Nocebo effect of informed consent: circulatory collapse before elective caesarean section

Usichenko, Taras; Hacker, H.; Hesse, Thomas

doi:10.1016/j.ijoa.2016.05.008

Cited by 2 publications

(2 citation statements)

References 9 publications

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“…One patient developed bradycardia and hypotension during the placebo intervention after the parturient woman was informed about such adverse effects of acupuncture. The incident was immediately treated without consequences for mother and child, 21 and the data for this patient were included in the intention-to-treat analysis. All other patients tolerated the acupuncture and placebo intervention well.…”

Section: Adverse Events and Quality Of Lifementioning

confidence: 99%

Effectiveness of Acupuncture for Pain Control After Cesarean Delivery

et al. 2022

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IMPORTANCE A pharmacological approach to pain control after cesarean delivery is often insufficient on its own. Acupuncture is a promising method for mitigating postoperative pain and reducing postoperative opioid requirements. OBJECTIVE To evaluate the efficacy and effectiveness of acupuncture as an adjunctive therapy for pain control after cesarean delivery, compared with a placebo intervention and standard care alone. DESIGN, SETTING, AND PARTICIPANTSThis single-center, placebo-controlled, patient-and assessor-blinded randomized clinical trial was conducted from January 13, 2015, to June 27, 2018, at a tertiary university hospital in Greifswald, Germany. Participants were women who were scheduled for elective cesarean delivery under spinal anesthesia and were randomized to either the acupuncture group (n = 60) or placebo group (n = 60). Another 60 consecutive patients who met the eligibility criteria and received the standard postoperative analgesia were selected to form a nonrandomized standard care group. The intention-to-treat analysis was performed from August 19, 2019, to September 13, 2019. INTERVENTIONSIn addition to standard pain treatment, each patient in the acupuncture group received auricular and body acupuncture with indwelling intradermal needles, whereas patients in the placebo group were treated with nonpenetrating placebo needles. MAIN OUTCOMES AND MEASURESThe primary outcome was pain intensity on movement, which was measured using an 11-item verbal rating scale. Secondary outcomes were analgesia-related adverse effects, analgesics consumption, time to mobilization and Foley catheter removal, quality of patient blinding to randomization, and patient satisfaction with treatment of pain. RESULTSA total of 180 female patients (mean [SD] age, 31 [5] years) were included in the intentionto-treat analysis. The mean pain intensity on movement in the acupuncture group on the first postoperative day was lower than in the placebo group (4.7 [1.8] vs 6.0 [2.0] points; Cohen d, 0.73; 95% CI, 0.31-1.01; P = .001) and the standard care group (6.3 [1.3] points; Cohen d, 1.01; 95% CI, 0.63-1.40; P < .001). On the first postoperative day, 59 patients (98%) in the acupuncture group were fully mobilized vs 49 patients (83%) in the placebo group (relative risk [RR], 1.18; 95% CI, 1.06-1.33; P = .01) and 35 patients (58%) in the standard care group (RR, 1.69; 95% CI, 1.36-2.09; P < .001). The Foley catheter was removed in a total of 57 patients (93%) from the acupuncture group vs 43 patients (72%) from the placebo group (RR, 1.33; 95% CI, 1.12-1.57; P = .003) and 42 patients (70%) from the standard care group (RR, 1.37; 95% CI, 1.14-1.62; P = .002). Other parameters were comparable across the 3 study groups.

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Section: Adverse Events and Quality Of Lifementioning

confidence: 99%

Effectiveness of Acupuncture for Pain Control After Cesarean Delivery

et al. 2022

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“…Nevertheless, the conclusion by those authors that “patients should not be told to expect a headache as this may be a self-fulfilling prophecy” cannot mean omission of risk information, but requires a reconsideration of the way we present it. In addition, harsh risk information can destabilize circulation, increase anxiety and stress, both strong predictors for a bad outcome, and even keep patients from a necessary therapy (Zech et al, 2015a; Usichenko et al, 2016). A structured literature search in PubMed with the terms “(informed consent) AND nocebo” resulted in 27 suitable articles (Wells and Kaptchuk, 2012; Howick, 2012; Faasse and Petrie, 2013; Cohen, 2014; Heisig et al, 2015; Wilhelm et al, 2018).…”

Section: Nocebo Effectsmentioning

confidence: 99%

Nocebo Effects and Negative Suggestions in Daily Clinical Practice – Forms, Impact and Approaches to Avoid Them

Hansen

Zech

2019

Front. Pharmacol.

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Medical situations are hot spots in the life of a patient with potentially long lasting effects arising from the use of either negative expressions or encouraging statements, or the lack of empathy or a positive physician-patient relationship. Health care personnel should be aware of and evaluate what patients are exposed to, hear and see. Knowing more about the effects of nocebos and negative suggestions, combined with increased attention to these matters, provides the basis for better recognition of detrimental influences in their own clinical environment and to be able to avoid, stop or neutralize them. After anamnesis patients should not be left with a focus on a negative past, but shifted to positive experiences prior to their illness, or to positive expectations in the future following surgery and rehabilitation. For example, after examining an injured leg the doctor should not turn to the computer for documentation unless he has shifted the patient’s focus on the other, unimpaired leg. “Is that painful too? No? Good! Can you feel that? Yes? Perfect! Can you bend that knee, move these toes? Great! That’s good.” This example draws attention to the fact that negative effects (discussed in the following) substantially are dependent on the focus of the patient and thus can be affected by focus shift and distraction. Patients, their symptoms and their healing are negatively affected by the omission of placebo effects, by nocebo effects and by negative suggestions.

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Nocebo effect of informed consent: circulatory collapse before elective caesarean section

Cited by 2 publications

References 9 publications

Effectiveness of Acupuncture for Pain Control After Cesarean Delivery

Effectiveness of Acupuncture for Pain Control After Cesarean Delivery

Nocebo Effects and Negative Suggestions in Daily Clinical Practice – Forms, Impact and Approaches to Avoid Them

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