Effectiveness and Safety of Using Chatbots to Improve Mental Health: Systematic Review and Meta-Analysis

Background The global shortage of mental health workers has prompted the utilization of technological advancements, such as chatbots, to meet the needs of people with mental health conditions. Chatbots are systems that are able to converse and interact with human users using spoken, written, and visual language. While numerous studies have assessed the effectiveness and safety of using chatbots in mental health, no reviews have pooled the results of those studies. Objective This study aimed to assess the effectiveness and safety of using chatbots to improve mental health through summarizing and pooling the results of previous studies. Methods A systematic review was carried out to achieve this objective. The search sources were 7 bibliographic databases (eg, MEDLINE, EMBASE, PsycINFO), the search engine “Google Scholar,” and backward and forward reference list checking of the included studies and relevant reviews. Two reviewers independently selected the studies, extracted data from the included studies, and assessed the risk of bias. Data extracted from studies were synthesized using narrative and statistical methods, as appropriate. Results Of 1048 citations retrieved, we identified 12 studies examining the effect of using chatbots on 8 outcomes. Weak evidence demonstrated that chatbots were effective in improving depression, distress, stress, and acrophobia. In contrast, according to similar evidence, there was no statistically significant effect of using chatbots on subjective psychological wellbeing. Results were conflicting regarding the effect of chatbots on the severity of anxiety and positive and negative affect. Only two studies assessed the safety of chatbots and concluded that they are safe in mental health, as no adverse events or harms were reported. Conclusions Chatbots have the potential to improve mental health. However, the evidence in this review was not sufficient to definitely conclude this due to lack of evidence that their effect is clinically important, a lack of studies assessing each outcome, high risk of bias in those studies, and conflicting results for some outcomes. Further studies are required to draw solid conclusions about the effectiveness and safety of chatbots. Trial Registration PROSPERO International Prospective Register of Systematic Reviews CRD42019141219; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42019141219

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Effectiveness and Safety of Using Chatbots to Improve Mental Health: Systematic Review and Meta-Analysis (Preprint)

10.2196/preprints.16021 ◽

2019 ◽

Author(s):

Alaa Ali Abd-Alrazaq ◽

Asma Rababeh ◽

Mohannad Alajlani ◽

Bridgette M Bewick ◽

Mowafa Househ

Keyword(s):

Mental Health ◽

Systematic Review ◽

Health Workers ◽

Meta Analysis ◽

Visual Language ◽

Risk Of Bias ◽

Mental Health Workers ◽

Bibliographic Databases ◽

Reference List ◽

Weak Evidence

BACKGROUND The global shortage of mental health workers has prompted the utilization of technological advancements, such as chatbots, to meet the needs of people with mental health conditions. Chatbots are systems that are able to converse and interact with human users using spoken, written, and visual language. While numerous studies have assessed the effectiveness and safety of using chatbots in mental health, no reviews have pooled the results of those studies. OBJECTIVE This study aimed to assess the effectiveness and safety of using chatbots to improve mental health through summarizing and pooling the results of previous studies. METHODS A systematic review was carried out to achieve this objective. The search sources were 7 bibliographic databases (eg, MEDLINE, EMBASE, PsycINFO), the search engine “Google Scholar,” and backward and forward reference list checking of the included studies and relevant reviews. Two reviewers independently selected the studies, extracted data from the included studies, and assessed the risk of bias. Data extracted from studies were synthesized using narrative and statistical methods, as appropriate. RESULTS Of 1048 citations retrieved, we identified 12 studies examining the effect of using chatbots on 8 outcomes. Weak evidence demonstrated that chatbots were effective in improving depression, distress, stress, and acrophobia. In contrast, according to similar evidence, there was no statistically significant effect of using chatbots on subjective psychological wellbeing. Results were conflicting regarding the effect of chatbots on the severity of anxiety and positive and negative affect. Only two studies assessed the safety of chatbots and concluded that they are safe in mental health, as no adverse events or harms were reported. CONCLUSIONS Chatbots have the potential to improve mental health. However, the evidence in this review was not sufficient to definitely conclude this due to lack of evidence that their effect is clinically important, a lack of studies assessing each outcome, high risk of bias in those studies, and conflicting results for some outcomes. Further studies are required to draw solid conclusions about the effectiveness and safety of chatbots. CLINICALTRIAL PROSPERO International Prospective Register of Systematic Reviews CRD42019141219; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42019141219

