Abstract
Background:
Depression is a prevalent disorder for patients with stroke. Clinical researches indicate that sertraline is utilized to treat post-stroke depression (PSD) effectively. However, no systematic review has investigated this issue yet presently. Thus, this study aims to systematically assess the efficacy and safety of sertraline for patients with PSD.
Methods:
Literature sources will be divided into 2 sections: electronic sources and manual sources. We will search electronic literature sources as follows: EMBASE, MEDICINE, Web of Science, Cochrane Library, Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure from their inceptions to the February 28, 2019. Manual sources include dissertations, ongoing trials, and conference abstracts. Two reviewers will select the literatures, extract and collect data information, and evaluate the risk of bias independently. Statistical analysis will be carried out by using RevMan 5.3 software.
Results:
Primary outcome is depression. It can be measured by Hamilton depression scale, Beck Depression Inventory, or any other scales. Secondary outcome are anxiety (as assessed by Hamilton anxiety scale, or other tools) response rate, activities of daily living (as measured by Barthel Index, or other scales), quality of life (as measured by 36-Item Short Form Health Survey), and safety.
Conclusions:
The results of this systematic review may summarize the up-to-date evidence on the efficacy and safety of sertraline for patients with PSD.
Ethics and dissemination:
This systematic review will not need any ethical approval, because it will not analyze any individual patient data. The findings of this study are expected to disseminate at peer-reviewed journals.
Keywords: efficacy, post-stroke depression, randomized controlled trial, safety, sertraline, systematic review
1. Introduction
Post-stroke depression (PSD) is a very frequent and serious complication for stroke survivors.[1–3] Although the stroke detection is much easier for clinical practice, the identification of PSD is still challenging, because of some neurological symptoms that may conceal some primary moods.[2] It has been estimated that about one-third stroke survivors experience such disorders,[4–6] especially during the first stage after stroke.[7,8] In fact, a recent study reported that about 85% of patients with strokes can be developed depression disorders at least 5 times within 5 years of poststroke.[4] In addition, studies have reported that such condition also has close association with delayed rehabilitation, social withdrawal, and poor quality of life post the stroke.[9–15]
Sertraline has been reported to treat PSD effectively.[16–24] However, no systematic review has performed to assess the efficacy and safety of sertraline for the treatment of PSD among the stroke survivors presently. Therefore, in this study, we will systematically evaluate the efficacy and safety of sertraline for patients with PSD.
2. Methods
2.1. Study registration
This systematic review is registered on PROSPERO (CRD42019126136). It has been reported abide to the guidelines of Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) Protocol statement.[25]
2.2. Eligibility criteria for study selection
2.2.1. Types of studies
Randomized controlled trials (RCTs) of sertraline for patients with PSD will be included in this study. However, non-clinical trials, non-RCTs, quasi-RCTs, and any other studies will not be included.
2.2.2. Types of interventions
The experimental treatments can be any forms of sertraline monotherapy only. The control therapies can be any interventions, except sertraline.
2.2.3. Types of patients
Patients with PSD, regardless the race, sex, and age will be included in this systematic review.
2.3. Types of outcome measurements
2.3.1. Primary outcome
Depression (as measured by Hamilton depression scale, Beck Depression Inventory or any other scales).
2.3.2. Secondary outcome
Anxiety (as assessed by Hamilton anxiety scale, or other tools);
Response rate;
Activities of daily living (as measured by Barthel Index, or other scales);
Quality of life (as measured by 36-Item Short Form Health Survey);
Safety (any adverse events or reactions).
2.4. Search strategy
2.4.1. Electronic databases sources
We will search EMBASE, MEDICINE, Web of Science, Cochrane Library, Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure from their inceptions to the February 28, 2019. Each database will be searched without any language restrictions. We have showed the detailed search strategy for database of Cochrane Library in Table 1. Similar search strategies will be applied to all other electronic databases.
Table 1.
Search strategy applied in Cochrane Library database.
2.4.2. Other literature sources
We will also search dissertations, ongoing trials, and conference abstracts to avoid missing any potential studies.
2.5. Study selection
Two reviewers will independently scan the titles and abstracts for all records in accordance with the pre-designed eligibility criteria. All studies that meet the initial eligibility criteria will be read in full texts for further selection. A third reviewer will help to resolve any disagreements arise between 2 reviewers. The process of search strategy and study selection will be presented in PRISMA study flowchart.
2.6. Data extraction
A standardized data extraction sheet will be utilized to collect data and important information. Two reviewers will independently carry out data extraction according to the predefined sheet. Any divergences between 2 reviewers will be solved by consulting a third reviewer. Extracted information will comprise of generation information (e.g., title, first author, published year, race, age, diagnostic criteria, etc.), Study methods (e.g., randomization, concealment, blinding, etc.), treatment details (e.g., drug, dosage, duration, etc.), and outcomes (e.g., all primary, secondary, safety outcomes).
