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/ .

A comprehensive evaluation between dexmedetomidine and midazolam for intraoperative sedation in the elderly: protocol for a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: The sedative effect of intraoperative sedation in elderly surgery exerts critical influence on the prognosis. Comparison on the safety and efficacy between dexmedetomidine and midazolam in many clinical randomized controlled trials (RCTs) was inconsistent and suspicious. We aim to comprehensively evaluate the safety and efficacy between dexmedetomidine and midazolam for intraoperative sedation in the elderly via meta-analysis and systematic reviews. METHODS: RCTs regarding to the comparison of sedative effects and safety between dexmedetomidine and midazolam in elderly patients (aged ≥ 60 years) will be comprehensively searched from 2000 October to 2022 May through 4 English databases and 4 Chinese databases. After extraction in duplicate, the systematic review and meta-analysis will be performed on the primary outcomes (hemodynamic changes, sedative effect, cognitive function) and secondary outcomes (analgesic effect, surgical characteristics, complications, or adverse reactions) for assessing the two therapy methods using Review Manager software (Version 5.3). Sensitivity analysis will be conducted to evaluate the heterogeneity of the results; funnel plot and Egger's trial will be performed to analyze publication bias of the included studies, and trial sequential analysis will be applied to assess the robustness and reliability of preliminary meta-analysis results. Finally, rating quality of evidence and strength of recommendations on the meta results will be summarized by Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. DISCUSSION: This systematic review and meta-analysis will evaluate the safety and efficacy between dexmedetomidine and midazolam for intraoperative sedation in the elderly; it will give an insight on the application of dexmedetomidine and midazolam and will provide evidence-based reference for clinical decision-making. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021221897.

Clinical evidence of Xinbao Pills efficacy on chronic heart failure patients: A protocol for systematic review and meta-analysis.

BACKGROUND: Chronic heart failure (CHF) is a common cardiovascular disease and results in high rate of morbidity, mortality, hospitalizations, and disability, causing medical concern around the world. Xinbao Pill (XBP) has been widely applied to clinical practice for patients with CHF but lacks studies to verify its efficacy. This study provides a protocol of systematic review, with which we will verify the adjunctive efficacy and safety of XBP on CHF with evidence-based studies. METHODS: Included studies will be retrieved according to inclusion and exclusion criteria from five English databases (the MEDLINE via PubMed, the Cochrane Library, EMBASE, the Web of Science and Ovid database), and four Chinese databases (China Science and Technology Journal Database [VIP], Chinese Biomedical Literature Database [CBM], Wan-fang Database, China National Knowledge Infrastructure [CNKI]) from October 1990 to October 2018. The New York Heart Association (NYHA), heart rate and mortality will be marked as major outcomes. We will use RevMan V.5.3 software to calculate the data synthesis and will conduct meta-analysis based on the collected data. RESULTS: Mortality, NYHA function classification, heart rate, the left ventricular ejection fractions (LVEF), 6-minute walk test (6MWT), hospitalization or rehospitalization, NT-proBNP, and adverse effects will be measured and comprehensively assessed to evaluate the adjunctive effect of XBP on CHF from this systematic review and meta-analysis with current clinical evidence. CONCLUSION: The systematic review and meta-analysis will assess the adjunctive effect of XBP in the treatment of CHF with up-to-date clinical evidence.

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].

Arterial Vascular Structures Running Through Retrotransverse Foramen and Retrotransverse Groove of the Atlas Vertebrae.

