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).

The closest we've come to a branded placebo, up till now (apart from Obecalp and our product), is CEBOCAP, available through Walgreens in three strengths (!) "by prescription only" (!!)

It seems that Cebocap is manufactured by Forest Pharmaceuticals but we can't find any reference to them on the Forest site. Cebocap is also listed at Canadacure, but that site notes that it's "Only Available By Prescription ... and Not available in Canada".

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

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.

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."
Ref. 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.

Ref. The Skeptics Dictionary, <a href="http://skepdic.com/placebo.html" title="http://skepdic.com/placebo.html">http://skepdic.com/placebo.html</a>

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.

The online skeptic Robert Todd Carroll accepts that there is a placebo effect, but has concerns that administration of a placebo is superfluous at best.

(To) those who say "what difference does it make why something works, as long as it seems to work" I reply that it is likely that there is something which works even better, something for the other two-thirds or one-half of humanity who, for whatever reason, cannot be cured or helped by placebos or spontaneous healing or natural regression of their pain. (1)

He assumes, though, that a placebo is given or administered in place of another therapy. If the sophisticated plumbing that is modern surgery is the best way to fix a problem, not many people would argue that administration of a sugar pill is a better course of action. But if the sugar pill engages a positive somatic response, say in the alleviation of pain, and if it is pharmacologically inert and (save perhaps in the case of diabetes) harmless, if in fact it is pleasing to the patient, who can say it should be withheld?

Whichever way we cut the arguments and the theories, the placebo effect is real and it is real because it engages those parts of human beings which defy reduction to the mechanical. It is real because it therapeutically engages human capacities and capabilities for which conventional medicine has only approximations and crude theorization, if not actual distrust. It may work in what to many are the scientific borderlands, but the important thing for us is that it works.
"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. (2)

Refs
(1) Robert Todd Carroll, Placebo Effect (The Skeptics Dictionary), http://skepdic.com/placebo.html, accessed 12 January 2007
(2) Margaret Talbot, The Placebo Prescription, New York Times Magazine, September 2001, http://www.nytimes.com/library/magazine/home/20000109mag-talbot7.html, accessed 1 July 2007

Typically, as people experiencing dis-ease, we want to know whether a therapy works. We are less concerned to know how it works, just whether it works.
Just how the placebo effect comes about is unresolved, despite the burgeoning research effort. Theories include:

• Benefit from attention – we respond positively because we receive enhanced and focused attention from a practitioner

• Stimulus response – like Pavlov’s dogs, we respond somatically to the suggestion which accompanies the administration of a therapy because we have experienced benefit from such therapy in the past

• Beliefs, expectations, and the attribution of meaning – as with stimulus-response, our assumptions and expectations about the efficacy of a therapy conditions a somatic response: the higher our expectations, the greater our response

• Relationship with therapist – we respond positively to positive relations with our therapist

• Pleasing the therapist – in our effort to be ‘good patients’, we respond positively to our therapist’s expectations (1)

It is reasonable to say that there is no scientific consensus on how it works. In general, most agree that the placebo effect (and its reverse, the nocebo effect, where negative reactions are experienced) operates in the borderland between the ‘mind’ and ‘body’ constructions assumed by conventional medicine. And while conventional medical science has little to offer us by way of explanation, our subjective experience of the placebo effect needn’t baffle us.

Michael Jospe, a professor at the California School of Professional Psychology who has studied the placebo effect for more than 20 years, points out that all people experience physiological reactions to anticipation and stress--something like the fight-or-flight response--that help them to survive and cope. When you step out of your office and a spider jumps out at you, Jospe analogizes, "you'll get a fright and have a physiological reaction. And the next time you go out that way, the thought that it could happen again can produce a physiological reaction before you even open the door." So, he says, the relationship between a thought and a negative psychophysiological reaction like fear is something we experience daily.

That goes for positive associations, too, Jospe continues. "The placebo effect is part of the human potential to react positively to a healer. You can reduce a patient's distress by doing something which might not be medically effective." It's like kids and Band-Aids, Jospe says. "When you put a Band-Aid on a child and it has stars or comics on it, it can actually make the kid feel better by its soothing effect, though there's no medical reason it should make the child feel better." (2)

Refs
(1) Mayo Clinic - Consumer Health Tips and Products, Placebo Effect: Harnessing Your Mind’s Power to Heal, December 30, 2003,
(2) Tamar Nordenberg, The Healing Power of Placebos, US Food and Drug Administration

‘I will follow that system of regimen which, according to my ability and judgment, I consider for the benefit of my patients, and abstain from whatever is deleterious and mischievous.’ Hippocratic Oath (1)

There is a large and burgeoning literature on the phenomenon of the ‘placebo effect’, that is, the tendency of people experiencing illness to improve through an engagement with a medically inactive remedy, ranging from sham surgery to administration of an inert injection or oral medication.
Most recently this literature is inspired by the increasing use of antidepressant medications in the treatment of major depressive disorders (MDD’s), where ‘fewer than half of the depressed patients who receive active medications in psychiatric trials show clinically significant improvement’ and where placebo medication has been shown to be effective in up to 70% of cases. (2)

Apart from MDD’s, people taking placebos often report reduction in pain, healed ulcers, eased nausea and even disappearing warts. The literature rarely denounces the existence of a placebo effect; disagreement and controversy arises most often in understanding how it comes about, and more importantly, how it might be used.

It can be argued that the foundation of modern western medicine resides in the distinction between ‘mind’ and ‘body’, the former understood as a philosophical construction which places it outside the realm of medical practice (unless seen, in the psychiatric model, as a function of the brain and nervous system), the latter as a kind of sophisticated machine. This machine can ultimately be understood analytically, through an understanding of its functional components and their complex interactions.

The placebo effect disrupts this assumption of a mind-body boundary, especially where conventional medicine relates it dismissively to complementary and alternative medicines (CAM’s): ‘You may think that such-and-such was effective, but it was only a placebo effect.’ This misses the point. To dismiss, say, homeopathy as ‘merely a placebo’ is not to dismiss it at all, since there is a tacit recognition that there is in fact a placebo effect, that in a greater or lesser degree, the thing actually works.

The fact that it works outside the reductionist and analytical paradigm is the real issue. Put this way, it is not an argument about therapies, but an argument about prestige and power, played out socially, culturally, politically and economically.

Refs:
(1) Hippocratic Oath
(2) 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