2.7. Missing data dealing with
We will contact primary authors to require any insufficient or missing data from primary studies. If we can not receive those data, we will just pool the available data, and it will be discussed as a limitation.
2.8. Risk of bias assessment
Cochrane risk of bias tool will be used to assess the methodological quality for all eligible RCTs. This tool includes random sequence generation, allocation concealment, blinding, incomplete outcome data, selective reporting, and other biases. Each item will be further divided into 3 types, including high, unclear and low risk of bias. Two reviewers will assess the methodological quality for each eligible study independently. Any disagreements between 2 reviewers will be solved by a third reviewer through discussion.
2.9. Data synthesis
RevMan 5.3 (Cochrane Community, London, UK) software will be used to pool the data and to conduct meta-analysis. Mean difference or standardized mean difference and 95% confidence intervals (CIs) will be reported for continuous data, and risk ratio and 95% CIs for dichotomous data. Heterogeneity will be determined by using I2 test. When I2 ≤50%, heterogeneity is regarded acceptable, while when I2 >50%, it is considered as substantial. Meanwhile, subgroup analysis will be operated to identify possible reasons for substantial heterogeneity according to the different interventions, outcomes, and methodological quality.
When heterogeneity is acceptable, a fixed-effect model will be used to pool the data, and meta-analysis will be conducted if it is possible. When heterogeneity is significant, we will use a random-effect model to pool the data and perform meta-analysis if there is acceptable heterogeneity after subgroup analysis. Otherwise, the data will not be pooled and just narrative summary will be presented.
Additionally, sensitivity analysis will be performed for robustness check of pooled outcome results by removing low quality trials. If it is possible, funnel plot and Egger regression test will be conducted to check any possible publication bias.[26,27]
3. Discussion
PSD seriously affect quality of life in stroke survivors. Its increasing incidence also brings a heavy burden for patients, their families, and the society. Although lots of clinical studies have reported the efficacy of sertraline for patients with PSD, no study has systematically assessed its efficacy and safety. Thus, it is very necessary and important to conduct a systematic review to systematically evaluate the efficacy and safety of sertraline for PSD in stroke survivors. The results of this study will provide most recent evidence of sertraline for treating PSD for clinician and health policy makers.
Author contributions
Conceptualization: Zhengfa Bai, Liu-yi Wang.
Data curation: Zhengfa Bai, Liu-yi Wang.
Formal analysis: Zhengfa Bai.
Funding acquisition: Liu-yi Wang.
Investigation: Liu-yi Wang.
Methodology: Zhengfa Bai, Liu-yi Wang.
Project administration: Liu-yi Wang.
Resources: Zhengfa Bai.
Software: Zhengfa Bai.
Supervision: Liu-yi Wang.
Validation: Zhengfa Bai, Liu-yi Wang.
Visualization: Zhengfa Bai, Liu-yi Wang.
Writing – original draft: Zhengfa Bai, Liu-yi Wang.
Writing – review & editing: Zhengfa Bai, Liu-yi Wang.
Footnotes
Abbreviations: PRISMA = Preferred Reporting Items for Systematic Reviews and Meta-Analysis, PSD = post-stroke depression, RCTs = randomized controlled trials.
This study was partly supported by the Yan’an Specialized Project for Transformation and Promotion of Achievements (2018CGZH-15). The supporter had no role in this study.
PROSPERO registration number: PROSPERO CRD42019126136.
The authors declare that they have no conflict of interest.
