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Efficacy and safety evaluation of Ginkgo biloba dropping pill (GBDP) on stable angina pectoris complicated with depression: A placebo-controlled, randomized, double-blind, multicenter study.
He, X, Liu, D, Ni, S, Li, Z, Li, S, Wu, T, Dong, X, Zhang, X, Tang, Y, Ling, Y, et al
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2024;:155264
Abstract
BACKGROUND Stable angina pectoris (SAP) is a clinical condition characterized by reversible and temporary myocardial ischemia and hypoxia. A majority of SAP patients also experience depressive disorders, which adversely affect their disease prognosis and overall quality of life. However, the clinical utility of existing antidepressants is constrained by their side effects. Ginkgo biloba dropping pill (GBDP), a Chinese patented medication, has demonstrated efficacy in the treatment of both coronary heart disease and mental disorders. This prospective, randomized, double-blind, multicenter clinical trial aimed to assess the effectiveness and safety of GBDP as an adjuvant therapy for SAP complicated by depression. METHODS Participants were randomly assigned in a 1:1 ratio to receive either GBDP or a placebo (5 pills, three times a day) in addition to standard therapy for a duration of 12 weeks. The Seattle Angina Questionnaire (SAQ) was administered every 4 weeks during the treatment, and angina event frequency was assessed weekly. The 36-item Short-Form (SF-36) and Hamilton Depression Scale (HAMD) scores were measured both before and after the treatment. RESULTS Out of the 72 patients, 68 (n = 34 per group) completed the entire study. At the first visit (4 weeks ± 3 days), the SAQ-Angina Stability score in the GBDP group was significantly higher than that in the placebo group (p < 0.05). While the average weekly frequency of angina episodes in the placebo group notably increased after 12 weeks of treatment (p < 0.05), it displayed an improving trend in the GBDP group (p > 0.05). By the endpoint, each subcategory score of SF-36 in the GBDP group exhibited significant improvement compared to baseline (p < 0.05). The comparison of score improvement between the two groups revealed that the SF-PCS score of the GBDP group was higher than that of the placebo group (p < 0.05). HAMD scores in both groups significantly increased after treatment (p < 0.05). No discernible difference in the incidence of adverse reactions was observed between the two groups (p > 0.05). CONCLUSION In patients with SAP complicated by depression, GBDP, when combined with standard treatment, rapidly and safely alleviates angina pectoris symptoms. It demonstrates therapeutic potential in enhancing the quality of life and alleviating depressive symptoms.
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Association of possible sarcopenia with all-cause mortality in patients with solid cancer: A nationwide multicenter cohort study.
Yin, L, Song, C, Cui, J, Lin, X, Li, N, Fan, Y, Zhang, L, Liu, J, Chong, F, Cong, M, et al
The journal of nutrition, health & aging. 2024;(1):100023
Abstract
OBJECTIVES The concept of possible sarcopenia (PS) was recently introduced to enable timely intervention in settings without the technologies required to make a full diagnosis of sarcopenia. This study aimed to investigate the association between PS and all-cause mortality in patients with solid cancer. DESIGN Retrospective observational study. SETTING AND PARTICIPANTS 13,736 patients with 16 types of solid cancer who were ≥18 years old. MEASUREMENTS The presence of both a low calf circumference (men <34 cm or women <33 cm) and low handgrip strength (men <28 kg or women <18 kg) was considered to indicate PS. Harrell's C-index was used to assess prognostic value and the association of PS with mortality was estimated by calculating multivariable-adjusted hazard ratios (HRs). RESULTS The study enrolled 7207 men and 6529 women (median age = 57.8 years). During a median follow-up of 43 months, 3150 deaths occurred. PS showed higher Harrell's C-index (0.549, 95%CI = [0.541, 0.557]) than the low calf circumference (0.541, 95%CI = [0.531, 0.551], P = 0.037) or low handgrip strength (0.542, 95%CI = [0.532, 0.552], P = 0.026). PS was associated with increased mortality risk in both univariate (HR = 1.587, 95%CI = [1.476, 1.708]) and multivariable-adjusted models (HR = 1.190, 95%CI = [1.094, 1.293]). Sensitivity analyses showed that the association of PS with mortality was robust in different covariate subgroups, which also held after excluding those patients who died within the first 3 months (HR = 1.162, 95%CI = [1.060, 1.273]), 6 months (HR = 1.150, 95%CI = [1.039, 1.274]) and 12 months (HR = 1.139, 95%CI = [1.002, 1.296]) after enrollment. CONCLUSION PS could independently and robustly predict all-cause mortality in patients with solid cancer. These findings imply the importance of including PS assessment in routine cancer care to provide significant prognostic information to help mitigate sarcopenia-related premature deaths.
