'New research shows that deception may not be necessary for the placebo effect'

There's an emerging discussion on the efficacy of a placebo *even when the patient knows they're taking a placebo*, and this is fleshed out interestingly in the discussion of whether a placebo smartphone app would actually work.

'Placebos are used to test treatments, but in the future they could *be* the treatment.'

We've found a new website, Placeboeffect, which holds itself up as 'The Official Placebo Effect Resource' (whatever 'official' means in the world of placebos!) Here you can access classes, essays, an ebook and other resources on the phenomenon, though not placebos themselves. We think the '101' guides are particularly interesting.

Also interesting is the proposition of a 'placebo method' which the site suggests can be more effective than simply taking a sugar pill. We agree with the general tenet of this proposition, and took quite a bit of care to suggest a protocol for taking a course of placebos, contained in a small booklet that accompanies our product. We call this 'Creating the Conditions to Get the Most From Your Placebo"

Use placebos when you need help, or when all else fails.

Placebos stimulate your healing system to maintain wellbeing, sometimes bringing forth what seem like miraculous results. Faith, hope, trust and love optimize the conditions for the placebo effect to work. You can create such conditions by recalling the memory of a positive experience, or by simply acknowledging, in your inner being, the many reasons to be grateful for the precious gift of life, and also your capacity to ease your own physical, mental or emotional suffering. You may choose to create your own ritual, meditating on visualisations or affirmations of your intention to become well. You may choose to look to writings, art, conversations or the web for inspiration.

Be playful and light, allow room for laughter. You have nothing to lose but fear and anxiety.

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".

Australia's Sun-Herald newspaper referred to us in a general article on the placebo effect. Placebos: the future of medicine?

We also made it into Body & Soul magazine (in an article that looks quite similar).

Great summary of placebo effect(s), amusing, sharp and provocative. A great way to spend three minutes!

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.)

You know you've made it when they run a story on Fox News. Forget Harvard (where the groundbreaking placebo study took place that allowed patients to KNOW they were trialling placebos). The Harvard study told participants the 'medication' they were taking was inert, however it 'would engage the mind-body and self healing thing'.

Marc Siegel, from something called the 'Fox News Medical A-Team', comments on video here.

In other news, the more mainstream Wall Street Journal comments on the research here and here.

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.

 

 

 

We were fascinated to see a story on Australia's ABC News about recent research into the placebo effect. Pain researcher Damien Finniss, from Sydney's Royal North Shore Pain Management and Research Institute, has published a paper in The Lancet on the phenomenon of the placebo effect. The ABC story makes two points which in our view have not received sufficient attention, namely:

* that the placebo effect is engaged even when a patient is aware s/he is receiving placebo (the 'no-blind test'); and
* that responsible practitioners consider the agency of placebo in the course of treatment.

Consistent with other researchers we've read, Finniss and his colleagues are concerned with ethical issues in practitioner-client relationships in consideration of conscious engagement with the placebo effect. This is what we'd expect from responsible researchers and health professional. At the same time, we're aware of anecdotal evidence and some research (contained elsewhere in this blog) that in any case there is widespread 'de facto' use of placebos in general practice and elsewhere, as for example in the presciption of an antiobiotic in the treatment of a viral condition.

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).

One for those who can't start the day without a caffeine hit. ;-)

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

The story of Universal Placebos began way back in 2002, as part of a conversation Michael had with some of his students about the way 'intangibles' are sold in the knowledge economy. Wouldn't it be interesting, thought the group, if you were just to 'fess up that the thing you were selling was actually valueless, in and of itself, and that its value lay in intangibles - that what was being offered was an idea, a thought, an impulse, a vibe ...?

What about just going to market with a bottle of 'placebos', sugar pills of the kind used extensively in drug trials, harmless but possibly not 'ineffective'...?

Then, on the 6th of November, 2006, four people (Michael & Ludmila Doneman, Brian & Margi Bruce) had a conversation during a visit to the Bruce's home in Mullumbimby and the placebo idea came up. Brian, a homeopath, was immediately interested because of the resonance of the placebo idea with the nature and intent of homeopathy and other so-called complementary therapies, the placebo being a refinement and simplification of the metaphysical approach to healing.

So we began to research placebos, and found that the 'placebo effect' was widely recognised and accepted by scientists. In other words, it is invariably the case in clinical drug trials, where a proportion of the trial group is given an inert substance - a placebo - that a certain proportion of the control (placebo) group will respond in the same way as the group taking the test drug. This was especially remarkable in trials of the new SSRI designer-psych drugs like Prozac, where up to 70% of the placebo group have reported the same symptomatic responses as those taking SSRI's.

There is very little dedicated research on how or why the placebo effect actually works, it's just acknowledged as always being present to some degree. Now, for the first time, the lay person can take advantage of the proven healing qualities of the placebo effect.

So these are the two directions that lead to Universal Placebos - one about the importance of the *idea* that sits behind a product, and one about the importance of the *idea* that sits behind a therapy. Together, they have given rise to the Placebo pilules, which you can buy in this site, and to this site iself, which we offer as a clearinghouse and discussion point on the placebo effect.

We are very interested in the way the placebo phenomenon raises issues about the practices of the gigantic medical-pharmaceutical industrial complex, and the role of non-mainstream and traditional medicines and therapies.

We make no therapeutic claims at all, beyond the assertion that the placebo effect is generally considered to be present, to 'work' for at least some of the people some of the time. Placebos are not intended as alternatives to *any* other therapy. Being totally inert, they can do no harm, except perhaps where the ingestion of a tiny amount of sugar might be an issue. If you need an operation, if you need analgaesia, if you need drug therapy for a chronic condition, by all means get the best advice you can and go ahead with it. But consider complementing any such therapy with a placebo, or to be more specific, with the spirit of faith, hope, trust and love which we recommend as part of taking a placebo.

'Faith, hope, trust and love' - when did you last see those words on a physician's prescription?

We also want to hold this lightly, to have fun with it, to enjoy a spirit of playfulness related to the placebo and what it represents. As Australians we love a cheeky sense of humour, and we love taking pot shots at big, self-righteous institutions. In many ways Universal Placebos has succeeded if it brings you a smile.

With love

Marg, Brian, Ludmila, Michael
February 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.