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The effectiveness of listening to the Holy Quran to improve mental disorders and psychological well-being: Systematic review and meta-analysis

10.21203/rs.3.rs-44376/v1 ◽

2020 ◽

Author(s):

Alaa Abd-alrazaq ◽

Ashraf A Malkawi ◽

Ahmed H Maabreh ◽

Tanvir Alam ◽

Bridgette M Bewick ◽

...

Keyword(s):

Mental Health ◽

Systematic Review ◽

Mental Disorders ◽

Meta Analysis ◽

Well Being ◽

Complementary Therapy ◽

Risk Of Bias ◽

Bibliographic Databases ◽

Reference List ◽

Psychological Well Being

Abstract Background: Listening to the Quran is one of spiritual therapies that have been used for treating mental disorders. Many studies have been conducted to assess the effect of listening to the Quran on mental health and psychological wellbeing. Several reviews were conducted to summarise results of such evidence. However, they either focused on studies published in a certain country (Iran), focused on certain setting (intensive care unit), or were written by Persian language. Moreover, none of them synthesised results of studies statistically.Objective: The study aimed to assess the effectiveness of listening to the Quran to improve mental disorders and psychological well-being by summarizing and pooling the findings of previous literature.Methods: A systematic review was conducted to accomplish this objective. The search sources included 6 bibliographic databases (e.g., MEDLINE, PsycINFO, CINHAL), the search engine “Google Scholar”, and backward and forward reference list checking of the included studies and relevant reviews. Two reviewers independently carried out the study selection, data extraction, risk of bias assessment, and quality of evidence evaluation. Results of the included studies were synthesized narratively and statistically, as appropriate.Results: Of 1724 citations retrieved, 11 studies met the eligibility criteria. Of these studies, 7 were included in meta-analysis. The evidence showed that listening to the Quran is significantly effective in improving state anxiety, trait anxiety, general anxiety, depression, stress and mental health. However, the evidence quality ranged from very low to low due to the high risk of bias, heterogeneity, and impression.Conclusion: Listening to the Quran has the potential to improve mental disorders and psychological well-being. Until high-quality studies approve its effect, health professionals and individuals should consider listening to the Quran as a complementary therapy to already available interventions. Researchers should conduct further studies to compare the effectiveness of reciting and listening to the Quran and Al-Ruqya Al-Shariya with active interventions on mental disorders and psychological well-being among Muslims and non-Muslims from different countries.

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Clinical effectiveness and cost effectiveness of individual mental health workers colocated within primary care practices: a systematic literature review

BMJ Open ◽

10.1136/bmjopen-2020-042052 ◽

2020 ◽

Vol 10 (12) ◽

pp. e042052

Author(s):

Jean-Baptiste Woods ◽

Geva Greenfield ◽

Azeem Majeed ◽

Benedict Hayhoe

Keyword(s):

