Efficacy and safety of Chinese herbal medicine to prevent and treat COVID-19 household close contacts in Hong Kong: an open-label, randomized controlled trial.

Objectives: To evaluate the efficacy and safety of CHM in the prevention of COVID-19 infection and treatment for COVID-19 related symptoms. Design: Prospective open-label randomized controlled trial. Setting: Participants' home in Hong Kong. Participants: Participants who had household close contact with COVID-19-infected family members. Interventions: Close contacts were stratified into 4 groups (cohort A, B, C, D) based on symptoms and infection status and were randomized in 4:1 ratio to receive CHM granules (9g/sachet, two times daily) or blank control for 7 days with 2 weeks of follow-up. Main outcome measures: The primary outcome measure was the rate of positive nucleic acid tests. Secondary outcomes were the proportion of developed COVID-19 related symptoms and adverse events during the whole 3-week study period. Subgroup analysis was used to evaluate demographic factors associated with positive infection rates. Results: A total of 2163 contacts were enrolled and randomly assigned to the CHM group (1720 contacts) and blank control (443 contacts) group. During the 21 days, the rate of PCR-positive cases in cohort A was markedly lower in the CHM group (3.6%) compared to the control group (7.0%) (P=0.036). Overall, the rate of infection in the CHM group was significantly lower than that in the control group (10.69% vs. 6.03%; RR 0.56, 95% CI 0.39-0.82) after 7-day treatment. No serious adverse events were reported during the medication period. Conclusion: The preliminary findings indicate that CHM may be effective and safe in preventing COVID-19. Future double-blind, randomized controlled trials and long-term follow-up are needed to fully evaluate the efficacy of CHM in a larger contact population. Clinical trial registration: ClinicalTrials.gov, identifier NCT05269511.

A multi-center cross-sectional study of Chinese Herbal Medicine-Drug adverse reactions using active surveillance in Singapore's Traditional Chinese Medicine clinics.

BACKGROUND: This study aimed to investigate the rates and causality of patient-reported adverse events (AEs) associated with concomitant Chinese Herbal Medicine (CHM) and Western Medicine prescription drug (WMPD) consumption through active surveillance in Singapore's Traditional Chinese Medicine (TCM) clinics. METHODS: A cross-sectional study was conducted at five TCM clinics across Singapore from 8th May till 8th July 2023. Patients were screened to determine rates of CHM and WMPD consumption, and then interviewed if an AE was reported. An expert committee assessed the AE reports to determine causality. Along with descriptive statistics, odds ratios were calculated to determine AE occurrence likelihoods for patients who consumed both CHM and WMPD compared to CHM consumption alone. RESULTS: 1028 patients were screened and 62.65% of them reported concurrent CHM-WMPD consumption. Patients who consumed CHM and WMPD were 3.65 times more likely to experience an AE as compared to CHM consumption alone. 18 AE reports were adjudicated, with most AEs deemed unlikely due to CHM consumption. CONCLUSIONS: A large proportion of patients consumed CHM and WMPD concurrently, thus increasing their risk of experiencing AEs compared to those consuming CHM only. Active surveillance is applicable for detecting AEs, collecting data for causality assessment, and analysis.

Are Tai Chi and Qigong effective in the treatment of traumatic brain injury? A systematic review.

