One of the comments on my recent SharePost “Lyrica Reduces Fibromyalgia Pain in Clinical Trial” posed a couple of excellent questions: “How can a person receive a 50% reduction in their FM/Chronic Pain with only a placebo pill? Does that mean it's all in our minds and we really don't have the pain at all?”
First, I want to say that this absolutely does not mean our pain is all in our minds. Rather, the pain reduction reported in this study can be attributed to what is called “The Placebo Effect.” Scientists estimate that, in any research study, up to one-third of the participants receiving a placebo will experience symptom improvement. No one is really sure exactly why this happens. Scientists have debated the placebo effect for decades. Several theories have been suggested:
- Natural endorphins – Belief that one is receiving the medication may trigger the release of endorphins, neurotransmitters that act as the body’s natural painkillers.
- Reduced anxiety – The expectation of feeling better may soothe the autonomic nervous system and reduce the levels of stress chemicals like adrenaline.
- Altered perception – An individual’s interpretation of symptoms may change with the hope of feeling better. For example, what was considered a nine on the pain scale, may be interpreted as only a six.
- Behavioral changes – Taking part in a clinical trial may motivate one to improve their diet, exercise or rest more, which could result in some symptom improvement.
- Normal waxing and waning – Disorders such as fibromyalgia and chronic fatigue syndrome will naturally wax and wane over time. A waning of symptoms experienced while taking a placebo may just be a coincidence.
- Remembered wellness – Research has shown that the brain responds to an imagined event in much the same way as it responds to an actual event. If the person taking the placebo expects to feel better, the brain may respond by remembering a time before the symptoms began, bringing about actual physical improvement.
The Use of Placebos in Clinical Trials
The placebo effect is one of the reasons new drugs are frequently tested against a control group taking a placebo. One way the effectiveness of a drug is measured is by comparing the group or groups taking the drug with the control group taking the placebo. If the groups taking the actual drug do not improve significantly more than the group taking the placebo, then the drug will likely not get FDA approval. For example, in this Lyrica trial, 15 percent of participants taking the placebo experienced a 50 percent reduction in pain. However, nearly twice as many (up to 30 percent) of those taking the Lyrica experienced a similar improvement –– a statistically significant number.
The Mind-Body Connection
Multiple studies over the past century have proven that there is a powerful connection between the mind and the body. The placebo effect may be a good demonstration of that mind-body connection. I have always personally believed that our attitude (positive or negative) and what we focus our minds on can make a big difference in how we feel. No, a positive attitude won’t cure us, but it can improve our pain perception as well as our overall sense of well-being. And that can make a huge difference in our lives.
For more information read, “The Healing Power of Placebos” from the January-February 2000 issue of the FDA Consumer magazine.
Published On: May 21, 2007