-
The Cochrane Database of Systematic... Feb 2017Theoretically, autologous serum eye drops (AS) offer a potential advantage over traditional therapies on the assumption that AS not only serve as a lacrimal substitute... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Theoretically, autologous serum eye drops (AS) offer a potential advantage over traditional therapies on the assumption that AS not only serve as a lacrimal substitute to provide lubrication but contain other biochemical components that allow them to mimic natural tears more closely. Application of AS has gained popularity as second-line therapy for patients with dry eye. Published studies on this subject indicate that autologous serum could be an effective treatment for dry eye.
OBJECTIVES
We conducted this review to evaluate the efficacy and safety of AS given alone or in combination with artificial tears as compared with artificial tears alone, saline, placebo, or no treatment for adults with dry eye.
SEARCH METHODS
We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 5), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to July 2016), Embase (January 1980 to July 2016), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to July 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We also searched the Science Citation Index Expanded database (December 2016) and reference lists of included studies. We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 5 July 2016.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) that compared AS versus artificial tears for treatment of adults with dry eye.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened all titles and abstracts and assessed full-text reports of potentially eligible trials. Two review authors extracted data and assessed risk of bias and characteristics of included trials. We contacted investigators to ask for missing data. For both primary and secondary outcomes, we reported mean differences with corresponding 95% confidence intervals (CIs) for continuous outcomes. We did not perform meta-analysis owing to differences in outcome assessments across trials.
MAIN RESULTS
We identified five eligible RCTs (92 participants) that compared AS versus artificial tears or saline in individuals with dry eye of various origins (Sjögren's syndrome-related dry eye, non-Sjögren's syndrome dry eye, and postoperative dry eye induced by laser-assisted in situ keratomileusis (LASIK)). We assessed the certainty of evidence as low or very low because of lack of reporting of quantitative data for most outcomes and unclear or high risk of bias among trials. We judged most risk of bias domains to have unclear risk in two trials owing to insufficient reporting of trial characteristics, and we considered one trial to have high risk of bias for most domains. We judged the remaining two trials to have low risk of bias; however, these trials used a cross-over design and did not report data in a way that could be used to compare outcomes between treatment groups appropriately. Incomplete outcome reporting and heterogeneity among outcomes and follow-up periods prevented inclusion of these trials in a summary meta-analysis.Three trials compared AS with artificial tears; however, only one trial reported quantitative data for analysis. Low-certainty evidence from one trial suggested that AS might provide some improvement in participant-reported symptoms compared with artificial tears after two weeks of treatment; the mean difference in mean change in symptom score measured on a visual analogue scale (range 0 to 100, with higher scores representing worse symptoms) was -12.0 (95% confidence interval (CI) -20.16 to -3.84; 20 participants). This same trial found mixed results with respect to ocular surface outcomes; the mean difference in mean change in scores between AS and artificial tears was -0.9 (95% CI -1.47 to -0.33; 20 participants; low-certainty evidence) for fluorescein staining and -2.2 (95% CI -2.73 to -1.67; 20 participants; low-certainty evidence) for Rose Bengal staining. Both staining scales range from 0 to 9, with higher scores indicating worse results. The mean change in tear film break-up time was 2.00 seconds longer (95% CI 0.99 to 3.01; 20 participants; low-certainty evidence) in the AS group than in the artificial tears group. Investigators reported no clinically meaningful differences in Schirmer's test scores between groups (mean difference -0.40 mm, 95% CI -2.91 to 2.11; 20 participants; low-certainty evidence). None of these three trials reported tear hyperosmolarity and adverse events.Two trials compared AS versus saline; however, only one trial reported quantitative data for analysis of only one outcome (Rose Bengal staining). Trial investigators of the two studies reported no differences in symptom scores, fluorescein staining scores, tear film break-up times, or Schirmer's test scores between groups at two to four weeks' follow-up. Very low-certainty evidence from one trial suggested that AS might provide some improvement in Rose Bengal staining scores compared with saline after four weeks of treatment; the mean difference in Rose Bengal staining score (range from 0 to 9, with higher scores showing worse results) was -0.60 (95% CI -1.11 to -0.09; 35 participants). Neither trial reported tear hyperosmolarity outcomes. One trial reported adverse events; two of 12 participants had signs of conjunctivitis with negative culture that did resolve.