BACKGROUND: Traumatic brain injury (TBI) adversely affects both young and old and is a growing public health concern. The common functional, psychological, and cognitive changes associated with TBI and recent trends in its management, such as recommending sub-threshold aerobic activity, and multi-modal treatment strategies including vestibular rehabilitation, suggest that Tai Chi/Qigong could be beneficial for TBI. Tai Chi and Qigong are aerobic mind-body practices with known benefits for maintaining health and mitigating chronic disease. To date, no systematic review has been published assessing the safety and effectiveness of Tai Chi/Qigong for traumatic injury. METHODS: The following databases were searched: MEDLINE, CINAHL Cochrane Library, Embase, China National Knowledge Infrastructure Database, Wanfang Database, Chinese Scientific Journal Database, and Chinese Biomedical Literature Database. All people with mild, moderate, or severe TBI who were inpatients or outpatients were included. All Types of Tai Chi and Qigong, and all comparators, were included. All measured outcomes were included. A priori, we chose "return to usual activities" as the primary outcome measure as it was patient-oriented. Cochrane-based risk of bias assessments were conducted on all included trials. Quality of evidence was assessed using the grading of recommendation, assessment, development, and evaluation (GRADE) system. RESULTS: Five trials were assessed; three randomized controlled trials (RCTs) and two non-RCTs; only two trials were conducted in the last 5 years. No trial measured "return to normal activities" or vestibular status as an outcome. Four trials - two RCTs and two non-RCTS - all found Tai Chi improved functional, psychological and/or cognitive outcomes. One RCT had a low risk of bias and a high level of certainty; one had some concerns. One non-RCTs had a moderate risk of bias and the other a serious risk of bias. The one Qigong RCT found improved psychological outcomes. It had a low risk of bias and a moderate level of certainty. Only one trial reported on adverse events and found that none were experienced by either the exercise or control group. CONCLUSION: Based on the consistent finding of benefit in the four Tai Chi trials, including one RCT that had a high level of certainty, there is a sufficient signal to merit conducting a large, high quality multi-centre trial on Tai Chi for TBI and test it against current trends in TBI management. Based on the one RCT on TBI and Qigong, an additional confirmatory RCT is indicated. Further research is indicated that reflects current management strategies and includes adverse event documentation in both the intervention and control groups. However, these findings suggest that, in addition to Tai Chi's known health promotion and chronic disease mitigation benefits, its use for the treatment of injury, such as TBI, is potentially a new frontier. SYSTEMATIC REVIEW REGISTRATION: PROSPERO [ CRD42022364385 ].

Electro-acupuncture for central obesity: a patient-assessor blinded, randomized sham-controlled clinical trial.

BACKGROUND: Central obesity is considered as a significant health threat to individuals. Scientific research has demonstrated that intra-abdominal fat accumulation is associated with higher metabolic and cardiovascular disease risks independent of Body Mass Index (BMI). This study aimed to evaluate the efficacy and safety of electro-acupuncture in treating central obesity compared with sham acupuncture. METHOD: This was a patient-assessor blinded, randomized, sham-controlled clinical trial. One hundred sixty eight participants aged between 18 and 65 years old with BMI ≥ 25 kg/m2 and waist circumference (WC) of men ≥ 90 cm / women ≥ 80 cm were enrolled and allocated to the acupuncture or sham acupuncture group equally. For the acupuncture group, disposable acupuncture needles were inserted into eight body acupoints, including Tianshu (ST-25), Daheng (SP-15), Daimai (GB-26), Qihai (CV-6), Zhongwan (CV-12), Zusanli (ST-36), Fenglong (ST-40), and Sanyinjiao (SP-6) with electrical stimulation. For the control group, Streitberger's non-invasive acupuncture needles were utilized at the same acupoints with identical stimulation modalities. The treatment duration was 8 weeks with 2 sessions per week and the follow-up period was 8 weeks. The primary outcome was the change in WC before and after the treatment. The secondary outcomes were the changes in hip circumference, waist-to-hip circumference ratio, BMI, and body fat percentage during the treatment and follow-up period. RESULTS: The acupuncture group displayed a significant change in WC compared to the sham group both treatment and follow-up period (MD = -1.1 cm, 95% CI = -2.8 to 4.1). Significant change in body fat percentage was recorded for both groups after treatment but no significance was observed during the follow-up period (MD = -0.1%, 95% CI = -1.9 to 2.2). The changes in hip circumference were also significant both treatment and follow-up period for the acupuncture group (MD = -2.0 cm, 95% CI = -3.7 to -1.7). Compared with sham acupuncture, the body weight (MD = -1 kg, 95% CI = -3.3 to 5.3), BMI (MD = -0.5, 95% CI = -0.7 to 1.9) also decreased significantly within and between groups. The incidence of adverse events was similar in the two groups. CONCLUSION: This study provided evidence that electro-acupuncture could be effective in treating central obesity by reducing WC, hip circumference, body weight, BMI, and waist-to-hip circumference ratio. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03815253, Registered 24 Jan 2019.

