Efficacy and Safety of Lianhuaqingwen Capsules for the Prevention of Coronavirus Disease 2019: A Prospective Open-Label Controlled Trial

Coronavirus disease 2019 (COVID-19) has become a global pandemic. Community and close contact exposures continue to drive the COVID-19 pandemic. There is no confirmed effective treatment for suspected cases and close contacts. Lianhuaqingwen (LH) capsules, a repurposed Chinese herbal product that is currently on the market, have proven effective for influenza and COVID-19. To determine the safety and efficacy of LH capsules for the prevention of COVID-19, we conducted a prospective open-label controlled trial of LH capsules on subjects who had close contact with people infected with COVID-19. Subjects received LH capsules (4 capsules, three times daily) or the usual medical observation for 14 days. The primary endpoint was the rate of positive nucleic acid tests of nasal and pharyngeal swabs during the quarantine medical observation period. We included 1976 patients, including 1101 in the treatment group and 875 in the control group. The rate of positive nucleic acid tests in the treatment group was significantly lower than that in the control group (0.27% vs. 1.14%, respectively; mean difference: −0.87%; 95% CI: −1.83 to −0.13; p = 0.0174 ) during the quarantine medical observation period (14 days). Among subjects with different close contact states, there was no significant difference in the rate of positive nucleic acid test results among close contacts in the treatment group and the control group (6.45% vs. 11.43%, respectively; p = 0.6762 ). Among secondary close contacts, the rate of positive nucleic acid tests in the treatment group was significantly lower than that in the control group (0.09% vs. 0.71%, respectively; p = 0.0485 ). No serious adverse events were reported. Taken together, and in light of the safety and effectiveness profiles, these results show that LH capsules can be considered to prevent the progression of COVID-19 after close contact with an infected person. This trial is registered with ChiCTR2100043012.

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Safety and Efficacy of Repurposed Siddha Medicines in Mild, Moderate, and Severe COVID-19 Patients Admitted To a Government Tertiary Hospital Near Chennai, Tamil Nadu– An Open-Labeled, Randomized, Controlled Trial.

10.21203/rs.3.rs-999914/v1 ◽

2021 ◽

Author(s):

Christian G J ◽

Meenakumari Ramasamy ◽

Shanthimalar Ramalingam ◽

Sankar Ganesan ◽

Ravichandran Vadugam Muthusamy ◽

...

Keyword(s):

Treatment Group ◽

Standard Care ◽

Tamil Nadu ◽

Controlled Trial ◽

Standard Of Care ◽

Tertiary Hospital ◽

Control Group ◽

Open Label ◽

Randomized Controlled ◽

Oxygenation Status

Abstract BackgroundCOVID-19 resulted in loss of human lives owing to respiratory failure caused by dysregulated immune system. Though many treatments are evaluated, the most appropriate is yet to be established. We hypothesized accelerated recovery and reduced mortality in mild, moderate and severe COVID-19 with Siddha regimen consisting of natural products.MethodsIn a randomized, controlled open-label trial conducted on 200 hospitalized COVID-19 patients, they were allocated equally to be treated with add-on Siddha regimen with Standard care or only standard care. The primary and secondary end points were accelerated recovery (≤ 7 days) and mortality comparison between the groups respectively. Patients were followed through 90 days.ResultsIn this study the accelerated recovery was 59.0% and 27.0% in treatment and control group (ITT analyses) (p < 0.001) respectively and Odds for it were four times higher in the treatment group (OR: 3.9; 95% CI: 1.9, 8.0). The estimated median time for recovery in the treatment group was 7 days (95% CI: 6.0, 8.0; p=0.003) and 10 days (95% CI: 8.7, 11.3) in control. Hazard ratio for death in control was 2.3 times that of treatment group. No adverse reactions or alarming laboratory values were observed in response to intervention. In severe treatment group (n=80), mortality was 15.0% and 39.5% in control (n=81). The COVID stage progression was 65% less in treatment group.ConclusionSiddha regimen demonstrated that they can synergistically improve oxygenation status, enhance the recovery rate and reduce the mortality better as compared to only Standard of Care.

