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Transcription:

A questionnaire survey on the use of placebo in clinical practice by nurses in Japan 1 1 2 2 1 4 1964 5, 6 1998 GCP 1 School of Nursing, Faculty of Medicine, Toho University 2Faculty of Medical Technology, Teikyo University

informed consent I.C. I.C. meta analysis study 7, 8 9 16 17 20 2004 American Society for Pain Management Nursing 21 2005 The American Pain Society 22 2008American Medical Association 23 I.C. 24 25 26, 27 25, 28 29 30 46.9 24.7 2003 25, 28 placebo sham operation touch 31 p.339 32 33 300 3 1 1 3 1 2008

3 3 2007 2008 300 9541908 3 2 1 2008 12 1 2009 1 31 1 2 17 3 12 3 4 5 5 3 2 T X 2 SPSS 16.0 SPSS Japan Inc. 5 08 049

1 2 1908 352 18.4 300 499 19.3 243 500 699 15.468 700 20.141 300 499 69 1 2 0 61 302 2 60 1 3 205 163 12 300 499 n 243 SD 500 699 n 68 700 n 41 total n 352 36.5 8.6 36.9 9.1 35.5 8.2 36.3 8.6 14.2 8.3 14.8 8.8 13.6 8.0 14.3 8.4 * 3 2 235 97 7 3 63 26 152 63 26 11 157 65 52 21 34 14 114 47 111 46 18 7 65 96 3 4 21 31 39 57 7 10 49 72 10 15 8 12 25 37 33 49 9 13 39 98 6 15 31 78 3 8 23 58 5 13 11 28 17 43 16 40 7 17 * 399 97 1 90 26 222 64 36 10 299 65 70 20 54 15 156 45 160 46 34 10

n 5 5 10 10 10 10 5 10 1 5 1 300 499 n 243 283 98 4 2 116 50 114 49 3 1 9 4 112 46 110 46 10 4 0 33 14 209 86 81 48 38 22 50 30 57 28 148 72 38 19 62 31 45 22 500 699 n 68 67 99 1 1 29 43 38 57 0 0 26 39 40 60 1 1 0 7 10 61 90 14 34 16 39 11 27 19 32 41 68 10 17 20 34 10 17 == 10 700 n 41 39 98 20 53 17 45 1 2 18 45 20 50 0 7 18 32 82 7 25 8 29 13 46 11 34 21 66 6 19 9 28 6 19 total n 352 344 98 6 2 165 49 169 50 4 1 10 3 156 45 170 49 12 3 0 47 14 302 86 102 43 62 26 74 31 86 30 210 70 53 26 91 45 60 29 300 499 n 209 500 699 n 61 700 n 32 total n 302 173 85 91 45 15 7 49 82 28 47 7 12 28 90 12 39 2 6 250 83 131 43 24 8 123 59 98 48 52 25 51 24 3 1 33 54 26 43 20 33 6 10 3 5 17 53 12 38 9 28 5 16 173 58 136 46 81 27 62 21 7 2 137 68 64 32 45 76 14 24 25 78 7 22 207 71 85 29 124 60 82 40 39 67 19 33 20 62 12 38 183 62 113 38 179 86 30 14 52 85 9 15 32 100 0 263 87 39 13 80 38 84 40 111 53 6 3 21 34 24 39 33 54 3 5 19 59 13 41 17 53 0 120 40 121 41 161 54 9 3 201 96 1 1 6 3 56 92 2 3 0 30 94 287 96 4 1 7 2

7 75 155 72149 2042 38113 29 24 20 14 8 90 300 500 1415 3 9 7 6 8 700 2 4 302282 93 40 96 6 4 M1 6.84 M 2 3.97 2 df 320, t 2.097, p 0.037 300 499 n 243 500 699 n 68 700 n 41 total n 352 137 61 87 39 35 57 26 43 20 51 19 49 192 59 132 41 28 12 211 88 3 5 63 95 2 5 39 95 33 10 314 90 55 23 184 77 14 21 53 79 3 8 38 92 72 21 276 79 112 48 121 52 115 95 36 31 4 3 38 58 27 42 27 100 9 33 0 24 59 17 41 14 82 5 29 1 6 174 52 165 48 156 95 50 30 5 3

5 7 6 p 0.001 p 0.03 p 0.001 p 0.04 6 5 1 2 3 4 5 3 25793.1 8 6 23478.0 6 ** * ** * **p<0.001 *p<0.05 n 352 41 26 81 54 25 56 106 38 48 28 58 55 100 41 8 22 68 42 59 39 118 74 70 46 20 44 172 62 121 72 48 45 145 59 28 78 93 58 91 61

n 302 n 257 n 234 88 29 23 8 158 53 74 25 149 50 15 5 164 57 152 51 218 86 153 60 117 46 86 34 148 64 35 15 29 13 123 53 123 54 149 50 98 33 81 27 137 46 87 29 90 31 80 28 88 29 29 11 72 28 91 36 95 38 50 22 79 35 87 38 80 35 80 30 62 21 175 59 59 20 85 29 62 21 190 64 46 16 59 20 7 3 28 11 44 17 71 28 32 14 114 50 112 49 28 12 28 16 86 7 5 2 1 12 60 70 10 68 95 5 48 3 7 25 60 0.84 1.11 1.33

