Efficiency of Nicotinamide-based Supportive Therapy in Lymphopenia for Patients With COVID-19: A Randomized Controlled Trial

Background: The purpose of this study was to investigate the efficiency of nicotinamide-based supportive therapy in lymphopenia for patients with coronavirus disease-2019 (COVID-19). Methods: 24 patients diagnosed with the COVID-19 were randomly divided into two groups (n=12) during hospitalization in the ratio of 1:1. Based on the conventional treatment, the treatment group was given 100mg nicotinamide, five times a day. The control group only received routine treatments. The primary endpoint was the change in absolute lymphocyte counts. The secondary endpoints included both the in-hospital death and the composite endpoint of aggravation, according to upgraded oxygen therapy, improvement of nursing level, and ward rounds of superior physicians for changes of conditions. Results: The full blood counts before and after receiving the nicotinamide were comparable in each group (all P>0.05). Before and after receiving the nicotinamide, mean absolute lymphocyte counts were similar between the two groups ([0.94±0.26]*109/L versus [0.89±0.19]*109/L, P=0.565; [1.15±0.48]*109/L versus [1.02±0.28]*109/L, P=0.445, respectively). Therefore, there was no statistically significant difference in the lymphocyte improvement rate between the two groups (23.08±46.10 versus 16.52±24.10, P=0.67). There was also no statistically significant difference for the secondary endpoints between the two groups.Conclusion: Among patients with COVID-19, there was no statistically significant difference in change of full blood counts and the absolute lymphocyte counts before and after intervention in both groups. Therefore, no new evidence was found for the effect of niacinamide on lymphopenia in patients with COVID-19.Trial registration: ClinicalTrials.gov, NCT04910230. Registered 1 June 2021-retrospectively registered.

Clinical Effectiveness and Safety of Chinese Herbal Medicine Compound Kushen Injection as an Add-On Treatment for Breast Cancer: A Systematic Review and Meta-Analysis

Objective. To systematically evaluate the effect and safety of compound Kushen injection (CKI) as an add-on treatment on the treatment for breast cancer. Methods. We searched eight major electronic databases from their inception to November 1, 2021, for randomized clinical trials (RCTs) comparing CKI plus chemotherapy with chemotherapy alone. Primary outcomes included objective response rate (ORR) and disease control rate (DCR), health-related quality of life (HRQoL), progression-free survival (PFS), and overall survival (OS). Secondary outcomes included adverse drug reactions (ADRs) and tumor marker level. We used Cochrane’s RevMan 5.3 for data analysis. The GRADEpro was used to appraise the certainty of evidence. Trial sequential analysis (TSA) was applied to estimate the required sample size in a meta-analysis and test the robustness of the current results. Results. Thirty RCTs with 2556 participants were totally included. CKI plus chemotherapy showed significant effects in increasing ORR (RR 1.30, 95%CI [1.18, 1.43], I2 = 27%, n = 1694), increasing DCR (RR 1.21, 95%CI [1.15, 1.28], I2 = 16%, n = 1627), increasing HRQol as measured by Karnofsky Performance Scale (KPS) score improvement rate (RR 1.42, 95% CI [1.26, 1.61], I2 = 37%, n = 1172), increasing the PFS (MD 2.24 months, 95%CI [1.26, 3.22], n = 94) and the OS (MD 2.24 months, 95%CI [1.45, 3.43], n = 94), compared to chemotherapy alone. The results showed that CKI plus chemotherapy had a lower risk of ADRs than that of chemotherapy alone group. The certainty of evidence of the included trials was generally low to very low. TSA for ORR and KPS score improvement rate demonstrated that the current results reached a sufficient power regarding both numbers of trials and participants. Conclusions. Low certainty of evidence suggested that the combination of CKI and conventional chemotherapy appeared to improve ORR, DCR, and KPS score in breast cancer patients. Conclusions about PFS and OS could not be drawn due to lack of evidence. Additionally, CKI appeared to relieve the risk of ADRs in patients with breast cancer receiving chemotherapies. However, due to weak evidence, the findings should be further confirmed in large and rigorous trials.