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Cefazolin plus Ceftazidime versus Imipenem / Cilastatin Monotherapy for Treatment of Capd Peritonitis — a Randomized Controlled Trial

Peritoneal Dialysis International ◽

10.1177/089686080402400508 ◽

2004 ◽

Vol 24 (5) ◽

pp. 440-446 ◽

Cited By ~ 22

Author(s):

Chi-Bon Leung ◽

Cheuk-Chun Szeto ◽

Kai-Ming Chow ◽

Bonnie Ching-Ha Kwan ◽

Angela Yee-Moon Wang ◽

...

Keyword(s):

Treatment Group ◽

Response Rate ◽

Controlled Trial ◽

Group Versus ◽

Similar Efficacy ◽

Primary Response ◽

Control Group ◽

Cure Rate ◽

Open Label ◽

Complete Cure

Background Peritonitis is a serious complication of peritoneal dialysis (PD). We studied the efficacy of imipenem / cilastatin monotherapy in the treatment of PD-related peritonitis. Methods We performed an open-label, randomized control study comparing imipenem / cilastatin monotherapy (treatment group) versus cefazolin plus ceftazidime (control group) in the treatment of PD peritonitis. The result was further compared to a historic group treated with cefazolin plus netilmycin. Outcome measures were primary response rate at day 10 and complete cure rate. Results We enrolled 51 patients in the treatment group, 51 in the control group, and identified 96 in the historic group. The primary response rate to the assigned antibiotics was 49.0%, 51.0%, and 49.0% for the treatment, control, and historic groups, respectively ( p = 0.97). The primary response rate allowing for change in antibiotic was 82.4%, 90.2%, and 82.3%, respectively, for the three groups ( p = 0.41). The complete cure rate was 72.5%, 80.4%, and 82.3%, respectively ( p = 0.60). Tenckhoff catheter removal was needed in 6 cases in the treatment group, 6 cases in the control group, and 13 cases in the historic group ( p = 0.90). Conclusions We concluded that monotherapy of imipenem / cilastatin has similar efficacy compared to the two standard regimens of cefazolin plus ceftazidime or netilmycin in the treatment of PD peritonitis.

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A Four Month Randomized Controlled Trial on the Efficacy of Once-daily Fenofibrate Monotherapy in Persons with Spinal Cord Injury

Scientific Reports ◽

10.1038/s41598-019-53753-7 ◽

2019 ◽

Vol 9 (1) ◽

Cited By ~ 1

Author(s):

Michael F. La Fountaine ◽

Christopher M. Cirnigliaro ◽

Joshua C. Hobson ◽

Alexander T. Lombard ◽

Adam F. Specht ◽

...

Keyword(s):

Spinal Cord ◽

Spinal Cord Injury ◽

Treatment Group ◽

Controlled Trial ◽

Serum Lipoprotein ◽

Control Group ◽

Lipoprotein Profile ◽

Open Label ◽

Once Daily ◽

Cord Injury

AbstractAn open-label, randomized clinical trial of once-daily fenofibrate monotherapy administered for 2- (Mo2) and 4- (Mo4) months using modified intervention thresholds for triglyceride (TG) was performed in persons with chronic spinal cord injury (SCI). Fenofibrate (145 mg tablet) was self-administered daily in 10 persons with SCI for 4 months with monthly blood testing to quantify the lipoprotein profile (e.g., serum TG, LDL-C, and HDL-C concentrations). Eight SCI participants were control subjects. In comparison to the control group, the treatment group at Mo2 had a 40% (±12%; p < 0.05) reduction in serum TG concentration, a 28% (±21%; p < 0.05) increase in HDL-C and 14% (±20%; p < 0.05) decline in LDL-C. In the same comparison at Mo4, the treatment group maintained a 40% (±20%; p < 0.05) reduction in serum TG concentration, had an 18% in reduction in LDL-C (±12%; p < 0.05) and a 23% (±23%; p < 0.05) increase in HDL-C. Fenofibrate monotherapy for Mo2 and Mo4 initiated in persons with SCI resulted in a robust and favorable change in the serum lipoprotein profile and ratios, suggesting reduced risk for cardiovascular disease.

