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Abstract Background Appropriately defining and using the minimal important change (MIC) and the minimal clinically important difference (MCID) are crucial for determining whether the results are clinically significant. The aim of this study is to survey the status of randomized controlled trials (RCTs) for insomnia interventions to assess the inclusion and interpretation of MIC/MCID values. Methods We conducted a cross-sectional study to survey the status of RCTs for insomnia interventions to assess the inclusion and appropriate interpretation of MIC/MCID values. A literature search was conducted by searching the main sleep medicine journals indexed in PubMed, the Excerpta Medica Database (EMBASE), and the Cochrane Central Register of Controlled Trials (CENTRAL) to identify a broad range of search terms. We included RCTs with no restriction on the intervention. The included studies used the Insomnia Severity Index (ISI) or the Pittsburgh Sleep Quality Index (PSQI) questionnaire as the outcome measures. Results 81 eligible studies were identified, and more than one-third of the included studies used MIC/MCID (n = 31, 38.3%). Among them, 21 studies with ISI as the outcome used MIC defined as a relative decrease ranging from 3 to 8 points. The most frequently used MIC value was a 6-point decrease (n = 7), followed by 8-point (n = 6) and 7-point decrease (n = 4), a 4 to 5-points decrease (n = 3), and a 30% reduction from baseline; 6 studies used MCID values, ranging from 2.8 to 4 points. The most frequently used MCID value was a 4-point decrease in the ISI (n = 4). 4 studies with PSQI as the outcome used a 3-point change as the MIC (n = 2) and a 2.5 to 2.7-point difference as MCID (n = 2). 4 non-inferiority design studies considered interval estimation when drawing clinically significant conclusions in their MCID usage. Conclusions The lack of consistent MIC/MCID interpretation and usage in outcome measures for insomnia highlights the urgent need for further efforts to address this issue and improve reporting practices.

Background Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has posed a significant burden on affected individuals and healthcare systems. While pharmacological treatments are commonly used, non-pharmacological management strategies have gained attention for their potential benefits in improving CP/CPPS symptoms. However, the comparative efficacy of these non-pharmacological interventions remains unclear. The aim of this study is to assess the comparative effectiveness of non-pharmacological interventions for CP/CPPS regarding prostatic symptoms.Method This systematic review and network meta-analysis will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A comprehensive search will be conducted in electronic databases, including PubMed, Embase, Cochrane Library and Web of Science, to identify relevant studies. Eligible studies will include randomised controlled trials investigating non-pharmacological management strategies for CP/CPPS. Two independent reviewers will screen the retrieved citations, extract data and assess the risk of bias. Data synthesis will involve performing a network meta-analysis to compare the efficacy of different non-pharmacological interventions while considering both direct and indirect evidence.Ethics and dissemination The review does not require ethical approval. The findings of the review will be disseminated through publication in an academic journal, presentations at conferences and various media outlets.PROSPERO registration number CRD42024506143.

This paper aims to present a Statistical Analysis Software (SAS) macro %BBIplus, offering estimation and visualisation methods for the Bang’s Blinding Index (BBI) for randomised controlled trials (RCTs) with various designs. We developed the SAS macro programme %BBIplus to facilitate the implementation of BBI. This user-friendly programme allows for easy and rapid estimation and visualisation of BBI across different scenarios, including pairwise comparison RCTs with two arms, double-dummy design RCTs with three arms and factorial design RCTs with four arms. The programme requires no pre-existing data set, and users only need to input the number of individuals of correct, uncertain or wrong guesses in each intervention or control group. We illustrate the functionality of %BBIplus using blinding assessment data from three previously published RCTs: BBR (adjunctive berberine reduces antipsychotic-associated weight gain and metabolic syndrome in patients with schizophrenia: a randomised controlled trial), SELECT-TDCS (the sertraline versus electrical current therapy for treating depression clinical study: results from a factorial, randomised controlled trial) and ELECT-TDCS (trial of electrical direct-current therapy versus escitalopram for depression) studies. The programme estimates the BBI for each arm, providing point estimates, 95% CI and associated p values. Additionally, %BBIplus can visualise the estimations through forest plots and make the judgement for the success of blinding easily and rapidly. This tool caters to the needs of clinical trial investigators, offering a comprehensive solution for estimating and visualising the blinding index under various RCT designs.

