OBJECTIVES: To determine the effectiveness of ACE inhibitor administration in people with sickle cell disease for decreasing intraglomerular pressure, microalbuminuria and proteinuria and to to assess the safety of ACE inhibitors as pertains to their adverse effects.
SEARCH METHODS: The authors searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Hameoglobinopathies Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Date of the most recent search: 18 October 2021. We also searched clinical trial registries. Date of the most recent search: 22 August 2021.
SELECTION CRITERIA: Randomized or quasi-randomized controlled trials of ACE inhibitors designed to reduce microalbuminuria and proteinuria in people with sickle cell disease compared to either placebo or standard treatment regimen.
DATA COLLECTION AND ANALYSIS: Three authors independently applied the inclusion criteria in order to select studies for inclusion in the review. Two authors assessed the risk of bias of studies and extracted data and the third author verified these assessments.
MAIN RESULTS: Seven studies were identified through the searches. Six studies were excluded. The included study randomized 22 participants (7 males and 15 females) having proteinuria or microalbuminuria with sickle cell disease and treated the participants for six months (median length of follow up of three months) with captopril or placebo. Overall, the certainty of the evidence provided in this review was very low, since most risk of bias domains were judged to have either an unclear or a high risk of bias. Because of this, we are uncertain whether captopril makes any difference, in total urinary albumin excretion (at six months) as compared to the placebo group, although it yielded a mean difference of -49.00 (95% confidence interval (CI) -124.10 to 26.10) or in the absolute change score, although it yielded a mean difference of -63.00 (95% CI -93.78 to -32.22). At six months albumin excretion in the captopril group was noted to decrease from baseline by a mean (standard deviation) of 45 (23) mg/day and the placebo group was noted to increase by 18 (45) mg/day. Serum creatinine and potassium levels were reported constant throughout the study (very low-certainty evidence). The potential for inducing hypotension should be highlighted; the study reported a decrease of 8 mmHg in systolic pressure and 5 mmHg in diastolic and mean blood pressure (very low-certainty evidence).
AUTHORS' CONCLUSIONS: Overall, we judged the certainty of the evidence to be very low. The included study selectively reported its results, was not powered to detect a group difference, should it exist, and otherwise did not offer enough information to allow us to judge the bias inherent in the study. Indirectness (in relation to the limited age and type of population included) and imprecision (wide confidence intervals around the effect estimate) were observed. More long-term studies involving multiple centers and larger cohorts using a randomized-controlled design are warranted, especially among the pediatric age group. Detailed reporting of each outcome measure is necessary to allow a clear cut interpretation in a systematic review. One of the difficulties encountered in this review was the lack of detailed data reported in the included study. Overall, we judged the certainty of this evidence to be very low.
OBJECTIVES: We determined the proportion of PIOs in neonatal RCTs included in Cochrane Neonatal reviews.
METHODS: We extracted up to 5 outcomes from each RCT included in Cochrane Neonatal reviews published until January 2018, with independent determination of PIOs among authors followed by a discussion leading to a consensus. We defined PIOs as outcomes that matter to patient care, such as clinical events or physiological or laboratory parameters that are widely used to guide management.
RESULTS: Among 6,832 outcomes extracted from 1,874 RCTs included in 276 reviews, 5,349 (78.3%) were considered PIOs; 461 studies (24.5%) included 5 or more PIOs, 1,278 (68.2%) included 1-4 PIOs, while 135 (7.2%) had no PIO included. PIOs were observed more often among dichotomous than among continuous outcomes (94.9 vs. 61.5%; RR: 1.54; 95% CI: 1.50-1.58), and more among subjective than among objective outcomes (95.9 vs. 76.8%; RR: 1.25; 95% CI: 1.22-1.28). Newer studies were more likely to have a greater number of PIOs (adjusted OR: 1.033 [95% CI: 1.025-1.041] with each publication year).
CONCLUSIONS: The large and increasing representation of PIOs over the years suggests an improving awareness by neonatal trialists of the need to incorporate important outcomes in order to justify the utilization of resources. Further research should explore the reasons for non-inclusion or non-reporting of PIOs in a small proportion of RCTs.
METHODS: An international working group was formed of nutrition researchers from 14 institutions in 12 different countries and on five continents. Using meetings over a period of one year, we interrogated the CONSORT statement specifically for its application to report nutrition trials.
RESULTS: We provide a total of 28 new nutrition-specific recommendations or emphasised recommendations for the reporting of the introduction (three), methods (twelve), results (five) and discussion (eight). We also added two additional recommendations that were not allocated under the standard CONSORT headings.
CONCLUSION: We identify a need to provide guidance in addition to CONSORT to improve the quality and consistency of the reporting and propose key considerations for further development of formal guidelines for the reporting of nutrition trials. Readers are encouraged to engage in this process, provide comments and conduct specific studies to inform further work on the development of reporting guidelines for nutrition trials.