AUTHORS' CONCLUSIONS
Overall, investigators reported inconsistency in possible benefits of AS for improving participant-reported symptoms and other objective clinical measures. There might be some benefit in symptoms with AS compared with artificial tears in the short-term, but we found no evidence of an effect after two weeks of treatment. Well-planned, large, high-quality RCTs are warranted to examine participants with dry eye of different severities by using standardized questionnaires to measure participant-reported outcomes, as well as objective clinical tests and objective biomarkers to assess the benefit of AS therapy for dry eye.
Topics: Adult; Dry Eye Syndromes; Humans; Lubricant Eye Drops; Ophthalmic Solutions; Randomized Controlled Trials as Topic; Serum; Sodium Chloride; Tears
PubMed: 28245347
DOI: 10.1002/14651858.CD009327.pub3 -
Journal of Tropical Medicine 2020In endemic African areas, such as Tanzania, spp. cause human febrile illnesses, which often go unrecognized and misdiagnosed, resulting in delayed diagnosis,... (Review)
Review
In endemic African areas, such as Tanzania, spp. cause human febrile illnesses, which often go unrecognized and misdiagnosed, resulting in delayed diagnosis, underdiagnosis, and underreporting. Although rapid and affordable point-of-care tests, such as the Rose Bengal test (RBT), are available, acceptance and adoption of these tests at the national level are hindered by a lack of local diagnostic performance data. To address this need, evidence on the diagnostic performance of RBT as a human brucellosis point-of-care test was reviewed. The review was initially focused on studies conducted in Tanzania but was later extended to worldwide because few relevant studies from Tanzania were identified. Databases including Web of Science, Embase, MEDLINE, and World Health Organization Global Index Medicus were searched for studies assessing the diagnostic performance of RBT (sensitivity and specificity) for detection of human brucellosis, in comparison to the reference standard culture. Sixteen eligible studies were identified and reviewed following screening. The diagnostic sensitivity (DSe) and specificity (DSp) of RBT compared to culture as the gold standard were 87.5% and 100%, respectively, in studies that used suitable "true positive" and "true negative" patient comparison groups and were considered to be of high scientific quality. Diagnostic DSe and DSp of RBT compared to culture in studies that also used suitable "true positive" and "true negative" patient comparison groups but were considered to be of moderate scientific quality varied from 92.5% to 100% and 94.3 to 99.9%, respectively. The good diagnostic performance of RBT combined with its simplicity, quickness, and affordability makes RBT an ideal (or close to) stand-alone point-of-care test for early clinical diagnosis and management of human brucellosis and nonmalarial fevers in small and understaffed health facilities and laboratories in endemic areas in Africa and elsewhere.
PubMed: 33014074
DOI: 10.1155/2020/6586182 -
Optometry and Vision Science : Official... Aug 2023Dry eye is a common condition with serious implications worldwide. The unique composition of autologous serum (AS) eye drops has been hypothesized as a possible...
BACKGROUND
Dry eye is a common condition with serious implications worldwide. The unique composition of autologous serum (AS) eye drops has been hypothesized as a possible treatment.
OBJECTIVES
This study aimed to review the effectiveness and safety of AS.
DATA SOURCES
We searched five databases and three registries up to September 30, 2022.
STUDY ELIGIBILITY
We included randomized controlled trials (RCTs) comparing AS with artificial tears, saline, or placebo for participants with dry eye.
STUDY APPRAISAL AND SYNTHESIS METHODS
We adhered to Cochrane methods for study selection, data extraction, risk-of-bias assessment, and synthesis. We used the Grading of Recommendations Assessment, Development and Evaluation framework to evaluate the certainty of evidence.
RESULTS
We included six RCTs with 116 participants. Four trials compared AS with artificial tears. We found low-certainty evidence that AS may improve symptoms (0- to 100-point pain scale) after 2 weeks of treatment compared with saline (mean difference, -12.00; 95% confidence interval, -20.16 to -3.84; 1 RCT, 20 participants). Ocular surface outcomes (corneal staining, conjunctival staining, tear breakup time, Schirmer test) were inconclusive. Two trials compared AS with saline. Very low-certainty evidence suggested that Rose Bengal staining (0- to 9-point scale) may be slightly improved after 4 weeks of treatment compared with saline (mean difference, -0.60; 95% confidence interval, -1.11 to -0.09; 35 eyes). None of the trials reported outcomes of corneal topography, conjunctival biopsy, quality of life, economic outcomes, or adverse events.