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Effects of Chinese heart-healthy diet on blood lipids, glucose, and estimated 10-y cardiovascular disease risk among Chinese adults: results on secondary outcomes of a randomized controlled trial.
Li, Q, Feng, L, Sun, J, Zhu, H, Zeng, G, Gao, P, Yuan, J, Zhao, Y, Li, S, Lan, X, et al
The American journal of clinical nutrition. 2024;(2):333-343
Abstract
BACKGROUND Healthy diet is essential for cardiovascular disease risk management, but its effects among Chinese patients, whose diets differ from Western diets, remain largely unknown. METHODS In this multicenter, patient- and outcome assessor-blind, randomized controlled feeding trial, 265 Chinese adults with baseline systolic blood pressure 130 to 159 mmHg were randomly assigned into Chinese heart-healthy (CHH) diet or usual diet for a 28-d intervention after a 7-d run-in period on usual diet. Blood lipids and glucose were measured from overnight fasting blood samples before and after the intervention. Ten-year cardiovascular disease risk was estimated using models previously developed and validated in Chinese. The changes in secondary outcomes of serum total cholesterol (TC), blood glucose, and 10-y cardiovascular disease risk over the intervention period were compared between intervention groups, adjusting for center, among participants with baseline and follow-up blood samples available. Sensitivity analyses were done with further adjustment for baseline values and covariables; missing data imputed; and among per-protocol population. RESULTS Among 256 eligible participants (130 on CHH diet, 126 on control diet), 42% had hypercholesterolemia and 15% had diabetes at baseline. In the control group, TC and 10-y cardiovascular disease risk decreased after the intervention by 0.16 mmol/L and 0.91%, respectively, but blood glucose increased by 0.25 mmol/L. Compared with usual diet, the CHH diet lowered TC (-0.14 mmol/L, P = 0.017) and 10-y cardiovascular disease risk (-1.24%, P = 0.001) further. No effect on blood glucose was found. All sensitivity analyses confirmed the results on TC and 10-y cardiovascular disease risk, and analysis with multiple variables adjusted showed a borderline significant effect on blood glucose (-0.17 mmol/L, P = 0.051). The differences in intake of nutrients and food groups between intervention groups explained the results. CONCLUSIONS The CHH diet reduced TC and 10-y cardiovascular disease risk and was likely to reduce blood glucose among Chinese adults with mild hypertension. Further studies with longer terms are warranted. This trial was registered at clinicaltrials.gov as NCT03882645.
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Using a new human milk fortifier to optimize human milk feeding among very preterm and/or very low birth weight infants: a multicenter study in China.