Chemical structures, extraction and analysis technologies, and bioactivities of edible fungal polysaccharides from Poria cocos: An updated review.

Poria cocos is a popular medicinal food. Polysaccharides are the key component of Poria cocos, forming 70-90 % of the dry sclerotia mass. Recent studies indicate that Poria cocos polysaccharides (PCP-Cs) have multiple beneficial functions and applications. A literature search was conducted using the Web of Science Core Collection and PubMed databases. For this review, we provided an updated research progress in chemical structures, various extraction and analysis technologies, bioactivities of PCP-Cs, and insights into the directions for future research. The main polysaccharides identified in Poria cocos are water-soluble polysaccharides and acidic polysaccharides. Hot water, alkali, supercritical fluid, ultrasonic, enzyme, and deep eutectic solvent-based methods are the most common methods for PCP-Cs extraction. Technologies such as near-infrared spectroscopy, high-performance liquid chromatography, and ultraviolet-visible spectrophotometry, are commonly used to evaluate the qualities of PCP-Cs. In addition, PCP-Cs have antioxidant, immunomodulatory, neuroregulatory, anticancer, hepatoprotective, and gut microbiota regulatory properties. Future research is needed to focus on scaling up extraction, enhancing quality control, elucidating mechanisms of bioactivities, and the utilisation of PCP-Cs in food industries. Overall, Poria cocos is a good source of edible fungi polysaccharides, which can be developed into functional foods with potential health benefits.

Management of chronic pain secondary to temporomandibular disorders: a systematic review and network meta-analysis of randomised trials.

OBJECTIVE: We explored the comparative effectiveness of available therapies for chronic pain associated with temporomandibular disorders (TMD). DESIGN: Systematic review and network meta-analysis of randomised clinical trials (RCTs). DATA SOURCES: MEDLINE, EMBASE, CINAHL, CENTRAL, and SCOPUS were searched to May 2021, and again in January 2023. STUDY SELECTION: Interventional RCTs that enrolled patients presenting with chronic pain associated with TMD. DATA EXTRACTION AND SYNTHESIS: Pairs of reviewers independently identified eligible studies, extracted data, and assessed risk of bias. We captured all reported patient-important outcomes, including pain relief, physical functioning, emotional functioning, role functioning, social functioning, sleep quality, and adverse events. We conducted frequentist network meta-analyses to summarise the evidence and used the GRADE approach to rate the certainty of evidence and categorise interventions from most to least beneficial. RESULTS: 233 trials proved eligible for review, of which 153-enrolling 8713 participants and exploring 59 interventions or combinations of interventions-were included in network meta-analyses. All subsequent effects refer to comparisons with placebo or sham procedures. Effects on pain for eight interventions were supported by high to moderate certainty evidence. The three therapies probably most effective for pain relief were cognitive behavioural therapy (CBT) augmented with biofeedback or relaxation therapy (risk difference (RD) for achieving the minimally important difference (MID) in pain relief of 1 cm on a 10 cm visual analogue scale: 36% (95% CI 33 to 39)), therapist-assisted jaw mobilisation (RD 36% (95% CI 31 to 40)), and manual trigger point therapy (RD 32% (29 to 34)). Five interventions were less effective, yet more effective than placebo, showing RDs ranging between 23% and 30%: CBT, supervised postural exercise, supervised jaw exercise and stretching, supervised jaw exercise and stretching with manual trigger point therapy, and usual care (such as home exercises, self stretching, reassurance).Moderate certainty evidence showed four interventions probably improved physical functioning: supervised jaw exercise and stretching (RD for achieving the MID of 5 points on the short form-36 physical component summary score: 43% (95% CI 33 to 51)), manipulation (RD 43% (25 to 56)), acupuncture (RD 42% (33 to 50)), and supervised jaw exercise and mobilisation (RD 36% (19 to 51)). The evidence for pain relief or physical functioning among other interventions, and all evidence for adverse events, was low or very low certainty. CONCLUSION: When restricted to moderate or high certainty evidence, interventions that promote coping and encourage movement and activity were found to be most effective for reducing chronic TMD pain. REGISTRATION: PROSPERO (CRD42021258567).

