Oral antiviral clevudine compared with placebo in Korean COVID-19 patients with moderate severity

Background: Clevudine, an antiviral drug for chronic hepatitis B virus infection, is expected to inhibit the replication of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. Therefore, we conducted a prospective, single-blind, proof of concept clinical study to examine the antiviral efficacy and safety of clevudine compared to placebo in Korean corona virus disease 19 (COVID-19) patients with moderate severity. Methods: Adults with confirmed SARS-CoV-2 infection and symptom onset within 7 days were randomized 2:1 to 120 mg clevudine or placebo to receive one of treatments orally once-daily for 14 days. Antiviral efficacy outcomes were the proportion of patients with real-time reverse transcription polymerase chain reaction (RT-PCR) negative result for SARS-CoV-2 infection and cycle threshold (Ct) value changes from baseline. Clinical efficacy outcomes included proportion of patients who showed improvement in lung involvement by imaging tests, proportion of patients with normal body temperature, proportion of patients with normal oxygen saturation, and the changes in C-reactive protein (CRP) from baseline. Safety outcomes included changes in clinical laboratory tests, vital signs measurement, and physical examination from baseline, and incidence of adverse events. Results: The proportion of patients with real-time RT-PCR negative test and Ct value changes showed no significant difference between clevudine group and placebo group. The changes in Ct value from baseline were significantly greater in clevudine group compared to placebo group in patients with hypertension, and patients who underwent randomization during the first 5 and 7 days after the onset of symptoms. All clinical efficacy outcomes had no significant difference between clevudine group and placebo group. Clevudine was well tolerated and there was no significant difference in safety profile between two treatment groups. Conclusions: This is the first clinical study to compare the antiviral efficacy and safety of clevudine to placebo in Korean COVID-19 patients with moderate severity. The study has demonstrated a possible favorable outcome for the reduction of SARS-CoV-2 replication, with acceptable safety profile, when COVID-19 patients were treated with clevudine. Further large-scale clinical studies, preferably with various clinical endpoints and virus titer evaluation, are required to better understand the effectiveness of using clevudine in COVID-19 treatment. Considering recent trend in clinical development for antiviral drugs, we need to design a clinical study aiming for reducing clinical risk of COVID-19 in mild to moderate patients with at least one risk factor for serious illness.

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A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum

Nutrients ◽

10.3390/nu12123794 ◽

2020 ◽

Vol 12 (12) ◽

pp. 3794

Author(s):

Yu Hwa Park ◽

Do Hoon Kim ◽

Jung Suk Lee ◽

Hyun Il Jeong ◽

Kye Wan Lee ◽

...

Keyword(s):

Clinical Trial ◽

Uric Acid ◽

Placebo Group ◽

Serum Uric Acid ◽

Controlled Study ◽

Efficacy And Safety ◽

Food Ingredient ◽

Double Blind ◽

Double Blind Placebo ◽

Significant Difference

This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of Chrysanthemum indicum Linn flower extract and Cinnamomum cassia extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subjects (40 subjects with an intake of DKB114 and 40 subjects with that of placebo) who had asymptomatic hyperuricemia (7.0–9.0 mg/dL with serum uric acid) was randomly assigned. No significant difference between the DKB114 and placebo groups was observed in the amount of uric acid in serum after six weeks of intake. However, after 12 weeks of intake, the uric acid level in serum of subjects in the DKB114 group decreased by 0.58 ± 0.86 mg/dL and was 7.37 ± 0.92 mg/dL, whereas that in the placebo group decreased by 0.02 ± 0.93 mg/dL and was 7.67 ± 0.89 mg/dL, a significant difference (p = 0.0229). In the analysis of C-reactive protein (CRP) change, after 12 weeks of administration, the DKB114 group showed an increase of 0.05 ± 0.27 mg/dL (p = 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL (p = 0.0324), a statistically significant difference (p = 0.0443). In the analysis of amount of change in apoprotein B, after 12 weeks of administration, the DKB114 group decreased by 4.75 ± 16.69 mg/dL (p = 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL (p = 0.2187), a statistically significant difference between the administration groups (p = 0.0189). In the clinical pathology test, vital signs and weight measurement, and electrocardiogram test conducted for safety evaluation, no clinically significant difference was found between the ingestion groups, confirming the safety of DKB114. Therefore, it may have potential as a treatment for hyperuricemia and gout. We suggest that DKB114 as a beneficial and safe food ingredient for individuals with high serum uric acid. Trial registration (CRIS.NIH. go. Kr): KCT0002840.

