Reporting Conflicts of Interest and Funding in Health Care Guidelines: The RIGHT-COI&F Checklist.

BACKGROUND: Conflicts of interest (COIs) of contributors to a guideline project and the funding of that project can influence the development of the guideline. Comprehensive reporting of information on COIs and funding is essential for the transparency and credibility of guidelines. OBJECTIVE: To develop an extension of the Reporting Items for practice Guidelines in HealThcare (RIGHT) statement for the reporting of COIs and funding in policy documents of guideline organizations and in guidelines: the RIGHT-COI&F checklist. DESIGN: The recommendations of the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network were followed. The process consisted of registration of the project and setting up working groups, generation of the initial list of items, achieving consensus on the items, and formulating and testing the final checklist. SETTING: International collaboration. PARTICIPANTS: 44 experts. MEASUREMENTS: Consensus on checklist items. RESULTS: The checklist contains 27 items: 18 about the COIs of contributors and 9 about the funding of the guideline project. Of the 27 items, 16 are labeled as policy related because they address the reporting of COI and funding policies that apply across an organization's guideline projects. These items should be described ideally in the organization's policy documents, otherwise in the specific guideline. The remaining 11 items are labeled as implementation related and they address the reporting of COIs and funding of the specific guideline. LIMITATION: The RIGHT-COI&F checklist requires testing in real-life use. CONCLUSION: The RIGHT-COI&F checklist can be used to guide the reporting of COIs and funding in guideline development and to assess the completeness of reporting in published guidelines and policy documents. PRIMARY FUNDING SOURCE: The Fundamental Research Funds for the Central Universities of China.

Acupuncture for Treating Attention Deficit Hyperactivity Disorder in Children: A Systematic Review and Meta-Analysis.

Background and Objectives: Attention-deficit hyperactivity disorder (ADHD) is a common childhood disorder characterized by inattention, hyperactivity, and impulsivity. However, it is uncertain whether the use of acupuncture (AT) in children with ADHD is supported by the current evidence. This review aims to provide updated evidence of the effectiveness of acupuncture in children with ADHD. Methods: Nine databases were searched from their inception to 28 July 2022. Two authors independently screened potentially eligible studies. The quality assessment of the selected studies was performed using Version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB 2). The characteristics of the included studies were presented in a tabular form, and a meta-analysis was performed on the treatment effects of AT on ADHD symptoms. Results: Fourteen studies involving 1185 patients evaluating the efficacy of AT for ADHD treatment were included in this review. Compared to conventional medicine alone, the meta-analysis indicated that AT as an add-on to conventional medicine has a positive effect on improving conduct problems, learning problems, hyperactivity-impulsivity, and hyperactivity symptoms in ADHD patients. Similarly, AT alone was found to improve learning problems, hyperactivity-impulsivity, and hyperactivity symptoms in ADHD patients and exhibited better total treatment efficacy than conventional medicine alone. No major adverse events were reported. The risk of bias of the included studies was generally concerning. Conclusions: Evidence on the effectiveness of AT for ADHD patients is currently too limited to provide recommendations for its usage. More studies with the proper methodology are needed for the validation of AT interventions in treating children with ADHD.

Methodology and experiences of rapid advice guideline development for children with COVID-19: responding to the COVID-19 outbreak quickly and efficiently.

BACKGROUND: Rapid Advice Guidelines (RAG) provide decision makers with guidance to respond to public health emergencies by developing evidence-based recommendations in a short period of time with a scientific and standardized approach. However, the experience from the development process of a RAG has so far not been systematically summarized. Therefore, our working group will take the experience of the development of the RAG for children with COVID-19 as an example to systematically explore the methodology, advantages, and challenges in the development of the RAG. We shall propose suggestions and reflections for future research, in order to provide a more detailed reference for future development of RAGs. RESULT: The development of the RAG by a group of 67 researchers from 11 countries took 50 days from the official commencement of the work (January 28, 2020) to submission (March 17, 2020). A total of 21 meetings were held with a total duration of 48 h (average 2.3 h per meeting) and an average of 16.5 participants attending. Only two of the ten recommendations were fully supported by direct evidence for COVID-19, three recommendations were supported by indirect evidence only, and the proportion of COVID-19 studies among the body of evidence in the remaining five recommendations ranged between 10 and 83%. Six of the ten recommendations used COVID-19 preprints as evidence support, and up to 50% of the studies with direct evidence on COVID-19 were preprints. CONCLUSIONS: In order to respond to public health emergencies, the development of RAG also requires a clear and transparent formulation process, usually using a large amount of indirect and non-peer-reviewed evidence to support the formation of recommendations. Strict following of the WHO RAG handbook does not only enhance the transparency and clarity of the guideline, but also can speed up the guideline development process, thereby saving time and labor costs.

Guidelines for the prevention and management of children and adolescents with COVID-19.

Children are the future of the world, but their health and future are facing great uncertainty because of the coronavirus disease 2019 (COVID-19) pandemic. In order to improve the management of children with COVID-19, an international, multidisciplinary panel of experts developed a rapid advice guideline at the beginning of the outbreak of COVID-19 in 2020. After publishing the first version of the rapid advice guideline, the panel has updated the guideline by including additional stakeholders in the panel and a comprehensive search of the latest evidence. All recommendations were supported by systematic reviews and graded using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Expert judgment was used to develop good practice statements supplementary to the graded evidence-based recommendations. The updated guideline comprises nine recommendations and one good practice statement. It focuses on the key recommendations pertinent to the following issues: identification of prognostic factors for death or pediatric intensive care unit admission; the use of remdesivir, systemic glucocorticoids and antipyretics, intravenous immunoglobulin (IVIG) for multisystem inflammatory syndrome in children, and high-flow oxygen by nasal cannula or non-invasive ventilation for acute hypoxemic respiratory failure; breastfeeding; vaccination; and the management of pediatric mental health. CONCLUSION: This updated evidence-based guideline intends to provide clinicians, pediatricians, patients and other stakeholders with evidence-based recommendations for the prevention and management of COVID-19 in children and adolescents. Larger studies with longer follow-up to determine the effectiveness and safety of systemic glucocorticoids, IVIG, noninvasive ventilation, and the vaccines for COVID-19 in children and adolescents are encouraged. WHAT IS KNOWN: • Several clinical practice guidelines for children with COVID-19 have been developed, but only few of them have been recently updated. • We developed an evidence-based guideline at the beginning of the COVID-19 outbreak and have now updated it based on the results of a comprehensive search of the latest evidence. WHAT IS NEW: • The updated guideline provides key recommendations pertinent to the following issues: identification of prognostic factors for death or pediatric intensive care unit admission; the use of remdesivir, systemic glucocorticoids and antipyretics, intravenous immunoglobulin for multisystem inflammatory syndrome in children, and high-flow oxygen by nasal cannula or non-invasive ventilation for acute hypoxemic respiratory failure; breastfeeding; vaccination; and the management of pediatric mental health.

