Renal toxicity with mammalian target of rapamycin inhibitors: A meta-analysis of randomized clinical trials

A meta-analysis of randomized clinical trials (RCT) was done to determine the relative risk (RR) of acute kidney injury (AKI) with the use of mammalian target of rapamycin (mTOR) inhibitors. Citations from PubMed/Medline, clinical trials.gov, package inserts and abstracts from major conferences were reviewed to include RCTs comparing arms with or without mTOR inhibitors. The RR of all grade AKI in patients taking mTOR inhibitors compared to patients not on mTOR inhibitors was 1.55 (95% CI: 1.11 to 2.16, P=0.010). There was no significant difference in the risk of high-grade AKI for the two groups (RR=1.29, P=0.118, 95% CI: 0.94 to 1.77). There was no significant difference in the incidence rates for either all grade or high-grade AKI between the two groups. There was no publication bias and the trials were of high quality per Jadad scoring.

Download Full-text

Risk of pneumonitis with mammalian target of rapamycin (mTOR) inhibitors everolimus and temsirolimus.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e13573 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e13573-e13573

Author(s):

Vishal Navnitray Ranpura ◽

Shenhong Wu

Keyword(s):

Clinical Trials ◽

Cancer Patients ◽

Meta Analysis ◽

Single Agent ◽

Mammalian Target Of Rapamycin ◽

Cancer Therapeutics ◽

Mtor Inhibitors ◽

High Grade ◽

Significant Difference ◽

American Society

e13573 Background: Pneumonitis is associated with the use of mTOR inhibitors, everolimus and temsirolimus, which have been used widely in cancer therapeutics and clinical trials. Currently, the overall risk of pneumonits in patients treated with mTOR inhibitors has not been defined. We performed a systematic review and meta-analysis of published clinical trials to assess the risk of pneumonitis in cancer patients treated with mTOR inhibitors. Methods: Databases from PUBMED, the Web of Science, and abstracts presented at the American Society of Clinical Oncology conferences until May 2012 were searched to identify relevant studies. Eligible studies included prospective clinical trials in which patients received treatment with everolimus or temsirolimus as a single agent or in combination with other agents. Summary incidence, relative risk (RR), and 95% confidence interval (CI) were calculated employing a fixed- or random-effects model based upon the heterogeneity of the included studies. Results: A total of 2,303 patients with a variety of tumors from 18 studies (everolimus: 12, temsirolimus: 6) were included for the analysis. The overall incidences of all-grade and high-grade pneumonitis with mTOR inhibitors were 6.5% (95% CI: 3.7-11.1%) and 2.5% (95% CI 1.2-5.4%) respectively. The risk of all-grade pneumonitis did not vary significantly with tumor types (P=0.079), but vary significantly with their combination with other agents (P<0.001). There was no significant difference between everolimus and temsirolimus in the incidence of all-grade (P=0.22) and high-grade (P=0.28) pneumonitis. In comparison with controls, mTOR inhibitors significantly increased the risk of all-grade (RR=5.2, 95% CI: 2.09-12.93, P<0.001) but not high-grade pneumonits (RR=2.63, 95% CI: 0.66-10.40, P=0.41). Conclusions: The risk of pneumonitis is increased in cancer patients receiving mTOR inhibitors without significant difference between everolimus and temsirolimus.

Download Full-text

Incidence and risk of treatment-related mortality in patients with renal cell cancer (RCC) and non-RCC treated with mammalian target of rapamycin (mTOR) inhibitors.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.6_suppl.347 ◽

2013 ◽

Vol 31 (6_suppl) ◽

pp. 347-347

Author(s):

Toni K. Choueiri ◽

Youjin Je ◽

Guru Sonpavde ◽

Matt D. Galsky ◽

Marina Kaymakcalan ◽

...