LIMITATIONS
We were unable to use all data because of unclear reporting.
CONCLUSIONS
The effectiveness of AS is uncertain based on current data. Symptoms improved slightly with AS compared with artificial tears for 2 weeks. Staining scores improved slightly with AS compared with saline, with no benefit identified for other measures.
IMPLICATIONS OF KEY FINDINGS
High-quality, large trials enrolling diverse participants with varying severity are needed. A core outcome set would allow for evidence-based treatment decisions consistent with current knowledge and patient values.
Topics: Humans; Lubricant Eye Drops; Dry Eye Syndromes; Serum; Tears; Saline Solution
PubMed: 37410855
DOI: 10.1097/OPX.0000000000002042 -
PLoS Neglected Tropical Diseases Mar 2024Brucellosis, a widely spread zoonotic disease, poses significant diagnostic challenges due to its non-specific symptoms and underreporting. Timely and accurate diagnosis... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Brucellosis, a widely spread zoonotic disease, poses significant diagnostic challenges due to its non-specific symptoms and underreporting. Timely and accurate diagnosis is crucial for effective patient management and public health control. However, a comprehensive comparative review of available diagnostic tests is lacking.
METHODOLOGY/PRINCIPAL FINDINGS
This systematic review addressed the following question: 'What is the accuracy of the available tests to confirm human brucellosis?' Two independent reviewers examined articles published up to January 2023. The review included original studies reporting symptomatic patients with brucellosis suspicion, through any index test, with sensitivity and/or specificity as outcomes. As exclusion criteria were considered: sample size smaller than 10 patients, studies focusing on complicated brucellosis, and those lacking essential information about index or comparator tests. Sensitivity and specificity were assessed, with consideration for the index test, and 'culture' and 'culture and standard tube agglutination test (SAT)' were used as reference standards. Bias assessment and certainty of evidence were carried out using the QUADAS-2 and GRADE tools, respectively. A total of 38 studies reporting diagnostic test performance for human brucellosis were included. However, the evidence available is limited, and significant variability was observed among studies. Regarding the reference test, culture and/or SAT are deemed more appropriate than culture alone. Rose Bengal, IgG/IgM ELISA, and PCR exhibited equally high performances, indicating superior overall diagnostic accuracy, with very low certainty of the evidence.
CONCLUSIONS/SIGNIFICANCE
This systematic review underscores the potential of the Rose Bengal test, IgG/IgM ELISA, and PCR as promising diagnostic tools for brucellosis. However, the successful implementation and recommendations for their use should consider the local context and available resources. The findings highlight the pressing need for standardization, improved reporting, and ongoing advancements in test development to enhance the accuracy and accessibility of brucellosis diagnosis.
Topics: Humans; Rose Bengal; Brucellosis; Sensitivity and Specificity; Immunoglobulin G; Immunoglobulin M
PubMed: 38452046
DOI: 10.1371/journal.pntd.0012030 -
PloS One 2020Brucellosis is an endemic disease in food-producing animals in Mosul, Iraq. The objectives of the study reported here were: (i) to identify and assess the evidence and... (Meta-Analysis)
Meta-Analysis
Brucellosis is an endemic disease in food-producing animals in Mosul, Iraq. The objectives of the study reported here were: (i) to identify and assess the evidence and knowledge gaps in published studies that have examined brucellosis in different food-producing animals in Mosul, Iraq; using systematic review approach, and (ii) to quantify the seroprevalence of brucellosis in the city using meta-analysis approach. Google Scholar was used as a search engine to track pertinent peer-reviewed research reports. The search was conducted on November 24, 2019. Keywords used were: brucella, animal, Mosul, Iraq. Peer-reviewed published studies, MSc theses, and PhD dissertations written in Arabic or English were included. Duplicate records were removed, and the screening process was conducted at three levels: titles, abstracts, and full-text articles. Identified studies that have reported the seroprevalence of brucellosis were included in a meta-analysis to calculate an overall prevalence. A total of 214 records were initially identified. Seventeen research reports were added from personal contact and qualified articles' references list. Thirty six articles were qualified for review after removing 35 duplicate records, 155 titles, 11 abstracts, and 5 full text articles. Seventeen studies reported the prevalence of brucellosis, 11 studies assessed different serological tests for diagnosis of brucellosis, 9 studies isolated Brucella spp. from animal specimens and/or animal products, and 4 studies assessed vaccination procedures against brucellosis. The overall seroprevalence of brucellosis in food-producing animals in Mosul over a period of 40 years was 14.14%, including 14.46% for sheep, 12.99% for goats, 11.69% for cattle, and 22.64% for buffalo. The study concluded that the disease is evident in the city with increasing trends over the years, buffalo shows high seroprevalence, the degree of agreement of Rose-Bengal test as a screening test is fair compared to more accurate serological tests such as ELISA; and the disease constitutes a public health concern in the city. Additional studies are important to identify the overlooked predisposing factors, estimate the abortion rate attributable to brucellosis in food-producing animals, and evaluate efficacy of vaccination programs in reducing the prevalence of brucellosis and/or abortion rate.
