Efficacy And Safety
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(FIVE YEARS 20882)



2021 ◽  
Vol 51 (3) ◽  
Miguel Ángel Valdovinos-Díaz

Probiotics are used as non-pharmacological therapy for Irritable Bowel Syndrome (IBS). Probiotics have mechanisms of action that can influence the complex pathophysiology of IBS. Evidence of the efficacy and safety of probiotics in IBS is based on various meta-analysis that showed these agents have a limited but superior effect on the management of IBS. The recommendations on the use of probiotics in IBS in the clinical practice guidelines published to date remain controversial. Some recommend the use of probiotics for global symptoms and abdominal pain, while others state that there is low quality evidence for a recommendation. Currently, probiotics are frequently prescribed by doctors for the treatment of patients with IBS. A greater number of high-quality clinical trials are needed to define which probiotic strains are effective in the different IBS phenotypes.

2021 ◽  
pp. 1-13
Hiroyasu Yamamoto ◽  
Kiyoshi Nobori ◽  
Yoshimi Matsuda ◽  
Yasuhiro Hayashi ◽  
Takanori Hayasaki ◽  

<b><i>Introduction:</i></b> Molidustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that predominantly induces renal production of erythropoietin (EPO). Molidustat was evaluated for the treatment of anemia associated with chronic kidney disease (CKD) in the “Molidustat Once Daily Improves Renal Anemia by Inducing EPO” (MIYABI) program, which comprises 5 phase 3 clinical trials. The present MIYABI Non-Dialysis Correction (ND-C) study investigated the efficacy and safety of molidustat in Japanese patients with renal anemia who were not undergoing dialysis and were not receiving erythropoiesis-stimulating agent (ESA) treatment. <b><i>Methods:</i></b> This was a 52-week, randomized (1:1), open-label, active-control, parallel-group, multicenter, phase 3 study in Japanese patients with renal anemia associated with CKD (stages 3–5). Molidustat or the ESA darbepoetin alfa (hereinafter referred to as darbepoetin) were initiated at 25 mg once daily or 30 μg every 2 weeks, respectively, and doses were regularly titrated to correct and to maintain hemoglobin (Hb) levels in the target range of ≥11.0 g/dL and &#x3c;13.0 g/dL. The primary efficacy outcome was the mean Hb level and its change from baseline during the evaluation period (weeks 30–36). The safety outcomes included evaluation of all adverse events. <b><i>Results:</i></b> In total, 162 patients were randomized to receive molidustat (<i>n</i> = 82) or darbepoetin (<i>n</i> = 80). Baseline characteristics were generally well balanced between treatment groups. The mean (standard deviation) Hb levels at baseline were 9.84 (0.64) g/dL for molidustat and 10.00 (0.61) g/dL for darbepoetin. The mean (95% confidence interval [CI]) for mean Hb levels during the evaluation period for molidustat (11.28 [11.07, 11.50] g/dL) and darbepoetin (11.70 [11.50, 11.90] g/dL) was within the target range. Based on a noninferiority margin of 1.0 g/dL, molidustat was noninferior to darbepoetin in the change in mean Hb level during the evaluation period from baseline; the least-squares mean (95% CI) difference (molidustat-darbepoetin) was −0.38 (−0.67, −0.08) g/dL. The proportion of patients who reported at least 1 treatment-emergent adverse event (TEAE) was 93.9% for molidustat and 93.7% for darbepoetin. Most TEAEs were mild (54.9% for molidustat and 63.3% for darbepoetin) or moderate (22.0% for molidustat and 22.8% for darbepoetin) in intensity. There were 3 deaths in the molidustat group and 1 in the darbepoetin group. <b><i>Discussion/Conclusion:</i></b> In the MIYABI ND-C study, molidustat appeared to be an efficacious and generally well-tolerated alternative to darbepoetin for the treatment of renal anemia in Japanese patients who were not undergoing dialysis and were not receiving ESA treatment.

