Publication status and reporting quality of case reports on acupuncture-related adverse events: A systematic reviews of case studies.

Introduction: Case reports on acupuncture-related adverse events (AEs) have been consistently published in the literature. This review aims to assess the current publication status of case reports on acupuncture-related AEs and evaluate their reporting quality in order to identify areas for improvement. Methods: This study is a systematic review (SR) of case reports. Studies describing cases for acupuncture-related AEs between 2010 and 2023 (until July) were searched in PubMed, Embase, and local databases (China and Korea), as well as by hand-searching references included in published relevant SRs. A bibliometric analysis was conducted to examine the publication trends of the included literature. The appropriateness of the acupuncture described in the cases, the causality assessment between AEs and acupuncture treatment, and the presence of necessary items from the CAse REport guidelines (CARE) checklist were narratively analyzed. Results: A total of 169 case reports were included in this review. Over the past decade, an average of 12 case reports on acupuncture-related AEs were published annually. However, only 38.2% of the articles provided sufficient information to determine the appropriateness of the acupuncture treatment used in the reported cases, and considerable numbers of the included case reports did not suggest enough information for the assessment of a causal relationship. The majority of cases did not report the timeline (n = 164), patient perspectives (n = 157), and informed consent (n = 121) items from the CARE checklist. Discussion: Acupuncture-related AEs persist in being frequently reported in the literature. Nonetheless, the information concerning acupuncture and causality assessment within these publications is still found to be insufficient. The development of reporting guidelines for future case reports on acupuncture-related AEs is anticipated to promote an academic environment conducive to more comprehensive reporting.

Alternative treatment and grey areas. / Alternativ behandling og gråsoner.

Links are made in the media these days between alternative treatment and various health-related activities such as shamanism, aesthetic medicine and health blogging, which have widely differing responsibilities, duties and rights. What does the term alternative treatment mean?

Reflexology for acute rhinosinusitis - Results from a blinded, early-phase comparative trial.

BACKGROUND: Reflexology is commonly used as an adjunct to conventional treatment by patients with respiratory tract infections. The effect of reflexology needs to be tested in a full-scale randomized controlled study. Small early-phase trials can give an indication on whether full-size clinical trials are warranted. The objective of this study is to determine whether the study design is feasible in a full-scale study of reflexology as an add-on to usual care compared to usual care alone in acute rhinosinusitis, and further if there is a statistical indication of an effect of reflexology warranting a full-scale study. METHODS: 20 patients with symptoms compatible with acute rhinosinusitis, and an illness duration of 28 days or less were randomized to additional reflexology treatment along with usual medical care, or usual care alone. The patients scored how much each of 16 sinus-related symptoms bothered them in the past few days on a six-point scale (zero = no problem to five = severe problem). To determine if there is a statistical indication of an effect of reflexology warranting a full-scale study, the separation test was used. RESULTS: The methodology was considered feasible and could therefore be applied in a full-scale study of reflexology for acute rhinosinusitis. The mean reduction in symptom score from baseline to day two was 0.95 in the reflexology group and 0.78 in the control group. From baseline to day ten the mean reduction in symptom score was 2.12 in the reflexology group and 1.63 in the control group. A statistical indication of effect in a full-scale study in favor of reflexology was found from baseline to day ten but not from baseline to day two. CONCLUSIONS: The research methodology in this study could be used in a full-scale study of reflexology in acute sinusitis. The results from the separation test indicates an effect warranting a full-scale study of reflexology regarding effects in acute sinusitis ten days after treatment.

Correction to: Complementary and alternative medicine for treatment of atopic eczema in children under 14 years old: a systematic review and meta-analysis of randomized controlled trials.