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Chinese medicine (Q-14) in the Treatment of Patients with Coronavirus Disease 2019 (COVID-19): A Single-center, Open label, Randomised Controlled Trial

10.1101/2021.01.25.21249417 ◽

2021 ◽

Author(s):

Jia Liu ◽

Wei Yang ◽

Yue Liu ◽

Cheng Lv ◽

Lianguo Ruan ◽

...

Keyword(s):

Treatment Group ◽

Standard Care ◽

Controlled Trial ◽

Control Group ◽

Chest Discomfort ◽

Open Label ◽

Conversion Time ◽

Q 14 ◽

Randomised Controlled ◽

And Control

ABSTRACTOBJECTIVETo evaluate the efficacy and safety of Chinese medicine (Q-14) plus standard care compared with standard care alone in adult with coronavirus disease 2019 (COVID-19).Study DESIGNSingle-center, open label, randomised controlled trial.SETTINGWuhan Jinyintan Hospital, Wuhan, China, February 27 to March 27, 2020.PARTICIPANTS204 patients with laboratory confirmed COVID-19 were randomised in to treatment group and control group, which was 102 patients each group.INTERVENTIONSIn treatment group, Q-14 was administrated at 10g (granules), twice daily for 14 days and plus standard care. In control group, patients were given standard care alone for 14 days.MAIN OUTCOME MEASUREThe primary outcome was conversion time of SARS-CoV-2 viral assay. Adverse events were analyzed in the safety population.RESULTSAmong 204 patients, 195 were analyzed according to the intention to treat principle. There were 149 patients (71 vs. 78 in treatment group and control group respectively) turning to negative via SARS-CoV-2 viral assay. No statistically significance showed in conversion time between treatment group and control group (FAS: Median (IQR): 10.00 (9.00-11.00) vs. 10.00 (9.00-11.00); Mean rank: 67.92 vs. 81.44; P=0.051.). Time to recovery of fever was shorter in treatment group as compared in control group. The disappearance rate of symptom in cough, fatigue, chest discomfort was significantly higher in treatment group. In chest computed tomography (Chest CT) examinations, overall evaluation of chest CT examination after treatment compared with baseline showed more patients improved in treatment group .There were no significant differences in the other outcomes.CONCLUSIONAdministration of Q-14 on standard care for COVID-19 was useful for improvement of symptoms (such as fever, cough, fatigue and chest discomfort), while did not result in a significantly higher probability of negative conversion of SARS-CoV-2 viral assay. No serious adverse events were reported.TRIAL REGISTRATIONChiCTR2000030288

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Clinical Characteristics of 24 Asymptomatic Infections with COVID-19 Screened among Close Contacts in Nanjing, China

10.1101/2020.02.20.20025619 ◽

2020 ◽

Cited By ~ 22

Author(s):

Zhiliang Hu ◽

Ci Song ◽

Chuanjun Xu ◽

Guangfu Jin ◽

Yaling Chen ◽

...

