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Nevin Manimala Statistics

COMPLItiCATIONS IN SIMULTANEOUS BILATERAL TOTAL KNEE ARTHROPLASTY, IS IT A SAFE PROCEDURE?

J ISAKOS. 2023 Aug 22:S2059-7754(23)00550-3. doi: 10.1016/j.jisako.2023.08.007. Online ahead of print.

ABSTRACT

BACKGROUND: There is controversy regarding various aspects of simultaneous bilateral total knee replacement (SBTKR). We found disparity in the postoperative outcomes and complications associated with the procedure in the literature linked with the topic.

OBJECTIVE: To retrospectively analyze the need for blood transfusion after surgery and complications associated with total knee replacement according to the type of procedure (SBTKR or unilateral).

METHODS: Retrospective cohort analytical study. We included 251 patients with severe knee osteoarthritis that were divided into two groups. 124 (49%) who underwent SBTKR and 127 upon whom unilateral total knee replacement (UTKR) was performed. Demographic data, days of hospitalization, complications within the first 90 days after surgery (thromboembolic events, superficial and deep infection, stiffness, death); and percentages of patients transfused with blood products during hospitalization were evaluated.

RESULTS: There were no statistical differences in the analysis of postoperative complications in the first 90 days after surgery. In the SBTKR group, 8 patients (6.5%) presented some thromboembolic complication during the postoperative period, while this event was observed in only 2 patients (1.5%) from the other group. The analysis showed a statistically significant drop in postoperative hemoglobin, on average that of 0.8 g/dl, in the SBTKR patient group compared to the UTKR group (95% CI 0,44-1,13; p<0,001). A higher proportion of patients who required transfusion were observed in the SBTKR group (40%) (OR=7,12; 95% CI 3,3 – 16; p<0,001). We analyzed the cause of postoperative transfusion in the patients who required transfusion taking into account two parameters: hemoglobin less than 8 g/dl and the clinical needs of the patients (symptoms of hypotension, decay, difficulty to rehabilitate without pain, dyspnea). 59 patients received transfusion (50 in the SBTKR group and 9 in the other group). Of these, 19 patients (32.2%) did not meet any transfusion criteria.

CONCLUSION: We consider SBTKR a safe procedure, which does not increase postoperative complications compared to UTKR. Although there is an increase in blood loss in SBTKR, it does not generate clinical symptoms of relevance.

LEVEL OF EVIDENCE: Level III.

PMID:37619961 | DOI:10.1016/j.jisako.2023.08.007

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Nevin Manimala Statistics

Identification of multivariable Boolean patterns in microbiome and microbial gene composition data

Biosystems. 2023 Aug 22:105007. doi: 10.1016/j.biosystems.2023.105007. Online ahead of print.

ABSTRACT

Virtually every biological system is governed by complex relations among its components. Identifying such relations requires a rigorous or heuristics-based search for patterns among variables/features of a system. Various algorithms have been developed to identify two-dimensional (involving two variables) patterns employing correlation, covariation, mutual information, etc. It seems obvious, however, that comprehensive descriptions of complex biological systems need also to include more complicated multivariable relations, which can only be described using patterns that simultaneously embrace 3, 4, and more variables. The goal of this manuscript is to (a) introduce a novel type of associations (multivariable Boolean patterns) that can be manifested between features of complex systems but cannot be identified (described) by traditional pair-vise metrics; (b) propose patterns classification method, and (c) provide a novel definition of the pattern’s strength (pattern’s score) able to accommodate heterogeneous multi-omics data. To demonstrate the presence of such patterns, we performed a search for all possible 2-, 3-, and 4-dimensional patterns in historical data from the Human Microbiome Project (15 body sites) and collection of H. pylori genomes associated with gastric ulcers, gastritis, and duodenal ulcers. In all datasets under consideration, we were able to identify hundreds of statistically significant multivariable patterns. These results suggest that such patterns can be common in microbial genomics/microbiomics systems.

PMID:37619924 | DOI:10.1016/j.biosystems.2023.105007

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Nevin Manimala Statistics

Systematic review and meta-analysis of outcomes after semi-conversion with graft preservation for failed endovascular aneurysm repair

J Vasc Surg. 2023 Aug 22:S0741-5214(23)01926-2. doi: 10.1016/j.jvs.2023.08.113. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the outcomes after semi-conversion (open conversion with graft preservation) after failed endovascular aneurysm repair (EVAR). The primary outcomes were 30-day mortality and semi-conversion failure. Secondary outcomes were 30-day major systemic complications, endoleak recurrence, reinterventions, overall survival.