Abstract Background Premature Ventricular Complexes (PVCs) are very common in clinical practice, with frequent PVCs (more than 30 beats per hour) or polymorphic PVCs significantly increasing the risk of mortality. Previous studies have shown that vagus nerve stimulation improves ventricular arrhythmias. Stimulation of the auricular distribution of the vagus nerve has proven to be a simple, safe, and effective method to activate the vagus nerve. Transcutaneous au ricular vagus nerve stimulation (taVNS) has shown promise in both clinical and experimental setting for PVCs; however, high-quality clinical studies are lacking, resulting in insufficient evidence of efficacy. Methods The study is a prospective, randomized, parallel-controlled trial with a 1:1 ratio between the two groups. Patients will be randomized to either the treatment group (taVNS) or the control group (Sham-taVNS) with a 6-week treatment and a subsequent 12-week follow-up period. The primary outcome is the proportion of patients with a ≥ 50% reduction in the number of PVCs monitored by 24-hour Holter. Secondary outcomes include the proportion of patients with a ≥ 75% reduction in PVCs, as well as the changes in premature ventricular beats, total heartbeats, and supraventricular premature beats recorded by 24-hour Holter. Additional assessments compared score changes in PVCs-related symptoms, as well as the score change of self-rating anxiety scale (SAS), self-rating depression scale (SDS), and 36-item short form health survey (SF-36). Discussion The TASC-V trial will help to reveal the efficacy and safety of taVNS for frequent PVCs, offering new clinical evidence for the clinical practice. Trial registration Clinicaltrials.gov: NCT04415203 (Registration Date: May 30, 2020).

Abstract Background Hot flashes are the common and debilitating symptom among prostate cancer (PCa) patients undergoing androgen deprivation therapy (ADT). Strong evidence from multiple rigorously designed studies indicated that pharmacological option such as venlafaxine provides partial relief, but the tolerability is poor when dose is not tapered. Hence, alternative therapy is needed. Previous studies reported that acupuncture may be helpful in the management of hot flashes. However, the insufficient randomized controlled trial limited the quality of evidence. Methods Five hospitals will recruit 120 acupuncture naïve patients with moderate-to-severe hot flashes after prostate cancer received ADT in China from February 2023 to December 2024. Participants will be randomly 2:1:1 allocated to the 18 sessions of verum acupuncture at true acupuncture points plus usual care, 18 sessions of non-penetrating sham acupuncture at non-acupuncture points plus usual care, or usual care alone over 6 weeks. The primary outcome measure is the change of mean weekly hot flashes symptom severity score (HFSSS) at the end of treatment compared with baseline. Expected Results and Conclusion We will be able to measure the effectiveness of acupuncture for patients with PCa suffering from ADT-induced hot flashes and whether acupuncture is superior to sham acupuncture and usual care. The proposed acupuncture treatment might provide an alternative option for those patients. Trial Registration Clinicaltrials.gov (NCT05069467).

Abstract Background Insomnia is a highly prevalent symptom occurred during and post-chemotherapy. Acupuncture may have beneficial effects in the management of chemotherapy-associated insomnia. This study was conducted to determine the efficacy and safety of acupuncture in improving chemotherapy-associated insomnia in breast cancer patients. Methods This assessor-participant blinded, randomized, sham-controlled trial was conducted from November 2019 to January 2022 (follow-up completed July 2022). Participants were referred by oncologists from two Hong Kong hospitals. Assessments and interventions were conducted at the outpatient clinic of School of Chinese Medicine, the University of Hong Kong. The 138 breast cancer patients with chemotherapy-associated insomnia were randomly assigned to receive either 15 sessions of active acupuncture regimen by combining needling into body acupoints and acupressure on auricular acupoints or sham acupuncture control (69 each) for 18 weeks, followed by 24 weeks of follow-up. The primary outcome was measured using Insomnia Severity Index (ISI). Secondary outcomes included the Pittsburgh Sleep Quality Index, Actiwatch and sleep diary for sleep parameters, depression and anxiety, fatigue and pain, and quality of life. Results There were 87.7% (121/138) participants who completed the primary endpoint (week-6). The active acupuncture regimen was not superior to the sham control in reducing ISI score from baseline to 6 weeks (mean difference: − 0.4, 95% CI − 1.8–1.1; P = 0.609), but produced short-term treatment and long-term follow-up better outcomes in improving sleep onset latency, total sleep time, sleep efficiency, anxiety, depression, and quality of life. Participants of the active acupuncture group had a pronouncedly higher cessation rate of sleeping medications than the sham control (56.5% vs. 14.3%, P = 0.011). All treatment-related adverse events were mild. No participants discontinued treatments due to adverse events. Conclusion The active acupuncture regimen could be considered as an effective option for the management of chemotherapy-associated insomnia. It also could serve as a tapering approach to reduce and even replace the use of sleeping medications in breast cancer patients. Trial registration Clinicaltrials.gov : NCT04144309. Registered 30 October 2019.

