Perceived mechanism of effect

Anything classified as alternative medicine by definition does not have a healing or medical effect. However, there are different mechanisms through which it can be perceived to “work”. The common denominator of these mechanisms is that effects are miss-attributed to the alternative treatment.

Placebo effect

A placebo is a treatment with no intended therapeutic value. An example of a placebo is an inert pill, but it can include more dramatic interventions like sham surgery. The placebo effect is the concept that patients will perceive an improvement after being treated with an inert treatment. The opposite of the placebo effect is the nocebo effect, when patients who expect a treatment to be harmful will perceive harmful effects after taking it.

Placebos do not have a physical effect on diseases or improve overall outcomes, but patients may report improvements in subjective outcomes such as pain and nausea.^[119] A 1955 study suggested that a substantial part of a medicine’s impact was due to the placebo effect.^[120][119] However, reassessments found the study to have flawed methodology.^[120][121] This and other modern reviews suggest that other factors like natural recovery and reporting bias should also be considered.^[119][121]

All of these are reasons why alternative therapies may be credited for improving a patient’s condition even though the objective effect is non-existent, or even harmful.^{[116][35][47]} David Gorski argues that alternative treatments should be treated as a placebo, rather than as medicine.^[35] Almost none have performed significantly better than a placebo in clinical trials.^{[8][46][122][76]} Furthermore, distrust of conventional medicine may lead to patients experiencing the nocebo effect when taking effective medication.^[116]

Regression to the mean

A patient who receives an inert treatment may report improvements afterwards that it did not cause.^[119][121] Assuming it was the cause without evidence is an example of the regression fallacy. This may be due to a natural recovery from the illness, or a fluctuation in the symptoms of a long-term condition.^[121] The concept of regression toward the mean implies that an extreme result is more likely to be followed by a less extreme result.

Other factors

There are also reasons why a placebo treatment group may outperform a “no-treatment” group in a test which are not related to a patient’s experience. These include patients reporting more favourable results than they really felt due to politeness or “experimental subordination”, observer bias, and misleading wording of questions.^[121] In their 2010 systematic review of studies into placebos, Asbjørn Hróbjartsson and Peter C. Gøtzsche write that “even if there were no true effect of placebo, one would expect to record differences between placebo and no-treatment groups due to bias associated with lack of blinding.”^[119] Alternative therapies may also be credited for perceived improvement through decreased use or effect of medical treatment, and therefore either decreased side effects or nocebo effects towards standard treatment.^[116]

Use and regulation

Appeal

Practitioners of complementary medicine usually discuss and advise patients as to available alternative therapies. Patients often express interest in mind-body complementary therapies because they offer a non-drug approach to treating some health conditions.^[123]

In addition to the social-cultural underpinnings of the popularity of alternative medicine, there are several psychological issues that are critical to its growth, notably psychological effects, such as the will to believe,^[124] cognitive biases that help maintain self-esteem and promote harmonious social functioning,^[124] and the post hoc, ergo propter hoc fallacy.^[124]

Marketing

Alternative medicine is a highly profitable industry, with a strong lobby. This fact is often overlooked by media or intentionally kept hidden, with alternative practice being portrayed positively when compared to “big pharma”.^[6]

The popularity of complementary & alternative medicine (CAM) may be related to other factors that Edzard Ernst mentioned in an interview in The Independent:

Why is it so popular, then? Ernst blames the providers, customers and the doctors whose neglect, he says, has created the opening into which alternative therapists have stepped. “People are told lies. There are 40 million websites and 39.9 million tell lies, sometimes outrageous lies. They mislead cancer patients, who are encouraged not only to pay their last penny but to be treated with something that shortens their lives. “At the same time, people are gullible. It needs gullibility for the industry to succeed. It doesn’t make me popular with the public, but it’s the truth.^[125]

Paul Offit proposed that “alternative medicine becomes quackery” in four ways: by recommending against conventional therapies that are helpful, promoting potentially harmful therapies without adequate warning, draining patients’ bank accounts, or by promoting “magical thinking.”^[40] Promoting alternative medicine has been called dangerous and unethical.^{[n 11][127]}