A clinical pathway for integrative medicine in the treatment of functional constipation in Hong Kong, China.

OBJECTIVE: Functional constipation (FC) is a common intestinal disease worldwide. Despite the presence of criteria such as Roman IV, there is no standardized diagnosis and treatment algorithm in Hong Kong that combines both Western and Chinese medicine approaches. This study integrates current effective and safe diagnosis and treatment methods for FC and provides a clear and scientific pathway for clinical professionals and patients. METHODS: A systematic search of the PubMed, Cochrane Library, and China National Knowledge Infrastructure databases was performed from their inception to June 30th, 2022, collecting the current evidence about the efficacious integrative management for FC. We organized a meeting of professionals in fields relevant to treatment and management of FC to develop a consensus agreement on clinical pathway process. RESULTS: We developed a clinical pathway for the treatment of FC based on the most recent published guidelines and consultation with experts. This pathway includes a hierarchy of recommendations for every step of the clinical process, including clinical intake, diagnostic examination, recommended labs, diagnostic flowchart, and guidance for selection of therapeutic drugs. CONCLUSION: This pathway establishes clinical standards for the diagnosis and treatment of FC using Chinese medicine and Western medicine; it will help to provide high-quality medical services in Hong Kong for patients with FC. Please cite this article as: Wei DJ, Li HJ, Lyu ZP, Lyu AP, Bian ZX, Zhong LL. A clinical pathway for integrative medicine in the treatment of functional constipation in Hong Kong, China. J Integr Med. 2023; 21(6): 550-560.

Recent advances in the influences of drying technologies on physicochemical properties and biological activities of plant polysaccharides.

Plant polysaccharides, as significant functional macromolecules with diverse biological properties, are currently receiving increasing attention. Drying technologies play a pivotal role in the research, development, and application of various foods and plant polysaccharides. The chemical composition, structure, and function of extracted polysaccharides are significantly influenced by different drying technologies (e.g., microwave, infrared, and radio frequency) and conditions (e.g., temperature). This study discusses and compares the principles, advantages, disadvantages, and effects of different drying processes on the chemical composition as well as structural and biological properties of plant polysaccharides. In most plant-based raw materials, molecular degradation, molecular aggregation phenomena along with intermolecular interactions occurring within cell wall components and cell contents during drying represent primary mechanisms leading to variations in chemical composition and structures of polysaccharides. These differences further impact their biological properties. The biological properties of polysaccharides are determined by a combination of multiple relevant factors rather than a single factor alone. This review not only provides insights into selecting appropriate drying processes to obtaining highly bioactive plant polysaccharides but also offers a fundamental theoretical basis for the structure-function relationship of these compounds.

Validation of the Cantonese version of the Traditional Chinese Medicine (TCM) Body constitution Questionnaire in elderly people.