OBJECTIVE: Retrotransverse foramen (RTF) and retrotransverse groove (RTG) are anatomic variations of the atlas (C1) vertebrae. RTF contains an anastomotic vein connecting atlanto-occipital and atlanto-axodian venous sinuses. The purpose of this study was to analyze the arterial vascular structures running though the RTF and RTG. METHODS: Three-dimensional volume rendered computed tomography angiography (3D VR CTA) images of 427 patients (264 men, 163 women; age 17-87 years) were reviewed and evaluated using the RadiAnt DICOM Viewer (version 5.0.2; Medixant, Poznan, Poland). The incidence of RTF or RTG, the incidence of the V3 segment of vertebral artery variants, and the artery vascular structures inside the RTF and RTG anatomic variation of C1 were analyzed. RESULTS: Fifty (11.7%) atlases presented RTF anatomical variant; 113 (26.5%) atlases presented RTG anatomical variants. The incidence of the V3 segment of vertebral artery variants was 0.94% (4 of 427). Three (0.7%) were persistent first intersegmental artery and 1 (0.2%) was the fenestration of the vertebral artery on left side. In 4 cases of C1 vertebral artery V3 segmental variants, there were no RTF and RTG. No artery vascular structure was found in RTF or RTG. CONCLUSIONS: The RTF or RTG of C1 was a common anatomical variant. No arterial vascular structure runs though the RTF or RTG. The presence of C1 RTF and RTG variants had no effect on the V3 segmental course of the vertebral artery. Preoperative understanding of these variations using 3D CTA are helpful for the safe execution of the upper cervical posterior approach surgeries.

Retrotransverse Foramen and Retrotransverse Groove Anatomic Variations of the Atlas Vertebra in the Chinese Population.

OBJECTIVE: To analyze the prevalence of retrotransverse foramen (RTF) or retrotransverse groove (RTG) anatomic variations in Chinese atlas vertebra (C1). METHODS: Three-dimensional volume-rendered computed tomography angiography images of 427 subjects (264 males, 163 females; 17-87 years old) were reviewed and evaluated using dedicated software. The prevalence of RTF and RTG anatomic variation of C1 was analyzed. RESULTS: RTF anatomic variants were present in 50 (11.7%) atlases. Bilateral RTF, unilateral left RTF, and unilateral right RTF were present in 16 (3.8%), 20 (4.9%), and 14 (3.3%) vertebrae. Comparison between males and females revealed differences in bilateral RTF (P = 0.010) and unilateral left RTF (P = 0.008). RTG anatomic variants were present in 113 (26.5%) atlases. Bilateral RTG, unilateral left RTG, and unilateral right RTG were present in 39 (9.1%), 30 (7.0%), and 44 (10.3%) vertebrae. Comparison between males and females revealed differences in RTG (P = 0.000), bilateral RTG (P = 0.006), and unilateral left RTG (P = 0.034). RTF was detected in 36 cases on the left and 30 cases on the right. RTG was detected in 69 cases on the left and 79 cases on the right. There were no side differences in the prevalence of RTF and RTG. CONCLUSIONS: The incidence of RTG is higher than the incidence of RTF. Incidence of bilateral RTF, bilateral RTG, unilateral left RTF, unilateral left RTG, and RTG differed between males and females. Preoperative understanding of these variations using three-dimensional computed tomography angiography is helpful for safe execution of upper cervical posterior approach surgery.

[Infraoccipital needle-knife for cervical vertigo].

OBJECTIVE: To observe the clinical effect differences between infraoccipital needle-knife and massage for cervical vertigo. METHODS: A total of 366 patients with cervical vertigo were randomly assigned into a needle-knife group (186 cases) and a massage group (180 cases). With cases dropping excluded, 183 cases in the needle-knife group and 176 cases in the massage group were included. Needle-knife was used at Fengchi (GB 20), infraoccipital ashi point, etc. in the needle-knife group. The treatment was given for one course, once three days, 5 times as one course. The traditional massage was applied in the massage group for one course, including systematic stroking, kneading, and the application of pressure and plucking, etc., once every two days and 7 times as one course. The dizziness handicap inventory (DHI) score was observed before and after treatment, as well as 3, 6, and 12 months after treatment. The effects were also evaluated. RESULTS: The total effective rate was 92.3% (169/183) in the needle-knife group, which was better than 85.2% (150/176) in the massage group (P<0.05). Compared with those before treatment, the DHI scores at all the observation time points after treatment were improved in the two groups (all P<0.05), with better improvements after treatment as well as 3 and 6 months after treatment in the needle-knife group (all P<0.05). There was no significant difference in the improvement of DHI scores between the two groups 12 months after treatment (P>0.05). The recurrence rate was 10.3% (12/117) in the needle-knife group, and it was 10.7% (11/103) in the massage group 12 months after treatment (P>0.05). CONCLUSIONS: Infraoccipital needle-knife achieves apparent effect for cervical vertigo, which is superior to massage in short period.