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American Osteopathic Association's Position Against ceive their symptoms to be relieved by the treatment and trust in their treating physician’s treatment plan or prescrip- tion (or both) for the symptom relief are American Osteopathic more likely to obtain relief.2 Association’s Position Placebo responses are necessary for controlled clinical trials in which the Against Use of Placebos patient is informed that a placebo may for Pain Management indeed be used. Physiologic responses in End-of-Life Care to placebo can be pleasant or unpleasant to the patient. An unpleasant psycho- Council on Palliative Care Issues* somatic effect attributable to adminis- tration of a placebo is called a nocebo response. A pleasant effect is called a positive placebo response. Jerome4(p221) notes: A positive placebo response A number of organizations have advised against the use of placebo substitu- simply speaks to the strength of tion, including the American Pain Society, Agency for Healthcare Policy and an individual’s central control pro- Research, World Health Organization, Healthcare Facilities Accreditation Pro- cesses (i.e., mind) to recruit their gram, Joint Commission on Accreditation of Healthcare Organizations, Edu- descending inhibitory system to cation for Physicians on End-of-Life Care Project (cosponsored by the Amer- block pain. The osteopathically ican Medical Association and The Robert Wood Johnson Foundation), American trained physician knows that pain Nursing Association, and the American Society of Pain Management Nurses. relief occurs both in the mind and This white paper describes the literature and rationale in support of the in the body. American Osteopathic Association’s (AOA’s) position on the controversial sub- ject of the use of placebos for pain management in terminally ill patients. The basis of the placebo effect in a The following policy statement was adopted by the AOA’s House of Del- therapeutic physician-patient relation- egates in 2005. This statement was drafted by the association’s Council on Pal- ship also involves good communication liative Care Issues, which at that time was called the End-of-Life Care Com- skills as well as listening to the mittee. patient.4,10,11 This statement has been modified to adhere to the house style of JAOA— To summarize, a placebo is an agent, The Journal of the American Osteopathic Association. necessarily used in controlled clinical trials, that has no inherent physiologic action, yet is designed to mimic a therapy with a known active physio- he issues of placebo use, placebo Definition of Terms logic effect. Positive changes resulting T effect, and placebo abuse as they Placebo Effect, Placebo Substitution, from administration of placebo are due affect pain management are fraught with and Nocebo Response to expectations of success by the patient. opinion, confusion, and misunder- A placebo is a substance presumed to be Thus, the use of placebo effect is based standing. The placebo effect of medica- pharmacokinetically inert. Placebo sub- on the patient’s perception of the role of tion can be a significant resultant action of stitution means the substitution of a phys- the placebo agent with symptom relief. any prescription. However, the substitu- iologically inactive substance for a com- A positive patient-physician relation- tion of a placebo in place of effective pain parison with the physiologically active ship may enhance the placebo effect. medication has been widely recognized as substance. Placebo effect is the positive unethical, ineffective, and potentially psychosomatic response of an individual Addiction, Substance Abuse harmful.1-8(pp37-30) to a treatment.9 The placebo effect is an and Dependence, Tolerance, important adjunct in the symptomatic Withdrawal, and Pseudoaddiction treatment of patients. The alleviation of Some physicians inappropriately justify *For 2004-2005, the members of what is now the symptoms has an inherent positive psy- using placebo in pain management to American Osteopathic Association’s Council on chological component: Patients who per- avoid “addicting” the patient. Palliative Care Issues, were Karen J. Nichols, DO, chair (AOA Board of Trustees); Katherine E. Gal- luzzi, DO, vice-chair; Bruce P. Bates, DO; Benneth Ann Husted, DO; Jimmie P. Leleszi, DO, Cleanne This continuing medical education publication is supported by an educational grant Cass, DO; and Dennis Lavery (National Associa- from Purdue Pharma LP. tions of Osteopathic Foundations’ observer). Ken- neth Simon, DO, was a 2000-2004 member. American Osteopathic Association • Position Statement on Use of Placebos JAOA • Supplement 4 • Vol 107 • No 6 • June 2007 • ES35 Addiction, as defined by a consensus the assessment of the patient in pain withdrawal symptoms, and pseudoad- document from