scholarly journals The Clinical Efficacy and Safety of Gumiganghwal-Tang in Knee Osteoarthritis: A Phase II Randomized Double Blind Placebo Controlled Study

2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Sung Hae Chang ◽  
Yun-Kyung Song ◽  
Seong-Su Nah
Keyword(s):  
Adverse Events ◽  
Knee Osteoarthritis ◽  
Knee Pain ◽  
Clinical Efficacy ◽  
Global Assessment ◽  
Womac Score ◽  
Controlled Study ◽  
Dependent Manner ◽  
Efficacy And Safety ◽  
Total Womac Score

Background. Gumiganghwal-tang (GMGHT) is a traditional herbal medicine consisting of nine different herbs. GMGHT inhibits the mRNA expression and production of inflammatory cytokines tumor necrosis factor-α (TNF- α), interleukin-6 (IL-6), and TNF- β on lipopolysaccharide- (LPS-) stimulated peritoneal macrophages in a dose-dependent manner. It is empirically used for the treatment of inflammatory disease, but there are few reports of clinical trials that investigate its efficacy and safety. The current study aimed to investigate the clinical efficacy and safety of GMGHT in patients with knee osteoarthritis (OA). Methods. This was a multicenter, two-armed, double-blinded, randomized, placebo controlled study of GMGHT over 6 weeks. Eligible patients who fulfilled the American College of Rheumatology criteria for OA were randomized to receive either GMGHT or the placebo. Clinical assessments included measurement of knee pain and function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), patient global assessment (PGA), and knee pain scores every 2 weeks. Results. A total of 128 patients were enrolled (91.4% female; mean age, 58.7 ± 8.1 years). At baseline, pain visual analogue score (VAS) was 67.2 ± 1.4, resp. 71.3 ± 1.6 (treatment, resp. placebo group, p=0.84), and total WOMAC score was 55.2 ± 1.6, resp. 55.6 ± 1.5 (p = 0.84). After 6 weeks, the pain VAS was 43.0 ± 2.5, resp. 61.6 ± 2.5 (p < 0.01) and the total WOMAC score was 34.1 ± 2.4, resp. 46.9 ± 1.8 (p < 0.01). No patients withdrew because of treatment emergent adverse events. Expected adverse events including dyspepsia, liver function abnormality, and lower extremity edema were comparable between both groups. Conclusions. Treatment with GMGHT resulted in significant improvement in pain, function, and global assessment, and it was generally safe and well tolerated in patients with OA.

scholarly journals Efficacy and safety of Sahastara remedy for pain relief: A systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Vol 10 (4) ◽  
pp. 375-382
Author(s):  
Wiraphol Phimarn ◽  
Chatmanee Taengthonglang ◽  
Kritsanee Saramunee ◽  
Bunleu Sungthong
Keyword(s):  
Pain Relief ◽  
Adverse Events ◽  
Pain Score ◽  
Oswestry Disability Index ◽  
Global Assessment ◽  
Meta Analysis ◽  
Womac Score ◽  
Index Score ◽  
Efficacy And Safety ◽  
Oswestry Disability Index Score

The Sahastara (SHT) remedy is an herbal medicine that can be used as an alternative treatment for improving pain symptoms. The aim of this study was to evaluate the efficacy and safety of the SHT remedy for pain relief. PubMed, Scopus, ScienceDirect, TCI, and ThaiLis were systematically searched for relevant articles from inception to April 2021. We only included randomized clinical trials (RCTs) in which the efficacy and safety of the SHT remedy were compared with those of non-steroidal anti-inflammatory drugs (NSAIDs). Study selection, data extraction, and quality assessment were independently performed by two reviewers. The clinical therapeutic outcomes were the pain score, WOMAC score, Oswestry Disability Index score, 100 meters walk result, global assessment, and adverse events of the SHT remedy. The outcomes were assessed and pooled using a random-effects model. Heterogeneity was assessed using the I2 test. Four studies with 213 participants were included in the analysis. The efficacy of the SHT remedy was not different from that of NSAIDs in terms of the pain score (standardized mean difference [SMD] = -0.31; 95% CI = -1.26, 0.65; I2 = 91%), WOMAC score (SMD = 0.05; 95% CI = -0.30, 0.41; I2 = 0.0%), Oswestry Disability Index score (SMD = -0.41, 95% CI = -1.18, 0.35), 100 meters walk result (SMD = 0.31; 95% CI = -0.25, 0.87; I2 = 0.0%), and global assessment (relative risk = 0.85; 95% CI = 0.62, 1.16; I2 = 0.0%). Moreover, there were no statistically significant differences between the SHT remedy and NSAID treatment groups in terms of adverse events or liver function. This meta-analysis demonstrated that the SHT remedy is not different from NSAIDs in terms of clinical therapeutic efficacy and adverse events. However, larger and well-designed studies are needed to confirm this conclusion.

