Education

No treatment plan is complete without addressing issues of individual patient education as a means of facilitating self-management of symptoms and prevention of future problems.

Where we are today in modern medicine

The patient today is confronted with a modern medical system that is both extraordinarily expensive and bureaucratic, and creates scores of drugs that are required by law to list pages of potential side effects and risks, often being withdrawn from the market after years of use due to harm that we find the pharmaceutical company knew about in the first place. A commission formed by the U.S. Senate Committee on Finance, and headed by a conservative Republican senator from Iowa, Charles Grassley, has uncovered the most egregious abuses of research fraud, enormous payments to top research specialists by pharmaceutical companies, ghost writing of many research reports and even textbooks for medical schools set up by pharmaceutical companies, and an elaborate system of enormous monetary incentives and promotions to guide drug prescription. Recent fines of up to $2.3 billion (Pfizer and Eli Lilly in 2010) for illegal marketing of drugs (to medical doctors and prescribing clinical nursing specialists) for medical conditions not approved as safe by the FDA, and requirements that all financial ties to drug companies be publicly addressed and NIH researchers sever all ties to special financial interests, after an anonymous survey found that over 40% admitted to taking financial incentive to alter medical research, underscores the enormity of the problem of public trust in the medical institutions that we depend on.

Many experts assumed that with these changes, the act of misconduct, or falsification, in published scientific studies, would dramatically decrease. Instead, a large study by Albert Einstein College of Medicine in New York, published in 2012 in the Proceedings of the National Academy of Sciences, found that of 2,047 retracted articles in biomedical and life sciences in recent years, about 3/4 of the retracted papers were withdrawn due to misconduct. Dr. Arturo Casadevail, an author of the study, was quoted in the New York Times as stating that the problem of lying and falsifying scientific data was a lot worse than was thought. In 2011, the journal Nature reported that this number of retracted scientific studies and papers had risen tenfold in the last decade. Many experts, such as Dr. Ferric C. Fang of the University of Washington, are stating that the problem reflects perverse incentives that drive scientists to knowingly publish false data, or to make sloppy mistakes due to reduced time and budgets allotted for these studies. The biggest problem cited, though, is the fact that many of these falsified scientific studies are still cited without update of fraud or mistake. While the percentage of overall papers retracted due to fraud was relatively small, the effects include a falsified citing of data that is useful to promote products and convince patients. Added to these retractions are hundreds of thousands of papers that have published corrections, also useful in the business of citing the wrong data to sell medicine. The systematic culture of only rewarding medical and scientific research that is published first, not the best, most accurate, or most pertinent studies, is blamed as the chief cause of all of this falsification in published studies. Manipulation of the system of published medical science has created enormous problems and eroded public faith in the system.

Even with increased government scrutiny and enormous fines, the problems of unethical and illegal behavior from our health care industry is not going away. The pharmaceutical industry, often now referred to as “Big Pharm”, is a prime example. In 2012, the U.S. government collected its largest fine yet for improper marketing of drugs for medical conditions not approved by the FDA. GlaxoSmithKline agreed out of court to settle charges of both criminal and civil crimes for $3 billion in fines for promoting its best selling antidepressives, such as Paxil and Wellbutrin, for unapproved uses, and failing to report safety data when its best selling diabetes drug, Avandia, was approved. It was discovered by foreign regulators that Avandia came with considerable cardiovascular risks, and sales have since plummetted. Marketing of a number of drugs for medical conditions not approved, and illegal sales techniques, were found with such often prescribed drugs as Advair, Flovent, Imitrex, Lamictal, and Valtrex. The settlement comes with an agreement that sales representatives are no longer compensated by the volume of sales, which has led to many of the improper marketing strategies of drugs, rewarding physicians and hospitals with financial incentives to increase sales, instead of allowing prescription to be determined by what is best for the patient, and most economical for the healthcare expenditure. Also in 2012, Abbot Laboratories agreed to a $1.6 billion settlement of fines, and Johnson and Johnson may settle a case for $2 billion. Even these enormous fines have not changed the way business is done, though, as the companies were shown to already have set aside these enormous sums of money in anticipation of fines, and apparently, this was figured into the cost of the drugs, which of course is passed on to the consumer and taxpayers.

Elliot Spitzer, former attorney general for the state of New York, has long investigated such healthcare illegality, and states: “What we’re learning is that money doesn’t deter corporate malfeasance. The only thing that will work in my view is C.E.O.s and officials being forced to resign and individual culpability being enforced (with prison sentences).” (NY Times July 3, 2012). Mr. Spitzer sued GlaxoKlineSmith for similar criminal acts in improper marketing in 2004. In the first half of 2012, over $10 billion has been agreed to in settlements for fines for these criminal acts, and over $30 billion in the last 3 years. With out of court settlements, the public is not made aware that such enormous criminal and civil fines are levied, and little public pressure to change the culture of pharmaceutical and medical prescription and treatment results, despite the enormous costs passed to patients to pay for these fines, and the enormous amount of harm from improper treatment and adverse effects. Even the New York Times only reports these stories in the business section, not the general news section of the paper, keeping it out of the public eye. But slowly, the public is becoming aware.

The failure of modern industry research to provide reliable and complete date for patients, physicians, and governments to choose the best therapy

In 2011, the esteemed medical researcher, Dr. Peter C. Gotzsche, of the Nordic Cochrane Centre, at the University of Copenhagen, Denmark, published a paper in BMC Medicine, entitled Why we need easy access to all data from all clinical trials and how to accomplish it. In this paper, Dr. Gotzsche stresses the imminent need and importance for international registration of all human medical trials of pharmaceutical and other medical treatment, and outlines steps to achieve this goal, which would stop the hiding of important public health information, and provide a reliable method to judge the actual efficacy of pharmaceutical treatments. Dr. Gotzsche pointed out that similar calls for action have come from the World Health Organization (WHO), Organization for Economic Cooperation and Development (OECD), the US National Institutes of Health (NIH), the US Congress, the European Commission, the Cochrane Collaboration, th UK Medical Research Council, and funders of medical research, such as the Bill and Melinda Gates Foundation and the Hewlett Foundation. Such open data sharing from private companies is a moral imperative, and would lead to enormous improvement in utilization of healthcare resources based on research that we can trust, according to Dr. Grotzsche. The paper he presented can be accessed by clicking on this link:http://www.trialsjournal.com/content/12/1/249. Dr. Grotzsche cited present laws that have been instrumental in reducing public harm, such as the US Freedom of Information Act, which has been used by the FDA to uncover false reporting of adverse effects and risks of new pharmaceuticals, and prevent public harm. He also cited the efforts of the New York Attorney General in uncovering repeated and persistent fraud by pharmaceuticals, and investigations by the European Medicines Agency, which have uncovered ghost writing and falsehood in various cases of drugs approved based completely on industry studies, such as Tamiflu.

While we assume that our drug regulatory agencies are effective in protecting the public welfare, Dr. Grotzsche notes that these drug regulatory agencies have been the exception to the call for open data sharing of human clinical trial data. He notes that of all drugs approved in the US and Europe between 1997 and 2000, 5.3% were lated withdrawn from the market because of serious public harm, and that this figure appears to be rising steadily. The reason cited for withholding this information is that individuals could selectively use the information to further malpractice legal claims, and that the government regulatory agencies should have ultimate control of such data. As time goes on, though, the world public is growing increasingly wary of risks of new pharmaceuticals, and increasingly losing trust in the institutions set up to protect the public from such harm.