Keyword(s):

Nucleic Acid ◽

Clinical Characteristics ◽

Close Contact ◽

Contact Tracing ◽

Severe Illness ◽

Asymptomatic Carriers ◽

Asymptomatic Infections ◽

Clinical Records ◽

Close Contacts ◽

Nucleic Acid Tests

AbstractBackgroundPrevious studies have showed clinical characteristics of patients with the 2019 novel coronavirus disease (COVID-19) and the evidence of person-to-person transmission. Limited data are available for asymptomatic infections. This study aims to present the clinical characteristics of 24 cases with asymptomatic infection screened from close contacts and to show the transmission potential of asymptomatic COVID-19 virus carriers.MethodsEpidemiological investigations were conducted among all close contacts of COVID-19 patients (or suspected patients) in Nanjing, Jiangsu Province, China, from Jan 28 to Feb 9, 2020, both in clinic and in community. Asymptomatic carriers were laboratory-confirmed positive for the COVID-19 virus by testing the nucleic acid of the pharyngeal swab samples. Their clinical records, laboratory assessments, and chest CT scans were reviewed.FindingsNone of the 24 asymptomatic cases presented any obvious symptoms before nucleic acid screening. Five cases (20.8%) developed symptoms (fever, cough, fatigue, etc.) during hospitalization. Twelve (50.0%) cases showed typical CT images of ground-glass chest and 5 (20.8%) presented stripe shadowing in the lungs. The remaining 7 (29.2%) cases showed normal CT image and had no symptoms during hospitalization. These 7 cases were younger (median age: 14.0 years; P = 0.012) than the rest. None of the 24 cases developed severe COVID-19 pneumonia or died. The median communicable period, defined as the interval from the first day of positive nucleic acid tests to the first day of continuous negative tests, was 9.5 days (up to 21 days among the 24 asymptomatic cases). Through epidemiological investigation, we observed a typical asymptomatic transmission to the cohabiting family members, which even caused severe COVID-19 pneumonia.InterpretationThe asymptomatic carriers identified from close contacts were prone to be mildly ill during hospitalization. However, the communicable period could be up to three weeks and the communicated patients could develop severe illness. These results highlighted the importance of close contact tracing and longitudinally surveillance via virus nucleic acid tests. Further isolation recommendation and continuous nucleic acid tests may also be recommended to the patients discharged.

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Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

Otolaryngology ◽

10.1177/0194599821994742 ◽

2021 ◽

pp. 019459982199474

Author(s):

Maggie Xing ◽

Dorina Kallogjeri ◽

Jay F. Piccirillo

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Training ◽

Mixed Model ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Functional Index ◽

Open Label ◽

Randomized Controlled ◽

The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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Effectiveness of Measures to Eradicate Staphylococcus aureus Carriage in Patients with Community-Associated Skin and Soft-Tissue Infections: A Randomized Trial

Infection Control and Hospital Epidemiology ◽

10.1086/661285 ◽

2011 ◽

Vol 32 (9) ◽

pp. 872-880 ◽

Cited By ~ 89

Author(s):

Stephanie A. Fritz ◽

Bernard C. Camins ◽

Kimberly A. Eisenstein ◽

Joseph M. Fritz ◽

Emma K. Epplin ◽

...

Keyword(s):

