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Placebo As a Treatment for Depression Walter A NEUROPSYCHOPHARMACOLOGY 1994-VOL. 10, NO.4 265 REVIEW AND COMMENTARIES Placebo as a Treatment for Depression Walter A. Brown, M.D. The placebo response rate in depression consistently falls the psychotherapies (expectation of improvement, between 30 and 40%. Among more severely depressed support, mobilization of hope) are provided with pill patients antidepressants offer a clear advantage over placebo treatment. placebo; among less severely depressed patients and those The placebo response in depression has been viewed with a relatively short episode duration the placebo as a nuisance rather than as a therapeutic and research response rate is close to 50% and often indistinguishable opportunity. I propose that the initial treatment for from the response rate to antidepressants. In the selected depressed patients should be four to six weeks of treatment of depression none of the psychotherapies have placebo. Patients so treated should be informed that the consistently been shown to offer an advantage over pill placebo pill contains no drug but that this treatment can placebo. This is not entirely surprising given the fact that be helpful. [Neuropsychopharmacology 10:265-269, the common, and arguably the therapeutic, features of 1994J 1992; 1991). KEY WORDS: Placebo; Depression; Psychotherapy; C. Beasley, personal communication [One Antidepressant explanation for this apparent increase in the placebo response is that the relative paucity of side effects with I am proposing that the initial treatment for a sizable the newer drugs makes the results of placebo-controlled portion of depressed patients should be four to six studies less biased by knowledge of which patients are weeks of placebo. This proposal rests on the necessity and are not on "active" drug.] to limit the costs of health care, the medical dictum, pri­ Although among moderately to severely depressed mum non nocere, and, most of all, the inconvenient patients the response rate to antidepressants (60to 70%) but undeniable fact that a substantial proportion of is consistently better than that to placebo, the differ­ depressed patients improve with placebo alone. ence in response rates to these two treatment modali­ 30 More than years of double-blind placebo­ ties is only about 35%. Among less severely depressed controlled antidepressant efficacystudies have consis­ 30 40% patients the improvementrate with placebo approaches tently shown that to of moderately to severely 70% (Brown et a1. 1988) and does not differ from the depressed patients improve with placebo treatment response to antidepressants. Clearly, fewer than half 1965; 1985; (Klerman and Cole Stark and Hardison the depressed patients treated with antidepressants 1988). Brown et a1. Recent data suggest that these benefit from their pharmacologic activity. placebo response rates, which have been widely repli­ Various psychotherapies are widely used as ad­ 30 cated over the past years, may actually be underes­ juncts to antidepressant medication and as the sole timates. Some studies of the newer antidepressants treatment for less severe depressive syndromes. None 50% show placebo response rates close to (Brown et al. of the psychotherapies systematically studied in the treatment of acute depression - behavioral, interper­ From the Brown University School of Medicine and the Depart­ sonal and cognitive among them - have been consis­ ment of Veterans AffairsMedical Center,Providence, Rh ode Island 02908. tently shown to offer an advantage over pill placebo Address correspondence to Walter A. Brown, M.D., Department (Elkin et al. 1989; Robinson et a1. 1990). of Veterans Affairs,Medical Center,830 Chalkstone Avenue,Research What is this placebo treatment that compares so fa­ Service (151), Providence, RI 02908. Received June 11,1993; revised July 21,1993; accepted February vorably to conventional treatments? The general term 2,1993. "placebo" resists a coherent, internallyconsistent defmi- Published 1994 by Elsevier Science Inc. 655 Avenue of the Americas, New York, NY 10010 0893-133X/94/$7.00 266 W.A. Brown NEUROPSYCHOPHARMACOLOGY 1994-VOL. 10, NO. 4 tion. A placebo is commonly defIned, in contrast to apies are more effective than waiting list controls (effect "real" treatment, as inactive and nonspecifIc. But size = 0.84) the psychotherapies are not more effective placebos are clearly active; they exert influence and are than pill-placebo controls (effect size = 0.28). These data effective. As for nonspecifIc, although its meaning with in the aggregate are consistent in suggesting that pill respect to placebo is not entirely clear, it probably refers, placebo is more effective than no treatment. among other things, to an imprecise or undefIned mode So, assuming that placebo