PubMed · 9289628
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B Bornkessel. 1997. [Randomized controlled trials].. https://pubmed.ncbi.nlm.nih.gov/9289628/
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This systematic review aimed to collate randomized controlled trials (RCTs) of various interventions used to treat tardive dyskinesia (TD) and, where appropriate, to combine the data for meta-analysis. Clinical trials were identified by electronic searches, handsearches and contact with principal investigators. Data were extracted independently by two reviewers, for outcomes related to improvement, deterioration, side-effects and drop out rates. Data were pooled using the Mantel-Haenzel Odds Ratio (fixed effect model). For treatments that had significant effects, the number needed to treat (NNT) was calculated. From 296 controlled clinical trials, data were extracted from 47 trials. For most interventions, we could identify no RCT-derived evidence of efficacy. A meta-analysis showed that baclofen, deanol and diazepam were no more effective than a placebo. Single RCTs demonstrated a lack of evidence of any effect for bromocriptine, ceruletide, clonidine, estrogen, gamma linolenic acid, hydergine, lecithin, lithium, progabide, seligiline and tetrahydroisoxazolopyridinol. The meta-analysis found that five interventions were effective: L-dopa, oxypertine, sodium valproate, tiapride and vitamin E; neuroleptic reduction was marginally significant. Data from single RCTs revealed that insulin, alpha methyl dopa and reserpine were more effective than a placebo. There was a significantly increased risk of adverse events associated with baclofen, deanol, L-dopa, oxypertine and reserpine. Meta-analysis of the impact of placebo (n=485) showed that 37.3% of participants showed an improvement. Interpretation of this systematic review requires caution as the individual trials identified tended to have small sample sizes. For many compounds, data from only one trial were available, and where meta-analyses were possible, these were based on a small number of trials. Despite these concerns, the review facilitated the interpretation of the large and diverse range of treatments used for TD. Clinical recommendations for the treatment of TD are made, based on the availability of RCT-derived evidence, the strength of that evidence and the presence of adverse effects.
BACKGROUND: The European double-blind, placebo(PLA) controlled study of mycophenolate mofetil (MMF) for prevention of acute renal allograft rejection showed that MMF 2 and 3 g when added to a standard double-drug regimen of cyclosporine and corticosteroids significantly reduced the incidence of acute rejection/treatment failure at 6 months. Our study presents 3-year data for patient and graft survival, and safety in the MMF-treated patients. METHODS: The trial included 491 patients who were randomly assigned to receive PLA (n=166), MMF 2g (n=165), or MMF 3 g (n=160). Patients in the PLA group discontinued taking their PLA medication at 1 year posttransplantation; subsequently, they were followed-up only regarding patient and graft survival and the occurrence of malignancies. RESULTS: The 3-year patient survival was 88.9, 92.7, and 91.8% in the PLA, MMF 2 g, and MMF 3 g groups, respectively. The 3-year graft survival (including death as a cause of graft loss) was 78, 84.8, and 81.2%, respectively. Acute allograft rejection was a principal cause of graft loss in all groups (PLA, 10.8%; MMF 2 g, 4.6%; MMF 3 g, 6.3%). Differences in 3-year graft loss rates (excluding death) and 95% confidence intervals for intent-to-treat comparisons of PLA versus MMF 2 g and 3 g, respectively, were 7.3% (1.1, 14.2) and 3.2% (-3.8, 10.1). This leads to a relative risk of graft loss of 0.55 in the MMF 2 g arm compared with the PLA arm. Acute allograft rejection had a major impact on graft loss at 3 years; 31.5% of patients with biopsy-proven acute rejection within 6 months of transplantation lost their graft by the end of 3 years. In contrast, only 6.6% who had no early acute rejection lost their graft by the end of the 3-year study period. Diarrhea, anemia, and leukopenia were the most common clinically relevant adverse events, occurring predominantly in the MMF 3 g group. Only one patient (MMF 3 g) developed cytomegalovirus tissue-invasive disease after the first year posttransplant. Over the 3-year posttransplant period, 12 patients developed malignancies (5 in the PLA group, 3 in the MMF 2 g group, and 4 in the MMF 3 g group). CONCLUSIONS: At 3 years posttransplantation, MMF was associated with 7.6% reduction in the incidence of graft loss (excluding death). These data indicate that MMF treatment not only results in a reduction of the incidence of acute rejections but also leads to reduction of late allograft loss.
To determine necessity and timing of booster of hepatitis B vaccine, we need to observe the duration of its protection. We report the results of a 15-year follow-up of a cohort of 649 children who participated a randomized, double blind, placebo-controlled trial on a plasma-derived hepatitis B vaccine in 1982. During the 15 years after vaccination, more vaccinated children had anti-HBs of 10 S/N ratios or over, compared with the controls, at all nine observations. At 15 years 50.0% (26/52) of the participants studied in the vaccinated group and 33.3% of the tested controls (18/54) retained anti-HBs levels of S/N ratios> or =10 (P < 0.09). However, since 5 years after vaccination, median S/N ratios of anti-HBs among the vaccinated children with detectable anti-HBs were lower than those of the controls except that detected at 15 years. 16.7% (9/54) of the tested children in the control group were HBsAg positive at 15 years after vaccination, in comparison with 1.9% (1/52) of the tested children in the vaccinated (P < 0.02). 28 chronic HBsAg carriers were identified in the control cohort over the 15 years, whereas only 1 case was noted in the vaccinated group (8.2% vs. 0.3%, P < 0.00001), corresponding to an efficacy of 96%.