Mental Health ◽

Primary Care ◽

Cost Effectiveness ◽

Health Worker ◽

Health Workers ◽

Risk Of Bias ◽

Mental Health Workers ◽

Mental Health Worker ◽

Care Practices ◽

Primary Care Practices

ObjectivesMental health disorders contribute significantly to the global burden of disease and lead to extensive strain on health systems. The integration of mental health workers into primary care has been proposed as one possible solution, but evidence of clinical and cost effectiveness of this approach is unclear. We reviewed the clinical and cost effectiveness of mental health workers colocated within primary care practices.DesignSystematic literature review.Data sourcesWe searched the Medline, Embase, PsycINFO, Healthcare Management Information Consortium (HMIC) and Global Health databases.Eligibility criteriaAll quantitative studies published before July 2019 were eligible for the review; participants of any age and gender were included. Studies did not need to report a certain outcome measure or comparator in order to be eligible.Data extraction and synthesisData were extracted using a standardised table; however, pooled analysis proved unfeasible. Studies were assessed for risk of bias using the Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I) tool and the Cochrane collaboration’s tool for assessing risk of bias in randomised trials.ResultsFifteen studies from four countries were included. Mental health worker integration was associated with mental health benefits to varied populations, including minority groups and those with comorbid chronic diseases. Furthermore, the interventions were correlated with high patient satisfaction and increases in specialist mental health referrals among minority populations. However, there was insufficient evidence to suggest clinical outcomes were significantly different from usual general practitioner care.ConclusionsWhile there appear to be some benefits associated with mental health worker integration in primary care practices, we found insufficient evidence to conclude that an onsite primary care mental health worker is significantly more clinically or cost effective when compared with usual general practitioner care. There should therefore be an increased emphasis on generating new evidence from clinical trials to better understand the benefits and effectiveness of mental health workers colocated within primary care practices.

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The effects of non-clinician guidance on effectiveness and process outcomes of digital mental health interventions: A systematic review and meta-analysis. (Preprint)

10.2196/preprints.36004 ◽

2021 ◽

Author(s):

Calista Leung ◽

Julia Pei ◽

Kristen Hudec ◽

Farhud Shams ◽

Richard Munthali ◽

...

Keyword(s):

Mental Health ◽

Systematic Review ◽

Psychosocial Support ◽

Meta Analysis ◽

Grey Literature ◽

Risk Of Bias ◽

Health Interventions ◽

Cochrane Central Register ◽

Process Outcomes ◽

Mental Health Interventions

BACKGROUND Digital mental health interventions are increasingly prevalent in the current context of rapidly evolving technology, and research indicates that they yield effectiveness outcomes comparable to in-person treatment. Integrating professionals (i.e. psychologists, physicians) into digital mental health interventions has been common, and the inclusion of guidance within programs can increase adherence to interventions. However, employing professionals to enhance mental health programs may undermine the scalability of digital interventions. Therefore, delegating guidance tasks to paraprofessionals (peer supporters, technicians, lay counsellors, or other non-clinicians) can help reduce costs and increase accessibility. OBJECTIVE This systematic review and meta-analysis evaluates the effectiveness, adherence, and other process outcomes of non-clinician guided digital mental health interventions. METHODS Four databases (MEDLINE, EMBASE, CINAHL, and PSYCInfo) were searched for randomized controlled trials published between 2010 and 2020 examining digital mental health interventions. Three journals focused on digital intervention were also hand searched and grey literature was searched using ProQuest and the Cochrane Central Register of Control Trials (CENTRAL). Two researchers independently assessed risk of bias using the Cochrane Risk of Bias Tool 2. Data were collected on effectiveness, adherence, and other process outcomes, and meta-analyses were conducted for effectiveness and adherence outcomes. Non-clinician guided interventions were compared with treatment as usual, clinician-guided interventions, and unguided interventions. RESULTS Thirteen studies qualified for inclusion. Results indicate that non-clinician guided interventions yielded higher post-treatment effectiveness outcomes when compared to conditions involving control programs (e.g. online psychoeducation, monitored attention control) or waitlist controls (k=7, Hedges g=-0.73 (95% CI -1.08 to -0.38)). There are significant differences between non-clinician guided interventions and unguided interventions as well (k=6, Hedges g=-0.17 (95% CI -0.23 to -0.11)). In addition, non-clinician guided interventions did not differ in effectiveness from clinician-guided interventions (k=3, Hedges g=0.08 (95% CI -0.01 to 0.17)). These results suggest that guided digital mental health interventions are helpful to improve mental health outcomes regardless of the qualification, and that the presence of a non-clinician guide improves effectiveness outcomes more than no guidance. Non-clinician guided interventions did not yield significantly different effects on adherence outcomes when compared with unguided interventions (k=3, OR 1.58 (95% CI 0.51 to 4.92)), although a general trend of improved adherence was observed within non-clinician guided interventions. CONCLUSIONS Integrating paraprofessionals and non-clinicians appear to improve outcomes of digital mental health interventions, and may also enhance adherence outcomes (though the trend was nonsignificant). Further research should focus on the specific types of tasks these paraprofessionals can successfully provide (i.e. psychosocial support, therapeutic alliance, technical augmentation) and their associated outcomes. CLINICALTRIAL The protocol is preregistered on PROSPERO (CRD42020191226).

