Widespread use of pure and impure placebo interventions by GPs in Germany

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1 Family Practice 2012; 29:79 85 doi: /fampra/cmr045 Advance Access publised on 1 August 2011 Ó Te Autor Publised by Oxford University Press. All rigts reserved. For permissions, please journals.permissions@oup.com. Widespread use of pure and impure placebo interventions by GPs in Germany Karin Meissner a,b, *, Lisa Höfner a, Margrit Fässler b,c and Klaus Linde b a Institute of Medical Psycology, Ludwig-Maximilians-University of Munic, Goetestrasse 31, Munic, Germany, b Institute of General Practice, Tecnisce Universität Müncen, Orleansstrasse 47, Munic, Germany and c Institute of Biomedical Etics, University of Zuric, Pestalozzistrasse 24, 8032 Zuric, Switzerland. *Correspondence to Karin Meissner, Institute of Medical Psycology, Ludwig-Maximilians-University of Munic, Goetestrasse 31, Munic, Germany; karin.meissner@med.lmu.de Received 26 April 2011; Revised 20 June 2011; Accepted 28 June Aim. To collect data on te use of placebo interventions by GPs in Germany. Metods. A questionnaire was mailed to 400 randomly selected GPs in Bavaria. Non-responders were reminded by telepone after 4 weeks and were given a second copy of te questionnaire after a furter 3 weeks. Results. In all, 208 completed questionnaires were returned. Te majority of GPs (88%) ave used a placebo at least once in teir practice; 45% ave used pure placebos, suc as saline injections and sugar pills, at least once last year; te median frequency of use was 5 [interquartile range (IQR), 2 10]. Te use of impure placebos during te past year was more common: 76% of GPs ave used impure placebos, i.e. medical interventions tat ave parmacological or pysical activity but ave no intrinsic effect (e.g. parmacological or pysical action) on te patient s disease or its symptoms, wit a median frequency of 20 times per year (IQR, 10 50). Te main reason for te use of placebo was a possible psycological effect, followed by te expectation of patients to receive a treatment. For te majority of GPs placebo interventions were etically justified if tey were used for a possible psycological effect. Conclusions. Placebo interventions are a widely accepted part of medical treatment in German general practices and are used primarily for teir psycological effects. Impure placebos are used muc more frequently tan pure placebos. Keywords. Medical etics, placebo effect, placebos/terapeutic use, primary ealt care, professional patient relations, questionnaires. Introduction In te past decade, numerous studies ave sown tat placebo interventions can improve te ealt and well-being of patients. Te deliberate use of placebos in practice, owever, remains problematic for etical reasons. At te same time, surveys in various countries ave sown tat pysicians use placebos regularly in teir practice. 1 For example, a recent survey of internists and reumatologists in te United States sowed tat 80% of tem prescribe placebo treatments to teir patients, 46% at least once a mont. 2 Te frequency of placebo administration differs between ospital and outpatient setting: According to a Danis study 86% of GPs confirmed te use of placebo interventions in te past year in contrast to only 54% of pysicians in ospital. 3 Furtermore, te frequency of use of placebo seems to vary wit te type of placebo: A Swiss survey sowed tat impure placebos are used more often tan pure placebos. 4 Impure placebos are defined as medical interventions tat ave a parmacological or pysical activity, but not for te actual disease or its symptoms (e.g. antibiotics for viral infections, vitamin supplements witout vitamin deficiency), wile pure placebos are inert treatments, suc as sugar tablets and saline injections. Te present study aimed to investigate te frequencies and motivations for te use of pure and impure placebos in German practices of general medicine. We were also interested in te attitudes towards placebo use, and wat GPs tell teir patients if tey want to administer a placebo. Since te use of placebos probably depends on wat te person knows about placebo effects, we also posed questions about te assumed mecanisms of placebo analgesia and te potential impact of positive expectations on ealt. Metods Questionnaire and procedure A pilot version of te questionnaire was sent to 20 GPs in Bavaria. A furter five GPs were interviewed after 79

