Hanshiyi Formula, a medicine for Sars-CoV2 infection in China, reduced the proportion of mild and moderate COVID-19 patients turning to severe status: A cohort study.

We formulated a traditional Chinese medicine (TCM) prescription, Hanshiyi Formula (HSYF), which was approved and promoted by the Wuhan Municipal Health Commission for treating mild and moderate coronavirus disease 2019 (COVID-19). We aimed to evaluate the effect of HSYF on the progression to severe disease in mild and moderate COVID-19 patients. We conducted a retrospective cohort study of patients with mild and moderate COVID-19 in a quarantine station in Wuchang District, Wuhan. Using the real-time Internet information collection application and Centers for Disease Control for the Wuchang District, patient data were collected through patient self-reports and follow-ups. HSYF intervention was defined as the exposure. The primary outcome was the proportion of patients who progressed to a severe disease status, and a stratification analysis was performed. Univariate and multivariate regression analyses were performed to identify influencing factors that may affect the outcome. Further, we used propensity score matching (PSM) to assess the effect of HSYF intervention on the conversion of mild and moderate to a severe disease status. Totally, 721 mild and moderate COVID-19 patients were enrolled, including 430 HSYF users (exposed group) and 291 non-users (control group). No cases in the exposed group and 19 (6.5 %, P < 0.001) cases in the control group progressed to severe disease, and the difference between the two groups (exposed group-control group) was -6.5 % [95 % confidence interval (CI): (-8.87 %, -4.13 %)]. Univariate regression analysis revealed sex (male), age, fever, cough, and fatigue as risk factors for progression to severe disease. After PSM, none of the HSYF users and 7 (4.7 %, P = 0.022) non-users transitioned to severe disease, and the difference between the two groups (exposed group-control group) was -4.7 % [95 % CI: (-8.2 %, -1.2 %)]. Multivariate regression analysis revealed that sex (male) [OR: 3.145; 95 % CI: 1.036-9.545; P = 0.043] and age (> 48 years) [odds ratio (OR): 1.044; 95 % CI: 1.001-1.088; P = 0.044] were independent risk factors for conversion to severe disease. Therefore, HSYF can significantly reduce the progression to severe disease in patients with mild and moderate COVID-19, which may effectively prevent and treat the disease. However, further larger clinical studies are required to verify our results.

Electroacupuncture for Reflex Sympathetic Dystrophy after Stroke: A Meta-Analysis.

BACKGROUND: Reflex sympathetic dystrophy (RSD) is the common complication among stroke and cerebral injury patients, which is lack of safe and effective treatment. Electroacupuncture (EA) may potentially be a reliably therapy, but the evidence is insufficiency. METHODS: Cochrane Library, MEDLINE, Embase, Chinese National Knowledge Infrastructure, Wan Fang Data, the Chinese Biology Medicine disc, etc., were searched, until July 20, 2018. We included random control trials that contrast EA with conventional rehabilitation therapy for the treatment of RSD. Main outcomes were visual analog scale score and Fugl-Meyer upper limb motor function scoring scale, other outcomes such as Barthel index, and hand swelling score were also collected. Data in included studies were extracted into an excel and pooled by Stata/MP 14.1. RESULTS: We incorporated 13 studies involving 1040 RSD patients and outcomes were from 2 to 6 weeks' follow-up. The analgesic effect between 2 groups had statistically significant difference (weighted mean difference [WMD] = -1.122, 95% confidence interval [CI] [-1.682 to -.562], P = .000], a statistical difference existed in improving dysfunction between 2 groups: (WMD = 6.039, 95% CI [2.231-.916], P = .000). EA groups had a better effect on improving activities of daily life abilities (WMD = 12.170, 95% CI [6.657-17.682], P < .00011] and better detumescence effect (WMD = -.800, 95% CI [-1.972 to -.212], P = .000] contrast to conventional rehabilitation therapy. CONCLUSIONS: This meta-analysis supports that EA has a positive effect on alleviating pain, improving limb dysfunction, and promoting activities of daily living. On account of moderate-quality random control trials and high heterogeneity, further high-quality studies are imperative to optimize the EA treatment program.

Acupuncture for symptoms in menopause transition: a randomized controlled trial.