Social factors

Authors have speculated on the socio-cultural and psychological reasons for the appeal of alternative medicines among the minority using them in lieu of conventional medicine. There are several socio-cultural reasons for the interest in these treatments centered on the low level of scientific literacy among the public at large and a concomitant increase in antiscientific attitudes and new age mysticism.^[124] Related to this are vigorous marketing^[128] of extravagant claims by the alternative medical community combined with inadequate media scrutiny and attacks on critics.^[124][129] Alternative medicine is criticized for taking advantage of the least fortunate members of society.^[6]

There is also an increase in conspiracy theories toward conventional medicine and pharmaceutical companies,^[34] mistrust of traditional authority figures, such as the physician, and a dislike of the current delivery methods of scientific biomedicine, all of which have led patients to seek out alternative medicine to treat a variety of ailments.^[129] Many patients lack access to contemporary medicine, due to a lack of private or public health insurance, which leads them to seek out lower-cost alternative medicine.^[130] Medical doctors are also aggressively marketing alternative medicine to profit from this market.^[128]

Patients can be averse to the painful, unpleasant, and sometimes-dangerous side effects of biomedical treatments. Treatments for severe diseases such as cancer and HIV infection have well-known, significant side-effects. Even low-risk medications such as antibiotics can have potential to cause life-threatening anaphylactic reactions in a very few individuals. Many medications may cause minor but bothersome symptoms such as cough or upset stomach. In all of these cases, patients may be seeking out alternative therapies to avoid the adverse effects of conventional treatments.^[124][129]

Prevalence of use

According to recent research, the increasing popularity of the CAM needs to be explained by moral convictions or lifestyle choices rather than by economic reasoning.^[131]

In developing nations, access to essential medicines is severely restricted by lack of resources and poverty. Traditional remedies, often closely resembling or forming the basis for alternative remedies, may comprise primary healthcare or be integrated into the healthcare system. In Africa, traditional medicine is used for 80% of primary healthcare, and in developing nations as a whole over one-third of the population lack access to essential medicines.^[132]

Some have proposed adopting a prize system to reward medical research.^[133] However, public funding for research exists. In the US increasing the funding for research on alternative medicine is the purpose of the US National Center for Complementary and Alternative Medicine (NCCAM). NCCAM has spent more than US$2.5 billion on such research since 1992 and this research has not demonstrated the efficacy of alternative therapies.^{[122][134][135][136][137][138]} The NCCAM’s sister organization in the NIC Office of Cancer Complementary and Alternative Medicine gives grants of around $105 million every year.^[139] Testing alternative medicine that has no scientific basis has been called a waste of scarce research resources. ^[140][141]

That alternative medicine has been on the rise “in countries where Western science and scientific method generally are accepted as the major foundations for healthcare, and ‘evidence-based’ practice is the dominant paradigm” was described as an “enigma” in the Medical Journal of Australia.^[142]

In the US

In the United States, the 1974 Child Abuse Prevention and Treatment Act (CAPTA) required that for states to receive federal money, they had to grant religious exemptions to child neglect and abuse laws regarding religion-based healing practices.^[143] Thirty-one states have child-abuse religious exemptions.^[144]

The use of alternative medicine in the US has increased,^[10][145] with a 50 percent increase in expenditures and a 25 percent increase in the use of alternative therapies between 1990 and 1997 in America.^[145] Americans spend many billions on the therapies annually.^[145] Most Americans used CAM to treat and/or prevent musculoskeletal conditions or other conditions associated with chronic or recurring pain.^[130] In America, women were more likely than men to use CAM, with the biggest difference in use of mind-body therapies including prayer specifically for health reasons”.^[130] In 2008, more than 37% of American hospitals offered alternative therapies, up from 27 percent in 2005, and 25% in 2004.^[146][147] More than 70% of the hospitals offering CAM were in urban areas.^[147]