The response of the health industry to erosion of public trust

The scope of this problem of healthcare industry malfeasance is so overwhelming that the public and patients often no longer know what to trust. On the one hand we have a big problem with erosion of patient trust in their prescribed healthcare and rising costs that are discouraging care. On the other hand, we have a history of healthcare that operates on the notion that the patient adopts an attitude of unconditional and complete trust in their physicians and takes what is prescribed or undergoes treatment that is recommended, often not even knowing the name of the drug or what it actually does. The underlying issues of trust and care have prompted many patients to turn to the internet to research their medical issues and treatments in order to take a more proactive approach and feel more assured in the medical decisions, but are here faced with a daunting amount of information and presentation driven by commercial interest, advertising and promotion, and slanted presentations. There seems to be no way to get back to a system where one feels reassured that there are compassionate professional doctors whose main concern is the patient's health and well being.

This growing problem has stimulated the health care industry to adopt more “patient-centered approaches” and adopt such protocols as “mind-body medicine”. Patient-centered approaches have been created in response to widespread patient distrust in a system where there is no longer a single familiar general practice doctor to explain and guide care. Instead, patients are led through an elaborate labrynth of specialists who increasingly spend less time with patients and make medical decisions focused on just one aspect of the health problems without much knowledge of the whole medical history and scope. The patient-centered approach promotes integrating the assessment of a health problem with understanding of the whole person, building a long-term relationship between the doctor and patient and finding common ground in goals of therapy, incorporating prevention and promoting healthy practices in the patient's life, realistically confronting the impact of costs and time in the patient's life, and allocating resources in practice that are practical for the patient. In essence, moving allopathic medicine in the direction of Complementary Medicine and the holistic approach.

The other major response to a growing patient discomfort and distrust of the modern medical industry was adoption of the “mind-body medicine”. This twenty-first century approach in modern allopathic medicine seeks to respond to the enormous research evidence that ties psychological and social factors to physical function and health outcomes. The goal of experts in this field was to have the physician confront psychosocial stress, such as emotional problems, anxiety and depression disorders, behavioral and cognitive disorders, and even the subject of individual profiles of work stress, family interactions, and emotional responses that often have a great effect on both the advent and course of disease, and the response to symptoms and perpetuation of the disease or symptoms related to injury. Here too, modern medicine seems highly influenced by the history and practice of Complementary Medicine and the holistic approach. In the classic early comprehensive test of Traditional Chinese Medicine, the Huang Di de Nei Jing (patriarch Huang Di's Canon on physical medicine and the holistic approach), TCM physicians in 300 BC stated that a central cause of disease in internal medicine is emotional and social constraint, and devoted much attention to the importance of understanding these aspects in the individual patient when assessing their medical condition. Whether or not this newfound emphasis on “mind-body” medicine and a “patient-centered” approach is a new attempt to displace Complementary Medicine by trickery or an actual evolution of the integration of Traditional Chinese Medicine and holistic medical science is still in question.

The big question confronting modern medicine is how to present this complex system of confusing elements and issues to the patient and also help them feel more at ease. On the one hand, the patient confronted with serious health problems just wants someone to take care of them, and wants to trust this person. On the other hand, there is much distrust now built into the system, and the health care providers seem increasingly detached from the individual and part of bigger and bigger institutional frameworks, prompting many patients to feel uncomfortable with completely putting their treatment in the hands of strangers in this institutional framework. The age of the family doctor is over, unless you have the money to afford the quickly growing “concierge practice”, where for a yearly fee, your medical doctor will act as the family physician of the past, taking the time to create an actual knowledgeable relationship between physician and patient, and guiding all diagnostics and decision-making with a patient-centered approach. Even though our medical field is adopting these new tactics related to holistic medicine, though, the industry is driving more and more physicians out of private practice and into a corporate controlled world of health managed organizational care. Here, the actual practice of the patient-centered approach may be merely mimicked.

The results of these changes are that some prominent HMOs, such as Kaiser, and some prominent MPGs (medical provider groups), such as Brown & Toland, as well as many large healthcare corporations, such as Sutter Health, are now spending enormous amounts of money advertising their new “patient-centered” and “mind-body” approaches and emphasis on a holistic preventative and healthy friendly approach in medicine. Many patients are not feeling reassured by massive advertising that these approaches are being taken seriously. Massive advertising itself generates mistrust. Many of these new approaches also seem to be creating salesmanship and treatment approaches that offer an array of somewhat superficial treatment for serious chronic health problems, such as light massage, stress management classes, relaxation techniques, imagery, biofeedback, and hypnosis. The adoption of treatment techniques and preventative medicine developed over centuries in China, such as practices of Tai Chi, yoga, Qi Gong, individualized lifestyle and dietary counseling, and incorporation of a variety of treatments, such as deep tissue massage and soft tissue mobilization, nutrient and herbal medicine, and acupuncture are usually not included in this new “mind-body approach” and “patient-centered” medicine, and even effective standard treatment, such as cognitive and behavioral therapy and counseling, are not easily obtained. Economics and marketing still seems to play a too prominent role in the offering of these “mind-body therapies”. The sense of distrust on the part of the patient will not be alleviated by such tactics.

For those of us that follow medical trade and industry journals, we have noticed that the evolution of Complementary and Integrative Medicine into standard care hit an immediate snag when hospitals and clinics experimented with opening so-called Complementary and Alternative Medicine (CAM) clinics as part of their complexes. These clinics were kept separate from the standard care facilities, and over a few years, reports of economic disincentives were reported in trade journals. The CAM clinics succeeded in being well liked and appreciated by the patient population, with high ratings of success, yet statistics showed that they hurt the bottom line of the hospital and clinic in most cases, reducing the number of total patient visits and profits. Many of these CAM clinics were closed or reduced in scope. Although more than a third of major hospitals in the United States now offer some form of acupuncture, the practice of acupuncture and Complementary Medicine is almost always very controlled and restricted in these institutions, and this replaces support for acupuncture and Complementary Medicine in general, with few referrals allowed outside of the system to respected physicians in private practice that specialize in acupuncture, herbal and nutrient medicine, and the traditional physiotherapies. Similar stories were generated by programs that sought to assign a system of medical overseeing to each patient, coordinating care, and giving a more holistic perspective to the use of various specialists, often by utilizing a less expensive clinical nursing specialist to organize the patient care and testing, and establish a more proactive relationship with the patient. Trials of these programs were also reported to be well liked and efficient, yet the number of patient visits to the doctors and clinics were significantly decreased, and the economics of this strategy curtailed expansion of such holistic care management programs.