Development of a STandard reporting guideline for Evidence briefs for Policy (STEP): context and study protocol.

BACKGROUND: Evidence briefs for policy (EBP) draw on best-available data and research evidence (e.g., systematic reviews) to help clarify policy problems, frame options for addressing them, and identify implementation considerations for policymakers in a given context. An increasing number of governments, non-governmental organizations and research groups have been developing EBP on a wide variety of topics. However, the reporting characteristics of EBP vary across organizations due to a lack of internationally accepted standard reporting guidelines. This project aims to develop a STandard reporting guideline of Evidence briefs for Policy (STEP), which will encompass a reporting checklist and a STEP statement and a user manual. METHODS: We will refer to and adapt the methods recommended by the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) network. The key actions include: (1) developing a protocol; (2) establishing an international multidisciplinary STEP working group (consisting of a Coordination Team and a Delphi Panel); (3) generating an initial draft of the potential items for the STEP reporting checklist through a comprehensive review of EBP-related literature and documents; (4) conducting a modified Delphi process to select and refine the reporting checklist; (5) using the STEP to evaluate published policy briefs in different countries; (6) finalizing the checklist; (7) developing the STEP statement and the user manual (8) translating the STEP into different languages; and (9) testing the reliability through real world use. DISCUSSION: Our protocol describes the development process for STEP. It will directly address what and how information should be reported in EBP and contribute to improving their quality. The decision-makers, researchers, journal editors, evaluators, and other stakeholders who support evidence-informed policymaking through the use of mechanisms like EBP will benefit from the STEP. Registration We registered the protocol on the EQUATOR network. ( https://www.equator-network.org/library/reporting-guidelines-under-development/#84 ).

Ginseng for erectile dysfunction.

BACKGROUND: Dietary supplements with ginseng, or ginseng alone, are widely used for a broad range of conditions, including erectile dysfunction. Ginseng is particularly popular in Asian countries. Individual studies assessing its effects are mostly small, of uneven methodological quality and have unclear results. OBJECTIVES: To assess the effects of ginseng on erectile dysfunction. SEARCH METHODS: We conducted systematic searches on multiple electronic databases, including CENTRAL, MEDLINE, Embase, CINAHL, AMED, and loco-regional databases of east Asia, from their inceptions to 30 January 2021 without restrictions on language and publication status. Handsearches included conference proceedings. SELECTION CRITERIA: We included randomized or quasi-randomized controlled trials that evaluated the use of any type of ginseng as a treatment for erectile dysfunction compared to placebo or conventional treatment. DATA COLLECTION AND ANALYSIS: Two authors independently classified studies and three authors independently extracted data and assessed risk of bias in the included studies. We rated the certainty of evidence according to the GRADE approach. MAIN RESULTS: We included nine studies with 587 men with mild to moderate erectile dysfunction, aged from 20 to 70 years old. The studies all compared ginseng to placebo. We found only short-term follow-up data (up to 12 weeks).  Primary outcomes Ginseng appears to have a trivial effect on erectile dysfunction when compared to placebo based on the Erectile Function Domain of the International Index of Erectile Function (IIEF)-15 instrument (scale: 1 to 30, higher scores imply better function; mean difference [MD] 3.52, 95% confidence interval [CI] 1.79 to 5.25; I² = 0%; 3 studies; low certainty evidence) assuming a minimal clinically important difference (MCID) of 4.  Ginseng probably also has a trivial effect on erectile function when compared to placebo based on the IIEF-5 instrument (scale: 1 to 25, higher scores imply better function; MD 2.39, 95% CI 0.89 to 3.88; I² = 0%; 3 studies; moderate certainty evidence) assuming a MCID of 5. Ginseng may have little to no effect on adverse events compared to placebo (risk ratio [RR] 1.45, 95% CI 0.69 to 3.03; I² = 0%; 7 studies; low certainty evidence). Based on 86 adverse events per 1000 men in the placebo group, this would correspond to 39 more adverse events per 1000 (95% CI 27 fewer to 174 more). Secondary outcomes Ginseng may improve men's self-reported ability to have intercourse (RR 2.55, 95% CI 1.76 to 3.69; I² = 23%; 6 studies; low certainty evidence). Based on 207 per 1000 men self-reporting the ability to have intercourse in the placebo group, this would correspond to 321 more men (95% CI 158 more to 558 more) per 1000 self-reporting the ability to have intercourse. Ginseng may have a trivial effect on men's satisfaction with intercourse based on the Intercourse Satisfaction Domain of the IIEF-15 (scale: 0 to 15, higher scores imply greater satisfaction; MD 1.19, 95% CI 0.41 to 1.97; I²=0%; 3 studies; low certainty evidence) based on a MCID of 25% improvement from baseline. It may also have a trivial effect on men's satisfaction with intercourse based on item 5 of the IIEF-5 (scale: 0 to 5, higher scores imply more satisfaction; MD 0.60, 95% CI 0.02 to 1.18; 1 study; low certainty evidence) based on a MCID of 25% improvement from baseline. No study reported quality of life as an outcome. We found no trial evidence to inform comparisons to other treatments for erectile dysfunction, such as phosphodiesterase-5 inhibitors. We were unable to conduct any predefined subgroup analyses. AUTHORS' CONCLUSIONS: Based on mostly low certainty evidence, ginseng may only have trivial effects on erectile function or satisfaction with intercourse compared to placebo when assessed using validated instruments. Ginseng may improve men's self-reported ability to have intercourse. It may have little to no effect on adverse events. We found no trial evidence comparing ginseng to other agents with a more established role in treating erectile dysfunction, such as phosphodiesterase-5 inhibitors.