Abstract Objectives Neuroinflammation has been suggested that affects the processing of depression. There is renewed interest in berberine owing to its anti-inflammatory effects. Herein, we investigated whether berberine attenuate depressive-like behaviors via inhibiting NLRP3 inflammasome activation in mice model of depression. Methods Adult male C57BL/6N mice were administrated corticosterone (CORT, 20 mg/kg/day) for 35 days. Two doses (100 mg/kg/day and 200 mg/kg/day) of berberine were orally administrated from day 7 until day 35. Behavioral tests were performed to measure the depression-like behaviors alterations. Differentially expressed gene analysis was performed for RNA-sequencing data in the prefrontal cortex. NLRP3 inflammasome was measured by quantitative reverse transcription polymerase chain reaction, western blotting, and immunofluorescence labeling. The neuroplasticity and synaptic function were measured by immunofluorescence labeling, Golgi–Cox staining, transmission electron microscope, and whole-cell patch-clamp recordings. Results The results of behavioral tests demonstrated that berberine attenuated the depression-like behaviors induced by CORT. RNA-sequencing identified that NLRP3 was markedly upregulated after long-term CORT exposure. Berberine reversed the concentrations of peripheral and brain cytokines, NLRP3 inflammasome elicited by CORT in the prefrontal cortex and hippocampus were decreased by berberine. In addition, the lower frequency of neuronal excitation as well as the dendritic spine reduction were reversed by berberine treatment. Together, berberine increases hippocampal adult neurogenesis and synaptic plasticity induced by CORT. Conclusion The anti-depressants effects of berberine were accompanied by reduced the neuroinflammatory response via inhibiting the activation of NLRP3 inflammasome and rescued the neuronal deterioration via suppression of impairments in synaptic plasticity and neurogenesis.

Context: Acupuncture is a promising therapy for relieving symptoms in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), which affects 9–16% of adult men worldwide. Objective: This study aims to explore the efficacy and safety of acupuncture for CP/CPPS. Evidence acquisition: Nine electronic databases were searched. Only randomized controlled trials were included. Two reviewers extracted data and assessed the risk of bias of trials using the revised Cochrane risk-of-bias (RoB 2.0) tool. Stata 17.0 was used to analyze the data. Evidence synthesis: Twelve trials were included. The results of a meta-analysis showed that acupuncture had larger effect sizes (standardized mean difference [SMD] = –1.20, confidence interval or CI [–1.69, –0.71], acupuncture compared with sham acupuncture; SMD = –1.01, CI [–1.63, –0.38], acupuncture compared with medication; SMD = –0.91, CI [–1.29, –0.54], acupuncture plus medication compared with medication) in reducing the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score. In decreasing NIH-CPSI pain domain score, acupuncture also led to larger effect sizes (SMD = –0.94, CI [–1.18, –0.70], acupuncture compared with sham acupuncture; SMD = –1.04, CI [–1.29, –0.79], acupuncture compared with medication; SMD = –0.85, CI [–1.23, –0.48], acupuncture plus medication compared with medication), whereas the effect sizes in the reduction of NIH-CPSI urinary domain and quality of life domain scores were medium. Compared with sham acupuncture and medication, acupuncture appears to be more effective in improving the global response rate. Results from four trials indicated that acupuncture was better than sham acupuncture in decreasing the International Prostate Symptom Score. No serious adverse effects were found in the acupuncture treatment. Conclusions: Current evidence supports acupuncture as an effective treatment for CP/CPPS-induced symptoms, particularly in relieving pain. Comprehensive acupuncture treatment according to individual symptoms should be considered in future clinical practice and trials for CP/CPPS. Patient summary: In this study, we further verified the efficacy of acupuncture in patients with chronic prostatitis/chronic pelvic pain syndrome, especially in reducing pain.

Background The comorbidity of cardiovascular disease (CVD) and depression has been well established, as depression usually presents simultaneously with CVD risk factors. However, the potential association between cumulative exposure to CVD risk and depression remains unclear, so we conducted the current investigation. To our knowledge, this is the first study that employs the cumulative risk model to examine the effect of CVD risk factors on depression using nationally representative population and gender, age and CVD status-stratified subpopulations.Aims To systematically study the possible individual and cumulative effect of 18 CVD risk factors on depression.Methods A cross-sectional, secondary analysis investigated associations between 18 CVD risk factors and depression. The interaction effect between CVD risk factors and age, gender and CVD status was also examined. Enrolment included 20 816 participants from the US National Health and Nutrition Examination Survey 2005–2016. Participants with Patient Health Questionnaire-9 scores over 15 or who were using an antidepressant were considered depressive; 18 known cardiovascular risk factors were incorporated in the present study.Results At the individual risk factor level, smoking, drinking, living alone, sleep quality, body mass index, waist circumference and diabetes status had differential associations with depression risk according to the gender, age or CVD status of the participants. Most importantly, gender-stratified cumulative risk analysis indicated that similar depression risk was found in both genders with a small number of CVD risk factors (odds ratio (OR)adjusted=1.32; 95% confidence interval (CI): 0.87 to 1.99), but females had a significantly higher depression risk compared with males under high cumulative risk exposure (ORadjusted=2.86; 95% CI: 1.79 to 4.59).Conclusions Clarifying the association of numerous CVD risk factors with depression according to gender, age and overall CVD status may be beneficial for risk stratification and the prevention of depression in clinical practice. Moreover, the observed novel evidence of high cumulative risk exposure-mediated gender disparities in depression risk may shed light on the underlying mechanism of females’ greater vulnerability to depression.

