Background. Shenfu injection (SFI) has shown a remarkable therapeutic effect in patients with chronic heart failure (CHF) during the acute phase of symptom aggravation since it became commercially available in 1987. However, the therapeutic effect of SFI has not been validated in a standard clinical study. As a pilot clinical trial, this study aimed to evaluate the safety and efficacy of SFI for treatment of CHF patients during the acute phase. Methods. A total of 160 patients experiencing acute phase CHF were enrolled in this study and randomly assigned to receive the placebo (placebo group, 150 ml glucose (GS)) or SFI (SFI group, 50 ml SFI + 100 ml GS) in addition to their standard medications for CHF treatment. The treatment lasted for 7 ± 1 days, and the follow-up continued for 28 ± 3 days after treatment. The primary endpoints were New York Heart Association (NYHA) classification and Traditional Chinese Medicine (TCM) syndrome scores. Results. After 7±1 days of treatment, the efficacy of SFI according to improvements in NYHA and TCM syndrome scores in the SFI group (78.38% and 89.19%, respectively) was significantly higher than that in the placebo group (61.43% and 60.00%, respectively; P<0.05). The SFI group had a longer increase in amplitude than the placebo group (113.00 m versus 82.99 m, P<0.05). The incidence of adverse events and other safety indices showed no significant differences between the two groups. Conclusion. SFI combined with conventional therapy for treatment of CHF during acute symptom aggravation ameliorated the cardiac dysfunction and clinical symptoms and improved the patients’ quality of life without any significant AEs compared with the conventional therapy alone.
Background Traditional Chinese medicine (TCM) has been widely used in the treatment of coronavirus disease 2019 (COVID-19). Tongue features should be referred for diagnosis and treatment of diseases in TCM. Therefore, it is necessary to analyze the tongue features of the patients suffered from COVID-19. Methods COVID-19 Symptom Database (established by Evidence-based Medicine Center of Tianjin University of TCM) was searched for eligible tongue pictures. The tongue pictures were assessed by TCM experts to extract the data of tongue color, coating color, tongue body shape and coating proper feature. The relationship between tongue features and patient’s condition was analyzed. Results Patients diagnosed as mild and moderate COVID-19 commonly had light red tongue and white coating. Severe patients had purple tongue and yellow coating. The proportion of critical patients with tender tongue increased to 75%. Greasy coating was a significant characteristic of patients with COVID-19. The proportions of greasy coating were 53.33%, 73.30%, 83.67 and 87.5% in disease category of mild, moderate, severe and critical. In addition, the thick coating proportion increased from mild (24.89%) to critical (50.00%). Conclusions Tongue features have certain relationship with the category of COVID-19. Tongue features can serve as potential indicators for the evaluation of patient’s condition and prognosis. Further studies are needed to enhance the quantification of tongue features and develop standards.
BackgroundAcute exacerbation is a common cause of hospitalization in patients with chronic heart failure, and coronary heart disease is the most common cause. Shenfu injection, a Traditional Chinese Medicine injection, widely used in the adjuvant treatment of patients with acute exacerbation of chronic heart failure, shows some treatment effect in improving the symptoms and the quality of life, but it lacks the rigorous clinical evaluation of research reports. This paper describes the protocol for the clinical assessment of Shenfu injection loading in the treatment of patients with acute exacerbation of chronic heart failure.MethodsThis protocol adopts the design of a prospective, randomized, multicenter, blind imitation, placebo-controlled trial to assess the efficacy and safety of Shenfu injection loading in the treatment of patients with acute exacerbation of chronic heart failure due to coronary heart disease. The research will be carried out in 12 hospitals in China and is expected to enroll 160 inpatients with acute exacerbation of chronic heart failure due to coronary heart disease (yang and qi deficiency syndrome). On the basis of the conventional therapy of western medicine, patients will be randomized to either the treatment group (100 ml 5% glucose injection + 50 ml Shenfu injection) or the control group (150 ml 5% glucose injection) for 7 ± 1 days and follow-up for 28 ± 3 days. The primary outcomes are New York Heart Association cardiac function classification and Traditional Chinese Medicine syndromes. The secondary outcomes are left ventricular ejection fraction, brain natriuretic peptide level, Lee’s heart failure score, 6-minute walking distance, and the incidence and readmission rate of cardiovascular events (including the emergency rate due to acute exacerbation of chronic heart failure).DiscussionThis trial will assess the effect of loading Shenfu injection in the treatment of patients with acute exacerbation of chronic heart failure caused by coronary heart disease (yang-qi deficiency syndrome) on the symptoms and signs of heart failure, exercise tolerance, and other aspects, and observe its influence on the short-term prognosis with follow-up. The results of the study will provide clinical research evidence for application of Shenfu injection in the treatment.Trial registrationThis trial was registered on 26 December 2012 at the Chinese Clinical Trials Register (Identifier: ChiCTR-TRC-12002857).Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0729-7) contains supplementary material, which is available to authorized users.