Clinical Efficacy of Platelet-Rich Plasma Injection and Its Association With Growth Factors in the Treatment of Mild to Moderate Knee Osteoarthritis: A Randomized Double-Blind Controlled Clinical Trial As Compared With Hyaluronic Acid

2021 ◽  
Vol 49 (2) ◽  
pp. 487-496
Author(s):  
Yong-Beom Park ◽  
Jun-Ho Kim ◽  
Chul-Won Ha ◽  
Dong-Hyun Lee
Keyword(s):  
Hyaluronic Acid ◽  
Growth Factors ◽  
Knee Osteoarthritis ◽  
Clinical Outcomes ◽  
Clinical Efficacy ◽  
Global Assessment ◽  
Platelet Rich Plasma ◽  
Patient Global Assessment ◽  
Symptomatic Knee Osteoarthritis ◽  
Symptomatic Knee

Background: Although platelet-rich plasma (PRP) has potential as a regenerative treatment for knee osteoarthritis, its efficacy varies. Compositional differences among types of PRP could affect clinical outcomes, but the biological characterization of PRP is lacking. Purpose: To assess the efficacy of intra-articular PRP injection in knee osteoarthritis as compared with hyaluronic acid (HA) injection and to determine whether the clinical efficacy of PRP is associated with its biological characteristics. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 110 patients with symptomatic knee osteoarthritis received a single injection of leukocyte-rich PRP (1 commercial kit) or HA. Clinical data were assessed at baseline and at 6 weeks and 3 and 6 months after injection. The primary endpoint was an improvement in the International Knee Documentation Committee (IKDC) subjective score at 6 months, and the secondary endpoints were improvements in scores based on the Patient Global Assessment, the visual analog scale (VAS) for pain, the Western Ontario and McMaster Universities Osteoarthritis Index, and the Samsung Medical Center patellofemoral score. Cell counts and concentrations of growth factors and cytokines in the injected PRP were assessed to determine their association with clinical outcomes. Results: PRP showed significantly improvement in IKDC subjective scores at 6 months (11.5 in the PRP group vs 6.3 in the HA group; P = .029). There were no significant differences between groups in other clinical outcomes. The Patient Global Assessment score at 6 months was better in the PRP group ( P = .035). The proportion of patients who scored above the minimal clinically important difference (MCID) for VAS at 6 months was significantly higher in the PRP group ( P = .044). Within the PRP group, the concentrations of platelet-derived growth factors were high in patients with a score above the MCID for VAS at 6 months. The incidence of adverse events did not differ between the groups ( P > .05). Conclusion: PRP had better clinical efficacy than HA. High concentrations of growth factors were observed in patients who scored above the MCID for clinical outcomes in the PRP group. These findings indicate that concentration of growth factors needs to be taken into consideration for future investigations of PRP in knee osteoarthritis. Registration: NCT02211521 (ClinicalTrials.gov identifier).

scholarly journals Efficacy and safety associated with the infusion speed of intravenous immunoglobulin for the treatment of Kawasaki disease: a randomized controlled trial

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Saori Fukui ◽  
Mitsuru Seki ◽  
Takaomi Minami ◽  
Kazuhiko Kotani ◽  
Kensuke Oka ◽  
...  
Keyword(s):  
Kawasaki Disease ◽  
Adverse Events ◽  
Intravenous Immunoglobulin ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Link Type ◽  
Cell Counts ◽  
Infusion Speed ◽  
Ivig Administration

Abstract Background High-dose intravenous immunoglobulin (IVIG) is the mainstay of treatment for Kawasaki disease (KD). Usually, 2 g/kg of IVIG is administered over 10–24 h, depending on the institution or physician, but the association between infusion speed and effectiveness has not been reported. In this study, we evaluated the differences in efficacy and safety between two different IVIG administration speeds. Methods This was a multicenter, unblinded, randomized controlled study. Patients newly diagnosed with KD were randomized into two groups: one who received IVIG over 12 h (12H group, double speed), and one that received IVIG over 24 h (24H group, reference speed). The endpoints included the duration of fever, incidence of coronary artery abnormalities (CAAs) and of adverse events. Laboratory data were evaluated before and after IVIG administration. Results A total of 39 patients were enrolled. There was no difference between groups in fever duration after the initiation of IVIG (21 h vs. 21.5 h, p = 0.325), and no patient experienced CAAs. Two adverse events were observed in the 12H group (elevation of aspartate aminotransferase and vomiting), however no severe adverse events requiring treatments or extension of hospital stay were observed in either group. After initial IVIG administration, the change ratio of inflammatory markers, such as white blood cell counts, neutrophils, C-reactive protein, and albumin, did not show significant differences between the two groups. On the other hand, a greater increase of serum immunoglobulin G from its baseline level was observed in the 24H group compared to the 12H group (3037 ± 648 mg/dl vs. 2414 ± 248 mg/dl, p < 0.01). Conclusion The efficacy and safety of IVIG administered over 12 h (double speed) were similar to those administered over 24 h (reference speed). Trial registration University Hospital Medical Information Network (UMIN000014665). Registered 27 July 2014 – Prospectively registered, https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000017058

scholarly journals Efficacy and safety of Finasteride (5 alpha-reductase inhibitor) monotherapy in patients with benign prostatic hyperplasia: A critical review of the literature