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Efficacy and safety of netakimab in patients with psoriatic arthritis: results of the phase III PATERA clinical study

Rheumatology Science and Practice ◽

10.47360/1995-4484-2020-480-488 ◽

2020 ◽

Vol 58 (5) ◽

pp. 480-488

Author(s):

T. V. Korotaeva ◽

V. I. Mazurov ◽

A. M. Lila ◽

I. Z. Gaydukova ◽

A. L. Bakulev ◽

...

Keyword(s):

Placebo Group ◽

Psoriatic Arthritis ◽

Safety Profile ◽

Phase Iii ◽

Inadequate Response ◽

Efficacy And Safety ◽

Double Blind ◽

Acr20 Response ◽

American College Of Rheumatology ◽

Blinded Manner

Netakimab (NTK) is a humanized anti-interleukin-17А (IL-17A) monoclonal antibody approved for the treatment of psoriatic arthritis, ankylosing spondylitis, moderate to severe psoriasis. Here, we present the results of the 24-weeks double blind period of the PATERA study.Objective. The objective of the study was to evaluate the efficacy and safety of NTK compared to placebo in patients with psoriatic arthritis (PsA).Patients and methods. 194 patients with active PsA with an inadequate response to previous therapy with nonsteroidal anti-inflammatory drugs, conventional or biologic disease-modifying antirheumatic drugs, were randomized in a 1:1 ratio to receive subcutaneous 120 mg NTK or placebo at weeks 0, 1, 2, 4, 6, 8, 10, 14, 18, 22. At week 16 ACR20 (20% improvement in the American College of Rheumatology response criteria) non-responders in placebo group were reassigned to NTK in a blinded manner. The primary endpoint was the proportion of patients achieved ACR20 response at week 24.Results. 82,5% of patients in the NTK group and 9.3% of patients in the placebo group achieved ACR20 at week 24 with the 95% CI [0,63; 0,84] (p < 0,0001). Skin manifestations and axial disease significantly improved with NTK. The safety profile of NTK was comparable to placebo. The most frequent treatment-related AEs were expected and common for all other IL-17 inhibitors: increased alanine aminotransferase (ALT), infections, lymphopenia.Conclusion. NTK in the dose of 120 mg has superior efficacy over placebo in patients with active psoriatic arthritis. The safety profile is consistent with other IL-17 inhibitors.

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An analysis of the efficacy and safety of direct oral anticoagulants (DOACs) in gastrointestinal cancer-associated venous thromboembolism (GI-CAVTE).

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.4_suppl.505 ◽

2018 ◽

Vol 36 (4_suppl) ◽

pp. 505-505 ◽

Cited By ~ 1

Author(s):

Alejandro Recio Boiles ◽

Hani M. Babiker ◽

Aaron James Scott ◽

Steve Malangone ◽

Ali McBride ◽

...

Keyword(s):

