The placebo in practice

Carlino, Elisa; Pollo, Antonella; Benedetti, Fabrizio

doi:10.1097/spc.0b013e32835269c1

Cited by 20 publications

(12 citation statements)

References 54 publications

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“…Where and how temporal aspects of treatment expectations interface with the pain system in the brain needs to be explored using brain imaging technology. The timing effect is also noteworthy from a clinical perspective as it could open up new ways to enhance placebo effects (e.g., open-label placebo treatments; Kaptchuk & Miller, 2018) but even more importantly also the efficacy of active drug treatments (Carlino et al, 2012). Expectancy effects have been shown to contribute substantially to the overall treatment outcome of active drugs (Benedetti et al, 2003;Bingel et al, 2011).…”

Section: Discussionmentioning

confidence: 99%

‘External timing’ of placebo analgesia in an experimental model of sustained pain

Camerone

Wiech

Carlino

et al. 2021

European Journal of Pain

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Background Research on placebo analgesia commonly focuses on the impact of information about direction (i.e., increase or decrease of pain) and magnitude of the expected analgesic effect, whereas temporal aspects of expectations have received little attention so far. In a recent study, using short‐lasting, low‐intensity stimuli, we demonstrated that placebo analgesia onset is influenced by temporal information. Here, we investigate whether the same effect of temporal suggestions can be found in longer lasting, high‐intensity pain in a Cold Pressor Test (CPT). Methods Fifty‐three healthy volunteers were allocated to one of three groups. Participants were informed that the application of an (inert‐)cream would reduce pain after 5 min (P5) or 30 min (P30). The third group was informed that the cream only had hydrating properties (NE). All participants completed the CPT at baseline and 10 (Test 10) and 35 min (Test 35) following cream application. Percentage change in exposure time (pain tolerance) from baseline to Test 10 (Δ10) and to Test 35 (Δ35) and changes in heart rate (HR) during CPT were compared between the three groups. Results Δ10 was greater in P5 than in NE and P30, indicating that analgesia was only present in the group that was expecting an early onset of analgesia. Δ35 was greater in P5 and P30 compared to NE, reflecting a delayed onset of analgesia in P30 and maintained analgesia in P5. HR differences between groups were not significant. Conclusions Our data suggest that ‘externally timing’ of placebo analgesia may be possible for prolonged types of pain. Significance Research on placebo effects mainly focuses on the influence of information about direction (i.e., increase or decrease of pain) and magnitude (i.e., strong or weak) of the expected effect but ignores temporal aspects of expectations. In our study in healthy volunteers, the reported onset of placebo analgesia followed the temporal information provided. Such ‘external timing’ effects could not only aid the clinical use of placebo treatment (e.g., in open‐label placebos) but also support the efficacy of active drugs.

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Section: Discussionmentioning

confidence: 99%

‘External timing’ of placebo analgesia in an experimental model of sustained pain

Camerone

Wiech

Carlino

et al. 2021

European Journal of Pain

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“…A legitimate question therefore becomes how to reproduce these effects in clinical practice and, possibly, to maintain them over time. Even in pharmacological trials, where an active drug is administered to the intervention group, the importance of the ritual process and of the psychosocial context is being increasingly recognized [32]. The desire of harnessing this effect should, however, be balanced with the accepted right of properly consenting subjects; the inherent tension between these two factors poses challenges that deserve wide discussions by the scientific community.…”

Section: Discussionmentioning

confidence: 99%

Hawthorne Effect with Transient Behavioral and Biochemical Changes in a Randomized Controlled Sleep Extension Trial of Chronically Short-Sleeping Obese Adults: Implications for the Design and Interpretation of Clinical Studies

et al. 2014

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ObjectiveTo evaluate the effects of study participation per se at the beginning of a sleep extension trial between screening, randomization, and the run-in visit.DesignSubjects were screened, returned for randomization (Comparison vs. Intervention) after 81 days (median), and attended run-in visit 121 days later.SettingOutpatient.PatientsObese (N = 125; M/F, 30/95; Blacks/Whites/Other, N = 73/44/8), mean weight 107.6±19.7 kg, <6.5 h sleep/night.InterventionNon-pharmacological sleep extension.MeasurementsSleep duration (diaries and actigraphy watch), sleep quality (Pittsburgh Sleep Quality Index), daily sleepiness (Epworth Sleepiness Scale), fasting glucose, insulin and lipids.ResultsPrior to any intervention, marked improvements occurred between screening and randomization. Sleep duration increased (diaries: 357.4 ±51.2 vs. 388.1±48.6 min/night; mean±SD; P<0.001 screening vs. randomization; actigraphy: 344.3 ±41.9 vs. 358.6±48.2 min/night; P<0.001) sleep quality improved (9.1±3.2 vs. 8.2±3.0 PSQI score; P<0.001), sleepiness tended to improve (8.9±4.6 vs. 8.3±4.5 ESS score; P = 0.06), insulin resistance decreased (0.327±0.038 vs. 0.351±0.045; Quicki index; P<0.001), and lipids improved, except for HDL-C. Abnormal fasting glucose (25% vs. 11%; P = 0.007), and metabolic syndrome (42% vs. 29%; P = 0.007) both decreased. In absence of intervention, the earlier metabolic improvements disappeared at the run-in visit.LimitationsRelatively small sample size.ConclusionsImprovements in biochemical and behavioral parameters between screening and randomization changed the “true” study baseline, thereby potentially affecting outcome. While regression to the mean and placebo effect were considered, these findings are most consistent with the “Hawthorne effect”, according to which behavior measured in the setting of an experimental study changes in response to the attention received from study investigators. This is the first time that biochemical changes were documented with respect to the Hawthorne effect. The findings have implications for the design and conduct of clinical research.Trial RegistrationClinicalTrials.gov NCT00261898.