Keyword(s):

Adverse Events ◽

Renal Cell ◽

Fixed Effects ◽

Meta Analysis ◽

Cell Cancer ◽

Mammalian Target Of Rapamycin ◽

Mtor Inhibitors ◽

Target Of Rapamycin ◽

Therapeutic Modality ◽

Increased Risk

347 Background: Inhibition of the mammalian target of rapamycin (mTOR) is an established therapeutic modality for multiple malignancies including renal cell carcinoma (RCC). Agents that target mTOR have been sporadically associated with an increased risk of potentially life-threatening adverse events. We performed an up-to-date meta-analysis to determine the risk of fatal adverse events (FAEs) in cancer patients treated with mTOR inhibitors, including RCC. Methods: MEDLINE/PubMed, conferences and clinicaltrials.gov databases were searched for articles reported from January 1966 to June 2012. Eligible studies were limited to trials of US Food and Drug Administration—approved mTOR inhibitors (everolimus and temsirolimus) that reported on patients with cancer, randomized design, and adequate safety profiles. Data extraction was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Statistical analyses were conducted to calculate the summary incidence, relative risk (RR), and 95% Confidence Intervals (CIs) by using random-effects or fixed-effects models on the basis of the heterogeneity of included studies. Results: In all 2,990 patients from 8 randomized controlled trials (RCTs) were included, 2033 from everolimus trials and 957 from temsirolimus trials. The incidence of FAEs related to mTOR inhibitors use was 3.4% (95% CI, 1.9-6.0) with a RR of 2.33 (95% CI, 1.32 to 4.10; P = .003) compared to control patients. On subgroup analysis, no difference in the rate of FAEs was found between everolimus and temsirolimus or between tumor types (RCC vs. non-RCC). No evidence of publication bias was observed. Conclusions: The use of mTOR inhibitors is associated with an increased risk of FAEs in RCC and non-RCC patients, compared with control patients.

Download Full-text

Metabolic complications with the use of mTOR inhibitors for cancer therapy: A systematic review and meta-analysis.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.6_suppl.398 ◽

2013 ◽

Vol 31 (6_suppl) ◽

pp. 398-398 ◽

Cited By ~ 1

Author(s):

Shanthi Sivendran ◽

Jian Ying ◽

Benjamin Adam Gartrell ◽

Neeraj Agarwal ◽

Kenneth M. Boucher ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Adverse Events ◽

Incidence Rate ◽

Meta Analysis ◽

Mtor Inhibitors ◽

Incidence Rates ◽

Metabolic Complications ◽

Randomized Controlled Clinical Trials ◽

Grade 3

398 Background: mTOR inhibitors are approved in several malignancies including renal cell carcinoma (RCC). The risk of metabolic complications with these agents is not well characterized. Methods: PubMed was searched for articles published from 2001 until 2011. Eligible studies included prospective randomized trials evaluating temsirolimus, everolimus, and ridaforolimus in patients with all solid tumor malignancies. 16 eligible phase II clinical trials and 8 randomized controlled clinical trials were included in a systematic review and meta-analysis and the number of metabolic related AEs including hyperglycemia, hypercholesterolemia, and hypertriglyceridemia were extracted. Incidence rates and incident rate ratios were calculated. Results: In total, 24 trials (including 4,261 patients) were included. The average incidence rate of any grade metabolic adverse events and grade 3-4 metabolic adverse events was 0.70 per patient and 0.11 (95% CI, 0.08, 0.15) per patient respectively. Analysis of the 3,317 patients across 8 RCT’s revealed that the log incidence rate ratio (IRR) of any grade metabolic adverse events with mTOR inhibitor therapy compared with control was 1.08 (95% CI, 0.84, 1.31) using a random-effects model. The risk of grade 3-4 adverse events was also increased with an IRR of 1.52 (95% CI, 1.05, 1.99). The IRR of all grade hyperglycemia was 1.08 (95% CI, 0.76, 1.40) and of grade 3-4 hyperglycemia was 1.66 (95% CI, 1.12, 2.20). The IRR of all grade hypertriglyceridemia was 0.91 (95% CI, 0.56, 1.26) and of grade 3-4 hypertriglyceridemia was 0.70 (95% CI,- 0.43, 1.83). The IRR of all grade hypercholesterolemia was 1.21 (95% CI, 0.77, 1.65) and of grade 3-4 hypercholesterolemia was 1.21 (95% CI, 0.77, 1.65). These findings suggest a statistically significant increase in the risk of hyperglycemia, hypercholesterolemia (all grades and grade 3 and 4), and all grade hypertriglyceridemia associated with mTOR therapy when compared with control. Conclusions: The risk of all grade and grade 3-4 metabolic adverse events are increased in patients treated with mTOR inhibitors compared with control. However, grade 3-4 metabolic adverse events remain relatively uncommon.

