Blind and Double Blind—Sound Ominous?

Those terms certainly sound dangerous. But in the world of cancer clinical trials they refer to methods used to make sure experimental drugs are fairly and accurately tested. Blinded studies are also called randomized studies, although not every randomized study is blinded. Just to clear the air about eye safety, the term “blinded” originated when early participants were actually blindfolded—not likely to happen today.

In many clinical trials two or more drugs are compared in the experimental process. In order to make sure all participants are treated equally, they may not be told which of two or more treatments they are receiving—experimental drug (new), standard drug (the best now available), or maybe even a placebo (see previous entries about placebos) if no standard drug exists. This is a “blind” or “blinded” study. If you participate in a blinded study you will not know and will not be able to choose which treatment you receive. This is common in clinical trials.

It is also common for a blinded study to be a “double blinded” study. This is a second step to insure that all participants and all medical procedures are as fair and equal as possible. In a double blind study not only doesn’t the trial participant know what treatment they are receiving, but the doctors, nurses, and other personnel directly administering the trial do not know either. It is possible to be unblinded and know what one is getting - although this is rare. In general, unblinding happens only if there is a severe side effect and the care of the patient requires knowing what drug he or she is receiving.  Unblinding also happens when the clinical trial is over.

While this may seem frustrating for those involved, blinding increases the chances of determining the actual benefit (if there is one) of the experimental treatment being tested in the trial. 

Ominous? Of course not. It’s all just another part of the clinical trial process.

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(c) 2012 Tom Beer and Larry Axmaker

Red pills are better than blue pills and other interesting observations

In a follow up to its high profile story that we wrote about, CBS News 60 minutes discusses more fascinating facts about placebos.  Did you know that the color of the pills you take might matter?  Who would have thought?





Read more about placebos in an earlier post on our blog.


To put a smile on your face see Larry's latest cartoon


(c) 2012 Tom Beer and Larry Axmaker

Placebo makes it big! On national TV

The history of placebos and the placebo effect spans thousands of years.  We wrote about them recently.  CBS News' 60 Minutes recently ran an fascinating story about placebo effects in the treatment of depression.  The bottom line is that placebos offer important benefits to patients with depression, especially mild to moderate depression.  There have been many placebo-controlled studies in cancer.  Tumor responses are very rare and aren't fully understood.  Sometimes they may represent an immune system effect.  Improvement in symptoms is more common and may represent an effect of the mind-body connection.  The video program is worth a look and, like all 60 Minutes pieces, not without controversy.





To put a smile on your face see Larry's latest cartoon


(c) 2012 Tom Beer and Larry Axmaker

Clinical Trials can sometimes have unexpected benefits

As the co-author who has cancer and has participated in clinical trials, I tend to see the patient/participant side of clinical trials more than the medical side. I have participated in three clinical trials and my life has changed in ways not built into the study plan.

I’ll explain. My first trial, more than 15 years ago, was a prostate cancer prevention study. It was a double blind placebo study—half the men got an experimental medicine and half got a pill that was neutral (sugar pill). Nobody knew who got which pill—not the participants, doctors, or nurses. It turns out I took a placebo for several years. My PSA (a potential marker of prostate cancer) was in the normal range throughout the study.

At the end of the study I was offered a free prostate biopsy and agreed to have it. A prostate biopsy takes tissue samples from your prostate by injecting hollow needles through your colon and into your prostate. I never said it was fun. The bottom line was: even though my PSA was normal, the biopsy found a rather large and fast growing tumor. I started treatment shortly thereafter. Without the biopsy it may have been a few years before I was diagnosed, and possibly at a much later and more dangerous stage.

In a second clinical trial, everybody took the experimental drug and it didn’t seem to work for anybody. No harm—no foul.

My third trial was a six month strength building program for men with prostate cancer and their spouses—10 couples in our group.