Efficacy and safety of oral Guanxinshutong capsules in patients with stable angina pectoris in China: a prospective, multicenter, double-blind, placebo-controlled, randomized clinical trial

Abstract

BackgroundTo assess the efficacy and safety of oral Guanxinshutong (GXST) capsules in Chinese patients with stable angina pectoris (SAP) in a prospective, multicenter, double-Blind, placebo-controlled, randomized clinical trial (clinicaltrials.gov Identifier: NCT02280850).MethodsEligible patients were randomized 1:1 to the GXST or placebo group. Current standard antianginal treatment except for nitrate drugs was continued in both groups, who received an additional 4-week treatment of GXST capsule or placebo. Primary endpoint was the change from baseline in angina attack frequency after the 4-week treatment. Secondary endpoints included the reduction of nitroglycerin dose, score of Seatntle Agina Questionnaire, exercise tolerance test defined as time to onset of chest pain and ST-segment depression at least 1 mm greater than the resting one.ResultsA total of 300 SAP patients from 12 centers in China were enrolled between January 2013 and October 2015, and they were randomly divided into the GXST group and the placebo group (150 patients in each group). Of whom, 287 patients completed the study (143 patients in the GXST group, 144 patients in the placebo group). The baseline characteristics of the two groups were comparable. After 4-week treatment with GXST capsules, the number of angina attacks and the consumption of short-acting nitrates were significantly reduced. In addition, the quality of life of patients were also substantially improved in the GXST group. No significant differences in the time of onset of angina and 1-mm ST segment depression were noted between the two groups. 7 patients (4.1%) in the GXST group and 3 patients (2.1%) in the placebo group reported at least one adverse event, respectively.ConclusionsGXST capsules are beneficial for the treatment of SAP patients.

Investigation of the Multi-Target Mechanism of Guanxin-Shutong Capsule in Cerebrovascular Diseases: A Systems Pharmacology and Experimental Assessment

“…Rats were randomly divided into five groups ( n = 8 in each group): sham, middle cerebral artery occlusion, and MCAO + GXSTC pretreatment (0.5, 1.0, and 2.0 g/kg per day). These doses were chosen based on the dosage of GXSTC in clinical practice (0.3 g/capsule, 3 capsules once, 3 times a day) ( Li et al, 2019 ) and previous studies (0.5–2.0 g/kg in rats) ( Zhuo et al, 2012 ; Zhu et al, 2020 ). Rats in the sham and MCAO groups were pretreated with 0.9% saline solution, and rats in the GXSTC groups were pretreated with GXSTC (0.5, 1.0, and 2.0 g/kg per day, respectively) via intragastric administration for 7 days.…”

“…Traditional Chinese medicine (TCM) has been used for thousands of years to prevent and treat CBVDs. Guanxin-Shutong capsule, a combination of Mongolian medicines and traditional herbs, has been commonly used to treat angina pectoris and coronary heart diseases in China (Li et al, 2019) (Rivera et al, 2014) at a weight ratio of 16:8:2:1:1 by weight. The major active components of GXSTC include phenolic acids, tanshinones, saponins, and others (Gao et al, 2017).…”

“…Traditional Chinese medicine (TCM) has been used for thousands of years to prevent and treat CBVDs. Guanxin-Shutong capsule, a combination of Mongolian medicines and traditional herbs, has been commonly used to treat angina pectoris and coronary heart diseases in China ( Li et al, 2019 ); it consists of Choerospondias axillaris (Roxb.) B.L.Burtt and A.W.Hill [ Anacardiaceae; Choerospondiatis fructus ], Salvia miltiorrhiza Bunge [ Lamiaceae; Radix Salviae miltiorrhizae ], Syzigium aromaticum (L.) Merr.…”

Traditional Chinese Medicine for Coronary Artery Disease Treatment: Clinical Evidence From Randomized Controlled Trials

“…Again, the data showed that the safety of Shenzhu Guanxin Recipe was acceptable (22). A phase IV double-blind, randomized, and placebo-controlled study conducted at 12 centers in China indicated that after 4-week treatment with Guanxinshutong Capsule (冠 心 舒 通 胶 囊), the quality of life was substantially improved, and the number of angina attacks and the consumption of short-acting nitrates were significantly reduced (23). Both of these studies were based on the premise of standard western medication treatment with TCM, and there was no positive control group, so the study on Shengjie Tongyu Granule (升解通瘀颗粒) was born.…”

Guanxinshutong Alleviates Atherosclerosis by Suppressing Oxidative Stress and Proinflammation in ApoE−/− Mice

“…In an ischemia and reperfusion (MI/R) injury study, GXST significantly decreased levels of TNF- α , IL-1 β , and IL-6 and obviously inhibited NF- κ B activity in the MI/R model rat [ 14 ]. Furthermore, in a randomized clinical trial, GXST capsules are beneficial for the treatment of stable angina pectoris (SAP) patients [ 15 ]. It has also been shown that daily oral treatment of MI rats with GXST protects the heart against oxidative stress indicated by the increasing activities of total SOD, CATA, NOS and the levels of NO and GSH [ 16 ].…”