Comparing physicians’ and patients’ reporting on adverse reactions in randomized trials on acupuncture—a secondary data analysis

Abstract

Background: We aimed to compare patients' and physicians' safety reporting using data from large acupuncture trials (44,818 patients) and to determine associations between patient characteristics and reporting of adverse reactions. Methods: Six pragmatic randomized trials with an additional non-randomized study arm that included those patients who refused randomization were evaluated. Patients received acupuncture treatment for osteoarthritis of the hip or knee, chronic neck pain, chronic low back pain, chronic headache, dysmenorrhea, or allergic rhinitis or asthma. Safety outcomes were evaluated by questionnaires from both the physicians and the patients. To determine level of agreement between physicians and patients on the prevalence of adverse reactions, Cohen's kappa was used. With multilevel models associations between patient characteristics and reporting of adverse reactions were assessed. Results: Patients reported on average three times more adverse reactions than the study physicians: for bleeding/ haematoma, 6.7% of patients (n = 2458) vs. 0.6% of physicians (n = 255) and for pain, 1.7% of patients (n = 636) vs. 0.5% of physicians (n = 207). We found only minor agreements between patients and physicians (maximum Cohen's kappa: 0.50, 95% confidence interval [0.49;0.51] for depressive mood). Being a female and participation in the randomization were associated with higher odds of reporting an adverse reaction. Conclusions: In our study, patients' and physicians' reports on adverse reactions of acupuncture differed substantially, possibly due to differences in patients' and physicians' questionnaires and definitions. For the assessment of safety, we strongly support the inclusion of patients' and physicians' reports while ensuring standardization of data collection and definitions.

Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies

“…At this, policy makers should take into account the worldwide popularity of acupuncture which is likely to further increase, as its scientific level of evidence has led to more than 4000 practice guidelines recommending acupuncture for different mostly pain indications. 69 …”

“…In addition, included studies differed in reporters (acupuncturists, patients, acupuncturists also questioning patients, and independent assessors), the type of documentation (selection list, open questions, or a combination of both), and assessment time points. Due to the large variability of combinations, the individual impact of these factors could not be estimated, but literature suggests that patients report more AEs than therapists, 69 and that open questions presented to patients lead to lower risk estimates than the presentation of a selection list of possible AEs. 31 Thus, standardised AE assessment methods should be established for acupuncture studies.…”

Acupuncture and osteopathic medicine for atopic dermatitis: a three-armed, randomized controlled explorative clinical trial

“…The observed AEs are known and partly inherent to the methods. However, the number of patients reporting AEs exceeded those of earlier trials using ACU 20 or OM 21 to treat diagnoses other than AD. This is the first randomized controlled trial (RCT) investigating ACU and OM in patients with AD.…”

Safety of acupuncture in oncology: A systematic review and meta‐analysis of randomized controlled trials

“…In therapy for oncological patients and in acupuncture treatments, there seems to be a discrepancy between the assessment of AEs by physicians and patients. [140][141][142] In the future, clarifying research regarding the different assessments will be useful.…”

“…In the context of AEs, it also must be discussed whether these should be reported by clinicians and patients. In therapy for oncological patients and in acupuncture treatments, there seems to be a discrepancy between the assessment of AEs by physicians and patients 140‐142 . In the future, clarifying research regarding the different assessments will be useful.…”