I.C. 30 Todd 17 9 18 19 7 300 50n 408 I.C. 25 25 12, 14 13, 14 3 Beauchamp and ChildressI.C. (p.108 2 p.489 2 Kuhse p.94 34

300 19 20 22 C 20601003 1. Brody H. 2000 2004 1. 2. Beauchamp TL, Childress JF. 1989 1997 3. 3. Brown WA. The Placebo Effect. Sci Am 1998 278 190 95. 4. Bok S. Ethical issues in use of placebo in medical practice and clinical trials. In: Guess HA, Kleinman A,KusekJW,etal.eds.TheScienceofPlacebo. Toward an Interdisciplinary Reasearch Agenda. UK BMJ Books; 2002. 5. Daugherty CK, Ratain MJ, Emanuel EJ, et al. Ethical, scientific, and regulatory perspectives regarding the use of placebos in cancer clinical trials. J Clin Oncol 2008 26 81371 1378. 6. Dunlop BW, Banja J. A renewed, ethical defense of placebo-controlled trials of new treatments for major depression and anxiety disorders. J Med Ethics 2009 35 384 389. 7. Hróbjartsson A, Gøtzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. New Engl J Med. 2001 344 21594 1602. 8. Hróbjartsson A, Gøtzsche PC. Is the placebo powerless? Update of a systematic review with 52 new randomized randomized trials comparing placebo with no treatment. J Intern Med 2004 256 291 100. 9. Berger JT. Placebo medication use in patient care: a survey of medical interns. West J Med 1999 170 93 96. 10. Ernst E, Abbot NC. Placebos in clinical practice - results of a survey of nurses. Perfusion, 1997 4 128 130. 11. Hróbjartsson A, Norup M. The use of placebo interventions in medical practice - a national questionnaire survey of Danish clinicians. Eval Health Prof 2003 26 153 165. 12. Nitzan U, Lichtenberg P. Questionnaire survey on useofplacebo.brmedj2004 329 944 946. 13. Tilburt JC, Emanuel EJ, Kaptchuk TJ, et al. Prescribing placebo treatments : Results of national survey of US internists and rheumatologists. Br Med J 2008 337, a1938 1942. 14. Sherman R, Hickner J. Academic physicians use placebos in clinical practice and believe in the mind-body connection. J Gen Intern Med 2008 23 7 10. 15. Shaw DM. Prescribing placebos ethically: the appeal of negatively informed consent. J Med Ethics 2009 35 97 99. 16. Fässler M, Gnädinger M, Rosemann T, et al. Use of placebo interventions among Swiss primary care providers. BMC Health Serv Res 2009 9 144 152. 17. Todd B. The placebo effect Real or Imaginary? Geriatric Nursing 1987 8 3154 156. 18. Kwekkeboom KL. The placebo effect in symptom management. Oncol Nurs Forum 1997 24 8 1393 1399. 19. Chan CW, Thompson DR. The use of placebo in clinical nursing research. J Clin Nurs 2006 15 5521 524. 20. Ambrose EG. Placebos; the nurse and iron pills. J Med Ethics 2007 33 6235 238. 21. Coggins CC, Arnstein P, Leahy S. ASPMN Position Statement on the Use of Placebos in Pain Management. [Internet]. 2004. Available from: http://aspmn.org/pdfs/use 20of 20Placebos.pdf 22. SullivanM,TermanGW,PeckBetal.Position Statement on the Use of Placebos in Pain Management. J Pain [Internet]. 2005. 6 4215 217. Available from: http://www.ampainsoc.org/ advocacy/pdf/placebo.pdf 23. Bostick NA, Sade R, Levine MA, Stewart DM Jr. American Medical Association Council on Ethical and Judicial Affairs: Placebo use in clinical practice: report of the American Medical Association Council on Ethical and Judicial Affairs. J Clin Ethics 2008 19 158 61. 24. placebo 1993 9 61259 1267. 25. 2010 20 1185 199.

26... 1992 12 484 87. 27. 2003 2 2157 164. 28. 2008 18 1149 157. 29.. 1999 51 226 31. 30. 2004 8 5 11. 31. Chaput de Saintonge DM, Herxheimer A. Harnessing placebo effects in health care. Lancet 1994 344 995 998. 32. Placebo In: 1 1997. 33. Well-known placebo & placebo response 1999 41 112325 2337. 34. Kuhse H. 1997 2000 1