BACKGROUND: The Traditional Chinese Medicine (TCM) Body Constitution Questionnaire (For Elderly People) (TCMECQ) is a patient-reported outcome questionnaire developed in Mandarin in 2013 to differentiate the body constitutions of the elderly aged 65 and above. Considering the cultural and linguistic differences between Mainland China and Hong Kong (HK) Special Administrative Region, the TCMECQ was translated into Cantonese following "back translation" policy and validated in proper process. METHODS: Ten Chinese Medicine Practitioners (CMPs) and 30 senior citizens aged 65 or above were recruited to evaluate the first version of the Traditional Chinese Medicine Body Constitution Questionnaire (For Elderly People) (Cantonese version) (TCMECQ-C). Based on their comments, the second version was developed and discussed in the panel meeting to form the third version, validated the third version on 270 recruited seniors. Based on the validation results, a panel of 5 experts finalized the Questionnaire as the final version. The TCMECQ-C developers finalized the Questionnaire as the validated endorsed third version (i.e. final version). RESULTS: The item-level content validity index of most items of the TCMECQ-C (First Version) were ranging from 0.80 to 1.00 in terms of clarity, relevance and appropriateness. Factor loadings of Qi-deficiency Constitution ranging from 0.37 to 0.71, Yang-deficiency Constitution ranging from 0.36 to 0.65, Yin-deficiency Constitution ranging from 0.36 to 0.65, and Stagnant Qi Constitution ranging from 0.68 to 0.82. The chi-squared degree-of-freedom ratio was 2.13 (928.63/436), Goodness-of-Fit Index (0.83), Adjusted Goodness-of-Fit Index (0.79), Normed Fit Index (0.66), Comparative Fit Index (0.78), Incremental Fit Index (0.78), Relative Fit Index (0.61) and Tucker-Lewis Index (0.75), and Root Mean Square Error of Approximation (0.07) and Standardized Root Mean Square Residual (0.07), implied acceptable Confirmatory Factor Analysis model fit of the overall scale. A Pearson correlation coefficient (r) showed the sufficient convergent validity for excessive subscales (Phlegm-dampness Constitution and Dampness-heat Constitution with r = 0.35, p < 0.01). Cronbach's alpha coefficient ranged from 0.56 to 0.89, including Qi-deficiency Constitution (0.67), Yang-deficiency Constitution (0.84), Yin-deficiency Constitution (0.59), Stagnant Blood Constitution (0.56), Stagnant Qi Constitution (0.89), Inherited Special Constitution (0.76) and Balanced Constitution (0.73), indicating acceptable internal consistency for subscales. The intra-class correlation coefficients of the TCMECQ-C ranged from 0.70 to 0.87 (p < 0.001), indicating moderate to good test-retest reliability. CONCLUSION: TCMECQ-C is a valid and reliable questionnaire for assessing the body constitution in Cantonese elderly.

Persistent clinical symptoms and their association with CM syndromes in post-COVID-19 rehabilitation patients in Hong Kong.

Background: Heterogeneous clinical conditions were observed in individuals who had recovered from COVID-19 and some symptoms were found to persist for an extended period post-COVID. Given the non-specific nature of the symptoms, Chinese medicine (CM) is advantageous in providing holistic medical assessment for individuals experiencing persisting problems. Chinese medicine is a type of treatment that involves prescribing regimens based on CM Syndromes diagnosed by CM practitioners. However, inadequate research on CM elements behind the practice has faced scrutiny. Methods: This study analysed 1058 CM medical records from 150 post-COVID-19 individuals via a semi-text-mining approach. A logistic model with MCMCglmm was then utilised to analyse the associations between the indicated factors and identified conditions. Calculations were performed using R Studio and related libraries. Results: With the semi-text-mining approach, three common CM Syndromes (Qi and Yin Deficiency, Lung and Spleen Deficiency, Qi Deficiency of both Spleen and Lung) and nine clinical conditions (fatigue, poor sleep, dry mouth, shortness of breath, cough, headache, tiredness, sweating, coughing phlegm) were identified in the CM clinical records. Analysis via MCMCglmm revealed that the occurrence of persisting clinical conditions was significantly associated with female gender, existing chronic conditions (hypertension, high cholesterol, and diabetes mellitus), and the three persisting CM Syndromes. The current study triangulated the findings from our previous observational study, further showing that patients with certain post-COVID CM Syndromes had significantly increased log-odds of having persisting clinical conditions. Furthermore, this study elucidated that the presence of chronic conditions in the patients would also significantly increase the log-odds of having persistent post-COVID clinical conditions. Conclusion: This study provided insights on mining text-based CM clinical records to identify persistent post-COVID clinical conditions and the factors associated with their occurrence. Future studies could examine the integration of integrating exercise modules, such as health qigong Liuzijue, into multidisciplinary rehabilitation programmes.

TCM "medicine and food homology" in the management of post-COVID disorders.

