Tag Archives: Pain

Patients may be experiencing placebo effect, but it’s still an effect: “Placebo is active treatment”

 

In Respect the Needle in OA (osteoarthritis),  a rheumatologist says:

“… Dealing with osteoarthritis, both patients and their physicians often have a hard time understanding what to make of novel “cures” such as platelet-rich plasma (PRP), stem cell treatments, and so-called prolotherapy.

Although these are typically marketed as halting or reversing joint degeneration in OA, there is virtually no evidence that they actually do. Yet it’s impossible to discount the countless reports from patients that the treatments helped them in terms of pain and function.

The explanation may very well lie in the placebo effect, said Joel Block, MD, a well-known osteoarthritis specialist at Rush University, speaking at the American College of Rheumatology’s 2018 State of the Art Symposium.

But the thrust of Block’s 30-minute talk can be summed up in two words: So what?

The placebo effect is still an effect and a very important one, he argued repeatedly in addressing current knowledge about therapies, largely unregulated, now marketed nationwide in newspapers and online as “disease-modifying.”

It’s “extraordinarily strong” in osteoarthritis, Block said, for reasons that aren’t entirely clear. The experience from randomized trials is that one normally expects a 40% response rate with placebo with large effect sizes. Moreover, the improvements in patient-reported pain do not quickly disappear: the trial data indicates that placebo responses last beyond a year, he said.

“Placebo is active treatment,” Block said.

The placebo’s evil twin

The placebo effect is one of the most mystifying phenomena in medicine. When we expect a pill to make us feel better, it does. If we see others get better while using a medicine, we will too.

But the placebo effect has an evil twin: the nocebo. It can kick in when negative expectations steer our experience of symptoms and create side effects where none should occur.

This means, incredibly, that you can get side effects from a sugar pill. And sometimes these side effects are so severe that patients drop out of clinical trials. More info here.

Recent evidence suggests that the muscle aches might be a big nocebo.

More Research on ‘Open Label’ Placebos

Whether you know you’re taking a placebo pill or not, it will still have a beneficial effect, new research has revealed (Is the rationale more important than deception? A randomized controlled trial of open-label placebo analgesia.)

Scientists from Harvard University and the University of Basel prescribed a group of minor burn victims with a “treatment” cream, telling only some of them that it was a placebo.

After the cream was applied, both groups reported benefits, despite the placebo cream containing no medicine.

Read the full article here

On the subject of Open Label Placebos, here’s a link to research on their efficacy in chronic lower-back pain.

Who is More Likely to Experience a Strong Placebo Effect?

A new study finds that people who have a better handle on their negative emotions may be more likely to experience a stronger placebo effect. Researchers at the University of Luxembourg found that participants who were better at interpreting negative events in a positive light felt more relief from a placebo pain-relieving cream.

The placebo effect has traditionally been viewed in a negative light; however, within the last decade, researchers have investigated the placebo effect itself and found that placebos can trigger real biological changes in the body, including the brain.

In a related article:

“All participants reported less pain: the placebo effect was working. Interestingly, those with a higher capacity to control their negative feelings showed the largest responses to the placebo cream in the brain. Their activity in those brain regions that process pain was most reduced. This suggests that your ability to regulate emotions affects how strong your response to a placebo will be.”

PLACEBO AND FAKE SURGERY

Two thought-provoking articles relating the placebo effect to ‘sham surgery’, which has been canvassed in these pages previously.

In this meta-study, the authors point out that ” the literature is not chock full of studies comparing a surgical procedure to placebo. While the study of a drug versus placebo is standard practice, the picture changes radically when the placebo is a sham operation involving incisions and anesthesia …  Of about 3000 articles, 53 full-text articles were selected. They represented randomized controlled studies, with both an active intervention and a placebo arm involving a sham procedure. The authors defined a surgical outcome based on three elements:

•    The critical surgical component – the anatomic changes felt to result in a therapeutic effect

•    Placebo component – the patient’s expectations

•    Non-specific effects – changes in the natural history of an illness that might impact the outcome, the experience of being in a hospital, interactions with staff – the multitude of other factors.

In this study, the author admits that sham (placebo) srugery already occurs. Because it can work.

How?

“How can sham surgeries work? Bigness. In the same way that placebo pills and other modalities make people get better, the clinical evaluation, workup, stress and travel of surgery day, surgical prep, etc. all make for an almost unbeatable set of placebo-instituting conditions. And with some of the data which exist, sham surgeries perform better in the patients’ minds than a drug treatment that’s a comparator for the same condition.

Placebos and acupuncture

Here’s a link to a fascinating meta-analysis of the effectiveness of acupuncture in the treatment of chronic pain, controlling for some of the dodgy and unscientific ‘studies’ out there.

In this article, the outcomes of the study are listed and discussed, and it’s good news for acupuncturists.

