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Efficacy and safety of Lianhuaqingwen capsules, a repurposed Chinese herb, in patients with coronavirus disease 2019: A multicenter, prospective, randomized controlled trial.
Hu, K, Guan, WJ, Bi, Y, Zhang, W, Li, L, Zhang, B, Liu, Q, Song, Y, Li, X, Duan, Z, et al
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2021;:153242
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Abstract
BACKGROUND Coronavirus disease 2019 (Covid-19) has resulted in a global outbreak. Few existing targeted medications are available. Lianhuaqingwen (LH) capsule, a repurposed marketed Chinese herb product, has been proven effective for influenza. PURPOSE To determine the safety and efficacy of LH capsule in patients with Covid-19. METHODS We did a prospective multicenter open-label randomized controlled trial on LH capsule in confirmed cases with Covid-19. Patients were randomized to receive usual treatment alone or in combination with LH capsules (4 capsules, thrice daily) for 14 days. The primary endpoint was the rate of symptom (fever, fatigue, coughing) recovery. RESULTS We included 284 patients (142 each in treatment and control group) in the full-analysis set. The recovery rate was significantly higher in treatment group as compared with control group (91.5% vs. 82.4%, p = 0.022). The median time to symptom recovery was markedly shorter in treatment group (median: 7 vs. 10 days, p < 0.001). Time to recovery of fever (2 vs. 3 days), fatigue (3 vs. 6 days) and coughing (7 vs. 10 days) was also significantly shorter in treatment group (all p < 0.001). The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%, p < 0.001) and clinical cure (78.9% vs. 66.2%, p = 0.017) was also higher in treatment group. However, both groups did not differ in the rate of conversion to severe cases or viral assay findings (both p > 0.05). No serious adverse events were reported. CONCLUSION In light of the safety and effectiveness profiles, LH capsules could be considered to ameliorate clinical symptoms of Covid-19.
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JianpiQinghua granule reduced PPI dosage in patients with nonerosive reflux disease: A multicenter, randomized, double-blind, double-dummy, noninferiority study.
Zhang, J, Che, H, Zhang, B, Zhang, C, Zhou, B, Ji, H, Xie, J, Shi, X, Li, X, Wang, F, et al
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2021;:153584
Abstract
BACKGROUND Proton pump inhibitors (PPIs) play an important role in the treatment of nonerosive reflux disease (NERD), but their long-term and excessive uses have been associated with safety concerns. Chinese herbal medicine (CHM) has become a popular alternative treatment for this condition. METHODS A total of 204 patients were randomly assigned to the combination group or PPI group (1:1 ratio). They were given JianpiQinghua (JQ) granules (34.8 g) plus omeprazole (10 mg) plus dummy omeprazole (10 mg) or dummy JQ granules (34.8 g) plus omeprazole (20 mg) daily for 4 weeks. The primary endpoints were the rate of sufficient relief and complete resolution of GERD Q at week 4. Metabonomics and the gut microbiota were also assessed. RESULTS Complete resolution was observed in 40.8% of patients in the combination group and 26.8% of patients in the PPI group after 4 weeks (FAS analysis, OR, 1.88; 95% CI, 1.03-3.44; p = 0.039). Sufficient relief was observed in 50% of patients in the combination group and 43.30% of patients in the PPI group after 4 weeks (FAS analysis, OR, 1.31; 95% CI, 0.74-2.30; p = 0.35). Three patients had liver dysfunction, one of whom had a mild case and 2 of whom had moderate-to-severe cases in the combination group. Patients in the combination group showed a significant increase in richness and diversity of their gut microbiota compared with those in the PPI group. Metabonomics showed that the combination therapy could correct the glutamate metabolism pathway. CONCLUSION Our findings demonstrate the superior efficacy of JQ granules combined with omeprazole (10 mg) vs. omeprazole (20 mg) in terms of symptom relief in patients with NERD. TRIAL REGISTRATION ClinicalTrials.gov number NCT02892357. Registered on 14 February 2019.
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A multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the effects of qili qiangxin capsules in patients with chronic heart failure.
