Interindividual variations in beliefs about the placebo effect: a study in 300 rheumatology inpatients and 100 nurses

doi:10.1016/S1297-319X(00)00225-6

Joint Bone Spine

Volume 68, Issue 1, February 2001, Pages 65-70

https://doi.org/10.1016/S1297-319X(00)00225-6 Get rights and content

Abstract

Patients and methods. Three hundred patients admitted to a rheumatology department (mean age, 49.2 ± 15.5 years) and 100 nurses working in the same teaching hospital (mean age, 36 ± 8.6 years) completed a questionnaire on the placebo effect in the treatment of pain. Results. The patients believed that the percentages of subjects who responded occasionally or consistently to a placebo were 32% (± 22%) and 21% (± 17%), respectively. The figures given by the nurses were only slightly higher: 42% (± 23%) and 23% (± 17%), respectively. Only 27% of the patients and 58% of the nurses knew that pain could resolve completely under placebo therapy. The mean percentage improvement induced by placebo therapy as compared to the study analgesic was estimated at 21% (± 17%) by the patients and 30% (± 18%) by the nurses. Only 23% of patients and 24% of nurses knew about nocebo effects. Conclusion. These data suggest that during double-blind placebo-controlled trials three-quarters of the placebo arm patients who experience a marked improvement or a nocebo effect may believe they received the active drug. This is likely to reduce the difference between the placebo and active drug groups. Furthermore, most patients and nurses have a negative perception of placebo therapy. It may be useful to include a brief description of placebo and nocebo effects into the patient's information and informed consent documents used in double-blind placebo-controlled trials.

Section snippets

Methods

Three hundred patients (mean age 49 ± 15 years) admitted to a rheumatology department were interviewed consecutively by three pharmacy students, who used a questionnaire (table I). The overwhelming majority of these patients had been admitted because of pain: the main diagnoses were low back pain with nerve root pain, inflammatory joint disease, osteoarthritis, and vertebral fracture. The questionnaire items were administered in the same order in all patients (table I), starting with “Do you

Answers given by the 300 patients and 100 nurses

Fifty-nine percent of the patients said they knew about the placebo effect. However, the replies given by these patients were closely similar to those given by the patients who did not know about the placebo effect before the study (see below). All the nurses said they knew about the placebo effect (tables I and II).

The percentage of patients who respond occasionally to placebo therapy was estimated at 32 ± 22% (mean ± standard deviation) by the patients and at 42 ± 23% by the nurses.

Discussion

A striking finding from this study is the wide variability in opinions about the contribution of the placebo effect to the treatment of pain. This variability was found both among the patients and the nurses. Estimates of the percentages of patients who respond to placebo therapy varied by 22% among the patients and 23% among the nurses. Corresponding figures for the degree of improvement provided by placebo therapy were 17% and 18%, respectively. These data indicate that small double-blind

References (20)

S.M Sech et al.
The so-called ‘placebo-effect’ in benign prostatic hyperplasia treatment trials represents partially a conditional regression to the mean induced by censoring
Urology
(1998)
D.M Chaput de Saintonge et al.
Harnessing placebo effects in health care
Lancet
(1994)
G.S Kienle et al.
The powerful placebo effect: fact or fiction?
J Clin Epidemiol
(1997)
G ter Riet et al.
Is placebo analgesia mediated by endogenous opioids? A systematic review
Pain
(1998)
J.A Turner et al.
The importance of placebo effects in pain treatment and research
JAMA
(1994)
J.M Berthelot et al.
Harmful effects of the placebo-controlled design
Rev Rhum [Engl Ed]
(1998)
P.D Wall
Pain and the placebo response
Ciba Found Symp
(1993)
H.K Beecher
The powerful placebo
JAMA
(1955)
J Bruxelle
L’effet placebo dans le traitement de la douleur
Rev Prat
(1994)
F.J Evans
The placebo response in pain reduction
Adv Neurol
(1974)

There are more references available in the full text version of this article.

