Yixuan Li

The ethical use of placebos in herbal medicine (HM) clinical trials remains contested, particularly in contexts where traditional medical systems shape patients’ beliefs and expectations. Complexities in placebo preparation, insufficient transparency, and inconsistent consent practices pose challenges not only to scientific validity but also to ethical standards. This study aimed to explore stakeholder perspectives on placebo use in HM trials, with a specific focus on ethical concerns related to trust, informed consent, and trial integrity. In-depth qualitative interviews were conducted with 23 stakeholders, including clinical investigators, research coordinators, trial managers, pharmaceutical staff, and patient representatives. We applied an inductive, framework-based thematic analysis to identify key perceptions, challenges, and needs regarding placebo use. Participants demonstrated diverse understandings and attitudes toward placebos. Medical professionals, who often had higher levels of formal medical training, tended to describe placebos from a scientific perspective, whereas patients more commonly expressed skepticism rooted in concerns about trust and transparency. Pharmacists reported substantial challenges in developing indistinguishable HM placebos, raising questions about the ethical implications of adding small amounts of active ingredients. Participants also highlighted inconsistent practices in placebo composition and similarity evaluation, which raised concerns about blinding integrity and transparency, as well as insufficient communication that affected participant trust and overall trial integrity. Differences in professional and educational background appeared to shape how stakeholders perceived HM placebos, influencing informed consent and ethical conduct in trials. Enhancing understanding and transparency in placebo composition and similarity evaluation is essential to uphold ethical and scientific integrity of HM trials and to guide the development of clear guidelines for HM placebo design and communication. not applicable.

Background Medical research in complementary and alternative medicine (CAM) has increased recently, raising ethical concerns about the moral status of CAM. Medical academic journals are responsible for conducting ethical review (ER) of manuscripts to protect the interests of human subjects and to make ethical results available before deciding to publish. However, there has been no systematic analysis of the ER in CAM journals. This study is aim to evaluate the current status of ethical requirements and compliance in CAM journals. Methods This is a cross-sectional study. We reviewed instructions for authors (IFAs) of CAM journals included in the Journal Citation Reports (2021) (https://jcr.clarivate.com) for general information and requirements for ER. We also browsed the manuscripts regarding randomized controlled trials published by CAM journals in Q1 and Q2 section from January to June, 2023, to check the actual situation of ethical requirement. Descriptive statistics and Fisher’s exact test were used for statistical analysis. Results 27 journals and 68 manuscripts were ultimately included. 92.6% (25/27) IFAs included keywords of ER, indicating the presence of ethical considerations. However, no specific ER was required for CAM (n = 0). We categorized journals by Geographic origin, JCR section, Year of electronic JCR, Types of studies, % of OA Gold to explore the factors that could influence CAM journals to have certain ethical review policies. The results showed there was no statistical significance in certain ethical review policy in any classification of journals (p > 0.05). All RCT manuscripts included in the study generally met the requirements of the published journals for ethical review. Conclusions All IFAs discussed ER, but the content was scattered, unfocused, and there were no specific ER requirements regarding CAM. Although the manuscripts basically met the requirements of the journal, it was not possible to get closer to the process of ER in the manuscript. To ensure full implementation of these policies in the future, CAM journals should require authors to provide more details, or to form a list of items necessary for CAM ethical review.

Evidence suggests that participation in plaza dancing may affect mental health. This study for the first time quantified the relationships between plaza dancing and psychological well-being and ill-being. We systematically searched PubMed, Web of Science, CNKI, Wanfang, and VIP to identify relevant studies published from the databases since their inception to July 25, 2021. The standardized mean differences of pre-to-post intervention data were calculated in the meta-analysis. Subgroup and meta-regression analyses were performed to test the potential moderating effects of age, outcome classification, measurement instruments, district, publication year, total sample size, and the duration, frequency, and length of the square dance intervention. A total of 25 original articles met all the eligibility criteria and were included in the review, and 17 studies were included in the meta-analysis. The meta-analysis revealed that plaza dancing improved psychological well-being and reduced psychological ill-being. The study participants’ age and district did not seem to affect the effectiveness of the plaza dancing intervention. The duration and frequency of plaza dancing affected the association between square dance and psychological well-being and psychological ill-being. Plaza dancing has a significant positive effect on psychological well-being and psychological ill-being, and the effects are moderated by intervention modality. Generalizing plaza dancing interventions to promote psychological well-being and prevent or treat psychological ill-being is needed.Systematic Review Registration[www.crd.york.ac.uk/prospero], identifier [CRD42021272016].