Han, J, Zhang, L, Zhang, R, Han, S, Zhu, J, Hu, X, Sun, J, Qiu, G, Li, Z, Yan, W, et al
BMC pediatrics. 2024;(1):61
Abstract
BACKGROUND Human milk fortifier (HMF) composition has been optimized recently. But clinical evidence of its safety and efficacy is limited in Chinese population. The aim of this study was to evaluate effects of a new HMF in growth, nutritional status, feeding intolerance, and major morbidities among very preterm (VPT) or very low birth weight (VLBW) infants in China. METHODS VPT/VLBW infants admitted from March 2020 to April 2021 were prospectively included in the experimental (new HMF, nHMF) group, who received a new powdered HMF as a breast milk feeding supplement during hospitalization. Infants in the control group (cHMF) admitted from January 2018 to December 2019, were retrospective included, and matched with nHMF group infants for gestational age and birth weight. They received other kinds of commercially available HMFs. Weight gain velocity, concentrations of nutritional biomarkers, incidence of major morbidities, and measures of feeding intolerance were compared between the two groups. RESULTS Demographic and clinical characteristics of infants in nHMF and cHMF groups were comparable. Weight gain velocity had no significant difference between the nHMF (14.0 ± 3.5 g/kg/d) and the cHMF group (14.2 ± 3.8 g/kg/d; P = 0.46). Incidence of morbidities, including necrotizing enterocolitis, bronchopulmonary dysplasia, retinopathy of prematurity, culture-confirmed sepsis, and feeding intolerance during hospitalization between nHMF and cHMF, were similar (all P-values > 0.05). The time to achieve full enteral feeding [13.5 (10, 21) days] in the nHMF group was significantly shorter than that in the cHMF group [17 (12, 23) days, HR = 0.67, 95%CI: 0.49, 0.92; P = 0.01]. Compared with cHMF group, the decrease of blood urea nitrogen level over time in nHMF group was smaller (β = 0.6, 95%CI:0.1, 1.0; P = 0.01). CONCLUSIONS The new HMF can promote growth of preterm infants effectively without increasing the incidence of major morbidity and feeding intolerance. It can be used feasible in Chinese VPT/VLBW infants. TRIAL REGISTRATION This study was registered on ClinicalTrials.gov (NCT04283799).
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Effect of Baimai ointment on lumbar disc herniation: A multicentre, prospective, randomised, double-blind, placebo-controlled trial.
Sun, C, Sun, K, Wang, S, Wang, Y, Yuan, P, Li, Z, Yang, S, Zhang, J, Jia, Y, Wang, W, et al
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2024;:155138
Abstract
BACKGROUND Baimai ointment is a traditional Tibetan topical ointment, which is widely used for various diseases related to the skeletal muscular system and neurological rehabilitation. It has demonstrated good clinical effectiveness. However, there is currently a lack of high-quality evidence regarding the clinical effectiveness of Baimai ointment in treating lumbar disc herniation (LDH). PURPOSE In this study, we conducted a prospective, multicenter, double-blind, randomized controlled trial at eight hospitals in China to investigate the clinical effectiveness of Baimai ointment in the treatment of LDH. METHODS Participants aged 18-65 years were diagnosed as LDH and were randomly assigned to receive either Baimai ointment or placebo. The treatment duration was 2 weeks, with 1-week follow-up after treatment. The primary outcome measures included VAS and JOA score. The secondary outcome measures included Likert scale, compliance with health education and the incidence of rescue therapy. The intervention effects on these outcomes were examined by generalized estimating equations (GEE) with baseline measurement as the covariates. All statistical analysis were performed using SPSS 25.0 and Python 3.11. RESULTS In total, 228 participants were screened from August 25, 2021 to January 31, 2022 at 8 Grade-A tertiary hospitals in China. Finally, 194 eligible participants were randomly assigned to the Baimai ointment group and placebo group in a 1:1 ratio. At the end of 2-week treatment (14th day) and 1-week follow-up after treatment (21st day), the decrease of VAS reached 39.57% (95% CI: 34.29, 44.86) and 36.85% (95% CI: 32.04, 41.66), the decrease in JOA score reached 27.74% (95% CI: 23.05, 32.43) and 26.25 % (95% CI: 20.82, 31.69) in Baimai ointment group. A significant group-by-time interaction indicated a difference for VAS between intervention over time (χ2 = 26.81, p = 0.020), but JOA score and Likert scale did not reach statistical significance. The adjusted net difference of VAS was statistically significant from 10th day of treatment (p < 0.05). After 2-week treatment, the relief rate of VAS was 30.85% (21.95, 41.34) in Baimai ointment group and 22.73% (14.75, 33.13) in placebo group (χ2 = 1.53, p = 0.217). It demonstrated Baimai ointment in improving VAS and JOA score was valuable from a clinical view by measuring MCID. Moreover, the Likert scale, the incidence of rescue therapy and compliance with health education did not reach statistical significance. There was no evidence showing that Baimai ointment could cause serious adverse reactions in treating patients with LDH. CONCLUSION Baimai ointment demonstrated significantly higher rates of symptom relief compared to the placebo for LDH patients, particularly in terms of relieving pain. Moreover, further high-quality randomized controlled trials were necessary to confirm these positive results. The study protocol is registered with the Clinical Trials Registry (registration number: ISRCTN11912818).
