Tag Archives: placebo effect

Can Pill Color Prompt a “Nocebo” Response?

What’s the opposite of a placebo? An active drug, of course. But what’s the opposite of a placebo response? That would be a “nocebo” response, in which placebos produce adverse side effects.
 
“It’s somewhat hypothetical, but you can imagine that if somebody feels they will get better, they will get better, and if they feel that they’re taking something that’s not good for them, they might get worse,” according to Dr. Allan Krumholz, professor of neurology and director of the Maryland Epilepsy Center, Baltimore.

Image courtesy of Dr. Tricia Y. Ting

Pill color and appearance have been identified as a potential source of “nocebo” response, and differences in appearance between brand-name and generic drugs have been postulated to explain why some patients experience increased adverse events when they switch from brand-name to generics.

In response to this growing concern, in August 2010 the Food and Drug Administration solicited proposals for bioequivalence studies of the impact of switching from brand-name antiepileptic drug lamotrigine (Lamictal) to generic among patients with epilepsy in the outpatient setting.

This is a new way of conducting such trials. “Pharmacokinetics trials across all areas of medicine have traditionally been highly controlled single-dose studies in healthy volunteers dosed in the laboratory setting,” said lead investigator Dr. Tricia Y. Ting, a neurologist who works with Dr. Krumholz at the UMD epilepsy center.

Because the brand-name Lamictal and its generic counterparts look very different, the investigators decided to over-encapsulate the pills with identical coverings in order to “blind” the patients to which formulation they were taking.

But in order to do that, they first needed to determine whether the color of the pill would impact the patients’ perception of safety and efficacy. A group of 80 adult epilepsy patients were shown standard AA size capsules in five “global colors” (white, yellow, gray, caramel, maroon) and asked to select any color(s) considered “unacceptable” and to rank their preferences.

More patients deemed gray, caramel and maroon colors “unacceptable” (21%, 19%, and 20%, respectively) compared with the white and yellow (5% and 4%, respectively). There was a clear preference for white and yellow pills over the other, darker colors, without much difference between white and yellow.

But, there were patients who selected maroon as their “preferred” color. “Some people didn’t have any preference. Some had a very strong preference. One patient, an artist, liked the darker colors. It was different for different people,” noted Dr. Karen M. Aquino, a neurology fellow who worked on the nocebo study.

So what pill color will the bioequivalence study use? “To optimize drug adherence, white colored capsules will be used for over-encapsulation,” Dr. Ting wrote in her poster, which was presented at the American Epilepsy Society’s annual meeting in Baltimore. Dr. Krumholz and Dr. Aquino presented the pill color preference data in a separate poster at the meeting. The bioequivalence results are expected in 2013.

-Miriam E. Tucker (@MiriamETucker on Twitter)

Advertisements

Leave a comment

Filed under Allergy and Immunology, Alternative and Complementary Medicine, Clinical Psychiatry News, Drug And Device Safety, Endocrinology, Diabetes, and Metabolism, Family Medicine, IMNG, Internal Medicine, Neurology and Neurological Surgery, Primary care, Psychiatry, Uncategorized

The Top-Viewed Posts of 2010

Well, it’s that time of year: A time for reflection, a time for too much fattening food and drink, and probably way too much togetherness with relatives you spend the rest of the year trying to avoid. Here at Notes From the Road, we’d like to take a moment to reflect on the bounty that medicine has provided us in 2010 by sharing our most-viewed posts, as nearest as we can determine.

Via Flickr Creative Commons user yoppy

10. Would an Artificial Pancreas be a Diabetes “Cure?” By Miriam E. Tucker

The Juvenile Diabetes Research Foundation’s announcement yesterday of a partnership with Animas Corp. and DexCom Inc. to develop a first-generation automated insulin delivery system brought to my mind a question that is often debated in diabetes circles: Would a fully automated “artificial pancreas” represent a “cure” for type 1 diabetes? (Read more.)

9. Placebos vs. Antidepressants: Not Quite a Draw By Bob Finn

There’s a fascinating study in today’s Journal of the American Medical Association. It’s a meta-analysis of randomized controlled trials comparing antidepressants vs. placebo. And it showed that the placebo effect is so strong in depression that placebos work as well as paroxetine (Paxil) and imipramine (Tofranil) for all patients except those with major depressive disorder that’s classified as “very severe.” Placebo tied active medication for “mild,” “moderate,” and even “severe” depression. (Read more.)

8. Tocilizumab Approval Causes Buzz by Diana Mahoney

One year after asking the Roche group to submit additional data for its monoclonal antibody tocilizumab, the FDA has approved the biologic agent for the treatment of moderate to severe rheumatoid arthritis. (Read more.)

7. Head Injuries Predict Persistent, Bad Headaches by Sherry Boschert

Like many of the neurologists attending the annual meeting of the American Headache Society, I slipped into the hotel lobby during breaks in the program to watch World Cup soccer in bits and pieces. The images of players heading the ball caught my eye in a new way after hearing a couple of presentations about the associations between head injuries and persistent, more frequent, and disabling headaches. (Read more.)

6. Using Hemoglobin A1C to Diagnose Diabetes: What’s Your Take? By Miriam E. Tucker

The American Diabetes Association’s decision earlier this month to officially endorse hemoglobin A1c as a diagnostic test for diabetes is either timely, inappropriate, or long overdue, depending on whom you talk to. (Read more.)

5. Can Hemoglobin A1C Go Too Low? By Miriam E. Tucker

A new study showing increased mortality among type 2 diabetes patients at hemoglobin A1c levels below 7.5% raises a new question: Should diabetes guidelines be revised to include a minimum hemoglobin A1c level? (Read more.)

4. New Clues to the Root of Basal Cell Carcinoma by Doug Brunk

Findings from a novel investigation published in the Jan. 5, 2010, edition of Cancer Prevention Research are helping researchers better understand what causes basal cell carcinoma tumors. (Read more.)

3. Rheumatoid Arthritis 5.0 by Mitchel Zoler

Rheumatologists have remade rheumatoid arthritis, a pretty big deal for them if only because it’s “the major systemic rheumatic disease that we as a specialty treat,” said Dr. Michael E. Weinblatt, a Harvard rheumatologist, at the end of a 90-minute session on Sunday afternoon that unveiled a new definition of rheumatoid arthritis to the world. (Read more.)

2. Doctors Attend to Burning Man by Sherry Boschert

Next week more than 40,000 people from around the world will migrate to Black Rock Desert in Nevada to create a week-long community where clothing is optional, illicit drugs are common, and fantastical artwork is everywhere. Dr. Marc Nelson will be one of them at an event called Burning Man. (Read more.)

1. Doctors: Help Them Understand That “It Gets Better” By Mark Lesney

Any growing tolerance of a person’s right to his or her own sexuality that is evidenced in the mainstream culture has yet to impact the Lord of the Flies scenarios that exist for gay, lesbian, bisexual, transgendered, or questioning students in many schools across the country—something that is comically but bitingly portrayed in the Fox hit series “Glee.” (Read more.)

Thanks for following us in 2010. We hope you’ll be back for more in 2011.

— Alicia Ault (on Twitter @aliciaault)

1 Comment

Filed under Dermatology, Endocrinology, Diabetes, and Metabolism, Family Medicine, IMNG, Pediatrics, Primary care, Psychiatry, Rheumatology