METHODS: The review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The protocol was prospectively registered on PROSPERO (CRD42023421153). All studies reporting the outcomes of semi-conversions for failed EVAR were eligible for inclusion. Quality assessment was performed using the Methodological Index for Non-Randomized Studies (MINORS) tool. A random effects meta-regression of proportions was conducted using the double arcsine-Tukey transformation given the frequent zero event rate in the primary outcome. Heterogeneity was assessed with the I2 statistic.

RESULTS: 8 studies were included in the review after full text screening. 196 patients underwent semi-conversion at a mean time from EVAR of 47.4 months, 68.9% in an elective setting. Mean age at conversion was 78.1 years, and the main indication was isolated endoleak type II (70.1% of cases). Aortic clamping was not necessary in 92.3% of semi-conversions, the aortic sac was opened in 96.1% of cases, in 93.3% of cases ligation/suture of one or more culprit arteries were performed, and aortic neck banding was executed in 29.2%. At 30 days from surgery, the pooled mortality and the major systemic complications rates were 5.3% (I2: 24.9%) and 13.4% (I2: 54.3%) respectively. At follow-up, endoleak recurred after 12.6% semi-conversions (I2: 83.2%) and the rate of reinterventions was 7% (I2: 50.1%); the semi-conversion failure rate was 5.5% (I2: 54.1%) and the overall survival was 84.6% (I2: 33.3%).

CONCLUSION: Semi-conversions have acceptable 30-day mortality rates, but the early and mid-term risks of complications, reinterventions, ruptures and infections are not negligible. This procedure might be an alternative to complete or partial graft explant in patients whom aortic cross clamping is not ideal.

PMID:37619915 | DOI:10.1016/j.jvs.2023.08.113

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Nevin Manimala Statistics

An overview of fleas (Siphonaptera) in wild and domestic mammals from Algeria with new data from the central north and south of the country

Acta Trop. 2023 Aug 22:107004. doi: 10.1016/j.actatropica.2023.107004. Online ahead of print.

ABSTRACT

Fleas (Siphonaptera) are medically and veterinary important ectoparasites known to infest a wide range of host species. This study presents a systematic review complemented by new data on the diversity of flea species and host associations in Algeria. 198 mammals were examined, including previously understudied hosts such as sheep, red foxes, fennec foxes, and golden African wolves. Of these animals, 108 (54.55%) were infested with fleas. Overall, 1.906 fleas belonging to seven species (Archaeopsylla erinacei s.l., Ctenocephalides felis, C. canis, Nosopsyllus fasciatus, Pariodontis riggenbachi, Pulex irritans, Xenopsylla cheopis) were identified, originating from seven provinces across Algeria. Statistical analysis techniques were employed to process the data, including descriptive statistics, statistical tests, and principal component analysis (PCA). This study reveals the diverse flea fauna in Algeria and their association with various host species, including wild and domestic animals. This comprehensive survey aimed to combine literature reviews, fieldwork, and statistical analysis to understand fleas’ diversity and host associations. The findings contribute to the growing knowledge of flea ecology and host-parasite interactions, with implications for public health and veterinary practices in Algeria and potentially other regions with similar ecological characteristics.

PMID:37619901 | DOI:10.1016/j.actatropica.2023.107004

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Nevin Manimala Statistics

Effectiveness and safety of reduced-dose rivaroxaban for elderly patients with non-valvular atrial fibrillation: A subanalysis of the EXPAND study

Int J Cardiol. 2023 Aug 22:131290. doi: 10.1016/j.ijcard.2023.131290. Online ahead of print.

ABSTRACT

BACKGROUND: Establishing the appropriate rivaroxaban dose in older patients with non-valvular atrial fibrillation (NVAF) is important because of the high risk of adverse events. In this EXPAND study subanalysis, we examined the safety and efficacy of standard-dose (15 mg/day) and non-recommended reduced-dose (10 mg/day) rivaroxaban in patients aged ≥65 years with NVAF and preserved renal function.

METHODS: The entire analysis population (ALL cohort [n = 3982]; ≥65 years) was divided into early elderly (ELD) (65-74 years [n = 1444]) and late ELD (≥75 years [n = 2386]) sub-cohorts. Each sub-cohort was divided into reduced-dose and standard-dose groups. Kaplan-Meier survival curves with adjusted hazard ratios (aHRs) and 95% confidence intervals (CIs) were used to assess efficacy (thromboembolic events) and safety (hemorrhagic events) outcomes.

