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1.
Comparison of the effects of Pueraria mirifica gel and of placebo gel on the vaginal microenvironment of postmenopausal women with Genitourinary Syndrome of Menopause (GSM).
Sritonchai, C, Manonai, J, Sophonsritsuk, A, Cherdshewasart, W
Maturitas. 2020;:49-54
Abstract
OBJECTIVE To compare the effects of a 12-week course of 5%Pueraria mirifica gel and placebo gel on the prevalence of bacterial vaginosis, vaginal fungi, vaginal pH, vaginal health index (VHI), and genitourinary symptoms in postmenopausal women. STUDY DESIGN In a randomized, double-blinded, placebo-controlled study (TCTR20160517002), 60 postmenopausal women were randomly assigned to a 12-week course of eitherP. mirifica gel or identical placebo gel. MAIN OUTCOME MEASURE Vaginal Nugent score, fungal culture, pH, VHI, and genitourinary symptoms were evaluated at baseline and after 12 weeks of treatment. RESULTS After 12 weeks of treatment, the proportion of participants with an abnormal Nugent score in the P. mirifica and the placebo groups were 6.7 % (2/30) and 23.3 % (7/30), respectively (p = 0.006). The mean changes in Nugent scores and VHI were significantly higher in the P. mirifica group (p < 0.05). There were no significant decreases in the prevalence of symptoms between the two groups after treatment (p > 0.05). CONCLUSION A 12-week course of treatment with 5 % P. mirifica vaginal gel in postmenopausal women with GSM has been proved to be effective in reducing indicators of bacterial vaginosis compared with placebo gel. Nevertheless, the effect on alleviating genital symptoms was not demonstrated.
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2.
[Efficiency of immunomodulatotors for complex therapy of chronic recurrent cystitis in women].
Kuzmenko, AV, Kuzmenko, VV, Gyaurgiev, TA
Urologiia (Moscow, Russia : 1999). 2019;(2):9-14
Abstract
INTRODUCTION Currently, chronic recurrent cystitis is one of the most important problems in urology. Considering the role of immune status disorders in the pathogenesis of inflammatory diseases, the use of immunocorrective drugs as part of the complex therapy is of particular relevance. AIM: to study the efficiency of therapy for chronic recurrent bacterial cystitis in combination with immunomodulators (Galavit). MATERIALS AND METHODS A total of 60 women with acute stage of chronic recurrent bacterial cystitis were examined. The patients were randomized into 2 groups of 30 patients. In the control group, standard antibiotic therapy was administered. In the treatment group, patients received Galavit in combination with standard therapy. All patients were followed-up on the 1st, 5th and 10th day. Voiding diaries, chronobiological status and pain severity using a 5-point scale were evaluated. In addition, complete blood count, urinalysis, urine culture and enzyme immunoassay for determination of serum level of interleukin (IL) 1, IL-6, tumor necrosis factor (TNF-) were analyzed. A number of recurrences after 3 months of therapy was assessed. RESULTS Complex therapy in combination with Galavit in women with acute stage of chronic bacterial cystitis allows to decrease in desynchronosis by 20%, reduce pain by 2.5 times, frequency of urination by 1.7 times, the number of urgent voids and night urination by 2.4 and 5 times, respectively, by the 5th day of therapy. In the group of patients receiving immunomodulators a significantly more pronounced decrease in the level of IL-1, IL-6, TNF- and CRP was noted. During 3 months of follow-up, there were 2 recurrences in the control group and no recurrences in treatment group (10%). CONCLUSION The use of Galavit in the treatment of women with chronic recurrent bacterial cystitis has pathogenetic basis. A clear advantage of the drug is more rapid relief of symptoms, normalization of laboratory parameters, recovery of chronorhythms and the achievement of clinical remission.
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3.
The Use of a Combination of Vaccinium Macracarpon, Lycium barbarum L. and Probiotics (Bifiprost®) for the Prevention of Chronic Bacterial Prostatitis: A Double-Blind Randomized Study.