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“…Previous successful and unsuccessful experiences of a specific treatment are capable to influence the therapeutic outcome [ 170 ]. In order to plan a therapeutic intervention, it’s important to question about past memories of analgesic and hyperalgesic responses concerning a treatment; reinforcing the positive experiences and devaluating the negative ones [ 7 , 169 , 171 – 173 ]. For example, if a patient had a previous negative experience with a specific treatment, clinician should avoid adopting it.…”

Section: Clinical Applications and Translational Researchmentioning

confidence: 99%

“…Before starting the treatment clinicians should read records, thoroughly examine the patients, provide a confident diagnosis and propose, when available, different treatment options encouraging the patient’s involvement in the choice of therapy and treatment goals [ 169 , 171 , 184 – 186 ].…”

Section: Clinical Applications and Translational Researchmentioning

confidence: 99%

“…It is crucial to effectively inform about the efficacy of a specific treatment [ 169 , 172 ], considering that beliefs and behaviors could influence patients’ attitudes in a positive or negative way [ 7 , 169 ]. It is suitable to individualize consultation style according to the patient’s preference opting for a personal interaction and seeking for a warm, authentic and empathic style, limiting technical contacts to the minimum [ 169 , 171 , 172 , 176 , 188 – 190 ].…”

Section: Clinical Applications and Translational Researchmentioning

confidence: 99%

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Clinical relevance of contextual factors as triggers of placebo and nocebo effects in musculoskeletal pain

Rossettini

Carlino

Testa

2018

BMC Musculoskelet Disord

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196

172

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Placebo and nocebo effects are embodied psycho-neurobiological responses capable of modulating pain and producing changes at different neurobiological, body at perceptual and cognitive levels. These modifications are triggered by different contextual factors (CFs) presented in the therapeutic encounter between patient and healthcare providers, such as healing rituals and signs. The CFs directly impact on the quality of the therapeutic outcome: a positive context, that is a context characterized by the presence of positive CFs, can reduce pain by producing placebo effects, while a negative context, characterized by the presence of negative CFs, can aggravate pain by creating nocebo effects. Despite the increasing interest about this topic; the detailed study of CFs as triggers of placebo and nocebo effects is still lacked in the management of musculoskeletal pain.Increasing evidence suggest a relevant role of CFs in musculoskeletal pain management. CFs are a complex sets of internal, external or relational elements encompassing: patient’s expectation, history, baseline characteristics; clinician’s behavior, belief, verbal suggestions and therapeutic touch; positive therapeutic encounter, patient-centered approach and social learning; overt therapy, posology of intervention, modality of treatment administration; marketing features of treatment and health care setting. Different explanatory models such as classical conditioning and expectancy can explain how CFs trigger placebo and nocebo effects. CFs act through specific neural networks and neurotransmitters that were described as mediators of placebo and nocebo effects.Available findings suggest a relevant clinical role and impact of CFs. They should be integrated in the clinical reasoning to increase the number of treatment solutions, boosts their efficacy and improve the quality of the decision-making. From a clinical perspective, the mindful manipulation of CFs represents a useful opportunity to enrich a well-established therapy in therapeutic setting within the ethical border. From a translational perspective, there is a strong need of research studies on CFs close to routine and real-world clinical practice in order to underline the uncertainty of therapy action and help clinicians to implement knowledge in daily practice.

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The placebo in practice

Cited by 20 publications

References 54 publications

‘External timing’ of placebo analgesia in an experimental model of sustained pain

‘External timing’ of placebo analgesia in an experimental model of sustained pain

Hawthorne Effect with Transient Behavioral and Biochemical Changes in a Randomized Controlled Sleep Extension Trial of Chronically Short-Sleeping Obese Adults: Implications for the Design and Interpretation of Clinical Studies

Clinical relevance of contextual factors as triggers of placebo and nocebo effects in musculoskeletal pain

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