Background: The World Health Organization declared that COVID-19 is no longer a public health emergency of global concern on May 5, 2023. Post-COVID disorders are, however, becoming more common. Hence, there lies a growing need to develop safe and effective treatment measures to manage post-COVID disorders. Investigating the use of TCM medicinal foods in the long-term therapy of post-COVID illnesses may be beneficial given contemporary research's emphasis on the development of medicinal foods. Scope and approach: The use of medicinal foods for the long-term treatment of post-COVID disorders is highlighted in this review. Following a discussion of the history of the TCM "Medicine and Food Homology" theory, the pathophysiological effects of post-COVID disorders will be briefly reviewed. An analysis of TCM medicinal foods and their functions in treating post-COVID disorders will then be provided before offering some insight into potential directions for future research and application. Key findings and discussion: TCM medicinal foods can manage different aspects of post-COVID disorders. The use of medicinal foods in the long-term management of post-COVID illnesses may be a safe and efficient therapy choice because they are typically milder in nature than chronic drug use. These findings may also be applied in the long-term post-disease treatment of similar respiratory disorders.

Altered gut microbiota-host bile acid metabolism in IBS-D patients with liver depression and spleen deficiency pattern.

BACKGROUND: Dysregulation of gut microbiota-host bile acid (BA) co-metabolism is a critical pathogenic factor of diarrhea-predominant irritable bowel syndrome (IBS-D). Traditional Chinese Medicine (TCM), instructed by pattern differentiation, is effective in treating IBS-D, in which liver depression and spleen deficiency (LDSD) is the most prevalent pattern. Still, it is unclear the linkage between the LDSD pattern and the BA metabolic phenotype. PURPOSE: This study aimed to uncover the biological basis of the LDSD pattern from the BA metabolic perspective. METHODS: Patients with IBS-D completed questionnaires regarding the irritable bowel severity scoring system (IBS-SSS), stool frequency, Stool Bristol scale, and Self-Rating Scales of mental health. Fasting blood and morning feces were collected to analyze the gut metagenome and BA-related indices/metabolites. RESULTS: IBS-D patients with LDSD had a higher incidence of BA overexcretion (41% vs. 23% non-LDSD) with significant elevations in fecal total BAs and serum BA precursor 7α-hydroxy-4-cholesten-3-one levels. Compared to controls or non-LDSD patients, LDSD patients had a featured fecal BA profile, with higher proportions of deoxycholic acid (DCA), 7-ketodeoxycholic acid, and lithocholic acid. It is consistent with the BA-metabolizing genomic changes in the LDSD gut microbiota characterized by overabundances of 7-dehydroxylating bacteria and BA-inducible genes (baiCD/E/H). The score of bowel symptoms (stool frequency and abdominal pain) showing greater severity in the LDSD pattern were positively correlated with bai-expressing bacterial abundances and fecal DCA levels separately. CONCLUSION: We clarified a differed BA metabolic phenotype in IBS patients with LDSD, which closely correlates with the severity of bowel symptoms. It demonstrates that gut microbiota and host co-metabolism of BAs would provide crucial insight into the biology of the LDSD pattern and its internal relationship with IBS progression.

Acupuncture for post-stroke depression: a systematic review and network meta-analysis.

BACKGROUND: Patients with post-stroke depression (PSD) usually experience anxiety, hopelessness, and insomnia, which have a negative impact on their daily activities and post-stroke rehabilitation. Acupuncture (AC), as a minimally invasive technique, has become a popular choice for improving depression symptoms. However, it is still unclear which therapy is associated with the best outcomes for PSD. In this review, we aimed to explore the impact of AC in alleviating symptoms of PSD and to evaluate the difference in effectiveness between AC combined with pharmacotherapies and various non-pharmacotherapies. METHODS: Six databases and three clinical trials registration platforms were searched from inception to March 2023. Randomized clinical trial comparing needle-based AC with pharmacotherapy, and other non-pharmacotherapy or invalid group were included. Two independent reviewers identified eligible studies, and collected data using a pre-made form. A Bayesian network meta-analysis was conducted to assess and compare different techniques using RStudio 3.6.0 with the package 'GEMTC' V.0.8.1. The primary outcome was the efficacy for PSD assessed by scales measuring depressive symptoms. The secondary outcomes were effectiveness for neurological function and the quality of life. The ranking probabilities for all treatment interventions was performed using the Surface Under the Cumulative Ranking curve (SUCRA). The risk of bias was assessed by using the Revised Cochrane Risk of Bias tool 2. RESULTS: Sixty-two studies, involving 5308 participants published from 2003 to 2022, were included. The results showed that compared with western medicine (WM) (defined as pharmacotherapy for PSD), AC alone or with repetitive transcranial magnetic stimulation (RTMS), Traditional Chinese medicine (TCM) alone or with WM, were superior for alleviating depression symptoms. Compared to Usual Care, AC alone or plus other therapies could significantly decrease scores on the Hamilton Depression Rating scale. According to result of SUCRA, AC plus RTMS had the highest probability of improving depressive symptoms with a probability of 49.43%. CONCLUSIONS: The results of this study indicate that AC alone or combined with other therapies appears to be effective in improving depression symptoms of stroke survivors. Moreover, in comparison to WM, AC alone or plus RTMS, TCM, TCM with WM, or WM, were more effective in improving depression symptoms of PSD. Also, AC with RTMS seems to be the most effective with the highest probability. REGISTRATION: This study was registered in the International Prospective Register of Systematic Reviews (PROSPERO) database in November 2020 and updated in July 2021. The registration number is CRD42020218752.