Major Bleeding ◽

Safety Profile ◽

Bleeding Complications ◽

Categorical Variables ◽

Efficacy And Safety ◽

Long Term Outcome ◽

Historical Comparison ◽

Significant Difference ◽

Recurrent Vte ◽

Active Cancer

505 Background: Two major trials and meta-analysis of patients (pts) with active cancer and VTE suggests that apixaban (A) and rivaroxaban (R) showed similar efficacy to enoxaparin and warfarin while having less associated major bleeding. GICA is associated with a higher incidence of VTE compared to other tumors. Moreover, bleeding complications of DOACs are not well defined in GICA pts. We compared the efficacy and safety of DOACs in pts with active GICA and VTE at the University of Arizona Cancer Center (UACC). Methods: A retrospective chart review of pts receiving DOACs with GICA and VTE treated at UACC was performed (11/2013-02/2017). GICA subgroup extracted from clinical trial delineations followed: active cancer, defined as cancer diagnosed at any stage +/- 6 months of VTE diagnosis. Efficacy outcomes were recurrent DVT, nonfatal pulmonary embolism (PE), or fatal PE. Safety outcomes for major bleeding were Hg drop of ≥2 g/dL, transfusion of ≥2 units of PRBC, bleeding in a critical site, or bleeding contributing to death. Fisher exact test is used for testing the difference in categorical variables for p-value < 0.05. Results: Our review included pts on A (n = 28) and R (n = 34). Pts had similar baseline characteristics compared to AMPLIFY (n = 81) and pooled-EINSTEIN (n = 71). Recurrent VTE at 6 months were 7.1% and 2.9% for pts on A and R, respectively. VTE historical comparison to AMPLIFY (3.7%) and EINSTEIN (2.8%) showed no significant difference. Major bleeding at 6 months were 7.1% and 14.7% for A and R, respectively, compared to 2.3% AMPLIFY / 2.8% EINSTEIN. R had the one recurrent non-fatal PE event and a significantly worse safety profile with 2 fatal bleeds (hemopericardium and upper GI bleed) and 2 critical bleeding sites (subarachnoid hemorrhage and retroperitoneal) [p = 0.0348], whereas A had non-significant of the before stated. Conclusions: To our knowledge, this is the first retrospective analysis to present long-term outcome data of DOACs in pts with GICA and VTE, which showed a similar risk of recurrent VTE and worse safety profile with R versus A. This data warrants further prospective clinical analysis of the efficacy and safety of DOACs in pts with GICA and VTE.

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Prospective study comparing Xalatan® eye drops and two similar generics as to the efficacy and safety profile

European Journal of Ophthalmology ◽

10.1177/1120672117747030 ◽

2018 ◽

Vol 28 (4) ◽

pp. 378-384 ◽

Cited By ~ 2

Author(s):

Andreas Diagourtas ◽

Kostantinos Kagelaris ◽

Kostantinos Oikonomakis ◽

Andreas Droulias ◽

Nikolaos Kokolakis ◽

...

Keyword(s):

Intraocular Pressure ◽

Safety Profile ◽

Ocular Surface ◽

Disease Index ◽

Ocular Surface Disease ◽

Eye Drops ◽

Efficacy And Safety ◽

Ocular Surface Disease Index ◽

Significant Difference ◽

The Mean

Purpose: To evaluate the efficacy and safety between two generic prostaglandins Lataz–Xalaprost (Greece) and the corresponding original drops (Xalatan®). Material and methods: In this prospective randomized study, 60 patients diagnosed with open-angle glaucoma or ocular hypertension were enrolled, who had never received antiglaucoma treatment. Subjects were divided randomly into three groups (Xalatan, Lataz, and Xalaprost groups) and they were studied over 16 weeks. At each visit, the mean applanation tonometry values and tear break-up time were measured. The Ocular Surface Disease Index questionnaire was used to evaluate patient’s symptoms. Results: There was a statistically significant difference (p < 0.001) in the mean values of the intraocular pressure between the baseline and the last visit (Xalatan group: from 23.11 ± 1.61 mmHg to 15.81 ± 1.22 mmHg, Lataz group: from 23.26 ± 1.33 mmHg to 15.80 ± 1.47 mmHg, and Xalaprost group: from 23.08 ± 1.45 mmHg to 16.08 ± 1.38 mmHg). Both generic eye drops showed mean percentage intraocular pressure reduction comparable to the standards of prostaglandin analogues (Xalatan: 31.57%, Lataz: 32.06%, and Xalaprost: 30.34%). Xalatan reduced the tear break-up time less, followed by Lataz and then by Xalaprost (Xalatan: from 8.5 to 8 s, Lataz: from 8.2 to 7.4 s, and Xalaprost: from 8.7 to 7.7 s). Xalatan presented the best safety profile, followed by Lataz and least was Xalaprost, according to Ocular Surface Disease Index questionnaire’s results. Conclusion: No significant difference was recorded in the effectiveness of each generic prostaglandin compared to the original. Furthermore, no patient had to change medication. The differences that arose in the safety profile of the three eye drops suggest a prompt closer initial monitoring of patients who are administered generic eye drops.

