More placebos in the media, this time from Australia's 60 Minutes.

"We have in our minds, in our brains, the capacity to change the way we experience pain, to affect some of the illnesses that bring us in to see physicians. What we need to do is learn how to unlock those capacities and make use of them."

From Howstuffworks

"Here's where it gets crazy ... (the incidence of) the placebo effect itself is increasing."

"Approximately half the drugs that fail in late stage trials fail because they simply can't outperform placebos".

From PLoS ONE

Placebos administered without deception may be an effective treatment for IBS [Irritable Bowel Syndrome]. Further research is warranted in IBS, and perhaps other conditions, to elucidate whether physicians can benefit patients using placebos consistent with informed consent.*

Source the article here.

* Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, et al. (2010) Placebos without Deception: A Randomized Controlled Trial in Irritable Bowel Syndrome. PLoS ONE 5(12): e15591. doi:10.1371/journal.pone.0015591

Here's an article from a blog called PRACTICAL ETHICS (Ethics in the News) at the University of Oxford. It's pretty unfriendly to homeopathy, which we think isn't quite as cut and dried a domain of practice as the author, Bennett Foddy, assumes. Brian, one of our founders, is happy to advise on both homeopathic and placebo regimes. That's one point where we differ substantially with Foddy, and at least some of the literature does as well. Buying placebos from Boots, government subsidised or not, makes at least the 'pleasing the practitioner' script impossible. ("Pleasing the practitioner" is the idea that a patient's trust in the authority of an expert induces the placebo effect.)

A simple sugar pill may help treat a disease -- even if patients know they're getting fake medicine.

The finding, reported online Wednesday in the journal PloS One, may point the way to wider -- and more ethical -- applications of the well-known "placebo effect."

"The conventional wisdom is you need to make a patient think they're taking a drug, you have to use deception and lies," said lead author Ted Kaptchuk, an associate professor of medicine at Harvard Medical School. And, Kaptchuk added, it seems many doctors do this: In one report, as many as half of rheumatologists and internists surveyed said they had intentionally given patients ineffective medication in the hopes it would have a positive result.

Kaptchuk, however, wondered whether the deception was needed. When he first tried to persuade fellow researchers to explore a sort of "honest" placebo, "they said it was nuts," he said. After all, didn't the whole effect hinge on people believing they were getting real treatment?

Patients were easier to enlist. "People said, 'Wow, that's weird' and we said, 'Yeah, we think it might work.'"

The researchers enrolled 80 people suffering from irritable bowel syndrome, explaining the experiment while framing it positively -- they called it a novel "mind-body" therapy.

Half the patients were given a bottle with the word "placebo" printed on it. The pills it held, they were told, were like sugar pills. The patients were told they didn't even need to believe in the placebo effect, but had to take the pills twice daily.

The other half were given no treatment at all.

At the end of the three-week trial, 59 percent of the patients taking the placebo said their symptoms had been adequately relieved, far outstripping the 35 percent in the non-treatment group.

"We were all taken aback," Kaptchuk said. "We triple-checked the data before we decided it was real."

Read the research paper at Plos One: Placebos without Deception: A Randomized Controlled Trial in Irritable Bowel Syndrome

The placebo effect is a pervasive, albeit misunderstood, phenomenon in medicine. In the UK, over 60% of doctors surveyed said they had prescribed placebos in regular clinical practice. In a recent Times Magazine article, 96% of US physicians surveyed stated that they believe that placebo treatments have real therapeutic effects.

