Efficacy and safety of Qi-Jing Hui-Xin Decoction in the treatment of coronary microvascular angina: study protocol for a randomized, controlled, multi-center clinical trial.

BACKGROUND: With the increased understanding of heart disease, microvascular angina (MVA) is receiving greater attention from clinicians. Studies have shown that patients with MVA have significantly higher major cardiovascular events and all-cause mortality than the control population, and the search for effective treatments is of great clinical importance. Both basic and clinical studies have shown that Qi-Jing Hui-Xin Decoction (QJHX) can relieve angina symptoms and improve clinical efficacy, but there is a lack of high-quality clinical studies to provide a research basis. This article introduces the evaluation protocol of QJHX for the adjunctive treatment of MVA. METHODS/DESIGN: This is a prospective randomized controlled trial. The trial will enroll 150 patients with MVA. On the basis of Western drug treatment, patients will be randomized into two groups, and the experimental group will receive QJHX treatment for 12 weeks and follow-up at 24 week. The primary indicators are the clinical efficacy of angina pectoris and the evidence of traditional Chinese medicine (TCM) efficacy. Secondary indicators are the Seattle Angina Scale score, serum lipid levels, electrocardiogram, and echocardiogram diagnosis. Additional indicators are endothelial function and immunoinflammatory factors. Adverse events will be monitored throughout the trial. DISCUSSION: Integrated traditional Chinese and Western medicine is commonly used for angina in China. This study will evaluate the clinical effectiveness and safety of adding QJHX based on standardized Western medications. The results of the trial will provide high-level clinical research-based evidence for the application of QJHX in MVA. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900027015 . Registered on 28 October 2019.

Efficacy and safety of Suxiao Jiuxin Pill in the treatment of stable angina (Qi stagnation and blood stasis syndrome): study protocol of a randomized, double-blind, placebo-controlled, multi-center clinical trial.

BACKGROUND: Coronary heart disease (CHD) has become one of the biggest health problems in the world. Stable angina is a common clinical type of CHD with poor prognosis and high mortality. Although there are various interventions for stable angina, none of them can significantly reduce mortality. Both basic and clinical research have shown that Suxiao Jiuxin Pill (SJP) can relieve the symptoms of angina pectoris and improve the clinical efficacy, but there is a lack of high-quality clinical research to provide research-based evidence. We design a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of SJP for stable angina. METHODS/DESIGN: This is a prospective, randomized, double-blind, placebo-controlled, and multicenter trial. The trial will enroll 324 participants with chronic stable angina (Qi Stagnation and Blood Stasis syndrome). All participants will have received the conventional therapy of chronic stable angina. Participants will be randomized into two groups, conventional therapy plus SJP group and conventional therapy plus placebo group. Eligible participants will receive either SJP or placebo (five pills administered orally, three times daily) in addition to conventional treatment for 24 weeks. The primary outcomes are the symptom improvement rate of angina from baseline to 4 weeks after inclusion and major adverse cardiovascular events (MACE). The secondary outcomes are angina classification (CCS), improvement of traditional Chinese medicine (TCM) syndromes, Seattle Angina Scale score, the dosage of emergency drugs and the stopping rate, and electrocardiogram (EKG) efficacy. Adverse events will be monitored throughout the trial. DISCUSSION: Integrated traditional Chinese and Western Medicine is commonly used for angina in China. This study will evaluate the clinical effectiveness and safety of SJP for angina. The results of the trial will provide high-level clinical research-based evidence for the application of SJP instable angina. TRIAL REGISTRATION: This study protocol was registered on 14 March 2019. The registration number is ChiCTR1900021876 on the Chinese Clinical Trial Registry.

[Efficacy observation of chronic pelvic inflammation of different differentiated patterns/syndromes treated with acupoint embedding therapy].

OBJECTIVE: To compare the clinical efficacy on chronic pelvic inflammation between the acupoint embedding therapy and acupuncture, and to compare the efficacy of different patterns/syndroms in differentiation treated with acupoint embedding therapy. METHODS: Two hundred and eighteen cases were randomized into an embedding therapy group (115 cases) and an acupuncture group (103 cases). In both groups, Shenshu (BL 23), Guanyuanshu (BL 26), Zigong (EX-CA 1), Yaoyangguan (GV 3), Guanyuan (CV 4) and Qihai (CV 6) were selected as the main points. For qi and blood stagnation pattern/syndrome, Zhongdu (LR 6), Diji (SP 8) and the others were added; for cold and damp stagnation pattern/syndrome, Diji (SP 8) and Sanyinjiao (SP 6) were added; for stasis and phlegm pattern/syndrome due to spleen deficiency, Sanyinjiao (SP 6) and Zusanli (ST 36) were added. In the embedding therapy group, the catgut was embedded at 7 - 13 acupoints each time, once every 10 days. In the acupuncture group, the conventional acupuncture therapy was applied, once a day. The symptom scores were assessed in the aspects of the lower abdominal pain severity and attack frequency, lumbosacral soreness and distention, abnormality of vaginal discharge and the others. The efficacy was compared between the two groups. RESULTS: The total effective rate was 93.0% (107/115) in the embedding therapy group, which was better than 83.5% (86/103) in the acupuncture group (P < 0.05). The symptom scores were all reduced after treatment in the two groups (all P < 0.05). In the embedding therapy group, the efficacies were not significantly different among different patterns/syndromes (all P > 0.05). CONCLUSION: The acupoint embedding therapy achieves the definite efficacy on chronic pelvic inflammation and obtains the similar efficacies among the different differentiated patterns/syndromes of the disease.