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Panoramic versus CBCT used to reduce inferior alveolar nerve paresthesia after third molar extractions: a systematic review and meta-analysis

Dentomaxillofacial Radiology ◽

10.1259/dmfr.20190265 ◽

2020 ◽

Vol 49 (4) ◽

pp. 20190265

Author(s):

Nathalia Calzavara Del Lhano ◽

Rosangela Almeida Ribeiro ◽

Carolina Castro Martins ◽

Neuza Maria Souza Picorelli Assis ◽

Karina Lopes Devito

Keyword(s):

Systematic Review ◽

Panoramic Radiography ◽

Meta Analysis ◽

Inferior Alveolar Nerve ◽

Third Molar ◽

Risk Of Bias ◽

Third Molar Surgery ◽

Reference List ◽

Significant Heterogeneity ◽

Eligibility Criteria

Objectives: The aim of this systematic review was to verify whether CBCT in comparison with panoramic radiography reduced the cases of temporary paresthesias of the inferior alveolar nerve (IAN) associated with third molar extractions. Methods: The literature search included five databases (PubMed, Scopus, Web of Science, Cochrane, SciELO), in addition to gray literature and hand search of reference list of included studies. Two reviewers independently screened titles/abstracts, and full texts according to eligibility criteria, extracted data and evaluated risk of bias through Revised Cochrane Risk of Bias Tool for Randomized Trials (RoB 2.0). Data were meta-analyzed by comparing CBCT versus panoramic radiographs for number of events (temporary paresthesia after third molar surgery). Fixed effect model was used for non-significant heterogeneity; relative risk (RR) and 95% CI were calculated. The certainty of evidence was evaluated by Grading of Recommendations, Assessment, Development, and Evaluation (GRADE). Results: Four randomized controlled trials (RCTs) were included in meta-analysis, and for the majority of domains they presented low risk of bias. RR was 1.23 (95% IC: 0.75–2.02; I2: 0%; p = 0.43) favouring panoramic radiography, but without significant effect, and with moderate certainty of evidence. Conclusions: We concluded that both interventions had a similar ability to reduce temporary paresthesia of the IAN after third molar surgery with moderate certainty of evidence.

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The impact of eHealth group interventions on the mental, behavioural, and physical health of adults: A systematic review protocol

10.21203/rs.3.rs-37015/v2 ◽

2020 ◽

Cited By ~ 1

Author(s):

Cheryl L Currie ◽

Richard Larouche ◽

M. L. Voss ◽

Erin K. Higa ◽

Rae Spiwak ◽

...