Work on the placebo effect received an intellectual boost when the Harvard Placebo Study Group was founded at the beginning of 2001. This group is part of the Mind-Brain-Behavior Initiative at Harvard University, and its main characteristic is the interdisciplinary approach to the placebo phenomenon. The group is made up of 8 members: Anne Harrington (Historian of Science at Harvard), Howard Fields (Neuroscientist at Univ. of California in San Francisco), Dan Moerman (Anthropologist at Univ. of Michigan), Nick Humphrey (Evolutionary Psychologist at London School of Economics), Dan Wegner (Psychologist at Harvard), Jamie Pennebaker (Psychologist at Univ. of Texas in Austin), Ginger Hoffman (Behavioral Geneticist at Harvard) and Fabrizio Benedetti (Neuroscientist at Univ. of Turin). The main objective of the group is two-fold: to devise new experiments that may shed light on the placebo phenomenon and to write papers in which the placebo effect is approached from different perspectives.

 

 

 

Here's a web slide show with Mike Campbell and Alan Jones presenting on placebos at the Interesting South Conference, 20th August 2009. They even came up with a consent form allowing a doctor to prescribe placebos as needed ...!

It sounds counter-intuitive, but it seems that placebos are geting 'stronger' ... or more to the point, the placebo effect is increasingly recognised as touching the heart of the overall process of healing and the nature of wellness. A fascinating article on this dynamic phenomenon in Wired magazine - looks like the debate is going mainstream!

And lest we forget ... there's money at stake. Big money.

According to this article from the 'OnMedica' medical website, doctors are being encouraged to consider the "meta-placebo" effect: 'the healing belief that even fake/placebo treatments have positive effects . . . if both the doctor and the patient believe in the healing powers of the fake treatment, it does not matter that both know the treatment is fake'. No need to wait for medical tests to verify this hypothesis. A growing number have already experienced this effect using our Universal Placebos. See our Testimonials page.

Tuesday, 5 August 2008

Doctors could steer patients away from unproven alternative therapies if they could use dummy pills, suggests Dutch research.

Oskar van Deventer, a researcher from Leidschendam in the Netherlandspoints out that it is a well established medical fact that fake treatments do work.

If this is the case, he argues, doctors could include placebo pills in their medical armamentarium. But then the doctor might have to lie to the patient and this would present an ethical dilemma.

"On the one hand, the doctor does not want to lie to his patient. On the other hand, the effect of the fake treatment would diminish if the patient knows it is fake. For this reason, fake treatments are typically left to practitioners of so-called alternative medicine who are often not even aware of the ethical dilemma," he writes in the journal Medical Hypotheses.

However he believes this is not the case as telling the truth about the dummy treatment would not stop it from being effective. This type of treatment is called the ‘meta-placebo’ effect.

"This is based on the healing belief that even fake/placebo treatments have positive effects. That is, if both the doctor and the patient believe in the healing powers of the fake treatment, it does not matter that both know the treatment is fake," he says.

If such an effect does exist, it would solve a few complexities for today’s medics. They would not have to lie to patients when prescribing them placebos and by having such treatments at their disposal they could continue to regularly monitor patients’ symptoms whilst on the "treatment". The doctor could also help to prevent people from using alternative medicine, which can be both expensive and risky to health.

The hypothesis that the "meta-placebo" effect exists needs to be tested before such treatments can become evidence-based medicine.

Using the equivalent to the gold standard of the double blind trial would create a challenge for such research as would the dilemma over which condition to test it on, he says, but he calls on readers to help meet those challenges in testing the effect.

The article follows figures published by the Prescription Pricing Authority last month that show a fall in the prescribing of homeopathic remedies by GPs from 83,000 in 2005 to 49,300 in 2007.

However separately, a pilot study from five NHS homeopathic hospitals found 60% of the 1797 patients treated with homeopathic remedies reported an improvement in quality of life.

The top four most treated conditions were eczema, chronic fatigue syndrome, menopause and osteoarthritis. Amongst those four, the proportion of patients that reported an improvement in quality of life after six visits to the homeopath varied from 59.3% for chronic fatigue syndrome and 73.3% for menopause. Overall, 30 common conditions were being treated by homeopaths.