BACKGROUND: Acupuncture has been used for women during menopause transition, but evidence is limited. OBJECTIVE: We sought to evaluate the efficacy of electroacupuncture on relieving symptoms of women during menopause transition. STUDY DESIGN: We conducted a prospective, multicenter, randomized, participant-blinded trial in China mainland. Subjects were randomized to receive 24 treatment sessions of electroacupuncture at traditional acupoints or sham electroacupuncture at nonacupoints over 8 weeks with 24 weeks' follow-up. Primary outcome was the change from baseline in the total score of Menopause Rating Scale at week 8. Secondary outcomes included the changes from baseline in the average 24-hour hot flash score, the Menopause Rating Scale subscale scores, the total score of Menopause-Specific Quality of Life Questionnaire and its subscales, and serum female hormones. All analyses were performed with a 2-sided P value of < .05 considered significant based on the intention-to-treat principle. RESULTS: A total of 360 women (180 in each group) with menopause-related symptoms during menopause transition were enrolled from June 9, 2013, through Dec 28, 2015. At week 8, the reduction from baseline in the Menopause Rating Scale total score was 6.3 (95% confidence interval, 5.0-7.7) in the electroacupuncture group and 4.5 (95% confidence interval, 3.2-5.8) in the sham electroacupuncture group with a between-group difference of 1.8 (95% confidence interval, 0.9-2.8; P = .0002), less than the minimal clinically important difference of 5 points' reduction. For secondary outcomes, the between-group differences for the decrease in the mean 24-hour hot flash score were significant at weeks 8, 20, and 32, but all were less than the minimal clinically important difference in previous reports. Interestingly, the between-group differences for the Menopause-Specific Quality of Life Questionnaire total score reduction were 5.7 at week 8, 7.1 at week 20, and 8.4 at week 32, greater than the minimal clinically important difference of 4 points. Changes from baseline in follicle-stimulating hormone, luteinizing hormone, and estradiol levels at weeks 8 and 20 (P > .05 for all), with the exception of follicle-stimulating hormone/luteinizing hormone ratios (P = .0024 at week 8 and .0499 at week 20), did not differ between groups. CONCLUSION: Among women during menopause transition, 8 weeks' electroacupuncture treatment did not seem to relieve menopausal symptoms, even though it appeared to improve their quality of life. Generalizability of the trial results may be limited by mild baseline menopausal symptoms in the included participants.

Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial.

BACKGROUND: Acupuncture has been used for chronic constipation, but evidence for its effectiveness remains scarce. OBJECTIVE: To determine the efficacy of electroacupuncture (EA) for chronic severe functional constipation (CSFC). DESIGN: Randomized, parallel, sham-controlled trial. (ClinicalTrials.gov: NCT01726504). SETTING: 15 hospitals in China. PARTICIPANTS: Patients with CSFC and no serious underlying pathologic cause for constipation. INTERVENTION: 28 sessions of EA at traditional acupoints or sham EA (SA) at nonacupoints over 8 weeks. MEASUREMENTS: The primary outcome was the change from baseline in mean weekly complete spontaneous bowel movements (CSBMs) during weeks 1 to 8. Participants were followed until week 20. RESULTS: 1075 patients (536 and 539 in the EA and SA groups, respectively) were enrolled. The increase from baseline in mean weekly CSBMs during weeks 1 to 8 was 1.76 (95% CI, 1.61 to 1.89) in the EA group and 0.87 (CI, 0.73 to 0.97) in the SA group (between-group difference, 0.90 [CI, 0.74 to 1.10]; P < 0.001). The change from baseline in mean weekly CSBMs during weeks 9 to 20 was 1.96 (CI, 1.78 to 2.11) in the EA group and 0.89 (CI, 0.69 to 0.95) in the SA group (between-group difference, 1.09 [CI, 0.94 to 1.31]; P < 0.001). The proportion of patients having 3 or more mean weekly CSBMs in the EA group was 31.3% and 37.7% over the treatment and follow-up periods, respectively, compared with 12.1% and 14.1% in the SA group (P < 0.001). Acupuncture-related adverse events during treatment were infrequent in both groups, and all were mild or transient. LIMITATIONS: Longer-term follow-up was not assessed. Acupuncturists could not be blinded. CONCLUSION: Eight weeks of EA increases CSBMs and is safe for the treatment of CSFC. Additional study is warranted to evaluate a longer-term treatment and follow-up. PRIMARY FUNDING SOURCE: Ministry of Science and Technology of the People's Republic of China through the Twelfth Five-Year National Science and Technology Pillar Program.

Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial.