Abstract Background In this study, we attempted to assess the efficacy and safety of acupuncture for allergic rhinitis (AR), and to test the robustness of the estimated effects. Methods The Cochrane methodology standard was followed to conduct this systematic review. Randomized controlled trials (RCTs) comparing acupuncture with other therapies for AR were included. Furthermore, trial sequential analysis was conducted to test the robustness of pooled results. Thirty trials with 4413 participants were included. Results Acupuncture improved the nasal symptoms on Total Nasal Symptom Score (TNSS) and quality of life measured by Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in adults with AR, compared to acupuncture with no intervention. Acupuncture was also shown to be more effective than sham acupuncture for nasal symptom (RQLQ subscale, n = 489, MD − 0.60, 95% CI − 1.16 to − 0.04) and quality of life (RQLQ, n = 248, − 8.47 95% CI − 14.91, − 2.03). No clear difference was observed between acupuncture and cetirizine or loratadine. Interestingly, trial sequential analysis (TSA) failed to confirm the aforementioned results. The effect of acupuncture for children/adolescents with AR remains unclear due to insufficient data. The performance bias and attrition bias are serious in most studies that were included. Selection bias may also have affected the quality of the evidence. Conclusion Acupuncture may have an advantage over no intervention and sham acupuncture in improving nasal symptoms and quality of life for adults with AR. The effect of acupuncture and cetirizine or loratadine for AR may be similar. Additional trials are necessary to confirm these results.

Abstract The count of lymph node dissection (LND) has been confirmed as a prognostic indicator in various cancers while the correlation between LND counts and patient prognosis in renal cell carcinoma (RCC) was not fully studied. This research evaluated the link between LND counts and the prognosis of RCC patients. This study obtained RCC patients from the SEER database between 2010 and 2014. Univariate and multivariate Cox regression analyses were used to assess the predictive and prognostic value of LND. Besides, Kaplan–Meier (KM) survival analysis was used for survival analysis. Finally, 1264 patients were included in this study, which were divided into none LND groups (249), 1–3 LND groups (166), and 4 or more LND groups (549). Age, laterality, stage, M stage, and grade were statistically different among the three groups. In univariate Cox analysis, stage, M stage, T stage, and grade were significantly correlated with overall survival (OS). In multivariate Cox regression analysis, age, race, stage, T stage, and grade were used as independent prognostic factors. KM survival analysis revealed that grade, T stage, M stage, and stage were significantly correlated with OS. Subgroup analysis revealed that LND counts were not significantly associated with survival risk in subgroups with different clinical factors. The current North American population analysis revealed that age, race, stage, T stage, and grade may be used as independent prognostic factors for patients with RCC. Moreover, the increasing LND counts during surgery may not improve the tumor outcomes of RCC patients.

BackgroundDepression accompanying chronic pain (CP) is one of the most common comorbid psychiatric disorders. This study aimed to investigate the effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) combined with electroacupuncture at Baihui (GV20) and Yintang (GV29) acupoints compared with citalopram.MethodsSixty patients with depression and pain comorbidity were enrolled in a prospective 8-week, single-blind, randomized controlled trial. Participants were randomly assigned to receive either taVNS combined with electroacupuncture treatment (taVNS: 8 weeks, 3 sessions per week; electroacupuncture: 8 weeks, twice per day, no drugs) or citalopram treatment (8 weeks, 40 mg/day). The primary outcome was Montgomery–Åsberg Depression Rating Scale (MADRS). The secondary endpoints were evaluated using the McGill Pain Questionnaire (SF-MPQ), self-reported 36-Item Short Form Survey (SF-36), Pittsburgh Sleep Quality Index (PSQI), Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Scale (HAMA).ResultsBoth the taVNS combined with electroacupuncture and citalopram groups had significant reductions in depressive and pain symptoms, as indicated by the decrease in MARDS and SF-MPQ scores. Regarding the analgesic effect, the pain intensity score of the SF-MPQ showed a larger reduction with citalopram than with taVNS combined with electroacupuncture at 6 weeks (P = 0.036). The reduction in the BP score of the SF-36 was higher at week 4 (P = 0.000), with no significant difference observed at week 8 (P = 0.1110). This result indicated that the pain intensity can be improved rapidly with citalopram compared with taVNS combined with electroacupuncture. Similarly, the comparison of PSQI scores at 4, 6, and 8 weeks indicates that there was no significant difference between groups, except in the use of sleeping medications. At week 6, higher medication use was found in the citalopram group than in the taVNS combined with electroacupuncture group (P = 0.049).ConclusionIn summary, compared with citalopram, taVNS combined with electroacupuncture produces similar positive effects on depressive and pain symptoms in patients with depression and chronic pain, which last for at least 8 weeks.