Medical Hypotheses 2008; 71: 335–9; Homeopathy 2008; 97: 114-121

What a difference a mention in the NY Times makes! There's been an incredible amount of web traffic generated by a website advertising 'Obecalp' ('placebo backwards), including a very lively debate at one of our favourite sites, Boingboing

In the Boingboing exchanges, most people are objecting to (a) enculturating kids into pill-popping behaviours, and (b) deceiving kids about the actual nature of the pill. Nobody's gainsaying the operation of the so-called placebo effect, it seems to be more about the parenting issues ...

I guess the same objections would be raised to behaviour like putting a Flintstones-themed band-aid on a bumped knee that didn't actually need a band-aid, with the assurance that this would 'make it better'...?

Two things, in defence of the placebo-as-pill approach (and astute readers will be aware that the placebo effect can also be engaged through sham injections, sham surgery ... and possibly Mystical Words Uttered Backwards Under a Full Moon and so forth ...

As conscious purveyors of placebos, we're concerned with the potential of the placebo effect to inspire self-healing. We don't recommend that people lie about or misrepresent our product: it's a sugar pill, inert, side-effect free ... BUT the placebo effect exists, and there is some evidence to show that people ingesting a placebo *in the awareness that it's a placebo* may still gain some benefit. That's the 'honesty in parenting' bit.

As to the pill-popping-culture bit, well ... perhaps. One of our team is a homeopath, and consequently aware of the materialist critique that homeopathic remedies are also nothing else but placebos. In general, our feeling is 'so what? If there's no deception and misrepresentation, and the things actually work, what's the harm?'

We understand the passion and the aggro, to an extent. Nobody likes the idea of ripping people off and leveraging the pain of children. But we can assure you there's a case to be made for harmless and light-hearted exploration of the placebo effect, and especially for the questions it raises about the same pill-popping culture that encourages conventional practitioners to regularly use ineffective treatments (such as prescribing antibiotics for viral infections).

In 2005, global pharmaceutical sales totalled US$602 billion with growth of 7% from the previous year.
At an average annual growth rate of 14% between 1994 and 2003, pharmaceuticals top the OECD manufacturing trade growth stats, ahead of coke, refined petroleum products and nuclear fuel (8%), medical, precision and optical equipment (7.5%), aircraft and spacecraft (7.4%), and motor vehicles, trailers and semi-trailers (7.3%).
In 2006 the 10 largest pharmaceuticals firms accounted for 46 per cent of global sales.

Ref. Medicines Australia

Want to know where we get the 'up to 70% success' claim in our packaging?

"The placebo response, noted as an early or nonpersistent improvement in response to an inactive agent, represents one of the most significant challenges in central nervous system (CNS) drug development. Despite a wealth of documentation, there is no commonly accepted definition of this phenomenon. However, it is agreed that there has been a significant increase in the placebo response in the last 20 years, particularly in clinical trials with antidepressant medications for major depressive disorder (MDD).

Estimates as high as 70% have been reported for CNS clinical trials. (our italics) Such large placebo rates have a significant impact on the cost and speed of drug development.

Since fewer than half of the depressed patients who receive active medications in psychiatric trials show clinically significant improvement, some critics claim that antidepressants are no better than placebo treatment, and their illusory superiority depends on poorly designed studies and biased clinical evaluations. In a set of six identically designed, three-arm, parallel controlled trials submitted to the Food and Drug Administration for an antidepressant drug, Leber reported that antidepressants could not be distinguished from placebo in five of the six studies."

Ref. Richard Entsuah, Phil Vinall: Potential Predictors of Placebo Response: Lessons From a Large Database, Drug Information Journal. Ambler: 2007. Vol. 41, Iss. 3; pg. 315, 16 pgs

An article in the Journal of General Internal Medicine explores the actual use of placebos by conventional doctors

Abstract

Background - The placebo and the placebo effect are often investigated in the context of clinical trials. Little data exist on the use of placebos in the course of routine health care.