Cited by (38)

Psychological context effects of participant expectation on pain pressure thresholds as an adjunct to cervicothoracic HVLA thrust manipulation: A randomised controlled trial
2020, International Journal of Osteopathic Medicine
Citation Excerpt :
However, amongst healthcare providers, the adoption of placebo strategies seem to be commonplace [59]. Examples of professionals who condone the use of CFs for musculoskeletal pain specifically include; orthopaedic surgeons, rheumatology physicians and nurses, who all feel that placebo effects are real and permissible within the ethical boundaries of health care [60–62]. Also, it is not just professional staff who feel this practice is permissible.
Chronic pain is a growing global and economically costly problem leading the National Health Service (NHS) in the UK to actively search for novel strategies to improve health outcomes. Some trials have shown a benefit when practitioners use a positive communication style, however, much of the available literature investigating the use of positive language to alter patient expectation utilises subjective reports from patients.
To demonstrate whether positive and negative communication before a high-velocity low amplitude (HVLA) thrust spinal manipulation of the C7-T1 spine segments, and within an osteopathic consultation setting, increases and decreases (respectively) pain pressure thresholds (PPT) to form contextual placebo and nocebo effects.
pre-test, post-test randomised controlled design.
35 asymptomatic participants were recruited and randomised into three separate condition arms using a repeated measures cross-over design; negative communication (NegC), neutral communication (NeuC), or positive communication (PosC). Each condition included spinal manipulation (HVLA thrust) to the C7-T1 segments. PPTs were measured by an algometer over the spinous process of C7 pre and post each condition setting.
There was a significant effect of language style on PPT for the three conditions. Post-hoc tests demonstrated that positive communication had a significant effect on PPT (i.e., placebo effect), but the negative communication demonstrated no significant effect (i.e., no nocebo).
These results were discussed in the context of communication style used during an osteopathic clinical consultation to potentially improve health outcomes in NHS and other clinical settings (Clinical trial registry https://clinicaltrials.gov/number: NCT03855254).
The awareness of contextual factors, placebo and nocebo effects among nursing students: Findings from a cross-sectional study
2020, Nurse Education in Practice
Citation Excerpt :
However, despite the relevance of CFs, no studies have been conducted to date regarding nursing students’ conception, beliefs, and use. Studies available in the field have been performed among rheumatology, haemodialysis and non-haemodialysis nurses, managerial and clinical nurses (Alaloul et al., 2017; Baghcheghi and Koohestani, 2011; Berthelot et al., 2001; Nitzan and Lichtenberg, 2004; Palese et al., 2019b; Unver et al., 2013) without involving students. Therefore, the main purpose of this study was to explore (a) the definition of CFs among nursing students, (b) the use of CFs in their clinical practice, as well as the circumstances of utilization and the effects perceived, (c) their beliefs regarding CFs, as well as the (d) ethical implications, and (e) degree of communication regarding their use with patients in their daily practice.
Contextual Factors (CFs) have been documented to influence nursing interventions and patients' outcomes triggering placebo/nocebo effects. However, given that no studies to date have explored the beliefs and the use of CFs among nursing students, a cross-sectional study was undertaken. Two Italian nursing programmes were involved and a self-administered survey tool was used. A total of 510 students participated. The majority (266; 52.2%) defined CFs as an intervention without a specific effect on the condition being treated, but with a possible nonspecific effect. They reported a substantial level of confidence in CFs and in using them more than twice/week in addition to nursing interventions to optimise clinical outcomes. Physiological and psychological therapeutic effects were mostly reported by participants in treating insomnia (n = 351; 68.8%) and chronic pain (n = 310; 60.8%). The use of CF was considered ethically acceptable when it exerted beneficial psychological effects (n = 188; 36.8%). Participants communicated to patients that a CF is a treatment that can help and will not hurt (n = 128; 25.1%). Students are aware of the value of CFs. Increasing their emphasis in nursing programmes can promote nursing students’ consideration with regards to their use, their underlying mechanisms, their potential effects, as well as their ethical and comunicative implications.
Parental Attitudes About Placebo Use in Children
2017, Journal of Pediatrics
