from a remarkable healer Dora Kunz.
Each morning when you get out of bed, take a few slow deep breaths. Then think of someone who you feel loved by and makes you smile whether your grandmother, aunt or dog. Then when you get up and put your feet on the ground, say out loud, “Today is a new day- a new beginning.”
Watch the following two videos of people for whom the future appeared hopeless and yet had the courage to transcend their limitations and offer inspiration and joy.
Janine Shepherd: A broken body isn’t a broken person. Cross-country skier Janine Shepherd hoped for an Olympic medal — until she was hit by a truck during a training bike ride. She shares a powerful story about the human potential for recovery. Her message: you are not your body, and giving up old dreams can allow new ones to soar.
Ma Li and Zhai Xiaowei: Hand in Hand. This is a video of a broadcast that originally aired on China’s English-language CCTV channel 9 during a modern dance competition in Beijing, China in 2007. This very unique couple–she without an arm, he without a leg–was one of the finalists among 7000 competitors in the 4th CCTV national dance competition. It is the first time a handicapped couple had ever entered the competition. They won the silver medal and became an instant national hit. The young woman, in her 30’s, was a dancer who had trained since she was a little girl. Later in life, she lost her entire right arm in an automobile accident and fell into a state of depression for a few years. After rebounding, she decided to team with a young man who had lost his leg in a farming accident as a boy and who was completely untrained in dance. After a long and sometimes agonizing training regimen, this is the result. The dance is performed by Ma Li (馬麗) and Zhai Xiaowei (翟孝偉). The music “Holding Hands” is composed by San Bao and choreographed by Zhao Limin.
“Although difficult and going against my natural reaction to curl up in the response to my cramps, I stretched out on my back and breathed slowly so that my stomach got bigger with each inhalation. My menstrual pain slowly decreased and disappeared.
“For as long as I remember, I had stomach problems and when I went to doctors, they said, I had acid reflux. I was prescribed medication and nothing worked. The problem of acid reflux got really bad when I went to college and often interfered with my social activities. After learning diaphragmatic breathing so that my stomach expanded instead of my chest, I am free of my symptoms and can even eat the foods that previously triggered the acid reflux.”
In the late 19th earlier part of the 20th century many women were diagnosed with Neurasthenia. The symptoms included fatigue, anxiety, headache, fainting, light headedness, heart palpitation, high blood pressure, neuralgia and depression. It was perceived as a weakness of the nerves. Even though the diagnosis is no longer used, similar symptoms still occur and are aggravated when the abdomen is constricted with a corset or by stylish clothing (see Fig 1).
Figure 1. Wearing a corset squeezes the abdomen.
The constricted waist compromises the functions of digestion and breathing. When the person inhales, the abdomen cannot expand as the diaphragm is flattening and pushing down. Thus, the person is forced to breathe more shallowly by lifting their ribs which increases neck and shoulder tension and the risk of anxiety, heart palpitation, and fatigue. It also can contribute to abdominal discomfort since abdomen is being squeezed by the corset and forcing the abdominal organs upward. It was the reason why the room on top of stairs in the old Victorian houses was call the fainting room (Melissa, 2015).
During inhalation the diaphragm flattens and attempts to descend which increases the pressure of the abdominal content. In some cases this causes the stomach content to be pushed upward into the esophagus which could result in heart burn and acid reflux. To avoid this, health care providers often advice patients with acid reflux to sleep on a slanted bed with the head higher than their feet so that the stomach content flows downward. However, they may not teach the person to wear looser clothing that does not constrict the waist and prevent designer jean syndrome. If the clothing around the waist is loosened, then the abdomen may expand in all directions in response to the downward movement of the diaphragm during inhalation and not squeeze the stomach and thereby pushing its content upward into the esophagus.
Most people have experienced the benefits of loosening the waist when eating a large meal. The moment the stomach is given the room to spread out, you feel more comfortable. If you experienced this, ask yourself, “Could there be a long term cost of keeping my waist constricted?” A constricted waist may be as harmful to our health as having the emergency brake on while driving for a car.