Summary: Background: Pharmacological treatments for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) are empirically used. However, the quantitative comparative effectiveness and safety of multiple pharmacological treatments is lacking. Methods: PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science were searched from inception to March 22, 2022. Randomised controlled trials comparing two or more oral pharmacological treatments for patients with CP/CPPS were included. Title, abstract, and full-text screening were independently screened by four reviewers. Primary outcomes were efficacy (the National Institutes of Health Chronic Prostatitis Symptom Index [NIHCPSI] total score, pain score, urinary score, and quality of life score [QoL]) and safety (adverse events). This study was registered with PROSPERO, CRD42020184106. Findings: 25 studies (3514 patients) assessed 26 treatments. Low to very low quality evidence indicated that doxazosin (Mean difference [MD], –11.4, 95% Credible interval [CrI], –17.5 to –5.1) and the doxazosin, ibuprofen, and thiocolchicoside combination (MD, –11.6, CrI, –18.1 to –5.3) were significantly more effective than placebo in the NIHCPSI total score. Other NIHCPSI relative outcomes (pain, urinary, and QoL scores) showed a similar pattern. Low and very low quality evidence suggested that combination treatment including doxazosin, ibuprofen, and thiocolchicoside (odds ratios [OR], 3.2, CrI, 0.5 to 19.3) and the tamsulosin and dapoxetine combination (OR, 6.0, CrI, 0.7 to 67.3) caused more adverse events. In half of all comparisons regarding NIHCPSI pain scores and quality of life scores, heterogeneity was minimal or low. Heterogeneity was high in both NIHCPSI total symptom scores (I2 = 78.0%) and pain scores (I2 = 87. 0%) for tamsulosin versus placebo. There was also high heterogeneity in NIHCPSI urine scores for the combination of tamsulosin and ciprofloxacin versus tamsulosin (I2 = 66.8%), tamsulosin and levofloxacin versus tamsulosin (I2 = 93.3%), and tamsulosin versus placebo (I2 = 83%). Interpretation: Pharmacological treatments have little evidence supporting efficacy in CP/CPPS. Future studies could personalise therapy for individuals according to specific symptoms and identify non-pharmacological targets for CP/CPPS. Funding: Dr Jiani Wu received funding for this project from the China Association for Science and Technology (2017QNRC001), the China Academy of Chinese Medical Sciences (ZZ13-YQ-027), and the National Natural Science Foundation of China (82105037).

BackgroundPrevious studies in animals and humans indicated that transcutaneous vagus nerve stimulation (tVNS) and transcutaneous electrical acupoint stimulation (TEAS) on trigeminal nerve-innervated forehead acupoints can relief the symptoms of depression. However, due to the limited investigations on these two interventions, more research are needed to confirm their efficacy in depression. To improve the efficacy of the single treatment, we combined two treatments and created a novel non-invasive stimulation, transcutaneous electrical cranial-auricular acupoint stimulation (TECAS). To assess the efficacy and safety of TECAS, we compare it with a selective serotonin reuptake inhibitor (SSRI), escitalopram, for the treatment of depression.Methods/DesignThis is a multi-center, non-inferiority, randomized controlled trial that will involve 470 patients with mild to moderate depression. Patients will be randomly assigned to either the TECAS group or the escitalopram group in a 1:1 ratio. The TEAS group will receive two sessions of treatments per day for 8 consecutive weeks, and the escitalopram group will receive 8 weeks of oral escitalopram tablets prescribed by clinical psychiatrists as appropriate for their condition. The primary outcome is the clinical response as determined by Montgomery-Åsberg Depression Rating Scale (MADRS) scores at week 8, with −10% as the non-inferior margin. The secondary outcomes include the response rate determined by 17-item Hamilton Depression Rating Scale (HAMD-17), remission rate, changes from baseline in the scores on the MADRS, the HAMD-17, the Hamilton Anxiety Rating Scale (HAMA), the Pittsburgh Sleep Quality Index (PSQI), and the Short Form 36 Health Survey (SF-36).DiscussionThis will be the first randomized controlled trial to compare the efficacy of TECAS with escitalopram for depression. If effective, this novel intervention could have significant clinical and research implications for patients with depression.Clinical Trial Registration[ClinicalTrials.gov], identifier [NCT03909217].