Download Full-text

Carbon dioxide versus air insufflation enteroscopy: a systematic review and meta-analysis based on randomized controlled trials

Endoscopy International Open ◽

10.1055/a-0574-2357 ◽

2018 ◽

Vol 06 (06) ◽

pp. E637-E645 ◽

Cited By ~ 3

Author(s):

Julio Aquino ◽

Wanderley Bernardo ◽

Diogo de Moura ◽

Flávio Morita ◽

Rodrigo Rocha ◽

...

Keyword(s):

Clinical Trials ◽

Randomized Clinical Trials ◽

Data Extraction ◽

Meta Analysis ◽

Ambient Air ◽

Quality Analysis ◽

Cochrane Library ◽

Eligibility Criteria ◽

Co2 Insufflation ◽

Significant Difference

Abstract Objectives To compare the insufflation of CO2 and ambient air in enteroscopy. Search sources The investigators researched the electronic databases MedLine, Cochrane Library, Central, LILACS, BVS, Scopus and Cinahl. The grey search was conducted in the base of theses of the University of São Paulo, books of digestive endoscopy and references of selected articles and in previous systematic revisions. Study eligibility criteria The evaluation of eligibility was performed independently, in a non-blind manner, by two reviewers, firstly by title and abstract, followed by complete text. Disagreements between the reviewers were resolved by consensus. Data collection and analysis method Through the spreadsheet of data extraction, where one author extracted the data and a second author checked the extraction. Disagreements were resolved by debate between the two reviewers. The quality analysis of the studies was performed using the Jadad score. The software RevMan 5 version 5.3 was used for the meta-analysis. Results Four randomized clinical trials were identified, totaling 473 patients submitted to enteroscopy and comparing insufflation of CO2 and ambient air. There was no statistical difference in the intubation depth between the two groups. When CO2 insufflation was reduced, there was a significant difference in pain levels 1 hour after the procedure (95 % IC, –2.49 [–4.72, –0.26], P: 0.03, I2: 20%) and 3 hours after the procedure (95% IC, –3.05 [–5.92, –0.18], P: 0.04, I2: 0 %). There was a usage of lower propofol dosage in the CO2 insufflation group, with significant difference (95 % IC, –67.68 [–115.53, –19.84], P: 0.006, I2: 0 %). There was no significant difference between the groups in relation to the use of pethidine and to the oxygen saturation. Limitations Restricted number of randomized clinical trials and nonuniformity of data were limitations to the analysis of the outcomes. Conclusion The use of CO2 as insufflation gas in enteroscopy reduces the pain levels 1 hour and 3 hours after the procedure, in addition to the reduction of the sedation (propofol) dosage used.

Download Full-text

Acupuncture Treatments for Post-stroke Depression: A Systematic Review and Network Meta-analysis

10.21203/rs.3.rs-951353/v1 ◽

2021 ◽

Author(s):

Lam Wai Ching ◽

Hui Juan Li ◽

Jianwen Guo ◽

Liang Yao ◽

Janita Chau ◽

...

Keyword(s):

Clinical Trials ◽

Randomized Clinical Trials ◽

Rating Scale ◽

Meta Analysis ◽

Cochrane Library ◽

Depression Symptoms ◽

Post Stroke ◽

Significant Difference ◽

Post Stroke Depression ◽

The Impact

Abstract Background: Depression is one of the most common complications after stroke, with a prevalence of 30-33%. Patients with post-stroke depression (PSD) usually experience anxiety, hopelessness, and insomnia, which have a negative impact on their daily activities and post-stroke rehabilitation. In this review, we aimed to explore the impact of acupuncture in alleviating symptoms of PSD and to evaluate the difference in effectiveness between acupuncture combined with pharmacotherapies and various non-pharmacotherapies in order to provide guides and advice for clinical personnel. Methods: Six databases (Cochrane Library, PubMed, EMBASE, China National Knowledge Infrastructure, Wanfang Database, Chongqing VIP Database) and two clinical trials registration platforms were searched from inception to May 2021. Randomized clinical trials (RCTs) comparing needle-based acupuncture with pharmacotherapy, and other non-pharmacotherapy or invalid group were included. Two independent reviewers identified eligible studies. Two reviewers independently abstracted and recorded data into a pre-made form. A Bayesian network meta-analysis (NMA) was conducted to assess and compare different techniques using RStudio 3.6.0. The primary outcome was the change in scores of scales measuring depressive symptoms. The secondary outcomes were changes in serotonin levels and in quality of life. Results: Fifty-nine RCTs were included. The results of this NMA showed that compared with western medicine (WM), acupuncture alone or with repetitive transcranial magnetic stimulation (RTMS), Traditional Chinese medicine (TCM) alone or with WM, were superior for alleviating depression symptoms. Compared to Usual Care, acupuncture alone or plus other therapies could significantly decrease scores of the Hamilton Depression Rating scale. However, there was no significant difference found among acupuncture, WM, TCM with AC plus any of other treatment.Conclusions: The results of this study indicate that acupuncture alone or combined with other therapies appear to be effective in improving depression symptoms of stroke survivors. Moreover, in comparison with WM, acupuncture alone or plus RTMS, TCM, TCM with WM, or WM, were more effective in improving depression symptoms. Also, acupuncture with RTMS seems to be the most effective with the highest probability.