Objective - The aim of this study is to describe a group of academic physicians’ use of placebos and their knowledge, attitudes, and beliefs about placebos and the placebo effect.

Design - A 16-question anonymous web-based survey of physicians from Internal Medicine departments of 3 Chicago-area medical schools was used.

Results - There were 231/466 (50%) physicians who responded; of these, 45% reported they had used a placebo in clinical practice. The most common reasons for placebo use were to calm the patient and as supplemental treatment. Physicians did not widely agree on the definition of a placebo and had a variety of explanations for its mechanism of action. Ninety-six percent of the respondents believed that placebos can have therapeutic effects, and up to 40% of the physicians reported that placebos could benefit patients physiologically for certain health problems. Only 12% of the respondents said that placebo use in routine medical care should be categorically prohibited. Regarding “placebo-like” treatment, 48% of respondents reported giving at least 1 type of treatment in a situation where there was no evidence of clinical efficacy.

Conclusion - Nearly half of the respondents use placebos in clinical practice and most believe in the mind–body connection. The results of this study, based on retrospective self-reported behavior, are subject to recall bias and may not be representative of American physicians.

"Academic Physicians Use Placebos in Clinical Practice and Believe in the Mind–Body Connection"
- Rachel Sherman and John Hickner (University of Chicago Pritzker
School of Medicine), Journal of General Internal Medicine, Volume 23,
Number 1 / January, 2008

Amazing placebo experiment with knee surgery - points to the finding that there can be 'grades' in the placebo effect - big pills are more effective than small pills, coloured pills more effective than white ones, inert injections more effective than pills, and sham surgery more effective than any of them.
Of course, at Universal Placebos we feel it sufficient to stay with our modest, aesthetically pleasing, small white sugar pills, in doses of three. That's enough.

One of the rare studies into the action of the placebo effect in 'non-blind' clinical trials was undertaken by Lee C. Park and Uno Covi at the Johns Hopkins University School of Medicine in 1964. 'Non-blind' means that patients were informed that the pills they were issued were totally inert, that they were placebos, and in this case they were also assured that despite this the pills would be of benefit to them. The study concluded:'The primary finding is that patients can be willing to take placebo and can improve despite disclosure of the inert content of the pills; belief in pill as drug was not a requirement for improvement.'

(Some first-hand reports on our Testimonials page.)

Ref. L. C. Park, U. Covi, Nonblind Placebo Trial - An Exploration of Neurotic Patients' Responses to Placebo When Its Inert Content Is Disclosed, Archives of General Psychiatry, April 1965, Vol. 12, pp. 336-345

Placebo As Good As Common Treatments For Sinus InfectionsA placebo is likely to be just as effective as common acute sinusitis treatments involving a topical steroid and an antibiotic, according to an article published in the Journal of the American Medical Association. Ian G. Williamson, MD; Kate Rumsby, BA; Sarah Benge, PhD; Michael Moore, FRCGP; Peter W. Smith, PhD; Martine Cross, BA; Paul Little, MD - "Antibiotics and Topical Nasal Steroid for Treatment of Acute Maxillary Sinusitis - A Randomized Controlled Trial", Journal of the American Medical Association. 2007;298(21):2487-2496.

One of the problems scientists have in evaluating the placebo effect is the distinction that can be drawn between 'true' and 'perceived' placebo effects, where a 'perceived' effect might not not be directly attributable to the administration of a placebo. But they also acknowledge the general ignorance of definition and description when it comes to the 'true' placebo effect.'A review of the literature shows that most authors confuse the perceived placebo effect with the true placebo effect. The true placebo effect is highly variable, depending on several factors that are not fully understood.'Ref. E. Ernst, K. L. Resch, Concept of true and perceived placebo effects, British Medical Journal, 1995;311:551-553

A few - just a few - medical professionals bring up the ethics of therapists actually prescribing placebos as an element of treatment.

