Mishu Masuma Pervin, Uphoff Eleonora, Aslam Faiza, Philip Sharad, Wright Judy, Tirbhowan Nilesh, Ajjan Ramzi A, Al Azdi Zunayed, Stubbs Brendon, Churchill Rachel, Siddiqi Najma
Department of Health Sciences, University of York, York, UK.
Cochrane Common Mental Disorders, University of York, York, UK.
Cochrane Database Syst Rev. 2021 Feb 16;2(2):CD013281. doi: 10.1002/14651858.CD013281.pub2.
The prevalence of type 2 diabetes is increased in individuals with mental disorders. Much of the burden of disease falls on the populations of low- and middle-income countries (LMICs).
To assess the effects of pharmacological, behaviour change, and organisational interventions versus active and non-active comparators in the prevention or delay of type 2 diabetes among people with mental illness in LMICs.
We searched the Cochrane Common Mental Disorders Controlled Trials Register, CENTRAL, MEDLINE, Embase and six other databases, as well as three international trials registries. We also searched conference proceedings and checked the reference lists of relevant systematic reviews. Searches are current up to 20 February 2020.
Randomized controlled trials (RCTs) of pharmacological, behavioural or organisational interventions targeting the prevention or delay of type 2 diabetes in adults with mental disorders in LMICs.
Pairs of review authors working independently performed data extraction and risk of bias assessments. We conducted meta-analyses using random-effects models.
One hospital-based RCT with 150 participants (99 participants with schizophrenia) addressed our review's primary outcome of prevention or delay of type 2 diabetes onset. Low-certainty evidence from this study did not show a difference between atypical and typical antipsychotics in the development of diabetes at six weeks (risk ratio (RR) 0.46, 95% confidence interval (CI) 0.03 to 7.05) (among a total 99 participants with schizophrenia, 68 were in atypical and 31 were in typical antipsychotic groups; 55 participants without mental illness were not considered in the analysis). An additional 29 RCTs with 2481 participants assessed one or more of the review's secondary outcomes. All studies were conducted in hospital settings and reported on pharmacological interventions. One study, which we could not include in our meta-analysis, included an intervention with pharmacological and behaviour change components. We identified no studies of organisational interventions. Low- to moderate-certainty evidence suggests there may be no difference between the use of atypical and typical antipsychotics for the outcomes of drop-outs from care (RR 1.31, 95% CI 0.63 to 2.69; two studies with 144 participants), and fasting blood glucose levels (mean difference (MD) 0.05 lower, 95% CI 0.10 to 0.00; two studies with 211 participants). Participants who receive typical antipsychotics may have a lower body mass index (BMI) at follow-up than participants who receive atypical antipsychotics (MD 0.57, 95% CI 0.33 to 0.81; two studies with 141 participants; moderate certainty of evidence), and may have lower total cholesterol levels eight weeks after starting treatment (MD 0.35, 95% CI 0.27 to 0.43; one study with 112 participants). There was moderate certainty evidence suggesting no difference between the use of metformin and placebo for the outcomes of drop-outs from care (RR 1.22, 95% CI 0.09 to 16.35; three studies with 158 participants). There was moderate-to-high certainty evidence of no difference between metformin and placebo for fasting blood glucose levels (endpoint data: MD -0.35, 95% CI -0.60 to -0.11; change from baseline data: MD 0.01, 95% CI -0.21 to 0.22; five studies with 264 participants). There was high certainty evidence that BMI was lower for participants receiving metformin compared with those receiving a placebo (MD -1.37, 95% CI -2.04 to -0.70; five studies with 264 participants; high certainty of evidence). There was no difference between metformin and placebo for the outcomes of waist circumference, blood pressure and cholesterol levels. Low-certainty evidence from one study (48 participants) suggests there may be no difference between the use of melatonin and placebo for the outcome of drop-outs from care (RR 1.00, 95% CI 0.38 to 2.66). Fasting blood glucose is probably reduced more in participants treated with melatonin compared with placebo (endpoint data: MD -0.17, 95% CI -0.35 to 0.01; change from baseline data: MD -0.24, 95% CI -0.39 to -0.09; three studies with 202 participants, moderate-certainty evidence). There was no difference between melatonin and placebo for the outcomes of waist circumference, blood pressure and cholesterol levels. Very low-certainty evidence from one study (25 participants) suggests that drop-outs may be higher in participants treated with a tricyclic antidepressant (TCA) compared with those receiving a selective serotonin reuptake inhibitor (SSRI) (RR 0.34, 95% CI 0.11 to 1.01). It is uncertain if there is no difference in fasting blood glucose levels between these groups (MD -0.39, 95% CI -0.88 to 0.10; three studies with 141 participants, moderate-certainty evidence). It is uncertain if there is no difference in BMI and depression between the TCA and SSRI antidepressant groups.