Chiancone, F, Carrino, M, Meccariello, C, Pucci, L, Fedelini, M, Fedelini, P
Urologia internationalis. 2019;(4):423-426
Abstract
INTRODUCTION To evaluate the efficacy of Bifiprost® + Serenoa Repens 320 mg versus Serenoa Repens 320 mg alone for the prevention of chronic bacterial prostatitis (CBP) due to enterobacteriaceae. METHODS Between September 2016 and September 2018, 120 patients with CBP at the National Institutes of Health (NIH type II) with recurrent infections due to enterobacteriaceae (Escherichia Coli and Enterococcus faecalis) were enrolled and randomized into 2 groups each to receive Bifiprost® + Serenoa Repens 320 mg (Group A) or Serenoa Repens 320 mg alone (Group B) daily for 24 weeks (after receiving a proper antibiotic treatment with subsequent culture negativization). The primary endpoint was the reduction in the episodes of prostatitis. The secondary endpoint evaluated was the score of the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI). Evaluation was performed at baseline and at 12, 24, and 36 weeks. RESULTS The patients of the Group A experienced a significantly larger reduction in the prostatitis episodes than the Group B at 24 and 36 weeks, but they did not experience a significantly larger reduction at 12 weeks. After 12 weeks of treatment, the mean NIH-CPSI score was reduced in both groups compared with baselines, but no significant differences were seen between the Group A and Group B. On the contrary, we observed a significant difference in the mean NIH-CPSI score between the 2 groups at 24 and 36 weeks. CONCLUSION The association of Bifiprost® and Serenoa Repens 320 mg improves the prevention of the episodes of CBP due to enterobacteriaceae and ameliorates prostatitis-related symptoms after 6 months of therapy. The long-term impact on the entero-urinary route was also seen 3 months after the end of the treatment.
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4.
High-dose versus standard-dose amoxicillin/clavulanate for clinically-diagnosed acute bacterial sinusitis: A randomized clinical trial.
Matho, A, Mulqueen, M, Tanino, M, Quidort, A, Cheung, J, Pollard, J, Rodriguez, J, Swamy, S, Tayler, B, Garrison, G, et al
PloS one. 2018;(5):e0196734
Abstract
BACKGROUND The recommended treatment for acute bacterial sinusitis in adults, amoxicillin with clavulanate, provides only modest benefit. OBJECTIVE To see if a higher dose of amoxicillin will lead to more rapid improvement. DESIGN, SETTING, AND PARTICIPANTS Double-blind randomized trial in which, from November 2014 through February 2017, we enrolled 315 adult outpatients diagnosed with acute sinusitis in accordance with Infectious Disease Society of America guidelines. INTERVENTIONS Standard-dose (SD) immediate-release (IR) amoxicillin/clavulanate 875 /125 mg (n = 159) vs. high-dose (HD) (n = 156). The original HD formulation, 2000 mg of extended-release (ER) amoxicillin with 125 mg of IR clavulanate twice a day, became unavailable half way through the study. The IRB then approved a revised protocol after patient 180 to provide 1750 mg of IR amoxicillin twice a day in the HD formulation and to compare Time Period 1 (ER) with Time Period 2 (IR). MAIN MEASURE The primary outcome was the percentage in each group reporting a major improvement-defined as a global assessment of sinusitis symptoms as "a lot better" or "no symptoms"-after 3 days of treatment. KEY RESULTS Major improvement after 3 days was reported during Period 1 by 38.8% of ER HD versus 37.9% of SD patients (P = 0.91) and during Period 2 by 52.4% of IR HD versus 34.4% of SD patients, an effect size of 18% (95% CI 0.75 to 35%, P = 0.04). No significant differences in efficacy were seen at Day 10. The major side effect, severe diarrhea at Day 3, was reported during Period 1 by 7.4% of HD and 5.7% of SD patients (P = 0.66) and during Period 2 by 15.8% of HD and 4.8% of SD patients (P = 0.048). CONCLUSIONS Adults with clinically diagnosed acute bacterial sinusitis were more likely to improve rapidly when treated with IR HD than with SD but not when treated with ER HD. They were also more likely to suffer severe diarrhea. Further study is needed to confirm these findings. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02340000.
