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Effects of Goshajinkigan (TJ-107) for oxaliplatin-induced peripheral neurotoxicity using the functional assessment of cancer therapy/gynecologic oncology group 12-item neurotoxicity questionnaire in a Phase II, multicenter, randomized, double-blind, placebo-controlled trial.
Aoyama, T, Morita, S, Kono, T, Hata, T, Mishima, H, Sakamoto, J
Journal of cancer research and therapeutics. 2021;(6):1473-1478
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Abstract
BACKGROUND The aim of the present study was to evaluate the efficacy of TJ-107 for oxaliplatin-induced peripheral neurotoxicity in prospective, multi-institutional, randomized, double-blind, placebo-controlled Phase II trials using the functional assessment of cancer therapy/gynecologic oncology group 12-item neurotoxicity questionnaire (FACT-GOG-NTX-12). PATIENTS AND METHODS The patients who were registered to the Goshajinkigan oxaliplatin neurotoxicity evaluation study (UMIN000002211) were analyzed. A NTX-12 from the validated FACT/GOG-NTX-12 was assessed before treatment and at the end of every 2 cycles. RESULTS The comparisons of the median scores for TJ-107 and the placebo at 8 and 26 weeks were as follows: numbness or tingling in the hands (P = 0.5820), numbness or tingling in the feet (P = 0.3236), feeling of discomfort in the hands (P = 0.8219), feeling of discomfort in the feet (P = 0.5361), joint pain or muscle cramps (P = 0.1974), feeling weak all over (P = 0.2771), trouble hearing (P = 0.2832), ringing or buzzing in ears (P = 0.1031), trouble buttoning buttons (P = 0.1653), trouble feeling the shape of small objects when held in hand (P = 0.2919), trouble walking (P = 0.5406), and pain in the hands or feet when exposed to cold temperatures (P = 0.1872). CONCLUSION There might be no clinically significant difference between the use of TJ-107 and the severity and quality of life for patients treated with oxaliplatin.
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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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Traditional Chinese medicine shenhuang granule in patients with severe/critical COVID-19: A randomized controlled multicenter trial.
Zhou, S, Feng, J, Xie, Q, Huang, T, Xu, X, Zhou, D, Zhang, W, Sun, S, Liu, X, Wu, X, et al
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2021;:153612
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BACKGROUND Coronavirus disease 2019 (COVID-19) is still a pandemic, with a high mortality rate in severe/critical cases. Therapies based on the Shenghuang Granule have proved helpful in viral infection and septic shock. HYPOTHESIS/PURPOSE The objective of the current study was to compare the efficacy and safety of the traditional Chinese medicine, Shenhuang Granule, with standard care in hospitalized patients with severe/critical COVID-19. STUDY DESIGN AND METHODS This was an open-label, multicenter, randomized, controlled clinical trial. At 4 medical centers, a total of 111 severe/critical patients were randomly assigned to receive Shenhuang Granule (SHG group) twice a day for 14 days, in addition to standard care, or to receive standard care alone (Control group). The maximal follow up time was 75 days. The clinical endpoint was clinical improvement and mortality. RESULTS 54 patients were assigned to the control group and 57 to the SHG group. The overall mortality was 75.9% (41/54) in the control group, and 38.6% (22/57) in the SHG group (p < 0.01 vs. control). The post hoc analysis showed that in the severe category, the mortality of the control group vs. the SHG group was 58.8% (10/17) vs. 5.3% (1/19) (p < 0.01); while in the critical category, it was 83.8% (31/37) vs. 55.3% (21/38) (p < 0.05). In the severe category, the mortality of patients who eventually received an invasive ventilator in the control vs. the SHG group was 58.8% (10/17) vs. 0 (0/19) (p < 0.01). Administration of SHG was associated with increased lymphocytes and decreased adverse events. CONCLUSION Shenhuang Granule is a promising integrative therapy for severe and critical COVID-19.
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Efficacy and safety of Xiyanping injection in the treatment of COVID-19: A multicenter, prospective, open-label and randomized controlled trial.
Zhang, XY, Lv, L, Zhou, YL, Xie, LD, Xu, Q, Zou, XF, Ding, Y, Tian, J, Fan, JL, Fan, HW, et al
Phytotherapy research : PTR. 2021;(8):4401-4410
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Xiyanping (XYP) is a Chinese herbal medicine used in the clinic to treat respiratory infection and pneumonia. Recent evidence identified XYP as a potential inhibitor of severe acute respiratory syndrome coronavirus 2, implying XYP as a possible treatment for the coronavirus disease 2019 (COVID-19). Here, we conducted a prospective, multicenter, open-label and randomized controlled trial to evaluate the safety and effectiveness of XYP injection in patients with mild to moderate COVID-19. We consecutively recruited 130 COVID-19 patients with mild to moderate symptoms from five study sites, and randomized them in 1:1 ratio to receive XYP injection in combination with standard therapy or receive standard supportive therapy alone. We found that XYP injection significantly reduced the time to cough relief, fever resolution and virus clearance. Less patients receiving XYP injection experienced disease progression to the severe stage during the treatment process. No severe adverse events were reported during the study. Taken together, XYP injection is safe and effective in improving the recovery of patients with mild to moderate COVID-19. However, further studies are warranted to evaluate the efficacy of XYP in an expanded cohort comprising COVID-19 patients at different disease stages.