Li, X, Zhang, J, Huang, J, Ma, A, Yang, J, Li, W, Wu, Z, Yao, C, Zhang, Y, Yao, W, et al
Journal of the American College of Cardiology. 2013;(12):1065-1072
Abstract
OBJECTIVES The purpose of this study was to assess the effects of qili qiangxin capsules in patients with chronic heart failure (CHF). BACKGROUND Qili qiangxin capsules are a traditional Chinese medicine that has been approved in China for the treatment of CHF, but the evidence supporting its efficacy remains unclear. METHODS A total of 512 patients with CHF were enrolled and randomly assigned to receive the placebo or qili qiangxin capsules in addition to their standard medications for the treatment of CHF. The primary endpoint was the reduction or percent change in the plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) level during 12 weeks of treatment. RESULTS At the 12-week follow-up, a significant reduction in the NT-proBNP level from baseline was observed in both groups, but the qili qiangxin capsule group demonstrated a significantly greater reduction than the placebo group (p = 0.002); 47.95% of patients in the qili qiangxin capsule group demonstrated reductions in NT-proBNP levels of at least 30% compared with 31.98% of patients in the placebo group (p < 0.001). Treatment with qili qiangxin capsules also demonstrated superior performance in comparison to the placebo with respect to New York Heart Association functional classification, left ventricular ejection fraction, 6-min walking distance, and quality of life. CONCLUSIONS On a background of standard treatment, qili qiangxin capsules further reduced the levels of NT-proBNP. Together, our data suggest that qili qiangxin capsules could be used in combination therapy for CHF.
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[Observation on short-term therapeutic effect of zhenggan recipe in treating liver cirrhosis with alpha-feto-protein].
Yang, DG, Li, ZY, Deng, X, Li, X, Nie, G, He, Q
Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine. 2005;(10):931-3
Abstract
OBJECTIVE To observe the therapeutic effect of Zhenggan Recipe (ZGR) in treating liver cirrhosis with abnormal Alpha-fetoprotein (AFP), and to explore its mechanism. METHODS Sixty-four patients of liver cirrhosis with abnormal AFP were randomly divided into the treated group and the control group. All the patients received conventional combined Western medicinal treatment. Besides, additional ZGR was given to the patients in the treated group, one dose every day for orally taken in two times, 6 months as a therapeutic course. Changes in liver function (ALT, GGT, TBIL and ALB), AFP, T-lymphocyte subsets (CD4, CD4/CD8) and iconological examination were observed in the two groups before and after treatment to compared the efficacy. RESULTS ZGR could effectively lower the AFP level (P < 0.01), and improve the levels of CD4 and CD4/CD8 (P < 0.01 or P < 0.05). CONCLUSION ZGR can effectively lower the level of AFP, its mechanism might be related to the improving of cellular immune function of the patients.
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[Clinical observation on effect of shenqi fanghou recipe in preventing and treating radiation injury in patients with head and neck tumor].
Hu, YR, Wu, CQ, Liu, YJ, Wang, Y, Li, X, Zhong, H, Yu, Y
Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine. 2005;(7):623-5
Abstract
OBJECTIVE To observe the therapeutic effect of shenqi fanghou recipe (SFR) in preventing and treating radiation injury in patients with head and neck tumor. METHODS One hundred and forty patients with head and neck tumor, including nasopharyngeal carcinoma, carcinoma of tonsil or tongue, were randomly divided into 2 groups, 70 patients in the observed group were given modified SFR as adjuvant to radiotherapy, while 70 patients in the control group were treated with radiotherapy alone. The radiation reactions during radiotherapy and the condition of late stage radiation injury radiotherapy in patients in the 2 groups were observed. RESULTS The degree of oropharyngeal mucosa reaction, dryness in mouth and radiation dermatitis in cervical region in the observed group was milder than those in the control group, and the radiation injury induced late stage sequelae, such as the degree of mouth-opening was better and the cervical muscular sclerosis was better in the observed group than in the control group, showing significant difference (P < 0.01). CONCLUSION SFR has definite effect in preventing and treating radiation reaction and late stage radiation injury in patients with head and neck tumor.
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[Study on abnormality and regulation of T-lymphocyte subsets in peripheral blood of rheumatoid arthritis patients].
Li, YN, Zhao, YS, Li, X
Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine. 2002;(5):359-61
Abstract
OBJECTIVE To investigate the change of T-lymphocyte subsets in peripheral blood of rheumatoid arthritis (RA) patients and analyze the effects of Fuzheng Qubi Decoction (FZQBD) on T-cell subsets. METHODS Thirty RA patients were randomly divided into two groups, and treated with FZQBD or western medicine combination therapy respectively for one month, the percentage of peripheral CD3+, CD4+, CD8+ as well as the serum IgG and IgA levels were determined. RESULTS The percentage of peripheral CD4+, CD4+/CD8+ ratio, IgG and IgA levels increased significantly (P < 0.001) in RA patients before treatment. After 1 month of FZQBD treatment, the CD4+/CD8+ ratio decreased obviously (P < 0.05). CONCLUSION Abnormal cellular immunity exists in RA patients, FZQBD could adjust the abnormal T-lymphocyte subsets to normalize it.