Download Full-text

A comparison of thrombosis in total knee arthroplasty with and without a tourniquet: a meta-analysis of randomized controlled trials

Journal of Orthopaedic Surgery and Research ◽

10.1186/s13018-021-02366-w ◽

2021 ◽

Vol 16 (1) ◽

Author(s):

Jia Xie ◽

Hao Yu ◽

Fangyuan Wang ◽

Juehua Jing ◽

Jun Li

Keyword(s):

Clinical Trials ◽

Total Knee Arthroplasty ◽

Knee Arthroplasty ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Cochrane Library ◽

Level Of Evidence ◽

Significant Difference ◽

Duration Of Surgery ◽

Total Knee

Abstract Background Tourniquets are widely used in total knee arthroplasty (TKA), but the issue of their safety remains controversial. Previous studies have focused on TKA blood loss, duration of surgery, and hemostatic drugs. The purpose of this meta-analysis was to analyze the effect of tourniquet use on postoperative deep venous thrombosis (DVT). Methods PubMed, SCOPUS, Web of Science, Embase, and the Cochrane Library were searched for randomized clinical trials published before April 17, 2020, that compared the effect of tourniquet use on postoperative DVT, knee circumference, D-dimers, and pain measured using the visual analog scale (VAS). Results Fourteen clinical trials that included 1321 unique participants were included in the meta-analysis. Among the total, 721 and 600 participants were randomized to the tourniquet and non-tourniquet groups, respectively. The incidence of postoperative thrombosis in the tourniquet group was significantly higher than in the non-tourniquet group (RR 2.30, 95% CI 1.51–3.49, P < 0.0001, I2 = 0%). On the 1st, 3rd, and 5th to 21st days, and 3 to 6 weeks after surgery, the knee circumference difference of the tourniquet group was significantly larger than that of the non-tourniquet group (P < 0.05). However, 4 to 6 months after the surgery, no significant difference in knee circumference was found between the two groups (MD 0.14, 95% CI −0.02–0.31, P = 0.09, I2 = 0%). The VAS score of the tourniquet group was higher than the non-tourniquet group on the 3rd and 5th days after surgery (P < 0.05). However, this difference was not significant (MD 0.31, 95% CI −0.05–0.66, P = 0.09, I2 = 89%). Conclusion Results of this meta-analysis indicate that tourniquet application could increase the incidence of postoperative DVT and aggravate postoperative pain and swelling in the short term. Level of evidence Level III

Download Full-text

Brain Metastases Status and Immunotherapy Efficacy in Advanced Lung Cancer: A Systematic Review and Meta-Analysis

Frontiers in Immunology ◽

10.3389/fimmu.2021.669398 ◽

2021 ◽

Vol 12 ◽

Author(s):

Hao Hu ◽

Zhi-Yong Xu ◽

Qian Zhu ◽

Xi Liu ◽

Si-Cong Jiang ◽

...

Keyword(s):

Lung Cancer ◽

Systematic Review ◽

Clinical Trials ◽

Brain Metastases ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Sensitivity Analyses ◽