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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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Treatment of non-high-risk acute promyelocytic leukemia with realgar-indigo naturalis formula (RIF) and all-trans retinoid acid (ATRA): study protocol for a randomized controlled trial.
Zhang, X, Liu, L, Yao, Y, Gong, S, Wang, M, Xi, J, Chen, L, Wei, S, Zhang, H, Zhao, C, et al
Trials. 2020;(1):7
Abstract
BACKGROUND Acute promyelocytic leukemia (APL) is a highly curable disease when treated with all-trans retinoid acid (ATRA) and arsenic trioxide (ATO). The combination of ATO and ATRA has become the standard therapeutic protocol for induction therapy in non-high-risk APL. An oral arsenic realgar-indigo naturalis formula (RIF) has also showed high efficacy and it has a more convenient route of administration than the standard intravenous regimen. Unlike in previous trials, the arsenical agent was used simultaneously with ATRA during post-remission therapy in this trial. METHODS This study was designed as a multicenter, randomized controlled trial. The trial has a non-inferiority design with superiority being explored if non-inferiority is identified. All patients receive ATRA-ATO during the induction therapy. After achieving hematologic complete remission (HCR), patients were randomly assigned (1:1) to receive treatment with ATRA-RIF (experimental group) or ATRA-ATO (control group) as the consolidation therapy. During the consolidation therapy, the two groups receive ATRA plus RIF or intravenous ATO 2 weeks on and 2 to ~ 4 weeks off until molecular complete remission (MCR), then ATRA and oral RIF 2 weeks on and 2 to ~ 4 weeks off giving a total of six courses. DISCUSSION This trial aims to compare the efficacy of ATRA-ATO versus ATRA-RIF in non-high-risk patients with APL, to demonstrate that oral RIF application reduces the total hospitalization days and medical costs. The simple schedule was studied in this trial. TRIAL REGISTRATION ClinicalTrials.gov, NCT02899169. Registered on 14 September 2016.
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Simo decoction versus domperidone suspension for post-pyloric spiral nasoenteric tube placement: A multicenter, randomized, non-inferiority trial.
Xiao, Y, He, Z, Long, Y, Chen, W, Chen, D, Chi, R, Ye, H, Deng, X, Lv, B, Sun, C, et al
Clinical nutrition (Edinburgh, Scotland). 2020;(8):2406-2412
Abstract
BACKGROUND & AIMS Leveraging prokinetics to facilitate trans-pyloric migration is a conventional strategy. However, due to restrictions on the use of domperidone suspension, oral prokinetics is relatively modest. The study aims to assess the effectiveness of simo decoction as an alternative to domperidone suspension in facilitating post-pyloric placement of spiral nasoenteric tubes. METHODS A prospective, open-label, parallel, and non-inferiority randomized controlled trial was performed involving critically ill adults in 6 university hospitals in China between September 2017 and May 2019. Patients were randomly assigned to receive either simo decoction 20 ml q8h, or domperidone suspension 20 mg/20 ml q6h for 24 h. The primary outcome was procedure success defined as post-pyloric placement (spiral nasoenteric tubes reached the first portion of the duodenum or beyond confirmed by abdominal X-ray 24 h after tube insertion). RESULTS Of 268 patients assessed for eligibility, 224 patients were enrolled and randomly assigned to the simo decoction group or the domperidone suspension group (n = 112 per group). The success rate of post-pyloric placement was 41.1% (46/112) in the simo decoction group, as compared with 47.3% (53/112) in the domperidone suspension group (a risk difference of -6.3%, 95% CI, -19.2% to 6.7%, adjusted risk difference -3.7%, 95% CI -16.3% to 9.0%), in the intention-to-treat analysis, crossing the prespecified margin of -10% for non-inferiority. There were no differences between groups in the success rates of post-D1 (reaching the second portion of the duodenum or beyond), post-D2 (reaching the third portion of the duodenum or beyond), post-D3 (reaching the fourth portion of the duodenum or beyond) and proximal jejunum placement, the incidences of any adverse events, length of ICU stay or mortality in ICU. CONCLUSIONS Non-inferiority of simo decoction to domperidone suspension was not confirmed in facilitating post-pyloric placement of spiral nasoenteric tubes. Registration: The trial was registered with the Chinese Clinical Trial Registry at http://www.chictr.org.cn (registration number ChiCTR-INR-17011311).