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5.
Efficacy and safety of alternating norfloxacin and rifaximin as primary prophylaxis for spontaneous bacterial peritonitis in cirrhotic ascites: a prospective randomized open-label comparative multicenter study.
Assem, M, Elsabaawy, M, Abdelrashed, M, Elemam, S, Khodeer, S, Hamed, W, Abdelaziz, A, El-Azab, G
Hepatology international. 2016;(2):377-85
Abstract
BACKGROUND AND AIM Primary prevention of spontaneous bacterial peritonitis (SBP) is an important strategy to reduce morbidity and mortality in cirrhotic patients with ascites. Efficacy and safety of alternating rifaximin and norfloxacin as primary prophylaxis is questionable. METHODS Three hundred thirty-four cirrhotic patients with high SAAG (≥1.1) ascites, protein level in ascitic fluid less than 1.5 g/dL with advanced liver disease (Child-Pugh score >9 points with serum bilirubin level >3 mg/dL) or renal impairment (serum creatinine level >1.2 mg/dL, blood urea nitrogen level >25 mg/dL, or serum sodium level <130 mEq/L) were included in an open-label, randomized study aimed at comparing alternating use of norfloxacin and rifaximin vs. norfloxacin or rifaximin alone as primary prophylaxis for SBP. Both intention-to-treat and per-protocol efficacy analyses were done after 6 months of treatment by assessment of ascitic fluid neutrophil count. Safety analysis was done for all intention-to-treat populations. RESULTS Alternating norfloxacin and rifaximin showed superior prophylaxis by intention-to-treat (74.7 vs. 56.4% vs. 68.3%, p < 0.048). Pairwise analysis showed that alternating regimen had lower probability to develop SBP when compared to a norfloxacin-based regimen in intention-to-treat (p = 0.016) and per protocol analysis (p = 0.039). There was no difference among the studied groups regarding the incidence and severity of adverse events reported. CONCLUSIONS Alternating norfloxacin- and rifaximin-based primary prophylaxis for SBP showed higher efficacy with the same safety profile when compared with monotherapy of norfloxacin.
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Effect of probiotics on the incidence of ventilator-associated pneumonia in critically ill patients: a randomized controlled multicenter trial.
Zeng, J, Wang, CT, Zhang, FS, Qi, F, Wang, SF, Ma, S, Wu, TJ, Tian, H, Tian, ZT, Zhang, SL, et al
Intensive care medicine. 2016;(6):1018-28
Abstract
PURPOSE To evaluate the potential preventive effect of probiotics on ventilator-associated pneumonia (VAP). METHODS This was an open-label, randomized, controlled multicenter trial involving 235 critically ill adult patients who were expected to receive mechanical ventilation for ≥48 h. The patients were randomized to receive (1) a probiotics capsule containing live Bacillus subtilis and Enterococcus faecalis (Medilac-S) 0.5 g three times daily through a nasogastric feeding tube plus standard preventive strategies or (2) standard preventive strategies alone, for a maximum of 14 days. The development of VAP was evaluated daily, and throat swabs and gastric aspirate were cultured at baseline and once or twice weekly thereafter. RESULTS The incidence of microbiologically confirmed VAP in the probiotics group was significantly lower than that in the control patients (36.4 vs. 50.4 %, respectively; P = 0.031). The mean time to develop VAP was significantly longer in the probiotics group than in the control group (10.4 vs. 7.5 days, respectively; P = 0.022). The proportion of patients with acquisition of gastric colonization of potentially pathogenic microorganisms (PPMOs) was lower in the probiotics group (24 %) than the control group (44 %) (P = 0.004). However, the proportion of patients with eradication PPMO colonization on both sites of the oropharynx and stomach were not significantly different between the two groups. The administration of probiotics did not result in any improvement in the incidence of clinically suspected VAP, antimicrobial consumption, duration of mechanical ventilation, mortality and length of hospital stay. CONCLUSION Therapy with the probiotic bacteria B. Subtilis and E. faecalis are an effective and safe means for preventing VAP and the acquisition of PPMO colonization in the stomach.
