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This randomized clinical trial compares the clinical effectiveness of intravitreal therapy with ranibizumab vs aflibercept vs bevacizumab for the management of macular edema secondary to central retinal vein occlusion.

BackgroundThe use of complementary and alternative medicine (CAM) has been increasing rapidly throughout the world during the past decade. The use of CAM in the general Japanese population has been previously reported to be as high as 76%. This study aims to investigate the patterns of CAM use, perceived effectiveness and disclosure of CAM use to orthodox medical practitioners amongst patients attending typical primary and secondary care clinics in a busy district general hospital in Tokyo, Japan.MethodsThe authors analysed data collected during March 2002 on patients attending general outpatient clinics held at Shiseikai Daini Hospital in Tokyo, Japan. Data was collected by use of self-completed questionnaires distributed to patients in the outpatient clinics waiting area. Statistical analysis was performed using chi-square tests of independence.Results515 adults were approached to participate in this study and the overall response rate was 96% (n = 496). 50% of the patients were using or have used at least 1 CAM therapy within the last 12 months. The 5 most commonly used therapies were massage (n = 106, 43%), vitamins (n = 85, 35%), health foods including dietary supplements (n = 56, 23%), acupressure (n = 51, 21%) and kampo (n = 46, 19%). The majority of CAM users (75%, n = 145) found their CAM treatment to be effective (95% CI = 68–81%). Patients who were more likely to use CAM were females (p = 0.003) and those with a high number of medical conditions (p = < 0.0001). Only a small proportion of patients reported their CAM use to their physician (42%, n = 74). There was no significant difference in CAM use for the different age groups (p = 0.85), education level (p = 0.30) and financial status (p = 0.82).ConclusionPatterns of CAM usage in the sample surveyed was high (50%). Despite this high prevalence rate and presumed acceptance of CAM in Japan, the reporting of CAM use by patients to their physicians was low (42%). It is therefore important that physicians are aware of the possibility that their patients may be using CAM and also increase their knowledge and understanding of these treatments.

Objective To compare the effect of an invitation promoting informed choice for screening with a standard invitation on attendance and motivation to engage in preventive action. Design Randomised controlled trial. Setting Four English general practices. Participants 1272 people aged 40-69 years, at risk for diabetes, identified from practice registers using a validated risk score and invited to attend for screening. Intervention Intervention was a previously validated invitation to inform the decision to attend screening, presenting diabetes as a serious potential problem, and providing details of possible costs and benefits of screening and treatment in text and pie charts. This was compared with a brief, standard invitation simply describing diabetes as a serious potential problem. Main outcome measures The primary end point was attendance for screening. The secondary outcome measures were intention to make changes to lifestyle and satisfaction with decisions made among attenders. Results The primary end point was analysed for all 1272 participants. 55.8% (353/633) of those in the informed choice group attended for screening, compared with 57.6% (368/639) in the standard invitation group (mean difference −1.8%, 95% confidence interval −7.3% to 3.6%; P=0.51). Attendance was lower among the more deprived group (most deprived third 47.5% v least deprived third 64.3%; P<0.001). Interaction between deprivation and effect of invitation type on attendance was not significant. Among attenders, intention to change behaviour was strong and unaffected by invitation type. Conclusions Providing information to support choice did not adversely affect attendance for screening for diabetes. Those from more socially deprived groups were, however, less likely to attend, regardless of the type of invitation received. Further attention to invitation content alone is unlikely to achieve equity in uptake of preventive services.Trial registration Current Controlled Trials ISRCTN 73125647.

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Trial design We present a study protocol for a multi-centre, randomised, double-blind, parallel-group, placebo-controlled trial that seeks to test the feasibility, acceptability and effectiveness of a 52-week period of treatment with the first-in-class co-stimulatory blocker abatacept for preventing or delaying the onset of inflammatory arthritis. Methods The study aimed to recruit 206 male or female subjects from the secondary care hospital setting across the UK and the Netherlands. Participants who were at least 18 years old, who reported inflammatory sounding joint pain (clinically suspicious arthralgia) and who were found to be positive for serum autoantibodies associated with rheumatoid arthritis (RA) were eligible for enrolment. All study subjects were randomly assigned to receive weekly injections of investigational medicinal product, either abatacept or placebo treatment over the course of a 52-week period. Participants were followed up for a further 52 weeks. The primary endpoint was defined as the time to development of at least three swollen joints or to the fulfilment of the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA using swollen but not tender joints, whichever endpoint was met first. In either case, swollen joints were confirmed by ultrasonography. Participants, care givers, and those assessing the outcomes were all blinded to group assignment. Clinical assessors and ultrasonographers were also blinded to each other’s assessments for the duration of the study. Conclusions There is limited experience of the design and implementation of trials for the prevention of inflammatory joint diseases. We discuss the rationale behind choice and duration of treatment and the challenges associated with defining the “at risk” state and offer pragmatic solutions in the protocol to enrolling subjects at risk of RA. Trial registration Current Controlled Trials, ID: ISRCTN46017566 . Registered on 4 July 2014. Electronic supplementary material The online version of this article (10.1186/s13063-019-3403-7) contains supplementary material, which is available to authorized users.