Citation Excerpt :
Although our data suggest that the majority of surveyed parents were positive and accepting, most parents would consent to the prescription of placebo treatment only when the targeted condition was psychological in nature or considered a “minor condition,” such as a routine cold or occasional pain. These findings are consistent with previous surveys suggesting that participants believe that placebos work via psychological effects and expect psychologically vulnerable patients to respond to placebo.25,44 The underlying disease seems to be an important determinant in consenting to the use of placebo.25
To assess parental attitudes regarding placebo use in pediatric randomized controlled trials and clinical care.
Parents with children under age 18 years living in the US completed and submitted an online survey between September and November 2014.
Among all 1300 participants, 1000 (76.9%; 538 mothers and 462 fathers) met the study inclusion criteria. The majority of surveyed parents considered the use of placebos acceptable in some pediatric care situations (86%) and some pediatric trials (91.5%), whereas only 5.7% of parents found the use of placebos in children always unacceptable. The clinical use of placebo was considered acceptable by a majority of parents for only 7 (mostly psychological) of the 17 conditions presented. Respondents' judgment about acceptability was influenced by the doctors' opinions about the therapeutic benefits of placebo treatment, the conditions for pediatric placebo use, transparency, safety, and purity of placebos.
Most surveyed parents accepted the idea of using placebos in pediatric trials and within the clinic for some conditions without the practice of deception and with the creation of guidelines for ethical and safe use. This study suggests a need to reconsider pediatric trial design and clinical therapy in the light of generally positive parental support of appropriate placebo use.
Determinants of nocebo effect during oral drug provocation tests
2015, Allergologia et Immunopathologia
A “nocebo” effect is defined as troublesome symptoms after the administration of placebo. The aim of this study was to determine characteristics of nocebo responses and related factors.
Patients with a reliable history of drug-induced hypersensitivity reactions subjected to placebo-controlled oral drug provocation tests and reacted to placebo, were consecutively included in this case–control study. Controls consisted of the randomly selected subjects who had a history of drug hypersensitivity reaction but did not react to placebo. A structured questionnaire was performed by an allergy specialist.
There were 137 subjects (mean age: 43.10 ± 12.65 years), with nocebo and 91 subjects (42.38 ± 12.18 years) without any reaction to placebo. Most nocebo reactions (71.5%, n = 98) were classified as subjective, with local pruritus as the most common finding. A minority of nocebo reactions (11.7%, n = 16) were objective as cutaneous reactions including flushing and urticaria. Factors related with nocebo risks were university graduation (OR: 2.96, 95% CI: 1.27–6.93, p = 0.012) and non-atopy (OR: 2.12, 95% CI: 1.02–4.40, p = 0.043). In terms of the time of first and last historical reaction to drugs, each 1-unit (a month) increase in first reaction time (OR: 1.008, 95% CI: 1.00–1.02, p = 0.001) and last reaction time (OR: 1.019, 95% CI: 1.01–1.03, p < 0.001) were associated with increased nocebo risk.
In conclusion, subjects with high education, non-atopy, and older drug hypersensitivity reactions history seem to be more likely to experience nocebo effect during oral drug provocation tests. These risk factors should be considered and managed accordingly to complete the drug provocation procedure successfully.
Scientific tools, fake treatments, or triggers for psychological healing: How clinical trial participants conceptualise placebos
2012, Social Science and Medicine
Citation Excerpt :
Our own findings highlight the need to examine dominant discourses of placebos and suggest that societal level interventions may be needed to challenge what appear to be established notions that placebos are fake treatments that have illusory effects. The beliefs of trial and healthcare personnel may also need to be challenged: nurses commonly attribute certain personality traits, such as psychological fragility, to placebo responders (Berthelot et al., 2001; Ernst & Abbot, 1997), and a meta-analysis showing that anti-depressants and placebos are similarly effective in mild-moderate depression received particularly negative reactions in the professional and lay press (Kirsch, 2008). How to describe placebos to RCT participants is particularly important for open-label studies, such as another recent RCT that found that open-label (i.e., non-deceptive and non-concealed) placebo treatment administered in a context of a persuasive rationale can elicit clinically significant placebo responses (Kaptchuk et al., 2010).