A survey of Americans found that 88 percent thought that “there are some good ways of treating sickness that medical science does not recognize”.^[10] Use of magnets was the most common tool in energy medicine in America, and among users of it, 58 percent described it as at least “sort of scientific“, when it is not at all scientific.^[10] In 2002, at least 60 percent of US medical schools have at least some class time spent teaching alternative therapies.^[10] “Therapeutic touch” was taught at more than 100 colleges and universities in 75 countries before the practice was debunked by a nine-year-old child for a school science project.^[10][75]

Prevalence of use of specific therapies

The most common CAM therapies used in the US in 2002 were prayer (45%), herbalism (19%), breathing meditation (12%), meditation (8%), chiropractic medicine (8%), yoga (5–6%), body work (5%), diet-based therapy (4%), progressive relaxation (3%), mega-vitamin therapy (3%) and Visualization (2%)^[130][148]

In Britain, the most often used alternative therapies were Alexander technique, Aromatherapy, Bach and other flower remedies, Body work therapies including massage, Counseling stress therapies, hypnotherapy, Meditation, Reflexology, Shiatsu, Ayurvedic medicine, Nutritional medicine, and Yoga.^[149] Ayurvedic medicine remedies are mainly plant based with some use of animal materials.^[150] Safety concerns include the use of herbs containing toxic compounds and the lack of quality control in Ayurvedic facilities.^[69][71]

According to the National Health Service (England), the most commonly used complementary and alternative medicines (CAM) supported by the NHS in the UK are: acupuncture, aromatherapy, chiropractic, homeopathy, massage, osteopathy and clinical hypnotherapy.^[151]

In palliative care

Complementary therapies are often used in palliative care or by practitioners attempting to manage chronic pain in patients. Integrative medicine is considered more acceptable in the interdisciplinary approach used in palliative care than in other areas of medicine. “From its early experiences of care for the dying, palliative care took for granted the necessity of placing patient values and lifestyle habits at the core of any design and delivery of quality care at the end of life. If the patient desired complementary therapies, and as long as such treatments provided additional support and did not endanger the patient, they were considered acceptable.”^[152] The non-pharmacologic interventions of complementary medicine can employ mind-body interventions designed to “reduce pain and concomitant mood disturbance and increase quality of life.”^[153]

Regulation

The alternative medicine lobby has successfully pushed for alternative therapies to be subject to far less regulation than conventional medicine.^[6] Some professions of complementary/traditional/alternative medicine, such as chiropractic, have achieved full regulation in North America and other parts of the world^[154] and are regulated in a manner similar to that governing science-based medicine. In contrast, other approaches may be partially recognized and others have no regulation at all.^[154] In some cases, promotion of alternative therapies is allowed when there is demonstrably no effect, only a tradition of use. Despite laws making it illegal to market or promote alternative therapies for use in cancer treatment, many practitioners promote them.^[155][156]

Regulation and licensing of alternative medicine ranges widely from country to country, and state to state.^[154] In Austria and Germany complementary and alternative medicine is mainly in the hands of doctors with MDs,^[36] and half or more of the American alternative practitioners are licensed MDs.^[157] In Germany herbs are tightly regulated: half are prescribed by doctors and covered by health insurance.^[158]

Government bodies in the US and elsewhere have published information or guidance about alternative medicine. The U.S. Food and Drug Administration (FDA), has issued online warnings for consumers about medication health fraud.^[159] This includes a section on Alternative Medicine Fraud,^[160] such as a warning that Ayurvedic products generally have not been approved by the FDA before marketing.^[161]

Risks and problems

Negative outcomes

Adequacy of regulation and CAM safety

Many of the claims regarding the safety and efficacy of alternative medicine are controversial. Some alternative therapies have been associated with unexpected side effects, which can be fatal.^[162]

A commonly voiced concerns about complementary alternative medicine (CAM) is the way it’s regulated. There have been significant developments in how CAMs should be assessed prior to re-sale in the United Kingdom and the European Union (EU) in the last 2 years. Despite this, it has been suggested that current regulatory bodies have been ineffective in preventing deception of patients as many companies have re-labelled their drugs to avoid the new laws.^[163] There is no general consensus about how to balance consumer protection (from false claims, toxicity, and advertising) with freedom to choose remedies.

