Tag Archives: Drugs

A ‘weapon against the placebo effect’ …?

It seems that this damned placebo effect is getting in the way of developing and authorising new psychiatric drugs. It creates a ‘therapeutic bias'(!) and so the experimenters are experimenting with ways of controlling for it in trials, for example ‘SPCD, sequential parallel comparison design’. These are proving to be not (yet) up to the task, sufficient to be acceptable by bodies such as the RDA. The following is from The Placebo Effect Is Hobbling New Psychiatric Drugs

“The FDA’s rejection cast doubt upon the design, still in use in more than a dozen trials, as a weapon against the placebo effect.

That’s big news because the effect, also called the placebo response, has been growing stronger over the years in clinical studies that randomly assign patients to either an active drug or placebo. When the effect is high, it’s hard to know if a drug just isn’t good enough, if there are errors in the data, or if the participants taking the placebo—an inert pill meant to make them believe they’re getting the real thing—fared unusually well because of their expectations.

It’s a testament to the power of our minds to improve our health, at least temporarily. Many factors boost placebo response. “Most people, whether they know it or not, are biased to believe that they will receive the active drug even if they are told that they have a 50 percent chance of getting placebo, and this ‘therapeutic bias’ increases the placebo response,” says John Krystal, the chair of the psychiatric department at the Yale School of Medicine in New Haven, CT.”

Placebos and pain

Pain is a subjective state – that’s why practitioners typically ask us to ‘scale’ our experience of it, from a ‘1’ (slight) to a ’10’ (unbearable). And while it’s easy to see why the experience of pain is useful in an evolutionary sense (‘keep your hand out of the fire!’) it’s difficult to account for what mechanism is responsible for this experience. Different analgesics may have different effects (and affects) for different people, and some don’t seem to contraindicate – it seems you can ingest an opioid at the same time as paracetemol.

Enter the placebo effect! Here’s a recent research paper on placebos and pain. And also a fascinating article on ‘leveraging the Placebo Effect to Reduce Opioid Requirements’.

PLACEBOS and the immune response

Could brain stimulation slow cancer?

The idea is that ‘the placebo effect’ activates the same ‘Reward Circuit’ in the brain as that “activated by food, sex and social interactions (as well as gambling and addictive drugs)”. This in turn stimulates the immune system and generates ‘anti-tumor immunity’ against pathogens.

This is Scientific American, dear readers, and the claim is based on the kind of clinical experimentation that placebos are now inspiring. Placebo Studies!

“It’s like doing immunotherapy without medication.”

At the moment it’s just been shown in mice, and the ‘data are preliminary’, but even if it turns out only partly to be shown in humans, the implications are profound.

Five myths about placebos

1. The placebo effect is all in the mind.

“In reality, placebo treatments can cause measurable, biological changes similar to those triggered by drugs.”

2. Placebos work only if patients think they’re real.

“Over the past few years, however, scientists have found that this isn’t true. Honest (‘open label’) placebos work, too.”

3. Neurotic, suggestible people are more likely to respond to placebos.

“It’s not neurotic people who see benefits … but rather those who are optimistic, altruistic, resilient and straightforward.”

4. You have to take a placebo to get a placebo effect.

“It’s true that placebos won’t shrink a tumor, cure an infection or replace insulin in someone with diabetes. But many “real” medical treatments — particularly those that modify symptoms like pain, fatigue, nausea or depression — rely on the placebo effect.”

5. Drugs are always more effective than placebos.

A rigorous recent study of 152 trials found that placebo effects are often about the same as drug effects.

For more detail on all of the above, and references to research, read the Washington Post article.

A steroid shot for your knee pain? Just skip it!

Corticosteroids are a class of steroid hormones that are produced in the adrenal cortex of vertebrates, as well as the synthetic analogues of these hormones. They have been commonly prescribed for sufferers of knee pain and inflammation, called synovitis, or knee osteroarthritis. In common with most steroids, these drugs are associated with a wide variety of adverse side effects. Depending on the dose, these may include:

Elevated pressure in the eyes (glaucoma)
Fluid retention, causing swelling in your lower legs
High blood pressure
Problems with mood, memory, behavior and other psychological effects
Weight gain, with fat deposits in your abdomen, face and the back of the neck

Taking the drugs over a longer period may produce:

Clouding of the lens in one or both eyes (cataracts)
High blood sugar, which can trigger or worsen diabetes
Increased risk of infections
Thinning bones (osteoporosis) and fractures
Suppressed adrenal gland hormone production
Thin skin, bruising and slower wound healing

A recent study (full text here) has shown that a group of patients injected with a corticosteroid medication over two years showed no decrease in pain, relative to a group taking placebos. However, the ‘placebo group’ did not suffer the loss of cartilage (indicating progression of the condition) over that period.