2021 ◽  
Jin-Sung Kim ◽  
Jun Ho Lee ◽  
Junseok Bae ◽  
Dong Chan Lee ◽  
Sang-Ha Shin ◽  

Abstract BackgroundAdvances in minimally invasive surgery have expanded the indications for interlaminar full-endoscopic discectomy. Although the clinical outcomes for this approach may be equivalent to those of conventional microscopic discectomy, the supporting evidence is based on small, single-center, prospective, and retrospective studies. Therefore, a multicenter, randomized controlled trial is warranted.MethodsThis will be a prospective, multicenter, randomized controlled trial comparing the efficacy and safety of interlaminar full-endoscopic discectomy to those of conventional microscopic discectomy. The trial will enroll 100 participants with a lumbar disc herniation, 50 in each group. The primary outcome will be the Oswestry Disability Index (ODI) score at 12 months post-surgery. Secondary outcomes will be: back and leg pain (visual analog scale); the ODI; the EuroQol-5-Dimension score; patient satisfaction; and walking distance/time and time to return to daily activities post-surgery. Surgical outcomes will include postoperative drainage, operative time, duration of hospital stay, postoperative creatine kinase level as an indicator of muscle injury, and postoperative scarring. Postoperative magnetic resonance imaging, computed tomography, and simple radiography will be performed to evaluate radiographic outcomes between the two surgical approaches. Surgery-related complications and adverse effects will be evaluated as safety outcomes. A single assessor at each participating hospital, blinded to group allocation, will assess the enrolled participants at baseline, 2 weeks and 3, 6, and 12 months postoperatively.DiscussionThis trial is designed to determine whether interlaminar full-endoscopic discectomy is clinically comparable to microscopic discectomy to treat lumbar disc herniations. All efforts will be made to reduce bias, including adequate sample sizes, blinded analyses, and multicenter prospective registration. The outcomes will inform practice, providing the evidence needed for the use of interlaminar full-endoscopic over microscopic discectomy by confirming the potential of this technique to improve patient satisfaction and clinical outcomes.Trial registrationClinical Research Information Service; cris.nih.go.kr. (KCT0006277); protocol version (v1, June 8, 2021)

2021 ◽  
Ming-Ming Li ◽  
Fang Sun ◽  
Man-Xiu Huai ◽  
Chun-Ying Qu ◽  
Feng Shen ◽  

Abstract Background Portal hypertension (PH) frequently gives rise to severe and life-threatening complications, including hemorrhage accompanied by the rupture of esophageal and gastric varices. In contrast to the widely studied guidelines for the management of PH in adults, there remains controversial about the optimal endoscopic management of variceal bleeding in children for secondary prophylaxis. The study aims to determine the efficacy and safety of endoscopic variceal ligation (EVL) and sclerotherapy (EST) to control bleeding in children in our clinical center. Methods The retrospective study included 21 children with gastroesophageal variceal bleeding who were treated by endoscopic variceal ligation or sclerotherapy at Xinhua Hospital, Shanghai Jiaotong University School of Medicine between January 2007 and July 2020. The treatment outcome involving short-term hemostatic rate and long-term rebleeding rate were investigated. Adverse events related to the procedures, such as esophageal ulcer, esophageal stricture, abnormal embolization, pneumonia and perforation were also observed. Results The 21 pediatric patients who were diagnosed as moderate to severe esophageal varices concurrent with gastric varices experienced EVL or EST successfully. Hemostasis was achieved in 45 of 47 (95.7%) episodes of upper gastrointestinal bleeding. The mean volume of each single aliquot of cyanoacrylate injected was 0.3 ± 0.1 mL (range: 0.1–0.5 mL). Twenty-four patients (75%) reach varices eradication in the EVL group with a median number of procedures before eradication of 2 (1–4) and a median time to eradication of 3.40 months (1.10-13.33). Eleven patients (52.4%) developed rebleeding events, with the mean duration of hemostasis being 11.1 ± 11.6 mo (range: 1.0-39.2 mo). No treatment-related complications, for example, distal embolism, were noted with the exception of abdominal pain in one patient (4.8%). Conclusions Endoscopic variceal sclerotherapy or in combination with EVL turns out to be an effective and safe approach to treat variceal hemorrhage in children for secondary prophylaxis.