Aromatherapy for Symptom Relief in Patients with Burn: A Systematic Review and Meta-Analysis.

Background and Objectives: This review aimed to provide an updated review of evidence regarding the effects of aromatherapy in relieving symptoms of burn injuries, focusing on pain and physiological distress. Materials and Methods: Fifteen databases (including five English databases, four Korean medical databases, and four Iranian databases) and trial registries were searched for studies published between their dates of inception and July 2021. Two review authors individually performed study selection, data extraction, and risk of bias assessment, and any discrepancies were solved by a third review author. Results: Eight RCTs met our inclusion criteria and were analyzed in this updated systematic review. Our meta-analyses revealed that inhaled aromatherapy plus routine care showed beneficial effects in relieving pain after dressing, as compared to placebo plus routine care (p < 0.00001) and routine care alone (p = 0.02). Additionally, inhaled aromatherapy plus routine care (p < 0.00001) and aromatherapy massage plus routine care (p < 0.0001) also showed superior effects in calming anxiety, as compared to routine care alone. None of the included studies reported on AEs. Overall, the risk of bias across the studies was concerning. Conclusions: This updated review and synthesis of the studies had brought a more detailed understanding of the potential application of aromatherapy for easing the pain and anxiety of burn patients.

Reporting items for systematic reviews and meta-analyses of acupuncture: the PRISMA for acupuncture checklist.

BACKGROUND: Acupuncture is widely used worldwide, and systematic reviews on acupuncture are increasingly being published. Although acupuncture systematic reviews share several essential elements with other systematic reviews, some essential information for the application of acupuncture is not covered by the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement. Considering this, we aimed to develop an extension of the PRISMA statement for acupuncture systematic reviews. METHODS: We used the PRISMA statement as a starting point, and conducted this study referring to the development strategy recommended by the EQUATOR network. The initial items were collected through a wide survey among evidence users and a review of relevant studies. We conducted a three-round Delphi survey and one-day face-to-face meeting to select items and formulate the checklist. After the consensus meeting, we drafted the manuscript (including the checklist) and sent it to our advisory experts for comments, following which the checklist was refined and circulated to a group of acupuncture systematic review authors for pilot test. We also selected a sample of acupuncture systematic reviews published in 2017 to test the checklist. RESULTS: A checklist of five new sub-items (including sub items) and six modified items was formulated, involving content related to title, rationale, eligibility criteria, literature search, data extraction, and study characteristics. We clarified the rationales of the items and provided examples for each item for additional guidance. CONCLUSION: The PRISMA for Acupuncture checklist is developed for improving the reporting of systematic reviews of acupuncture interventions. TRIAL REGISTRATION: We have registered the study on the EQUATOR network ( http://www.equator-network.org/library/reporting-guidelines-under-development/#91 ).

Acupuncture for depression.

