Chance News 69

Placebo contents

According to Wikipedia,

A placebo (Latin: I shall please) is a sham or simulated medical intervention that can produce a (perceived or actual) improvement, called a placebo effect.

[The origin for the term placebo] dates back to a Latin translation of the Bible by Jerome. It was first used in a medicinal context in the 18th century. In 1785 it was defined as a "commonplace method or medicine" and in 1811 it was defined as "any medicine adapted more to please than to benefit the patient," sometimes with a derogatory implication.

Nowadays, so entrenched is the necessity of a comparison to a placebo, any medical treatment trial without a control arm containing a placebo would be viewed skeptically both statistically and medicinally. But, consider the provocative title of Golomb: “What's in Placebos: Who Knows? Analysis of Randomized, Controlled Trials.” Surprisingly,

No regulations govern placebo composition. The composition of placebos can influence trial outcomes and merits reporting.

The study looked at four prestigious journals: New England Journal of Medicine, JAMA, The Lancet and Annals of Internal Medicine. Included were 176 journal articles:

Most studies did not disclose the composition of the study placebo. Disclosure was less common for pills than for injections and other treatments (8.2% vs. 26.7%; P = 0.002).

Conclusion: Placebos were seldom described in randomized, controlled trials of pills or capsules. Because the nature of the placebo can influence trial outcomes, placebo formulation should be disclosed in reports of placebo-controlled trials.

Discussion

1. Golomb cites the following example: “For instance, olive oil and corn oil have been used as the placebo in trials of cholesterol-lowering drugs.” Under the assumption that these oils might be beneficial, rather than inert, why does this understate the positive benefit of the treatment?

2. Golomb cites another example where a lactose placebo was used in a gastrointestinal trial. Under the assumption that the lactose was harmful, why does this overstate the positive benefit of the treatment?

3. Why is modern communication, e.g., the internet, facebook, etc., a cause for concern when conducting a randomized control trial (with or without a placebo arm)?

4. Golomb further alleges, “failure to describe placebo ingredients breaches basic scientific standards of rigor.” Why would describing the placebo ingredients “disadvantage” the “publication prospects” of the researchers and “disadvantage” the publisher of the particular journal?

5. Medicine is not the only area of endeavor which should require a placebo arm. Name some others.

6. For the record, the term nocebo (I will harm) was coined in 1961 and refers to the negative effects of a sham or simulated medical intervention. An example sometimes given is a patient dying of fright due to being bitten by a non-poisonous snake. Give examples of some other nocebos.

7. Why would prayer be considered a placebo? Why would prayer be considered a nocebo?

8. Exorcism has been in the news lately. Justify exorcism as a treatment, a placebo or a nocebo.

Submitted by Paul Alper