Objectives: Randomized controlled trials evaluate diverse interventions. This can include medical interventions such as drugs or surgical procedures, or behavior change interventions (BCIs) that aim to change a habit, belief, or attitude to improve health, for example, healthy eating, psychological wellbeing. Harms are often recorded poorly or inconsistently within randomized controlled trials of BCIs. This scoping review aimed to collate and describe literature on categories, definitions, and mechanisms of harms from BCIs; methods of identifying plausible harms; and recommendations for recording harms. Study design and setting: A scoping review was conducted. Three databases (MEDLINE, PsycINFO, and CINAHL) were searched. Reference list checking and citation searching were performed. Articles were included if they discussed (1) interventions that aimed to modify behavior, (2) categories or mechanisms of harms, and (3) methods or recommendations for recording harms. All research designs were included. One reviewer reviewed titles, abstracts, and full texts; queries were checked with another reviewer. Data were extracted and synthesized descriptively by one reviewer and checked by another reviewer. A thematic map was constructed to summarize the review findings. Harms described from specific BCIs were identified, and examples were selected and summarized. Results: The review included 37 articles. Nineteen of 37 articles contributed to a thematic review. Three articles described categories of harms; categories of harm included physical, psychological, group and social interactions, cultural, equity, opportunity cost, environmental, and economic. Seven articles included mechanisms or underlying factors for harms including feelings of failure leading to shame or stigma, and group interventions enabling knowledge exchange on unhealthy behaviors. Twelve articles provided recommendations for recording harms, including taking a proportionate approach by focusing on the most plausible and important harms, collecting different perspectives on whether harms had occurred (eg, caregivers and family members), and using qualitative research methods to identify harms. One article described a three-step method to identify plausible harms from an intervention, and six articles supported aspects of the method. Eighteen of 37 articles contributed to a review which collated harms arising from specific interventions, for example, a peer support intervention in inflammatory bowel disease caused distressing conversations which might lead to anxiety and confrontation with a possible negative future. Conclusion: BCIs can cause harm. This review identified categories and proposed mechanisms of harms, as well as methods and recommendations for identifying and recording harms in BCIs for inclusion in forthcoming recommendations.

Background and ObjectiveConsidering that physicians and patients widely use acupuncture, it is necessary to explore its adverse effects during treatment. Herein, an evidence map was generated based on published studies to identify acupuncture-induced adverse effects and assess their severity, with the overarching goal of providing references for safe and effective implementation.MethodsA comprehensive literature search was performed in four public databases (PubMed, Embase, Web of science, and the Cochrane Library) to identify relevant studies published up to 15(th) June 2022. In addition, relevant studies were explored in the Epistemonikos database and reference lists were retrieved as a supplement. A MeaSurement Tool to Assess systematic Reviews, Version 2 (AMSTAR-2) quality assessment tool was applied to determine the methodological quality of included systematic reviews (SRs) and/or meta-analysis (MAs), whereas Microsoft Excel 2019 tool was used for data extraction and coding. Heatmaps were generated to display disease type, countries of origin for the first authors, and the sample sizes of original studies. Moreover, bubble charts comprehensively presented intervention categories, adverse reaction types, and evidence levels.ResultsA total of 535 SRs involving 33 adverse reactions were included. Among them, 22 studies were rated as high quality, 28 as moderate, 106 as low, and the rest were of critically-low quality. Numerous adverse effects were described in the studies, including syncope (86 SRs), organ or tissue injury (233 SRs), systemic reactions (113 SRs), infection (19 SRs), and other adverse events (373 SRs). Importantly, these adverse reactions were mainly associated with 19 acupuncture techniques, including electroacupuncture (n = 67), manual acupuncture (n = 47) and acupoint catgut embedding (n = 41). Furthermore, the 535 SRs described 23 diseases, among which symptoms, signs or clinical findings (83 SRs), mental, behavioral or neurodevelopmental disorders (67 SRs), and diseases of the nervous system (66 SRs) had the highest incidence.ConclusionThis evidence mapping explores the adverse effects of acupuncture, showing that there are multiple types of adverse reactions to acupuncture, with milder symptoms. The methodological assessment revealed that most of the included studies were of low- or critically low-quality. Therefore, there is a need for future randomized controlled trials and SRs to comprehensively analyze acupuncture-related adverse events in order to provide reliable and credible evidence.

We conducted the present bibliometric analysis to explore menopausal hormone therapy (MHT)-related research trends between 2000 and 2021. The Web of Science database was systematically searched from 2000 to 2021 to retrieve MHT-related publications. Visualization mapping and keyword cluster graphs were utilized to illustrate the research topics and hotpots. We included 11,616 MHT-related publications for this bibliometric analysis. The results showed that (1) MHT-related research had a very slow increase in the past 22 years, and the trend fluctuated. Sum of times cited and average citations per item had the same trend: a sharp decline from 2002 to 2003, and a rapid increase from 2003 to 2006, reaching the peak in 2006, then following a downward trend. The average H-index was 57, peaking in 2001; (2) the USA, the League of European Research Universities, and Dr. JoAann Manson from Harvard University contributed the most; (3) Menopause: The Journal of The North American Menopause Society had the most significant number of MHT-related publications; (4) the research hotpots primarily focused on MHT for treating menopausal symptoms and the impact of MHT on women's health. According to previous studies, MHT was the most effective treatment for managing vasomotor symptoms of menopause, but results from the clinical trials and observational studies regarding MHT adverse events remain inconsistent. Mechanisms are fundamental when clinical studies give conflicting results. Therefore, future studies should focus on adverse events and their mechanisms.