Nonprofit programs were also devised in some states, such as Oregon and Michigan, and these alternatives to standard insurance, such as Coops, provided a more patient-centered approach and coordination of care, which reduced costs and was very popular with patients and highly rated. Unfortunately, these too have been discouraged in the healthcare reform debate due to economic concerns. When a provision was included in the healthcare reform in Oregon, allowing employees to opt for these healthcare coops instead of being restricted to the plans in a company agreement, this too was fiercely attacked and eliminated in the 2011 budget debate. All of these public health initiatives and changes in the healthcare industry are spurred by public interest and demand, as well as a growing concern that wasteful spending in healthcare is creating a strong public health and financial burden, both on the individual and business purchasers of health insurance, and on the taxpayer, as the federal and state budget deficits grow out of control due to rising health care costs. Adoption of low-cost holistic medicines, holistic individualized management of total health care, healthcare insurance Coops where a family practice physician may spend time with each patient to actually institute real patient-centered and mind-body medicine, and an improved system of low-cost community healthcare clinics accessible to all, are ways to both decrease total health care costs and provide renewed public trust in the U.S. healthcare system. Reestablising public trust and belief in our healthcare system as primarily a public health concern, rather than a pure economic interest, is important for many reasons, but most importantly to improve the quality and effects of healthcare. Trust and belief are an important part of this equation.

Certainly, the spiral of exploding healthcare costs, institutionalizing of healthcare beyond expectations, and the massive amount of healthcare fraud and lobbying for enormous profits in public health have caught many Americans offguard in the debate over healthcare reform. While most Americans now see a need for serious healthcare reform, the widespread distrust in governmental management of healthcare is also a serious concern. Such books as the 2010 bestseller Deadly Spin, an insurance company insider speaks out on how corporate PR is killing health care and deceiving Americans, by Wendell Potter, one of the most powerful spinmeisters for the healthcare industry, show how the governmental debate on healthcare is easily controlled by enormous PR spending by Big Medicine. Mr. Potter explains how he helped come up with the terms “death panels” and “government-run health insurance” to spin public opinion against health care reform, but now regrets his corrupt and unethical business behavior because it has caused, and will cause, so much unnecessary suffering in the U.S. Mr. Potter, a former public relations executive at Cigna, explains how the killing of the public option insurance exchange allowed the healthcare industry to continue to focus on shareholder profit over healthcare benefits and ethical delivery of healthcare to the public, and to continue to manipulate doctors into putting profits before patients. He states that he was surprised that so many Americans could be so easily turned against an insurance option that would save them so much money. The reason for this is a widespread public distrust of medical delivery in this country, either governmental or private. The question of how this massive loss of trust in medicine occurred, and how to restore it, may be a defining social question of the twenty-first century.

The role of the Placebo in the regulation of new medical drugs and the complexity of the placebo effect and its ethical use

One intriguing aspect of the mind-body emphasis in medicine is the growing body of research that has investigated the placebo effect. For many years, the general attitude in medicine was that the psychosocial and mental aspects of physical disease were in many ways unreal. If standard tests reported negative findings, the “it's all in your head” attitude was a prevalent response, and the classic notion of the hypochondriac was a frequent implication. The term hypochondriac itself is revealing in medical history. The term actually means below the ribs, with hypo- meaning below or under, and chondrial referring to the rib cage. Many patients, especially women, with complaints of symptoms of fullness and discomfort under the rib cage in the abdomen were dismissed when no significant test findings revealed classic physical diseases such as peptic ulcers or heart problems. Subclinical liver dysfunction and gallbladder congestion were the actual cause of these complaints in most cases, and sometimes they were episodic and dependant on cyclical stress on liver metabolism related to menstrual cycles and hormonal fluctuations. The term “hypochondriac” was dismissive. In modern years, the patient still receives such common dismissiveness, with more difficult to diagnose chronic problems attributed to “stress” or aging. Many chronic pain complaints are now treated with anti-anxiety and anti-depression drugs, and anti-psychotic drugs are being used extensively for a wide variety of off-label symptoms. In effect, some degree of “placebo effect” is being tried by prescribing so many psych drugs for so many different physical complaints.

Perhaps nothing describes the present quandary over public trust and the placebo effect like a New York Times article in the Sunday Review of July 10, 2011. Here, Peter D. Kramer, a Brown University professor of psychiatry, bemoans the spate of articles by experts in the field that doubt the actual efficacy of antidepressant drugs. This article, entitled In Defense of Antidepressants, makes the case that antidepressant drugs did not statistically outperform placebo pills by a significant effect for mild to moderate depression, or show appreciable long term benefits versus an array of health risks, when the fully array of research was reviewed by Dr. Irving Kirsch, a reknowned professor of psychology and research specialist, because the pharmaceutical companies were so nervous about having to conduct two clinical trials by the government that they rushed these studies without analyzing the study participants properly. The rationale in this article was that the poor pharmaceutical companies were rushed into completing human clinical drug trials and so allowed patients without actual depression into these trials, thus creating excess positive benefits for the placebos. Now, logically, even if this could possibly be true, and the poor pharmaceuticals were not paying attention to choosing patients in their clinical drug trials that would make them look good, one has to ask why this logic does not apply to the group taking the antidepressant drugs as well. If these studies were rushed and patients got into the clinical trials without actually experiencing a depressive mood disorder, this would logically make the outcomes better for the patients in the study taking the actual drug as well. Reading this article, which supports antidepressant drugs, may serve to undermine public trust even more than the books and articles cited that cast doubt. Dr. Kramer’s 1993 book, entitled Listening to Prozac, heavily promoted this SSRI medication, noting that it made patients feel “better than well” and perhaps healthy patients should take Prozac as well to induce more socially desirable personality traits. Why Dr. Kramer is now responding to a 2002 article in Newsweek magazine by Dr. Kirsch, titled “The Empereror’s New Drugs”, in which Dr. Kirsch, a University of Connecticut and University of Lum, United Kingdom, professor, researcher, and psychologist, and expert on the placebo effect, states that in reviewing all clinical study data, not just that data proven to be selectively presented when seeking approval, that antidepressant drugs “may have no meaningful pharmacological effect at all”, is not clear. As always the story on drugs, research and public trust is so complicated as to conveniently confuse the public.

Much is made of the placebo effect, but does the public actually understand what this is and why drugs are compared to placebo? The placebo effect is the benchmark for modern scientific evidence of effectiveness of new drugs. After World War II, many new synthetic pharmaceuticals emerged from the vast amount of medical research and often misguided experiments performed by various nations during the war. In fact, the main reason for the wide number of civilian internment centers in World War II, by not only the Germans and Japanese, but many countries, was not a strict racial, religious or ethnic “cleansing”, but the urge to research many of the medical findings that emerged from extensive creation of chemical warfare agents in World War I, such as mustard gas etc., and the synthetic drugs created to treat numberous health problems that threatened to undermine military effectiveness. Before World War II most drug medicines were still based on herbal chemistry. After World War II, the science of synthetic drug medicine thus grew in an explosive manner. The U.S. created regulatory agencies to insure that a degree of safety was assured for these new drugs on the market when some of them created public alarm with unforeseen deaths, birth defects, and severe medical harm and risk. Public mistrust in the institutions that created new synthetic medicines prompted government intervention and minimal guidelines.

It was in World War II that an anesthesiologist by the name of Dr. Henry Beecher discovered that a nurse working in the surgical theater with him was giving shots of normal saline solution to wounded soldiers when supplies of morphine ran low, and that these injections had a remarkable placebo effect to relieve pain. After the war, Dr. Beecher continued his study at Harvard and studied the placebo effect, eventually publishing important papers outlining these effects, and proposing that the FDA improve its evaluation of new pharmaceuticals by including a randomized and double-blinded trial that compared the drug effects and side effects to that of the placebo. Dr. Beecher published the famous article entitled The Powerful Placebo in theJournal of the American Medical Association (JAMA), and state that any drug therapy may attribute about 35 percent of its effects to this placebo effect. Eventually, this research was deemed sound, and the FDA adopted the RCT, or randomized controlled trial, to assess more fully whether a new drug actually had a measurable effect beyond the placebo effect. The question was not whether the drug outperformed the placebo, but by how much.