Keyword(s):

Mental Health ◽

Systematic Review ◽

Physical Health ◽

Meta Analysis ◽

Primary Objective ◽

Risk Of Bias ◽

Community Dwelling ◽

Controlled Trials ◽

Sex And Gender ◽

The Impact

Abstract Background: COVID-19 has resulted in an increased demand for mental health services globally. There is emerging evidence for the efficacy for group eHealth interventions that support population-based mental health and wellbeing, but a systematic review is lacking. The primary objective of this systematic review is to summarize the evidence for eHealth group counselling and coaching programs for adults. A second objective is to assess, within studies selected for our primary objective, the impact of programs that encourage PA on outcomes compared to those that do not.Methods and Design: Randomized controlled trials that assess the impact of eHealth group counselling or coaching programs on mental health, health behaviour, or physical health conditions or concerns among community dwelling adults will be searched in MEDLINE, PsycInfo, CINHAL, and the Central Register of Controlled Trials. The review will be structured using PRISMA guidelines. Studies will be synthesized using the Cochrane Handbook and Synthesis Without Meta-Analysis (SWiM) reporting guideline. Quality will be evaluated using GRADE. Risk of bias will be assessed using the Cochrane Risk of Bias tool with higher quality studies prioritized when drawing conclusions. The role of sex and gender will be considered as well as possible gender biases at all stages of the review.Discussion: This review will examine the effectiveness of eHealth counselling and coaching programs delivered to adults in a group format. Findings will inform the decisions of governments, communities, and health care organizations responding to the COVID-19 pandemic in Canada. Systematic review registration: The protocol has been registered at the International Prospective Register of Systematic Reviews (PROSPERO: CRD42020187551).

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Mobile Apps that Promote Emotion Regulation, Positive Mental Health and Well-being in the General Population: Systematic Review and Meta-analysis (Preprint)

10.2196/preprints.31170 ◽

2021 ◽

Author(s):

Amelia Eisenstadt ◽

Shaun Liverpool ◽

Elisa Infanti ◽

Roberta Maria Ciuvat ◽

Courtney Carlsson

Keyword(s):

Mental Health ◽

Systematic Review ◽

Emotion Regulation ◽

General Population ◽

Mobile Apps ◽

Meta Analysis ◽

Well Being ◽

Positive Mental Health ◽

Risk Of Bias ◽

Health And Well Being

BACKGROUND Among the general public there appears to be a growing need and interest in receiving digital mental health and well-being support. In response to this, a number of mental health apps (MHapps) are becoming available for monitoring, managing and promoting positive mental health and well-being. Thus far, the evidence supports positive outcomes when users engage with digital interventions. However, there is high variability in the theoretical base informing MHapps and the features incorporated. Such differences can have implications for the efficacy of the apps and the level of engagement among specific target population groups. Moreover, such heterogeneity may influence the extent to which the data from various MHapps can be pooled to assess the strength of the evidence. OBJECTIVE We aimed to systematically review the available research on MHapps that promote emotion regulation, positive mental health, and well-being in the general population aged 18-45. More specifically, the review aimed at providing a systematic description of the theoretical background and features of MHapps while evaluating any potential effectiveness. METHODS A comprehensive literature search of key databases; MEDLINE (via Ovid), EMBASE (via Ovid), PsycINFO (via Ovid), Web of Science, and the Cochrane Register of Controlled Trials (CENTRAL) was conducted until January 2021. Studies were included if they described standalone mental health and well-being apps for adults without a formal mental health diagnosis. All studies were quality assessed against the Mixed Methods Appraisal Tool. In addition, the Cochrane risk-of-bias tool (ROB-2) was used to assess randomized control trials (RCTs). Data were extracted using a modified extraction form the Cochrane Handbook of Systematic Reviews. A narrative synthesis and meta-analysis was then undertaken to address the review aims. RESULTS In total, 3156 abstracts were identified. Of these, 52 publications describing 48 MHapps met the inclusion criteria. Together the studies evaluated interventions across 15 countries. Thirty-nine RCTs were identified that suggested there is some support for the role of individual MHapps in improving and promoting mental health and well-being. Regarding pooled effect, MHapps, when compared to controls, showed a small effect for reducing mental health symptoms (k = 19, g = -0.24, 95% CI [-0.34, -0.14], p < .05) and improving well-being (k = 13, g = 0.17, 95% CI [0.05, 0.29], p < .05), and a medium effect for emotion regulation (k = 6, g = 0.49, 95% CI [0.23,0.74], p<.05). There is also a wide knowledge base of creative and innovative ways to engage users in techniques, such as mood monitoring and guided exercises. Mindfulness and Cognitive Behavioural approaches appear to be the most common among MHapp developers. Studies were generally assessed to contribute unclear or high risk of bias, or be of medium to low methodological quality. CONCLUSIONS The emerging evidence for MHapps that promote positive mental health and well-being continue to show some evidence of promise. Despite a wide range of MHapps, there are not many that specifically promote emotion regulation. However, our findings may position emotion regulation as an important mechanism for inclusion in future positive mental health and well-being MHapps. A fair proportion of the included studies were pilot or feasibility trials (k = 17, 33%), and full scale RCTs reported high attrition rates and non-diverse samples. Given the number and pace at which MHapps are being released, further robust research is warranted to inform the development and testing of evidence-based programs. CLINICALTRIAL Mia Eisenstadt, Elisa Infanti, Shaun Liverpool. Characteristics and effectiveness of mobile apps that promote emotion regulation and well-being in the general population: a systematic review protocol. PROSPERO 2020 CRD42020213051 Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020213051