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Icosapent ethyl therapy for very high triglyceride levels: a 12-week, multi-center, placebo-controlled, randomized, double-blinded, phase III clinical trial in China.
Wang, Z, Zhang, X, Qu, Y, Zhang, S, Chen, Y, Chen, X, Qi, X, Liu, P, Liu, S, Jiang, S, et al
Lipids in health and disease. 2023;(1):71
Abstract
OBJECTIVES Eicosapentaenoic acid in its ethyl ester form is the single active component of icosapent ethyl (IPE). This study was a phase III, multi-center trial assessing the safety and efficiency of IPE for treating very high triglyceride (TG) in a Chinese cohort. METHODS Patients having TG levels (5.6-22.6 mmol/L) were enrolled and randomly assigned to receive a treatment of oral intake of 4 g or 2 g/day of IPE, or placebo. Before and after 12 weeks of treatment, TG levels were assessed and the median was calculated to determine the change between the baseline and week 12. In addition to examining TG levels, the impact of such treatments on other lipid changes was also investigated. The official Drug Clinical Trial Information Management Platform has registered this study (CTR20170362). RESULTS Random assignments were performed on 373 patients (mean age 48.9 years; 75.1% male). IPE (4 g/day) lowered TG levels by an average of 28.4% from baseline and by an average of 19.9% after correction for placebo (95% CI: 29.8%-10.0%, P < 0.001). In addition, plasma concentration of non-high-density lipoprotein cholesterol (non-HDL-C), very low-density lipoprotein (VLDL) cholesterol, and VLDL-TG remarkedly reduced after IPE (4 g/day) treatment by a median of 14.6%, 27.9%, and 25.2%, respectively compared with participants in placebo group. Compared to the placebo, neither 4 nor 2 g of IPE daily elevated LDL-C levels with statistical significance. IPE was well tolerated by all the treatment groups. CONCLUSIONS IPE at 4 g/day dramatically lowered other atherogenic lipids without a noticeable increase in LDL-C, thereby decreasing TG levels in an exceptionally high-TG Chinese population.
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A randomized controlled trial involving college student: Comparing 0.15% hyaluronic acid with 0.05% cyclosporine A and 3% diquafosol sodium in the Treatment of Dry Eye.
Xu, W, Zhao, X, Jin, H, Jin, H, Jia, F, Jiang, L, Li, Z
Medicine. 2023;(36):e34923
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Abstract
BACKGROUND To compare the efficacy of 0.15% hyaluronic acid (HA), 0.05% cyclosporine A (CsA) and 3% diquafosol sodium (DQS) ophthalmic solution for the treatment of moderate-to-severe dry eye disease (DED) in college students and the effect on inflammatory factors in tears. METHODS This was a prospective, randomized, multicenter trial. A total of 282 college students diagnosed with moderate-to-severe DED between October 2, 2022 and March 1, 2023 were included. A total of 282 patients were randomized to treatment in the group of 0.15% HA or 0.05% CsA or 3% DQS in a 1:1:1 assignment. There was a main end point which is the variations in the corneal staining score to determine non-inferiority of 0.15% HA. Secondary target end points were ocular surface disease index score, Schirmer test, tear meniscus height and tear film breakup time. In addition, the inflammatory factor levels of Interleukin-1β, Interleukin-6, transforming growth factor-β1 in tears were measured. Effectiveness was assessed at baseline, 4- and 12-weeks. RESULTS In our analysis, the average change from baseline in corneal staining score confirmed non-inferiority of 0.15% HA to 0.05% CsA and 3% DQS and manifested obvious improvement of all groups as well (P < .05). Values for ocular surface disease index score, Schirmer test, tear meniscus height and tear film breakup time showed obvious improvements in all groups (P < .05), however, the difference intergroup was not statistically significant. Value for inflammatory factor was significant improvement across all groups, although inflammatory factor scores in the 0.05% CsA group showed a clear trend of better improvement at 12 weeks compared with 0.15% HA groups (P < .01). No serious adverse reactions were observed. CONCLUSIONS College students taking 0.15% HA had clinically and statistically significant improvement in corneal staining score and other indicators, but it was inferior to 0.05% CsA in anti-inflammatory therapy for moderate to severe DED. However, 0.15% HA is still an effective, safe and well-tolerated treatment option that may offer additional benefits in terms of convenience and compliance.
