My Doctor Wants Me to Participate in an Arthritis Clinical Trial - I'm Worried About Placebo

My Doctor Wants Me to Participate in an Arthritis Clinical Trial - I'm Worried About Placebo

Clinical trials involving medicines for arthritis are valuable in that they may eventually lead to a cure for this condition.

It has been demonstrated that the placebo response in arthritis clinical trials can reach up to 30-40 percent. That means that roughly one-third of patients receiving placebo will pronounce they are feeling better... or patients receiving placebo will feel that they are 30-40 percent better than they were before taking medication.

In any event, the placebo response has been derided by academic physicians as proving that a given therapy doesn't work... and lauded by other physicians who feel that the placebo response should be harnessed. The latest study from Manchester is firmly in the camp of the latter group.

Research by the Human Pain Research Group at The University of Manchester suggests that people's responses to placebo vary according to their way of thinking.

Forty normal volunteers took part in an experiment funded by the Arthritis Research Campaign (the British equivalent of the American Arthritis Foundation) using an artificial pain stimulus, and were led to expect reduced pain after the application of a cream which was actually a placebo.

Lead researcher Alison Watson said: "Any medical treatment involves a placebo element; the psychological suggestion that it is going to work. So we theorized that a proportion of any treatment's effectiveness would relate to how much we wanted it to work, believed in it or trusted the person administering it.

"Doctors and nurses can transmit a lot of information about a treatment and its effectiveness through their words and gestures. We know that when people visit their preferred physician, the treatment or advice they receive will be more effective than that given by a physician they prefer not to see. Similarly, red pills have been shown to be more effective than green ones; so we wanted to test whether all this was due to expectations of successful treatment and trust in the person giving it."

Twenty-four of the volunteers initially received a moderately painful heat stimulus to both arms. The placebo cream was then applied to the skin, but they were led to believe that the cream on one of their arms may be a local anesthetic.

After the application of the cream, the intensity of the heat stimulus was turned down on one arm without informing the volunteer. Subsequently, the intensity was returned to its previous level, but - in contrast to the 16 people in the control group - 67 percent of the treatment group continued to perceive the heat as less painful.

Watson says, "The expectation of pain relief leads to a release of endorphins, the brain's natural pain killers, which is likely to contribute to a sensation of reward and well-being.

"Interestingly, there was an exact split in the range of responses to the placebo; a third of people reporting a reduction in the pain intensity in the "treated" arm only, another third in both arms and the remainder's intensity-ratings not being influenced by the application of the cream. The different responses can be related to the different levels of pain relief the volunteers expected, which may have allowed their individual suggestibility to influence their assessment of the pain experience.

"Our findings suggest that different individuals may have different styles of placebo response, which is likely to affect how they respond to real treatments too. Understanding these differences could better inform the way doctors and nurses provide treatments in the future.

"It could also facilitate more effective clinical trial design, which could substantially reduce the costs of developing new pain killers for patients with conditions like... arthritis.

"A further, exciting possibility is that we could develop talking and drug-based therapies to enhance people's response to placebos. The experimental methods we're using will allow us to test out such possibilities as a method of treating pain."

The response to treatment from a trusted physician should not be underestimated. It suggests that the rapport a person has with their physician is an important determinant of whether they will improve or not.

It also suggests that patients who wish to participate in an arthritis clinical trial should probably do so since they will often do better than they would if they didn't. The thirty-forty percent placebo response is significant.

Arthritis clinical trials also offer the benefit of free study related care so patients will benefit from cost savings as well. The testing during the course of arthritis clinical trials is valuable since it often uncovers health issue the patient was unaware of and may actually save their life. Finally, many clinical arthritis trials reimburse patients for time and travel which is another added bonus. Finally, clinical arthritis trials are often done by experienced and respected physicians... so your care will often be of much higher quality than it will be with a run-of-the-mill arthritis physician.

Dr. Wei (pronounced "way") is a board-certified rheumatologist and Clinical Director of the nationally respected Arthritis and Osteoporosis Center of Maryland (http://www.aocm.org). He is a Clinical Assistant Professor of Medicine at the University of Maryland School of Medicine and has served as a consultant to the Arthritis Branch of the National Institutes of Health. He is a Fellow of the American College of Rheumatology and the American College of Physicians. For more information on arthritis and related conditions, go to: Arthritis Treatment

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