Acne has several effects on physical symptoms, but the main impacts are on the quality of life, which can be improved by treatment. There are several acne treatments but less evidence comparing their relative efficacy. Thus, we assessed the comparative efficacy of pharmacological and nonpharmacological interventions for acne. We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials from inception to April 2019, to include randomized controlled trials for acne that compared topical antibiotics (TA), benzoyl peroxide (BPO), topical retinoids (TR), oral antibiotics (OA), lasers, light devices including LED device (LED), photodynamic therapy (PDT), and intense pulsed light, chemical peels (CP), miscellaneous therapies or complementary and alternative medicine (MTCAM), or their combinations. We performed Bayesian network meta-analysis with random effects for all treatments compared with placebo and each other. Mean differences (MDs) of lesions count and risk ratios of adverse events with their 95% credible intervals (CrIs) were calculated, and all interventions were ranked by the Surface Under the Cumulative Ranking (SUCRA) values. Additional frequentist additive network meta-analysis was performed to detect the robustness of results and potential interaction effects. Sensitivity analyses were carried out with different priors, and metaregression was to adjust for nine potential effect modifiers. In the result, seventy-three randomized controlled trials (27,745 patients with mild to moderate acne), comparing 30 grouped intervention categories, were included with low to moderate risk of bias. For adverse effects, OA had more risk in combination treatment with others. For noninflammatory lesions reduction, seventeen interventions had significant differences comparing with placebo and three interventions (TR+BPO: MD = −21.89, 95%CrI [−28.97, −14.76]; TR+BPO+MTCAM: −22.48 [−34.13, −10.70]; TA+BPO+CP: −20.63 [−33.97, −7.13]) were superior to others with 94, 94, and 91% SUCRA values, respectively. For inflammatory lesions reduction, nineteen interventions were significantly better than placebo, and three interventions (TR+BPO: MD = −12.13, 95%CrI [−18.41, −5.80]; TR+BPO+MTCAM: −13.21 [−.39, −3.04]; LED: −11.30 [−18.34, −4.42]) were superior to others (SUCRA: 81, 81, and 77%, respectively). In summary of noninflammatory and inflammatory lesions results, TR+BPO and TA+BPO were the best options compared to others. The frequentist model showed similar results as above. In summary, current evidence supports the suggestion that TR+BPO and TA+BPO are the best options for mild to moderate acne. LED is another option for inflammatory lesions when drug resistance occurs. All the combinations involved with OA showed more risk of adverse events than others. However, the evidence of this study should be cautiously used due to the limitations.
BackgroundFunctional constipation (FC) is a common bowel disorder that prevails worldwide. In China, although a heterogeneous prevalence of constipation is expected, it is currently not demonstrated. In this study, we aimed to evaluate the prevalence and related risk factors of FC in the Chinese population, according to the Rome criteria.MethodsWe searched the PubMed, the Embase, the Cochrane Library, the Web of Science, the China National Knowledge Infrastructure (CNKI), the Wanfang data knowledge service platform, the VIP information resource integration service platform, and the Chinese Biomedical Literature Service System (SinoMed) databases from the inception of database to July 2021. Population-based cross-section studies that enrolled adults with FC, diagnosed by the Rome criteria, were deemed eligible. We summarized the overall prevalence and detected the subgroup effect per the Rome I, Rome II, Rome III, and Rome IV criteria. We used the generalized linear mixed model (GLMM) with a random-effect intercept to pool the prevalence and performed pairwise meta-analyses for prevalence comparisons by risk factors.ResultsWe identified 3,213 records through our database search, and 39 studies from China, comprising 1,240,79 participants, met the eligibility criteria for our study. The pooled overall prevalence of FC using the Rome criteria was 8.5% in China. Heterogeneous prevalence was detected within the Rome criteria (Rome II: 10.6%, 95% CI: 7.2–15.4; Rome III: 6.5%, 95% CI: 3.4–12.0; Rome IV: 8.1%, 95% CI: 5.6–11.8). The prevalence increased between 1991 and 2020 (from 5.5% with 95% CI: 3.6–8.2 between 1991 and 2000 to 10.9% with 95% CI: 5.5–20.4 between 2011 and 2020). Higher prevalence was found in women [odds ratio (OR) = 1.53, 95% CI: 1.31–1.78] and the elderly (≥70 years vs. ≤ 29 years: OR = 3.38, 95% CI: 2.16–5.30) than in men and the younger population. A high-fiber diet was associated with lower prevalence (OR = 0.33, 95% CI: 0.15–0.75), whereas irregular bowel habit and inactivity were associated with higher prevalence (OR = 3.64, 95% CI: 2.64–5.03; OR = 1.97, 95% CI: 1.14–3.43). Unhealthy mental states, such as anxiety and depression, and poor sleep quality led to high prevalence (OR = 3.16, 95%C I: 1.96–5.11; OR = 2.74, 95% CI: 1.76–4.26; OR = 2.14, 95% CI: 1.69–2.72, respectively).ConclusionVarious types of FC prevail in China based on the different Rome criteria, personal characteristics, and habits. The prevalence also increased over the past three decades. The FC should be included under the primary care setting with uniform diagnosis criteria in China.Systematic Review Registrationhttp://www.crd.york.ac.uk/PROSPERO, CRD42021277172.
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