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PD53 Efficacy And Safety Of Nicotinamide In Hemodialysis Patients

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462318003161 ◽

2018 ◽

Vol 34 (S1) ◽

pp. 147-148

Author(s):

Salman Hussain ◽

Ambrish Singh ◽

Anwar Habib ◽

Abul Kalam Najmi

Keyword(s):

Systematic Review ◽

Placebo Group ◽

Safety Profile ◽

Biochemical Parameters ◽

Density Lipoprotein ◽

Hemodialysis Patients ◽

Efficacy And Safety ◽

Dialysis Patients ◽

Product Level ◽

Calcium Phosphorus

Introduction:Hyperphosphatemia is a most common problem in dialysis patients. Phosphorus imbalance in dialysis patients increases the risk of developing the bone mineral disorder and cardiovascular mortality. Randomized controlled trials (RCTs) presented variable findings concerning the reduction of phosphorous level in nicotinamide user. So, this systematic review is aimed to explore the efficacy and safety of nicotinamide in hemodialysis patients.Methods:This systematic review was conducted by adhering to the PRISMA guidelines. Study for inclusion was identified by running the suitable keywords in databases including PubMed, Embase, and Cochrane central from inception to 31 October 2017. Cochrane risk of bias tool was used to judge the quality of included RCTs. The change in serum phosphorus level was the primary outcome, while the change in other biochemical parameters including serum calcium, calcium-phosphorus product level, iPTH, platelets, lipid profile parameters, and the safety profile was considered under secondary outcomes. Review Manager (RevMan v5.3) was used for statistical analysis.Results:Finally four articles were qualified for inclusion in this study with a total of 274 participants of which 136 were in the treatment (nicotinamide) group. All the included studies showed statistically significant reduction in mean serum phosphorous, calcium-phosphorus product level in the treatment arm at the end point of the study, while the reduction in the placebo group was not statistically significant in all the studies. Among other biochemical parameters analyzed, only high-density lipoprotein (HDL) was found to be significantly increased from baseline to the endpoint of the study in the nicotinamide group, while the placebo group showed no significant change in all the included studies except the study by Shahbazian et al. Thrombocytopenia was the most commonly reported adverse event in the treatment group followed by diarrhea.Conclusions:Nicotinamide was found to be effective in the management of hyperphosphatemia in hemodialysis patients. The safety profile was found to be satisfactory.

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SARS-CoV-2 IgG antibody responses in rt-PCR positive cases: first report from India

10.1101/2020.11.13.20229716 ◽

2020 ◽

Author(s):

Girish Chandra Dash ◽

Debaprasad Parai ◽

Hari Ram Choudhary ◽

Annalisha Peter ◽

Usha Kiran Rout ◽

...

Keyword(s):

Antibody Response ◽

Infected Individual ◽

Antibody Responses ◽

Rt Pcr ◽

Serum Samples ◽

Igg Antibody ◽

Ct Value ◽

Significant Difference ◽

The Mean ◽

The Relationship

AbstractThe SARS-CoV-2 antibody responses remain poorly understood and the clinical utility of serological testing is still unclear. As it is thought to confer some degree of immunity, this study is carried out to know the relationship between demographics and ct value of confirmed rt-PCR patients. A total of 384 serum samples were collected between 4-6 weeks after confirmed SARS-CoV-2 infection. IgG positivity was found to be 80.2% (95% CI, 76.2 – 84.2). The IgG positivity increased with the decrease in the ct value, with highest of 87.6% positivity in individuals with <20 ct value. The mean (± SD) ct value of IgG positives and og IgG negatives was 23.34 (± 6.09) and 26.72 (± 7.031) respectively. There was no significant difference found between the demographic characteristics such as age, sex, symptoms and antibody response. The current study is first of its kind wherein we have assessed the correlation of ct of RT-PCR with development of IgG against SARS-CoV-2. Our study showed that although Ct value might not have any relation with severity of the diseases but is associated with the antibody response among the SARS-CoV-2 infected individual.