The Federal Food and Drug Administration (FDA) arose from the 1944 Public Health Service Act, which had its root in the Federal Food Drug and Cosmetic Act of 1938, the first significant regulatory agency of new drugs. Failures of the Public Health Service Act, which depended upon a large body of expert physicians and public health experts to advise on the safety of new drugs, somewhat voluntarily according to guidelines, resulted in the Drug Efficacy Study Implementation, which grew out of the Kefauver-Harris Drug Control Act of 1962, which required proof of effectiveness and safety of all new drugs before approval. This amendment of the Federal Food, Drug and Cosmetic Safety Act was spurred by the introduction of the drug Thalidomide, a morning sickness medication in pregnancy, that resulted in thousands of children being born with serious birth defects. Besides the evidence of physiological effect in scientific study, drugs had to prove that they were both safe and effective. The balance of risk versus benefit needed to be considered by the FDA to judge the appropriate level of safety, and the degee of actual effectiveness determined the allowance of increased risk. The chosen way to judge this was to compare the developed drug to a placebo in a series of clinical trials on human volunteers, simultaneously comparing efficacy to the placebo, and recording the side effects noted in both the patients using the drug and the placebo. The placebo effect, though, made this assessment more difficult, as patients taking the placebo showed both positive effects and increased incidence of potential side effects. This, in a sense, has made medical research a complicated issue to objectively evaluate, and an a priori assumption that the placebo has no actual effect an integral part of the official analysis of research.

Since this time, the notion that modern science was only validated by such evidence has become an accepted part of our scientific perspective as a whole. Empirical evidence, or observational evidence, of effectiveness and safety was deemend “unscientific”. Proof of efficacy, or effectiveness, was purely judged by comparison to a placebo, and sufficient proof of effectiveness greater than the “placebo effect” became the benchmark for judging how much risk and side effect we allowed in new drugs. An industry and science was created to design these human clinical trials in such a way to prove a large degree of effectiveness, so that increasingly risky drugs could be introduced onto the market under the FDA guidelines. Passage of the 1962 Drug Efficacy Amendment (Kefauver Harris Amendment) to the Federal Food, Drug and Cosmetic Act became the benchmark for regulation of new medical drug safety by assessing the actual positive effectiveness of the drug in human trials compared to placebo, and analyzing this degree of actual effectiveness, or efficacy, in relation to health risks presented by the drug. When negotiating this drug safety legislation, the pharmaceutical industry got certain concessions to insure business success, the most important of these concessions was the linking of the amount of money spent on research, development and clinical trials to be tied to the length of time that the company could hold an exclusive patent to the created drug before this became public domain. The length of time before the drug became “generic” determined the profits to be gained, and this was proportional to the amount of money spent on research, development and clinical trials. In time, this has added an enormous cost to medications for public health problems, and to the costs to government in the form of prescription drug benefits paid out under government programs. The “placebo effect” has become a very important issue to the enormous profits of the big pharmaceutical industry, and healthcare in general.

Implications of the placebo effect in judging efficacy of a variety of nonpharmaceutical treatments, including acupuncture stimulation

In recent years, large analysis of the placebo effect has found that it is still poorly understood, and that it has in fact changed over the last 40 years since the initiation of placebo clinical trials for drugs to judge benefit versus risk in the population. Studies have shown that the placebo effect in these clinical trials has in fact increased in efficacy itself. In effect, since 1962, the year of introduction of the Drug Efficacy Amendment to the Federal Food, Drug and Cosmetic Act, the ability of the placebo pill to actually improve the symptoms and health of the patient in clinical trials has steadily increased as the public has become more used to the notion of the placebo as a sound scientific principle employed in modern scientific method. In many cases, the new drugs being tested, no matter how potent they are, perform only slightly better than the placebo, and both the drug and the placebo appear in the clinical trials to have a very positive effect. Of course, one thing that is overlooked in general in these trials, is that we are also comparing the adverse effects seen in the patients receiving the drugs to these same effects noted in the placebo group. The curious fact is that the adverse effects noted in the placebo group have also increased over time. This works to the advantage of the drug industry, though, because the drug, despite the evidence of many adverse effects, does not seem to produce adverse effects much worse than the placebo. The entire evaluation of safety and efficacy is being altered by the apparent strength of the placebo effect in the general population. Some extreme examples of the placebo effect studies include a Japanese study of chemotherapy drugs for cancer. In this now famous study, a large group of patients volunteered to receive a new chemotherapy drug, and the patients were told to expect that their hair would fall out due to adverse effects of the drug. Not only all of the patients taking the drug had significant hair loss, but almost all of the patients in the placebo group also lost their hair. The dramatic efficacy of the placebo effect was, and is, baffling. Some mental process must by causing objective physiological changes that were as potent as any tangible drug we could create.

These findings are not widely discussed, though. The public, and research scientists and physicians, all have tried to avoid the subject of the placebo effect as much as possible. The level of uncertainty and distrust in modern science that could be generated from this topic is enormous. On the other hand, many competing medical treatments over the years, such as nearly all traditional medicines, had been routinely dismissed as quackery that had nothing to do with modern science, and were accused of being effective in the history of humankind because of the placebo effect, and not because of merits of the medicine itself. Acupuncture was a prime example of such criticism. Since the insertion of hair-fine needles under the skin does little by itself, and works purely by stimulating trigger points to effect normal physiological reactions, many of them in the mind, or brain, standard medicine dismissed the science of acupuncture as a mere “placebo effect”. This was an ironic criticism, since the placebo effect was shown to be very effective in the very clinical trials that proved efficacy of modern drugs. The standard medical industry went even farther with their criticisms, and demanded that the same double-blinded placebo-controlled clinical trials be used to prove efficacy of acupuncture before it was allowed to be paid for by standard insurance and government health programs. Despite an enormous amount of evidence of physiological effects and benefits from acupuncture, much of it dating to the nineteenth century in Europe, especially France, acupuncture was not going to be paid for, or incorporated into the standard medical system, until it passed these placebo-controlled trials. Now, this, of course, was problematic. Designing a placebo for sticking a patient with a needle, or any manual treatment technique for that matter, was a difficult problem. Blinding both the patient and the treating physician in the trial to whether they were using the “placebo” acupuncture or the real stuff was also an obvious problem. This type of difficulty, though, actually spurred an intense amount of research and study in the field of acupuncture. The challenge to researchers was enormous, and acupuncture became the most scientifically studied manual treatment in human history. The only problem was that in designing double-blinded human clinical trials with supposed “placebo”, or sham, acupuncture, that the actual acupuncture stimulation was dumbed down to such methods as an insertion via a blinded box on the skin. This type of acupuncture has much less potential effect than an expert actually using real stimulation techniques to achieve the correct trigger point effects. Since the introduction of these simplified human clinical trials of acupuncture, many human trials have now proven that actual needle stimulation techniques are much more effective than simply inserting the needle without stimulation.