BACKGROUND: Depression is recognised as a major public health problem that has a substantial impact on individuals and on society. People with depression may consider using complementary therapies such as acupuncture, and an increasing body of research has been undertaken to assess the effectiveness of acupuncture for treatment of individuals with depression. This is the second update of this review. OBJECTIVES: To examine the effectiveness and adverse effects of acupuncture for treatment of individuals with depression.To determine:• Whether acupuncture is more effective than treatment as usual/no treatment/wait list control for treating and improving quality of life for individuals with depression.• Whether acupuncture is more effective than control acupuncture for treating and improving quality of life for individuals with depression.• Whether acupuncture is more effective than pharmacological therapies for treating and improving quality of life for individuals with depression.• Whether acupuncture plus pharmacological therapy is more effective than pharmacological therapy alone for treating and improving quality of life for individuals with depression.• Whether acupuncture is more effective than psychological therapies for treating and improving quality of life for individuals with depression.• Adverse effects of acupuncture compared with treatment as usual/no treatment/wait list control, control acupuncture, pharmacological therapies, and psychological therapies for treatment of individuals with depression. SEARCH METHODS: We searched the following databases to June 2016: Cochrane Common Mental Disorders Group Controlled Trials Register (CCMD-CTR), Korean Studies Information Service System (KISS), DBPIA (Korean article database website), Korea Institute of Science and Technology Information, Research Information Service System (RISS), Korea Med, Korean Medical Database (KM base), and Oriental Medicine Advanced Searching Integrated System (OASIS), as well as several Korean medical journals. SELECTION CRITERIA: Review criteria called for inclusion of all published and unpublished randomised controlled trials comparing acupuncture versus control acupuncture, no treatment, medication, other structured psychotherapies (cognitive-behavioural therapy, psychotherapy, or counselling), or standard care. Modes of treatment included acupuncture, electro-acupuncture, and laser acupuncture. Participants included adult men and women with depression diagnosed by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV), Research Diagnostic Criteria (RDC), International Statistical Classification of Diseases and Related Health Problems (ICD), or Chinese Classification of Mental Disorders Third Edition Revised (CCMD-3-R). If necessary, we used trial authors' definitions of depressive disorder. DATA COLLECTION AND ANALYSIS: We performed meta-analyses using risk ratios (RRs) for dichotomous outcomes and standardised mean differences (SMDs) for continuous outcomes, with 95% confidence intervals (CIs). Primary outcomes were reduction in the severity of depression, measured by self-rating scales or by clinician-rated scales, and improvement in depression, defined as remission versus no remission. We assessed evidence quality using the GRADE method. MAIN RESULTS: This review is an update of previous versions and includes 64 studies (7104 participants). Most studies were at high risk of performance bias, at high or unclear risk of detection bias, and at low or unclear risk of selection bias, attrition bias, reporting bias, and other bias.Acupuncture versus no treatment/wait list/treatment as usualWe found low-quality evidence suggesting that acupuncture (manual and electro-) may moderately reduce the severity of depression by end of treatment (SMD -0.66, 95% CI -1.06 to -0.25, five trials, 488 participants). It is unclear whether data show differences between groups in the risk of adverse events (RR 0.89, 95% CI 0.35 to 2.24, one trial, 302 participants; low-quality evidence).Acupuncture versus control acupuncture (invasive, non-invasive sham controls)Acupuncture may be associated with a small reduction in the severity of depression of 1.69 points on the Hamilton Depression Rating Scale (HAMD) by end of treatment (95% CI -3.33 to -0.05, 14 trials, 841 participants; low-quality evidence). It is unclear whether data show differences between groups in the risk of adverse events (RR 1.63, 95% CI 0.93 to 2.86, five trials, 300 participants; moderate-quality evidence).Acupuncture versus medicationWe found very low-quality evidence suggesting that acupuncture may confer small benefit in reducing the severity of depression by end of treatment (SMD -0.23, 95% CI -0.40 to -0.05, 31 trials, 3127 participants). Studies show substantial variation resulting from use of different classes of medications and different modes of acupuncture stimulation. Very low-quality evidence suggests lower ratings of adverse events following acupuncture compared with medication alone, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) (mean difference (MD) -4.32, 95% CI -7.41 to -1.23, three trials, 481 participants).Acupuncture plus medication versus medication aloneWe found very low-quality evidence suggesting that acupuncture is highly beneficial in reducing the severity of depression by end of treatment (SMD -1.15, 95% CI -1.63 to -0.66, 11 trials, 775 participants). Studies show substantial variation resulting from use of different modes of acupuncture stimulation. It is unclear whether differences in adverse events are associated with different modes of acupuncture (SMD -1.32, 95% CI -2.86 to 0.23, three trials, 200 participants; very low-quality evidence).Acupuncture versus psychological therapyIt is unclear whether data show differences between acupuncture and psychological therapy in the severity of depression by end of treatment (SMD -0.5, 95% CI -1.33 to 0.33, two trials, 497 participants; low-quality evidence). Low-quality evidence suggests no differences between groups in rates of adverse events (RR 0.62, 95% CI 0.29 to 1.33, one trial, 452 participants). AUTHORS' CONCLUSIONS: The reduction in severity of depression was less when acupuncture was compared with control acupuncture than when acupuncture was compared with no treatment control, although in both cases, results were rated as providing low-quality evidence. The reduction in severity of depression with acupuncture given alone or in conjunction with medication versus medication alone is uncertain owing to the very low quality of evidence. The effect of acupuncture compared with psychological therapy is unclear. The risk of adverse events with acupuncture is also unclear, as most trials did not report adverse events adequately. Few studies included follow-up periods or assessed important outcomes such as quality of life. High-quality randomised controlled trials are urgently needed to examine the clinical efficacy and acceptability of acupuncture, as well as its effectiveness, compared with acupuncture controls, medication, or psychological therapies.

Acupuncture for symptomatic gastroparesis.

BACKGROUND: Gastroparesis, a state of delayed gastric emptying in the absence of mechanical obstruction of the stomach, has a substantial impact on people's daily function and quality of life when symptomatic. Current treatment options are based on limited evidence of benefits. Acupuncture is widely used to manage gastrointestinal disorders, although its role in people with symptomatic gastroparesis is unclear. We therefore undertook a systematic review of the evidence. OBJECTIVES: To assess the benefits and harms of acupuncture, in comparison with no treatment, sham acupuncture, conventional medicine, standard care, or other non-pharmacological active interventions for symptom management in people with gastroparesis. SEARCH METHODS: On 26 March 2018, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL Plus, PsycINFO, AMED, Korean medical databases (including Korean Studies Information, DBPIA, Korea Institute of Science and Technology Information, Research Information Centre for Health Database, KoreaMed, and the National Assembly Library), and Chinese databases (including the China Academic Journal). We also searched two clinical trials registries for ongoing trials. We imposed no language limitations. SELECTION CRITERIA: We selected all randomised controlled trials comparing the penetrating type of acupuncture with no treatment, sham acupuncture, conventional medicine, standard care, and other non-pharmacological active interventions for people with symptomatic gastroparesis of any aetiology (i.e. surgical, diabetic, or idiopathic). Trials reporting outcomes at least four weeks from baseline (short-term outcomes) were eligible. We defined long-term outcomes as those measured after 12 weeks from baseline. The primary outcome was improvement of gastroparesis symptoms in the short term. Secondary outcomes were: improvement of symptoms measured after three months, change in the rate of gastric emptying, quality of life, use of medication, and adverse events in the short and long term. DATA COLLECTION AND ANALYSIS: Two review authors independently selected eligible trials based on predefined selection criteria. Two review authors independently extracted data and evaluated the risk of bias. The review authors contacted investigators to obtain missing information wherever possible. MAIN RESULTS: We included 32 studies that involved a total of 2601 participants. Acupuncture was either manually stimulated (24 studies) or electrically stimulated (8 studies). The aetiology of gastroparesis was diabetes (31 studies) or surgery (1 study). All studies provided data on the proportion of people with symptoms 'improved', although the definition or categorisation of improvement varied among the studies. Most measured only short-term outcomes (28 studies), and only one study employed validated instruments to assess subjective changes in symptoms or reported data on quality of life or the use of medication. Reporting of harm was incomplete; minor adverse events were reported in only seven trials. Most studies had unclear risk of bias in terms of allocation concealment (29/32), outcome assessor blinding (31/32) and selective reporting (31/32), as well as high risk of bias in terms of participant/personnel blinding (31/32). Acupuncture was compared with sham acupuncture (needling on non-acupuncture points), three different types of gastrokinetic drugs (domperidone, mosapride, cisapride), and a histamine H2 receptor antagonist (cimetidine).There was low-certainty evidence that symptom scores of participants receiving acupuncture did not differ from those of participants receiving sham acupuncture at three months when measured by a validated scale.There was very low-certainty evidence that a greater proportion of participants receiving acupuncture had 'improved' symptoms in the short term compared to participants who received gastrokinetic medication (4 to 12 weeks) (12 studies; 963 participants; risk ratio (RR) 1.25; 95% confidence interval (CI) 1.17 to 1.33, I² = 8%). Short-term improvement in overall symptom scores favouring acupuncture was also reported in five studies with considerable heterogeneity.Acupuncture in combination with other treatments, including gastrokinetics, non-gastrokinetics and routine care, was compared with the same treatment alone. There was very low-certainty evidence in favour of acupuncture for the proportion of participants with 'improved' symptoms in the short term (4 to 12 weeks) (17 studies; 1404 participants; RR 1.22; 95% CI 1.16 to 1.28; I² = 0%). Short-term improvement in overall symptom scores, favouring acupuncture, were also reported (two studies, 132 participants; MD -1.96, 95% CI -2.42 to -1.50; I² = 0%).Seven studies described adverse events, including minor bleeding and hematoma, dizziness, xerostomia, loose stool, diarrhoea, abdominal pain, skin rash and fatigue. The rest of the trials did not report whether adverse events occurred.Subgroup analyses revealed that short-term benefits in terms of the proportion of people with 'improved' symptoms did not differ according to the type of acupuncture stimulation (i.e. manual or electrical). The sensitivity analysis revealed that use of a valid method of random sequence generation, and the use of objective measurements of gastric emptying, did not alter the overall effect estimate in terms of the proportion of people with 'improved' symptoms. The asymmetric funnel plot suggests small study effects and publication bias towards positive reporting. AUTHORS' CONCLUSIONS: There is very low-certainty evidence for a short-term benefit with acupuncture alone or acupuncture combined with gastrokinetic drugs compared with the drug alone, in terms of the proportion of people who experienced improvement in diabetic gastroparesis. There is evidence of publication bias and a positive bias of small study effects. The reported benefits should be interpreted with great caution because of the unclear overall risk of bias, unvalidated measurements of change in subjective symptoms, publication bias and small study reporting bias, and lack of data on long-term outcomes; the effects reported in this review may therefore differ significantly from the true effect. One sham-controlled trial provided low-certainty evidence of no difference between real and sham acupuncture in terms of short-term symptom improvement in diabetic gastroparesis, when measured by a validated scale. No studies reported changes in quality of life or the use of medication.Due to the absence of data, no conclusion can be made regarding effects of acupuncture on gastroparesis of other aetiologies. Reports of harm have remained largely incomplete, precluding assessments of the safety of acupuncture in this population. Future research should focus on reducing the sources of bias in the trial design as well as transparent reporting. Harms of interventions should be explicitly reported.