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Effects of Astragalus Extract Mixture HT042 on Height Growth in Children with Mild Short Stature: A Multicenter Randomized Controlled Trial.
Lee, D, Lee, SH, Song, J, Jee, HJ, Cha, SH, Chang, GT
Phytotherapy research : PTR. 2018;(1):49-57
Abstract
HT042 is a standardized functional food ingredient approved by Korean Food and Drug Administration with a claim 'HT042 can help height growth of children'. We aimed to evaluate the safety and efficacy of HT042 on height growth in children with mild short stature. A multicenter, randomized, double-blind, placebo-controlled parallel study was performed on children aged 6-8 years with height ranked below the 25th percentile. In 129 children, height gain was significantly higher in HT042 group than placebo group after 24 weeks (mean difference, 0.29 cm; 95% CI, 0.01 to 0.57 cm; p = 0.027). The difference was elevated when the efficacy analysis was restricted to children below the 10th percentile (mean difference, 0.45 cm; 95% CI, 0.04 to 0.87 cm; p = 0.031). Because bone age advancement was lower in HT042 group, height standard deviation score gain for bone age was higher in HT042 group and the difference was significant in children below the 10th percentile (mean difference, 0.20 score; 95% CI, 0.00 to 0.39 points; p = 0.045). Serum IGF-1 and IGFBP-3 levels were significantly increased compared with baseline within HT042 group, but group difference was not significant. HT042 supplementation helped to increase height growth in children without skeletal maturation and was more effective in much shorter children. The effects might be mediated by increases in serum IGF-1 and IGFBP-3 levels. Copyright © 2017 John Wiley & Sons, Ltd.
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Patient characteristics associated with treatment response in patients receiving salvianolate injection for stable angina.
Qi, Y, Yu, C, Tang, L, Li, S, Sun, X
Journal of evidence-based medicine. 2018;(2):83-88
Abstract
OBJECTIVE To explore patient characteristics associated with treatment response in patients receiving salvianolate injection for stable angina. METHODS An analysis was conducted of data from a multicenter, phase IV clinical trial undertaken in China that enrolled 2150 patients hospitalized for stable angina from 50 hospitals. The treatment outcomes were changes of angina severity and nitroglycerin use between baseline and the last day of treatment. We used logistic regression models to explore patient characteristics associated with the treatment response. RESULTS Patients who were overweight or obese (ORa 1.20, 95% CI 1.01 to 1.44), present with hypertension (ORa 1.23, 95% CI 1.01 to 1.49), experienced with 3 or more episodes of angina per week (ORa 1.77, 95% CI 1.44 to 2.17), or concomitantly using antiplatelet agents (ORa 1.44, 95% CI 1.17 to 1.78) were associated with better treatment response defined with the change of angina severity. Those of overweight or obesity (ORa 1.57, 95% CI 1.17 to 2.12) or concomitantly using calcium antagonists (ORa 2.38, 95% CI 1.39 to 4.08) fared better treatment response according to discontinuation or reduction of nitroglycerin use. CONCLUSIONS Patients diagnosed with stable angina and receiving salvianolate injection might fare better treatment response if they were overweight or obese, experienced with hypertension, three or more episodes of angina per week, or concomitantly using antiplatelet agents and calcium antagonists.
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A novel classification method for aid decision of traditional Chinese patent medicines for stroke treatment.
Zhao, Y, Liu, B, He, L, Bai, W, Yu, X, Cao, X, Luo, L, Rong, P, Zhao, Y, Li, G, et al
Frontiers of medicine. 2017;(3):432-439
Abstract
Traditional Chinese patent medicines are widely used to treat stroke because it has good efficacy in the clinical environment. However, because of the lack of knowledge on traditional Chinese patent medicines, many Western physicians, who are accountable for the majority of clinical prescriptions for such medicine, are confused with the use of traditional Chinese patent medicines. Therefore, the aid-decision method is critical and necessary to help Western physicians rationally use traditional Chinese patent medicines. In this paper, Manifold Ranking is employed to develop the aid-decision model of traditional Chinese patent medicines for stroke treatment. First, 115 stroke patients from three hospitals are recruited in the cross-sectional survey. Simultaneously, traditional Chinese physicians determine the traditional Chinese patent medicines appropriate for each patient. Second, particular indicators are explored to characterize the population feature of traditional Chinese patent medicines for stroke treatment. Moreover, these particular indicators can be easily obtained byWestern physicians and are feasible for widespread clinical application in the future. Third, the aid-decision model of traditional Chinese patent medicines for stroke treatment is constructed based on Manifold Ranking. Experimental results reveal that traditional Chinese patent medicines can be differentiated. Moreover, the proposed model can obtain high accuracy of aid decision.