AUTHORS' CONCLUSIONS: Only one study reported data on our primary outcome of interest, providing low-certainty evidence that there may be no difference in risk between atypical and typical antipsychotics for the outcome of developing type 2 diabetes. We are therefore not able to draw conclusions on the prevention of type 2 diabetes in people with mental disorders in LMICs. For studies reporting on secondary outcomes, there was evidence of risk of bias in the results. There is a need for further studies with participants from LMICs with mental disorders, particularly on behaviour change and on organisational interventions targeting prevention of type 2 diabetes in these populations.
精神障碍患者中2型糖尿病的患病率有所上升。疾病负担大多落在低收入和中等收入国家(LMICs)的人群身上。
评估药物、行为改变和组织干预与积极和非积极对照措施相比,在LMICs精神疾病患者中预防或延缓2型糖尿病的效果。
我们检索了Cochrane常见精神障碍对照试验注册库、Cochrane系统评价数据库、MEDLINE、Embase和其他六个数据库,以及三个国际试验注册库。我们还检索了会议论文集,并检查了相关系统评价的参考文献列表。检索截至2020年2月20日。
针对LMICs成年精神障碍患者预防或延缓2型糖尿病的药物、行为或组织干预的随机对照试验(RCT)。
由成对的综述作者独立进行数据提取和偏倚风险评估。我们使用随机效应模型进行荟萃分析。
一项纳入150名参与者(99名精神分裂症患者)的基于医院的RCT涉及了我们综述的主要结局,即预防或延缓2型糖尿病发病。该研究的低确定性证据未显示非典型和典型抗精神病药物在六周时糖尿病发生方面存在差异(风险比(RR)0.46,95%置信区间(CI)0.03至7.05)(在总共99名精神分裂症患者中,68名在非典型抗精神病药物组,31名在典型抗精神病药物组;分析中未考虑55名无精神疾病的参与者)。另外29项纳入2481名参与者的RCT评估了一项或多项综述的次要结局。所有研究均在医院环境中进行,并报告了药物干预情况。一项我们无法纳入荟萃分析的研究包括了药物和行为改变成分的干预。我们未发现组织干预的研究。低至中等确定性证据表明,在护理退出结局方面,使用非典型和典型抗精神病药物可能没有差异(RR 1.31,95% CI 0.63至2.69;两项研究,144名参与者),以及空腹血糖水平(平均差(MD)低0.05,95% CI 0.10至0.00;两项研究,211名参与者)。接受典型抗精神病药物治疗的参与者在随访时的体重指数(BMI)可能低于接受非典型抗精神病药物治疗的参与者(MD 0.57,95% CI 0.33至0.81;两项研究,141名参与者;证据的中等确定性),并且在开始治疗八周后总胆固醇水平可能更低(MD 0.35,95% CI 0.27至0.43;一项研究,112名参与者)。有中等确定性证据表明,在护理退出结局方面,使用二甲双胍和安慰剂没有差异(RR 1.22,95% CI 0.09至16.35;三项研究,158名参与者)。有中等至高确定性证据表明,在空腹血糖水平方面二甲双胍和安慰剂没有差异(终点数据:MD -0.35,95% CI -0.60至 -0.11;基线数据变化:MD 0.01,95% CI -0.21至0.22;五项研究,264名参与者)。有高确定性证据表明,接受二甲双胍治疗的参与者的BMI低于接受安慰剂治疗的参与者(MD -1.37,95% CI -2.04至 -0.70;五项研究,264名参与者;证据的高确定性)。在腰围、血压和胆固醇水平结局方面,二甲双胍和安慰剂没有差异。一项纳入48名参与者的研究的低确定性证据表明,在护理退出结局方面,使用褪黑素和安慰剂可能没有差异(RR 1.00,95% CI 0.38至2.66)。与安慰剂相比,接受褪黑素治疗的参与者的空腹血糖可能降低更多(终点数据:MD -0.17,95% CI -0.35至0.01;基线数据变化:MD -0.24,95% CI -0.39至 -0.09;三项研究,202名参与者,中等确定性证据)。在腰围、血压和胆固醇水平结局方面,褪黑素和安慰剂没有差异。一项纳入25名参与者的研究的极低确定性证据表明,与接受选择性5-羟色胺再摄取抑制剂(SSRI)治疗的参与者相比,接受三环类抗抑郁药(TCA)治疗的参与者的退出率可能更高(RR 0.34,95% CI 0.11至1.01)。不确定这些组之间空腹血糖水平是否没有差异(MD -0.39,95% CI -