Acupuncture and related interventions for the treatment of symptoms associated with carpal tunnel syndrome.

BACKGROUND: Carpal tunnel syndrome (CTS) is a compressive neuropathic disorder at the level of the wrist. Acupuncture and other methods that stimulate acupuncture points, such as electroacupuncture, auricular acupuncture, laser acupuncture, moxibustion, and acupressure, are used in treating CTS. Acupuncture has been recommended as a potentially useful treatment for CTS, but its effectiveness remains uncertain. We used Cochrane methodology to assess the evidence from randomised and quasi-randomised trials of acupuncture for symptoms in people with CTS. OBJECTIVES: To assess the benefits and harms of acupuncture and acupuncture-related interventions compared to sham or active treatments for the management of pain and other symptoms of CTS in adults. SEARCH METHODS: On 13 November 2017, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, AMED, CINAHL Plus, DARE, HTA, and NHS EED. In addition, we searched six Korean medical databases, and three Chinese medical databases from inception to 30 April 2018. We also searched clinical trials registries for ongoing trials. SELECTION CRITERIA: We included randomised and quasi-randomised trials examining the effects of acupuncture and related interventions on the symptoms of CTS in adults. Eligible studies specified diagnostic criteria for CTS. We included outcomes measured at least three weeks after randomisation. The included studies compared acupuncture and related interventions to placebo/sham treatments, or to active interventions, such as steroid nerve blocks, oral steroid, splints, non-steroidal anti-inflammatory drugs (NSAIDs), surgery and physical therapy. DATA COLLECTION AND ANALYSIS: The review authors followed standard Cochrane methods. MAIN RESULTS: We included 12 studies with 869 participants. Ten studies reported the primary outcome of overall clinical improvement at short-term follow-up (3 months or less) after randomisation. Most studies could not be combined in a meta-analysis due to heterogeneity, and all had an unclear or high overall risk of bias.Seven studies provided information on adverse events. Non-serious adverse events included skin bruising with electroacupuncture and local pain after needle insertion. No serious adverse events were reported.One study (N = 41) comparing acupuncture to sham/placebo reported change on the Boston Carpal Tunnel Questionnaire (BCTQ) Symptom Severity Scale (SSS) at three months after treatment (mean difference (MD) -0.23, 95% confidence interval (CI) -0.79 to 0.33) and the BCTQ Functional Status Scale (FSS) (MD -0.03, 95% CI -0.69 to 0.63), with no clear difference between interventions; the evidence was of low certainty. The only dropout was due to painful acupuncture. Another study of acupuncture versus placebo/sham acupuncture (N = 111) provided no usable data.Two studies assessed laser acupuncture versus sham laser acupuncture. One study (N = 60), which was at low risk of bias, provided low-certainty evidence of a better Global Symptom Scale (GSS) score with active treatment at four weeks after treatment (MD 7.46, 95% CI 4.71 to 10.22; range of possible GSS scores is 0 to 50) and a higher response rate (risk ratio (RR) 1.59, 95% CI 1.14 to 2.22). No serious adverse events were reported in either group. The other study (N = 25) did not assess overall symptom improvement.One trial (N = 77) of conventional acupuncture versus oral corticosteroids provided very low-certainty evidence of greater improvement in GSS score (scale 0 to 50) at 13 months after treatment with acupuncture (MD 8.25, 95% CI 4.12 to 12.38) and a higher responder rate (RR 1.73, 95% CI 1.22 to 2.45). Change in GSS at two weeks or four weeks after treatment showed no clear difference between groups. Adverse events occurred in 18% of the oral corticosteroid group and 5% of the acupuncture group (RR 0.29, 95% CI 0.06 to 1.32). One study comparing electroacupuncture and oral corticosteroids reported a clinically insignificant difference in change in BCTQ score at four weeks after treatment (MD -0.30, 95% CI -0.71 to 0.10; N = 52).Combined data from two studies comparing the responder rate with acupuncture versus vitamin B12, produced a RR of 1.16 (95% CI 0.99 to 1.36; N = 100, very low-certainty evidence). No serious adverse events occurred in either group.One study of conventional acupuncture versus ibuprofen in which all participants wore night splints found very low-certainty evidence of a lower symptom score on the SSS of the BCTQ with acupuncture (MD -5.80, 95% CI -7.95 to -3.65; N = 50) at one month after treatment. Five people had adverse events with ibuprofen and none with acupuncture.One study of electroacupuncture versus night splints found no clear difference between the groups on the SSS of the BCTQ (MD 0.14, 95% CI -0.15 to 0.43; N = 60; very low-certainty evidence). Six people had adverse events with electroacupuncture and none with splints. One study of electroacupuncture plus night splints versus night splints alone presented no difference between the groups on the SSS of the BCTQ at 17 weeks (MD -0.16, 95% CI -0.36 to 0.04; N = 181, low-certainty evidence). No serious adverse events occurred in either group.One study comparing acupuncture plus NSAIDs and vitamins versus NSAIDs and vitamins alone showed no clear difference on the BCTQ SSS at four weeks (MD -0.20, 95% CI -0.86 to 0.46; very low-certainty evidence). There was no reporting on adverse events. AUTHORS' CONCLUSIONS: Acupuncture and laser acupuncture may have little or no effect in the short term on symptoms of CTS in comparison with placebo or sham acupuncture. It is uncertain whether acupuncture and related interventions are more or less effective in relieving symptoms of CTS than corticosteroid nerve blocks, oral corticosteroids, vitamin B12, ibuprofen, splints, or when added to NSAIDs plus vitamins, as the certainty of any conclusions from the evidence is low or very low and most evidence is short term. The included studies covered diverse interventions, had diverse designs, limited ethnic diversity, and clinical heterogeneity. High-quality randomised controlled trials (RCTs) are necessary to rigorously assess the effects of acupuncture and related interventions upon symptoms of CTS. Based on moderate to very-low certainty evidence, acupuncture was associated with no serious adverse events, or reported discomfort, pain, local paraesthesia and temporary skin bruises, but not all studies provided adverse event data.