2 80 Family Practice Te International Journal for Researc in Primary Care filling out te pilot version in order to assure te clarity of questions. Te final questionnaire consisted of seven questions focusing on pure placebos, eigt questions on impure placebos and seven questions on demograpic data (Appendix). Questions about impure placebos were posed witout using te term placebo. Instead, tey were described as drugs and oter terapies wit no intrinsic effects (e.g. parmacological or pysical activity) on te current patient s symptoms. Te questionnaire was sent to 400 GPs. Tis was a random selection from te 6700 GPs in te database of te Bavarian Medical Association. Data collection was conducted from November 2009 to February A package containing a letter explaining te purpose of te study, a numbered questionnaire, a stamped return envelope and a small gift was sent to eac doctor. Te letter promised a lottery drawing of V100 among te responders. After identifying te non-responders, te questionnaires were renumbered to ensure anonymity. Non-responders were reminded by telepone to complete te questionnaire after 4 weeks and were given a second questionnaire copy after a furter 3 weeks. Data analysis We used descriptive statistics to summarize te results. Subgroup comparisons were done wit Ci-square test. Statistical analysis was performed wit SPSS (version 18). A P-value < 0.05 was considered significant. Results Study population In all, 219 of 400 questionnaires (55%) were returned. Eleven pysicians, wo worked exclusively as a psycoterapist, were excluded. Tus, we analysed 208 of 389 questionnaires, representing a response rate of 53%. Demograpic caracteristics of responders are summarized in TABLE 1. Frequencies of placebo use Eigty-eigt per cent of GPs confirmed tat tey ave used pure and/or impure placebos at least once in teir practice. Of te 208 pysicians, 101 (49%) Variable TABLE 1 Demograpic caracteristics of respondents - Age, mean ± SD ± Males/females, (67%)/69 (33%) - Certified specialization (87%) for general practice or internal medicine, - Years in practice, mean (SD) (9%) n reported tat tey ave used pure placebos outside of clinical trials, and 94 (45%) ave done so at least once during te last year. Te median frequency of use per year was 5 [interquartile range (IQR), 2 10]. Fortyone GPs (21%) ad placebo tablets in teir practice in stock. Te use of drugs and oter terapies wit no intrinsic activity (e.g. parmacological or pysical activity) for te patient s current symptoms (so-called impure placebos ) was confirmed by 175 of te 208 pysicians (84%). One undred and fifty-seven GPs (76%) reported tat tey ave used impure placebos at least once during te last year, wit a median frequency of 20 times per year (IQR, 10 50). Most often, erbal remedies were used as impure placebos (73%), followed by omeopatic remedies (62%), vitamin preparations (62%), minerals and micronutrients (58%), mild sedatives (30%), massages (30%), acupuncture (21%) and antibiotics (20%). Using a case example, we asked te doctors ow tey would treat a patient wit cold and coug, wen te patient insisted on antibiotics, but tere was no evidence of a bacterial aetiology of is symptoms. In suc a situation, 25% of surveyed GPs would prescribe antibiotics. Reasons for te use of placebo In all, 78 of te 101 (77%) doctors, wo gave pure placebos, used tem because of teir psycological effect, followed by te expectation of te patient to receive a treatment (57%), te impression of GPs tat te patient wanted more drugs tan necessary (47%), te andling of a difficult treatment situation (46%) and non-specific complaints (31%). A quarter of GPs (25%) reported te use of pure placebos for diagnostic reasons. Oter reasons were te prevention of drug dependence (22%), and use as an additional treatment option (19%). Te most common reason for te use of impure placebos was a possible psycological effect (79%), followed by te expectation of te patient to receive a treatment (52%), te use as an additional treatment option (47%), te andling of a difficult treatment situation (47%) and non-specific complaints (42%). We conducted exploratory analysis in order to learn more about te possible motives of te 25% of GPs, wo would prescribe antibiotics for non-bacterial infections, if te patient insists. Among all users of impure placebos, tis subgroup used impure placebos more frequently because te patient expected a treatment (68% versus 46%; P = 0.011), in order to deal wit a difficult treatment situation (62% versus 41%; P = 0.026), or as a furter treatment option (62% versus 41%; P = 0.026). Patient information Te ways in wic GPs inform teir patients during te administration of pure and impure placebos is summarized in Table 2. Only a few doctors informed teir patients tat te treatment itself ad no intrinsic effect on te current ealt complaints.

