Efficacy and Safety of Chinese Herbal Medicine Compared With Losartan for Mild Essential Hypertension: A Randomized, Multicenter, Double-Blind, Noninferiority Trial.

BACKGROUND: Hypertension is one of the most challenging public health problems worldwide. Previous studies suggested that the Songling Xuemaikang capsule (SXC)-a Chinese herbal formula-was effective for essential hypertension. However, the efficacy of SXC monotherapy for hypertension remains unclear. We aimed to compare the blood pressure (BP)-lowering efficacy and safety of SXC versus losartan in patients with essential hypertension. METHODS: In this multicenter, randomized, double-blind, noninferiority trial in China, patients 18 to 65 years of age with mild essential hypertension were randomly allocated to receive either SXC or losartan for 8 weeks. The primary outcome was the change in sitting diastolic BP from baseline to 8 weeks, with a predefined noninferiority margin of -2.5 mm Hg. RESULTS: Of the 755 patients who entered a 2-week run-in period, 628 patients (327 women and 301 men; mean [SD] age, 52.6 [9.2] years) were randomly assigned to the SXC (n=314) or losartan (n=314) group. The primary analysis based on the intention-to-treat principle showed that the change in diastolic BP from baseline to 8 weeks was similar between the SXC and losartan groups (-7.9 [8.0] versus -8.1 [7.9]). The lower boundary of 95% CI (mean difference, -0.24 [95% CI, -1.51 to 1.03]) was above the margin of -2.5 mm Hg, showing noninferiority. Results were consistent with per-protocol analysis. SXC produced greater improvements in total hypertension symptom score (-5.7 [4.2] versus -5.0 [4.0]; P=0.020) and total cholesterol (-0.1 [1.0] versus 0.1 [1.2]; P=0.025). There were no differences between groups in the other BP and patient-reported outcomes. Incidence and severity of adverse events were similar between groups. CONCLUSIONS: SXC was well tolerated and demonstrated noninferior to losartan in BP lowering in patients with mild hypertension. SXC might be an alternative for mild hypertension, particularly for patients with a preference for natural medicine. REGISTRATION: URL: www.chictr.org.cn; Unique identifier: ChiCTR-IPR-16008108.

A Prospective Randomized Multicenter Controlled Trial on Salvianolate for Treatment of Unstable Angina Pectoris in A Chinese Elderly Population.

OBJECTIVE: To evaluate the efficacy and safety of salvianolate in elderly patients with unstable angina pectoris (UAP). METHODS: A prospective double-blind randomized placebo-controlled multicenter trial in elderly patients with UAP from 13 third-grade class-A hospitals in China was performed. A total of 318 patients were randomly allocated in a 1:1 ratio to an experimental group (160 patients) and a control group (158 patients). The experimental group was treated with salvianolate for 14 days on the basis of conventional medicine, and the control group was given a placebo for 14 days with the same criteria. Follow-up was lasted 28 days in both groups. The primary endpoint was biweekly frequency of angina pectoris attacks. The secondary endpoints included biweekly dosage of nitroglycerin, the Seattle Angina Questionnaire, angina pectoris severity and duration, myocardial injury markers, high-sensitivity C-reactive protein (hs-CRP) and N-terminal pro-B-type natriuretic peptide (NT-proBNP), as well as major adverse cardiovascular events (MACEs). Safety was assessed according to adverse events and serious adverse events. RESULTS: Baseline characteristics were similar between treatment groups. Compared with those in the control group, the frequency of biweekly angina attacks (2.92 vs . 4.08, P=0.025), the biweekly dosage of nitroglycerin, as well as the severity and duration of angina attacks (P<0.01) were reduced by salvianolate. The Seattle Angina Questionnaire score was also significantly improved in the experimental group than in the control group (P<0.05). No significant differences were observed between the two groups with respect to the incidence of MACEs. Salvianolate was well tolerated. CONCLUSIONS: Salvianolate appear to have efficacy and well tolerated for elderly patients with UAP. [ClinicalTrials.gov identifier: NCT03037047].

Image-guided percutaneous (125)I seed implantation as a salvage treatment for recurrent soft tissue sarcomas after surgery and radiotherapy.

The purpose of this study was to evaluate the safety and efficacy of percutaneous iodine-125 ((125)I) seed implantation using computed tomography (CT) or ultrasound guidance in the treatment of recurrent soft tissue malignancies after surgery and radiotherapy. From February 2002 to September 2009, 18 patients with recurrent soft tissue sarcomas were treated under ultrasound or CT guidance. The actuarial median number of (125)I seeds implanted was 35 (range, 6-129), and the actuarial D90 of the implanted (125)I seeds ranged from 107.9 to 204.4 Gy (median, 147.1 Gy). The activity of the seeds ranged from 0.4 to 0.8 mCi (median, 0.7 mCi). Follow-up times ranged from 4 to 78 months (median, 20 months). The median local control was 41 months (95% CI, 15.9-66.1 months). The 1-, 2-, 3-, 4-, and 5-year local controls were 78.8%, 78.8%, 78.8%, 26.3%, and 0%, respectively. The median survival was 32 months (95% CI, 16-48 months). The actuarial 1-, 2-, 3-, 4-, and 5-year survivals were 76.6%, 61.3%, 39.4%, 39.4%, and 39.4%, respectively. Seven (7) patients (38.9%) experienced recurrence after seed implantation. Six (6) patients (33.3%) died of distant metastases and 1 died of stroke. Two (2) patients developed ulceration, 1 case caused by recurrence and another by a reaction of the skin to radiation. Percutaneous (125)I seed implantation for recurrent soft tissue malignancies under CT or ultrasound guidance is safe and is associated with high efficacy and low morbidity.

Diffusion tensor imaging study of the anterior limb of internal capsules in neuroleptic-naive schizophrenia.

RATIONALE AND OBJECTIVES: Abnormalities in brain structure have been implicated in psychosis. Herein, we investigated the differences in fractional anisotropy (FA) and average diffusion coefficient (ADC) in the bilateral anterior limb of internal capsules between neuroleptic-naive schizophrenic patients and appropriately matched healthy controls. MATERIALS AND METHODS: Magnetic resonance imaging was performed with a 1.5 T superconductive MR scanner, and diffusion tensor imaging was carried out in 21 neuroleptic-naive schizophrenic patients and 18 matched healthy controls. FA and ADC were measured by region of interest analysis. RESULTS: Compared with healthy controls, the neuroleptic-naive schizophrenic patients showed significantly reduced FA in the bilateral anterior limb of the internal capsule. However, the difference in the ADC values between the patients and the controls was not significant. CONCLUSIONS: FA of the bilateral anterior limb of the internal capsule was reduced in neuroleptic-naive schizophrenic patients, indicating that the integrity of the white matter of the bilateral thalamus-frontal connection or the bilateral thalamus-anterior cingulate gyrus connection was destroyed.