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1.
Efficacy of Qingpeng ointment (a Tibetan medicine) for acute gouty arthritis: a multi-center, randomized, double-blind, placebo-controlled trial.
Shang, YX, Wei, SF, Yang, KP, Liu, Y, Wei, S, Dong, X, Wang, XC, Xie, ZM, Fang, RL, Liang, LN, et al
BMC complementary medicine and therapies. 2024;(1):21
Abstract
BACKGROUND This study aims to assess the efficacy and safety of Qingpeng ointment (QPO), a Tibetan medicine for alleviating symptoms in individuals with acute gouty arthritis (AGA). METHODS This study was a randomized, double-blind, placebo-controlled trial that involved individuals with AGA whose joint pain, as measured on a visual analog scale (VAS) from 0 to 10, was equal to or greater than 3. The participants were randomly assigned to either the QPO or the placebo group and received their respective treatments twice daily for seven consecutive days. In case of intolerable pain, the participants were allowed to use diclofenac sodium sustained-release tablets as a rescue medicine. The primary outcomes measured were joint pain and swelling, while the secondary outcomes included joint mobility, redness, serum uric acid levels, C-reactive protein levels, and the amount of remaining rescue medicine. Any adverse events that occurred during the trial were also recorded. RESULTS A total of 203 cases were divided into two groups, with balanced baselines: 102 in the QPO group and 101 in the placebo group. For joint pain, differences between the groups were notable in the VAS scores [1.75 (0, 3.00) versus 2.00 (1.00, 3.50); P = 0.038], changes in VAS [5.00 (3.00, 6.00) versus 4.00 (2.00, 6.00); P = 0.036], and disappearance rate [26.47% compared to 15.84%; P = 0.046] after treatment. Concerning joint swelling, significant between-group differences were observed in the VAS scores [1.00 (0, 2.30) versus 2.00 (0.70, 3.00); P = 0.032] and disappearance rate [33.33% compared to 21.78%; P = 0.046] at treatment completion. The QPO group exhibited a statistically significant mobility improvement compared to the placebo group (P = 0.004). No significant differences were found in other secondary outcomes. Five patients, four from the QPO group and one from the other, encountered mild adverse events, primarily skin irritation. All of these cases were resolved after dosage reduction or discontinuation of the medication. CONCLUSIONS Compared to the placebo, QPO exhibits positive effects on AGA by alleviating pain, reducing swelling, and enhancing joint mobility, without causing significant adverse effects. TRIAL REGISTRATION ISRCTN34355813. Registered on 25/01/2021.
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2.
Efficacy and safety of Pien Tze Huang capsules in patients with herpes zoster: A multicenter, randomized, double-blinded, and placebo-controlled trial.
Wu, W, Yang, D, Sui, D, Zhu, M, Luo, G, Yang, Z, Wang, Y, Luo, H, Ling, L, Zhang, Z, et al
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2024;:155453
Abstract
BACKGROUND Herpes zoster (HZ) is a common medical condition accompanied by several distressing symptoms, including acute pain. Pien Tze Huang (PZH) is a well-known traditional Chinese medicine (TCM) with numerous pharmacological effects, including antiviral properties, neuroprotection, and immunity regulation. PURPOSE To investigate the efficacy and safety of PZH capsules in patients with HZ. STUDY DESIGN A multicenter, double-blinded, randomized, and placebo-controlled trial from 8 hospitals in 5 cities of China. METHODS Eligible participants were randomly assigned to the PZH capsule and placebo group at a 1:1 ratio. Treatment was conducted for 14 days with a window period of no more than 2 days. For the first 7 days, participants received antiviral drugs combined with PZH capsules (0.6 g/time, 3 times a day) or placebos. For the remaining 7 days, they were only treated with PZH capsules (0.6 g/time, 3 times a day) or placebos. RESULTS We included 222 patients in the full analysis set (FAS), and 187 patients in the per protocol set (PPS). The change of numeric rating scale pain scores from baseline to the seventh day (±1 day) after treatment in the PZH capsule group was statistically superior to the placebo group (FAS: 2.33 vs. 1.71, 97.5%CI: 0.03 ∼ 1.19; PPS: 2.29 vs. 1.51, 97.5%CI: 0.18 ∼ 1.38). In the PPS, there was a significant difference in the time (days) of pain relief between the placebo group and the PZH capsule group (Mean (SD): 5.71 (3.76) vs. 4.69 (3.57), p = 0.046). On the seventh day (±1 day) after treatment, the level of CD8+ cells in the PZH capsule group were higher than those of the placebo group (FAS: Mean (SD): 24.08 (6.81) vs. 21.93 (8.19), p = 0.007; PPS: Mean (SD): 24.26 (6.93) vs. 22.15 (8.51), p = 0.012). The level of cytotoxic lymphocyte cells found similar results on the seventh day (±1 day) (FAS: Mean (SD): 12.17 (4.65) vs. 10.55 (4.15), p = 0.018; PPS: Mean (SD): 12.25 (4.65) vs. 10.11 (3.93), p = 0.002). No serious adverse events were noted and PZH capsules were well tolerated. CONCLUSION PZH capsules confer therapeutic effects on HZ with the TCM symptom of stagnated heat of liver channel by substantially reducing the pain intensity, shortening the time of pain relief as well as regulating the immune function. On the basis of the efficacy and safety profiles, PZH capsules may be a promising complementary therapy for the treatment of HZ.