We are usually unaware that shallow rapid breathing in our chest can contribute to symptoms such as anxiety, neck and shoulder tension, heart palpitations, headaches, abdominal discomfort such as heart burn, acid reflux, irritable bowel syndrome, dysmenorrhea and even reduced fertility (Peper, Mason, & Huey, 2017; Domar, Seibel, & Benson, 1990).
Assess whether you are at risk for faulty breathing
Stand up and observe what happens when you take in a big breath and then exhale. Did you feel taller when you inhaled and shorter/smaller when you exhaled?
If the answer is YES, your breathing pattern may compromise your health. Most likely when you inhaled you lifted your chest, slightly arched your back, tightened and raised your shoulders, and lifted your head up while slightly pulling the stomach in. When you exhaled, your body relaxed and collapsed downward and even the stomach may have relaxed and expanded. This is a dysfunctional breathing pattern and the opposite of a breathing pattern that supports health and regeneration as shown in figure 2.
Figure 2. Incorrect and correct breathing. Source unknown.
Observe babies, young children, dogs, and cats when they are peaceful. The abdomen is what moves during breathing. While breathing in, the abdomen expands in all 360 degrees directions and when breathing out, the abdomen constricts and comes in. Similarly when dogs or cats are lying on their sides, their stomach goes up during inhalation and goes down during exhalation.
Many people tend to breathe shallowly in their chest and have forgotten—or cannot– allow their abdomen and lower ribs to widen during inhalation (Peper et al, 2016). These factors include:
- Constriction by the modern corset called “Spanx” to slim the figure or by wearing tight fitting pants. In either case the abdominal content is pushed upward and interferes with normal healthy breathing.
- Maintaining a slim figure by pulling the abdomen (I will look fat when my stomach expands; I will suck it in).
- Avoiding post-surgical abdominal pain by inhibiting abdominal movement. Numerous patients have unknowingly learned to shallowly breathe in their chest to avoid pain at the site of the incision of the abdominal surgery such as for hernia repair or a cesarean operation. This dysfunctional breathing became the new normal unless they actively practice diaphragmatic breathing.
- Slouching as we sit or watch digital screens or look down at our cell phone.
Observe how slouching affects the space in your abdomen.
When you shift from an upright erect position to a slouched or protective position the distance between your pubic bone and the bottom of the sternum (xiphoid process) is significantly reduced.
- Tighten our abdomen to protect ourselves from pain and danger as shown in Figure 3.
Figure 3. Erect versus collapsed posture. There is less space for the abdomen to expand in the protective collapsed position. Reproduced by permission from Clinical Somatics (http://www.clinicalsomatics.ie/).
Regardless why people breathe shallowly in their chest or avoid abdominal and lower rib movement during breathing, by re-establishing normal diaphragmatic breathing many symptoms may be reduced. Numerous students have reported that when they shift to diaphragmatic breathing which means the abdomen and lower ribs expand during inhalation and come in during exhalation as shown in Figure 4, their symptoms such as acid reflux and menstrual cramp significantly decrease.
Figure 4. Diaphragmatic breathing. Reproduced from: www.devang.house/blogs/thejob/belly-breathing-follow-your-gut.
Reduce acid reflux
A 21-year old student, who has had acid reflux (GERD-gastroesophageal reflux diseases) since age 6, observed that she only breathed in her chest and that there were no abdominal movements. When she learned and practiced slower diaphragmatic breathing which allowed her abdomen to expand naturally during inhalation and reduce in size during exhalation her symptoms decreased. The image she used was that her lungs were like a balloon located in her abdomen. To create space for the diaphragm going down, she bought larger size pants so that her abdominal could spread out instead of squeezing her stomach (see Figure 5).
Figure 5. Hydraulic model who inhaling without the abdomen expanding increases pressure on the stomach and possibly cause stomach fluids to be pushed into the esophagus.