2020 ◽  
Vol 91 (4) ◽  
pp. 205-210
Author(s):  
Gian Maria Busetto ◽  
Francesco Del Giudice ◽  
Daniele D'Agostino ◽  
Daniele Romagnoli ◽  
Andrea Minervini ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Benign Prostatic Hyperplasia ◽  
Adverse Events ◽  
Clinical Efficacy ◽  
Critical Review ◽  
Reductase Inhibitor ◽  
Prostate Volume ◽  
Prostatic Hyperplasia ◽  
Urinary Flow ◽  
Efficacy And Safety

Background: Combination therapy with 5 alpha-reductase inhibitor (5-ARI) and alpha-blocker can be considered as a gold standard intervention for medical management of lower urinary tract symptoms related to benign prostatic hyperplasia (LUTS/BPH). On the other hand, 5-ARI monotherapy and in particular Finasteride alone is currently getting focus of attention especially due to lack of systematic reviews investigating efficacy outcomes and/or adverse events associated. Objectives: Aim of the present critical review was to analyze current knowledge of clinical efficacy and incidence of adverse events associated with 5-ARI treatment for LUTS/BPH. Materials and methods: A systematic review of clinical trials of the literature of the past 20 years was performed using database from PubMed, Cochrane Collaboration and Embase. A total of 8821 patients were included in this study and inclusion criteria for studies selection were: data from randomized clinical trials (RCTs) focusing their attention on the clinical role of Finasteride monotherapy for symptomatic BPH. Parameters of research included prostate specific antigen (PSA), prostate volume (PV), International Prostate Symptom Score (IPPS), postvoid residual urine (PVR), voiding symptoms of IPSS (voiding IPSS), maximum urinary flow rate (Qmax), and adverse events (AEs). Results: Overall 12 original articles were included and critically evaluated. Sample sizes of patient actively treated with finasteride varied from 13 to 1524 cases analyzed in a single study. Follow-up after treatments ranged from 3 to 54 months. The effect of finasteride in reducing prostate volume (PV) was moderate (standardized mean difference (SMD) effect between 0.5 to 0.8 for all trials evaluable) while the effect on IPSS score and Qmax was considered significant (SMD in the 0.2 to 0.5 variation range). No severe AEs and/or psychiatric disorders were retrieved among the studies. Sexual health dysfunctions were significantly influenced by finasteride therapy when compared with placebo treated patients. Conclusions: Although significant clinical benefits of finasteride monotherapy were demonstrated, the effective size of the available reports included in the analysis is limited. Additional head-to-head studies would be needed to re-evaluate clinical efficacy and safety of 5-ARI in combination or not with alpha blockers.

scholarly journals Impact of cytochrome P450 2C19 polymorphisms on the clinical efficacy and safety of voriconazole: an update systematic review and meta-analysis

2021 ◽  
Author(s):  
Ying Zhang ◽  
Xu Hao ◽  
Kelu Hou ◽  
Lei Hu ◽  
Jingyuan Shang ◽  
...  
Keyword(s):  
Cytochrome P450 ◽  
Adverse Events ◽  
Success Rate ◽  
Clinical Efficacy ◽  
Search Algorithm ◽  
Efficacy And Safety ◽  
Increased Risk ◽  
Significant Difference ◽  
The Impact ◽  
Cyp2c19 Polymorphisms