Now, other manual therapies, such as surgery, electrical stimulation, physiotherapy, massage, etc. were not studied and proven with double-blinded placebo-controlled human clinical trials. The AHRQ (Agency for Healthcare Research and Quality), a part of the NIH (National Institutes of Health) and a part of the U.S. Department of Health and Human Services (which also includes the FDA), issued a statement in about 2005, showing that less than 15 percent of manual therapies were proven effective by a double-blinded placebo-controlled human clinical trial. Acupuncture, in fact, was almost the only manual treatment that was proven effective with this standard, according to the AHRQ! Surgery and other manual medicines did not have to prove efficacy with double-blinded placebo-controlled human clinical trials to approve use and payment. This demand on acupuncture was merely a means to delay its public acceptance. Certainly, these types of trials, designed to protect the public from adverse harm from new pharmaceutical synthetic drugs, were not demanded to protect the public from harm in acupuncture. The scientific community already understood that acupuncture was proven to be the safest medical treatment in human history, with almost no adverse effect or injury at all. The long history of this involved putdown of acupuncture and Traditional Chinese Medicine did also spur an intense interest in world research into the subject of the placebo and the placebo effect, though, which has been very elucidating.

A placebo is a simulated medical intervention, or sham treatment. The placebo effect was noted a long time ago, as the placebo, or sham treatment, also produces perceived or actual medical improvement. Placebos have historically long been used in medicine to treat patients, usually when standard treatment did not work. Even in ancient history, the documentation of placebo treatment was acknowledged as able to achieve great success with some patients when nothing else worked. The ethics of prescribing placebos, though, has been a considerabel disincentive, as this entails lying to, or deceiving, the patient. Nevertheless, this type of therapy has been widely considered by governmental health authorities throughout history, and usually discouraged because of the deception involved, decrease in public trust engendered by the practice, and supposedly unpredictable and unreliable outcomes of treatment. The book The Powerful Placebo in 1955, by Henry K. Beecher, generated quite the renewal of scientific interest in the subject, as well as extreme debate. When trying to access the 1955 Journal of the American Medical Association (JAMA) article on this important research publication today, the public now finds that the original article reviewing Beecher's research has been removed. This debate over the placebo effect became so intensified, with widespread acknowledgement of the placebo effect as an effective protocol, as evidenced by thousands of human clinical trials, that an effort was made to analyze this subject again, and again try to discount the placebo effect. In the meantime, a number of medical doctors were impressed with the placebo effect and had their patients sign agreements to the potential use of placebo in their therapy, thereby skirting the issue deceiving patients. The American Medical Association responded by condemning this practice. Some medical specialties, such as psychotherapy, touted the powerful benefits of the “placebo effect” in their work, though, and cited meta-analysis that showed that much of the positive effect of psychotherapy was in part due to the placebo effect. This branch of medicine, now an integral part of “mind-body medicine” had been criticized and denied insurance and government funding in the same way that acupuncture had been. Meta-analysis of research (cited below) in 2005 found that in some areas of treatment, such as depression disorders, research shows that the placebo pill actually outperforms standard pharmaceutical medication, whereas in psychotherapy, standard treatment consistently outperformed placebo psychotherapy.

Due to the amount of research investigating the placebo effect, especially in relation to acupuncture, this issue again surfaced in the 1990s. Denial of payment for the legitimate and proven effects of acupuncture was still in effect, and much of the reasoning behind this denial of an effective medical practice was that we did not really know whether these positive benefits could be attributed mainly to a placebo effect. Critics of this reasoning stated that even if acupuncture worked to some extent because of a placebo effect, that it still worked, and the patient was agreeing in full knowledge to receive the treatment. The criticism of acupuncture had generated a renewed debate about the embarassing placebo effect in medicine.

In 2001, a meta-analysis of the placebo effect was again conducted by the University of Copenhagen Department of Medical Philosophy and Clinical Theory (Asborn Hrobjartsson MD), which concluded with a systematic review of the Cochrane database that there was no evidence to support the notion that placebos had powerful clinical effects. A careful reading of the study produces some disturbing questions, though. The study authors also stated that although placebos did consistently show benefits on studies, that no significant effects on objective or binary outcomes was evident when compared to randomly chosen patient populations that received no treatment whatsoever, although they acknowledged that true benefits with placebos were seen in the treatment of pain in these studies, and when studies recorded continuous subjective outcomes. Now, the limiting of data to studies that actually recorded the outcomes of the placebo success, and that included a randomly chosen group that received no treatment, to establish this as a baseline, limited this study to only about 120 studies out of many thousands, or even hundreds of thousands. The choice of statistically judging the placebo effect with a binary outcome, which means that the outcome was judged only by two values, success or failure, severely limited the scope of analysis. When continuous subjective outcomes were measured, the effects of placebos were evident. Many researchers may claim that the outcome of this study was determined by the study design (or, in fact, rigged). And, in fact, this same ploy was used in the past to discount the placebo effect. Nothing new, here is some money, this is what I want to determine, design a study, publish the findings, and quote this study as the definitive proof. Unfortunately for the pharmaceutical industry, this study was widely criticized, and a subsequent study in 2010 had to be performed to try to get rid of the widespread continuing belief that scientific research shows that the placebo effect is indeed real. A big problem for health authorities and standard medicine had again occurred, and just won't go away.

The ongoing debate over the placebo effect affects not only the public perception of pharmaceutical drug efficacy, but is integral to the subject of mandating health care coverage of acupuncture and Complementary Medicine. On the one hand, acupuncture could not be paid for until it was definitively proven to not work via a placebo effect, and on the other hand, the placebo effect was being denied even its existence. This presents a complex and confusing conundrum for the health care industry. The denial of real positive physical benefits from acupuncture stimulation hinges on the notion that these effects are completely explained by the placebo effect, yet acknowledging the power of the placebo effect calls into question our whole system of judging drug safety by comparing effects of drugs against a placebo. Mental puzzles like these are not comfortable issues, and we are easily convinced to avoid thinking about them too much. But what are we to trust?

One problem for standard medicine is that if the public believes that the placebo effect is real, that trust in the randomized double-blinded placebo-controlled trials, and thus trust in the pharmaceutical industry, may be further undermined. This would equal a big loss of profit, and since most of modern medicine has evolved into writing pharmaceutical prescriptions, the loss of income may be substantial. The real question that many medical ethicists and philosophers ask, though, is not whether we should be administering placebos as standard therapy, which may never be acceptable to the public or the physicians, but how do we use the placebo effect and the knowledge of the study of the placebo effect to come up with treatments that actually benefit the public. A number of proposals and theories have resulted. In response to the 2001 attempt to once again discount the placebo effect, Daniel Moeoman and Wayne Jonas MD, proposed in the Annals of Internal Medicine that the term “placebo effect” in modern use often had little to do with an actual placebo, and the debate confused the public, and perhaps we should rename the effect “meaning response”, reflecting the broad observed and measured effects given to belief, as well as therapies that had little or no intrinsic objective effect on their own, such as acupuncture, but still elicited a measurable objective, as well as a subjective, effect. In modern terms, these experts stated, the term “placebo” has been applied for effect to a wide number of beneficial biological, social and human interactions, such as counseling in so-called “faith healing” as well as a wide number of medical treatments, many of which have been used successfully for millenia and now discounted as a so-called “placebo”. Such therapies that are now proven successful, such as color therapy, magnetic therapy, sound therapy, art therapy, and even prayer, as well as Qi Gong, Reiki, Therapeutic touch, etc. are now becoming again popular and accepted, even by some prominent medical organizations, yet we continue to discount the effects as placebos, when these interventions are not like a placebo pill in pharmaceutical studies. Even with placebo pills, studies have shown measurably different responses when one pill is red and the other blue. The mind-body effects here are complicated, and the general learned beliefs, cognitive and behavioral patterns in society and the human genome and epigenome are indeed complex.

