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PLACEBO--HOW TO VIOLATE A DOUBLE-BLIND STUDY--jk

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Active placebos versus antidepressants for depression (Cochrane Review)

Moncrieff J, Wessely S, Hardy R

ABSTRACT

A substantive amendment to this systematic review was last made on 27 July 1998. Cochrane reviews are regularly checked and updated if necessary.

Background: Although there is a consensus that antidepressants are effective in depression, placebo effects are also thought to be substantial. Side effects of antidepressants may reveal the identity of medication to participants or investigators and thus may bias the results of conventional trials using inert placebos. Using an 'active' placebo which mimics some of the side effects of antidepressants may help to counteract this potential bias [my emphasis].

Objectives: To investigate the efficacy of antidepressants when compared with 'active' placebos.

Search strategy: The Cochrane Collaboration Depression, Anxiety and Neurosis review groups's search strategy was used to search MEDLINE (1966-2000), PsychLIT (1980-2000) and EMBASE (1974-2000) and this was last done in July 2000. Reference lists from relevant articles and textbooks were searched and 12 specialist journals were handsearched up to 1996.

Selection criteria: Randomised and quasi randomised controlled trials comparing antidepressants with active placebos in people with depression.

Data collection and analysis: Since many different outcome measures were used a standard measure of effect was calculated for each trial. A subgroup analysis of inpatient and outpatient trials was conducted. Two reviewers independently assessed whether each trial met inclusion criteria.

Main results: Nine studies involving 751 participants were included. Two of them produced effect sizes which showed a consistent and statistically significant difference in favour of the active drug. Combining all studies produced a pooled estimate of effect of 0.39 standard deviations (confidence interval, 0.24 to 0.54) in favour of the antidepressant measured by improvement in mood. There was high heterogeneity due to one strongly positive trial [my emphasis]. Sensitivity analysis omitting this trial reduced the pooled effect to 0.17 (0.00 to 0.34). The pooled effect for inpatient and outpatient trials was highly sensitive to decisions about which combination of data was included but inpatient trials produced the lowest effects.

Reviewers' conclusions: The more conservative estimates from the present analysis found that differences between antidepressants and active placebos were small. This suggests that unblinding effects may inflate the efficacy of antidepressants in trials using inert placebos. Further research into unblinding is warranted.

Citation: Moncrieff J, Wessely S, Hardy R. Active placebos versus antidepressants for depression (Cochrane Review). In: The Cochrane Library, Issue 1 2003. Oxford: Update Software.


This is an abstract of a regularly updated, systematic review prepared and maintained by the Cochrane Collaboration. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).

 

HOW TO RECOGNIZE A PLACEBO & SOME EXAMPLES WHERE THIS HAS HAPPENED
 
The most convenient chemical tester is the tongue.  Simply bite into the pill.  Does it taste like an inert placebo?
 
 
 

PROFITS BEFORE PEOPLE:  CAPITALISM DOESN’T BELONG IN MEDICINE—jk

 

When business is measured by profits, the end results reflect this strongest of vectors.  Two end results are reflected in the below articles on migraines.  The measure of success for the corporate directors is net profits.  That a drug is effective is important to the directors only in so far as such a drug will on an average yield greater profits than a less effective one.  However, the profit motive drives directors to make their drugs appear more effective than they are, including in situations when they are not effective at all, or less effective than that of their competitors.  The end result is that the best interest of the patient (consumer) is compromised for increased profits.

 

One example is the drive for increasing drugs sales and as a consequence to show that a drug is useful in treating additional conditions.  Tranquilizers have found the new uses for the relief of back pain and migraines.  If a person is drugged so that he sleeps more hours, then he suffers less back pain and less head pain (during the hours that he spent sleeping).  The result is that drug companies do double-blind studies which show that the patients report less back pain when on the tranquilizer than those who were given a placebo.  However, the patients given a placebo—having been told they might receive a placebo--suspect such, for the lack change following the taking of the medication or the fact the pill doesn’t have a medicinal flavor, while those getting the drug for contrary reasons know they are not receiving a placebo.  Since knowledge of receiving a drug produces on an average a 30% report of effectiveness, and many in both groups (placebo & medicate) have figured out which group they are in, the results to show the tested drug is more effective than it truly is.  FDA approval follows successful complete of such a phase III testing of a drug.  Billions of dollars are made in this way. 

 

The doctors are motivated to prescribe the tranquilizer for several reasons.  One has been the persistent harassment of doctors by the DEA for prescribing opiates.  A number of them are in jail or have had their license to prescribe controlled drugs removed. In our less than fair legal system, a number of them have been unjustly jail (as was the case with Dr. Evans of Pennsylvania).  Wishing to minimalize their risk, tranquilizers are frequently prescribed for migraines and back pains.  Sleeping reduces the number of hours pain is consciously felt.[1]   Thus the only really effective treatment has been replaced by the minimally effective tranquilizers.  Secondly, doctors need to prescribe something so as to satisfy his customer’s expectation.  Most patient know that there are medications for back pain and migraines.  It is quicker (time is money) to write a prescription than explain why what is on the market really doesn’t work, and besides about 30% of the patients will believe that the drug helps simply due to the placebo effect.  It is in the doctor’s financial interest to prescribe a tranquilizer for both back pains and migraines. 

 

But does the patient want to be drugged throughout the day?  Most doctors simply make the decision for the patient without telling him he is being given a tranquilizer.  The only warning is the statement on the bottle about drossiness is a possible consequence of the medication—and possible a similar statement made by his doctor.  Can this be equated to making the patient more comfortable, as when prescribing opiates?  Hardly, for the consequences upon behavior are far more for the tranquilizer.  A better alternative would be to proscribe an opiate.  IN OTHER WORDS, THE BEST INTEREST OF THE PATIENT HAS BEEN COMPROMISED.

 

The use of inactive placebos is the most common way a drug company can end-run the purpose of a double blind study, and fulfill their financial purposes. 


[1]  Pain is felt when asleep.  People wake up from pain.  And doctors continue to block pain even when operating even though the patient has been put to “sleep”.  Such a patient will show effects of pain through changes in reparation and blood pressure—to name the principle two.