Advocates of CAM suggest that regulation of the industry will adversely affect patients looking for alternative ways to manage their symptoms, even if many of the benefits may represent the placebo affect.^[164] Some contend that alternative medicines should not require any more regulation than over-the-counter medicines that can also be toxic in overdose (such as paracetamol).^[165]

Interactions with conventional pharmaceuticals

Forms of alternative medicine that are biologically active can be dangerous even when used in conjunction with conventional medicine. Examples include immuno-augmentation therapy, shark cartilage, bioresonance therapy, oxygen and ozone therapies, and insulin potentiation therapy. Some herbal remedies can cause dangerous interactions with chemotherapy drugs, radiation therapy, or anesthetics during surgery, among other problems.^{[37][116][33]} An example of these dangers was reported by Associate Professor Alastair MacLennan of Adelaide University, Australia regarding a patient who almost bled to death on the operating table after neglecting to mention that she had been taking “natural” potions to “build up her strength” before the operation, including a powerful anticoagulant that nearly caused her death.^[166]

To ABC Online, MacLennan also gives another possible mechanism:

And lastly there’s the cynicism and disappointment and depression that some patients get from going on from one alternative medicine to the next, and they find after three months the placebo effect wears off, and they’re disappointed and they move on to the next one, and they’re disappointed and disillusioned, and that can create depression and make the eventual treatment of the patient with anything effective difficult, because you may not get compliance, because they’ve seen the failure so often in the past.^[167]

Side-effects

Conventional treatments are subjected to testing for undesired side-effects, whereas alternative therapies, in general, are not subjected to such testing at all. Any treatment – whether conventional or alternative – that has a biological or psychological effect on a patient may also have potential to possess dangerous biological or psychological side-effects. Attempts to refute this fact with regard to alternative therapies sometimes use the appeal to nature fallacy, i.e., “That which is natural cannot be harmful.” Specific groups of patients such as patients with impaired hepatic or renal function are more susceptible to side effects of alternative remedies.^[168][169]

An exception to the normal thinking regarding side-effects is Homeopathy. Since 1938, the U.S. Food and Drug Administration (FDA) has regulated homeopathic products in “several significantly different ways from other drugs.”^[170] Homeopathic preparations, termed “remedies”, are extremely dilute, often far beyond the point where a single molecule of the original active (and possibly toxic) ingredient is likely to remain. They are, thus, considered safe on that count, but “their products are exempt from good manufacturing practice requirements related to expiration dating and from finished product testing for identity and strength”, and their alcohol concentration may be much higher than allowed in conventional drugs.^[170]

Treatment delay

Alternative medicine may discourage people from getting the best possible treatment.^[171] Those having experienced or perceived success with one alternative therapy for a minor ailment may be convinced of its efficacy and persuaded to extrapolate that success to some other alternative therapy for a more serious, possibly life-threatening illness.^[172] For this reason, critics argue that therapies that rely on the placebo effect to define success are very dangerous. According to mental health journalist Scott Lilienfeld in 2002, “unvalidated or scientifically unsupported mental health practices can lead individuals to forgo effective treatments” and refers to this as opportunity cost. Individuals who spend large amounts of time and money on ineffective treatments may be left with precious little of either, and may forfeit the opportunity to obtain treatments that could be more helpful. In short, even innocuous treatments can indirectly produce negative outcomes.^[173] Between 2001 and 2003, four children died in Australia because their parents chose ineffective naturopathic, homeopathic, or other alternative medicines and diets rather than conventional therapies.^[174]

Unconventional cancer “cures”

