Cochrane Db Syst Rev
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Cochrane Db Syst Rev · Sep 2021
ReviewPostoperative adjuvant chemotherapy for resectable cholangiocarcinoma.
Cholangiocarcinoma (cancer in the bile duct) is an aggressive tumour for which surgical resection is a mainstay of treatment. Despite complete resection, recurrences of the cancer are common and lead to poor prognosis in patients. Postoperative adjuvant chemotherapy given after surgical resection may reduce the risk of cancer recurrence by eradicating residual cancer and micrometastatic lesions. The benefits and harms of postoperative adjuvant chemotherapy versus placebo, no intervention, or other adjuvant chemotherapies are unclear. ⋯ Based on the very low-certainty evidence found in four trials in people with curative-intent resection for cholangiocarcinoma, we are very uncertain of the effects of postoperative adjuvant chemotherapy (mitomycin-C and 5-FU; gemcitabine; gemcitabine plus oxaliplatin; or capecitabine) versus no postoperative adjuvant chemotherapy on mortality. The effects of postoperative adjuvant chemotherapy compared with no postoperative adjuvant chemotherapy on serious adverse events are also very uncertain, but the result of the single trial showed 20% higher occurrences of haematologic adverse events. We assessed the certainty of the evidence as very low due to overall high risk of bias, and imprecision. Due to insufficient power of the only identified trial, the best postoperative adjuvant chemotherapy regimen in people with only cholangiocarcinoma could not be established. We also lack randomised clinical trials with outcome data on adjuvant S-1 chemotherapy versus adjuvant gemcitabine-based chemotherapy in people with cholangiocarcinoma alone. There is a need for further randomised clinical trials designed to be at low risk of bias and with adequate sample size exploring the best adjuvant chemotherapy treatment after surgery in people with cholangiocarcinoma.
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Cochrane Db Syst Rev · Sep 2021
ReviewChimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma.
Diffuse large B-cell lymphoma (DLBCL) is an aggressive cancer of the lymphatic system. About 30% to 40% of people with DLBCL experience relapse and 10% are refractory to first-line treatment usually consisting of R-CHOP chemotherapy. Of those eligible for second-line treatment, commonly consisting of salvage chemotherapy followed by autologous stem-cell transplantation (ASCT), around 50% experience relapse. With a median overall survival of less than six to 12 months, the prognosis of individuals who relapse or are refractory (r/r) to advanced lines of treatment or of those who are ineligible for ASCT, is very poor. With the introduction of chimeric antigen receptor (CAR) T-cell therapy, a novel treatment option for these people is available. ⋯ The available evidence on the benefits and harms of CAR T-cell therapy for people with r/r DLBCL is limited, mainly because of the absence of comparative clinical trials. The results we present should be regarded in light of this limitation and conclusions should be drawn very carefully. Due to the uncertainty in the current evidence, a large number of ongoing investigations and a risk of substantial and potentially life-threatening complications requiring supplementary treatment, it is critical to continue evaluating the evidence on this new therapy.
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Cochrane Db Syst Rev · Sep 2021
ReviewKetamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder.
Many studies have recently been conducted to assess the antidepressant efficacy of glutamate modification in mood disorders. This is an update of a review first published in 2015 focusing on the use of glutamate receptor modulators in unipolar depression. ⋯ Our findings show that ketamine and esketamine may be more efficacious than placebo at 24 hours. How these findings translate into clinical practice, however, is not entirely clear. The evidence for use of the remaining glutamate receptor modulators is limited as very few trials were included in the meta-analyses for each comparison and the majority of comparisons included only one study. Long term non-inferiority RCTs comparing repeated ketamine and esketamine, and rigorous real-world monitoring are needed to establish comprehensive data on safety and efficacy.
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Cochrane Db Syst Rev · Sep 2021
Review Meta AnalysisSingle-dose intravenous ibuprofen for acute postoperative pain in adults.
Postoperative administration of non-steroidal anti-inflammatory drugs (NSAIDs) reduces patient opioid requirements and, in turn, may reduce the incidence and severity of opioid-induced adverse events (AEs). ⋯ There is insufficient evidence to support or refute the suggestion that IV ibuprofen is effective and safe for acute postoperative pain in adults.
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Cochrane Db Syst Rev · Sep 2021
ReviewNon-pharmacological interventions for stuttering in children six years and younger.
Stuttering, or stammering as it is referred to in some countries, affects a child's ability to speak fluently. It is a common communication disorder, affecting 11% of children by four years of age. Stuttering can be characterized by sound, part word or whole word repetitions, sound prolongations, or blocking of sounds or airflow. Moments of stuttering can also be accompanied by non-verbal behaviours, including visible tension in the speaker's face, eye blinks or head nods. Stuttering can also negatively affect behavioural, social and emotional functioning. ⋯ We identified four eligible RCTs, all of which compared the Lidcombe Program to a wait-list control group. In total, 151 children aged between two and six years participated in the four included studies. In the Lidcombe Program, the parent and their child visit a speech and language therapist (SLT) in a clinic. One study conducted clinic visits by telephone. In each clinic visit, parents were taught how to conduct treatment at home. Two studies took place in Australia, one in New Zealand and one in Germany. Two studies were conducted for nine months, one for 16 weeks and one for 12 weeks. The frequency of clinic visits and practice sessions at home varied within the programme. One study was partially funded by the Rotary Club, Wiesbaden, Germany; and one was funded by the National Health and Medical Research Council of Australia. One study did not report funding sources and another reported that they did not receive any funding for the trial. All four studies reported the outcome of stuttering frequency. One study also reported on speech efficiency, defined as articulation rate. No studies reported the other predetermined outcomes of this review, namely stuttering severity; communication attitudes; emotional, cognitive or psychosocial domains; or adverse effects. The Lidcombe Program resulted in a lower stuttering frequency percentage syllables stuttered (% SS) than a wait-list control group at post-test, 12 weeks, 16 weeks and nine months postrandomization (mean difference (MD) -2.16, 95% confidence interval (CI) -3.48 to -0.84, 4 studies, 151 participants; P = 0.001; very low-certainty evidence). However, as the Lidcombe Program is designed to take one to two years to complete, none of the participants in these studies had finished the complete intervention programme at any of the data collection points. We assessed stuttering frequency to have a high risk of overall bias due to high risk of bias in at least one domain within three of four included studies, and to have some concern of overall bias in the fourth, due to some concern in at least one domain. We found moderate-certainty evidence from one study showing that the Lidcombe Program may increase speech efficiency in young children. Only one study reported outcomes at long-term follow-up. The long-term effect of intervention could not be summarized, as the results for most of the children in the control group were missing. However, a within-group comparison was performed between the mean % SS at randomization and the mean % SS at the time of extended follow-up, and showed a significant reduction in frequency of stuttering. AUTHORS' CONCLUSIONS: This systematic review indicates that the Lidcombe Program may result in lower stuttering frequency and higher speech efficiency than a wait-list control group in children aged up to six years at post-test. However, these results should be interpreted with caution due to the very low and moderate certainty of the evidence and the high risk of bias identified in the included studies. Thus, there is a need for further studies from independent researchers, to evaluate the immediate and long-term effects of other non-pharmacological interventions for stuttering compared to no intervention or a wait-list control group.