Abstract Introduction Neck pain is a common condition that leads to serious pain, disability, and increased healthcare costs worldwide. Pharmacotherapy is one of the most common strategies to reduce neck pain in patients. The aim of this study was to analyze the real-world pattern of drugs prescribed for patients with neck pain in the USA. Methods Data on individuals who reported current neck pain in the 2009−2010 US National Health and Nutrition Examination Survey (NHANES) and with a history of persistent pain for at least 6 weeks or 3 months were extracted from the NHANES database. Those included in the study were divided into three groups based on the duration of pain: the without neck pain group (Group A); subacute group (Group B) with a history of 6 weeks of neck pain; and the chronic neck pain group (Group C) with a history of 3 months of neck pain. The use and duration of medication prescribed for Group A, B, and C patients were compared. Results The analysis revealed that opioid use was significantly more prevalent in the subacute and chronic neck pain group than in the without neck pain group (Group A) (adjusted odds ratio [aOR] 4.20, 95% confidence interval [CI] 2.07–8.52 and aOR 7.00, 95% CI 4.32–11.33, respectively). The factors strongly associated with higher opioid use included older age, low education level, and low family income. In the chronic neck group, opioids, followed in decreasing order of frequency by acetaminophen and nonsteroidal anti-infammatory drugs, were the most common analgesics used in combination with other analgesics. Conclusion Our analysis of the data shows that the long-term excessive use of opioids and the underutilization of other analgesics are two major issues in the treatment of neck pain in the USA. Possible improvements include improved education of patients by healthcare professionals on the use of opioids and more consideration given to non-pharmacotherapy options. Our results reveal the potential problem in pharmacotherapy choices for neck pain treatment and may help improve the current clinical practice in the USA and other countries.

Objective Insomnia is a highly prevalent and disturbing symptom in breast cancer patients under or post chemotherapy. If not appropriately treated, it can persist for years after the completion of cancer treatments. Acupuncture has been widely used for alleviating insomnia. The aim of this study is to examine the feasibility, efficacy and safety of acupuncture for chemotherapy-related insomnia among patients with breast cancer. Materials and Methods This is a trial protocol for a randomized, sham-controlled, subject- and assessor-blinded clinical trial. A total of 138 eligible participants will be assigned randomly to acupuncture or sham control group at a ratio of 1:1. Participants in acupuncture group will receive electroacupuncture (EA) plus auricular acupressure (AA) treatment, while subjects in sham acupuncture group will receive sham EA plus sham AA. Both acupuncture and sham treatments will be given twice weekly for 6 weeks, followed by maintenance treatments once every 4 weeks for 12 weeks (15 sessions totally). The primary outcome is the change of Insomnia Severity Index score between baseline and the end of 6-week treatment. Secondary outcome measurements include Actiwatch, sleep diary, Pittsburgh Sleep Quality Index, Functional Assessment of Cancer Therapy-Breast Cancer, Hospital Anxiety and Depression Scale, Brief Pain Inventory-Short Form, Brief Fatigue Inventory, Acupuncture Expectancy Scale, credibility, and adverse events. Participants will be followed up to 42 weeks. Conclusions This trial will expand our understanding of the feasibility, efficacy, and safety of acupuncture as a treatment for alleviating chemotherapy-related insomnia in patients with breast cancer. EA plus AA, if proven to be effective, can be implemented into routine settings to play a role in insomnia management for patients with breast cancer.