OBJECTIVES: To conduct a systematic review of RCTs involving topical drugs published in the Archives of Dermatology, Journal of the American Academy of Dermatology and British Journal of Dermatology for correct classification of studies as vehicle versus placebo-controlled.
METHODS: RCTs involving topical drugs published in the Archives of Dermatology, Journal of the American Academy of Dermatology and British Journal of Dermatology from January 1999 to November 2008 were identified through PubMed, supplemented by citation lists from the individual journals' web pages. Only original studies that involved using a topical control or used the term topical "vehicle" or "placebo" were selected. The studies were examined for correct classification as vehicle-controlled, the year of publication, country of origin, sample size, funding source and nature of study center.
RESULTS: Out of 132, 64 (49%) correctly classified their studies as vehicle-controlled. Pharmaceutical-funded studies (55%, P=0.01) were significantly associated with the use of correct classification.
LIMITATIONS: As only three peer-reviewed dermatology journals were studied, findings may not be generalized to other dermatology journals and other types of publications.
CONCLUSION: This systematic review highlights a common pitfall in the reporting of studies of topical dermatology drugs.
METHODS: A systematic review and meta-analysis was conducted by systematically searching electronic databases.
KEY FINDINGS: The pooled analysis of the included trials revealed that the use of uricosurics was not associated with the risk of mortality (pooled odds ratio [OR] = 1.03, 95% confidence interval [CI]: 0.94-1.12). However, there is a potential mortality benefit associated with the use of ascorbic acid (pooled OR = 0.78, 95% CI: 0.65-0.94).
CONCLUSIONS: The findings confirmed the safety of uricosurics in COVID-19 patients, despite their potential to cause uric acid excretion, which may possess antioxidant properties.
METHODS: We searched several databases, including PubMed, Web of Science, Embase (via Ovid), PsychINFO (through EBSCO), and The Cochrane Library, comprising the Cochrane Database of Systematic Reviews and the Cochrane Central Register of Controlled Trials. Additionally, Chinese databases such as CNKI (China National Knowledge Infrastructure) and Wan Fang Data were explored from their beginnings until October 22, 2023. Studies that investigated the impact of art therapy on anxiety compared to a control group were included. The methodological quality of these randomized controlled trials was evaluated using the Cochrane Handbook's risk of bias instrument.
RESULTS: Six studies involving 422 participants were included. The findings indicated a notable decrease in anxiety symptoms due to art therapy, with a Standardized Mean Difference (SMD) of -1.42, 95% Confidence Interval (95%CI -2.33, -0.51), p < 0.002. Notably, there was pronounced heterogeneity, as evidenced by Tau2 = 1.41, Chi2 = 101.19, df = 6, and I² = 94%, with Z = 3.06.
CONCLUSION: Art therapy significantly improved the anxiety symptoms of children and adolescents, positioning it as an effective means of treating anxiety.
METHODS: We systematically searched PubMed, Cochrane Library, Medline & CINAHL, Turning Research into Practice (TRIP), ProQuest Theses & Dissertations Databases, and China National Knowledge Infrastructure (CNKI) from inception till March 15, 2021. The primary outcome measure was a reduction in respiratory illness; decrease in frequency, symptoms, and duration. Random-effects model was used to estimate the odds ratio (OR) and 95% confidence interval (CI). We used Cochrane's RoB-2 to appraise the risk of bias of included RCTs.
RESULTS: A total of nine RCTs were eligible for this review, of which six were included in the meta-analysis. Overall, two studies demonstrated a high risk of bias. The meta-analysis revealed a significantly reduced odds of developing respiratory infections with the use of Lf relative to the control (pooled odds ratio = 0.57; 95% confidence interval 0.44 to 0.74, n = 1,194), with sufficient evidence against the hypothesis of 'no significant difference' at the current sample size.
CONCLUSIONS: The administration of Lf shows promising efficacy in reducing the risk of RTIs. Current evidence also favours Lf fortification of infant formula. Lf may also have a beneficial role in managing symptoms and recovery of patients suffering from RTIs and may have potential for use as an adjunct in COVID-19, however this warrants further evidence from a large well-designed RCT.
METHODS AND FINDINGS: A randomised clinical trial involving 146 Sudanese TB patients will be conducted at the Abu Anga hospital in Khartoum. The participants will be randomly assigned to the intervention and control groups. A 2-hour session will be offered to the intervention group in a one-day TB educational intervention course. The same educational materials will also be provided to the control group after the randomised controlled trial (RCT). Data will be collected at baseline, one month, and four months after the intervention. The primary outcome of interest is TB treatment adherence, while secondary outcomes include quality of life score, tuberculosis knowledge, and health belief domains. Generalised estimating equations (GEE) in SPSS software version 25.0 will be utilised to evaluate the changes over time.
CONCLUSIONS: This trial will provide information that could be used in improving TB control strategies to achieve better results in the adherence of healthcare services to the norms of the National Program and patient adherence to the disease treatment and cure.
TRIAL REGISTRATION: This study is registered at TCTR: (TCTR20210607006).