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3.
Insulin Glargine is More Suitable Than Exenatide in Preventing Muscle Loss in Non-Obese Type 2 Diabetic Patients with NAFLD.
Liu, L, Wang, R, Gao, J, Yan, J, Zhang, J, Zhang, Z, Liu, J, Lin, H, Rao, S, Yao, X, et al
Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association. 2023;(11):583-588
Abstract
AIM: This study investigated the effects of insulin glargine and exenatide on the muscle mass of patients with newly diagnosed type 2 diabetes (T2DM) and nonalcoholic fatty liver disease (NAFLD). METHODS We performed a post-hoc analysis of our previously study, a 24-week randomized controlled multicenter clinical trial (ClinicalTrials.gov, NCT02303730). Seventy-six patients were randomly assigned 1:1 to receive insulin glargine or exenatide treatment. The changes in psoas muscle area (PMA) (mm2) were obtained with the cross-sectional Dixonfat magnetic resonance images at the fourth lumber vertebra. RESULTS There were no significant differences in age, BMI, gender, and PMA in insulin glargine and exenatide groups at baseline. After treatment, PMA tended to increase by 13.13 (-215.52, 280.80) mm2 in the insulin glargine group and decrease by 149.09 (322.90-56.39) mm2 in the exenatide group (both p>0.05). Subgroup analysis showed a 560.64 (77.88, 1043.40) (mm2) increase of PMA in the insulin group relative to the Exenatide group in patients with BMI<28 kg/m2 (p0.031) after adjusting for gender, age, and research center. Interaction analysis showed an interaction between BMI and treatment (p0.009). However, no interaction was observed among subgroups with a BMI≥28 kg/m2 or with different genders and ages. CONCLUSION Compared to exenatide, insulin glargine can relativity increase PMA in patients with T2DM having BMI<28 kg/m2 and NAFLD.
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4.
Efficacy and safety of janagliflozin monotherapy in Chinese patients with type 2 diabetes mellitus inadequately controlled on diet and exercise: A multicentre, randomized, double-blind, placebo-controlled, Phase 3 trial.