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Complementary and alternative medicine for treatment of atopic eczema in children under 14 years old: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Due to limitations of conventional medicine for atopic eczema (AE), complementary and alternative medicine (CAM) is widely used as an alternative, maintaining, or simultaneous treatment for AE. We aimed to evaluate the beneficial and harmful effects of CAM for children with AE under 14 years old. METHODS: We searched for randomized trials on CAM in 12 Chinese and English databases from their inception to May 2018. We included children (< 14 years) diagnosed with AE, who received CAM therapy alone or combined with conventional medicine. We extracted data, and used the Cochrane "Risk of bias" tool to assess methodological quality. Effect was presented as relative risk (RR) or mean difference (MD) with 95% confidence interval (CI) using RevMan 5.3. RESULTS: Twenty-four randomized controlled trials involving 2233 children with AE were included. Methodological quality was of unclear or high risk of bias in general. The trials tested 5 different types of CAM therapies, including probiotics, diet, biofilm, borage oil, and swimming. Compared to placebo, probiotics showed improved effect for the SCORAD index (MD 9.01, 95% CI 7.12-10.90; n = 5). For symptoms and signs such as itching, skin lesions, CAM combined with usual care was more effective for symptom relief ≥95% (RR 1.47, 95% CI 1.30-1.68; n = 8), and for ≥50% symptoms improvement (RR 1.34, 1.25-1.45; n = 9) compared to usual care. There was no statistic significant difference between CAM and usual care on ≥95% improvement or ≥ 50% improvement of symptoms. However, swimming, diet and biofilm showed improvement of clinical symptoms compared with usual care. At follow-up of 8 weeks to 3 years, CAM alone or combined with usual care showed lower relapse rate (RR 0.38, 0.28-0.51, n = 2; RR 0.31, 0.24-0.40, n = 7; respectively) compared to usual care. Twelve out of 24 trials reported no occurrence of severe adverse events. CONCLUSIONS: Low evidence demonstrates that some CAM modalities may improve symptoms of childhood AE and reduce relapse rate. Safety remains unclear due to insufficient reporting. Further well-designed randomized trials are needed to confirm the potential beneficial effect and to establish safety use.

Placebo by proxy expectations toward acupuncture change over time: a survey comparing parental expectations to acupuncture pre- and postoperatively.

BACKGROUND: Patients entering a treatment have expectancy to outcome based on their previous experience, the information received, and the credibility of the treatment. Once the treatment has started, patients may detect and interpret contextual cues and somatic state. Influenced and conditioned by positive or negative interpretations, their reappraisal may improve or worsen the treatment outcome. The aims were to investigate whether parental pre-treatment expectancies towards acupuncture differ compared to post-treatment expectancies, and assess predictors for possible change of parental expectancy. Further, we wanted to explore whether the change correlates with the treatment outcome, i.e. postoperative vomiting in children. METHODS: Two hundred and eighty-two parents completed per- and 24 h postoperatively a survey on their expectancy to acupuncture treatment for alleviation of postoperative vomiting in children. The survey was embedded in a randomised controlled trial. RESULTS: Parental expectancy to acupuncture treatment changed over time. The changes were predicted by several variables such as children's gender, parents' age and education, previous experiences, and assignment to treatment group. The strongest predictor was parental anxiety to their child undergoing surgery. Further, the change of parental expectancy was correlated with postoperative vomiting. CONCLUSIONS: Anxious parents are prone to change their expectancy in a positive direction during the treatment period, which in turn may improve treatment outcome. Acupuncture therapists in clinical practice should pay a special attention to the potential that lies here, and acknowledge parental anxiety as a possible facilitator, and not a barrier, to elicit placebo by proxy effects. Further research to expand the findings of the present study into other treatments is in order. Future research should also provide more knowledge about how parental expectancy changes over time, and how different factors predict and produce change of parental expectancy. TRIAL REGISTRATION: ClinicalTrials.gov NCT01729052 . Registered November 20, 2012.

Prevalence and reasons for intentional use of complementary and alternative medicine as an adjunct to future visits to a medical doctor for chronic disease.

BACKGROUND: Intentional use of complementary and alternative medicine (CAM) has previously only been researched in small, possibly biased, samples. There seems to be a lack of scientific information regarding healthy individual's attitudes and presumed use of CAM. The aim of this study is to describe prevalence and characteristics of participants who intend to see a CAM provider compared to participants who intend to see a medical doctor (MD) only when suffering from a chronic, non- life-threatening disease and in the need of treatment. Further to describe differences between the groups regarding expected reasons for CAM use and expected skills of CAM providers. METHOD: The survey was conducted in January 2016 as part of the "TNS Gallup Health policy Barometer". In total, 1728 individuals aged 16-92 years participated in the study, constituting an overall response rate of 47%. The survey included questions regarding opinions and attitudes towards health, health services and health politics in Norway. RESULTS: The majority of the participants (90.2%) would see a MD only if they were suffering from a chronic, non- life-threatening disease and were in the need of treatment. Men over the age of 60 with a university education tended to see a MD only. Only 9.8% of all respondents would in addition visit a CAM provider. Being an intentional user of a MD + CAM provider was associated with being a woman under the age of 60. The respondents believed that CAM providers have professional competence based on formal training in CAM. They also believed that individuals seeing a CAM provider have poor health and are driven by the hope of being cured. Further, that they have heard that others have good experience with such treatment. CONCLUSION: Intentional use of CAM is associated with positive attitudes, trustworthiness, and presumed positive experiences in the CAM-patient-setting. Intentional CAM users also have the impression that CAM providers have professional competence based on formal training in alternative therapies.

Acupuncture versus usual care for postoperative nausea and vomiting in children after tonsillectomy/adenoidectomy: a pragmatic, multicentre, double-blinded, randomised trial.