She practiced diaphragmatic breathing many times during the day. In addition, the moment she felt stressed and tightened her abdomen, she interrupted this tightening and re-established abdominal breathing. Practicing this was very challenging since she had to accept that she would still be attractive even if her stomach expanded during inhalation. She reported that within two weeks her symptom disappeared and upon a year follow-up she has had no more symptoms. For a detailed description how this successfully cured irritable bowel syndrome see: https://peperperspective.com/2017/06/23/healing-irritable-bowel-syndrome-with-diaphragmatic-breathing/
Take control of menstrual cramps
Numerous college students have reported that when they experience menstrual cramps, their natural impulse is to curl up in a protective cocoon. If instead they interrupted this natural protective pattern and lie relaxed on their back with their legs straight out and breathe diaphragmatically with their abdomen expanding and going upward during inhalation, they report a 50 percent decrease in discomfort (Gibney & Peper, 2003). For some the discomfort totally disappears when they place a warm pad on their lower abdomen and focused on breathing slowly about six breaths per minute so that the abdomen goes up when inhaling and goes down when exhaling. At the same time, they also imagine that the air would flow like a stream from their abdomen through their legs and out their feet while exhaling. They observed that as long as they held their abdomen tight the discomfort including the congestive PMS symptoms remained. Yet, the moment they practice abdominal breathing, the congestion and discomfort is decreased. Most likely the expanding and constricting of the abdomen during the diaphragmatic breathing acts as a pump in the abdomen to increase the lymph and venous blood return and improve circulation.
Breathing is the body-mind bridge and offers hope for numerous disorders. Slower diaphragmatic breathing with the corresponding abdomen movement at about six breaths per minute may reduce autonomic dysregulation. It has profound self-healing effects and may increase calmness and relaxation. At the same time, it may reduce heart palpitations, hypertension, asthma, anxiety, and many other symptoms.
DeVault, K.R. & Castell, D.O. (2005). Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. The American Journal of Gastroenterology, 100, 190-200.
Domar, A.D., Seibel, M.M., & Benson, H. (1990). The Mind/Body Program for Infertility: a new behavioral treatment approach for women with infertility. Fertility and sterility, 53(2), 246-249.
Gibney, H.K. & Peper, E. (2003). Taking control: Strategies to reduce hot flashes and premenstrual mood swings. Biofeedback, 31(3), 20-24.
Johnson, L.F. & DeMeester, T.R. (1981). Evaluation of elevation of the head of the bed, bethanechol, and antacid foam tablets on gastroesophageal reflux. Digestive Diseases Sciences, 26, 673-680. https://www.ncbi.nlm.nih.gov/pubmed/7261830
Melissa. (2015). Why women fainted so much in the 19th century. May 20, 2015. Donloaded October 2, 1018. http://www.todayifoundout.com/index.php/2015/05/women-fainted-much-19th-century/
Peper, E., Booiman, A., Lin, I-M, Harvey, R., & Mitose, J. (2016). Abdominal SEMG Feedback for Diaphragmatic Breathing: A Methodological Note. Biofeedback. 44(1), 42-49.
Peper, E., Mason, L., Huey, C. (2017). Healing irritable bowel syndrome with diaphragmatic breathing. Biofeedback. (45-4)
Richard Harvey, PhD and Erik Peper, PhD
In a technologically modern world, many people have the option of spending 24 hours a day/ 7 days a week continuously interacting via telephone, text, work and personal emails or internet websites and various social media platforms such as Facebook, What’s App, Instagram, Twitter, LinkedIn and Snapchat. How many people do we know who work too many hours, watch too many episodes on digital screens, commute too many hours, or fill loneliness with online versions of retail therapy? In the rush of work-a-day survival as well as being nudged and bombarded with social media notifications, or advertisements for material goods, we forget to nurture meaningful friendships and family relationships (Peper and Harvey, 2018). The following ‘values clarification’ practice may help us identify what is most important to us and help keep sight of those things that are most relevant in our lives (Hofmann, 2008; Knott, Ribar, & Duson, 1989; Twohig & Crosby, 2009;. Peper, 2014).
Give yourself about 12 minutes of uninterrupted time to do this practice. Do this practice by yourself, in a group, or with family and friends. Have a piece of paper ready. Be guided by the two video clips at the end of the blog. Begin with the Touch Relaxation and Regeneration Practice to relax and let go of thoughts and worries, then follow it with the Value Clarification Practice.