Incidence and Risk Factors for Pneumonitis Associated With Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer: A Single Center Experience.

INTRODUCTION: Immune checkpoint inhibitor (ICI) pneumonitis causes substantial morbidity and mortality. Estimates of real-world incidence and reported risk factors vary substantially. METHODS: We conducted a retrospective review of 419 patients with advanced non-small cell lung cancer (NSCLC) who were treated with anti-PD-(L)1 with or without anti-CTLA-4 therapy. Clinical, imaging, and microbiological data were evaluated by multidisciplinary adjudication teams. The primary outcome of interest was grade ≥2 (CTCAEv5) pneumonitis. Clinicopathologic variables, tobacco use, cancer therapies, and preexisting lung disease were assessed for univariate effects using Cox proportional hazards models. We created multivariate Cox proportional hazards models to assess risk factors for pneumonitis and mortality. Pneumonitis, pneumonia, and progression were modeled as time-dependent variables in mortality models. RESULTS: We evaluated 419 patients between 2013 and 2021. The cumulative incidence of pneumonitis was 9.5% (40/419). In a multivariate model, pneumonitis increased the risk for mortality (HR 1.6, 95% CI, 1.0-2.5), after adjustment for disease progression (HR 1.6, 95% CI, 1.4-1.8) and baseline shortness of breath (HR 1.5, 95% CI, 1.2-2.0). Incomplete resolution was more common with more severe pneumonitis. Interstitial lung disease was associated with higher risk for pneumonitis (HR 5.4, 95% CI, 1.1-26.6), particularly in never smokers (HR 26.9, 95% CI, 2.8-259.0). CONCLUSION: Pneumonitis occurred at a high rate and significantly increased mortality. Interstitial lung disease, particularly in never smokers, increased the risk for pneumonitis.

Meta-Analysis of the Effectiveness and Safety of Shugan Jieyu Capsules for the Treatment of Insomnia.

A systematic review and meta-analysis were conducted to evaluate the clinical effectiveness and safety of Shugan Jieyu capsules for treating insomnia by searching seven databases up to February 21, 2022. The study was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The quality of the studies was assessed using the risk of bias assessment tool. This article describes in detail how to retrieve and screen the literature. The detailed steps for conducting the meta-analysis are also included in the protocol. Fourteen studies were found to be eligible, including 1,283 insomnia patients (644 with and 639 without Shugan Jieyu capsules at baseline). The meta-analysis showed a better total clinical effectiveness (odds ratio [OR]: 5.71, 95% confidence interval [CI]: 3.56 to 9.15) and a lower Pittsburgh Sleep Quality Index (PSQI) score (mean difference [MD]: -2.95, 95% CI: -4.97 to -0.93) with combined Shugan Jieyu capsules and Western medicine compared to Western medicine alone. The secondary outcomes showed that the Shugan Jieyu capsule group had significantly reduced adverse reactions and improvements in sleep duration, night awakening, nightmares with excessive dreaming, daytime sleepiness, and low energy. Further multicenter randomized trials must be encouraged to provide more concrete evidence on whether Shugan Jieyu capsules are beneficial in routine clinical practice.

Are tai chi and qigong effective in the treatment of TBI? A systematic review protocol.