2021 ◽  
pp. OP.21.00273
Madison Novice ◽  
Taylor Novice ◽  
N. Lynn Henry ◽  
Kyle Johnson ◽  
Jacqueline S. Jeruss ◽  

PURPOSE: Scalp cooling therapy (SCT) is the most effective method to reduce chemotherapy-induced alopecia (CIA), a highly distressing side effect of cancer treatment. Despite data supporting SCT efficacy and safety, SCT use in the United States is not widespread. Oncologists' interactions with scalp cooling were examined to identify facilitators and barriers to SCT implementation. METHODS: A 33-question survey was distributed through the ASCO Research Survey Pool to a nationally representative, random sample of 600 oncology providers. Outcome measures included knowledge of SCT, frequency of initiating conversations about SCT with patients, degree of support, and barriers for SCT. Significance was defined as P < .001. RESULTS: Of 155 (25.8%) responding providers, 62% of providers were in favor of SCT always or most of the time, but only 26% reported initiating discussions about SCT always or most of the time. Providers who treat breast cancer ( P ≤ .0001), those who report being very familiar with SCT ( P ≤ .0001), those who report having read SCT literature in the past 2 years ( P ≤ .0001), and those who work at a facility with machine SCT ( P ≤ .0001) were significantly more likely to initiate conversations with patients about SCT. Financial concerns (58%) were the primary reason for not recommending SCT use; efficacy (31%), staff or facility (24%), and safety (15%) concerns were also noted. Although safety concerns have decreased markedly over time, 14% of providers report patients who continue to express these concerns and 17% of providers see safety issues as barriers to supporting SCT. CONCLUSION: Our findings suggest that oncology provider familiarity and experience with SCT lead to increased support for scalp cooling, which may ultimately result in greater availability and utilization of SCT when indicated.

2021 ◽  
Vol 11 ◽  
Zhongyou Xia ◽  
Jinze Li ◽  
Lei Peng ◽  
Xiaoying Yang ◽  
Yulai Xu ◽  

ObjectiveTo compare the efficacy and safety of robotic-assisted adrenalectomy (RA) and standard laparoscopic adrenalectomy (LA) for pheochromocytoma (PHEO).MethodsWe systematically searched the Cochrane Library, PubMed, Embase, and Science databases for studies published through January 2021. Controlled trials on RA and LA for PHEOs were included. The meta-analysis was conducted with the Review Manager 5.4 software.ResultsFour studies with 386 patients were included in the analysis. There were no significant differences in OT (WMD: 0.16; 95% CI: -28.50 to 28.82; I2 = 89%; P = 0.99), transfusion rate (OR: 0.70; 95% CI: 0.07 to 7.07; I2 = 64%; P = 0.77), conversion rate (OR: 0.44; 95% CI: 0.07 to 2.88; I2 = 0%; P = 0.39), complication rate (OR: 1.06; 95% CI: 0.62 to 1.82; I2 = 0%; P = 0.84) among patients undergoing RA and LA. However, compared with patients who underwent LA, patients who underwent RA had a shorter LOS (OR: -0.50; 95% CI: -0.55 to 0.45; I2 = 31%; P&lt;0.01), less EBL (WMD: -0.85; 95% CI: -13.56 to -2.54; I2 = 44%; P&lt;0.01), and fewer IHD (OR: 0.34; 95% CI: 0.17 to 0.70; I2 = 0%; P&lt;0.01).ConclusionThe RA for pheochromocytoma achieve better outcomes over LA in terms of safety and efficacy.

2021 ◽  
Vol 12 ◽  
Anji Xiong ◽  
Deng Liu ◽  
Huini Chen ◽  
Guancui Yang ◽  
Chen Xiong ◽  

Background: Although infliximab has been recommended for the second-line treatment of seronegative spondyloarthropathy- or juvenile idiopathic arthritis-related uveitis, the issue of its systemic efficacy and safety in a broader diversity of refractory noninfectious uveitis is debatable. To assess the short-term and relatively long-term efficacy of infliximab in refractory noninfectious uveitis, we performed a systematic review and meta-analysis of observational studies.Methods: PubMed, Cochrane Library, EMBASE, and Wanfang Med Online were systematically searched from January 2005 to March 2020. Two investigators independently assessed eligibility. Data were independently collected by two investigators. The pooled proportions were estimated with patients for intraocular inflammation control and improvement of visual acuity. Pooled proportions with 95% credible intervals were computed. Study homogeneity was investigated using I2 statistics to quantify the percentage of variation across studies. To pool the results, the Mantel–Haenszel fixed-effects or random-effects models were used.Results: Of 2316 studies identified, 16 unique studies with 509 unique participants were included in the meta-analysis. The pooled proportions of intraocular inflammation control reached 92% (95% CI: 87%–98%; I2: 1%; p=0.42) and 95% (95% CI: 93%–97%; I2: 0%; p=0.91) in groups of ≤6- and ≥12-month follow-up durations. During the relatively long follow-up period, the pooled proportions of maintaining visual acuity stable or increasing at least one line reached 99% (95% CI: 96%–100%; I2: 0%; p=0.54) in the involved eyes. The corticosteroid-sparing effect of infliximab was also well demonstrated, with the proportion of corticosteroid-sparing success reaching 85.5% (112/131). Besides, about serious adverse events, 2.6% (13/500) of patients experienced hypersensitivity reactions, 2.4% (12/500) of patients experienced serious infections, 1.8% (9/500) of patients experienced autoimmune diseases, and 0.6% (3/500) of patients experienced neoplasia.Conclusions: This meta-analysis provided evidence that infliximab might be a promising choice in controlling inflammatory activity, gaining visual acuity, and sparing corticosteroid use with relatively few side effects when applied in treating refractory noninfectious uveitis.Systematic Review Registration: [website], identifier [registration number]