Placebos are an essential tool in randomised clinical trials, where they are used to control for bias and contextual healing effects. Placebos and their effects are also studied from multiple diverse perspectives, but the perspectives of placebo recipients are seldom considered. Research shows that people form cognitive and affective representations of active treatments such as medicines, and that they use these representations to guide their behaviour; it seems reasonable to suggest that people might also think about and develop representations of placebos. We adopted a qualitative approach to examine in detail how participants in one RCT, conducted in the USA, conceptualised placebos. 12 people were interviewed 3 times each, at the start, middle, and end of a trial of placebo effects and acupuncture for Irritable Bowel Syndrome (IBS). The interview data were analysed inductively and we identified four ways in which the participants conceptualised placebos: placebos are necessary for research; placebo effects are fake; placebo acupuncture is not real acupuncture; placebos have real effects mediated by psychological mechanisms. Participants’ conceptualisations of placebos were dynamic and situated in a broader psychological and socio-cultural context. Seeing placebo effects as legitimate seemed to be facilitated by having more holistic models of healing, viewing IBS as psychological, and seeing treatment as multifactorial. However, some participants maintained a negative view of placebo effects (e.g. as illusions) that was apparently inconsistent with their other beliefs (e.g. in mind-body healing mechanisms). This may indicate a dominance of negative discourses around placebos at a socio-cultural level. Negative views of placebos are inconsistent with evidence that placebo treatments can have positive effects on symptoms. RCT participants should be informed about potential benefits of placebo treatments to avoid misunderstandings and unease. Future work should improve methods of providing participants with full accurate information about placebos and their effects.
The placebo effect in rheumatology: New data
2011, Joint Bone Spine
Citation Excerpt :
Study patients should be routinely asked about which treatment they believe they are taking to check that the proportions of patients believing they received each treatment are similar throughout the study [2,38]. In all likelihood, healthcare provider knowledge and opinion about the placebo effect probably influence the placebo effect [39]. For instance, the denial by many surgeons that their interventions can have placebo effects (found in nearly all operated patients) further enhances the strong placebo effect of surgical procedures.
The placebo effect is often poorly understood or confused with evaluation bias or spontaneous improvement, particularly when study inclusion criteria select patients at the peak of their symptoms. Cerebral imaging studies have confirmed that the placebo effect exists, although it is now known to involve a combination of conditioned reflexes and reward anticipation. The magnitude of the placebo effect can be evaluated by randomly dividing patients into three groups, one of which receives no treatment at all; by crossover studies; or by the newly developed open-hidden study design. This last design has established that rebound effects can occur after placebo discontinuation, and other experiments have shown that anxiety is associated with a weaker placebo response. This anti-placebo effect of anxiety, similar to the nocebo effect, may involve the release of cholecystokinin. The strength of the placebo effect varies across procedures and joints. A marked placebo effect can be seen in rheumatology patients, as shown recently by two high-quality double-blind studies that found no difference between vertebroplasty and a sham procedure. Effective blinding is crucial both to obtain a strong placebo effect and to separate an intrinsic effect from a placebo effect. Beliefs of the patients and physicians regarding the active drug and the existence and strength of the placebo effect could also be usefully evaluated throughout clinical studies.

View all citing articles on Scopus

View full text

ORIGINAL ARTICLEInterindividual variations in beliefs about the placebo effect: a study in 300 rheumatology inpatients and 100 nurses

Abstract

Section snippets

Methods

Answers given by the 300 patients and 100 nurses

Discussion

Urology

Lancet

J Clin Epidemiol

Pain

The importance of placebo effects in pain treatment and research

JAMA

Harmful effects of the placebo-controlled design

Rev Rhum [Engl Ed]

Pain and the placebo response

Ciba Found Symp

The powerful placebo

JAMA

L’effet placebo dans le traitement de la douleur

Rev Prat

The placebo response in pain reduction

Adv Neurol

ORIGINAL ARTICLE
Interindividual variations in beliefs about the placebo effect: a study in 300 rheumatology inpatients and 100 nurses