treatment offers some­ of action or an effect on more than one condition. By thing therapeutic, what are its active ingredients? Frank either defInitionplacebos are no less specifIc than many points out that placebo treatment includes the features indisputably valid treatments. In placebo-controlled shared by all of the psychotherapies, features that he drug efficacy studies, from which much of the data on believes are the curative elements: a person in distress; placebo response in depression come, the term placebo an expert; an explanation for the condition; and a heal­ enjoys a concrete, albeit exclusionary, defInition; it is ing ritual promoting positive expectation and reversal a pharmacologically inert capsule or injection. And the of demoralization (Frank and Frank 1991). placebo effect or response is the improvement that oc­ Expectation is probably the best studied component curs in the placebo-treated group. In a drug efficacy of the placebo response. In a variety of naturalistic study there is no necessity to identify the components studies expectation of improvement has been shown of treatment that induced the placebo response; this to be positively correlated with treatment outcome response is strictly an annoyance factor that has to be (Frank and Frank 1991). And when expectation is subtracted from the drug response in order to deter­ manipulated in experimental paradigms the effect of mine the true drug effect. a pharmacologically inert substance is directly related But placebo-treated subjects in double-blind clini­ to the expected effect; when subjects given a pharmaco­ cal trials receive much more than an inert capsule. They logically inert substance are told that they have received are the recipients of the common treatment factors pres­ caffeine, alcohol, or an analgesic they report subjective ent in any plausible treatment situation. These include experiences and show behavioral and some of the phys­ expectation of improvement, demand for improve­ iologic changes typical of these substances (Kirsch 1985). ment, and clinician enthusiasm, effort, and commit­ Pillingestion itself may well contribute to the ther­ ment. The subjects of antidepressant clinical trials also apeutic effect of placebo treatment (Frank and Frank receive to varying degrees, depending on the treatment 1991). There are no studies examining the effect of pill setting and clinician, the opportunity to verbalize dis­ ingestion per se on depression. But there are data sug­ tress, encouragement, mobilization of hope, attention, gesting that pill ingestion in itself can influence health. and positive regard. And they usually receive these In a study assessing propranolol's effect on mortality things about once a week. in myocardial infarction survivors, more than 2,000men It can be assumed that some "placebo responders" and women who had survived a myocardial infarction are spontaneous remitters who would have improved were randomized to receive either propranolol or with the passage of time alone. So, does placebo treat­ placebo (Horwitz et al. 1990). At one-year follow up, ment offer any advantage over a "wait and see ap­ patients who had taken propranolol regularly (more proach," over the mere passage of time? I am not aware than 75% of prescribed medication) had half the mor­ of any studies that have directly compared the effec­ tality rate of those who had taken it less regularly. No tiveness of pill placebo in the treatment of depression surprise. But the same relationship held for placebo; to the passage of time alone. But three lines of evidence, patients who took placebo regularly also had half the none of which are in themselves defInitive or free of mortality rate of those who took it less regularly. The bias, converge to suggest that placebo treatment pro­ relationship between adherence to placebo treatment vides greater symptom relief than no treatment. and mortality could not be accounted for by differences First, depressed patients assigned to "waiting list" between good and poor adherers on psychosocial and control groups show negligible improvement (Robin­ medical factors that influence mortality (Horwitz et al. son et al. 1990; Wilson et al. 1983). Second, among 1990). depressed patients entering antidepressant clinical trials The apparent health-promoting effectsof pill inges­ 10% fewer than improve during the one to two weeks tion have been attributed to the fact that in our culture of single-blind placebo treatment typically preceding medication symbolizes the physician's healing power. double-blind placebo treatment (Loebel et al. 1986). In Adding to the psychological benefItsof a pill's symbolic contrast, during the fIrst one to two weeks of double­ value may be conditioning effects derived from previ­ blind treatment patients
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