Experimental and clinical data suggest a role of sex steroids in the pathogenesis of multiple sclerosis (MS). Scant information is available about the potential effect of oral contraceptive (OC) use on the prognosis of the disease. We aimed to evaluate this. The study population consisted of 132 women with relapsing-remitting MS before receiving disease modifying treatment and a mean disease duration 6.2 (SD 5.1) years. Three groups of patients were distinguished according to their OC behavior: [1] never-users, patients who never used OC [2] past-users, patients who stopped OC use before disease onset, and [3] after-users, those who used these drugs after disease onset. Multiple linear and logistic regression models were used to analyze the association between oral contraceptive use and annualized relapse rates, disability accumulation and severity of the disease. After-user patients had lower Expanded Disability Status Scale (EDSS) and Multiple Sclerosis Severity Score (MSSS) values than never users (p b 0.001 and p = 0.002, respectively) and past users (p = 0.010 and p = 0.002, respectively). These patients were also more likely to have a benign disease course (MSSS b 2.5) than never and past users together (OR: 4.52, 95%CI: 2.13-9.56, p b 0.001). This effect remained significant after adjustment for confounders, including smoking and childbirths (OR: 2.97, 95%CI: 1.24, 6.54, p = 0.011 and for MSSS β: − 1.04; 95% C.I. − 1.78, − 0.30, p = 0.006). These results suggest that OC use in women with relapsing-remitting MS is possible associated with a milder disabling disease course.

SummaryBackgroundWe aimed to assess 24-month outcomes of wearing an organic light-emitting sleep mask as an intervention to treat and prevent progression of non-central diabetic macular oedema.MethodsCLEOPATRA was a phase 3, single-blind, parallel-group, randomised controlled trial undertaken at 15 ophthalmic centres in the UK. Adults with non-centre-involving diabetic macular oedema were randomly assigned (1:1) to wearing either a light mask during sleep (Noctura 400 Sleep Mask, PolyPhotonix Medical, Sedgefield, UK) or a sham (non-light) mask, for 24 months. Randomisation was by minimisation generated by a central web-based computer system. Outcome assessors were masked technicians and optometrists. The primary outcome was the change in maximum retinal thickness on optical coherence tomography (OCT) at 24 months, analysed using a linear mixed-effects model incorporating 4-monthly measurements and baseline adjustment. Analysis was done using the intention-to-treat principle in all randomised patients with OCT data. Safety was assessed in all patients. This trial is registered with Controlled-Trials.com, number ISRCTN85596558.FindingsBetween April 10, 2014, and June 15, 2015, 308 patients were randomly assigned to wearing the light mask (n=155) or a sham mask (n=153). 277 patients (144 assigned the light mask and 133 the sham mask) contributed to the mixed-effects model over time, including 246 patients with OCT data at 24 months. The change in maximum retinal thickness at 24 months did not differ between treatment groups (mean change −9·2 μm [SE 2·5] for the light mask vs −12·9 μm [SE 2·9] for the sham mask; adjusted mean difference −0·65 μm, 95% CI −6·90 to 5·59; p=0·84). Median compliance with wearing the light mask at 24 months was 19·5% (IQR 1·9–51·6). No serious adverse events were related to either mask. The most frequent adverse events related to the assigned treatment were discomfort on the eyes (14 with the light mask vs seven with the sham mask), painful, sticky, or watery eyes (14 vs six), and sleep disturbance (seven vs one).InterpretationThe light mask as used in this study did not confer long-term therapeutic benefit on non-centre-involving diabetic macular oedema and the study does not support its use for this indication.FundingThe Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research partnership.