the American Academy who has or may have the potential for a diction may help physicians understand of Pain Medicine, the American Pain substance abuse. The Diagnostic and Sta- and more effectively treat these patients. Society, and the American Society of tistical Manual of Mental Disorders, Fourth Tolerance represents a markedly Addiction Medicine12 is Edition (DSM-IV),13 lists definitive cri- diminished effect that can occur with teria for diagnosis of psychological and continued use of most medications; the ... a primary, chronic, neurobio- physical dependence on substances. This degree depends on the daily dose and logic disease, with genetic, psy- text categorizes “Substance-Related Dis- length of use. The need for medication chosocial, and environmental fac- orders” but does not use the term addic- titration, because of either development tors influencing its development tion; further, nowhere in the DSM-IV do of tolerance or incomplete responsive- and manifestations. It is charac- criteria for diagnosing and treating var- ness, is a part of routine medical care. terized by behaviors that include ious forms of substance abuse include Tolerance occurs as the result of com- one or more of the following: the administration of placebos. pensatory changes in receptors or impaired control over drug use, Substance dependence is defined as a increased clearance resulting from induc- compulsive use, continued use cluster of cognitive, behavioral, and phys- tion of various metabolic pathways, or despite harm, and craving. iologic symptoms. The essential feature both. The problem of tolerance therefore of a substance-dependent individual is should be anticipated as a possible out- Actually, it is rare for a person to develop continuous use of the substance despite come in patients treated with prescrip- an addiction to pain medications. significant substance-related problems tion pain medications. Substance abuse is defined as psycho- such as deleterious effects on occupation, Withdrawal is defined by the DSM- logical and physical dependence on sub- relationships, and health. IV13 as a maladaptive behavioral change stances. Some physicians are concerned Fearing that a patient is manifesting having physiologic and cognitive con- that prescribing narcotics may lead to a substance-related disorder, physicians comitants which occurs when blood or substance abuse and therefore may may become uncomfortable with tissue concentrations of a substance attempt to use a placebo to assess requests for increased dosages of pain decline in an individual who had main- whether the patient truly requires nar- medications. A better understanding of tained prolonged use of the substance, cotics for pain relief. However, no sci- the concepts of tolerance, physical frequently inappropriately. Examples of entific basis exists for using placebo in dependence, physiologic-dependence withdrawal include the onset of seizures © 2007 Jupiterimages Corporation ES36 • JAOA • Supplement 4 • Vol 107 • No 6 • June 2007 American Osteopathic Association • Position Statement on Use of Placebos or delirium tremens in a newly national standard that uses clin- abstinent alcohol chemically ical guidelines as the determinant dependent individual. of ordinary care. This is seen in the Pseudoaddiction is the term used decision in the case of Nowatske v to describe the behavior of a Oserloh, where the court stated, patient in pain who is receiving “should customary medical prac- an insufficient amount or an inap- tice fail to keep pace with devel- propriate dosing frequency of opment and advances in medical administration (or both) of the pre- science, adherence to custom scribed pain medication. In an might constitute a failure to exer- effort to obtain relief, the patient cise ordinary care.”18 in pain will request more frequent Guidelines developed by the or increased medication, or both. then Agency for Health Care Such “drug-seeking behavior” has Policy and Research (now the been deemed as “proof” of “addic- Agency for Healthcare Research tion.” The reason for such requests and Quality),1 the Healthcare Facil- is frequently that the patient is ities Accreditation Program,19 the receiving an underdose because American Pain Society,8 as well as of administration of too little of the the National Pharmaceutical medication or because of too long Council and Joint Commission on a delay between doses of the pain Accreditation of Healthcare Orga- medication, or both. In such nizations20 are good examples of instances, the patient receives inap- sources the courts are using to propriate pain relief, which is not determine ordinary practice. These an appropriate criterion of a sub- guidelines do not support the use © 2007 Jupiterimages Corporation stance-abusing patient according of placebo
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