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Kabasura Kudineer (KSK), a poly-herbal Siddha medicine, reduced SARS-CoV-2 viral load in asymptomatic COVID-19 individuals as compared to vitamin C and zinc supplementation: findings from a prospective, exploratory, open-labeled, comparative, randomized controlled trial, Tamil Nadu, India

Trials ◽

10.1186/s13063-021-05583-0 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

S. Natarajan ◽

C. Anbarasi ◽

P. Sathiyarajeswaran ◽

P. Manickam ◽

S. Geetha ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Viral Load ◽

Vitamin C ◽

Tamil Nadu ◽

Controlled Trial ◽

Control Group ◽

Rt Pcr ◽

Randomized Controlled ◽

Ct Value ◽

Significant Difference

Abstract Introduction Despite several ongoing efforts in biomedicine and traditional medicine, there are no drugs or vaccines for coronavirus disease 2019 (COVID-19) as of May 2020; Kabasura Kudineer (KSK), a polyherbal formulation from India’s Siddha system of medicine, has been traditionally used for clinical presentations similar to that of COVID-19. We explored the efficacy of KSK in reducing viral load and preventing the disease progression in asymptomatic, COVID-19 cases. Methods A prospective, single-center, open-labeled, randomized, controlled trial was conducted in a COVID Care Centre in Chennai, India. We recruited reverse-transcription polymerase chain reaction (RT-PCR)-confirmed COVID-19 of 18 to 55 years of age, without clinical symptoms and co-morbidities. They were randomized (1:1 ratio) to KSK (60 mL twice daily for 7 days) or standard of care (7 days supplementation of vitamin C 60,000 IU morning daily and zinc 100 mg evening daily) groups. The primary outcomes were reduction in the SARS-CoV-2 load [as measured by cyclic threshold (CT) value of RT-PCR], prevention of progression of asymptomatic to symptomatic state, and changes in the immunity markers including interleukins (IL-6, IL-10, IL-2), interferon gamma (IFNγ), and tumor necrosis factor (TNF α). Siddha clinical assessment and the occurrence of adverse effects were documented as secondary outcomes. Paired t-test was used in statistical analysis. Results Viral load in terms of the CT value (RdRp: 95% CI = 1.89 to 5.74) declined significantly on the seventh day in the KSK group and that of the control group, more pronounced in the study group. None progressed to the symptomatic state. There was no significant difference in the biochemical parameters. We did not observe any changes in the Siddha-based clinical examination and adverse events in both groups. Conclusion KSK significantly reduced SARS-CoV-2 viral load among asymptomatic COVID-19 cases and did not record any adverse effect, indicating the use of KSK in the strategy against COVID-19. Larger, multi-centric trials can strengthen the current findings. Trial registration Clinical Trial Registry of India CTRI2020/05/025215. Registered on 16 May 2020

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Correlation between Cycle Threshold (Ct) Value and IL-6 and D-Dimer in Chip-based RT-PCR Positive COVID-19 Cases: Study from a Stand-alone Laboratory

Asian Journal of Research in Infectious Diseases ◽

10.9734/ajrid/2021/v8i330236 ◽

2021 ◽

pp. 1-9

Author(s):

Chhavi Gandhi ◽

H. N. Ravikumar ◽

Vani Ravikumar ◽

C. Vani

Keyword(s):