Arthritis medication: placebo beats supplements

Many people take glucosamine and chondroitin supplements for arthritis pain, but a controlled trial has found no evidence that the combination works. In fact, in this study, the placebo worked better.

Spanish researchers randomized 164 men and women with knee osteoarthritis to take a single daily dose of 1,500 milligrams of glucosamine and 1,200 of chondroitin, or an identical looking placebo. The study is in Arthritis & Rheumatology.

Read the full article here.

 

On Placebos and Depression Drugs

We note an interesting ‘counter narrative’ emerging – that is, scepticism about the commonly held view that drug treatments designed for mood disorders such as depression often engage the Placebo Effect. In this counter-narrative,

“Drug trials don’t show much in the way of classic placebo effects. The rise in placebo responses over the years is more likely due to the supportive factors in drug trials…and increasing problems with enrollment.”

The new finding—no upward trend in placebo responses—is unexpected and certain to be contested. Meanwhile, it stands as a rebuke to a popular narrative. By that account, drug effects had been hyped, expectations soared, and the inflated hopes were reflected in rising placebo response rates.”

This is fine, except the counter-narrative also resonates with challenges about the efficacy of conventional ‘gold-standard’ ‘blind’ ‘placebo controlled’ drug trials, where it has been shown that trials funded by drug companies (who by definition have a vested interest in their outcome) are 30% more likely to return ‘favourable’ results than trials which are not funded in this way. The ‘placebo effect’ might be the design and execution of the trial itself, not the actual function and efficacy of the placebo …!

Read the whole article here.

Placebos Help Kids With Migraines as Well as Drugs Do

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NBC News reports:

“The study included about 300 kids aged 8 to 17, enrolled at 31 centers. They had 11 migraines on average in the month before the study began and were randomly assigned to take either of the drugs or placebo pills daily for six months. Migraine frequency in the study’s last month was compared with what kids experienced before the study. At least half of kids in each group achieved the study goal, reducing migraine frequency by half.”

The same report, with a couple of videos, is over at CBS.

Prescribe a placebo?

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In Why Placebos Really Work: The Latest Science the Wall Street Journal points to the increasing frequency of ‘serious’ science envisioning health interventions that consciously include placebos and invoke the placebo effect. It seems the mind-body divide is something of an illusion!

Nevertheless, even though at least 50% of doctors actively prescribe placebos – often active drugs in such low doses that there is no apparent therapeutic benefit, or vitamins, antibiotics or over-the-counter analgesics like aspirin – they are still disinclined to prescribe a sugar pill. I guess they feel like it’s cheating, somehow.

Taking dummy pills might reduce dependence on addictive drugs

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An international expert on the “placebo effect” says with addiction and abuse of opioid prescription drugs on the rise, it may be time for doctors treating patients with chronic conditions or addictions to consider intermittently substituting substances like morphine with dummy pills.

With or without telling patients.

……

“Placebos are being used in routine medical practice now by many doctors in many circumstances, but the main goal is to reduce intake of drugs. If we are talking about narcotics and other drugs of abuse, the approach is, for example, give morphine on six consecutive days and then a placebo on the seventh day. There are three or four studies with good scientific approaches to this and in those three countries I mentioned, placebo prescribing is more common.”

Asked about the ethics of substituting pills, he said:

“If you want to reduce intake of certain drugs, why not? I think that’s perfectly ethical, but if you want to prescribe placebos so you aren’t bothered by hospital patients in the middle of the night, that’s a different situation.”

Benedetti told delegates that researchers now understand more about the psychosocial context for real drug or placebo treatment effects. Certain words spoken by the health professional (“This pill is really going to help you”), the rituals associated with treatment (such as needle injections) and other sensory experiences all influence whether patients have positive expectations of health improvement. Personality traits can be important factors in who responds to placebos; optimists are more susceptible to having a placebo response while skeptics may have a nil effect.

Full article here.