Background: Traumatic brain injury (TBI) adversely affects both young and old and is a growing public health issue. A number of recent trends in managing TBI, such as recommending sub-threshold aerobic activity, tailoring multi-modal treatment strategies, and studying the possible role of low-grade inflammation in those with persistent symptoms, all suggest that the physical and cognitive exercise of tai chi/qigong could have benefit. Method: Designed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, the following databases will be searched: MEDLINE, CINAHL, Cochrane Library, Embase, China National Knowledge Infrastructure Database, Wanfang Database, Chinese Scientific Journal Database, and Chinese Biomedical Literature Database. All clinical trials on mild, moderate and/or severe TBI with tai chi and/or qigong as the treatment group and any comparison group, in any setting will be included. Four reviewers will independently select studies; two reviewers for the English and two for the Chinese databases. Cochrane-based risk of bias assessments will be conducted on all included studies. An analysis will then be conducted with the grading of recommendation, assessment, development, and evaluation (GRADE) instrument. Results: This review will summarize the clinical trial evidence on tai chi/qigong for TBI including type of TBI, age/sex of participants, type and length of intervention and comparator, outcome measures, and any adverse events. The risk of bias will be considered, and the strengths and weaknesses of each trial will be analyzed. Discussion: The results of this review will be considered with respect to whether there is enough evidence of benefit to merit a more definitive randomized controlled trial.Systematic Review Registration: PROSPERO [CRD42022364385].

STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM): Extending the CONSORT statement.

OBJECTIVES: Massage is a common therapy of nonpharmacological treatments, particularly in Tuina (Chinese massage) as its most common style, detailed guidance in reporting the intervention is warranted for its evaluation and replication. Based on the CONSORT (Consolidated Standards of Reporting Trials), we aimed to develop an Extension for Tuina/Massage, namely "The STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM)." METHODS: A group of professional clinicians, trialists, methodologists, developers of reporting guidelines, epidemiologists, statisticians, and editors has developed this STRICTOTM checklist through a standard methodology process recommended by the EQUATOR (Enhancing the QUAlity and Transparency of Health Research) Network, including prospective registration, literature review, draft of the initial items, three rounds of the Delphi survey, consensus meeting, pilot test, and finalization of the guideline. RESULTS: A checklist of seven items (namely Tuina/Massage rationale, details of Tuina/Massage, intervention regimen, other components of the intervention, Tuina/Massage provider background, control or comparator interventions, and precaution measures), and 16 subitems were developed. Explanations and examples (E&E) for each item are also provided. CONCLUSIONS: The working group hopes that the STRICTOTM, in conjunction with both the CONSORT statement and extension for nonpharmacologic treatment, can improve the reporting quality and transparency of Tuina/Massage clinical research.

Propensity score analysis with missing data using a multi-task neural network.

BACKGROUND: Propensity score analysis is increasingly used to control for confounding factors in observational studies. Unfortunately, unavoidable missing values make estimating propensity scores extremely challenging. We propose a new method for estimating propensity scores in data with missing values. MATERIALS AND METHODS: Both simulated and real-world datasets are used in our experiments. The simulated datasets were constructed under 2 scenarios, the presence (T = 1) and the absence (T = 0) of the true effect. The real-world dataset comes from LaLonde's employment training program. We construct missing data with varying degrees of missing rates under three missing mechanisms: MAR, MCAR, and MNAR. Then we compare MTNN with 2 other traditional methods in different scenarios. The experiments in each scenario were repeated 20,000 times. Our code is publicly available at https://github.com/ljwa2323/MTNN . RESULTS: Under the three missing mechanisms of MAR, MCAR and MNAR, the RMSE between the effect and the true effect estimated by our proposed method is the smallest in simulations and in real-world data. Furthermore, the standard deviation of the effect estimated by our method is the smallest. In situations where the missing rate is low, the estimation of our method is more accurate. CONCLUSIONS: MTNN can perform propensity score estimation and missing value filling at the same time through shared hidden layers and joint learning, which solves the dilemma of traditional methods and is very suitable for estimating true effects in samples with missing values. The method is expected to be broadly generalized and applied to real-world observational studies.