There have always been “many therapies offered outside of conventional cancer treatment centers and based on theories not found in biomedicine. These alternative cancer cures have often been described as ‘unproven,’ suggesting that appropriate clinical trials have not been conducted and that the therapeutic value of the treatment is unknown.” However, “many alternative cancer treatments have been investigated in good-quality clinical trials, and they have been shown to be ineffective….The label ‘unproven’ is inappropriate for such therapies; it is time to assert that many alternative cancer therapies have been ‘disproven’.”^[118]

Edzard Ernst has stated:

any alternative cancer cure is bogus by definition. There will never be an alternative cancer cure. Why? Because if something looked halfway promising, then mainstream oncology would scrutinize it, and if there is anything to it, it would become mainstream almost automatically and very quickly. All curative “alternative cancer cures” are based on false claims, are bogus, and, I would say, even criminal.^[175]

Rejection of science

There is no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking.

— P.B. Fontanarosa, Journal of the American Medical Association (1998)^[42]

“CAM”, meaning “complementary and alternative medicine”, is not as well researched as conventional medicine, which undergoes intense research before release to the public.^[176] Practitioners of science-based medicine also discard practices and treatments when they are shown ineffective, while alternative practitioners do not.^[6] Funding for research is also sparse making it difficult to do further research for effectiveness of CAM.^[177] Most funding for CAM is funded by government agencies.^[176] Proposed research for CAM are rejected by most private funding agencies because the results of research are not reliable.^[176] The research for CAM has to meet certain standards from research ethics committees, which most CAM researchers find almost impossible to meet.^[176] Even with the little research done on it, CAM has not been proven to be effective.^[178] Studies that have been done will be cited by CAM practitioners in an attempt to claim a basis in science. These studies tend to have a variety of problems, such as small samples, various biases, poor research design, lack of controls, negative results, etc. Even those with positive results can be better explained as resulting in false positives due to bias and noisy data.^[179]

Alternative medicine may lead to a false understanding of the body and of the process of science.^[171][180] Steven Novella, a neurologist at Yale School of Medicine, wrote that government-funded studies of integrating alternative medicine techniques into the mainstream are “used to lend an appearance of legitimacy to treatments that are not legitimate.”^[181] Marcia Angell considered that critics felt that healthcare practices should be classified based solely on scientific evidence, and if a treatment had been rigorously tested and found safe and effective, science-based medicine will adopt it regardless of whether it was considered “alternative” to begin with.^[12] It is possible for a method to change categories (proven vs. unproven), based on increased knowledge of its effectiveness or lack thereof. A prominent supporter of this position is George D. Lundberg, former editor of the Journal of the American Medical Association (JAMA).^[42]

Writing in 1999 in CA: A Cancer Journal for Clinicians Barrie R. Cassileth mentioned a 1997 letter to the US Senate Subcommittee on Public Health and Safety, which had deplored the lack of critical thinking and scientific rigor in OAM-supported research, had been signed by four Nobel Laureates and other prominent scientists. (This was supported by the National Institutes of Health (NIH).)^[182]

In March 2009, a staff writer for the Washington Post reported that the impending national discussion about broadening access to health care, improving medical practice and saving money was giving a group of scientists an opening to propose shutting down the National Center for Complementary and Alternative Medicine. They quoted one of these scientists, Steven Salzberg, a genome researcher and computational biologist at the University of Maryland, as saying “One of our concerns is that NIH is funding pseudoscience.” They noted that the vast majority of studies were based on fundamental misunderstandings of physiology and disease, and had shown little or no effect.^[181]

Writers such as Carl Sagan, a noted astrophysicist, advocate of scientific skepticism and the author of The Demon-Haunted World: Science as a Candle in the Dark (1996), have lambasted the lack of empirical evidence to support the existence of the putative energy fields on which these therapies are predicated.^[74]

Sampson has also pointed out that CAM tolerated contradiction without thorough reason and experiment.^[183] Barrett has pointed out that there is a policy at the NIH of never saying something doesn’t work, only that a different version or dose might give different results.^[122] Barrett also expressed concern that, just because some “alternatives” have merit, there is the impression that the rest deserve equal consideration and respect even though most are worthless, since they are all classified under the one heading of alternative medicine.^[184]

