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Background: Over the counter (OTC) artificial tears historically have been the first line of treatment for dry eye syndrome and dry eye-related conditions like contact lens discomfort, yet currently we know little regarding the overall efficacy of individual, commercially available artificial tears. This review provides a much needed meta-analytical look at all randomized and quasi-randomized clinical trials that have analyzed head-to-head comparisons of OTC artificial tears., Objectives: To evaluate the effectiveness and toxicity of OTC artificial tear applications in the treatment of dry eye syndrome compared with another class of OTC artificial tears, no treatment, or placebo., Search Methods: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2015, Issue 12), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to December 2015), EMBASE (January 1980 to December 2015), Latin American and Caribbean Health Sciences (LILACS) (January 1982 to December 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en) and the US Food and Drugs Administration (FDA) website (www.fda.gov). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 4 December 2015. We searched reference lists of included trials for any additional trials not identified by the electronic searches., Selection Criteria: This review includes randomized controlled trials with adult participants who were diagnosed with dry eye, regardless of race and gender. We included trials in which the age of participants was not reported, and clinical trials comparing OTC artificial tears with another class of OTC artificial tears, placebo, or no treatment. This review did not consider head-to-head comparisons of artificial tears with another type of dry-eye therapy., Data Collection and Analysis: We followed the standard methodological procedures expected by Cochrane. Two authors independently screened the search results, reviewed full-text copies for eligibility, examined risk of bias, and extracted data. We performed meta-analysis for trials that compared similar interventions and reported comparable outcomes with sufficient data. We summarized all other included trial results in the text., Main Results: We included 43 randomized controlled trials (3497 participants with dry eye). Due to the heterogeneity of study characteristics among the included trials with respect to types of diagnostic criteria, interventions, comparisons, and measurements taken, our ability to perform meta-analyses was limited. The review found that, in general, there was uncertainty whether different OTC artificial tears provide similar relief of signs and symptoms when compared with each other or placebo. Nevertheless, we found that 0.2% polyacrylic acid-based artificial tears were consistently more effective at treating dry eye symptoms than 1.4% polyvinyl alcohol-based artificial tears in two trials assessing this comparison (175 participants). All other included artificial tears produced contradictory between-group results or found no between-group differences. Our review also found that OTC artificial tears may be generally safe, but not without adverse events. Overall, we assessed the quality of evidence as low due to high risks of bias among included trials and poor reporting of outcome measures which were insufficient for quantitative analysis. Furthermore, we identified an additional 18 potentially eligible trials that were reported only in clinical trial registers with no associated results or publications. These trials reportedly enrolled 2079 total participants for whom no data are available. Such lack of reporting of trial results represents a high risk of publication bias., Authors' Conclusions: OTC artificial tears may be safe and effective means for treating dry eye syndrome; the literature indicates that the majority of OTC artificial tears may have similar efficacies. This conclusion could be greatly skewed by the inconsistencies in study designs and inconsistencies in reporting trial results. Additional research is therefore needed before we can draw robust conclusions about the effectiveness of individual OTC artificial tear formulations.

Objective: To evaluate the effectiveness/safety of systemic methotrexate (MTX) treatment versus transcatheter arterial chemoembolization using different embolic agents for termination of cesarean scar pregnancy (CSP)., Methods: Women with CSP were randomized to receive intravenous infusion of MTX (group 1, n=13), or chemoembolization with MTX and either gelatin sponge (GS; group 2, n=15) or polyvinyl alcohol (PVA; group 3, n=16) particles. Uterine suction curettage followed all procedures. Bleeding volume, time until resolution of serum β-hCG, and length of hospital stay were recorded as outcome endpoints., Results: Bleeding volume was smaller in groups 2 (mean ± SD, 73±20 mL) and 3 (63±22 mL) than in group 1 (952±471 mL) (P<0.001). Time until resolution of β-hCG was shorter in groups 2 (29±16 days) and 3 (30±19 days) than in group 1 (57±25 days) (P<0.01). Length of hospital stay was shorter in groups 2 (13±4 days) and 3 (12±3 days) than in group 1 (36±8 days) (P<0.01)., Conclusion: Transcatheter arterial chemoembolization was more effective than systemic MTX treatment for termination of CSP. Large cohort studies are warranted to compare effectiveness between PVA and GS particles., (Copyright © 2011 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.)