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Multicenter Randomized Double-Blind Phase III Trial of Donafenib in Progressive Radioactive Iodine-Refractory Differentiated Thyroid Cancer.
Lin, Y, Qin, S, Yang, H, Shi, F, Yang, A, Han, X, Liu, B, Li, Z, Ji, Q, Tang, L, et al
Clinical cancer research : an official journal of the American Association for Cancer Research. 2023;(15):2791-2799
Abstract
PURPOSE The phase II/III study of donafenib was initiated when there was no available treatment indicated for Chinese patients with progressive radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC). Donafenib, an oral tyrosine kinase inhibitor (TKI), showed good efficacy and tolerability in the phase II study. We aimed to further evaluate the antitumor activity and safety of donafenib in Chinese patients with RAIR-DTC. PATIENTS AND METHODS This multicenter, double-blind, placebo-controlled, phase III study enrolled 191 patients with progressive RAIR-DTC and randomized in a ratio of 2:1 to donafenib (300 mg twice daily, n = 128) or matched placebo (n = 63). An open-label donafenib treatment period was allowed upon disease progression. The primary endpoint was progression-free survival (PFS) assessed by the independent review committee. The second endpoints include objective response rate (ORR), disease control rate (DCR), safety, etc. RESULTS Donafenib demonstrated prolonged median PFS over placebo [12.9 vs. 6.4 months; hazard ratio (HR), 0.39; 95% confidence interval (CI), 0.25-0.61; P < 0.0001] in Chinese patients with RAIR-DTC. Improved ORR (23.3% vs. 1.7%; P = 0.0002) and DCR (93.3% vs. 79.3%; P = 0.0044) were observed in the donafenib group over placebo. For donafenib, the most common grade ≥ 3 treatment-related adverse events (AE) included hypertension (13.3%) and hand-foot syndrome (12.5%), 42.2% underwent dose reduction or interruption, and 6.3% experienced discontinuation. CONCLUSIONS Donafenib was well-tolerated and demonstrated clinical benefit in terms of improved PFS, ORR, and DCR in patients with RAIR-DTC. The results suggest that donafenib could be a new treatment option for patients with RAIR-DTC.
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Effect of Incorporating 1 Avocado Per Day Versus Habitual Diet on Visceral Adiposity: A Randomized Trial.
