|Davinder Singh Rana, Ish Anand, Anuradha Batra, Prahlad Kumar Sethi, Seema Bhargava
Background and objectives: Studies in different populations have shown that ischemic stroke can trigger an acute phase response resulting in a rise of plasma concentration of C-reactive protein (CRP) and high level of high-sensitivity CRP (hsCRP) is a risk factor for ischemic stroke. The objective of this study was to investigate the association of high hsCRP levels (≥ 1 mg/L) with ischemic stroke and its subtypes in Indian patients.
Methods: This prospective observational case-control study included 150 patients (96 males, 54 females; aged 24–81 years) with first acute ischemic stroke who were admitted within 72 hours after onset, and 150 age- and sex-matched healthy controls. The study was conducted from July 2016 to July 2017. The patients were classified according to Trial of ORG 10172 in Acute Stroke Treatment classification. hsCRP levels were assessed in all included stroke patients.
Results: The mean serum level of hsCRP was significantly higher in patients with first acute ischemic stroke than in healthy controls (P < 0.001). The mean serum level of hsCRP was higher in patients who had more severe stroke on admission. The prevalence of high serum level of hsCRP was highest in large-artery atherosclerosis (35.2%), followed by in cardioembolic (28.2%) stroke. The mean serum level of hsCRP was highest in large-artery atherosclerosis, followed by in stroke of undetermined etiology and cardioembolic subtype. High serum level of hsCRP was significantly associated with hypertension and age (P < 0.001 or P < 0.05). Multiple Logistic regression analysis revealed that high level of hsCRP was independently associated with acute ischemic stroke [odds ratio (OR) = 3.87, 95% confidence interval (CI): 2.39–6.27]. High hsCRP level was strongly associated with cardioembolic stroke (OR = 4.97, 95% CI: 2.5–9.65), large-artery atherosclerosis (OR = 4.75, 95% CI: 2.57–8.81), and stroke of undetermined etiology (OR = 3.36, 95% CI: 1.72–6.54).
Conclusion: High hsCRP level is strongly associated with acute ischemic stroke and its subtypes, and it is an independent predictor of acute ischemic stroke.
Ethics: The study was approved by the Sir Ganga Ram Hospital Ethics Committee (EC/07/14/701) on July 5, 2014.
|Xu Chen, Xiao-Long Zhang, Chang-Ming Wang, Lei Feng, Gang Wang
Background and objectives: Patients with depression can experience sleep disorder. Current treatments for depression, such as duloxetine and selective serotonin reuptake inhibitors, not only have a slow onset of action but also are associated with side effects such as dizziness, blurred vision, and ataxia. The main active ingredient of cordyceps sinensis, cordycepin, may have antidepressant effects, as well as pro-immunity, anti-inflammatory, anti-tumor, anti-fatigue, and anti-viral properties. In this randomized controlled trial, we investigate the safety and effectiveness of cordyceps sinensis (containing approximately 1.0% cordycepin) in combination with duloxetine in treating sleep disorder in patients with depression.
Methods: In this randomized, double-blind, placebo-controlled, prospective trial, we plan to include 286 patients with depression receiving treatment at Beijing Anding Hospital of Capital Medical University, China. These patients are randomly assigned to undergo cordyceps sinensis combined with duloxetine or placebo combined with duloxetine. Duloxetine is assigned in an open manner, while cordyceps sinensis and placebo are assigned in a double-blind manner. Participants or their legal guardians are informed of the study protocol and medication and sign informed consent. A total of 246 patients were included in the polit study.
Results: The primary outcome measure is the proportion of patients with ≥ 50% difference in 17-item-Hamilton Depression Rating Scale total score after 6 weeks of treatment relative to baseline. The secondary outcome measures are complete remission rate after 6 weeks of treatment; effectiveness rate after 1, 2, and 4 weeks of treatment; changes in Athens Insomnia Scale score, 17-item-Hamilton Depression Rating Scale total score, Arizona Sexual Experience Scale score, Mini-International Neuropsychiatric Interview suicide score, Digit Symbol Substitution Test score, Perceived Deficits Questionnaire-Depression score, 16-item Quick Inventory of Depressive Symptomatology Self-Report Scale score, 7-item Generalized Anxiety Disorder Scale score, and Sheehan Disability Scale score after 1, 2, 4, and 6 weeks of treatment relative to baseline; changes in Insight and Treatment Attitude Questionnaire score, and time and proportion of sleep drug use during the study period after 6 weeks of treatment relative to baseline; electroencephalogram results after 2 and 6 weeks of treatment; and blood biomarkers, safety indicators, and adverse events after 6 weeks of treatment. Results of a pilot study (during 2012–2016) involving 246 patients with depression receiving duloxetine 60 mg/d or fluoxetine 20 mg/d revealed that there was a similar percentage difference in 17-item-Hamilton Depression Rating Scale total score after 6 weeks of treatment relative to baseline and a similar incidence of drug use-related adverse events for both treatments.
Discussion: We plan to perform a future study involving 286 patients to validate that cordyceps sinensis combined with duloxetine can effectively improve sleep symptoms of depression. The trial will provide data to support the clinical application of cordyceps sinensis.
Ethics and registration: This study was approved by Hospital Ethics Committee, Beijing Anding Hospital of Capital Medical University, China (approval No. 2017-79-2017111-2) on December 20, 2017. This study was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR-INR-17014074). Protocol version: 3.0.