| Literature DB >> 19664267 |
Margrit Fässler1, Markus Gnädinger, Thomas Rosemann, Nikola Biller-Andorno.
Abstract
BACKGROUND: Placebo interventions can have meaningful effects for patients. However, little is known about the circumstances of their use in clinical practice. We aimed to investigate to what extent and in which way Swiss primary care providers use placebo interventions. Furthermore we explored their ideas about the ethical and legal issues involved.Entities:
Mesh:
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Year: 2009 PMID: 19664267 PMCID: PMC2731747 DOI: 10.1186/1472-6963-9-144
Source DB: PubMed Journal: BMC Health Serv Res ISSN: 1472-6963 Impact factor: 2.655
Definition of Placebo Intervention, Pure, and Impure Placebos
| We define a placebo intervention as a diagnostic or therapeutic sham intervention or as an intervention with substances or physical methods which have no direct pharmacological, biochemical or physical mechanism of action according to the current standard of knowledge. The term includes a considerable variety of interventions, thus not only the administration of lactose tablets or isotonic saline solution. | |
| Are inert substances or methods such as sugar pills or isotonic saline solution. | |
| Refer to substances or methods which have a known pharmacological or physical activity but which cannot be expected to have any direct therapeutic effects for the respective disease and in the chosen dosage, e.g. vitamin infusions for cancer or peppermint pills for pharyngitis. | |
Sample characteristics
| Group of physicians | 233 | |
| Paediatricians | 67 (29%) | |
| GPs in urban areas | 41 (18%) | |
| GPs in suburban areas | 55 (24%) | |
| GPs in rural areas | 70 (30%) | |
| Gender | 227 | |
| Women | 65 (29%) | |
| Men | 162 (71%) | |
| Age (years) | 228 | 52 + 9 |
| Days per week working in private practice | 197 | 4.1 + 1.2 |
| Patients seen per day | 224 | |
| <15 | 35 (16%) | |
| 15–30 | 150 (67%) | |
| >30 | 39 (17%) |
Use of placebo interventions and the question whether the participants view the respective intervention as placebo intervention
| Positive suggestions | 180 | 146 (81%) | 34 (19%) | 197 | 62 (32%) |
| Simple ointments and/or bandages for contusions without visible skin damages | 181 | 137 (76%) | 44 (24%) | 197 | 52 (27%) |
| „Sugar pills” | 196 | 14 (7%) | 182 (93%) | 197 | 3 (2%) |
| Injections with saline solution | 198 | 20 (10%) | 178 (90%) | 199 | 4 (2%) |
| Therapies without pharmacological or physical efficacy for the patient's conditions (e.g. vitamins or antibiotics without approved indication) | 195 | 119 (61%) | 76 (39%) | 196 | 12 (6%) |
| Diagnostic practices: | |||||
| • non-essential physical examinations of the patient | 193 | 171 (89%) | 22 (11%) | 200 | 38 (19%) |
| • non-essential technical examinations of the patient without relevant risks (e.g. ultrasound, MRI) | 195 | 134 (69%) | 61 (31%) | 197 | 24 (12%) |
| • non-essential technical examinations of the patient with relevant risks (e.g. computed tomography) | 192 | 59 (31)% | 133 (69%) | 195 | 21 (11%) |
Motives for the use of placebo interventions among the 167 users
| To conform with the requests of the patient | 159 | 17 (11%) | 83 (52%) | 59 (37%) |
| To gain a therapeutic advantage through the placebo effect | 157 | 31 (20%) | 77 (49%) | 49 (31%) |
| To still be able to offer a treatment option to a patient with an „incurable” disease | 154 | 12 (8%) | 55 (36%) | 87 (56%) |
| To offer a treatment in situations in which standard treatments may strongly burden patients with side effects or are contraindicated | 158 | 13 (8%) | 46 (29%) | 99 (63%) |
| To offer a treatment to patients whose complaints and test results are not attributable to a certain disease (unspecific complaints) | 162 | 24 (15%) | 80 (49%) | 58 (36%) |
| To offer treatment to difficult patients with psychological peculiarities, i.e. constant unwarranted complaints | 156 | 19 (12%) | 61 (39%) | 76 (49%) |
| To test whether the pain is psychogenic or organic | 154 | 20 (13%) | 12 (8%) | 122 (79%) |
| To avoid drug addiction | 155 | 12 (8%) | 35 (23%) | 108 (70%) |
*Definitions see Table 1.
The total percentage may not equal 100 due to rounding.
What participants tell their patients when using placebos for therapeutic purposes
| 35 | 119* | |
| I tell them | ||
| ... this is a drug/a therapy. | 22 (63%) | 77 (65%)* |
| ... this is a placebo. | 0 (0%) | 0 (0%) |
| ... this is a medicine with no specific effect. | 4 (11%) | 32 (27%)* |
| I say nothing. | 9 (26%) | 10 (8%) |
| I never use placebos for therapeutic purposes. | 187 | 89* |
Only one answer allowed, *p < 0.001 vs. pure placebo by McNemar's χ2 test.
Percentages refer to the number of users.
Statements regarding the ethical and legal legitimacy of placebo use
| N | I agree | I am un-certain | I disagree | N | I agree | I am un-certain | I disagree | p value* | |
| The use of placebos | |||||||||
| • must be rejected in principle because it is ineffective. | 220 | 58 | 37 | 125 | 220 | 41 | 26 | 153 | p < 0.05 |
| • must be rejected in principle because it implies deceiving the patient. | 223 | 101 | 39 | 83 | 221 | 52 | 39 | 130 | p < 0.001 |
| • must be rejected in principle because of legal concerns. | 220 | 43 | 84 | 93 | 221 | 30 | 67 | 124 | n.s. |
| • can be used as long as physician and patient work together in partnership. | 220 | 132 | 35 | 53 | 221 | 166 | 25 | 30 | p < 0.001 |
| • is acceptable for the benefit of the patient and for minimizing harm to the patient. | 219 | 120 | 43 | 56 | 221 | 158 | 24 | 39 | p < 0.01 |
| • is for me a traditional component of medical practice. | 219 | 37 | 25 | 157 | 217 | 91 | 26 | 100 | p < 0.001 |
Multiple answers allowed. * Significance testing by use of McNemar's Chisquare test, pure vs. impure placebo ("I am uncertain"-answers were excluded from analysis).
The total percentage may not equal 100 due to rounding.
Presumed disappointment of patients if they learned that they had been intentionally treated with a pure or impure placebo*
| Yes, many of my patients | 123 (55%) | 49 (22%) |
| Yes, some of my patients | 47 (21%) | 53 (24%) |
| Mostly no | 27 (12%) | 103 (46%) |
| I do not know. | 26 (12%) | 20 (9%) |
* Counts for pure vs. impure placebo were significantly different, Wilcoxon's, z = 8.7, p < 0.001.