Aims: To assess the impact of cytochrome P450 (CYP) 2C19 polymorphisms on the clinical efficacy and safety of voriconazole. Methods: We systematically searched PubMed, EMBASE, CENTRAL, ClinicalTrials.gov, and three Chinese databases from their inception to March 18, 2021 using a predefined search algorithm to identify relevant studies. Studies that reported voriconazole-treated patients and information on CYP2C19 polymorphisms were included. The efficacy outcome was success rate. The safety outcomes included overall adverse events, hepatotoxicity and neurotoxicity. Results: A total of 20 studies were included. Intermediate metabolizers (IMs) and Poor metabolizers (PMs) were associated with increased success rates compared with normal metabolizers (NMs) (risk ratio (RR): 1.18, 95% confidence interval (CI): 1.03~1.34, I2=0%, p=0.02; RR: 1.28, 95%CI: 1.06~1.54, I2=0%, p=0.01). PMs were at increased risk of overall adverse events in comparison with NMs and IMs (RR: 2.18, 95%CI: 1.35~3.53, I2=0%, p=0.001; RR: 1.80, 95% CI: 1.23~2.64, I2=0%, p=0.003). PMs demonstrated a trend towards an increased incidence of hepatotoxicity when compared with NMs (RR: 1.60, 95%CI: 0.94~2.74, I2=27%, p=0.08), although there was no statistically significant difference. In addition, there was no significant association between CYP2C19 polymorphisms and neurotoxicity. Conclusions: IMs and PMs were at a significant higher success rate in comparison with NMs. PMs were significantly associated with an increased incidence of all adverse events compared with NMs and IMs. Researches are expected to further confirm these findings. Additionally, the relationship between hepatotoxicity and CYP2C19 polymorphisms deservers clinical attention.

scholarly journals 167 Randomized, Double-Blind, Active-Controlled Study of Starting Aripiprazole Lauroxil with 1-Day Initiation in Acutely Ill Patients with Schizophrenia

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 306-307
Author(s):  
Peter J. Weiden ◽  
Amy Claxton ◽  
Yangchun Du ◽  
Sergey Yagoda ◽  
David Walling ◽  
...  
Keyword(s):  
Adverse Events ◽  
Outpatient Setting ◽  
Controlled Study ◽  
Injection Site Pain ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Secondary Analyses ◽  
Site Pain ◽  
Over Time ◽  
Funding Acknowledgements

Abstract:Objective:Evaluate efficacy and safety of a 2-month dose of aripiprazole lauroxil (AL) with a 1-day initiation regimen during hospitalization for an acute exacerbation of schizophrenia.Methods:In the phase 3b double-blind ALPINE study, adults with schizophrenia were randomized to AL (AL NanoCrystal® Dispersion + oral aripiprazole 30 mg day 1; AL 1064 mg day 8 and every 8 weeks) or paliperidone palmitate (PP 234 mg day 1; PP 156 mg day 8 and every 4 weeks). Patients were discharged after 2 weeks of hospitalization and followed through week 25. Primary endpoint was within-group changes in PANSS total score from baseline to week 4 (observed cases). Secondary analyses included within-group changes at weeks 9 and 25 (observed) and between-group comparisons at weeks 4, 9, and 25 (MMRM). Adverse events (AEs) were monitored throughout the study.Results:200 patients were randomized (AL, n=99; PP, n=101); 56.6% and 42.6%, respectively, completed the study. Within-group changes from baseline in PANSS were −17.4 for AL and −20.1 for PP at week 4 (both groups, P<0.001) and continued to decline at weeks 9 (AL, −19.8; PP, −22.5) and 25 (AL, −23.3; PP, −21.7). The change in PANSS over time was similar between groups. AEs occurring in ≥10% of patients in either group were injection site pain (AL, 17.2%; PP, 24.8%), akathisia (AL, 9.1%; PP, 10.9%), and weight increased (AL, 9.1%; PP, 16.8%).Conclusions:AL and PP were effective and well-tolerated for initiating treatment of schizophrenia in the hospital and continuing in the outpatient setting.Funding Acknowledgements:This study was funded by Alkermes, Inc.

scholarly journals Single-Blind, Prospective, Randomized Study of Cefmetazole and Cefoxitin in the Treatment of Postcesarean Endometritis

1995 ◽  
Vol 3 (1) ◽  
pp. 28-33 ◽  
Author(s):  
Ashwin Chatwani ◽  
Mark Martens ◽  
David A. Grimes ◽  
Molly Chatterjee ◽  
Melvin Noah ◽  
...  
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Cesarean Delivery ◽  
Clinical Efficacy ◽  
Randomized Study ◽  
Prospective Randomized Study ◽  
Efficacy And Safety ◽  
Cure Rate ◽  
Clinical Responses ◽  
Single Blind

Objective: The purpose of this study was to compare the clinical efficacy and safety of cefmetazole given by IV push with that of parenterally administered cefoxitin for the treatment of endometritis following cesarean delivery.Methods: In a single-blind, multicenter, prospective, randomized study, 355 patients with endometritis after cesarean delivery were enrolled and received medication. Administered was either cefmetazole sodium, 2 g by IV push over 1 min q 8 h, or cefoxitin sodium, 2 g IV q 6 h in a 2:1 ratio. The patients were followed for clinical responses and side effects.Results: The cure rate for cefmetazole was 89% and for cefoxitin it was 79% (P = 0.006). The adverse events were similar in both groups.Conclusions: Cefmetazole was significantly more effective than cefoxitin in the treatment of endometritis following cesarean delivery.

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