Ji, L, Jiang, X, Hao, Q, Cheng, Z, Wang, K, Pang, S, Liu, M, Guo, Y, Chen, X, Su, X, et al
Diabetes, obesity & metabolism. 2023;(5):1229-1240
Abstract
AIMS: To evaluate the efficacy and safety of janagliflozin, a selective renal sodium-glucose cotransporter-2 inhibitor, as monotherapy in drug-naive Chinese patients with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS This Phase 3 trial included a 24-week, multicentre, randomized, double-blind, placebo-controlled period, followed by a 28-week extension period. A total of 432 patients with glycated haemoglobin (HbA1c) levels ≥7.0% (53 mmol/mol) and ≤10.5% (91 mmol/mol) were randomized (1:1:1) to receive once-daily placebo, 25 mg or 50 mg janagliflozin. After 24 weeks, patients on placebo were switched and re-randomized (1:1) to 25 mg or 50 mg janagliflozin, whereas patients on janagliflozin maintained the initial therapy. The primary endpoint was change from baseline in HbA1c after 24 weeks. RESULTS At Week 24, the placebo-adjusted least squares mean changes in HbA1c were -0.80% (95% confidence interval [CI] -0.98% to -0.62%)/-8.7 mmol/mol (95% CI -10.7 mmol/mol to -6.8 mmol/mol) and -0.88% (95% CI -1.06% to -0.70%)/-9.6 mmol/mol (95% CI -11.6 mmol/mol to -7.7 mmol/mol), respectively (P < 0.001 for both). A higher proportion of patients achieved HbA1c <7.0% (53 mmol/mol) with janagliflozin 25 mg and janagliflozin 50 mg compared with placebo (47.2%, 49.3%, and 23.5%, respectively). Both janagliflozin doses significantly decreased fasting plasma glucose, 2-hour postprandial glucose, body weight and systolic blood pressure, as well as increased high-density lipoprotein (HDL) cholesterol and insulin sensitivity compared with placebo (P < 0.05 for all). The trends in improvement of these variables were sustained during the 28-week extension period. Overall incidences of adverse events were 67.8%, 71.5% and 60.7% with janagliflozin 25 mg, janagliflozin 50 mg and placebo, respectively. The incidence of urinary tract infections and genital fungal infections was low. No severe hypoglycaemia or ketoacidosis occurred. CONCLUSIONS Janagliflozin 25 mg and 50 mg monotherapy once-daily effectively improved glycaemic control, reduced body weight and blood pressure, improved HDL cholesterol and insulin sensitivity, and was generally well tolerated.
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5.
Efficacy and safety of iruplinalkib (WX-0593) in ALK-positive crizotinib-resistant advanced non-small cell lung cancer patients: a single-arm, multicenter phase II study (INTELLECT).
Shi, Y, Chen, J, Zhang, H, Zhang, Z, Zhang, Y, Wang, Z, Zhang, S, Zhao, J, Liu, C, Wang, X, et al
BMC medicine. 2023;(1):72
Abstract
BACKGROUND Iruplinalkib (WX-0593) is an anaplastic lymphoma kinase (ALK)/c-ros oncogene 1 (ROS1) tyrosine kinase inhibitor. Here we reported the single-arm, phase II study (INTELLECT) results of the efficacy and safety of iruplinalkib for ALK-positive crizotinib-resistant advanced non-small cell lung cancer (NSCLC) patients. METHODS ALK-positive crizotinib-resistant advanced NSCLC patients aged ≥18 years, with Eastern Cooperative Oncology Group performance status of 0-2 were eligible. Patients received iruplinalkib 180 mg orally once daily for a 21-day cycle with a 7-day lead-in phase at 60 mg orally once daily. The primary endpoint was the independent review committee (IRC)-assessed objective response rate (ORR). RESULTS From August 7, 2019, to October 30, 2020, 146 patients were included. As of the data cut-off date on November 30, 2021, the median follow-up time was 18.2 months (95% confidence interval [CI] 16.8-18.8). IRC-assessed ORR and disease control rate (DCR) were 69.9% (95% CI 61.7-77.2%) and 96.6% (95% CI 92.2-98.9%), respectively. Investigator-assessed ORR and DCR were 63.0% (95% CI 54.6-70.8%) and 94.5% (95% CI 89.5-97.6%), respectively. Investigator-assessed median duration of response and progression-free survival (the same as median time to progression) were 13.2 months (95% CI 10.4-17.7) and 14.5 months (95% CI 11.7-20.0), respectively. Corresponding IRC-assessed results were 14.4 months (95% CI 13.1-not evaluable [NE]), 19.8 months (95% CI 14.5-NE), and NE (95% CI 14.5-NE), respectively. Investigator-assessed intracranial ORRs were 46% (41/90, 95% CI 35-56%) in patients with central nervous system metastases and 64% (27/42, 95% CI 48-78%) in patients with measurable intracranial lesions. Overall survival data were immature. Treatment-related adverse events (TRAEs) occurred in 136/146 (93.2%) patients. The most common TRAEs were aspartate aminotransferase increased (63 [43.2%]), alanine aminotransferase increased (54 [37.0%]), and blood creatine phosphokinase increased (51 [34.9%]). Dose interruption, reduction, and discontinuation due to TRAEs occurred in 21 (14.4%), 16 (11.0%), and four (2.7%) patients, respectively. CONCLUSIONS In this study, iruplinalkib (WX-0593) demonstrated favorable efficacy and manageable safety profiles in patients with ALK-positive crizotinib-resistant advanced NSCLC. Iruplinalkib could be a new treatment option for this patient population. TRIAL REGISTRATION Center for Drug Evaluation of National Medical Products Administration of China: CTR20190789, registered on April 28, 2019; ClinicalTrials.gov: NCT04641754, registered on November 24, 2020.