Advanced Lung Cancer ◽

Tumor Type ◽

Significant Difference

BackgroundBrain metastases (BMs) indicate poor outcomes and are commonly excluded in immunotherapy clinical trials in advanced lung cancer; moreover, the effect of BM status on immunotherapy efficacy is inconsistent and inconclusive. Therefore, we conducted a meta-analysis to assess the influence of BM status on immunotherapy efficacy in advanced lung cancer.MethodsElectronic databases and all major conference proceedings were searched without language restrictions according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. We extracted randomized clinical trials on lung cancer immunotherapy that had available overall survival (OS) and/or progression-free survival (PFS) data based on the BM status. All analyses were performed using random effects models.ResultsFourteen randomized clinical trials with 9,089 patients were identified. Immunotherapy conferred a survival advantage to BM patients [OS-hazard ratio (HR), 0.72; 95% confidence interval (CI), 0.58–0.90; P = 0.004; and PFS-HR, 0.68; 95% CI, 0.52–0.87, P = 0.003]. Non-BM patients could also derive a survival benefit from immunotherapy (OS-HR, 0.76; 95% CI, 0.71–0.80; P <0.001; and PFS-HR, 0.68; 95% CI, 0.56–0.82, P <0.001). The pooled ratios of OS-HRs and PFS-HRs reported in BM patients versus non-BM patients were 0.96 (95% CI, 0.78–1.18; P = 0.72) and 0.97 (95% CI, 0.79–1.20; P = 0.78), respectively, indicating no statistically significant difference between them. Subsequent sensitivity analyses did not alter the results. Subgroup analyses according to tumor type, line of therapy, immunotherapy type, study design, and representation of BM patients reconfirmed these findings.ConclusionWe demonstrated that BM status did not significantly influence the immunotherapy efficacy in lung cancer, suggesting that both BM and non-BM patients could obtain comparable benefits.Systematic Review Registrationhttps://www.crd.york.ac.uk/prospero/, identifier (CRD42020207446).

Download Full-text

Binocular treatment for amblyopia: A meta-analysis of randomized clinical trials

PLoS ONE ◽

10.1371/journal.pone.0257999 ◽

2021 ◽

Vol 16 (10) ◽

pp. e0257999

Author(s):

Matilde Roda ◽

Marco Pellegrini ◽

Natalie Di Geronimo ◽

Aldo Vagge ◽

Michela Fresina ◽

...

Keyword(s):

Clinical Trials ◽

Visual Acuity ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Random Effect ◽

Random Effect Model ◽

Complementary Therapy ◽

Convincing Evidence ◽

Cochrane Central Register ◽

Significant Difference

Background To date, there is still no consensus regarding the effect of binocular treatment for amblyopia. The purpose of this systematic review and meta-analysis was to summarize the available evidence to determine whether binocular treatment is more effective than patching in children with amblyopia. Methods Four electronic databases (PubMed, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials) were searched for studies that compared binocular treatment and patching in children with amblyopia. The outcome measures were visual acuity and stereopsis. Pooled effects sizes were calculated with a random-effect model. The standardized difference in means (SDM) with 95% confidence intervals (CI) was calculated. Sensitivity analysis and assessment of publication bias were performed. Results Five randomized clinical trials were included. No significant difference in visual acuity between patients treated with binocular treatment and patching was observed (SDM = -0.12; 95% CI: -0.45–0.20; P = 0.464). No significant difference in stereopsis between patients treated with binocular treatment and patching was observed (SDM = -0.07; 95% CI: -0.61–0.48; P = 0.809). For both variables, the between-study heterogeneity was high (respectively, I2 = 61% and I2 = 57%). Conclusions This meta-analysis found no convincing evidence supporting the efficacy of binocular treatment as an alternative to conventional patching. Therefore, the binocular treatment cannot fully replace traditional treatment but, to date, it can be considered a valid complementary therapy in peculiar cases. Further studies are required to determine whether more engaging therapies and new treatment protocols are more effective.

Download Full-text

The Use of Oseltamivir as Adjunctive Therapy for the Treatment of Hand-Food-and-Mouth Disease: A Meta-Analysis of Randomized Clinical Trials

Frontiers in Pharmacology ◽

10.3389/fphar.2021.653691 ◽

2021 ◽

Vol 12 ◽

Author(s):

Yijing Zhao ◽

Yangyang Sun ◽

Raphael N. Alolga ◽

Gaoxiang Ma ◽

Fan Wang

Keyword(s):

Clinical Trials ◽

Adjunctive Therapy ◽

Adverse Reactions ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Final Analysis ◽