Touch Relaxation and Regeneration Practice
Turn off your cell phone and let other know not to interrupt for the next 12 minutes, then engage in the following six-minute relaxation exercise. If your attention wanders during the practice, then bring your attention back to the various sensations in your body.
- Sit comfortably, then lift your arms from your lap, holding them parallel to the floor and tighten your arms while making a fist in each hand. While holding your fists tightly closed, keep breathing for a total of 10 seconds before dropping the arms to your lap while you relax all of your muscles. Attend for 20 seconds to the changing sensations in arms and hands as they relax. If your attention wanders bring it back to the sensations in your arm and hands.
- Tighten your buttock muscles and bend your ankles so that the toes move upwards in a direction towards your knees. Keep breathing and hold your toes upwards for 10 seconds and then let the toes move down to the floor, letting go and relaxing all the muscles of the lower trunk and legs. Feel your knees widening and feel your buttock muscles relaxing. Continue attending to the body and muscle sensations for the next 20 seconds. If your attention wanders bring it back to the sensations in your body.
- Tighten your whole body by pressing your knees together, lifting your arms up from your lap, making a fist and wrinkling your face. Hold the tension while continuing to breath for 10 seconds. Let go and relax and feel the whole body sinking and relaxing and being supported by the chair for the next 20 seconds.
- Bring your right hand to your left shoulder. Over the next 10 seconds, inhale for three or four seconds and as you exhale for five or six seconds, with your right hand stroke down your left arm from your shoulder to past your hand. Imagine that the exhaled air is flowing through your arm and out your hand. Repeat at least once more.
- Bring your left hand to your right shoulder. Inhale for three or four seconds and as you exhale for five or six seconds with your left hand stroke down your right arm from your shoulder to past your hand. Imagine that the exhaled air is flowing through your arm and out your hand. Repeat at least once more.
- Bring both hands to the sides of your hips. Inhale for three or four seconds and as you exhale for five or six seconds stroke your legs with your hands from the hips to the ankles. Imagine that the exhaled air is flowing through your legs and out your feet. Repeat a least once more.
- Close your eyes and inhale for three or four seconds, then hold your breath for seven seconds slowly exhale for eight seconds. Imagine as you exhale the air flowing through your arms and out your hands and through your legs and out your feet. Continue breathing easily and slowly such as inhaling for three or four seconds, and out for five to seven seconds. If your attention wanders just bring it back to the sensations going down your arms and legs. Feel the relaxation and peacefulness.
- Take another deep breath and then stretch and continue with the Value Clarification
Value Clarification Practice
Get the paper and pen and do the following Value Clarification Practice.
- Quickly (e.g. 30-60 seconds) list the 10 most important things in your life. For the activity to work, the list must contain 10 important things that may be concrete or abstract, ranging from material things such as a smart phone or a car to immaterial things such as family, love, god, health… If you need to, break up a larger category into smaller pieces. For example, if one item on the list is family, and you only have seven items on the list, assuming you have a family of four, then identify separate family members in order to complete a list of 10 important things.
- To start off, in only 10 seconds, please cross off three items from the list, then explain why you removed those three. If done in a group of people turn to the person explain why you made these choices.
- Next, in only 10 seconds, please cross off three more, then explain why you kept what you kept. If done in a group of people turn to the person explain why you made these choices.
- Finally, in only 10 seconds, please cross off three more, then reveal the one most important thing on your list. Share your choice for the item you kept and how you felt while crossing items from the list or keeping them.
- When engaging with this type of values clarification practice, please remind yourself and others that the items on the list were never gone, they are always in your life to the extent that you can honor the presence of those things in your life.
We have done these exercises with thousands of student and adults. The most common final item on the list is family or an individual family member. Sometimes, categories such as health or god appear, however it is extremely rare that material items make it to the final round. For example, no one would report that their last item is their job, their bank account, their house, or their smart phone. It is common that people have difficulty choosing the last item on their list, often taking more than 10 seconds to choose. For example, they find that they cannot choose between eliminating individual family members. For those who find the activity too difficult, remind them that the exercise is voluntary and meant as a ‘thought experiment’ which they may stop at any time.