OBJECTIVES: To investigate the effect of a standardised acupuncture on nausea and vomiting in children after tonsillectomy with or without adenoidectomy when possible placebo effects were precluded. METHODS: A pragmatic, multicentre, double-blinded, randomised controlled trial. The study was conducted over 10 months in 2012-2013 at three ambulatory clinics. Two hundred and eighty-two children, age 1-11 years, American Society of Anesthesiologists grade ≤II, were included. To equalise expectancy effects, all parents were told that their child would receive acupuncture. However, children were randomly allocated to perioperative bilateral needling acupuncture at PC6, depth 7 mm, mean time 17 min (SD 5-45) during anaesthesia plus usual care, or to usual care only. The regional ethics committee approved this approach. Primary endpoints were nausea and vomiting 24 h postoperatively. RESULTS: This study did not demonstrate any effect of acupuncture (95% CI) compared with standard care. The overall vomiting in the acupuncture and usual-care groups was 44.2% and 47.9%, respectively. Nausea was experienced by 31.7% in the acupuncture group and by 32.6% in the usual-care group. The test power was acceptable for comparisons of vomiting. CONCLUSIONS: The findings suggest that when controlling for possible placebo effects standardised PC6 acupuncture needling during anaesthesia without further stimulation of PC6 is not effective in reducing nausea and vomiting in children after tonsillectomy with or without adenoidectomy. Future studies should investigate acupuncture treatment which balances adequate dose and technique and a feasible, child-friendly acupuncture treatment. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT01729052.

Placebo by Proxy--the Influence of Parental Anxiety and Expectancy on Postoperative Morbidities in Children.

BACKGROUND: Placebo effects emerging from expectancies of relatives, also known as placebo by proxy, is a rather unexplored field. In this study, we assume a correlation between parental anxiety/expectancy and postoperative morbidities in children. Accordingly, a reduction of parental anxiety is expected to enhance the effect of treatment. METHODS: From October 2012 to June 2013, parents of 282 children completed a self-report closed-ended questionnaire embedded in a main RCT at three ambulatory care centers. RESULTS: There were no significant associations between parental expectancy or anxiety and children experiencing vomiting and pain. CONCLUSION: The present study is the first to investigate placebo by proxy in acupuncture treatment for children. The findings were not able to demonstrate any placebo effect by proxy. Unknown confounders and limitations of methods may have contributed to the negative findings. Thus, the findings must be read with precaution, as the possibility of a type II error cannot be excluded. TRIAL REGISTRATION: ClinicalTrials.gov NCT01729052.

Acupuncture and related techniques in ambulatory anesthesia.

PURPOSE OF REVIEW: Along with a growing awareness of quality in healthcare, has come a focus on postanesthetic morbidities, which still remain challenging in our daily practice of anesthesia. Acupuncture and related techniques (acustimulation) are often suggested to be adequate treatments with low cost and minimal adverse effects. This review focuses on the current evidence and applicability of these techniques for use in ambulatory anesthesia. RECENT FINDINGS: Trials exploring the effects of acustimulation may produce ambiguous results and sometimes be difficult to evaluate. Controversies still remain as to the clinical relevance. Recent trials suggest that acustimulation may prevent postoperative pain, nausea and vomiting. There are also promising results for the use of the techniques in reducing preoperative anxiety, postoperative shivering and emergence delirium. SUMMARY: Pharmacological drug treatment may be only partially effective and produce an adverse event. Research suggests that acustimulation may alleviate postoperative morbidities, although the body of evidence of the effect is equivocal. The treatments are easy to perform, and adverse events and costs are minimal. It may be profitable to implement this beneficial treatment to asmbulatory patients.

Acupuncture adverse events in China: a glimpse of historical and contextual aspects.

The article by He and colleagues, "Adverse Events Following Acupuncture: A Systematic Review of the Chinese Literature for the Years 1956-2010" is an important and timely contribution. In this commentary, the article is reviewed and issues are highlighted about how to interpret and contextualize the results of their study. While their review has been well performed, certain areas have been identified where the results may be inaccurate due to problems in the reporting of original incidents. For example, potential problems were found in the reporting of the minor adverse event (AE) of fainting and the more serious AEs of pneumothorax and hepatitis. The article by He and colleagues highlights the issue that almost all AEs associated with acupuncture in the modern period are due to the administration of the therapy rather than the therapy itself. Future prospective studies can address some of the shortcomings identified in this review.

Can medical thermal images predict acupuncture adverse events? A case history.

Malaise and fainting are unpleasant acupuncture adverse effects. This paper shows how the use of thermography might identify subjects before the systematic responses become clinically significant.