Background: Unresectable intrahepatic cholangiocarcinoma has a poor prognosis, with a median survival of 5 to 8 months without treatment. Response and survival after chemoembolization were evaluated., Methods: Lobar or segmental chemoembolization with cisplatinum, doxorubicin, mitomycin-C, ethiodol, and polyvinyl alcohol particles was performed at monthly intervals for 1-4 sessions until the entire intrahepatic tumor burden was treated. Cross-sectional imaging and clinical and laboratory evaluation were performed before treatment, 1 month after treatment, and then every 3 months. A second cycle of treatment was performed for intrahepatic recurrence. Toxicity was assessed using NCI CTC v.3.0. Response was evaluated using RECIST criteria, and survival was estimated with Kaplan-Meier analysis., Results: Sixty-two patients were treated. Thirty-seven had pathologically proven cholangiocarcinoma, and 25 had poorly differentiated adenocarcinoma of unknown primary, likely cholangiocarcinoma. One hundred and twenty-two total procedures were performed during the initial cycle of treatment (mean, 2.0 per patient). Twenty patients received a second cycle, for a total of 165 procedures. There were 5 major complications. Thirty-day disease-specific mortality was 0%. Forty-five of 62 patients were evaluable for morphologic response after completion of their initial cycle: 11% (n = 5) partial responses, 64% (n = 29) stable, and 24% (n = 11) progressed. Median time to progression from first chemoembolization was 8 months, with 28% free of progression at 12 months. Median survival from time of diagnosis was 20 months, with 1-, 2-, and 3-year survival of 75%, 39%, and 17%, respectively. Median survival from time of first chemoembolization was 15 months, with 1-, 2-, and 3-year survival of 61%, 27%, and 8%, respectively. There was no statistically significant difference in survival between patients with cholangiocarcinoma and those with poorly differentiated adenocarcinoma. Patients who also received systemic chemotherapy had improved overall survival (median 28 vs 16 months, P = .02; HR, 1.94; 95% CI, 1.13-3.33)., Conclusions: Chemoembolization provided local disease control (PR + SD) of intrahepatic cholangiocarcinoma and adenocarcinoma of unknown primary in 76%. Overall survival after chemoembolization showed the best outcomes for those receiving multidisciplinary integrated liver-directed and systemic therapies., (Copyright © 2010 American Cancer Society.)

Objectives: The aim of this study was to assess a novel semisolid material as a potential topical drug delivery system for acute laceration. The objectives were to correlate physical characterization data using rheologic studies and to compare with clinical assessment of performance in an emergency department (ED)., Methods: Polyvinyl alcohol (PVA) hydrogels, cross-linked using tetrahydroxyborate (THB), were characterized using texture profile analysis. Formulation samples were applied to acute lacerations presented to the ED and factors, such as in vivo residency time and cohesive removal, were assessed., Results: Viscosity was shown to be related to mechanical characteristics, whereas adhesiveness depended on the THB concentration. Residence in, and clean removal from, lacerations was evaluated on 29 patients. Formulation F3 (10.0% PVA, 2.5% w/w THB) displayed the most appropriate characteristics for clinical use by scoring highest in qualitative assessments. Other formulations exhibited difficulties in application and removal due to excessive adhesiveness. The release of a model local anesthetic drug was proportional to the concentration of drug incorporated, but was not substantially affected by small changes in the formulation constituents., Conclusions: Using a combination of pharmaceutical evaluation and clinical assessment, it was shown that cross-linked PVA semisolids are a suitable formulation for drug administration to acute lacerations, with potential for induction of anesthesia prior to wound repair., (© 2011 by the Society for Academic Emergency Medicine.)

Background: Unresectable colorectal liver metastases have a 1- and 2-year survival of 55% and 33% with current systemic therapies. The authors evaluated response and survival after transarterial chemoembolization., Methods: Chemoembolization with cisplatin, doxorubicin, mitomycin C, ethiodized oil, and polyvinyl alcohol particles was performed at monthly intervals for 1 to 4 sessions. Cross-sectional imaging and clinical and laboratory evaluation were performed before treatment, 1 month after treatment, and then every 3 months. A second cycle was performed for intrahepatic recurrence. Toxicity was assessed using National Cancer Institute's Common Toxicity Criteria version 3.0. Response was evaluated using Response Evaluation Criteria in Solid Tumors criteria. Progression and survival were estimated with Kaplan-Meier analysis., Results: A total of 245 treatments were performed over 141 cycles on 121 patients. Ninety-five of 141 treatment cycles were evaluable for response: 2 (2%) partial response, 39 (41%) stable disease, and 54 (57%) progression. Median time to disease progression (TTP) in the treated liver was 5 months, and median TTP anywhere was 3 months. Median survival was 33 months from diagnosis of the primary colon cancer, 27 months from development of liver metastases, and 9 months from chemoembolization. Survival was significantly better when chemoembolization was performed after first- or second-line systemic therapy (11-12 months) than after third- to fifth-line therapies (6 months) (P = .03). Presence of extrahepatic metastases did not adversely affect survival (P = .48)., Conclusions: Chemoembolization provided local disease control of hepatic metastases after 43% of treatment cycles. Median survival was 27 months overall, and 11 months when initiated for salvage after failure of second-line systemic therapy., (Copyright © 2010 American Cancer Society.)