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A systematic review and meta-analysis of group peer support interventions for people experiencing mental health conditions

BMC Psychiatry ◽

10.1186/s12888-021-03321-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Natasha Lyons ◽

Chris Cooper ◽

Brynmor Lloyd-Evans

Keyword(s):

Mental Health ◽

Systematic Review ◽

Health Services ◽

Peer Support ◽

Support Groups ◽

Meta Analysis ◽

Risk Of Bias ◽

Health Conditions ◽

Mental Health Conditions ◽

Meta Analyses

Abstract Background Peer support is being integrated within mental health services to further the development of a recovery approach. However, the most effective models and formats of intervention delivery are unknown. We conducted this systematic review and meta-analysis to determine the effectiveness of peer support for improving outcomes for people with lived experience of mental health conditions, when delivered as group interventions. Methods Studies reporting randomised controlled trials of group peer support interventions for people experiencing mental health conditions were identified by searching MEDLINE, PsycINFO, Embase and Cochrane CENTRAL, from inception until July 12th 2019 and undertaking supplementary searches. Included studies were assessed for risk of bias and meta-analyses were conducted if three or more trials provided usable data. Results Eight trials met eligibility criteria, providing data from 2131 participants. Six trials had either high or unclear risk of bias. Interventions were categorised as mutual support groups, or peer support groups, sub-categorised as anti-stigma or self-management interventions. Meta-analyses were only possible for peer support groups and five outcomes. We found evidence that group peer support may make small improvements to overall recovery but not hope or empowerment individually, or to clinical symptoms. Evidence for effectiveness for outcomes which could not be meta-analysed was mixed. Conclusions Findings from the few eligible trials suggest group peer support interventions may be specifically effective for supporting personal recovery and have a limited impact on other outcomes, though there were some risks of bias to study findings. Interventions were heterogeneous and most social outcomes were absent in the literature, highlighting further limitations to the current evidence-base. There is insufficient evidence available from trials of group peer support torecommend the routine implementation of these interventions across mainstream mental health services at present. More high-quality trials of peer-developed, group peer support interventions are needed in order tomake firm conclusions about intervention effectiveness.