Importance: Electroacupuncture involving the lumbosacral region may be effective for women with stress urinary incontinence (SUI), but evidence is limited. Objective: To assess the effect of electroacupuncture vs sham electroacupuncture for women with SUI. Design, Setting, and Participants: Multicenter, randomized clinical trial conducted at 12 hospitals in China and enrolling 504 women with SUI between October 2013 and May 2015, with data collection completed in December 2015. Interventions: Participants were randomly assigned (1:1) to receive 18 sessions (over 6 weeks) of electroacupuncture involving the lumbosacral region (n = 252) or sham electroacupuncture (n = 252) with no skin penetration on sham acupoints. Main Outcomes and Measures: The primary outcome was change from baseline to week 6 in the amount of urine leakage, measured by the 1-hour pad test. Secondary outcomes included mean 72-hour urinary incontinence episodes measured by a 72-hour bladder diary (72-hour incontinence episodes). Results: Among the 504 randomized participants (mean [SD] age, 55.3 [8.4] years), 482 completed the study. Mean urine leakage at baseline was 18.4 g for the electroacupuncture group and 19.1 g for the sham electroacupuncture group. Mean 72-hour incontinence episodes were 7.9 for the electroacupuncture group and 7.7 for the sham electroacupuncture group. At week 6, the electroacupuncture group had greater decrease in mean urine leakage (-9.9 g) than the sham electroacupuncture group (-2.6 g) with a mean difference of 7.4 g (95% CI, 4.8 to 10.0; P < .001). During some time periods, the change in the mean 72-hour incontinence episodes from baseline was greater with electroacupuncture than sham electroacupuncture with between-group differences of 1.0 episode in weeks 1 to 6 (95% CI, 0.2-1.7; P = .01), 2.0 episodes in weeks 15 to 18 (95% CI, 1.3-2.7; P < .001), and 2.1 episodes in weeks 27 to 30 (95% CI, 1.3-2.8; P < .001). The incidence of treatment-related adverse events was 1.6% in the electroacupuncture group and 2.0% in the sham electroacupuncture group, and all events were classified as mild. Conclusions and Relevance: Among women with stress urinary incontinence, treatment with electroacupuncture involving the lumbosacral region, compared with sham electroacupuncture, resulted in less urine leakage after 6 weeks. Further research is needed to understand long-term efficacy and the mechanism of action of this intervention. Trial Registration: clinicaltrials.gov Identifier: NCT01784172.

Regulatory Effects of Astragaloside IV on Hyperglycemia-Induced Mitophagy in Schwann Cells.

OBJECTIVE: This study aimed to observe the regulatory effects of astragaloside IV (AS-IV) on hyperglycemia-induced mitochondrial damage and mitophagy in Schwann cells and to provide references for clinical trials on AS-IV in the treatment of diabetic peripheral neuropathy. METHODS: Schwann cells were grown in a high-glucose medium to construct an autophagy model; the cells were then treated with AS-IV and N-acetylcysteine (control) to observe the regulatory effects of AS-IV on oxidative stress and mitophagy. RESULTS: AS-IV exhibited antioxidant activity and inhibited the overactivation of autophagy in Schwann cells, significantly reducing the level of reactive oxygen species and downregulating the expression of autophagy-related proteins (LC3, PINK, and Parkin) under hyperglycemic conditions, thereby exerting a protective effect on mitochondrial morphology and membrane potential. CONCLUSION: AS-IV can maintain the mitochondrial function of Schwann cells under hyperglycemic conditions by effectively alleviating oxidative stress and overactivation of mitophagy. The evidence from this study supports an AS-IV-based therapeutic strategy against diabetic peripheral neuropathy.

Efficacy of acupuncture in subpopulations with functional constipation: A protocol for a systematic review and individual patient data meta-analysis.

BACKGROUND: Several systematic reviews have suggested that acupuncture is effective against functional constipation, but it is unknown whether variations in treatment effect across subgroups remain consistent. Our purpose of this study is to explore the heterogeneity of treatment effect of acupuncture on functional constipation across subgroups. METHODS: We will search eleven English and Chinese electronic databases and three clinical trial registries from inception to December 2021. Randomized controlled trials that evaluate acupuncture compared with sham acupuncture or no treatment for functional constipation will be eligible if they report at least one primary outcome. The primary outcomes will include the change in weekly complete spontaneous bowel movements or spontaneous bowel movements from baseline. Two authors will independently identify the relevant studies, assess the risk of bias using the Cochrane RoB 2 tool and contact the primary researchers of the eligible trials for individual patient data. Individual patient data obtained from the original trial author will be standardized and all trial data will be combined into a single database. Generalized linear mixed effects model will be used to determine possible subgroup effects by adding an interaction term for predefined subgroup and treatment. SYSTEMATIC REVIEW REGISTRATION: International Prospective Register of Systematic Reviews (Number: CRD42020188366).