3 Placebo use in Germany 81 TABLE 2 Information of patients by GPs wen giving out pure placebos (n = 101) and impure placebos (n = 175) TABLE 3 Attitudes towards te use of pure placebos by users (n = 101) and non-users (n = 107) Information Pure placebos, Impure placebos, Item User, Non-user, Ci-quadrat P-value - Treatment stimulates 49 (49%) 136 (78%) self-ealing powers - Treatment is 46 (46%) 49 (28%) igly effective - Treatment as 44 (44%) 65 (37%) elped oter patients - Description of 12 (12%) 57 (33%) expected effects - No information 11 (11%) 8 (5%) - Treatment itself actually is not effective 2 (2%) 10 (6%) Attitudes Te attitudes towards te placebos were different for users and non-users of bot pure placebos (Table 3) and impure placebos (Table 4). Te most frequent justification for te use of placebo was a possible psycological effect. Placebo-related beliefs Te first question wit respect to pure placebos presented te case of a cronic pain patient wo received a saline injection instead of is usual analgesics and reported pain relief tereafter. Te GPs were asked about teir beliefs regarding te reasons for tis improvement. Te answers are displayed in Figure 1. Wen asked about possible effects of expectations, 197 doctors (95%) answered tat subjective symptoms suc as stress could be relieved; 184 doctors (89%) deemed possible tat disease-related subjective symptoms, as pain or itcing, would improve; 159 GPs (76%) expected tat bodily functions, suc as autonomic and immunological processes, would improve. Only tree doctors (1%) did not expect any improvements by expectations. Discussion Tis is te first survey on te use of placebo interventions in outpatients in Germany. In all, 88% of respondents ad administered eiter a pure or an impure placebo at least once in teir practice. Impure placebos were used muc more frequently tan pure placebos: Tey were administered by more pysicians (76% versus 45% in te preceding year) and more often (median 20 versus 5 times in te preceding year). For bot pure and impure placebos, te most frequently reported reason for use was a possible psycological effect. Te majority of GPs believed tat expectations can improve subjective and objective symptoms. Bot pure and impure placebos were usually administered witout informing te patient tat Acceptable,... - wen used for teir 94 (93.1) 67 (62.6) <0.001 psycological effect - wen used for 62 (61.4) 36 (33.6) <0.001 diagnostic reasons - because tey do 50 (49.5) 40 (37.4) not arm - wen all oter treatment options are exausted 36 (35.6) 34 (31.8) Not acceptable, because of... - treatening te 2 (2.0) 30 (28.0) <0.001 doctor patient relationsip - decepting te patient 3 (3.0) 25 (23.4) < lack of efficacy 0 (0.0) 5 (4.7) legal problems 1 (1.0) 5 (4.7) Item TABLE 4 Attitudes towards te use of impure placebos by users (n = 175) and non-users (n = 33) User, Non-user, Ci-quadrat P-value Acceptable,... - wen used for teir 144 (82.3) 14 (42.4) <0.001 psycological effect - wen clinical 113 (64.6) 18 (54.5) experience sowed usefulness - wen all oter 110 (62.9) 9 (27.3) <0.001 treatment options are exausted - wen patient s demand 95 (54.3) 6 (18.2) <0.001 Not acceptable, because of... - decepting te 2 (1.1) 9 (27.3) <0.001 patient - treatening te 6 (3.4) 8 (24.2) <0.001 doctor patient relationsip - lack of efficacy 1 (0.6) 3 (9.1) legal problems 6 (3.4) 1 (3.0) te treatment ad no intrinsic effect on te current ealt complaints. Te response rate of 55% in our survey is acceptable but not ig. Our sample consisted only of GPs from Bavaria, and we cannot rule out tat te results may be different in oter states of Germany. A major problem in any survey on placebo use is te concept of impure placebo. Te decision weter an intervention is still an active treatment or a placebo depends on personal attitudes and situational factors. If pysicians are asked to define placebo tey generally describe