Objective: Chemotherapy-associated insomnia is a highly prevalent complaint in breast cancer patients. This study was undertaken to evaluate the safety, feasibility, and preliminary effectiveness of electroacupuncture plus auricular acupressure for chemotherapy-associated insomnia in patients with breast cancer. Materials and Methods: In this randomized, wait-list controlled trial, thirty breast cancer patients under or post chemotherapy with insomnia were randomly allocated to the acupuncture or wait-list control group. Participants in acupuncture group received electroacupuncture plus auricular acupressure treatment twice weekly for 6 weeks. Participants in wait-list group received the same regimen of treatment after 6-week of waiting period. Insomnia Severity Index (ISI) served as the primary outcome measurement. Secondary outcomes were sleep parameters recorded with sleep diary and actiwatch, as well as the scores of Pittsburgh Sleep Quality Index (PSQI), Hospital Anxiety and Depression Scale (HADS), and Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B). Results: Twenty-eight participants completed study (13 in the acupuncture group vs 15 in the wait-list control group). At week-6 post-intervention, ISI score change from baseline showed significant between-group difference favoring acupuncture group of −2.9 points (95% CI: −5.2 to −0.6, P = .014). The acupuncture group showed greater improvements in the total sleep time recorded by sleep diary ( P = .026), scores of PSQI ( P = .012), HADS-depression ( P = .020), and FACT-B ( P

Background: Cancer is the second leading cause of death before the age of 70. Improved cancer survival has put increasing demands on cancer care. Palliative care is the specialized multi-disciplinary care providing relief from the pain, symptoms, and stress of serious illness. The study aims to evaluate the adjunctive effect of acupuncture for advanced cancer patients in a collaborative model of palliative care. Methods/Design: This is a single-blinded, randomized, sham-controlled trial. One hundred twenty advanced cancer patients undergoing palliative care will be randomized in a ratio of 2:1:1 to manual acupuncture plus standard care group (ASC), sham acupuncture plus standard care group (SSC), and standard care group (SC). Patients in ASC and SSC will receive 9 sessions of acupuncture or sham acupuncture for 3 weeks, and will be followed up for 2 months. The primary measure is the change from baseline score of the Edmonton Symptom Assessment System at 3 weeks. The secondary measures include the Brief Fatigue Inventory, Hospital Anxiety and Depression Scale, Insomnia Severity Index, Numeric Rating Scale, and European Organization for Research and Treatment of Cancer Quality of Life 15 items Questionnaire for Palliative Care. Discussion: The finding of this trial will provide high-quality evidence on the adjunctive effect of acupuncture to standard care on advanced cancer patients undergoing palliative care. Trial Registration: Clinicaltrials.gov, NCT04398875 ( https://www.clinicaltrials.gov/ct2/show/NCT04398875 ), Registered on 21 May 2020.

Abstract Background Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common condition affecting men of all ages. Acupuncture may be an effective treatment option for CP/CPPS, but evidence is limited. We propose to evaluate the effectiveness of acupuncture in a rigorously conducted trial. Methods Ten hospitals will recruit 440 participants with CP/CPPS in China from October 2017 to December 2019. Participants will be randomly allocated to acupuncture or sham acupuncture with a 1:1 ratio using computerized simple random sampling. The whole study consists of 2-week baseline, 8-week treatment, and 24-week follow up. Twenty 30-mintute sessions of acupuncture or sham acupuncture treatment will be provided between week 1 and 8. The two co-primary outcomes are the proportion of responders at week 8 and week 32. Secondary outcomes include proportion of responders in the two groups at different time points; change in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score; change in the NIH-CPSI subscales; change in the International Prostate Symptom Score; change in the Hospital Anxiety and Depression Scale; expectation assessments; proportions of participants in each response category of the Global Response Assessment; change in the International Index of Erectile Function 5; change in the five-level EuroQol five-dimensional questionnaire and a visual analogue scale; and changes in peak and average urinary flow rate. Discussion This study will provide robust evidence on whether acupuncture is effective for relieving symptoms of CP/CPPS. Trials registration ClinicalTrials.gov, NCT03213938. Registered on 5 July 2017.

Poststroke cognitive impairment (PSCI) is a severe sequela of stroke. There are no effective therapeutic options for it. In this study, we evaluated whether electroacupuncture (EA) on the trigeminal nerve-innervated acupoints could alleviate PSCI and identified the mechanisms in an animal model. The male Sprague-Dawley rat middle cerebral artery occlusion (MCAO) model was used in our study. EA was conducted on the two scalp acupoints, EX-HN3 (Yintang) and GV20 (Baihui), innervated by the trigeminal nerve, for 14 sessions, daily. Morris water maze and novel object recognition were used to evaluate the animal’s cognitive performance. Neuroprotection and synaptic plasticity biomarkers were analyzed in brain tissues. Ischemia-reperfusion (I/R) injury significantly impaired spatial and cognition memory, while EA obviously reversed cognitive deterioration to the control level in the two cognitive paradigms. Moreover, EA reversed the I/R injury-induced decrease of brain-derived neurotrophic factor, tyrosine kinase B, N-methyl-D-aspartic acid receptor 1, α-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid receptor, γ-aminobutyric acid type A receptors, Ca2+/calmodulin-dependent protein kinase II, neuronal nuclei, and postsynaptic density protein 95 expression in the prefrontal cortex and hippocampus. These results suggest that EA on the trigeminal nerve-innervated acupoints is an effective therapy for PSCI, in association with mediating neuroprotection and synaptic plasticity in related brain regions in the MCAO rat model.