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6.
Effectiveness of kumquat decoction for the improvement of cough caused by SARS-CoV-2 Omicron variants, a multicentre, prospective observational study.
Hua, Q, Tang, L, Shui, J, Liu, Y, Zhang, G, Xu, X, Yang, C, Gao, W, Liao, G, Liu, Q, et al
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2023;:155008
Abstract
BACKGROUND Kumquat decoction is a traditional Chinese medicine formula and has been widely used to alleviate the coronavirus disease 2019 (COVID-19)-related cough in China. However, the effectiveness and safety of kumquat decoction remain unclear. PURPOSE To assess the effectiveness and safety of kumquat decoction for COVID-19-related cough. STUDY DESIGN A multicentre, prospective observational study. METHODS We enrolled consecutive patients with mild-to-moderate COVID-19 from December 31, 2022, to January 3, 2023, during the Omicron phase in Yangshuo County, China. The primary outcome was the time from study baseline to sustained cough resolution by the last follow-up day on January 31, 2023. The effectiveness was evaluated by Cox proportional hazards models based on propensity score analyses. The secondary outcomes were the resolution of cough and other COVID-19-related symptoms by Days 3, 5, and 7. RESULTS Of 1434 patients, 671 patients were excluded from the analysis of cough resolution. Among the remaining 763 patients, 481 (63.04%) received kumquat decoction, and 282 (36.96%) received usual care. The median age was 38.0 (interquartile range [IQR] 29.0, 50.0) years, and 55.7% were women. During a median follow-up of 7.000 days, 68.2% of patients in the kumquat group achieved sustained cough resolution (93.77 per 1000 person-days) compared to 39.7% in the usual care group (72.94 per 1000 person-days). The differences in restricted mean survival time (RMST) (kumquat decoction minus usual care group) for cough resolution were -0.742 days (95% CI, -1.235 to -0.250, P = 0.003) on Day 7. In the main analysis using propensity-score matching, the adjusted hazard ratio (HR) for cough resolution (kumquat decoction vs. usual care group) was 1.94 (95% CI, 1.48 to 2.53, P < 0.001). Similar findings were found in multiple sensitivity analyses. In addition, the use of kumquat decoction was associated with the resolution of cough, and a stuffy nose on Days 5 and 7, as well as the resolution of sore throat on Day 7 following medication. CONCLUSION In this study among patients with COVID-19-related cough, receiving kumquat decoction was associated with an earlier resolution of cough symptoms.
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7.
Combination of Nicorandil and Beta-Adrenergic Receptor Blockers in Patients with Coronary Artery Disease: A Real-World Observational Study.
Cheng, J, Qiu, L, Zhang, Z, Li, N, Shu, H, Xiao, Z, Zhou, N
Journal of cardiovascular pharmacology and therapeutics. 2023;:10742484231197559
Abstract
BACKGROUND The effect of combined nicorandil and beta-adrenergic receptor blockers (BBs) compared with that of BBs alone on long-term clinical outcomes in patients with coronary artery disease (CAD) remains undetermined. METHODS A multicenter retrospective cohort study was performed. Adult patients who had been hospitalized for CAD and treated for angina with a combination of nicorandil and BBs or BBs alone were included. The effect of different treatments on the cumulative incidence of major adverse cardiovascular event (MACE) and their components within a follow-up duration of 2.5 years were analyzed using Kaplan-Meier survival curves. An inverse probability of treatment weighting (IPTW) method was used to adjust for the possible effect of confounding factors. RESULTS A total of 137,714 patients were screened, of whom 16,912 individuals (mean age: 61.5 years, men: 67.1%) were successfully enrolled. Among the enrolled participants, 4669 received the combined treatment of nicorandil and BBs, while 12,243 received BBs alone. After IPTW, the results demonstrated that the combined treatment was associated with a significantly reduced incidence of MACE (hazard ratio [HR] 0.79, 95% conidence interval [CI] 0.72-0.87) and stroke (HR 0.48, 95% CI 0.42-0.54) but not of MI (HR 1.03, 95% CI 0.92-1.15) or all-cause mortality (HR 0.93, 95% CI 0.64-1.37). Sensitivity analyses revealed similar results. CONCLUSIONS A combined antiangina treatment of nicorandil and BBs may be more effective than treatment of BBs alone in reducing the long-term incidence of MACE in patients with CAD.