Interleukin 6 ◽

Clinical Sample ◽

Threshold Value ◽

Clinical Samples ◽

Rt Pcr ◽

Cycle Threshold ◽

Ct Value ◽

Asymptomatic Patients ◽

Significant Difference ◽

D Dimer

Background: Novel Coronavirus (SARS-COV-2) is a leading cause of morbidity and mortality since the beginning of 2020 leading to range of symptoms from mild flu to respiratory distress, which is called COVID-19. RTPCR being the main diagnostic test can confirm the presence of the virus in the clinical samples, while various studies have defined Interleukin-6 and D-dimer as potent biomarker for severity. In this study, we have attempted to correlate the severity of COVID-19 with the presence of IL-6 and D-dimer and the Cycle threshold (Ct vlue) as determined by chip based RTPCR. Aim: The study aims to correlate the Cycle threshold value obtained after chip-based RT-PCR with markers such as IL-6 and D-Dimers. Methodology: It is a retrospective, observational study done in 799 subjects in a span of three months (August 2020 to October 2020) at R V Metropolis Diagnostic and Healthcare Pvt Ltd. All symptomatic patients who tested positive in the Laboratory for COVID-19 by chip-based RT-PCR were included. Chip based RTPCR or Truenat test was performed on Nasopharyngeal swabs of the suspected subjects. Interleukin-6 was determined by Electrochemiluminiscence assay while D-dimer was done on the principle of Chemiluminiscence. Statistical Analysis Used: SPSS 12.0 version. Results: Total number of subjects enrolled were 799, with mean age of the subjects being 46.80± 17.55 years. In the study, males were found to be affected by COVID-19 more than females with ratio of male to female being 1.65:1. 498 (62.3%) of males presented with COVID-19 while it was observed in 301 (37.6%) females. Out of 799 subjects, 289 (36.2%) were symptomatic and out of 289 subjects, 140 (17.5% of total subjects) required hospitalisation. Cycle threshold values of both screening as well as confirmatory genes were determined separately in the cases of symptomatic and asymptomatic cases and there was no significant difference between the Ct values in cases of symptomatic and asymptomatic patients. Symptomatic patients were subcategorised under hospitalised and non-hospitalised and Again, no significant difference was seen between the two subset of patients in terms of Ct-value and, indirectly, the viral load of their clinical sample. The results convey that IL-6 and D-Dimer was significantly high (p=0.001 and <0.001 respectively) in case of symptomatic patients.D-Dimer was significantly high (p= <0.001) in the patients who needed hospitalisation. IL-6 was significantly raised as well (p=0.02). Screening and confirmatory gene were found to have no significant relationship with IL-6 and D-Dimer, neither any correlation was observed with them. Conclusion: Biomarkers such as Interleukin-6 and D-dimer can very well help in determining the severity and need for hospitalisation in a COVID-19 affected patient, but they have been found to have no relationship with cycle threshold value of RTPCR in our study.

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Comparative Analysis of Enoxaparin versus Rivaroxaban in the Treatment of Cancer Associated Venous Thromboembolism: Experience from a Tertiary Care Cancer Centre

10.21203/rs.2.23842/v2 ◽

2020 ◽

Author(s):

Anadil Faqah ◽

Hassan Sheikh ◽

Muhammad Abu Bakar ◽

Fatima Tayyaab ◽

Sahrish Khawaja

Keyword(s):