Reflect how much of your time is spent nurturing what is most important to you? In many cases we feel compelled to finish some employment priorities instead of making time for nurturing our family relationship. And when we become overwhelmed with work demands, we retreat to sooth our difficulties by checking our email or browsing social media rather than supporting the family connections that are so important to us.
Organize an action plan to honor and support your commitment to the items on your list that you value the most. If possible let other people know what you are doing.
- Describe in detail what you will do in real life and in real time in service to honor and support your relationships with the things that you value.
- Describe in detail what you will do, when you will do it, with whom you will do it, at what time you will do it, and anticipate what will get in the way of doing it. For example, how will you resolve any conflicts between what you plan and what you actually do when there is not enough time to carry out your plans?
- Schedule a time during the following week for feedback about your plans to honor and support the things you value.
Many people experience that it is challenging to make time to honor and support their primary values given the ongoing demands of daily living. To be congruent with our values means making ongoing choices such as listening and sharing experiences with your partner versus binging on videos or, using your smartphone for answering email or texting instead of watching your child play ball.
The values you previously identified are similar to those identified by patients who are in hospice and dying. For them as they look back on their lives, the five most common regret are (Ware, 2009; Ware, 2012):
- I wish I’d the courage to live a life true to myself, not the life others expected of me.
- I wish I hadn’t worked so hard.
- I wish I had the courage to express my feelings.
- I wish I had stayed in touch with my friends.
- I wish I had let myself be happier.
Take the time to plan actions that support your identified values. Feel free to watch the following videos that guide you through the activities described here.
Hofmann, S.G. (2008). Acceptance and commitment therapy: New wave or Morita therapy?. Clinical Psychology: Science and Practice, 15(4), 280-285. https://doi.org/10.1111/j.1468-2850.2008.00138.x
Knott, J.E., Ribar, M.C. & Duson, B.M. (1989). Thanatopics: Activities and Exercises for Confronting Death, Lexington Books: Lexington, MA. https://www.amazon.com/Thanatopics-Activities-Exercise-Confronting-Death/dp/066920871X
Peper, E. (October 19, 2014). Choices-Creating meaningful days. https://peperperspective.com/2014/10/19/choices-creating-meaningful-days/
Peper, E. & Harvey, R. (2018). Digital addiction: increased loneliness, depression, and anxiety. NeuroRegulation. 5(1),3–8. doi:10.15540/nr.5.1.3 http://www.neuroregulation.org/article/view/18189/11842
Twohig, M.P. & Crosby, J.M. (2009). Values clarification. In: O’Donohue & W.T., Fisher, J.E., Eds. Cognitive behavior therapy: applying empirically supported techniques in your practice. Wiley: Hoeboken, N.J., p. 681-686.
Ware, B. (2009). Regrets of the dying. https://bronnieware.com/blog/regrets-of-the-dying/
Ware, B. (2012). The top five regrets of dying: A life transformed by the dearly departing. Hay House. ISBN: 978-1401940652
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.
How can people be so caring and sometimes cruel? What are the evolutionary, genetic, epigenetic, developmental, familial, tribal, community and cultural determinants that allow human beings to be heroic and give their own life for others or be killers and unbelievably cruel. Stanford biology professor Robert Sapolsky‘s book, Behave: The Biology of Humans at Our Best and Worst, explores what drives human behavior. It is a remarkable tour de force to explore and explain why we do as we do. Watch his February 6, 2018 lecture at the Jewish Community Center of San Francisco.
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
Klopfer, B., (1957). Psychological Variables in Human Cancer, Journal of Projective Techniques, 21(4), 331–340. http://www.tandfonline.com/doi/abs/10.1080/08853126.1957.10380794
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
Breathing affects all aspects of your life. This invited keynote, Breathing and posture: Mind-body interventions to improve health, reduce pain and discomfort, was presented at the Caribbean Active Aging Congress, October 14, Oranjestad, Aruba. www.caacaruba.com
The presentation includes numerous practices that can be rapidly adapted into daily life to improve health and well-being.