Postmarketing Reevaluation of Chinese Traditional Therapy Kangbingdu Oral Liquid in the Treatment of the Common Cold.

Background: Observational studies from China suggest that Kangbingdu oral liquid (KBD) may be effective in treating the common cold. Objective: Reevaluation of efficacy and safety of Kangbingdu oral liquid after marketing and expanding population. Design: Prospective, Pragmatic randomized controlled trial (Chictr.org.cn registration number: chiCTR-TRC-12002399). Setting. Eleven hospitals from 3 provinces in China. Patients were recruited through 11 centers, including 7 teaching hospitals, 2 University health services, one military clinic, and one community hospital. Patients. 2647 persons aged 18 to 75 years with Common cold. Intervention. Patients were randomly allocated to 2 groups: the treatment group Kangbingdu oral liquid (composed of 9 Chinese herbal medicines and honey) and the placebo group were divided into a standard-dose group of 10 ml every time, a middle dose group of 20 ml every time, high dose group of 30 ml every time, 3 times daily. Interventions and control were given for 5 days. Measurements. The primary outcome is the mean amount of total scores measured by the 11-primary symptoms: to observe the change of main symptoms from severe to disappear and to calculate and compare the mean amount of total scores after the periods of observation. Secondary outcomes are the disappearance rate of each symptom and the median time of body temperature returned to normal. Results: On day 5, the Kangbingdu liquid group had significant reductions in the mean amount of total scores measured by the 11-primary symptoms (7.39 [95% CI 7.26 to 7.51] compared to the placebo group (6.43 [95%: CI 6.24 to 6.62]). The Kangbingdu liquid can improve the remission rate of accompanying symptoms on day 5 including aversion to wind, aversion to cold, fever, cough, stuffy, runny nose, sore throat, muscular aches, headache, fatigue, and sweat (P < 0.0001). Significant reductions in time of body temperature to return to normal in the Kangbingdu liquid group (P50, 48.33 [95% CI 46.00 to 52.50] compared with the control group (P50, 64.59 [95% CI 51.08 to 70.50] (P=0.0022). 13 (0.7%) participants in the Kangbingdu liquid group and 1(0.2%) participants in the placebo group (P > 0.05) had treatment-related AEs, which mainly include diarrhea and dyspepsia in the Kangbingdu liquid group and constipation in the placebo group. Conclusion: The study's conclusion in this paper was based on the placebo, Kangbingdu oral liquid two groups which clinically diagnosed the common cold and flu. (1) Kangbingdu oral liquid can effectively improve the comprehensive clinical symptoms of common adult cold, also improved main symptoms, including sore throat, muscle aches, headache, and so on. (2) Kangbingdu oral liquid effectively shortens the time of body temperature to return to normal.

Acupuncture Case Registry Study: Rationale, Implementations, and Achievements.

The acupuncture case registry study is focusing on acupuncture therapy data from patient cases. The main objective is to collect real-world data and integrate clinically meaningful outcome evaluation indicators to uncover and evaluate real-world acupuncture efficacy and safety, explore factors affecting acupuncture efficacy, and provide real-world evidence to complement RCTs. Since the International Acupuncture Case Registry data collection system's establishment in 2017, 16 projects have been underway, including two acupuncture specialty therapies and 15 diseases. Data from 3404 patients included extensive information on the diagnosis and treatment of acupuncture and the evaluation of its efficacy. In order to serve as a guide for future studies, this article discusses the value of and rationale for establishing acupuncture case registry studies, how to distinguish them from patient registries, and crucial techniques for implementing registry studies in terms of applications, patient recruitment, costakeholder collaboration, data collection and management, study quality control, and ethics.

[Minimal clinically important difference of the frequency of bowel movement for patients with chronic severe functional constipation treated with acupuncture].

OBJECTIVE: To estimate the minimal clinically important difference (MCID) of the frequency of bowel movement for the patients with chronic severe functional constipation treated with acupuncture so as to provide the evidence for the clinical decision. METHODS: In this study, 813 patients with chronic severe functional constipation treated with acupuncture in two previous randomized controlled trials were included. Through the anchor-based method (anchored by the item 28 "satisfaction with previous treatment" of the patient assessment of constipation-quality of life [PAC-QOL]) and the distribution-based method, the MCID of the weekly frequency of complete spontaneous bowel movement (CSBM) and spontaneous bowel movement (SBM) was analyzed statistically in the patients. RESULTS: The MCID of the mean weekly frequency of CSBM and SBM was 1.3 times and 1.6 times in patients with chronic severe functional constipation treated with acupuncture, respectively. CONCLUSION: The mean increase of the weekly CSMB is ≥ 1.3 times and that of SBM is ≥ 1.6 times after treatment when compared with the baseline respectively, suggesting the clinical significance.