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Positive regulatory effects of perioperative probiotic treatment on postoperative liver complications after colorectal liver metastases surgery: a double-center and double-blind randomized clinical trial.
Liu, Z, Li, C, Huang, M, Tong, C, Zhang, X, Wang, L, Peng, H, Lan, P, Zhang, P, Huang, N, et al
BMC gastroenterology. 2015;:34
Abstract
BACKGROUND Colorectal liver metastases (CLM) occur frequently and postoperative intestinal infection is a common complication. Our previous study showed that probiotics could decrease the rate of infectious complications after colectomy for colorectal cancer. To determine the effects of the perioperative administration of probiotics on serum zonulin levels which is a marker of intestinal permeability and the subsequent impact on postoperative infectious complications in patients with CLM. METHODS 150 patients with CLM were randomly divided into control group (n = 68) and probiotics group (n = 66). Probiotics and placebo were given orally for 6 days preoperatively and 10 days postoperatively to control group and probiotics group respectively. We used the local resection for metastatic tumor ,while for large tumor, the segmental hepatectomy. Postoperative outcome were recorded. Furthermore, complications in patients with normal intestinal barrier function and the relation with serum zonulin were analyzed to evaluate the impact on the liver barrier dysfunction. RESULTS The incidence of infectious complications in the probiotics group was lower than control group. Analysis of CLM patients with normal postoperative intestinal barrier function paralleled with the serum zonulin level. And probiotics could also reduce the concentration of serum zonulin (P = 0.004) and plasma endotoxin (P < 0.001). CONCLUSION Perioperative probiotics treatment could reduce the serum zonulin level, the rate of postoperative septicemia and maintain the liver barrier in patients undergoing CLM surgery. we propose a new model about the regulation of probiotics to liver barrier via clinical regulatory pathway. We recommend the preoperative oral intake of probiotics combined with postoperative continued probiotics treatment in patients who undergo CLM surgery. TRIAL REGISTRATION ChiCTR-TRC- 12002841 . 2012/12/21.
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Comparative trial between the use of amoxicillin and amoxicillin clavulanate in the removal of third molars.
Iglesias-Martín, F, García-Perla-García, A, Yañez-Vico, R, Aced-Jiménez, E, Arjona-Gerveno, E, González-Padilla, JD, Gutierrez-Pérez, JL, Torres-Lagares, D
Medicina oral, patologia oral y cirugia bucal. 2014;(6):e612-5
Abstract
OBJECTIVE The purpose of this study was to compare the use of amoxicillin (1g) vs amoxicillin and clavulanate (875/125mg) after extraction of retained third molars for prevention of infectious complications. STUDY DESIGN The study involved 546 patients attending for removal a retained third molar and divided in to two groups: Group 1 - amoxicillin and clavunate (875/125mg) group (n=257) and Group 2 - amoxicillin (1g) group (n=289). All patients were recalled for investigating the possibility of infection, presence of diarrhea and further analgesic intake. RESULTS From a total of 546 patients, the frequency of infection was 1.4%, without no statistically differences between the two groups. Group 1 showed statistically higher presence of patients with gastrointestinal complications (p>0.05). In 546 patients, 2.7% of patients reported severe pain that would not relieve with medication. CONCLUSION The results of our study show that the use of amoxicillin (1g) and amoxicillin and clavunate (875/125mg) is similar efficacious in preventing infection after retained third molar extraction but amoxicillin and clavunate (875/125mg) produces more gastrointestinal discomfort.
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9.
Antibacterial honey for the prevention of peritoneal-dialysis-related infections (HONEYPOT): a randomised trial.