A study of the placebo effect in 2010, headed by Ted Kaptchuk, Associate Professor of Medicine at Harvard Medical School, received much attention in the press because the participants, 80 patients with more severe symptoms related to Irritable Bowel Syndrome, improved remarkably when taking a pill that they were told was a placebo. The patients who were randomly assigned to a group that were given pills marked placebo showed significant improvement over those that received no pill or treatment whatsoever. These patients were told that the placebo pills contained an inert substance, such as sugar, that was proven in clinical studies to produce significant improvements in IBS symptoms through mind-body healing processes, and that following a strict schedule and dosage was critical to the effect. 59 percent of the patients taking the pills marked placebo showed significant improvement, compared to 35 percent of those that were not given any pills. All participants continued on their standard therapeutic regimens, and all participants received the same warm and empathetic attention from physicians administering the trial. The outcome was measured by questionaires that asessed symptoms of discomfort, pain, bloating, constipation and diarrhea. The results were remarkable given that the patients were told that they were taking a placebo pill that contained no actual medicine. If this were a trial of a pharmaceutical drug, this drug would be hailed as a remarkably successful and potent new drug, and billions of dollars in profit would be made. This clinical trial demonstrated the complex scope of the “placebo effect” in clinical practice. Another larger trial is being designed at this time to confirm these findings of the effectiveness of the placebo even when the patient is informed of treatment utilizing a placebo.

Some of the questions that arise from this study are 1) do most people think that they are actually being tricked in such a study, and actually taking an effective medicinal pill? 2) how much can we really trust standard blinded, placebo-controlled trials of pharmaceutical medicines if the placebo works so well, and some of the effects of the real pill are a placebo effect? 3) What exactly makes a person get better? 4) does the general public now fully believe in mind-body healing effects? and 5) how do we utilize this effect in clinical practice? The questions that Dr. Kaptchuk was trying to answer is how does a placebo effect work? Ted Kaptchuk is a reknowned physician that practices acupuncture and Traditional Chinese Medicine (TCM) successfully, heading pain clinics at various Boston hospitals in his career since earning a Doctor of Oriental Medicine in 1975 by completing study at the Macau Institute of Chinese Medicine in southern China. Dr. Kaptchuk served as director of a pain and stress clinic at Lemuel Shattuck Hospital in Boston, and now directs the Asian Medicine and Healing Program at Harvard, where he holds the title of Associate Professor. The difficulties of convincing medical doctors that acupuncture did more than just exert a placebo effect, despite very successful outcomes of almost all clinical studies with patients, has been a motivator for Dr. Kaptchuk to thoroughly study the placebo effect. Early in his career, he wrote a widely read book on acupunture and TCM called The Web that has no Weaver, which sought to explain Asian traditional medical science in terms that were familiar to modern scientists. Later, as scientific study of the effects of acupuncture stimulation and herbal medicine were conducted in Europe and the United States, under the stipulation that acupuncture must adhere to standards of clinical trials set up to judge the safety and efficacy of new drugs, which no other manual medicine in modern use had to adhere to, Dr. Kaptchuk found himself swimming uphill, or against the tide of a strong bias in Western medical journals and research. If he said, well, in a sense, the acupuncture stimulation, which is fairly inert on its own, does exert a type of “placebo effect”, and this is its strength, and makes it an effective and safe therapy when performed correctly, standard medical experts would say, “Aha”, I told you it was just a placebo effect, and not real or dependable. If Dr. Kaptchuk would say, but it‘s not really a placebo effect like that from a sugar pill, since it actually stimulates a set of real physiological reactions, like ultrasound or cold radiation therapy, then the medical experts would say then that most of the effects attributed to it were only “placebo effects” that depended upon the relationship of the patient and physician, or the beliefs of the patient. This circular putdown seemed like it would go on forever, and was often published in newspapers and magazines, as well as being constantly told to doctors and then passed to patients.

A 2008 study that Dr. Kaptchuk participated in found that 50 percent of U.S. physicians admitted to secretly giving placebos to unsuspecting patients. This study was published in the British Medical Journal. The ethical implications, though, to this practice, have long generated much criticism, both in the medical community and the patient public, and the threat of lawsuits from this practice is obviously high. On the other hand, recent studies show that in some parts of the United States, an examination of pharmaceuticals showed that almost 20 percent of them were fake, or contained medication but not manufactured by the company that the drug label indicated. Studies have also shown a widespread market in expired drugs that were relabeled and sold by relatively large businesses. One wonders whether a significant amount of benefits are derived as a placebo effect from these illicit drugs. Perhaps an expanded attitude toward placebo effects and use of placebos will soon become part of our sociocultural norm. This may finally dispel the criticisms of acupuncture as a mere placebo.

By 2012, we finally have seen some serious randomized controlled trials of manual procedures and devices, such as surgery and pacemakers. The U.S. government databaseClinicalTrials.gov, though, reports that only 4.8 percent of new protocols for medical devices utilize a sham device in human clinical trials. One such study, with a sham cardiac pacemaker utilized, revealed that the actual cardiac pacemaker had no benefit greater than a placebo device. A 2002 surgical study of arthroscopic surgery to repair osteoarthritic knees utilized a sham surgical procedure that left the patient with incision scars, and the long-term outcomes with real and sham surgery showed no statistically significant difference. As more of these RCTs of surgical procedures and medical devices are finally performed, serious questions are being raised, as with acupuncture, concerning the extent of the placebo effect, and the proven efficacy of the procedure or device over placebo.

The questions of trust, distrust, belief, and the many aspects and implications of the placebo effect will continue to be a defining problem in modern medicine for some time. The introduction of a more patient-centered approach, mind-body medicine, and integration with holistic medical sciences is a positive step forward for humanity, though. Hopefully, as a society and culture we can use this tricky subject and debate to make our healthcare system more effective, economical, and safer.

Comparison of the effects and benefits proven by randomized, placebo-controlled human clinical trials of acupuncture and herbal medicine compared to these effects and benefits seen in the same randomized, placebo-controlled human clinical trials of pharmaceutical drugs and standard therapies

For many years, the public has been convinced that acupuncture and herbal medicine is not a scientifically valid medical science, purely because there is not sufficient modern scientific proof from randomized, double-blinded, placebo-controlled human clinical trials (RCTs). Now, scientific method has used many means to judge scientific validity besides these trials, which were only demanded as a means of scientific judgment in the 1950s when the U.S. government created an agency to oversee and regulate new synthetic pharmaceutical drugs and cosmetic drugs. These types of trials were created as the easiest method to prove safety of new pills, not as a means of proving effect. In fact, it was well known to scientists at this time that the placebo effect was very powerful, and comparison to placebo was not a completely valid means of judging the degree of effect of the new drug. Nevertheless, this type of trial was simple, and effective, to gauge the relative safety, and the results of the both beneficial effects and negative effects of the drugs, compared to the placebo effect, could help regulators gauge the risk versus benefit ratio, and add to the judgment of whether new drugs with significant health risks and side effects were still worth approving for the market. In the past, though, the human culture has used many different scientific methods to explore scientific fact. Even modern scientific method depends on a series of scientific steps, from observation (empirical) to theory, and then confirmation of theory by objective analysis. Some aspects of our reality can be duplicated in a laboratory, and today, we are even building enormously expensive laboratories, such as the large Haldron particle accelerator, to replicate even cosmic effects, such as the creation of actual particle building blocks of physical reality.