Margaret Talbot proposes in the New York Times Magazine (1/09/2000):"The truth is that the placebo effect is huge -- anywhere between 35 and 75 percent of patients benefit from taking a dummy pill in studies of new drugs -- so huge, in fact, that it should probably be put to conscious use in clinical practice, even if we do not entirely understand how it works."

Others might balk at the suggestion, but there seems to be an ethical shadow-line, where a drug-focused therapy may overlap with the physician's responsibility (duty?) to care for his or her patient as more than a machine, as a being of heart-mind."The placebo effect can occur," as the physician Herbert Spiegel once put it, "when conditions are optimal for hope, faith, trust and love." It might sound sentimental, but then sentiment, working hand in hand with science, can make medical practice so much more powerful. A world in which placebo -- preferably in the form of deft encouragement, but sometimes in the form of a harmless pill -- was tolerated, even embraced, would be a world in which doctors never forgot that medical practice consists not only of the technologies of diagnosis and treatment but also of the careful tending of a patient's expectations and the unabashed willingness to comfort."

Margaret Talbot, The Placebo Prescription, New York Times Magazine

Even the skeptics (American English for 'sceptics') can't come down *too* hard on placebos:

"A person's beliefs and hopes about a treatment, combined with their suggestibility, may have a significant biochemical effect. Sensory experience and thoughts can affect neurochemistry. The body's neurochemical system affects and is affected by other biochemical systems, including the hormonal and immune systems. Thus, it is consistent with current knowledge that a person's hopeful attitude and beliefs may be very important to their physical well-being and recovery from injury or illness.
However, it may be that much of the placebo effect is not a matter of mind over molecules, but of mind over behavior. A part of the behavior of a "sick" person is learned. So is part of the behavior of a person in pain. In short, there is a certain amount of role-playing by ill or hurt people. Role-playing is not the same as faking or malingering. The behavior of sick or injured persons is socially and culturally based to some extent. The placebo effect may be a measurement of changed behavior affected by a belief in the treatment. The changed behavior includes a change in attitude, in what one says about how one feels, and how one acts. It may also affect one's body chemistry.

From The Skeptics Dictionary

Placebo Effect Accounts for Fifty Percent of Improvement in Depressed Patients Taking Antidepressants (1996 Press Release, American Psychological Association)

TORONTO -- The debate about treating depression with drugs, psychotherapy, or a combination of both drugs and psychotherapy has raged on over the years. But a recent analysis of 39 studies of 3,252 depressed patients, presented at the American Psychological Association's (APA) 104th annual convention, found that 50 percent of the drug effect is due to the placebo response.

In other words, a patient taking antidepressant medication with a self-reported improvement rate of 10 points, can attribute half (.5) of that improvement to the placebo effect. To determine the placebo effect of antidepressant medications, psychologist Guy Sapirstein, Ph.D., at the University of Connecticut, analyzed 39 studies of depressed patients from 1974 to 1995. The studies included patients with a primary diagnosis of depression, were randomized, and controlled for patients who received no treatment.

Studies that measured the effects of antidepressant medications such as fluoxetine (Prozac), sertaline (Zoloft) and paroxetine (Paxil) were included in the analysis. Dr. Sapirstein concluded that the pharmacologic and nonpharmacologic effects of antidepressants indicates that while only 27 percent of the response to medication is due to the medication alone (a true pharmacologic effect), 50 percent is due to the psychological impact of administering the medication (placebo effect) and 23 percent is due to other 'nonspecific factors.' 'People benefitting from drugs are benefitting because they think that taking the antidepressant medicine is working,'

Dr. Sapirstein said. 'If we take these results and say that improvement is due to what the patients think, then how people think and its effect on how they feel are more powerful than the chemical substance,' he added. In addition, the study found that patients who either took medication or underwent psychotherapy exclusively had similar treatment outcomes. The promise of future treatment, which was controlled for by the wait-listed patients, did not affect depression levels.