Clinically meaningful nocebo effect in acupuncture?

Abstract

The conclusion of Kooga et al. [[1]Koog Y.H. Lee J.S. Wi H. Clinically meaningful nocebo effect in acupuncture treatment: a systematic review.J Clin Epidemiol. 2014; 67: 858-869Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar] that “the nocebo effect of acupuncture is clinically meaningful and the rate of patients with any adverse event may be a more appropriate indicator of the nocebo effect” deserves some comments.First, opposing placebo and nocebo is a misconception. Indeed, conditioning and expectations are the main factors triggering a response, whether positive or negative. It is the cognitive information itself, which produces the response, for both the level and the direction [[2]Marchand S. Gaumond I. Placebo and nocebo: how to enhance therapies and avoid unintended sabotage to pain treatment.Pain Manag. 2013; 3: 285-294Crossref PubMed Google Scholar]. If you place a placebo into a person's drink without telling him, it does not work!Second, the selection of the trials is a limitation as subjectivity is present in most cases. Kooga et al. analyzed 31 and 39 trials, reporting adverse events and dropouts, respectively. However, allocation concealment was present in only 26 and patients blinding in only 15 (Table 1 of Kooga et al. [[1]Koog Y.H. Lee J.S. Wi H. Clinically meaningful nocebo effect in acupuncture treatment: a systematic review.J Clin Epidemiol. 2014; 67: 858-869Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar]). Could they provide results when selecting trials, which meet these both basic conditions.Finally, although statistically significant, how could the small difference they observed for adverse events be clinically relevant? Even the small analgesic effect of acupuncture seems to lack clinical relevance and cannot be clearly distinguished from bias [[3]Madsen M.V. Gøtzsche P.C. Hróbjartsson A. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups.BMJ. 2009; 338: a3115Crossref PubMed Scopus (252) Google Scholar].Placebos do not have clinically meaningful objective effects: the subjective patient-reported alleviation is not significant, being observed in only one-third of the trials and only under certain conditions. Placebo is Latin for “I will please”; the doctor's duty is not to please but to help. There is no need for placebos to provide reassurance, comfort, and hope. Several factors are pivotal in establishing and maintaining relationships with patients: patience, openness, attentive listening, trust, sharing authority, and commitment. No placebo can replace them [[4]Braillon A. Placebo is far from benign: it is disease-mongering.Am J Bioeth. 2009; 9: 36-38Crossref PubMed Scopus (10) Google Scholar]. The conclusion of Kooga et al. [[1]Koog Y.H. Lee J.S. Wi H. Clinically meaningful nocebo effect in acupuncture treatment: a systematic review.J Clin Epidemiol. 2014; 67: 858-869Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar] that “the nocebo effect of acupuncture is clinically meaningful and the rate of patients with any adverse event may be a more appropriate indicator of the nocebo effect” deserves some comments. First, opposing placebo and nocebo is a misconception. Indeed, conditioning and expectations are the main factors triggering a response, whether positive or negative. It is the cognitive information itself, which produces the response, for both the level and the direction [[2]Marchand S. Gaumond I. Placebo and nocebo: how to enhance therapies and avoid unintended sabotage to pain treatment.Pain Manag. 2013; 3: 285-294Crossref PubMed Google Scholar]. If you place a placebo into a person's drink without telling him, it does not work! Second, the selection of the trials is a limitation as subjectivity is present in most cases. Kooga et al. analyzed 31 and 39 trials, reporting adverse events and dropouts, respectively. However, allocation concealment was present in only 26 and patients blinding in only 15 (Table 1 of Kooga et al. [[1]Koog Y.H. Lee J.S. Wi H. Clinically meaningful nocebo effect in acupuncture treatment: a systematic review.J Clin Epidemiol. 2014; 67: 858-869Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar]). Could they provide results when selecting trials, which meet these both basic conditions. Finally, although statistically significant, how could the small difference they observed for adverse events be clinically relevant? Even the small analgesic effect of acupuncture seems to lack clinical relevance and cannot be clearly distinguished from bias [[3]Madsen M.V. Gøtzsche P.C. Hróbjartsson A. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups.BMJ. 2009; 338: a3115Crossref PubMed Scopus (252) Google Scholar]. Placebos do not have clinically meaningful objective effects: the subjective patient-reported alleviation is not significant, being observed in only one-third of the trials and only under certain conditions. Placebo is Latin for “I will please”; the doctor's duty is not to please but to help. There is no need for placebos to provide reassurance, comfort, and hope. Several factors are pivotal in establishing and maintaining relationships with patients: patience, openness, attentive listening, trust, sharing authority, and commitment. No placebo can replace them [[4]Braillon A. Placebo is far from benign: it is disease-mongering.Am J Bioeth. 2009; 9: 36-38Crossref PubMed Scopus (10) Google Scholar]. Clinically meaningful nocebo effect occurs in acupuncture treatment: a systematic reviewJournal of Clinical EpidemiologyVol. 67Issue 8PreviewTo investigate the nocebo effect using randomized acupuncture trials that include sham and no-treatment groups. Full-Text PDF Response to letter: Nocebo and placebo effects may not be separate in acupunctureJournal of Clinical EpidemiologyVol. 67Issue 12PreviewWe thank Dr. Alain Braillon for his interest in our article on the nocebo effect in acupuncture [1]. In our article [2], we calculated the magnitude of the nocebo effect in acupuncture using data from clinical trials and found that this effect is clinically meaningful, with a risk difference of 0.049 [95% confidence interval (CI): 0.012, 0.086]. Full-Text PDF