Staphylococcus Aureus ◽

Soft Tissue ◽

Controlled Trial ◽

Control Group ◽

Open Label ◽

Intention To Treat ◽

Intranasal Mupirocin ◽

Mupirocin Ointment ◽

Hygiene Education ◽

To Receive

Background.Despite a paucity of evidence, decolonization measures are prescribed for outpatients with recurrent Staphylococcus aureus skin and soft-tissue infection (SSTI).Objective.Compare the effectiveness of 4 regimens for eradicating S. aureus carriage.Design.Open-label, randomized controlled trial. Colonization status and recurrent SSTI were ascertained at 1 and 4 months.Setting.Barnes-Jewish and St. Louis Children's Hospitals, St. Louis, Missouri, 2007–2009.Participants.Three hundred patients with community-onset SSTI and S. aureus colonization in the nares, axilla, or inguinal folds.Interventions.Participants were randomized to receive no therapeutic intervention (control subjects) or one of three 5-day regimens: 2% mupirocin ointment applied to the nares twice daily, intranasal mupirocin plus daily 4% chlorhexidine body washes, or intranasal mupirocin plus daily dilute bleach water baths.Results.Among 244 participants with 1-month colonization data, modified intention-to-treat analysis revealed S. aureus eradication in 38% of participants in the education only (control) group, 56% of those in the mupirocin group (P = .03 vs controls), 55% of those in the mupirocin and chlorhexidine group (P = .05), and 63% off those in the mupirocin and bleach group (P = .006). Of 229 participants with 4-month colonization data, eradication rates were 48% in the control group, 56% in the mupirocin only group (P = .40 vs controls), 54% in the mupirocin and chlorhexidine group (P = .51), and 71% in the mupirocin and bleach group (P = .02). At 1 and 4 months, recurrent SSTIs were reported by 20% and 36% of participants, respectively.Conclusions.An inexpensive regimen of dilute bleach baths, intranasal mupirocin, and hygiene education effectively eradicated S. aureus over a 4-month period. High rates of recurrent SSTI suggest that factors other than endogenous colonization are important determinants of infection.Trial Registration.ClinicalTrials.gov identifier: NCT00513799.

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Development and evaluation of an online medication safety module for medical students at a rural teaching hospital: the Winchester District Memorial Hospital

BMJ Open Quality ◽

10.1136/bmjoq-2021-001385 ◽

2021 ◽

Vol 10 (2) ◽

pp. e001385

Author(s):

Ali Elbeddini ◽

Yasamin Tayefehchamani

Keyword(s):

Online Learning ◽

Medical Students ◽

Medication Safety ◽

Controlled Trial ◽

Effective Means ◽

Intervention Group ◽

Control Group ◽

Open Label ◽

Online Module ◽

Learning Module

ObjectiveTo design, implement and assess an online learning module for third-year and fourth-year medical students addressing medication safety.DesignThis study was a prospective, parallel, open-label, randomised controlled trial with two arms: (1) a control arm in which students were given five articles to read about medication safety, and (2) an intervention arm in which students were given access to an interactive web-based learning module on medication safety. Pretesting and post-testing were done online to evaluate change in medication safety knowledge.ResultsTen students completed the study in the intervention group (online module) and six students completed the study in the control group. The increase in score obtained on the post-test, relative to the pretest, was 15.4% in the group who completed the online module and 2.0% in the control group (difference=13.4%, 95% CI 0.5% to 26.2%, p=0.04).ConclusionStudents who completed an online educational tool about medication safety demonstrated a significantly greater increase in knowledge than those who completed a few readings. Online learning modules can be a convenient and effective means of teaching safe prescribing concepts to medical trainees.

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Effectiveness of sustained natural apophyseal glides in females with cervicogenic headache: A randomized controlled trial

Journal of Back and Musculoskeletal Rehabilitation ◽

10.3233/bmr-210018 ◽

2021 ◽

pp. 1-7

Author(s):

Muhammad Kashif ◽

Nosheen Manzoor ◽

Rimsha Safdar ◽

Hafsa Khan ◽

Maryam Farooq ◽

...

Keyword(s):