Topics: Animals; Brucella; Brucellosis; Buffaloes; Cattle; Cattle Diseases; Goat Diseases; Goats; Humans; Iraq; Seroepidemiologic Studies; Sheep; Sheep Diseases
PubMed: 32645099
DOI: 10.1371/journal.pone.0235862 -
The Cochrane Database of Systematic... Aug 2013=Theoretically, autologous serum eye drops (AS) have a potential advantage over traditional therapies based on the assumption that ASserve not only as a lacrimal... (Review)
Review
BACKGROUND
=Theoretically, autologous serum eye drops (AS) have a potential advantage over traditional therapies based on the assumption that ASserve not only as a lacrimal substitute to provide lubrication, but also contain other biochemical components mimicking natural tears more closely. The application of AS in dry eye treatment has gained popularity as a second-line therapy in the treatment of dry eye.Published studies on the subject indicate that autologous serum could be an effective treatment for dry eye.
OBJECTIVES
To evaluate the efficacy and safety of AS compared to artificial tears for treating dry eye.
SEARCH METHODS
We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2013, Issue 3),Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE,(January 1950 to April 2013), EMBASE (January 1980 to April 2013), Latin American and Caribbean Literature on Health Sciences(LILACS) (January 1982 to April 2013), themetaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov(www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We also searched the Science Citation Index Expanded database (September 2013) and reference lists of included studies. We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 15 April 2013.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) in which AS was compared to artificial tears in the treatment of dry eye in adults.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened all titles and abstracts and assessed full-text articles of potentially eligible trials. Two review authors extracted data and assessed the methodological quality and characteristics of the included trials.We contacted investigators for missing data. For both primary and secondary outcomes, we reported mean differences with corresponding 95% confidence intervals(CIs) for continuous outcomes.
MAIN RESULTS
We identified four eligible RCTs in which AS was compared with artificial tear treatment or saline in individuals (n = 72 participants)with dry eye of various etiologies (Sjögren’s syndrome-related dry eye, non-Sjögren’s syndrome dry eye and postoperative dry eye induced by laser-assisted in situ keratomileusis (LASIK)). The quality of the evidence provided by these trials was variable. A majority of the risk of bias domains were judged to have an unclear risk of bias in two trials owing to insufficient reporting of trial characteristics.One trial was considered to have a low risk of bias for most domains while another was considered to have a high risk of bias for most domains. Incomplete outcome reporting and heterogeneity in the participant populations and follow-up periods prevented the inclusion of these trials in a summary meta-analysis. For the primary outcome, improvement in participant-reported symptoms at one month, one trial (12 participants) showed no difference in participant-reported symptoms between 20% AS and artificial tears. Based on the results of two trials in 32 participants, 20% AS may provide some improvement in participant-reported symptoms compared to traditional artificial tears after two weeks of treatment. One trial also showed positive results with a mean difference in tear breakup time (TBUT) of 2.00 seconds (95% CI 0.99 to 3.01 seconds) between 20% AS and artificial tears after two weeks, which were not similar to findings from the other trials. Based on all other objective clinical assessments included in this review, AS was not associated with improvements in aqueous tear production measured by Schirmer's test (two trials, 33 participants), ocular surface condition with fluorescein (four trials, 72 participants) or Rose Bengal staining (three trials, 60 participants), and epithelial metaplasia by impression cytology compared to artificial tears (one trial, 12 participants). Data on adverse effects were not reported by three of the included studies. In one study, there were no serious adverse events reported with the collection of and treatment with AS.