Johnson, DW, Badve, SV, Pascoe, EM, Beller, E, Cass, A, Clark, C, de Zoysa, J, Isbel, NM, McTaggart, S, Morrish, AT, et al
The Lancet. Infectious diseases. 2014;(1):23-30
Abstract
BACKGROUND There is a paucity of evidence to guide the best strategy for prevention of peritoneal-dialysis-related infections. Antibacterial honey has shown promise as a novel, cheap, effective, topical prophylactic agent without inducing microbial resistance. We therefore assessed whether daily application of honey at the exit site would increase the time to peritoneal-dialysis-related infections compared with standard exit-site care plus intranasal mupirocin prophylaxis for nasal carriers of Staphylococcus aureus. METHODS In this open-label trial undertaken in 26 centres in Australia and New Zealand, participants undergoing peritoneal dialysis were randomly assigned in a 1:1 ratio with an adaptive allocation algorithm to daily topical exit-site application of antibacterial honey plus standard exit-site care or intranasal mupirocin prophylaxis (only in carriers of nasal S aureus) plus standard exit-site care (control group). The primary endpoint was time to first infection related to peritoneal dialysis (exit-site infection, tunnel infection, or peritonitis). The trial is registered with the Australian New Zealand Clinical Trials Registry, number 12607000537459. FINDINGS Of 371 participants, 186 were assigned to the honey group and 185 to the control group. The median peritoneal-dialysis-related infection-free survival times were not significantly different in the honey (16·0 months [IQR not estimable]) and control groups (17·7 months [not estimable]; unadjusted hazard ratio 1·12, 95% CI 0·83-1·51; p=0·47). In the subgroup analyses, honey increased the risks of both the primary endpoint (1·85, 1·05-3·24; p=0·03) and peritonitis (2·25, 1·16-4·36) in participants with diabetes. The incidences of serious adverse events (298 vs 327, respectively; p=0·1) and deaths (14 vs 18, respectively; p=0·9) were not significantly different in the honey and control groups. 11 (6%) participants in the honey group had local skin reactions. INTERPRETATION The findings of this trial show that honey cannot be recommended routinely for the prevention of peritoneal-dialysis-related infections. FUNDING Baxter Healthcare, Queensland Government, Comvita, and Gambro.
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10.
Moxifloxacin versus amoxicillin/clavulanic acid in outpatient acute exacerbations of COPD: MAESTRAL results.
Wilson, R, Anzueto, A, Miravitlles, M, Arvis, P, Alder, J, Haverstock, D, Trajanovic, M, Sethi, S
The European respiratory journal. 2012;(1):17-27
Abstract
Bacterial infections causing acute exacerbations of chronic obstructive pulmonary disease (AECOPD) frequently require antibacterial treatment. More evidence is needed to guide antibiotic choice. The Moxifloxacin in Acute Exacerbations of Chronic Bronchitis TriaL (MAESTRAL) was a multiregional, randomised, double-blind non-inferiority outpatient study. Patients were aged ≥ 60 yrs, with an Anthonisen type I exacerbation, a forced expiratory volume in 1 s < 60% predicted and two or more exacerbations in the last year. Following stratification by steroid use patients received moxifloxacin 400 mg p.o. q.d. (5 days) or amoxicillin/clavulanic acid 875/125 mg p.o. b.i.d. (7 days). The primary end-point was clinical failure 8 weeks post-therapy in the per protocol population. Moxifloxacin was noninferior to amoxicillin/clavulanic acid at the primary end-point (111 (20.6%) out of 538, versus 114 (22.0%) out of 518, respectively; 95% CI -5.89-3.83%). In patients with confirmed bacterial AECOPD, moxifloxacin led to significantly lower clinical failure rates than amoxicillin/clavulanic acid (in the intent-to-treat with pathogens, 62 (19.0%) out of 327 versus 85 (25.4%) out of 335, respectively; p=0.016). Confirmed bacterial eradication at end of therapy was associated with higher clinical cure rates at 8 weeks post-therapy overall (p=0.0014) and for moxifloxacin (p=0.003). Patients treated with oral corticosteroids had more severe disease and higher failure rates. The MAESTRAL study showed that moxifloxacin was as effective as amoxicillin/clavulanic acid in the treatment of outpatients with AECOPD. Both therapies were well tolerated.