Some critics of alternative medicine are focused upon health fraud, misinformation, and quackery as public health problems, notably Wallace Sampson and Paul Kurtz founders of Scientific Review of Alternative Medicine and Stephen Barrett, co-founder of The National Council Against Health Fraud and webmaster of Quackwatch.^[185] Grounds for opposing alternative medicine include that:

• It is usually based on religion, tradition, superstition, belief in supernatural energies, pseudoscience, errors in reasoning, propaganda, or fraud.^{[129][10][8][186]}
• Alternative therapies typically lack any scientific validation, and their effectiveness is either unproved or disproved.^{[8][105][106][dubious – discuss]}
• Treatments are not part of the conventional, science-based healthcare system.^{[187][22][188][189]}
• Research on alternative medicine is frequently of low quality and methodologically flawed.^[22][190]
• Where alternative therapies have replaced conventional science-based medicine, even with the safest alternative medicines, failure to use or delay in using conventional science-based medicine has caused deaths.^[173][174]
• Methods may incorporate or base themselves on traditional medicine, folk knowledge, spiritual beliefs, ignorance or misunderstanding of scientific principles, errors in reasoning, or newly conceived approaches claiming to heal.^{[129][8][191]}

Many alternative medical treatments are not patentable,^[192] which may lead to less research funding from the private sector. In addition, in most countries, alternative therapies (in contrast to pharmaceuticals) can be marketed without any proof of efficacy – also a disincentive for manufacturers to fund scientific research.^[193]

English evolutionary biologist Richard Dawkins, in his 2003 book A Devil’s Chaplain, defined alternative medicine as a “set of practices that cannot be tested, refuse to be tested, or consistently fail tests.”^[194] Dawkins argued that if a technique is demonstrated effective in properly performed trials then it ceases to be alternative and simply becomes medicine.^[195]

CAM is also often less regulated than conventional medicine.^[176] There are ethical concerns about whether people who perform CAM have the proper knowledge to treat patients.^[176] CAM is often done by non-physicians who do not operate with the same medical licensing laws which govern conventional medicine,^[176] and it is often described as an issue of non-maleficence.^[196]

According to two writers, Wallace Sampson and K. Butler, marketing is part of the training required in alternative medicine, and propaganda methods in alternative medicine have been traced back to those used by Hitler and Goebels in their promotion of pseudoscience in medicine.^[8][197]

In November 2011 Edzard Ernst stated that the “level of misinformation about alternative medicine has now reached the point where it has become dangerous and unethical. So far, alternative medicine has remained an ethics-free zone. It is time to change this.”^[198]

Conflicts of interest

Some commentators have said that special consideration must be given to the issue of conflicts of interest in alternative medicine. Edzard Ernst has said that most researchers into alternative medicine are at risk of “unidirectional bias” because of a generally uncritical belief in their chosen subject.^[199] Ernst cites as evidence the phenomenon whereby 100% of a sample of acupuncture trials originating in China had positive conclusions.^[199] David Gorski contrasts evidence-based medicine, in which researchers try to disprove hyphotheses, with what he says is the frequent practice in pseudoscience-based research, of striving to confirm pre-existing notions.^[200] Harriet Hall writes that there is a contrast between the circumstances of alternative medicine practitioners and disinterested scientists: in the case of acupuncture, for example, an acupuncturist would have “a great deal to lose” if acupuncture were rejected by research; but the disinterested skeptic would not lose anything if its effects were confirmed; rather their change of mind would enhance their skeptical credentials.^[201]

Use of health and research resources

Research into alternative therapies has been criticized for “…diverting research time, money, and other resources from more fruitful lines of investigation in order to pursue a theory that has no basis in biology.”^[47][35] Research methods expert and author of Snake Oil Science, R. Barker Bausell, has stated that “it’s become politically correct to investigate nonsense.”^[122] A commonly cited statistic is that the US National Institute of Health had spent $2.5 billion on investigating alternative therapies prior to 2009, with none being found to be effective.^[122]