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8.
Efficacy of Mobile-Based Cognitive Behavioral Therapy on Lowering Low-density Lipoprotein Cholesterol Levels in Patients With Atherosclerotic Cardiovascular Disease: Multicenter, Prospective Randomized Controlled Trial.
Li, D, Xu, T, Xie, D, Wang, M, Sun, S, Wang, M, Zhang, S, Yang, X, Zhang, Z, Wang, S, et al
Journal of medical Internet research. 2023;:e44939
Abstract
BACKGROUND Elevated low-density lipoprotein cholesterol (LDL-C) is an established risk factor for atherosclerotic cardiovascular disease (ASCVD). However, low adherence to medication and lifestyle management has limited the benefits of lowering lipid levels. Cognitive behavioral therapy (CBT) has been proposed as a promising solution. OBJECTIVE This trial aimed to evaluate the efficacy of mobile-based CBT interventions in lowering LDL-C levels in patients with ASCVD. METHODS This multicenter, prospective, randomized controlled trial enrolled 300 patients with ASCVD, who were randomly assigned to the mobile-based CBT intervention group and the control group in a ratio of 1:1. The intervention group received CBT for ASCVD lifestyle interventions delivered by WeChat MiniApp: "CBT ASCVD." The control group only received routine health education during each follow-up. The linear regression and logistic regression analyses were used to determine the effects of a mobile-based CBT intervention on LDL-C, triglyceride, C-reactive protein, the score of General Self-Efficacy Scale (GSE), quality of life index (QL-index), and LDL-C up-to-standard rate (<1.8 mmol/L) at the first, third, and sixth months. RESULTS Finally, 296 participants completed the 6-month follow-up (CBT group: n=148; control group: n=148). At baseline, the mean LDL-C level was 2.48 (SD 0.90) mmol/L, and the LDL-C up-to-standard rate (<1.8 mmol/L) was 21.3%. Mobile-based CBT intervention significantly increased the reduction of LDL-C change (%) at the 6-month follow-up (β=-10.026, 95% CI -18.111 to -1.940). In addition, this benefit remained when baseline LDL-C <1.8 mmol/L (β=-24.103, 95% CI -43.110 to -5.095). Logistic regression analysis showed that mobile-based CBT intervention moderately increased the LDL-C up-to-standard rates (<1.8 mmol/L) in the sixth month (odds ratio 1.579, 95% CI 0.994-2.508). For GSE and QL-index, mobile-based CBT intervention significantly increased the change of scores (%) at the 1-, 3-, and 6-month follow-up (all P values <.05). CONCLUSIONS In patients with ASCVD, mobile-based CBT is effective in reducing LDL-C levels (even for those who already had a standard LDL-C) and can improve self-efficacy and quality of life. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR2100046775; https://www.chictr.org.cn/showproj.aspx?proj=127140.
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9.
Effect of Vigileo/FloTrac System-Guided Aggressive Hydration in Acute Myocardial Infarction Patients to Prevent Contrast-Induced Nephropathy After Urgent Percutaneous Coronary Intervention.