Objective. To evaluate the clinical effectiveness and safety of acupuncture therapy in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) or functional diarrhea (FD) in adults. Method. Five electronic databases—PubMed, EMBASE, CNKI, VIP, and Wanfang—were searched, respectively, until June 8, 2020. The literature of clinical randomized controlled trials of acupuncture for the treatment of IBS-D or FD in adults were collected. Meta-analysis was conducted by Using Stata 16.0 software, the quality of the included studies was assessed by the RevMan ROB summary and graph, and the results were graded by GRADE. Result. Thirty-one studies with 3234 patients were included. Most of the studies were evaluated as low risk of bias related to selection bias, attrition bias, and reporting bias. Nevertheless, seven studies showed the high risk of bias due to incomplete outcome data. GRADE’s assessments were either moderate certainty or low certainty. Compared with loperamide, acupuncture showed more effectiveness in weekly defecation (SMD=−0.29, 95% CI [-0.49, -0.08]), but no significant improvement in the result of the Bristol stool form (SMD=−0.28, 95% CI [-0.68, 0.12]). In terms of the drop-off rate, although the acupuncture group was higher than the bacillus licheniformis plus beanxit group (RR=2.57, 95% CI [0.24, 27.65]), loperamide group (RR=1.11, 95% CI [0.57, 2.15]), and trimebutine maleate group (RR=1.19, 95% CI [0.31, 4.53]), respectively, it was lower than the dicetel group (RR=0.83, 95% CI [0.56, 1.23]) and affected the overall trend (RR=0.93, 95% CI [0.67, 1.29]). Besides, acupuncture produced more significant effect than dicetel related to the total symptom score (SMD=−1.17, 95% CI [-1.42, -0.93]), IBS quality of life (SMD=2.37, 95% CI [1.94, 2.80]), recurrence rate (RR=0.43, 95% CI [0.28, 0.66]), and IBS Symptom Severity Scale (SMD=−0.75, 95% CI [-1.04, -0.47]). Compared to dicetel (RR=1.25, 95% CI [1.18, 1.32]) and trimebutine maleate (RR=1.35, 95% CI [1.13, 1.61]), acupuncture also showed more effective at total efficiency. The more adverse effect occurred in the acupuncture group when comparing with the dicetel group (RR=11.86, 95% CI [1.58, 89.07]) and loperamide group (RR=4.42, 95% CI [0.57, 33.97]), but most of the adverse reactions were mild hypodermic hemorrhage. Conclusion. Acupuncture treatment can improve the clinical effectiveness of IBS-D or FD, with great safety, but the above conclusions need to be further verified through the higher quality of evidence.

Background The comorbidity of cardiovascular disease (CVD) and depression has been well established, as depression usually presents simultaneously with CVD risk factors. However, the potential association between cumulative exposure to CVD risk and depression remains unclear, so we conducted the current investigation. To our knowledge, this is the first study that employs the cumulative risk model to examine the effect of CVD risk factors on depression using nationally representative population and gender, age and CVD status-stratified subpopulations. Aims To systematically study the possible individual and cumulative effect of 18 CVD risk factors on depression. Methods A cross-sectional, secondary analysis investigated associations between 18 CVD risk factors and depression. The interaction effect between CVD risk factors and age, gender and CVD status was also examined. Enrolment included 20 816 participants from the US National Health and Nutrition Examination Survey 2005-2016. Participants with Patient Health Questionnaire-9 scores over 15 or who were using an antidepressant were considered depressive; 18 known cardiovascular risk factors were incorporated in the present study. Results At the individual risk factor level, smoking, drinking, living alone, sleep quality, body mass index, waist circumference and diabetes status had differential associations with depression risk according to the gender, age or CVD status of the participants. Most importantly, gender-stratified cumulative risk analysis indicated that similar depression risk was found in both genders with a small number of CVD risk factors (odds ratio (OR)adjusted=1.32; 95% confidence interval (CI): 0.87 to 1.99), but females had a significantly higher depression risk compared with males under high cumulative risk exposure (ORadjusted=2.86; 95% CI: 1.79 to 4.59). Conclusions Clarifying the association of numerous CVD risk factors with depression according to gender, age and overall CVD status may be beneficial for risk stratification and the prevention of depression in clinical practice. Moreover, the observed novel evidence of high cumulative risk exposure-mediated gender disparities in depression. [ABSTRACT FROM AUTHOR]