4 82 Family Practice Te International Journal for Researc in Primary Care FIGURE 1 GPs beliefs regarding te reasons for pain relief by placebo pure placebos (5). Many pysicians do not know te term impure placebo, and surveys eiter explain it in questionnaires or as we did use circumscriptions. Te data on pure placebos are terefore more reliable tan te data on impure placebos. Te frequency of placebo use in our study is comparable to data from Denmark and te United States, according to wic 86% and 80% of GPs or internists give placebos. 2,3 Furtermore, te proportion of German pysicians wo use pure placebos in outpatients is similar to tat in te ospital 6 and to respective data from Israel. 7 Tese data are contrasted by recent results from Switzerland, were only 17% of GPs confirmed te use of pure placebos. 4 Similarly, te use of impure placebos in te Swiss survey was lower tan in ours (54% versus 84%, respectively). Weter tese differences will be attributable to national differences or to different types of questions remains to be investigated. Impure placebos seem to be used rater regularly by German GPs at a first glance (in median, 20 times per year). Altoug te true figure may even be iger, we want to empasize tat German GPs treat 250 patients per week. 8 Tus, impure placebos appear to be prescribed more sporadically tan regularly. Our findings suggest tat most GPs possibly because of teir own experiences take placebo effects seriously. However, tere were also more pragmatic reasons for te administration of placebos, suc as te request for treatment of te patient, a difficult treatment situation, or non-specific complaints of te patients. Apparently, GPs feel sometimes under pressure to administer a treatment altoug tere is no specific treatment for te current patients symptoms. Ten tey resort to placebo interventions in order to meet te patients needs. 9 Especially te deeper motivations of prescribing impure placebos could be even more complex. Qualitative studies suggest tat a complex mixture of internalized role models, perceived patient expectations, fear of conflicts and lack of time play a major role. 9,10 Also te question of wat exactly determines te coice of a pure or impure placebo remains unclear. Tese questions probably require qualitative approaces to be resolved. Only a minority of pysicians informed teir patients tat te treatment ad no pysical or parmacological effect on te current condition. Te most popular information during administration of placebos was te stimulation of self-ealing powers (Table 2). Tis seems plausible since it is a popular concept to describe te effects of alternative treatments and placebo interventions. 11,12 Te GPs ideas about te mecanisms of placebo analgesia (Fig. 1) fit well wit te latest understanding of te psycological mecanisms of placebo effects. 13 Few doctors ave argued tat te pain was psycogenic, simulated or not real, or te patient was mentally unstable. Tis is in contrast to a survey of tirty years ago, wen te majority of doctors still used placebos to determine weter pain was real. 14 Te attitude of GPs wit respect to te administration of placebo interventions was surprisingly liberal. Bot pure and impure placebos were regarded etically justifiable for most of te GPs if used for a possible psycological treatment effect. Etical concerns regarding te impairment of te doctor patient relationsip and deceptive beaviour were almost exclusively found among non-users (Tables 3 and 4). A disturbing finding

5 Placebo use in Germany 83 was tat some of te GPs do not esitate to give impure placebos, wic are potentially armful, suc as antibiotics for common cold wit no evidence for a bacterial genesis. Non-indicated prescription of antibiotics may be detrimental and clearly is in contrast wit te etical principle of nil nocere. Also te use of armless placebos is etically controversial. 15 Te German Medical Association as recently defined a few situations in wic placebos can be administered in an etically acceptable way. 16 Following tese recommendations, te pysician can use placebos witout mentioning te term placebo. In contrast, in te USA, te non-deceptive and transparent use of placebos is discussed as te only viable way to administer placebos. 17 In conclusion, we found evidence for a widespread and liberal use of placebo interventions among German GPs. Te proportion of GPs wo confirmed te use of placebos was pretty similar to most available data from oter countries. Placebo effects were perceived as real and serious penomena. Qualitative studies are needed to better understand te GPs motivations, especially for te use of impure placebos. Declaration Funding: Müncener Universitätsgesellscaft, Munic, Germany (31443 to K.M.). Etical approval: Etical committee of te Ludwig- Maximilians-University Munic. Conflict of interest: none. References 1 Fässler M, Meissner K, Scneider A, Linde K. Frequency and circumstances of placebo use in clinical practice a systematic review of empirical studies. BMC Med 2010; 8: Tilburt JC, Emanuel EJ, Kaptcuk TJ, Curlin FA, Miller FG. Prescribing "placebo treatments": results of national survey of US internists and reumatologists. BMJ 2008; 337: a Hrobjartsson A, Norup M. Te use of placebo interventions in medical practice a national questionnaire survey of Danis clinicians. Eval Healt Prof 2003; 26: Fässler M, Gnädinger M, Rosemann T, Biller-Andorno N. Use of placebo interventions among Swiss primary care providers. BMC Healt Serv Res 2009; 9: Fent R, Rosemann T, Fässler M, Senn O, Huber CA. Te use of pure and impure placebo interventions in primary care a qualitative approac. BMC Fam Pract 2011; 12: Bernateck M, Karst M, Eberard S, Vivell W, Fiscer MJ, Stictenot DO. Placebo terapy. Analysis of extent and expectations in a tertiary referral center]. Scmerz 2009; 23: Nitzan U, Lictenberg P. Questionnaire survey on use of placebo. BMJ 2004; 329: Koc K, Miksc A, Scürmann C, Joos S, Sawicki PT. Das deutsce Gesundeitswesen im internationalen Vergleic: Die Perspektive der Hausärzte. Dtsc Arztebl 2011; 108: Comaroff J. A bitter pill to swallow: placebo terapy in general practice. Soc Rev 1976; 24: Scwartz RK, Soumerai SB, Avorn J. Pysician motivations for nonscientific drug prescribing. Soc Sci Med 1989; 28: Jonas WB. Alternative medicine learning from te past, examining te present, advancing to te future. JAMA 1998; 280: Walac H, Jonas WB. Placebo researc: te evidence base for arnessing self-ealing capacities. J Altern Complement Med 2004; 10 (suppl 1): S Meissner K, Kols N, Colloca L. Introduction to placebo effects in medicine: mecanisms and clinical implications. Pilos Trans R Soc Lond B Biol Sci 2011; 366: Goodwin JS, Goodwin JM, Vogel AV. Knowledge and use of placebos by ouse officers and nurses. Ann Int Med 1979; 91: Hrobjartsson A. Clinical placebo interventions are unetical, unnecessary, and unprofessional. J Clin Etics 2008; 19: Bundesärztekammer. Stellungname des wissenscaftlicen Beirats der Bundesärztekammer Placebo in der Medizin.. Deutsces A rzteblatt. 2010; 107: C Kaptcuk TJ, Friedlander E, Kelley JM, et al. Placebos witout deception. A randomized controlled trial in irritable bowel syndrome. Plos One. 2010; 5. Appendix: Englis translation of te questionnaire Questionnaire on te use of non-specific treatment effects in ambulatory ealt care I. Questionnaire 1. A forty-year-old man, self-employed, visits you in your practice complaining of a cold and coug. He wants an antibiotic, so tat e can work again as soon as possible. On examination, you can see no medical indication for an antibiotic. Te patient insists, owever, as antibiotics ad elped im very well during te last cold. Wat would you do most likely in tat situation? (multiple answers possible) Prescribe an antibiotic. Prescribe/recommend a drug or a treatment for symptoms of common cold. Offer a ceck-up in te next few days. Oter: 2. Have you ever used medicine or terapies, even if you considered tat tey ad no intrinsic effect (e.g. parmacological or pysical action) on te patient s disease or its symptoms? Yes No continue wit question 7 3. Roug estimate, in ow many patients in te last year? In approx. patients in te last year. 4. Wat was your motivation? (multiple answers possible)

6 84 Family Practice Te International Journal for Researc in Primary Care Because te patient was expecting a terapy. Because of a possible psycological treatment effect. In patients wit symptoms tat could not be ascribed to any particular disease ( non-specific complaints ). To be able to still offer a treatment option to patients wit untreatable, incurable disease. For constantly complaining patients, to bridge a difficult treatment situation. For oter reasons: Are acceptable wen te patient wants tis terapy. Are acceptable if te clinical experience as sown a benefit. Are not acceptable because tey involve te deception of te patient. Are not acceptable because tey endanger te trust between doctor and patient. Are not acceptable because te efficacy is insufficient. Are not acceptable because of legal problems. 