Safety and Efficacy of the C-117 Formula for Vulnerable Carotid Artery Plaques (Spchim): A Randomized Double-Blind Controlled Pilot Study.

OBJECTIVE: To investigate the safety and efficacy of the Herbal Medicine C-117 (C-117) formula in the treatment of carotid atherosclerotic vulnerable plaques. METHODS: This was a prospective, single-centre, randomized, double-blind study. A total of 120 eligible patients were randomly divided into two groups to receive the C-117 formula or placebo. As the basic treatment, both groups were treated according to the Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Stroke in China using statins to regulate blood lipids, blood pressure lowering drugs, drugs for controlling blood sugar, and antiplatelet drugs according to the indications. The primary outcomes were the change in stability, the mean change of the plaque Crouse score, and the area and number of bilateral carotid artery plaques before and after 6 months of treatment. The secondary outcomes were the total number of cardiocerebrovascular events during the treatment and follow-up and the mean changes of lipid levels. RESULT: After 180 days of treatment, the plaque Crouse score(95% CI, 0.39 (0.01-0.77), P=0.046) and plaque area (95% CI, 2.14 (-10.10-14.39), P=0.727) were lower in the C-117 formula group than that before treatment. The plaque Crouse score of the control group (95% CI, 0.17 (-0.24-0.57), P=0.417) was lower than that before treatment, while the plaque area (95% CI, -0.35 (-9.35-8.65), P=0.938) increased, but without statistical significance. There was no significant difference in the reduction of the intima-media thickness (IMT), plaque Crouse score, or plaque area between the two groups after treatment (P>0.05). Subgroup analysis of patients whose Lipitor medication time ≥ 20% of the 6-month treatment showed that the levels of total cholesterol, triglycerides, and low-density lipoprotein were lower in the two groups after treatment than before, and the low-density lipoprotein levels in the C-117 formula group significantly decreased (95% CI, 2.99 (-0.08-0.39), P=0.005), but there was no statistical difference between the two groups after treatment (P>0.05). No serious adverse events occurred in the two groups after 180 days of treatment. CONCLUSION: The C-117 formula may be antiatherosclerotic by strengthening statins to reduce the low-density lipoprotein levels and reducing the carotid plaque Crouse scores. Clinical trials with large sample sizes, long-term interventions, and follow-up are needed to investigate the efficacy of the C-117 formula. CLINICAL TRIALS REGISTRATION: This trial is registered with clinicaltrials.gov identifier: NCT03072225 (registered retrospectively on 1st March 2017).

Safety and efficacy of herbal medicine for acute intracerebral hemorrhage (CRRICH): a multicentre randomised controlled trial.

OBJECTIVE: To evaluate the safety and efficacy of removing blood stasis (RBS) herbal medicine for the treatment of acute intracerebral haemorrhage (AICH) within a 6-hour time window. STUDY DESIGN: A randomised, multicentre, double-blind, placebo-controlled study performed in 14 hospitals in China. PARTICIPANTS AND INTERVENTIONS: Patients with AICH were randomly assigned to receive a placebo, the ICH-1 (Intracerebral Haemorrhage) formula (eight herbs, including the RBS herbs hirudo and tabanus) or the ICH-2 formula (six herbs without the RBS herbs hirudo and tabanus) within 6 hours of ICH onset. OUTCOMES: The primary safety outcome was the incidence of haematoma enlargement at 24 hours and at 10 days after treatment. The secondary outcome was the incidence of poor prognosis (mortality or modified Rankin Scale score ≥5) assessed at 90 days after symptom onset. RESULTS: A total of 324 subjects were randomised between October 2013 and May 2016: 105 patients received placebo; 108 patients received the ICH-1 formula; and 111 patients received the ICH-2 formula. The incidence of haematoma enlargement at 24 hours was 7.8% in the placebo group, 12.3% in the ICH-1 group and 7.5% in the ICH-2 group; the incidence of haematoma enlargement on day 10 was 1.1% in the placebo group, 1.1% in the ICH-1 group, and 3.1% in the ICH-2 group, with no significant differences among the groups (P>0.05). The mortality rates were 3.8% in the placebo group, 2.8% in the ICH-1 group, and 0.9% in the ICH-2 group; the incidences of poor prognosis were 7.1% in the placebo group, 6.0% in the ICH-1 group and 4.8% in the ICH-2 group at 3 months, with no significant differences among the groups (p>0.05). However, the overall frequency of treatment-emergent adverse events in the ICH-1 group (12.1%) was higher among the three groups (5.8% and 2.8%, respectively, p<0.05). All three cases of serious adverse events were in the ICH-1 group. CONCLUSIONS: Ultra-early administration of ICH-1 formula for AICH patients did not exert significant beneficial effects on clinical outcomes but increased the risk of bleeding, which probably resulted from the inclusion of RBS herbal medicines in ICH-1. TRIALREGISTRATION NUMBER: NCT01918722.

Clinical Evaluation of Herbal Medicine (ICH-012) in Treating Acute Cerebral Haemorrhage: Safety and Efficacy from 6- to 72-Hour Time Window (CRRICHTrial-II).

