Clinical efficacy of Kuanxiong aerosol for patients with prehospital chest pain: A randomized controlled trial.

BACKGROUND: Kuanxiong Aerosol (KXA)(CardioVent®), consisting of Asarum sieboldii Miq. oil, Santalum album L. oil, Alpinia officinarum Hance oil, Piper longum L. oil and borneol, seems to relieve the symptoms of chest pain and serve as a supplementary treatment for prehospital chest pain in emergency department. STYLE OF THE STUDY: This randomized controlled trial aimed to determine the clinical effect and safety of KXA for patients with prehospital chest pain. METHODS: A total of 200 patients were recruited from Guangdong Provincial Hospital of Chinese Medicine and randomly divided into KXA group (n = 100) and Nitroglycerin Aerosol (NA) group (n = 100) by SAS 9.2 software. All patients were treated with standardized Western medicine according to the pre-hospital procedure. The experimental group and NA group was additionally treated with KXA and NA respectively. The primary outcome was the relieving time of prehospital chest pain (presented as relief rate) after first-time treatment. The secondary outcomes included the evaluation of chest pain (NRS scores, degree of chest pain, frequency of chest pain after first-time treatment), efficacy in follow-up time (the frequency of average aerosol use, emergency department visits, 120 calls, medical observations and hospitalization at 4 weeks, 8 weeks, 12 weeks), alleviation of chest pain (Seattle angina questionnaire, chest pain occurrence, and degree of chest pain at 12-weeks treatment) and the change of TCM symptoms before and after 12-weeks treatment. In addition, the safety of KXA was also assessed by the occurrence of adverse events. The database was created using Epidata software, and statistical analysis was conducted by SPSS 23.0 software. RESULTS: A total of 194 participants finally completed the trial, the results showed that after first-time treatment, KXA had a higher relief rate (72.2%) of chest pain within 30 min than that of NA group (59.4%, p = 0.038), KXA group had a lower degree of chest pain (p = 0.005), lower NRS score (p = 0.011) and higher reduction of NRS score (p = 0.005) than the NA. In the follow-up period, KXA group decreased the frequency of 120 call better than that of NA group at 4 weeks (p = 0.040), but KXA had a similar efficacy as NA in the improvement on the of frequency of chest pain, aerosol use, emergency department visits, 120 call, medical observation and hospitalization at 4 weeks, 8 weeks and 12 weeks (p>0.05). There also had no difference between the two groups on the occurrence of chest pain, degree of chest pain, physical limitation, angina stability, treatment satisfaction, and disease perception between the two groups at 12 weeks (p>0.05). In addition, KXA and NA both improved the patient's chest pain, but not the TCM symptoms. In terms of safety, KXA showed similar safety as NA in this study. CONCLUSIONS: KXA relieved prehospital chest pain faster than NA and had a better remission effect on the prehospital chest pain than that of the NA group in short-period. In long-period, KXA showed similar efficacy on the improvement of prehospital chest pain as NA. KXA may be a safe and reliable therapy for prehospital chest pain.

Feasibility of electroacupuncture at Baihui (GV20) and Zusanli (ST36) on survival with a favorable neurological outcome in patients with postcardiac arrest syndrome after in-hospital cardiac arrest: study protocol for a pilot randomized controlled trial.

BACKGROUND: At present, even the first-line medication epinephrine still shows no evidence of a favourable neurological outcome in patients with sudden cardiac arrest (SCA). The high mortality of patients with postcardiac arrest syndrome (PCAS) can be attributed to brain injury, myocardial dysfunction, systemic ischaemia/reperfusion response, and persistent precipitating pathology. Targeted temperature management, the only clinically proven method in the treatment of PCAS, is still associated with a series of problems that have not been completely resolved. Acupuncture is a crucial therapy in traditional Chinese medicine. On the basis of the results of previous studies, we hypothesize that electroacupuncture (EA) might provide therapeutic benefits in the treatment of PCAS. This study will explore the feasibility of EA on SCA patients. METHODS: This is a prospective pilot, randomized controlled clinical trial. Eligible patients with PCAS after in-hospital cardiac arrest (IHCA) admitted to our department will be randomly allocated to the control group or the EA group. Both groups will receive standard therapy according to American Heart Association guidelines for cardiopulmonary resuscitation. However, the EA group will also receive acupuncture at the Baihui acupoint (GV20) and Zusanli acupoint (ST36) with EA stimulation for 30 min using a dense-dispersed wave at frequencies of 20 and 100 Hz, a current intensity of less than 10 mA, and a pulse width of 0.5 ms. EA treatment will be administered for up to 14 days (until either discharge or death). The primary endpoint is survival with a favourable neurological outcome. The secondary endpoints are neurological scores, cardiac function parameters, and other clinical parameters, including Sequential Organ Failure Assessment (SOFA) scores and Acute Physiology and Chronic Health Evaluation (APACHE) II scores, on days 0 to 28. DISCUSSION: This study will provide crucial clinical evidence on the efficacy of EA in PCAS when used as an adjunctive treatment with AHA standard therapy. TRIAL REGISTRATION: chictr.org.cn : ChiCTR2000040040. Registered on 19 November 2020. Retrospectively registered. http://www.chictr.org.cn/ .

Efficacy and safety of Puerarin injection on acute heart failure: A systematic review and meta-analysis.

Objective: This study aimed to assess the adjunctive efficacy and safety of Puerarin injection (PI) on acute heart failure (AHF) based on a systematic review and meta-analysis. Methods: Nine databases were searched from March 1990 to March 2022 to identify randomized controlled trials (RCTs) related to the adjunctive treatment of PI for AHF. The Cochrane collaboration tool was used to assess the risk of bias in the included studies. Meta-analysis and subgroup and sensitivity analyses were conducted by RevMan 5.3 software. The evidence's certainty was evaluated by grading recommendations assessment, development, and evaluation (GRADE) methods. Results: A total of 8 studies were included with a total of 614 patients with AHF. The meta-analysis demonstrated that adjunctive treatment with PI on AHF was superior to conventional medicine alone. It increased the total effective rate (RR = 1.38; 95% CI, 1.22-1.55; p < 0.001) and improved left ventricular ejection fraction [SMD = 0.85; 95% CI (0.62, 1.09); p < 0.001]. Regarding safety, a total of 11.9% (23/194) adverse reactions were observed in the PI group and 9.8% (19/194) adverse reactions in the control group, and there were no significant differences in the incident rate of adverse events between both groups [RR = 1.16; 95% CI (0.66-2.05); p = 0.061]. The outcomes' evidentiary quality was assessed as "moderate." Conclusion: PI had an adjunctive effect on AHF combined with conventional medicine, and it seemed to be safe and more effective than the conventional medical treatment alone for improving the total clinical effective rate and left ventricular ejection fraction. But further well-designed RCTs are required to confirm the efficacy and safety of XBP in treating AHF due to the poor methodological quality of the included RCTs. Systematic Review Registration: [https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=327636], identifier [CRD42022327636].