An assessment of the use of complementary and alternative medicine by Korean people using an adapted version of the standardized international questionnaire (I-CAM-QK): a cross-sectional study of an internet survey.

BACKGROUND: In Korea, there are two types of medical doctors: one practises conventional medicine (hereafter called a physician), and the other practises traditional medicine (hereafter called a Korean medical doctor). This study aimed to compare the provision of complementary and alternative medicine (CAM) by these providers to CAM use per self-judgement in Korea. METHODS: We analysed 1668 Korean people via an internet survey with the Korean adopted version of the I-CAM-Q, namely, the International Questionnaire to measure use of CAM, to understand whether respondents used CAM based either on a prescription or advice from a physician or a Korean medical doctor or on self-judgement. RESULTS: In the previous 12 months, the proportions of respondents who were treated by a physician, who were treated by a Korean medical doctor and who were not treated by anyone were 67.9, 20.7 and 14.2%, respectively. Among the respondents who received CAM based on a prescription or advice from a physician, traditional Korean medicine practices and dietary supplements were commonly used; only a small percentage used other CAM therapies. Respondents who received CAM based on a prescription or advice from a Korean medical doctor showed similar results. Acupuncture and moxibustion, traditional Korean medicines (decoction), or cupping were more commonly used. Korean traditional medicines as over-the-counter (OTC) drugs were more commonly used by respondents who received CAM therapy based on a prescription or advice from a physician than by those who received CAM therapy based on a prescription or advice from a Korean medical doctor. A total of 74% of the responders used any CAM by self-judgement in the previous 12 months. CONCLUSIONS: For the use of CAM in Korea, in addition to the Korean traditional medical care provided by Korean medical doctors, general physicians advised people regarding Korean traditional medical care and dietary supplements.

Anti-adipogenic effects of the traditional herbal formula Dohongsamul-tang in 3T3-L1 adipocytes.

BACKGROUND: Blood stasis syndrome (BSS) is a general pattern identification and refers to pathological stagnation of blood circulation, dysfunction of endothelial cells or metabolic disorder in traditional Korean medicine (TKM). Dohongsamul-Tang (DHSMT) is a well-known traditional herbal formula which used for treatment and prevention of BSS by promoting blood circulation in TKM. METHODS: Cytotoxicity of DHSMT was examined by cell counting kit-8 (CCK-8). We also investigated the anti-adipogenesis effect of DHSMT by using Oil Red O staining, intracellular triglyceride assay leptin ELISA and western blot analysis in 3T3-L1 adipocytes. In addition, the accumulation of adiponectin, resistin and plasminogen activator inhibitor-1 (PAI-1) were measured by magnetic bead panel kit. RESULTS: Oil Red O staining showed that DHSMT markedly reduced fat accumulation without affecting cell cytotoxicity. DHSMT also significantly decreased accumulation of triglyceride and adipokines such as leptin, adiponectin, resistin and PAI-1 compared with fully differentiated adipocytes. Furthermore, our results found that DHSMT significantly suppressed the adipocyte differentiation by downregulating adipogenic-specific transcriptional factors such as peroxisome proliferator-activated receptor gamma (PPARγ), CCAAT/enhancer binding proteins alpha (C/EBPα) and fatty acid binding protein 4 (FABP4) in adipocytes. CONCLUSIONS: Taken together, our findings provide that DHSMT has potential for treatment and prevention of obesity or MS related to BSS.

Survey of integrative lumbar spinal stenosis treatment in Korean medicine doctors: preliminary data for clinical practice guidelines.