Mouth Disease ◽

Increased Risk ◽

Fever Clearance Time ◽

Significant Difference

Background: Hand-foot-and-mouth disease (HFMD) is a common childhood illness caused by enteroviruses. Oseltamivir (OS), a neuraminidase inhibitor, has been frequently used as an adjunctive therapy for the treatment of HFMD. Solid evidence, however, is lacking regarding the efficacy of such adjunctive therapy. This work is to conduct a meta-analysis of randomized clinical trials (RCTs) to assess the efficacy of oseltamivir for HFMD in children.Methods: Eligible studies from inception to October 10, 2020 were identified by searching six databases (PubMed, Embase, CENTRAL, CNKI, Wanfang, and VIP database). Quality of evidence was assessed using the Cochrane Collaboration tool.Results: Of a total of 91 entries, 11 RCTs involving 977 HFMD children were included in the final analysis. The results showed that the therapy combined with oseltamivir was more effective, with higher effective rate (RR, 0.84; 95% CI, 0.80 to 0.87; p < 0.01), shorter fever clearance time (days) (SMD, −0.74; 95% CI, −1.12 to −0.35; p < 0.01), shorter rash regression time (days) (MD, −0.89; 95% CI, −1.05 to −0.72; p < 0.01) and shorter clinical cure time (SMD, −1.08; 95% CI, −1.55 to −0.61; p < 0.01). No significant difference was observed in the risk of adverse reactions between the groups with and without oseltamivir.Conclusion: The use of oseltamivir as adjunctive therapy shows effectiveness and no increased risk of adverse reactions for the treatment of HFMD in children.

Download Full-text

Evaluation of the Effectiveness of Digital Technology Interventions to Reduce Loneliness in Older Adults: Systematic Review and Meta-analysis (Preprint)

10.2196/preprints.24712 ◽

2020 ◽

Author(s):

Syed Ghulam Sarwar Shah ◽

David Nogueras ◽

Hugo Cornelis van Woerden ◽

Vasiliki Kiparoglou

Keyword(s):

Older Adults ◽

Clinical Trials ◽

Digital Technology ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Public Health Issue ◽

Future Research ◽

Physical And Mental Health ◽

Significant Difference

BACKGROUND Loneliness is a serious public health issue, and its burden is increasing in many countries. Loneliness affects social, physical, and mental health, and it is associated with multimorbidity and premature mortality. In addition to social interventions, a range of digital technology interventions (DTIs) are being used to tackle loneliness. However, there is limited evidence on the effectiveness of DTIs in reducing loneliness, especially in adults. The effectiveness of DTIs in reducing loneliness needs to be systematically assessed. OBJECTIVE The objective of this study is to assess the effectiveness of DTIs in reducing loneliness in older adults. METHODS We conducted electronic searches in PubMed, MEDLINE, CINAHL, Embase, and Web of Science for empirical studies published in English from January 1, 2010, to July 31, 2019. The study selection criteria included interventional studies that used any type of DTIs to reduce loneliness in adults (aged ≥18 years) with a minimum intervention duration of 3 months and follow-up measurements at least 3 months after the intervention. Two researchers independently screened articles and extracted data using the PICO (participant, intervention, comparator, and outcome) framework. The primary outcome measure was loneliness. Loneliness scores in both the intervention and control groups at baseline and at follow-up at 3, 4, 6, and 12 months after the intervention were extracted. Data were analyzed via narrative synthesis and meta-analysis using RevMan (The Cochrane Collaboration) software. RESULTS A total of 6 studies were selected from 4939 screened articles. These studies included 1 before and after study and 5 clinical trials (4 randomized clinical trials and 1 quasi-experimental study). All of these studies enrolled a total of 646 participants (men: n=154, 23.8%; women: n=427, 66.1%; no gender information: n=65, 10.1%) with an average age of 73-78 years (SD 6-11). Five clinical trials were included in the meta-analysis, and by using the random effects model, standardized mean differences (SMDs) were calculated for each trial and pooled across studies at the 3-, 4-, and 6-month follow-ups. The overall effect estimates showed no statistically significant difference in the effectiveness of DTIs compared with that of usual care or non-DTIs at follow-up at 3 months (SMD 0.02; 95% CI −0.36 to 0.40; P=.92), 4 months (SMD −1.11; 95% CI −2.60 to 0.38; P=.14), and 6 months (SMD −0.11; 95% CI −0.54 to 0.32; P=.61). The quality of evidence was very low to moderate in these trials. CONCLUSIONS Our meta-analysis shows no evidence supporting the effectiveness of DTIs in reducing loneliness in older adults. Future research may consider randomized controlled trials with larger sample sizes and longer durations for both the interventions and follow-ups. INTERNATIONAL REGISTERED REPORT RR2-10.1136/bmjopen-2019-032455

Download Full-text