Treatment Group ◽

Controlled Trial ◽

Neck Disability Index ◽

Placebo Treatment ◽

Cervicogenic Headache ◽

Control Group ◽

P Value ◽

Head Positioning ◽

Significant Difference ◽

Neck Disability

BACKGROUND: Cervicogenic headache (CGH) is a common condition that results in significant disability. To treat this dysfunction, Mulligan described sustained natural apophyseal gliders (SNAGs) as a manual therapy approach. However, only inconclusive short-term evidence exists for treating CGH with SNAGs. OBJECTIVE: The present study aims to investigate the effect of SNAGs in the treatment of CGH. METHODS: Fourty female patients ranging from 20 to 40 years with CGH were randomly assigned to two groups: 20 in a treatment group and 20 in a control group. SNAGs were applied to the treatment group while the control group received placebo treatment. Both groups received their respective treatment for 20 minutes, alternately three times per week, for a total of 12 times in four weeks. The outcome measures were the Neck Disability Index (NDI) and the Visual Analogue Scale (VAS). Participants were assessed at baseline and at the end of each week. The data was analyzed using SPSS version 20. Independent t-testing was used to reveal changes between groups. One-way ANOVA was used to determine changes within groups. The level of significance was P< 0.05. RESULTS: Twenty participants (100%) in the treatment group and 17 (85%) in the control group had a history of headache aggravation with active movements or passive head positioning. There was no significant difference at baseline (p> 0.05), indicating that both groups were homogeneous at the time of recruitment. The p value (p< 0.05) showed a significant difference in pain and level of disability at three and four weeks (p< 0.05) in patients treated with SNAGs. However, the cervical range of motion (ROM) showed a statistically significant improvement in flexion and extension in the treatment group (p< 0.05) while there was no significant improvement in side flexion and rotation ROM in both groups (p> 0.05). CONCLUSION: This study found that SNAGs were effective in reducing pain and neck disability and improved ROM in females with CGH.

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2021 Mark Coventry Award: Use of a smartphone-based care platform after primary partial and total knee arthroplasty: a prospective randomized controlled trial

The Bone & Joint Journal ◽

10.1302/0301-620x.103b6.bjj-2020-2352.r1 ◽

2021 ◽

Vol 103-B (6 Supple A) ◽

pp. 3-12 ◽

Cited By ~ 1

Author(s):

David A. Crawford ◽

Paul J. Duwelius ◽

Michael A. Sneller ◽

Michael J. Morris ◽

Jason M. Hurst ◽

...

Keyword(s):

Emergency Department ◽

Treatment Group ◽

Knee Arthroplasty ◽

Care Management ◽

Controlled Trial ◽

Emergency Department Visits ◽

Control Group ◽

Randomized Controlled ◽

Prospective Randomized Controlled Trial ◽

Total Knee

Aims The purpose is to determine the non-inferiority of a smartphone-based exercise educational care management system after primary knee arthroplasty compared with a traditional in-person physiotherapy rehabilitation model. Methods A multicentre prospective randomized controlled trial was conducted evaluating the use of a smartphone-based care management system for primary total knee arthroplasty (TKA) and partial knee arthroplasty (PKA). Patients in the control group (n = 244) received the respective institution’s standard of care with formal physiotherapy. The treatment group (n = 208) were provided a smartwatch and smartphone application. Early outcomes assessed included 90-day knee range of movement, EuroQoL five-dimension five-level score, Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) score, 30-day single leg stance (SLS) time, Time up and Go (TUG) time, and need for manipulation under anaesthesia (MUA). Results Overall, 90-day mean flexion was not significantly different between the control (121° (SD 11.7°)) and treatment groups (121o; p = 0.559); 90-day mean SLS was 22.7 seconds (SD 9.8) in controls and 24.3 seconds (SD 20.8) in treatment (p = 0.519); 90-day mean TUG times were 10.1 seconds (SD 4.8) in control and 9.3 seconds (SD 3.3) in treatment (p = 0.139). Mean KOOS JR scores were significantly different between control group (73.6 (SD 13.4)) and treatment group (70.4 (SD 12.6); p = 0.026). MUAs were performed in nine (3.7%) patients in the control group and four (1.9%) in the treatment group (p = 0.398). Physiotherapy was performed by 230 (94.4%) of control group and 123 (59.3%) of treatment group (p < 0.001). There were no significant differences between groups in postoperative urgent care visits, or readmissions within 90 days, with significantly fewer emergency department visits in the treatment group (16 (8.2%) vs five (2.5%), p = 0.014). Conclusion The use of the smartwatch/smartphone care platform demonstrated non-inferiority of clinically significant outcomes to traditional care models, while requiring significantly less postoperative physiotherapy and fewer emergency department visits. This platform could aid in decreasing postoperative costs, while improving patient engagement and communication with the healthcare team. Cite this article: Bone Joint J 2021;103-B(6 Supple A):3–12.

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