BACKGROUND: Considering that large variations exist amongst practitioners in lumbar disorder management and the significant costs that lumbar disorders incur, determining clinical practice patterns to provide preliminary data for standardization should be given higher priority. Lumbar spinal stenosis (LSS) is commonly treated using integrative non-surgical methods by Korean medicine doctors (KMDs) in Korea, and this is the first study to assess current Korean medicine practice trends for LSS. METHODS: A survey on KMD diagnosis, treatment, prognosis and decision-making in LSS treatment was developed in a 3-step procedure of preliminary drafting, revision based on extramural expert opinion, and final editing. The survey was conducted at the internal conference of a spine-specialty Korean medicine hospital on January 25th, 2015. RESULTS: The response rate was high at 79.19% (n = 118/149). Participants replied that they treated 7.3 ± 6.8 LSS patients/day using a multimodal treatment method consisting of acupuncture, pharmacopuncture, herbal medicine, Chuna manipulation, and electroacupuncture. Acupuncture mainly used Ashi points and MSAT, and pharmacopuncture mainly Shinbaro solution. The most frequently prescribed herbal medicine was Chungpa-jun, and the most commonly applied Chuna techniques were sidelying lumbar extension dysfunction correction technique, and prone lumbosacral joint distraction method. Radiological findings were mainly referred to for diagnosis, and clinical symptoms, age, radiological findings, and medical history were regarded to be important for prognosis. Participants replied that 7.8 ± 3.3 weeks were required for 50% reduction in pain, and 16.1 ± 7.7 weeks for 80% reduction. CONCLUSIONS: These results suggest that KMDs in Korea combine a conventional approach to LSS and a Korean medicine approach to low back pain for integration of empirical- and evidence-based diagnosis and treatment. The findings may contribute in bridging the divide between evidence and clinical practice guidelines for Korean medicine treatment of LSS and real-world clinical practice in future research.

A systematic review and meta-analysis on the effects of yoga on weight-related outcomes.

INTRODUCTION: Overweight and obesity are among the most important modifiable risk factors for chronic diseases and premature death. The aim of this review was to systematically assess and analyze the effects of yoga on weight-related outcomes. METHODS: Medline/PubMed, Scopus, and the Cochrane Library were screened through March 2015 for randomized controlled trials on yoga for weight-related outcomes in the general population or overweight/obese individuals. Risk of bias was assessed using the Cochrane risk of bias tool on the following domains: selection bias, performance bias, detection bias, attrition bias, reporting bias, and other bias. RESULTS: Out of 445 records identified during literature search, 30 trials with a total of 2173 participants were included. No effects on weight, body mass index, body fat percentage or waist circumference were found. In studies with healthy adult participants an effect of yoga compared to usual care was found regarding waist/hip ratio (SMD=--1.00; 95% CI=--1.44, -0.55; p<0.001). In studies with overweight/obese participants only, effects relative to usual care were found for body mass index (SMD=-0.99; 95% CI=-1.67, -0.31; p=0.004). Effects however were not robust against selection bias; and publication bias could not be ruled out. No intervention-related adverse events were reported. CONCLUSIONS: Despite methodological drawbacks, yoga can be preliminarily considered a safe and effective intervention to reduce body mass index in overweight or obese individuals.

Cordycepin Suppresses Thymic Stromal Lymphopoietin Expression via Blocking Caspase-1 and Receptor-Interacting Protein 2 Signaling Pathways in Mast Cells.

Cordycepin (3'-deoxyadenosine) is one of the active components isolated from Cordyceps militaris, and has been shown to have anti-inflammatory, anti-oxidant, anti-aging, and anti-cancer effects. Mast cell-derived thymic stromal lymphopoietin (TSLP) plays an important role in the pathogenesis of allergic inflammatory reactions. Here, we investigated the regulatory effect and mechanisms of cordycepin on the expression of TSLP in the human mast cell line, HMC-1 cells, and in the human keratinocyte cell line, HaCaT cells. Cordycepin significantly decreased the production and mRNA expression of TSLP through the inhibition of caspase-1 and nuclear factor-κB activation. Cordycepin also significantly reduced the phosphorylation of receptor-interacting protein 2 and inhibitory kappa B (IκB) kinase ß. Cordycepin significantly decreased the production and mRNA expression of interleukin (IL)-8, IL-1ß, IL-6, and tumor necrosis factor-α in activated HMC-1 cells. Moreover, cordycepin significantly decreased the levels of TSLP in activated HaCaT cells. Our studies suggest that cordycepin can be applied to the treatment of allergic inflammatory diseases exacerbated by TSLP.

Acupuncture and related interventions for symptoms of chronic kidney disease.