On the other hand, some aspects of our reality are not able to be duplicated in a laboratory. Here, scientists observe, measure, hypothesize, theorize, and try to objectively confirm theories with these measurements and calculations. In medicine, much or our treatment science is still based on demographic studies, which operate by comparing a section of the population associated with a particular health aspect, and comparing statistics within this population to match one type of fact to another. For example, we take the population that smokes cigarettes, look at their health problems, calculate patterns of disease, and declare that cigarettes cause these diseases. So, the use of a placebo-controlled trial is not the only scientific means of confirming something. With acupuncture, use of a placebo in study is, of course, very problematic, and so much study of the acupuncture effects in the past 180 years measured physiological changes and effects that appeared to result from the acupuncture stimulation. We now know in recent years, with the use of advanced technology, such as the functional MRI, and genetic testing, advanced molecular anaylysis, etc. that the acupuncture consistently produces strong physiological effects, and that these effects correspond to the traditional empirical observations and theories generated over thousands of years. Nevertheless, many scientists insisted that acupuncture was not a proven science until it passed the placebo-controlled trials.

In the last twenty years, acupuncture has become the single most studied medical treatment in history across the world. Much of this was due to the complexity of the physiological effects, and scientific curiosity, but a great amount of this study was generated both by the challenge to deny or confirm medical necessity and payment, and the challenge to actually verify acupuncture effects against a placebo, when the placebo needed to trick both the patient, and the physician administering the test, that this placebo could actually be a real needle stick into the flesh. Of course, in reality, this cannot be truly accomplished. We must settle for a compromise. The compromise was often the use of an acupuncture needle inserted into the skin, but at points other than those being studied, by a Licensed Acupuncturist that was hired and told that this acupuncture needle insertion was real, and should be performed to achieve a therapeutic effect. When the so-called sham, or placebo, acupuncture produced effects similar to the so-called real acupuncture, the scientists controlling the trial acted surprised that this so-called placebo actually worked, producing real benefits. The study summary concluded that the real acupuncture did not outperform this so-called placebo acupuncture by a significantly statistical percent, said statistically significant percent determined by the study designers, of course. The summary stated that there was no proof here that the acupuncture worked better than placebo.

To the astonishment of many, though, even with such a study design, the acupuncture, perfomed in the most minimal manner, without the usual needle manipulation that makes it effective, and utilizing a standardized point selection, instead of the more effective standard individualized point selection in actual clinical acpuncture practice, did significantly produce amazing therapeutic benefits and outperformed the so-called placebo, which was actually often just another actual needle stimulation. In the most accepted study design, a device, such as a box that held a guide tube for a needle, was used, thereby allowing the study to use sham needles that showed only the needle handle and lacked an actual needle point. The problem with this study design was that the patients probably could tell that they were not being stuck, and the physician administering treatment could only tap a needle handle, not actually use a trained technique to elicit the physiological responses important in acupuncture. In some cases, you could say that no real acupuncture stimulation, as seen in normal clincial use, was actually performed, and in these strange treatment trials, the effects could theoretically all be attributed to a placebo effect, since even the real acupuncture was not actually real acupuncture, but just a mechanical tapping of a needle into the skin.

Considering these obvious problems with this study design to judge acupuncture efficacy, how did these randomized, placebo-controlled human clinical trials actually compare to the same type of pharmaceutical trials. Let's look at an analysis of this question, performed by the standard of medical scientific analysis that most professionals cite, the Cochrane Library. A 2005 report of all CAM-related systematic reviews of randomized clinical trials (RCTs) of Complementary Medicine, meeting the most rigorous standards, compared to conventional treatment: These studies in the Cochrane Report found that for CAM, 38.4% of all studies concluded positive effect or possibly positive (12.4%) effect, 4.8% concluded no effect, 0.69% concluded harmful effect, and 56.6% concluded insufficient evidence. An assessment of conventional treatments (i.e. mostly pharmaceuticals) found that 41.3% concluded positive or possibly positive effect, 20% concluded no effect, 8.1% concluded net harmful effects, and 21.3% concluded insufficient evidence. However, the CAM review used the 2004 Cochrane database while the conventional review used the 1998 Cochrane database. These findings show that Complementary Medicine (most often in the form of acupuncture and herbal medicine) showed a medical treatment efficacy in RCTs comparable to scientific evidence of standard therapies, yet a considerably safer overall effect. This is not the impression that we usually get, though, from standard experts in the field, or from published stories in newspapers, magazines, hospital websites, insurance websites, or even government websites. This actual comparison is, in fact, astonishing. The fact that these acupuncture trials, with all the above stated problems to overcome, in fact performed as well as pharmaceutical trials, with much less evidence of harmful effects, is incredible.

Despite all of these facts, though, the vast majority of the public in the U.S. are still expected to believe that acupuncture and professional herbal and nutrient medicine, or Complementary Medicine, is still not proven scientifically. Slowly, this belief is changing, but the public in general now believes that more people actually “believe” acupuncture and herbal medicine than is actually the case. A 2002 study by the Centers of Disease Control found that while over 76 percent of Americans reported using Complementary and Alternative Medicine (CAM), that less than 2 percent had used acupuncture in the prior year. In this study, prayer was cited as the type of CAM used by about 45%, and self-medication with commercial non-prescribed herbs and nutrients was cited as about 20% of CAM therapy. Even meditation and yoga was cited as the form of CAM utilized more frequently than even chiropractic medicine. Sadly, despite a vast amount of scientific evidence, the belief and trust of the public is still easily manipulated by a commercial industry, and real scientific evidence is easily discounted. Now, human culture has long ago separated the physical and metaphysical, or science and religion. In science, we learn and observe the facts to generated a logical judgment. In religion, the subjects elude measurement, and in this realm we must believe. Nevertheless, the most frequently heard statement concerning acupuncture is whether or not you “believe” in acupuncture, despite the fact that acupuncture is not a religion, but a science. The second most frequently heard statement concerning acupuncture is whether you have a needle “phobia”, but this is another realm of societal belief that we perhaps shouldn't even get into here.