Ling, W, Jiang, Z, Liu, K, Zhang, H, Qian, Y, Tian, J, Zhang, Z, Chen, Y, Qian, G
The American journal of cardiology. 2023;:77-82
Abstract
Tailored hydration strategies appear to provide an effective solution for preventing contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI). The Vigileo/FloTrac system could predict the patients' fluid responsiveness and tolerance to hydration. This prospective multicenter, randomized controlled, open-label study evaluated the efficacy of aggressive hydration guided by the Vigileo/FloTrac system for CIN prevention in patients with acute myocardial infarction (AMI). This trial enrolled patients with AMI undergoing urgent PCI, and these patients were randomized (1:1) to receive either aggressive hydration guided by Vigileo/FloTrac system (intervention group) or general hydration (control group). Patients with AMI in the intervention group received a loading dose of saline, and the hydration speed was adjusted according to the change of Vigileo/FloTrac index. The primary end point is CIN, which was defined as a >25% or >0.5 mg/100 ml increase in serum creatinine compared with baseline during the first 72 hours after urgent PCI. This trial was registered in ClinicalTrials.gov (NCT04382313). A total of 344 patients with AMI were enrolled and randomized in our trial, and the baseline characteristics, including risk factors of CIN, of the Vigileo/FloTrac-guided hydration group (n = 173) and control group (n = 171) were well balanced (all p >0.05). The total hydration volume in Vigileo/FloTrac-guided hydration group was significantly much more than control group (1,910 ± 600 vs 440 ± 90 ml, p <0.001). The incidence of CIN in the Vigileo/FloTrac-guided hydration group was significantly decreased than that in the control group (12.1% [21/173] vs 22.2% [38/171], p = 0.013). There was not significantly different in the incidence of acute heart failure after PCI (9.2% [16/173] vs 7.6% [13/171], p = 0.583). The incidence of main adverse cardiovascular events in the Vigileo/FloTrac-guided hydration group was lower than that in the control group but without statistically difference (30 events [17.3%] vs 38 events [22.2%], p = 0.256). In conclusion, Vigileo/FloTrac system-guided aggressive hydration could effectively decrease the risk of CIN for patients with AMI undergoing urgent PCI and avoid attack of acute heart failure at the same time.
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10.
The effect of dietary carbohydrate and calorie restriction on weight and metabolic health in overweight/obese individuals: a multi-center randomized controlled trial.
Sun, J, Ruan, Y, Xu, N, Wu, P, Lin, N, Yuan, K, An, S, Kang, P, Li, S, Huang, Q, et al
BMC medicine. 2023;(1):192
Abstract
BACKGROUND Both low-carbohydrate (LC) and calorie-restricted (CR) diets have been shown to have metabolic benefits. However, the two regimens have yet to be thoroughly compared. We conducted a 12-week randomized trial to compare the effects of these diets separately and in combination on both weight loss and metabolic risk factors in overweight/obese individuals. METHODS A total of 302 participants were randomized to LC diet (n = 76), CR diet (n = 75), LC + CR diet (n = 76), or normal control (NC) diet (n = 75) using a computer-based random number generator. The primary outcome was the change in body mass index (BMI). The secondary outcomes included body weight, waist circumference, waist-to-hip ratio, body fat, and metabolic risk factors. All participants attended health education sessions during the trial. RESULTS A total of 298 participants were analyzed. BMI change over 12 weeks was - 0.6 (95% CI, - 0.8 to - 0.3) kg/m2 in NC, - 1.3 (95% CI, - 1.5 to - 1.1) kg/m2 in CR, - 2.3 (95% CI, - 2.6 to - 2.1) kg/m2 in LC, and - 2.9 (95% CI, - 3.2 to - 2.6) kg/m2 in LC + CR. LC + CR diet was more effective than LC or CR diet alone at reducing BMI (P = 0.001 and P < 0.001, respectively). Furthermore, compared with the CR diet, the LC + CR diet and LC diet further reduced body weight, waist circumference, and body fat. Serum triglycerides were significantly reduced in the LC + CR diet group compared with the LC or CR diet alone. Plasma glucose, homeostasis model assessment of insulin resistance, and cholesterol concentrations (total, LDL, and HDL) did not change significantly between the groups during the 12-week intervention. CONCLUSIONS The reduction of carbohydrate intake without restricting caloric intake is more potent to achieve weight loss over 12 weeks when compared to a calorie-restricted diet in overweight/obese adults. The combination of restricting carbohydrate and total calorie intake may augment the beneficial effects of reducing BMI, body weight, and metabolic risk factors among overweight/obese individuals. TRIAL REGISTRATION The study was approved by the institutional review board of Zhujiang Hospital of Southern Medical University and registered at the China Clinical Trial Registration Center (registration number: ChiCTR1800015156).