References
- [1].Xu XM, Zou DZ, Shen LY, et al. Efficacy and feasibility of antidepressant treatment in patients with post-stroke depression. Medicine (Baltimore) 2016;95:e5349. [DOI] [PMC free article] [PubMed] [Google Scholar]
- [2].Das J. GKR. Post stroke depression: the sequelae of cerebral stroke. Neurosci Biobehav Rev 2018;90:104–14. [DOI] [PubMed] [Google Scholar]
- [3].Villa RF, Ferrari F, Moretti A. Post-stroke depression: mechanisms and pharmacological treatment. Pharmacol Ther 2018;184:131–44. [DOI] [PubMed] [Google Scholar]
- [4].Hackett ML, Pickles K. Part I: frequency of depression after stroke: an updated systematic review and meta-analysis of observational studies. Int J Stroke 2014;9:1017–25. [DOI] [PubMed] [Google Scholar]
- [5].Lenzi GL, Altieri M, Maestrini I. Post-stroke depression. Rev Neurol (Paris) 2008;164:837–40. [DOI] [PubMed] [Google Scholar]
- [6].Zavoreo I, Basić-Kes V, Bosnar-Puretić M, et al. Post-stroke depression. Acta Clin Croat 2009;48:329–33. [PubMed] [Google Scholar]
- [7].Robinson RG, Jorge RE. Post-stroke depression: a review. Am J Psychiatry 2016;173:221–31. [DOI] [PubMed] [Google Scholar]
- [8].Schulte-Altedorneburg M, Bereczki D. Post-stroke depression. Orv Hetil 2014;155:1335–43. [DOI] [PubMed] [Google Scholar]
- [9].Žikić TR, Divjak I, Jovićević M, et al. The effect of post stroke depression on functional outcome and quality of life. Acta Clin Croat 2014;53:294–301. [PubMed] [Google Scholar]
- [10].Srivastava A, Taly AB, Gupta A, et al. Post-stroke depression: prevalence and relationship with disability in chronic stroke survivors. Ann Indian Acad Neurol 2010;13:123–7. [DOI] [PMC free article] [PubMed] [Google Scholar]
- [11].Gawronski DW, Reding MJ. Post-stroke depression: an update. Curr Atheroscler Rep 2001;3:307–12. [DOI] [PubMed] [Google Scholar]
- [12].Ilut S, Stan A, Blesneag A, et al. Factors that influence the severity of post-stroke depression. J Med Life 2017;10:167–71. [PMC free article] [PubMed] [Google Scholar]
- [13].Espárrago Llorca G, Castilla-Guerra L, Fernández Moreno MC, et al. Post-stroke depression: an update. Neurologia 2015;30:23–31. [DOI] [PubMed] [Google Scholar]
- [14].De Ryck A, Brouns R, Fransen E, et al. A prospective study on the prevalence and risk factors of post-stroke depression. Cerebrovasc Dis Extra 2013;3:1–3. [DOI] [PMC free article] [PubMed] [Google Scholar]
- [15].Ayerbe L, Ayis S, Crichton SL, et al. Explanatory factors for the increased mortality of stroke patients with depression. Neurology 2014;83:2007–12. [DOI] [PMC free article] [PubMed] [Google Scholar]
- [16].Burns A, Russell E, Stratton-Powell H, et al. Sertraline in stroke-associated lability of mood. Int J Geriatr Psychiatry 1999;14:681–5. [PubMed] [Google Scholar]
- [17].Spalletta G, Caltagirone C. Sertraline treatment of post-stroke major depression: an open study in patients with moderate to severe symptoms. Funct Neurol 2003;18:227–32. [PubMed] [Google Scholar]
- [18].Finkenzeller W, Zobel I, Rietz S, et al. Interpersonal psychotherapy and pharmacotherapy for post-stroke depression. Feasibility and effectiveness. Nervenarzt 2009;80:805–12. [DOI] [PubMed] [Google Scholar]
- [19].Guo RY, Su L, Liu LA, et al. Effects of Linggui Bafa on the therapeutic effect and quality of life in patients of post-stroke depression. Zhongguo Zhen Jiu 2009;29:785–90. [PubMed] [Google Scholar]
- [20].Shao MJ. Therapeutic effect of traditional Chinese medicine smoked combined with sertraline on 30 cases of sequelae of stagnation of phlegm and stasis syndrome. Inner Mongolia Chinese Med 2016;35:84–5. [Google Scholar]
- [21].Huang XQ, Li FM, Lin N, et al. Clinical observation on 40 cases of post-stroke depression treated by Huoxue decoction combined with sertraline. Hunan J Trad Chin Med 2016;32:58–60. [Google Scholar]
- [22].Chen ZG. Wendan Decoction combined with Sertraline and Lilixin in the treatment of post-stroke depression. Clin Res Trad Chin Med 2015;7:98–9. [Google Scholar]
- [23].Duan DX, Wang P, Wu XY. Treatment of 30 cases of post-stroke depression with chaihu jieyu decoction and sertraline. Guangming Chin Med 2011;26:1204–6. [Google Scholar]
- [24].Xie BN, Wang JM, Wu CH, et al. Treatment of 36 cases of post-stroke depression with integrated traditional Chinese and Western Medicine. Hunan J Trad Chin Med 2010;26:58–9. [Google Scholar]
- [25].Moher D, Shamseer L, Clarke M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev 2015;4:1. [DOI] [PMC free article] [PubMed] [Google Scholar]
- [26].Sutton AJ, Duval SJ, Tweedie RL, et al. Empirical assessment of effect of publication bias on meta-analyses. BMJ 2000;320:1574–7. [DOI] [PMC free article] [PubMed] [Google Scholar]
- [27].Egger M, Davey Smith G, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315:629–34. [DOI] [PMC free article] [PubMed] [Google Scholar]