AUTHORS' CONCLUSIONS
Overall there was inconsistency in the possible benefits of AS in improving participant-reported symptoms and TBUT and lack of effect based on other objective clinical measures. Well-planned, large, high-quality RCTs are warranted, in different severities of dry eye and using standardized questionnaires to measure participant-reported outcomes and objective clinical tests as well as objective biomarkers to assess the benefit of AS therapy for dry eye.
Topics: Adult; Dry Eye Syndromes; Humans; Ophthalmic Solutions; Randomized Controlled Trials as Topic; Serum; Sodium Chloride
PubMed: 23982997
DOI: 10.1002/14651858.CD009327.pub2 -
Ophthalmic Research 2020To compare the efficacy of autologous serum (AS) eye drops and artificial tears (AT) in dry eye disease (DED). (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To compare the efficacy of autologous serum (AS) eye drops and artificial tears (AT) in dry eye disease (DED).
METHODS
Five databases (PubMed, Science Direct, the Cochrane Library, the Chinese National Knowledge Infrastructure, and the Wanfang Database) were searched for randomized controlled trials (RCTs). Efficacy was evaluated in terms of the Ocular Surface Disease Index (OSDI), Schirmer I test, tear break-up time (TBUT), and fluorescein and rose bengal staining of ocular surface. The estimated effects of AS or AT were expressed as a proportion with the 95% confidence interval and plotted on a forest plot.
RESULTS
Seven RCTs with 267 subjects were included in the meta-analysis. For most of the studies, subjects' age was around 50 years old, and the mostly treatment duration was within 8 weeks. The follow-up results showed that the OSDI after AS treatment was lower than that after the AT treatment: the mean difference (MD) was -10.75 (95% CI, -18.12; -3.39) points. There was no difference on the Schirmer I test after treatment between the two groups: the MD was 1.68 (95% CI, -0.65; 4.00) mm. The TBUT of the AS group was longer than that of the AT group, with an MD of 4.53 (95% CI, 2.02; 7.05) s. There was no statistically significant difference on fluorescein staining score of the ocular surface between the AS group and the AT group, the MD was -2.53 (95% CI, -6.08; 1.03) points. The rose bengal staining score of the AS group was slightly lower than that of the AT group after treatment: the MD was -0.78 (95% CI, -1.34; -0.22) points.
CONCLUSION
AS could be an effective treatment for DED, improving OSDI, TBUT, and rose bengal staining score. Further RCTs with large samples and long-term follow-up are still needed to determine the exact role of AS in the management of DED.
Topics: Dry Eye Syndromes; Humans; Lubricant Eye Drops; Ophthalmic Solutions; Randomized Controlled Trials as Topic; Serum
PubMed: 31884498
DOI: 10.1159/000505630 -
Ophthalmic Research 2019A meta-analysis was performed to evaluate the safety and efficacy of topical 3% diquafosol in treating patients with dry eye disease (DED). (Meta-Analysis)
Meta-Analysis
PURPOSE
A meta-analysis was performed to evaluate the safety and efficacy of topical 3% diquafosol in treating patients with dry eye disease (DED).
METHODS
Nine qualified randomized controlled trials incorporating 1,467 patients were included. Two of the reviewers selected the studies and independently assessed the risk of bias. The outcome measures were Schirmer score, tear film break-up time (TFBUT), rose bengal staining score, and corneal fluorescein staining score. To confirm the effect of diquafosol on dryness after cataract surgery, we performed a subgroup analysis according to the presence or absence of surgery.
RESULTS
We observed statistically significant improvements in scores on the Schirmer test (weighted mean difference 0.74 mm at 4 weeks; 95% CI: 0.24-1.24; I2 = 0%), fluorescein stain, rose bengal stain, and TFBUT after treatment with diquafosol compared with the group using other eye drops. As a result of the subgroup analysis of DED after cataract surgery, diquafosol was found to be more effective than the other eye drops with regard to TFBUT and rose bengal staining.
CONCLUSIONS
Topical diquafosol could be an effective treatment for DED, and also for DED after cataract surgery. Further randomized controlled trials with larger sample sizes for the different clinical types of DED are warranted to determine the efficacy and limitations of diquafosol for these different clinical types of DED.
Topics: Cataract Extraction; Dry Eye Syndromes; Humans; Ophthalmic Solutions; Polyphosphates; Randomized Controlled Trials as Topic; Tears; Uracil Nucleotides
PubMed: 30654362
DOI: 10.1159/000492896