[Systematic review and meta-analysis of acupuncture and moxibustion: existing problems and countermeasures].

There are some common problems in the systematic review and meta-analysis on acupuncture-moxibustion, e.g. indistinct definition and errors in methodology. In order to further improve the quality of relevant literature, in association with the characteristics of acupuncture-moxibustion, based on the framework of PICOS (P: population, I: interventions, C: comparisons, O: outcomes, S: study designs), the paper explores how to construct specific research questions. In methodology, the paper analyzes the common problems from five aspects, including literature retrieval, bias assessment, analysis and interpretation of results, selection of other types of meta-analysis and the update of methodology. Based on the analysis above, the paper discusses the corresponding countermeasures.

Effect of heat-clearing and detoxifying Chinese medicines combined with conventional therapy on mild hand, foot, and mouth disease with fever: An individual patient data meta-analysis.

BACKGROUND: In China, heat-clearing and detoxifying Chinese medicines combined with conventional therapy are commonly applied to treat the mild hand, foot, and mouth disease (HFMD). However, there is lack of solid evidence on the efficacy and safety of such therapies. METHODS: We conducted a pooled analysis with individual patient data from 5 strictly randomized controlled clinical trials to assess the efficacy and safety of this combination therapy for mild HFMD. An intention-to-treat analysis was performed. A 2-stage meta-analysis method was adopted to analyze the pooled effect size. RESULTS: In total, 947 patients were included. Compared with conventional therapy, the combination therapy significantly reduced the progression rate of HFMD from mild to severe (odds ratio [OR] 0.43, 95% confidence interval [CI]: 0.22 to 0.83, P = .01). Meanwhile, the healing time of skin rash and oral ulcer in the combination therapy group was significantly shorter than that of conventional therapy. The overall hazard ratio (HR) of healing time of the skin rash or oral ulcer was 1.22 (95%CI: 1.04 to 1.43; P = .02). However, except Jinlianqingre effervescent tablets, the combination therapy cannot shorten the time to fever resolution (HR 1.12, 95%CI: 0.97 to 1.29, P = .14). Because of the heterogeneity, Jinlianqingre effervescent tablets were analyzed separately and the HRs of the time to fever resolution and the healing time of skin rash or oral ulcer were 3.88 (95%CI: 3.19 to 4.72; P < .0001) and 3.79 (95%CI: 2.81 to 5.11; P < .0001), respectively. There were 30 adverse events reported in total; 2 cases were related to Chinese medicines. CONCLUSION: In conclusion, the heat-clearing and detoxifying Chinese medicines on top of conventional therapy can effectively reduce the progressive rate of mild HFMD and improve healing of skin and oral mucosal lesions. More studies are needed for the time to fever resolution.

[Cultural anthropology of traditional Chinese medicine].

Biological, psychological and sociological model of medicine substantializes the old model lacking the social humane attributes. The new medical model makes people take medical anthropology into research and highly evaluate traditional medical system. Cultural anthropology of traditional Chinese medicine (TCM) is part of medical anthropology with three major characteristics: wide research scope, specificity, and integration. It has developed its own research methods, such as field investigation, comprehensive inspection and comparison study. Cultural anthropology provides an efficient research method for TCM, and its application would further develop TCM theory and form comprehensive evaluation on TCM effects.

[Clinical outcome assessment and the effect measure].

Effect of clinical intervention on human body is multistage and multifaceted, involving physiology, psychology, social function and the surrounding resources, etc. Therefore, the range of clinical outcome assessment includes patient, his or her family and care giver. The evaluation of clinical intervention mainly focuses on its effectiveness, safety and health economics. Effects of clinical interventions are measured by comparisons of the outcome of intervention and control groups. Different effect measures come from different comparisons.

[Methods of selecting outcome variables for clinical intervention].

Abstract: There are two stages for selecting the clinical intervention outcome variables. One is crude collection and the other is precise collection. The selection methods include brainstorming method, Delphi method, Gordon method, systematic review, systematic analysis method, mathematic model method and so on. Each method has some advantages or disadvantages. When selecting the clinical intervention outcome variables, researchers should make sure the research aim, the representative and the sensitivity of the variables, and select all kinds of recommended methods comprehensively, then decide which method should be used.