Objective: Our objective was to determine the efficacy of fibrin glue to prevent complications and nasal mucociliary clearance (MCC) after septoplasty compared with a nonabsorbable packing requiring removal (polyvinyl alcohol [PVA] sponge)., Study Design: Prospective clinical trial with planned data collection., Setting: The study was conducted at Haydarpasa Numune Education and Research Hospital., Methods: A total of 44 patients, who had septoplasty operations, were included in the study. We evaluated postoperative pain, sleep disturbance on the night of surgery, bleeding, septal hematoma, synechia, infection, and MCC values in the fibrin glue and PVA sponge groups., Results: The pain scores in the fibrin glue group were significantly lower than in the PVA sponge group (P < 0.01). A statistically significant difference was noted in the number of patients who had mild bleeding in favor of the fibrin glue group (P < 0.05). In the fibrin glue group, 95.7 percent of patients reported that they had normal sleep; in the PVA sponge group, only 23.8 percent of patients reported normal sleep (P < 0.01). In the fibrin glue group, a significant decrease was noted in postoperative MCC values compared with preoperative values (P < 0.01). However, in the PVA sponge group, a significant increase was noted in postoperative clearance values compared with preoperative values (P < 0.01)., Conclusion: In our series of patients, we have seen no gross complications from fibrin glue usage. Fibrin glue can be readily used in septoplasty; it requires no special treatment, has an adequate hemostatic effect, and appears to promote the regeneration of mucociliary activity of the injured mucosa postoperatively., (Copyright 2010 American Academy of Otolaryngology-Head and Neck Surgery Foundation. Published by Mosby, Inc. All rights reserved.)

Background: The authors evaluated the impact of bland particle embolization on survival in patients with metastatic sarcoma to the liver., Methods: Twenty-four patients with liver-dominant metastases from sarcoma were treated with particle embolization from 1996 to 2002. Primary tumors included 16 gastrointestinal stromal tumors (GISTs), 7 intestinal leiomyosarcomas, and 1 liposarcoma. Thirteen patients had known extrahepatic disease. Embolization was performed by using polyvinyl alcohol or trisacryl microspheres to effect stasis in the target vessel(s). Follow-up images to assess response were obtained 4 weeks after the procedure. Decrease in the size of the target lesion by >25% or development of >50% necrosis on follow-up imaging was considered a treatment response., Results: Nineteen patients had metachronous liver metastases, and the median disease-free interval was 22 months (range 10-156 months) from resection of the primary tumor. Ten patients underwent prior liver resection for metastatic disease. Of 15 evaluable patients, 9 patients (60%) had a radiographic response. The median follow-up for all patients was 21 months. The median follow-up for surviving patients was 59 months. Overall survival from the time of initial embolization was 62% at 1 year, 41% at 2 years, and 29% at 3 years. Patients who had radiographic evidence of response survived significantly longer than patients who did not respond (63 months vs. 19 months; P < .007). Patients with GIST survived significantly longer than patients with visceral leiomyosarcoma (median, 36 months vs. 18 months; P < .03)., Conclusions: Bland embolization was efficacious in some patients with metastatic sarcoma to the liver. Radiographic evidence of response was correlated with improved survival. This regional therapy may enter the treatment algorithm for patients who have unresectable disease or disease that has failed conventional therapies., ((c) 2006 American Cancer Society.)

Two types of flat plates made from a polyvinyl alcohol (PVA) hydrogel with a water content of 80 and 20 (PVA-H80, PVA-H20), 20 x 10 x 1 mm in size, were subcutaneously implanted into each of 50 young, male Wistar rats. As a control, a sham operation was done on another set of 50 rats (Sham Op group). The shape and transparency of the PVA hydrogel were unchanged for up to 24 months. Tumors arose in 14 rats from the PVA-H80 group. In the PVA-H20 group, tumors appeared in 15 rats. The average tumor latency was 598 +/- 109 days in the PVA-H80 and 637 +/- 94 days in the PVA-H20. There was no difference in tumor incidence between the PVA-H20 and PVA-H80 groups (p < 0.05). In the Sham Op group, no malignant tumors appeared. Histopathologically, the tumors induced by hydrogel plates were malignant tumors resembling fibrosarcoma or malignant fibrous histiocytoma. This indicates that PVA hydrogel implants also induce solid state carcinogenesis at a similarly high rate to medical grade hydrophobic material reported in a previous study., (Copyright 2001 John Wiley & Sons, Inc. J Biomed Mater Res 56: 289-296, 2001)