Information Resources

A 2002 article addressing the problems in labeling treatments as placebo effect and treating such a wide array of therapies as a placebo, without nuancing this meaning, and making it seem as if all of these theapies were the same as a sugar pill, is discussed in this article in the Annals of Internal Medicine: http://www.annals.org/content/136/6/471.full Placebo responses have been attributed to standard therapy as well. This 1968 article in Rheumatology examines the anti-inflammatory effects of ultra-sound therapy as a placebo effect: http://rheumatology.oxfordjournals.org/content/25/1/77.long A 2005 analysis of the placebo effect at the University of Wisconsin found that re-analysis of the studies used to deny the placebo effect in 2001 in fact showed that the placebo effect was robust and actually approaches the treatment effect in a number of medical disorders. For example, with the treatment of depression, pill placebo therapy is shown to be nearly as effective as active medications, wheras pyschotherapies are shown to be more effective than psychological placebos in human clinical trials:http://www.ncbi.nlm.nih.gov/pubmed/15827993 A 2003 review of the placebo effects in clinical trials of antidepressant medication found that in the trials that demonstrated a high placebo response (>30% improvement of symptoms with a placebo pill), the placebo actually outperformed the medication in about 80% of cases, whereas in studies demonstrating a low placebo response (less than a 30% improvement over baseline symptoms with use of a placebo pill) the medications consistently outperformed the placebo pills, although not dramatically. The variance in the placebo response is thought to be a factor of study design, and highlights the complexity of the placebo effect: http://www.ncbi.nlm.nih.gov/pubmed/12695731 A 2006 study of placebo effects utilizing a sham acupuncture device versus an inert pill, conducted by Ted Kaptchuk DOM, Associate Professor at Harvard Medical School, showed that the placebo effect is indeed nuanced and complex:http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1370970/?tool=pmcentrez A number of studies, including one large study printed in the British Medical Journal, in 2008, showed that a survey of U.S. physicians found 50% admitting to using a placebo pill in treatment at some time in their career:http:/www.findingdulcinea.com/news/health/September-October-08/Doctors-Placebo-Prescriptions-Have-Some-Crying-Foul.html A 2010 study by Dr. Kaptchuk at Harvard found that the placebo effect worked even when the patients were told that they were taking an inert placebo:http://www.whereismydoctor.com/news/placebos-work-even-if-patients-are-in-on-the-secret_948 A 2010 article in the New York Times Health section by Dr. Amir Afkhami, an assistant professor at George Washington University, and an author of the U.S. State Department's Iraq Mental Health Initiative, found that interviewing and observing an Islamic faith healer showed that there was much similarity in his approach to standard supportive therapy in Western medicine, and the effects, which could be labeled a sham, or placebo effect, were indeed helpful to the patient observed and counseled:http://www.nytimes.com/2010/12/28/health/28cases.html

 

Below are Books

Back in Control: A spine surgeon's roadmap out of chronic pain
Back in Control: A spine surgeon's roadmap out of chronic pain

In Back in Control, Dr. Hanscom focuses on an aspect of chronic pain that the medical world has largely overlooked: you must calm your nervous system in order to get better. Beyond any other book about back pain, Back in Control reveals how to quiet a turbocharged central nervous system and make a full recovery. His life-changing system has helped hundreds of patients heal their pain. These patients’ stories, as well as his own, show that you can take charge of your care and set yourself on the road to a healthy, rich and full life.

Back in Control: A spine surgeon's roadmap out of chronic pain

This book needs to be out there for everybody who could finally get rid of back pain.

7 Steps to a Pain-Free Life: How to Rapidly Relieve Back and Neck Pain
7 Steps to a Pain-Free Life: How to Rapidly Relieve Back and Neck Pain

The magic cure is the McKenzie Method--seven very specific exercises that allow the spine to return to its natural position. But forget the doctors--McKenzie asserts that the management of your back pain is your responsibility. Practice his seven unique exercises (the book includes seven each for the back and neck) consistently and at regular intervals and just about anyone can cure his or her own back or neck pain without the help of professionals.

7 Steps to a Pain-Free Life: How to Rapidly Relieve Back and Neck Pain

I highly recommend this book to anyone with neck and back pain.

Back Sense: A Revolutionary Approach to Halting the Cycle of Chronic Back Pain
Back Sense: A Revolutionary Approach to Halting the Cycle of Chronic Back Pain

Drawing on their work with patients and studies from major scientific journals and corporations, the authors of Back Sense–all three are former chronic back pain sufferers themselves–developed a revolutionary self-treatment approach targeting the true causes of chronic back pain. It is based on conclusive evidence proving that stress and inactivity are usually the prime offenders, and it allows patients to avoid the restrictions and expense of most other treatments. After showing readers how to rule out the possibility that a rare medical condition is the source of their problem, Back Sense clearly and convincingly explains the actual factors behind chronic back pain and systematically leads readers toward recapturing a life free of back pain.

Back Sense: A Revolutionary Approach to Halting the Cycle of Chronic Back Pain

I recommend this book for anyone who has ever suffered from neck or back related pain.

Healing Back Pain: The Mind-Body Connection
Healing Back Pain: The Mind-Body Connection

Dr. John E. Sarno is a medical pioneer whose program has helped thousands of thousands of people overcome their back conditions--without or drugs or dangerous surgery. Now, using his groundbreaking research into TMS (Tension Mytostis Syndrome), Dr. Sarno goes one step further: after identifying stress and other psychological factors in back pain, he demonstrates how many of his patients have gone on to heal themselves without exercise or other physical therapy.

Healing Back Pain: The Mind-Body Connection

Most of the people I tell about the book say things like, "Oh - I'm sure that would work for most people, but my back pain is different - it's real.

The Pain-Free Program: A Proven Method to Relieve Back, Neck, Shoulder, and Joint Pain
The Pain-Free Program: A Proven Method to Relieve Back, Neck, Shoulder, and Joint Pain

If you're one of the millions who suffer from chronic back, neck, shoulder, and joint pain, all you can think about is relief. Now, exercise physiologist Anthony Carey presents a breakthrough whole-body approach to pain relief that will help your body function and heal the way it was designed to.

The Pain-Free Program: A Proven Method to Relieve Back, Neck, Shoulder, and Joint Pain

A must read for any back pain patient or doctor!

End Back Pain Forever: A Groundbreaking Approach to Eliminate Your Suffering
End Back Pain Forever: A Groundbreaking Approach to Eliminate Your Suffering

Norman Marcus, one of the nation’s leading back pain specialists, estimates that more than 75 percent of back pain cases can be cured by treating the muscles rather than through surgery or drugs. Yet too many doctors don’t recognize this, leaving patients struggling for solutions.

End Back Pain Forever: A Groundbreaking Approach to Eliminate Your Suffering

An excellent guide for the sufferer of back pain.

8 Steps to a Pain-Free Back
8 Steps to a Pain-Free Back

Step-by-step guide designed to help those suffering from back pain re-educate their bodies and regain the posture for which our bodies evolved. 

8 Steps to a Pain-Free Back: Natural Posture Solutions for Pain in the Back, Neck, Shoulder, Hip, Knee, and Foot

"A great book for someone who is serious about achieving a pain-free back and willing to work to reach that goal."  —American Association of Orthopaedic Surgeons

Foundation: Redefine Your Core, Conquer Back Pain, and Move with Confidence
Foundation: Redefine Your Core, Conquer Back Pain, and Move with Confidence

Foundation training shifts the focus from the front of your body to the back. By strengthening the full posterior chain and correcting poor movement patterns, you will maximize power, flexibility, and endurance and say goodbye to back pain.

Foundation: Redefine Your Core, Conquer Back Pain, and Move with Confidence

I highly recommend this book to anyone who has constant back pain, is considering back surgery or has back problems in spite of recent back surgery.