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A Protocol for a Systematic Review and Meta-Analysis of Mind–Body Modalities to Manage the Mental Health of Healthcare Workers during the COVID-19 Era

Healthcare ◽

10.3390/healthcare9101320 ◽

2021 ◽

Vol 9 (10) ◽

pp. 1320

Author(s):

Chan-Young Kwon ◽

Boram Lee

Keyword(s):

Mental Health ◽

Systematic Review ◽

Healthcare Workers ◽

Tai Chi ◽

Intervention Studies ◽

Meta Analysis ◽

Well Being ◽

Bibliographic Databases ◽

Randomized Controlled Clinical Trials ◽

General Populations

The coronavirus disease 2019 (COVID-19) pandemic has become an unprecedented threat to humanity worldwide, including healthcare workers (HCWs). Mind–body modalities have been used to improve the mental health, well-being, quality of life, and physical health of clinical and general populations, and may also be used to improve the mental health of HCWs during COVID-19. The objective of this review is to analyze the effectiveness of mind–body modalities for the mental health of HCWs in the COVID-19 era. Six electronic bibliographic databases were comprehensively searched to find intervention studies using mind–body modalities, including meditation, mindfulness-based intervention, autogenic training, yoga, tai chi, qigong, breathing exercise, music therapy, guided imagery, biofeedback, prayer, and faith-based techniques for HCWs. All intervention studies conducted from December 2019 to August 2021 will be included. Quality assessment will be performed according to study type, and Cochrane Collaboration’s Risk of Bias tool will be used for randomized controlled clinical trials (RCTs). If sufficient homogeneous data from RCTs exist, a meta-analysis will be performed. Dichotomous data and continuous data are presented as risk ratios and mean differences with their 95% confidence intervals, respectively. The results of this systematic review will be disseminated through the publication of a manuscript in a peer-reviewed journal or by presentation at a conference.

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Is rituximab effective for systemic sclerosis? A systematic review and meta-analysis

Advances in Rheumatology ◽

10.1186/s42358-021-00170-y ◽

2021 ◽

Vol 61 (1) ◽

Author(s):

Marina Maria Vieira de Figueiredo Caldas ◽

Kesley Pablo Morais de Azevedo ◽

Ana Clara de França Nunes ◽

Victor Hugo de Oliveira ◽

Isac Davidson Santiago Fernandes Pimenta ◽

...

Keyword(s):

Systematic Review ◽

Systemic Sclerosis ◽

Lung Disease ◽

Therapeutic Option ◽

Meta Analysis ◽

Statistical Significance ◽

Risk Of Bias ◽

Bibliographic Databases ◽

Positive Effects ◽

Manual Search

Abstract Background Systemic sclerosis (SSc) is a clinically complex and challenging disease, that leads to skin fibrosis. Its most frequent complication is interstitial lung disease (ILD), which leads to a worse prognosis. In this situation, cyclophosphamide is considered the gold standard for its treatment, despite the controversies regarding its efficacy and toxicity. However, studies using rituximab (RTX) have shown that this drug may be a promising therapeutic option. Objectives This paper objective was to analyze the scientific evidence on the RTX effects on SSc. Methods A systematic review (SR) was performed including clinical trials (CTs) on the use of RTX in SSc, published up to May 2020. The studies were identified through systematic searches in bibliographic databases using a predefined search strategy. The following databases were used: PUBMED, SCOPUS, SCIELO, LILACS, SCIENCE DIRECT, WEB OF SCIENCE, COCHRANE, WHOLIS, PAHO and EMBASE. Also, a manual search was performed. The methodological quality of the studies was determined using Jadad scale, Risk of Bias Tool (RoB 2.0) and Risk of Bias in Non-Randomized Studies - of Interventions tool (ROBINS-I). A meta-analysis of the randomized CTs was performed, using Review Manager. Results Ten CTs were included in this SR. Of these, three were randomized and seven were non-randomized. Five showed a statistically significant improvement in forced vital capacity (FVC) at some time during follow-up. Regarding the skin, eight studies showed statistically significant improvements according toa the modified Rodnan skin score. The meta-analysis found positive effects of RTX in SSc, with a statistical significance for lung disease. Conclusion Rituximab is a promising strategy for the SSc-associated ILD and cutaneous fibrosis treatment. PROSPERO registration number: CRD42019132018.

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