‘When comparing legit acupuncture to standard care, there was a statistically significant benefit to acupuncture … “We saw a measurable effect there,” he explains. “If acupuncture were a drug, we’d say the drug works.”’

…and later, in relation to the placebo effect:

‘Many people equate placebo effects with scams. “The term placebo has always had this very negative connotation,” says Vitaly Napadow, director of the Center for Integrative Pain Neuroimaging at Harvard Medical School. But Napadow says our poor opinion of placebo needs revising. The human body has built-in systems for stoking or calming pain and other subjective sensations. “If a placebo can target and modulate these endogenous systems, that’s a good and a real thing,” he says.’

Meanwhile, in two comprehensive studies into the value of acupuncture treatment in treating women’s health issues, we see mixed results.

‘These studies shed new light on when and when not to consider using acupuncture,” Dr. Josephine Briggs and David Shurtleff, of the U.S. National Center for Complementary and Integrative Health, wrote in an editorial to accompany the studies.

The research done to date on acupuncture has shown that, generally, its benefits are limited to outcomes that are subjective, such as pain, Briggs and Shurtleff wrote. People’s positive expectations and the reassurance they feel from the procedure likely contribute to the benefits. “Clearly these ancient practices are helping reveal the complexity of the links between the mind and the body,” the editorial said.’

Yes, the placebo effect is all in your mind. And it’s real.

It seems that the research on the placebo effect is broadening and deepening.

“Over the last several years, doctors noticed a mystifying trend: Fewer and fewer new pain drugs were getting through double-blind placebo control trials, the gold standard for testing a drug’s effectiveness.”

This recent article, which includes some useful links for further reading, points to the degree in which the placebo effect (classified by the writer as a ‘family of overlapping psychological phenomena’) is being studied and considered. The family of placebo effects ranges ‘from the common sense to some head scratchers’, and include:

1) Regression to the mean
2) Confirmation bias
3) Expectations and learning
4) Pharmacological conditioning (‘This is where things get a little weird’)
5) Social learning
6) A human connection

Interestingly, it seems that at least in pain studies, ‘there’s evidence that placebos actually release opioids in the brain’.

In another article in Mother Jones, What the Heck Is a Placebo Anyway?, the authors propose ‘… we now know that they (placebos) often involve real chemicals produced by the body—real drugs from your “internal pharmacy.” Some of these chemicals are used by the brain to make sure that your expectation meets reality. When expectation doesn’t meet reality, the brain steps in and forces it to fit.’

Over at Fox News (of all people), quoting the Wall Street Journal, they’re suggesting ‘Placebo drugs really work, evidence suggests‘.

Placebo ‘drugs’? Come on, folks, that misses the point a bit!

Placebos and surgery

“Certain types of elective surgery only benefit patients because of placebo effect, says Prof Andy Carr.”

We’ve posted on this previously, on the mater of ‘sham srugery’ for knee pain actually having a substantial impact on lessening pain. In this case, a senior orthopaedic surgeon in Britain, says “The correct thing has got to be to do … trials – not to continue doing operations where we don’t know whether or not there’s a strong placebo component or an entire placebo component because that means that tens or hundreds of thousands of patients are having unnecessary operations,” he said.

That’s right – ‘tens or hundreds of thousands’.

Another professor, also from Oxford, points out the opinion, which we have seen has been gathering momentum (and scientific respectablity) over the past couple of years, that ‘deception’ is not a requirement for the engagement of the placebo effect. “In the modern world where we’re trying to limit the amount of time physicians spend with patients we’re going in the opposite direction of what the science is telling us, which is that [expectation] is really important physiologically and therapeutically and we’re throwing that away.”

Read the whole Guardian article here.

‘I knew they were sugar pills but I felt fantastic’

And more on the efficacy of so-called ‘open label’ placebos (like ours!)

Linda Buonanno had suffered 15 years of intense cramps, bloating, diarrhoea and pain she describes as “worse than labour”. She was willing to try anything to get relief from her irritable bowel syndrome (IBS) and leapt at the chance to take part in a trial of an experimental new therapy. Her hope turned to disappointment, however, when the researcher handed her a bottle of capsules he described as placebos containing no active ingredients.

Nonetheless, she took the pills twice daily. Four days later, her symptoms all but vanished. “I know it sounds crazy,” says Buonanno, of Methuen, Massachusetts. “I felt fantastic. I knew they were just sugar pills, but I was able to go out dancing and see my friends again.”

Placebos have a reputation problem. It is widely believed they are only effective when those taking them are deceived into thinking they are taking real drugs. As such, prescribing dummy or fake treatments is unethical. Yet in Buonanno’s case there was no deception. And she is not alone. A review of five studies, involving 260 patients, published last month found that “open-label” placebos – those that patients know contain no active medication – can improve symptoms in a range of conditions. This growing body of evidence raises a number of important questions. How do open-label placebos work? Which conditions do they work for? And should doctors prescribe them?

Read the whole article here.

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.