| you read about medical research studies, you often | | | | phenomenal properties of the brain to believe. |
| see the term “place” used. Since our | | | | It has been estimated that up to 40 per cent of |
| center is very active in clinical research, the question | | | | volunteers enrolled into a clinical research trial for |
| of placebo comes up a lot from our prospective | | | | arthritis respond positively to placebo. So it’s |
| study volunteers so I though maybe explaining | | | | no surprise that drugs in development need to be |
| placebo and its role in research would be useful. | | | | compared to a dummy drug to ensure that the |
| A placebo is similar to a blank bullet. A placebo is | | | | positive response is greater than that of placebo. |
| given for comparison with the “real' | | | | The exact reason why patients respond so well to |
| treatment.” It is a dummy treatment that | | | | placebo in arthritis studies may be that they receive |
| contains no active substances. The placebo is made | | | | extraordinary care while they are participating. |
| to look and taste identical to the drug being tested, | | | | And it’s not a phenomenon that’s |
| so that people in the studies do not know if they are | | | | restricted to drugs. For instance, arthroscopic surgery |
| getting the placebo or the “real” | | | | for osteoarthritis of the knee was felt to be a |
| treatment. Often it is referred to as a “sugar | | | | beneficial therapy. However, there have been at least |
| pill.” However, placebo treatments may be | | | | two placebo controlled studies demonstrating that |
| given intravenously or into the joint in arthritis studies. | | | | arthroscopic surgery as a treatment for osteoarthritis |
| Researchers often talk about the “placebo | | | | of the knee is not effective when compared to a |
| effect”. This is where patients feel better | | | | sham procedure. Obviously, this is a controversial |
| after having a placebo treatment because they | | | | topic among orthopedists. |
| expect to feel better. | | | | Most studies in arthritis give volunteers about a one |
| In a “single blind” study, only the | | | | in four chance of drawing placebo. And many studies |
| patient doesn’t know what they’re | | | | which have a placebo arm also have a later phase of |
| getting. The investigator (scientist) does know. | | | | the study, where if it is shown that the study drug is |
| In a double-blind study neither the patient nor the | | | | effective, that people who received placebo can now |
| investigator knows what the patient is getting. This is | | | | receive the study drug “open label”. |
| a much better design, since an investigator who | | | | This means they receive the real study drug and |
| knows what the patient is getting can convey an | | | | they get it for free. Not a bad deal. |
| unconscious bias towards the patient. In other words, | | | | Among the biggest reasons for the high cost of |
| if the investigator knows the patient is getting the | | | | medicines is the inability to complete clinical trials in a |
| “real drug” they might unconsciously | | | | timely fashion. The most significant hurdle to |
| bias the patient to having a better response than | | | | accomplishing this is patient recruitment into these |
| they ordinarily would. And on the flip side, if the | | | | studies, particularly arthritis studies. And the reason |
| investigator knows the patient is getting a placebo, | | | | most often given is “I don’t want to |
| he or she may have negative expectations for | | | | receive placebo.” |
| outcome that they unconsciously convey to the | | | | If patients understand the nature of placebo and |
| patient. | | | | realize that it is not harmful, that there is an excellent |
| Another phenomenon that many people don’t | | | | chance they’ll improve with whatever |
| know about is the “nocebo response.” | | | | treatment they get, that they realize that |
| This is when a patient gets a negative response to | | | | they’re getting excellent care, that they may |
| the dummy treatment. In other words, they get | | | | also get free drug later on in the study, and that |
| worse when they take the sham treatment. | | | | they often get paid to participate, then it becomes a |
| Unfortunately, the word “placebo” has | | | | good idea to at least considering being a clinical trial |
| a negative connotation because people don’t | | | | enrollee. |
| realize why placebo is used and also because they | | | | For more information about participating in an arthritis |
| feel that if they don’t get the | | | | clinical trial, call the Arthritis and Osteoporosis Center |
| “drug” that they will become worse. | | | | of Maryland at (301) 694-5800 or (888) 71-STUDY. |
| Placebos are used in research trials because of the | | | | |