The timed up and go test in idiopathic normal pressure hydrocephalus: a Nationwide Study of 1300 patients

Background The aim of this study was to describe the outcome measure timed up and go (TUG) in a large, nationwide cohort of patients with idiopathic normal pressure hydrocephalus (iNPH) pre- and post-operatively. Furthermore, to compare the TUG test to the 10-m walk test (10MWT), the iNPH scale, the modified Rankin scale (mRS) and the Mini Mental State Examination (MMSE), which are commonly applied in clinical assessment of iNPH. Methods Patients with iNPH (n = 1300), registered in the Swedish Hydrocephalus Quality Registry (SHQR), were included. All data were retrieved from the SHQR except the 10MWT, which was collected from patient medical records. Clinical scales were examined pre- and 3 months post-operatively. Data were dichotomised by sex, age, and preoperative TUG time. Results Preoperative TUG values were 19.0 [14.0–26.0] s (median [IQR]) and 23 [18–30] steps. Post-operatively, significant improvements to 14.0 [11.0–20.0] s and 19 [15–25] steps were seen. TUG time and steps were higher in women compared to men (p < 0.001) but there was no sex difference in improvement rate. Worse preoperative TUG and younger age favoured improvement. TUG was highly correlated to the 10MWT, but correlations of post-operative changes were only low to moderate between all scales (r = 0.22–0.61). Conclusions This study establishes the distribution of TUG in iNPH patients and shows that the test captures important clinical features that improve after surgery independent of sex and in all age groups, confirming the clinical value of the TUG test. TUG performance is associated with performance on the 10MWT pre- and post-operatively. However, the weak correlations in post-operative change to the 10MWT and other established outcome measures indicate an additional value of TUG when assessing the effects of shunt surgery.

Reconsidering Ventriculoperitoneal Shunt Surgery and Postoperative Shunt Valve Pressure Adjustment: Our Approaches Learned From Past Challenges and Failures

Treatment for idiopathic normal pressure hydrocephalus (iNPH) continues to develop. Although ventriculoperitoneal shunt surgery has a long history and is one of the most established neurosurgeries, in the 1970s, the improvement rate of iNPH triad symptoms was poor and the risks related to shunt implantation were high. This led experts to question the surgical indication for iNPH and, over the next 20 years, cerebrospinal fluid (CSF) shunt surgery for iNPH fell out of favor and was rarely performed. However, the development of programmable-pressure shunt valve devices has reduced the major complications associated with the CSF drainage volume and appears to have increased shunt effectiveness. In addition, the development of support devices for the placement of ventricular catheters including preoperative virtual simulation and navigation systems has increased the certainty of ventriculoperitoneal shunt surgery. Secure shunt implantation is the most important prognostic indicator, but ensuring optimal initial valve pressure is also important. Since over-drainage is most likely to occur in the month after shunting, it is generally believed that a high initial setting of shunt valve pressure is the safest option. However, this does not always result in sufficient improvement of the symptoms in the early period after shunting. In fact, evidence suggests that setting the optimal valve pressure early after shunting may cause symptoms to improve earlier. This leads to improved quality of life and better long-term independent living expectations. However, in iNPH patients, the remaining symptoms may worsen again after several years, even when there is initial improvement due to setting the optimal valve pressure early after shunting. Because of the possibility of insufficient CSF drainage, the valve pressure should be reduced by one step (2–4 cmH2O) after 6 months to a year after shunting to maximize symptom improvement. After the valve pressure is reduced, a head CT scan is advised a month later.

Mobile Health Platform to Augment Integrated Behavioral Health Care: Pilot in a Large Health System (Preprint)

BACKGROUND Digital and mobile technologies have potential to improve the delivery and scale of integrated care models. OBJECTIVE We aimed to assess acceptability and feasibility, preliminary clinical outcomes, and implementation barriers of a mobile health platform used to augment an existing integrated behavioral health program. METHODS The mobile platform was used by three behavioral health care managers responsible for coordinating disease management in six primary care practices. 89 of 245 individuals (36%) who were referred by their PCP for behavioral health services consented to app-augmented behavioral health care. The mobile health platform functions included chat communication, monthly depression self-report assessments, and psychoeducational content. RESULTS The clinical improvement rate in our sample was 72% although follow-up assessments were only available for 49% of participants. At least one action in the mobile app was completed by 87% of participants (n=78; median=7; IQR=12, 0-130). Behavioral health care managers cited increased documentation burden and language as barriers to use. CONCLUSIONS Our pilot of mobile technology in collaborative care highlights important implementation barriers. Future research should systematically evaluate the implementation of digital and mobile health technology in collaborative care.

Evaluation of an Ayurvedic formulation in clinical recovery of COVID-19 patients: A placebo controlled pilot study among moderate-severe patients