Venous Thromboembolism ◽

Cancer Patients ◽

Safety Profile ◽

Tertiary Care ◽

Significant Risk ◽

Outcome Analysis ◽

Minor Bleeding ◽

Efficacy And Safety ◽

Safety Outcome ◽

Significant Difference

Abstract BACKGROUND Venous Thromboembolism (VTE) in cancer patients is associated with increased mortality and morbidity. While newer data on use of direct oral anticoagulants (DOACs) in treating cancer associated thrombosis (CAT) is promising; its data is still few and inconsistent across literature. We designed the study to assess if rivaroxaban would be an appealing alternate choice to treat CAT.METHODS We conducted a retrospective study to evaluate the efficacy and safety profile of rivaroxaban versus enoxaparin in cancer patients after developing a symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE). Baseline patient characteristics and laboratory values were assessed in each arm. Primary efficacy outcome was measured by radiographically confirmed VTE recurrence at different intervals. Primary safety outcome was measured by presence of major and minor bleeding using the ISTH scale. RESULTS Our study recruited 150 cancer patients with radiologically confirmed DVT and PE; 80 patients were evaluated in enoxaparin arm and 70 patients in rivaroxaban arm. Our results showed that there was no statistically significant difference between the incidence of VTE recurrence at 6 months between the enoxaparin and rivaroxaban arm (10% vs 14.2%, p=0.42). Historically significant risk factors for VTE in cancer patients such as high platelet count, high leukocyte count, low hemoglobin level, high risk gastrointestinal, genitourinary and lung cancers were not found to be independently significantly associated with the risk of VTE recurrence. Primary safety outcome analysis also showed no statistically significant difference in major (11.2% vs 11.4%) and minor (15% vs 10%) bleeding between enoxaparin versus rivaroxaban arm respectively (p=0.65). CONCLUSION We conclude that there was no significant difference seen between the efficacy and safety profile of enoxaparin and rivaroxaban in our cancer patient population.

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Efficacy and safety of Kami-guibi-tang for mild cognitive impairment: a pilot, randomized, double-blind, placebo-controlled trial

BMC Complementary Medicine and Therapies ◽

10.1186/s12906-021-03428-6 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Hee-Yeon Shin ◽

Ha-Ri Kim ◽

Geon-Ho Jahng ◽

Chul Jin ◽

Seungwon Kwon ◽

...

Keyword(s):

Cognitive Impairment ◽

Placebo Group ◽

Mild Cognitive Impairment ◽

Adverse Events ◽

Vital Signs ◽

Efficacy And Safety ◽

Mri Findings ◽

Double Blind ◽

Double Blind Placebo ◽

Significant Difference

Abstract Background Mild cognitive impairment (MCI) is considered an intermediate phase between normal aging and dementia. As the majority of cases of amnestic MCI (aMCI) progress to Alzheimer’s disease (AD), it is considered the prodromal stage of AD, and a treatment target for prevention of further cognitive decline. However, no medications have been shown to have symptomatic or preventive benefits in MCI. Kami-guibi-tang (KGT) is a traditional herbal formula used in Korean medicine to treat amnesia, which is reported to increase acetylcholine levels via activation of choline acetyltransferase. The objective of this study was to evaluate the efficacy and safety of KGT in patients with aMCI. Methods This study was designed as a single-center, randomized, double-blind, placebo-controlled pilot study. Participants diagnosed with aMCI were randomized to receive either KGT or placebo granules for 24 weeks. The efficacy measure was a change in the Seoul Neuropsychological Screening Battery (SNSB) score. The safety measures included the occurrence of adverse events and abnormalities in vital signs and blood chemistry, electrocardiogram (ECG), and brain magnetic resonance imaging (MRI) findings. Results A total of 16 patients in the KGT group and 14 patients in the placebo group were investigated in the study. The mean score of Clinical Dementia Rating-Sum of Boxes (CDR-SB) significantly improved from 1.53 (0.64) points to 1.13 (0.62) points in the KGT group (p = 0.010), whereas it worsened from 1.61 (0.88) points to 1.75 (0.94) points in the placebo group. There was a significant difference in the CDR-SB scores between the two groups after the intervention (p = 0.045). The total SNSB-D scores and the scores in the memory domain after the treatment were significantly higher than the baseline values in the KGT group, but not in the placebo group. The frequency of adverse events was not significantly different between the two groups, and there were no abnormalities in vital signs or blood test, ECG, and brain MRI findings after the intervention. Conclusions KGT may provide a safe and effective treatment option for patients with aMCI. Further studies with a larger sample size are needed to validate the findings. Trial registration Korean Clinical Trial Registry, ID: KCT0002407; Registered on March 30, 2017, http://cris.nih.go.kr/

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