BACKGROUND: People living with chronic kidney disease (CKD) experience a range of symptoms and often have complex comorbidities. Many pharmacological interventions for people with CKD have known risks of adverse events. Acupuncture is widely used for symptom management in patients with chronic diseases and in other palliative care settings. However, the safety and efficacy of acupuncture for people with CKD remains largely unknown. OBJECTIVES: We aimed to evaluate the benefits and harms of acupuncture, electro-acupuncture, acupressure, moxibustion and other acupuncture-related interventions (alone or combined with other acupuncture-related interventions) for symptoms of CKD. In particular, we planned to compare acupuncture and related interventions with conventional medicine, active non-pharmacological interventions, and routine care for symptoms of CKD. SEARCH METHODS: We searched the Cochrane Kidney and Transplant Specialised Register up to 28 January 2016 through contact with the Information Specialist using search terms relevant to this review. We also searched Korean medical databases (including Korean Studies Information, DBPIA, Korea Institute of Science and Technology Information, Research Information Centre for Health Database, KoreaMed, the National Assembly Library) and Chinese databases (including the China Academic Journal). SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs that investigated the effects of acupuncture and related point-stimulation interventions with or without needle penetration that involved six sessions or more in adults with CKD stage 3 to 5, regardless of the language and type of publication. We excluded studies that used herbal medicine or co-interventions administered unequally among the study groups. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data and assessed risk of bias. We calculated the mean difference (MD) or standardised mean difference (SMD) with 95% confidence intervals (CI) for continuous outcomes and risk ratio (RR) for dichotomous outcomes. Primary outcomes were changes in pain and depression, and occurrence of serious of adverse events. MAIN RESULTS: We included 24 studies that involved a total of 1787 participants. Studies reported on various types of acupuncture and related interventions including manual acupuncture and acupressure, ear acupressure, transcutaneous electrical acupuncture point stimulation, far-infrared radiation on acupuncture points and indirect moxibustion. CKD stages included pre-dialysis stage 3 or 4 and end-stage kidney disease on either haemodialysis or peritoneal dialysis.None of the included studies assessed pain outcomes, nor formally addressed occurrence of serious adverse events, although three studies reported three participant deaths and three hospitalisations as reasons for attrition. Three studies reported minor acupuncture-related harms; the remainder did not report if those events occurred.All studies were assessed at high or unclear risk of bias in terms of allocation concealment. Seventeen studies reported outcomes measured for only two months.There was very low quality of evidence that compared with routine care, manual acupressure reduced scores of the Beck Depression Inventory score (scale from 0 to 63) (3 studies, 128 participants: MD -4.29, 95% CI -7.48 to -1.11, I(2) = 0%), the revised Piper Fatigue Scale (scale from 0 to 10) (3 studies, 128 participants: MD -1.19, 95% CI -1.77 to -0.60, I(2) = 0%), and the Pittsburgh Sleep Quality Index (scale from 0 to 21) (4 studies, 180 participants: MD -2.46, 95% CI -4.23 to -0.69, I(2) = 50%).We were unable to perform further meta-analyses because of the paucity of data and problems with clinical heterogeneity, such as different interventions, comparisons and timing of outcome measurements. AUTHORS' CONCLUSIONS: There was very low quality of evidence of the short-term effects of manual acupressure as an adjuvant intervention for fatigue, depression, sleep disturbance and uraemic pruritus in patients undergoing regular haemodialysis. The paucity of evidence indicates that there is little evidence of the effects of other types of acupuncture for other outcomes, including pain, in patients with other stages of CKD. Overall high or unclear risk of bias distorts the validity of the reported benefit of acupuncture and makes the estimated effects uncertain. The incomplete reporting of acupuncture-related harm does not permit us to assess the safety of acupuncture and related interventions. Future studies should investigate the effects and safety of acupuncture for pain and other common symptoms in patients with CKD and those undergoing dialysis.

Long term follow-up of cervical intervertebral disc herniation inpatients treated with integrated complementary and alternative medicine: a prospective case series observational study.

BACKGROUND: Symptomatic cervical intervertebral disc herniation (IDH) presenting as neck pain accompanied by arm pain is a common affliction whose prevalence continues to rise, and is a frequent reason for integrative inpatient care using complementary and alternative medicine (CAM) in Korea. However, studies on its long term effects are scarce. METHODS: A total 165 patients with cervical IDH admitted between January 2011 and September 2014 to a hospital that provides conventional and Korean medicine integrative treatment with CAM as the main modality were observed in a prospective observational study. Patients underwent CAM treatment administered by Korean medicine doctors (KMDs) in accordance with a predetermined protocol for the length of hospital stay, and additional conventional treatment by medical doctors (MDs) as referred by KMDs. Short term outcomes were assessed at discharge and long term follow-ups were conducted through phone interviews after discharge. Numeric rating scale (NRS) of neck and radiating arm pain, neck disability index (NDI), 5-point patient global impression of change (PGIC), and factors influencing long term satisfaction rates in PGIC were assessed. RESULTS: Of 165 patients who received inpatient treatment 20.8 ± 11.2 days, 117 completed the long term follow-up up at 625.36 ± 196.7 days post-admission. Difference in NRS between admission and discharge in the long term follow-up group (n = 117) was 2.71 (95% CI, 2.33, 3.09) for neck pain, 2.33 (95% CI, 1.9, 2.77) for arm pain, and that of NDI 14.6 (95% CI, 11.89, 17.32), and corresponding scores in the non-long term follow-up group (n = 48) were 2.83 (95% CI, 2.22, 3.45) for neck pain, 2.48 (95% CI, 1.84, 3.12) for arm pain, and that of NDI was 14.86 (95% CI, 10.41, 19.3). Difference in long term NRS of neck pain and arm pain from baseline was 3.15 (95% CI, 2.67, 3.64), and 2.64 (95% CI, 1.99, 3.29), respectively. PGIC was reported to be "satisfactory" or higher in 79.5% of patients at long term follow-up. CONCLUSIONS: Though the observational nature of this study limits us from drawing a more decisive conclusion, these results suggest that integrative treatment focused on CAM in cervical IDH inpatients may achieve favorable results in pain and functional improvement. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02257723. Registered October 2, 2014.

Moxibustion for the treatment of chemotherapy-induced leukopenia: a systematic review of randomized clinical trials.

PURPOSE: The purpose of this study is to assess the efficacy of moxibustion as a treatment of chemotherapy-induced leukopenia. METHODS: Twelve databases were searched from their inception through June 2014, without a language restriction. Randomized clinical trials (RCTs) were included if moxibustion was used as the sole treatment or as a part of a combination therapy with conventional drugs for leukopenia induced by chemotherapy. Cochrane criteria were used to assess the risk of bias. RESULTS: Six RCTs with a total of 681 patients met our inclusion criteria. All of the included RCTs were associated with a high risk of bias. The trials included patients with various types of cancer receiving ongoing chemotherapy or after chemotherapy. The results of two RCTs suggested the effectiveness of moxibustion combined with chemotherapy vs. chemotherapy alone. In four RCTs, moxibustion was more effective than conventional drug therapy. Six RCTs showed that moxibustion was more effective than various types of control interventions in increasing white blood cell counts. CONCLUSIONS: There is low level of evidence based on these six trials that demonstrates the superiority of moxibustion over drug therapies in the treatment of chemotherapy-induced leukopenia. However, the number of trials, the total sample size, and the methodological quality are too low to draw firm conclusions. Future RCTs appear to be warranted.