Introduction: The COVID-19 pandemic is a global health crisis that has affected millions of people worldwide. Apart from measures taken to reduce the transmission of virus and provide symptomatic relief to patients, a potent drug targeted against the virus is required to manage the disease. Traditional medicines with an array of phytochemicals and potent anti-viral properties, can provide alternate solution in the therapeutic cure of COVID-19.Objective: The present study investigates the efficacy of an Ayurvedic formulation, NOQ19, on the rate of recovery and clinical improvement among moderate-severe COVID-19 infected patients who were not on a ventilator or in intensive care unit.Methods: A placebo controlled randomized study design, with 1:1 ratio between the intervention and placebo arms was adopted. The participants were provided their respective intervention along with the standard of care treatment. A follow up was conducted on Day 7 and Day 10 to assess the rate of recovery and clinical improvement. Rate of recovery was the primary outcome measured and was determined by a negative result on the RT-PCR test. The secondary outcomes included clinical improvement among patients and were measured using blood biomarkers.Results: The NOQ19 arm had a higher percentage of population who turned RT-PCR negative on Day 7 (23%) when compared to the placebo arm (11%). Further subgroup analysis demonstrated that for both moderate and severe patients, there were a greater percentage of population who were RT-PCR negative in the NOQ19 arm compared to the placebo arm at Day 7: (NOQ-19: 22.22%, Placebo: 14.29% for moderate patients), (NOQ19: 23.08% Placebo: 0% for severe patients). By Day 10, both populations depicted an almost similar percentage of the population who were RT- PCR negative. Both the groups demonstrated an improvement in blood biomarkers, although the improvement was greater in the NOQ19 arm. None of the patients in the intervention arm reported any adverse events.Conclusion: The results of this pilot RCT indicates that NOQ19 along with standard of care treatment can be considered as an effective therapy for COVID-19 and aid early recovery from the disease.

Vitrectomy vs. Spontaneous Closure for Traumatic Macular Hole: A Systematic Review and Meta-Analysis

Objective: This systematic review and meta-analysis aimed to determine the traumatic macular hole (TMH) closure rate and visual acuity (VA) improvement rate by comparing two treatment methods for TMH: vitrectomy and observation for spontaneous closure.Methods: PubMed, Cochrane, Web of Science Library, Embase, CNKI, Wanfang, VIP, and Sino Med were systematically searched from their inception to June 10, 2021. Studies in the surgery group (n = 32) and studies in the observation group (n = 12) were meta-analyzed. The primary outcomes were the TMH closure and VA improvement rates in the surgery and observation groups. The secondary outcomes were best-corrected visual acuity (BCVA) improvement in the surgery group. Stata software (version 15.1) was used for the analyses.Results: Thirty-six studies that included 1,009 eyes were selected for this meta-analysis, among which 33 were retrospective studies and 3 were prospective studies. The meta-analysis showed that the random-model pooled event rate for TMH closure was 0.37 (95% confidence interval [CI], 0.26–0.48) in the observation group, while it was 0.9 (95% CI, 0.85–0.94) in the surgery group. The fixed-model pooled event rate for VA improvement was 0.39 (95% CI, 0.33–0.45) in the observation group, while the random-model pooled event rate of VA improvement for the surgery group was 0.72 (95% CI, 0.63–0.80). The pooled event rate for BCVA improvement in the surgery group was 0.39 (95% CI, 0.33–0.46).Conclusions: This meta-analysis suggests that TMH hole closure and VA improvement rates in the surgery group were significantly higher than those in the observation group. Vitrectomy is an effective method for treating TMH. However, further randomized controlled trials (RCTs) are required to evaluate the efficacy and safety of surgery and observation for TMH treatment.Systematic Review Registration:https://www.crd.york.ac.uk/PROSPERO/#recordDetails, identifier: CRD42021276684.

Low-Dose Statins Improve Prognosis of Patients with Ischaemic Stroke Undergoing Intra-Arterial Thrombectomy: A Prospective Cohort Study

Background: High-dose statins are recommended as preventive drugs in guidelines for patients with ischaemic stroke undergoing thrombectomy. Not only in clinical practice but also based on large-scale studies, low-dose statins have been widely used and demonstrated to be efficient in Asian populations. However, it remains unknown whether low-dose statin is related to the prognosis of patients with thrombectomy. Can low-dose statins reduce the risk of bleeding at the same time?Methods: We prospectively collected data from patients with acute ischaemic stroke undergoing intra-arterial thrombectomy. Efficacy outcomes were National Institutes of Health Stroke Scale (NIHSS) score improvement at 7 days after admission and a favourable functional outcome (FFO) at 90 days. Safety outcomes were rates of in-hospital haemorrhage events and death within 2 years. Results: We included 256 patients in this study. Compared with the control group, the low-dose statin group had a higher NIHSS improvement rate at 7 days, a higher FFO rate at 90 days and a lower death rate within 2 years. The low-dose statin group had a lower percentage of gastrointestinal haemorrhage. Statin use was significantly related to an improved NIHSS score (p=0.028, OR=1.773) at 7 days and FFO (P<0.001, OR=2.962) at 90 days and to lower death rates (P=0.025, or=0.554) within 2 years.Conclusion: In Asian acute ischaemic stroke patients with intra-arterial thrombectomy, low-dose statin use was significantly related to NIHSS improvement at 7 days, FFO at 90 days and decreased death rates within 2 years.