BACKGROUND: Hypertensive intracerebral haemorrhage (HICH), which is characterized by rapid change, high morbidity, and mortality, is extremely dangerous. Both medical and surgical treatments lack definitive evidence and remain controversial. A prospective RCT that we have conducted has shown that the usage of the herbal medicine ICH-012 within 6 h of the event may increase the risk of haematoma enlargement and gastrointestinal bleeding. However, the volume of haematoma remains stable after 6 h. Thus, we will increase the time window to the period from 6 to 72 h after onset to evaluate the safety and efficacy of ICH-012 treating ICH (ClinicalTrial.gov ID: NCT03354026). METHODS/DESIGN: The CRRICHTrial-II study, a prospective, double-blinded, controlled, multicentre RCT, includes three groups: A, B, and C. Group A patients were treated with 8 herbal medicines (with 2 herbal medicines of Hirudo and Tabanus as well as 6 other combined herbal medicines of Group B) and Group C were placebo. Patients should meet all the inclusion criteria: age between 18 and 80 and diagnosis of HICH by brain CT scan between 6 and 72 h from the onset. The CT scan will be taken at four critical time points: baseline, between 6 and 72h, 24h after onset, and between 10 and 14 days after onset. The drug intervention lasts 10 days, and there is a follow-up visit taken after 90 days. The haematoma enlargement after 24 h onset as demonstrated by CT is the primary outcome. DISCUSSION: A large amount of data from high-quality RCTs is needed for the extensive clinical application of herbal medicine. The CRRICHTrial-II will evaluate the safety and effectiveness of ICH-012 in a safer time window between 6 and 72 h and investigate the possible mechanisms of action and direction of herbal medicine in the haematoma growth after HICH. Trial registration at ClinicalTrial.gov, ID: NCT03354026, is registered on 23rd Nov. 2017.

Stapled side-to-side anastomosis might be benefit in intestinal resection for Crohn's disease: A systematic review and network meta-analysis.

BACKGROUND AND AIM: Intestinal anastomosis is an essential step in the intestinal resection in patients with Crohn's disease (CD). Anastomotic configuration such as handsewn end-to-end anastomosis (HEEA), stapled side-to-side anastomosis (SSSA) and so on may be a predictor of prognosis for postoperative CD patients. However, the association between anastomotic types and surgical outcomes are controversial. The aim of this review is to identify the optimal anastomosis for intestinal resection in patients with CD. METHODS: Clinical trials comparing anastomosis after intestinal resection in patients with CD were searched in the database of MEDLINE, EMBASE, and the Cochrane Library. Outcomes such as postoperative hospital stay, complications, mortality, recurrence, and reoperation were evaluated. Pairwise treatment effects were estimated through a random-effects network meta-analysis based on the frequency framework by using the STATA software and reported as the estimated summary effect for each comparison between the 2 treatments in the network with a 95% credible interval. RESULTS: A total of 1113 patients in 11 trials were included. In pair-wise comparisons between groups, for overall postoperative complications, SSSA showed a more probability of superiority to HEEA; for complications other than anastomotic leak, anastomotic leak, wound infection, postoperative hospital stay and mortality, there were no significant difference between groups; for clinical recurrence, SSSA showed a more probability of superiority to HEEA; for reoperation, SSSA showed a more probability of superiority to HEEA. The number of eligible randomized controlled trails (RCTs) was small, and more than half of the included trials were retrospective studies; selection bias may lead to a less power in this assessment; follow-up time between different groups was different, which may possibly have affected the interpretation of the analysis of long-term outcome. CONCLUSION: By comprehensive analyzing all the postoperative outcomes, SSSA appeared to be the optimal anastomotic strategy after intestinal resection for patients with CD.

Strategies for Preventing Endoscopic Recurrence of Crohn's Disease 1 Year after Surgery: A Network Meta-Analysis.

OBJECTIVE: To assess the benefits of different treatments that aim to prevent the endoscopic recurrence of Crohn's disease (CD) after ileal resection. METHODS: Randomized controlled trials (RCTs) were searched from MEDLINE, Embase, and the Cochrane Central Database. All the included RCTs with an endoscopic recurrence outcome which was defined as Rutgeerts' score ≥ i2 have a duration of more than 1 year. The quality of the included RCTs was assessed by the Cochrane Risk of Bias Tool. Pairwise treatment effects were estimated through a Bayesian random effects network meta-analysis by using the OpenBUGS 1.4 software and reported as odds ratios (ORs) with a 95% credible interval (CI). RESULTS: Fourteen RCTs (877 participants) were included. Two strategies were superior to placebo for preventing endoscopic recurrence of CD at 1 year after surgery: infliximab (d, -5.475; 95% CI, -10.47 to -1.632) and adalimumab (d, -7.273; 95% CI, -13.84 to -2.585). Nine strategies were not effective: budesnoid, mesalazine (in both high and low dose), azathioprine, Tripterygium wilfordii, mesalazine + infliximab, ornidazole, untreated intervention, and Lactobacillus GG. CONCLUSIONS: Except for infliximab and adalimumab, other strategies included in our analysis were not effective for preventing endoscopic recurrence of CD at 1 year after ileal resection.

Simultaneous measurement of external refractive index and temperature based on long-period-grating-inscribed Sagnac interferometer and fiber Bragg grating.

A compact Sagnac interferometer with a long-period grating (LPG) inscribed in a polarization-maintaining fiber (PMF-LPG) and a fiber Bragg grating (FBG) is proposed. The PMF-LPG is intrinsically sensitive to the external refractive index (ERI) and temperature, whereas the FBG is only sensitive to temperature. Simultaneous measurement of the ERI and temperature can be achieved by detecting wavelength shifts in the interference patterns of the Sagnac interferometer and the FBG. Because a Sagnac interference structure is used, a high ERI sensitivity of -21.07 nm∕refractive index unit in measurement range 1.33-1.43 is obtained, which is about three times higher than for the normal LPG ERI sensor.