5. Wic forms of drugs/terapies ave you already used for tat purpose (see question 2)? (multiple answers possible) (Here are just meant situations were you personally felt tat te treatment as no intrinsic/specific effects on te actual symptoms; we do not mean te general use of tese treatments). Minerals and trace elements Vitamins Mild sedatives Antibiotics Homeopatic remedies Pytoterapeutics Acupuncture Massages Oter: 6. How did you inform your patients? (multiple answers possible) Tis is a igly effective drug/a igly effective terapy. Tis terapy as elped many oter patients. Tis treatment promotes self-ealing/te ealing process. Tis is a treatment witout parmacological or pysical effect for your condition. I said wat effect is expected from te terapy. I said noting. I said (please add yourself): 7. Wat is your opinion towards te use of drugs and oter terapies tat do not ave any intrinsic effect (e.g. parmacological or pysical action) on te current disease of te patient or its symptoms? (multiple answers possible) Are acceptable if tey are used for teir psycological effect. Are acceptable wen all oter terapies ave been exausted. 8. Maybe you know te following case: A ospital patient wit severe pain receives a painkiller iv 3 times a day and on demand. On days wit very ig needs te painkiller is occasionally replaced by saline injections. Upon request, te patient reported in eac case tat te painkiller worked well. Wat conclusions can you draw from te effectiveness of te saline injection? (Multiple answers possible) Te pain ad not organic cause, but was psycogenic. Te pain was not particularly strong. Te pain was imagined. Te patient is very suggestible. Te patient is mentally unstable. Te patient as simulated te pain. Te intensity of pain decreased naturally. Te patient as given a favour answer. Te pain reduction was conditioned (learned). Te expectation of pain reduction as led to te decrease in pain. Te positive attention by te nursing staff as led to a decrease in pain. Oter: 9. Do you ave pre-fabricated placebo preparations (e.g. placebo tablets, injections wit saline solution, artificial sweetener pills, etc.) in stock in your practice? Yes No 10. Did you ever use in your practice placebos (e.g. placebo pills, saline injections, sweeteners, etc.) outside of clinical trials? No continue wit question 14 Yes 11. Roug estimate, in ow many patients in te last year? In approx. patients in te last year

7 Placebo use in Germany Wat was your motivation? (multiple answers possible) Because te patient was expecting a terapy. Because of a possible psycological treatment effect. In patients wit symptoms tat could not be ascribed to any particular disease ( non-specific complaints ). To be able to still offer a treatment option to patients wit untreatable, incurable disease. For constantly complaining patients, to bridge a difficult treatment situation. If a patient asked for more drugs tan you tougt necessary. As a test of weter symptoms were psycogenic or organic (differential diagnosis). To prevent drug dependence. For oter reasons: 13. Wat did you tell your patient? (multiple answers possible) Tis is a igly effective drug or a igly effective terapy. Tis treatment as elped many oter patients. Tis treatment promotes self-ealing/te ealing process. Tis is a treatment witout parmacological or pysical effect. I said wat effect is expected from te terapy. I said noting. I said: (Please add yourself) 14. Wat is your attitude towards te use of placebos? (multiple answers possible) Are acceptable if tey are used for teir psycological effect. Are acceptable wen all oter terapies ave been exausted. Are acceptable if tey are used as a diagnostic. Are acceptable because tey do not arm. Are not acceptable because tey involve te deception of te patient. Are not acceptable because tey endanger te trust between doctor and patient. Are not acceptable because te efficacy is insufficient. Are not acceptable because of legal problems. 15. Te placebo effect is often defined te proportion of improvement, wic goes back to a positive expectation of te patient and not to te specific effect factors of treatment (e.g. teir parmacological ingredients). Wat kinds of improvements can ave positive expectations of te patient you tink? (multiple answers possible) Positive influence on general subjective symptoms, e.g. stress reduction, relaxation. Positive influence on disease-relevant subjective symptoms, e.g. decrease of pain, itc, tinnitus. Positive influence on bodily functions, e.g. improvement of vegetative, biocemical or immunological functions. Positive expectations do not produce any improvement. II. Background information 1. Your age: 2. Your sex: female male 3. Are you a specialist? No yes, namely for 4. How many years ave you been in your practice? For approx. years 5. In wic area te practice is specialized? 6. How many patients do you treat on average per week? approx. patients per week 7. Would you be prepared for a personal interview on te subject? Yes Possibly No Tank for your elp!