Lichtenstein, AH, Kris-Etherton, PM, Petersen, KS, Matthan, NR, Barnes, S, Vitolins, MZ, Li, Z, Sabaté, J, Rajaram, S, Chowdhury, S, et al
Journal of the American Heart Association. 2022;(14):e025657
Abstract
Background Excess visceral adiposity is associated with increased risk of cardiometabolic disorders. Short-term well-controlled clinical trials suggest that regular avocado consumption favorably affects body weight, visceral adiposity, and satiety. Methods and Results The HAT Trial (Habitual Diet and Avocado Trial) was a multicenter, randomized, controlled parallel-arm trial designed to test whether consuming 1 large avocado per day for 6 months in a diverse group of free-living individuals (N=1008) with an elevated waist circumference compared with a habitual diet would decrease visceral adiposity as measured by magnetic resonance imaging. Secondary and additional end points related to risk factors associated with cardiometabolic disorders were assessed. The primary outcome, change in visceral adipose tissue volume during the intervention period, was not significantly different between the Avocado Supplemented and Habitual Diet Groups (estimated mean difference (0.017 L [-0.024 L, 0.058 L], P=0.405). No significant group differences were observed for the secondary outcomes of hepatic fat fraction, hsCRP (high-sensitivity C-reactive protein), and components of the metabolic syndrome. Of the additional outcome measures, modest but nominally significant reductions in total and low-density lipoprotein cholesterol were observed in the Avocado Supplemented compared with the Habitual Diet Group. Changes in the other additional and post hoc measures (body weight, body mass index, insulin, very low-density lipoprotein concentrations, and total cholesterol:high-density lipoprotein cholesterol ratio) were similar between the 2 groups. Conclusions Addition of 1 avocado per day to the habitual diet for 6 months in free-living individuals with elevated waist circumference did not reduce visceral adipose tissue volume and had minimal effect on risk factors associated with cardiometabolic disorders. Registration URL: https://clinicaltrials.gov; Unique identifier: NCT03528031.
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Effects of Cuisine-Based Chinese Heart-Healthy Diet in Lowering Blood Pressure Among Adults in China: Multicenter, Single-Blind, Randomized, Parallel Controlled Feeding Trial.
Wang, Y, Feng, L, Zeng, G, Zhu, H, Sun, J, Gao, P, Yuan, J, Lan, X, Li, S, Zhao, Y, et al
Circulation. 2022;(4):303-315
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Abstract
BACKGROUND More than one-fifth of the world's population consumes Chinese cuisines regularly, but no evidence-based healthy diets fitting the Chinese food culture are available for implementation. METHODS A multicenter, patient- and outcome assessor-blind, randomized feeding trial was conducted among 265 participants with 130 to 159 mm Hg baseline systolic blood pressure (SBP) for 4 major Chinese cuisines (Shangdong, Huaiyang, Cantonese, Szechuan). After a 7-day run-in period on a control diet matching the usual local diets, participants were randomized to continue with the control diet or the cuisine-based Chinese heart-healthy diet for another 28 days. The primary outcome was SBP, and secondary outcomes included diastolic blood pressure and food preference score. Linear regression models were used to estimate the intervention effects and adjustments for the center. The incremental cost per 1 mm Hg reduction in SBP was also calculated. RESULTS A total of 265 participants were randomized (135 on the Chinese heart-healthy diet and 130 on the control diet), with 52% women, mean age of 56.5±9.8 years, and mean SBP and diastolic blood pressure of 139.4±8.3 and 88.1±8.0 mm Hg, respectively, at baseline. The change in SBP and diastolic blood pressure from baseline to the end of the study in the control group was -5.0 (95% CI, -6.5 to -3.5) mm Hg and -2.8 (95% CI, -3.7 to -1.9) mm Hg, respectively. The net difference of change between the 2 groups in SBP and diastolic blood pressure were -10.0 (95% CI, -12.1 to -7.9) mm Hg and -3.8 (95% CI, -5.0 to -2.5) mm Hg, respectively. The effect size did not differ among cuisines (P for interaction=0.173). The mean food preference score was 9.5 (with 10 the best preferred) at baseline, and the net change during intervention was 0.1 (95% CI, -0.1 to 0.2; P=0.558). The incremental cost-effectiveness ratio per 1 mm Hg SBP reduction was CNY 0.4 (USD 0.06) per day. No difference in the number of adverse events was found between the 2 groups (P=0.259), and none of the adverse events was associated with the intervention. CONCLUSIONS The Chinese heart-healthy diet is effective, palatable, and cost-effective in reducing blood pressure in Chinese adults with high blood pressure, with a clinically significant effect applicable across major Chinese cuisine cultures. REGISTRATION URL: https://www. CLINICALTRIALS gov; Unique identifier: NCT03882645.