Dissatisfaction Risk Factors of Patients after Laminectomy for Thoracic Ossification of Ligamentum Flavum: A Retrospective Cohort Study of Different Follow-Up Periods

Objectives. To explore the influencing factors of satisfaction with postoperative treatment in patients diagnosed with thoracic ossification of the ligamentum flavum during different follow-up periods. Methods. This was a retrospective study of 57 patients who were diagnosed with thoracic ossification of ligamentum flavum (TOLF) and treated with laminectomy in the Spine Surgery Department of the Third Hospital of Hebei Medical University from January 2010 to January 2017. The Patient Satisfaction Index (PSI) was collected at discharge and at 6-month, 1-year, and the last follow-up. According to the evaluation results, the patients could be divided into a satisfied group and a dissatisfied group. The patient’s Japanese Orthopaedic Association (JOA) score improvement rate was evaluated at the last follow-up. Possible influencing factors of the two groups of patients were compared and the related influencing factors of satisfaction with postoperative treatment in patients during different follow-up periods were summarized. Results. At the time of discharge, the dissatisfied and satisfied groups had significant differences in variables of diabetes mellitus, duration of preoperative symptoms, urination disorder, intramedullary signal change on MRI, dural ossification, residual rate of cross-sectional spinal canal area on CT, shape on the sagittal MRI, hospital stay, hospitalization expenses, postoperative pain in LE VAS, delayed wound healing, postoperative depression, and intercostal pain ( P < 0.05 ). There were also significant differences in urination disorder, postoperative pain according to the LE VAS, JOA score, and postoperative depression during the 6-month follow-up ( P < 0.05 ). There were no significant differences in other variables between the two groups ( P > 0.05 ). One year after the operation, there were significant differences between the dissatisfied group and the satisfied group in urination disorder, JOA score, and symptom recurrence ( P < 0.05 ). There were also significant differences in the JOA score and symptom recurrence at the final follow-up ( P < 0.05 ). For further analysis, the duration of preoperative symptoms in the satisfied group was less than 24 months and the duration of preoperative symptoms in the dissatisfied group was more than 24 months. The JOA scores of patients in the satisfied group and the dissatisfied group increased gradually with the improvement of neurological function in different follow-up periods, but, at the last follow-up, the JOA scores of patients in the satisfied group were significantly higher than those in the dissatisfied group. Conclusions. In conclusion, for thoracic ossification of ligamentum flavum patients who received laminectomy, dissatisfaction with the early and medium-term postoperative results may be related to diabetes, the duration of preoperative symptoms, hospitalization expenses, delayed wound healing, intercostal pain, and urination disorder, and dissatisfaction with the long-term postoperative results might be related to the low JOA score improvement rate and symptom recurrence.

Association between Helicobacter pylori infection and irritable bowel syndrome: a systematic review and meta-analysis

BackgroundHelicobacter pylori infection and irritable bowel syndrome (IBS) negatively affect the quality of life. Some previous studies found that H. pylori infection should be positively associated with the risk of IBS, but others did not. The present study aims to clarify this association, and to further analyse whether H. pylori treatment can improve IBS symptoms.Materials and methodsThe PubMed, EMBASE, Cochrane library, Chinese National Knowledge Infrastructure, China Science and Technology Journal and Wanfang databases were searched. Meta-analysis was performed using a random-effect model. The pooled odds ratios (ORs)/risk ratios (RRs) and their 95% CIs were calculated. Heterogeneity was evaluated using the Cochran’s Q test and I2 statistics. Meta-regression analysis was used to explore the sources of heterogeneity.ResultsThirty-one studies with 21 867 individuals were included. Meta-analysis of 27 studies found that patients with IBS had a significantly higher risk of H. pylori infection than those without (OR=1.68, 95% CI 1.29 to 2.18; p<0.001). The heterogeneity was statistically significant (I²=85%; p<0.001). Meta-regression analyses indicated that study design and diagnostic criteria of IBS might be the potential sources of heterogeneity. Meta-analysis of eight studies demonstrated that H. pylori eradication treatment had a higher improvement rate of IBS symptoms (RR=1.24, 95% CI 1.10 to 1.39; p<0.001). The heterogeneity was not significant (I²=32%; p=0.170). Meta-analysis of four studies also demonstrated that successful H. pylori eradication had a higher improvement rate of IBS symptoms (RR=1.25, 95% CI 1.01 to 1.53; p=0.040). The heterogeneity was not significant (I²=1%; p=0.390).ConclusionH. pylori infection is associated with an increased risk of IBS. H. pylori eradication treatment can improve IBS symptoms.