Giancarlo Agnelli ◽  
Andrés Muñoz ◽  
Laura Franco ◽  
Isabelle Mahé ◽  
Benjamin Brenner ◽  

AbstractEfficacy and safety of anticoagulant treatment for venous thromboembolism (VTE) may vary in patients with different cancer sites. We evaluated the rates of VTE recurrence and major bleeding and the relative efficacy and safety of 6-month treatment with oral apixaban or subcutaneous dalteparin in patients with different cancer sites randomized in the Caravaggio study. Primary cancer was located at gastrointestinal sites in 375 patients (32.5%), lung in 200 (17.3%), breast in 155 (13.4%), genitourinary sites in 139 (12%), gynecological sites in 119 (10.3%), and was hematological in 85 patients (7.4%). Rates of VTE recurrence were 10.9% in patients with gynecological, 8.8% with gastrointestinal, 6.5% with genitourinary, and 5.5% with lung cancer with lower rates in the other sites of cancer. Rates of major bleeding were 7.2% in patients with genitourinary and 4.8% with gastrointestinal cancer, with lower rates in patients with other sites of cancer. The observed absolute risk difference in VTE recurrence in favor of apixaban was 11.9% in patients with gynecological, 5.5% with lung, 3.7% with genitourinary cancer, and 0.6% with gastrointestinal cancer. None of the risk differences was statistically significant. The rates of major bleeding in patients treated with apixaban or dalteparin was similar across patients with different cancer sites. In conclusion, recurrences appear to be more common in patients with gastrointestinal and gynecological cancer and major bleedings in patients with genitourinary and gastrointestinal cancer. Oral apixaban is a valid oral alternative to subcutaneous dalteparin for the treatment of a large spectrum of patients with cancer-associated VTE.

Juexian Song ◽  
Yuting Nie ◽  
Xinzuo Qin ◽  
Pingping Wang ◽  
Huiqiang Lu ◽  

Abstract Objective To evaluate the efficacy and safety outcome and related risk factors of Naoxueshu in the treatment of acute SICH. Methods Two hundred twenty patients were enrolled in this study. Diagnosis of SICH was based on neuroimaging. All the patients received regular treatment and Naoxueshu oral liquid 10 ml 3 times a day for 14 consecutive days. Surgical intervention was conducted as needed. Efficacy and safety outcomes were evaluated. Results Hematoma volume decreased significantly 7 days after Naoxueshu treatment (from 27.3 ± 20.0 to 15.1 ± 15.1 ml, P < 0.0001), and it decreased further in 14-day result (6.9 ± 10.4 ml, P < 0.0001). Patients’ neurological function was improved remarkably with NIHSS scores from baseline 13 points to 7-day 7 points (P < 0.0001) and 14-day 4 points (P < 0.0001). Cerebral edema was relieved only 14 days after Naoxueshu treatment (from 3 to 2 points, P < 0.0001). No clinically significant change was found in 7-day and 14-day safety results. Female sex was related independently to large 7-day hematoma volume and worse 7-day NIHSS score while it would not affect patients’ 14-day outcomes. Rare cause of SICH (B = 17.4, P = 0.009) alone was related to large 14-day hematoma volume. Worse baseline NIHSS score (B = 0.3, P = 0.003) and early use of Naoxueshu (B = 2.9, P = 0.005) were related to worse 7-day and14-day neurological function. Conclusion Naoxueshu oral liquid could relieve hematoma volume and cerebral edema safely; meanwhile, it could improve patients’ neurological function. Sex, cause of SICH, and time from onset to receive Naoxueshu should be taken into consideration in the treatment of SICH.

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