RESULTS: The aHR for major bleeding did not differ between the dosages in any of the cohorts (aHRs: 0.86-0.93). There were no significant differences in the occurrence of stroke + systemic embolism (SE) or stroke + SE + myocardial infarction (MI) + cardiovascular (CV) death among the cohorts. The aHR for MI/unstable angina + interventional/CV surgery + CV death was higher with 10-mg/day rivaroxaban than 15-mg/day rivaroxaban in the ALL cohort (aHR: 1.56 [95% CI 1.02-2.37], p = 0.039) and the late ELD sub-cohort (aHR: 1.86 [95% CI 1.01-3.42], p = 0.045).

CONCLUSIONS: Reduced-dose rivaroxaban may increase the risk of coronary artery events. The use of rivaroxaban 15 mg/day in patients with NVAF aged ≥75 years with preserved renal function was supported.

PMID:37619876 | DOI:10.1016/j.ijcard.2023.131290

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Nevin Manimala Statistics

Postoperative Complications Following Schwab-Grade-I Versus Schwab-Grade-II PCO in Treating Severe Rigid Kyphoscoliosis Patients: A Comparative Matched-Group Outcomes with Minimum 2-Year Follow-Up

Spine J. 2023 Aug 22:S1529-9430(23)03344-2. doi: 10.1016/j.spinee.2023.08.006. Online ahead of print.

ABSTRACT

BACKGROUND CONTEXT: Standard partial facetectomies, [Smith-Petersen Osteotomy, (SPO)], (Schwab-grade-I) and complete facet resection also known as Ponte osteotomy, [PO], (Schwab-grade-II) are narrowly akin and collectively appreciated as posterior column shortening osteotomies (PCOs). The former is considered a gentler osteotomy grade than the latter. The spine literature provides very little information on their comparison regarding perioperative complications and major curve correction rate outcomes.

PURPOSE: To determine whether Schwab-grade-I PCO (SPO) and Schwab-grade-II PCO (PO) are comparably safe in the surgical management of severe rigid scoliosis or kyphoscoliosis patients.

STUDY DESIGN/SETTING: Retrospective single-center comparative clinical study.

PATIENT SAMPLE: A total of 38 patients with severe rigid scoliosis or kyphoscoliosis were propensity score matched in this study, [SPO-treated]; n=21 (55.30%) and [PO-treated]; n=17 (44.70%), who underwent primary spinal deformity corrective surgery, respectively.

OUTCOME MEASURES: Outcomes included demographics, baseline pulmonary functional outcomes, perioperative complications incidence, hospital costs, Oswestry disability index (ODI), and scoliosis research society-22 (SRS-22) questionnaire scores.

METHODS: Following approval by the institutional review board (IRB) of Beijing Chaoyang Hospital-Affiliated Capital Medical University in Beijing, out of a total of 82 consecutive surgical patients with complete data demonstrating severe and/or rigid spinal deformity, a pool of 38/82 (46.3%) propensity-matched adults (≥18 years) with severe rigid scoliosis or kyphoscoliosis patients defined with a preoperative major curve magnitude of ≥80 degrees on anteroposterior plain radiographs, and flexibility of <25% on bending plain radiographs who underwent primary spinal deformity corrective surgery were retrospectively evaluated. The patients were dichotomized into two (2) osteotomy groups: standard (partial) facetectomy (SPO-treated), n=21 with an average age of 24.67 years, (i.e., Schwab-grade-I PCO) and complete facet excision, (PO-treated), (i.e., Schwab-grade-II PCO), n=17 with an average age of 23.12 years. The minimum follow-up period was 2 years. Primary outcomes included baseline and clinical features. Secondary outcomes included perioperative [intraoperative, immediate, and at 2-year postoperative] complication rates. Tertiary outcomes included perioperative ODI and SRS-22 scores. Statistical analyses were carried out by Student t-test and Pearson’s Chi-squared test (Fisher’s Exact Test), through Python statistical software package. Statistical significance was set at (p<0.05).

RESULTS: Of the 38 matched severe rigid scoliosis or kyphoscoliosis patients, 55.30% (n=21) were SPO-treated and 44.70% (n=17) were PO-treated patients, respectively. The overall average age of patients was 23.97 years, with a female incidence of 76.32%. Major curve correction rates were 49.19% and 57.40% in SPO-treated and PO-treated patients, respectively, (p>0.05). Immediately following surgery, comparable overall complication rates of 28.57% (n=6/21) vs 29.41% (n=5/17) were observed in the SPO-treated and PO-treated patients, respectively, (p=0.726). We observed incidences of 9.52%, (n=2/21) vs 5.88%, (n=1/17) for surgical intensive care unit (SICU) admission, and incidences of 4.76%, (n=1/21) vs 5.88%, (n=1/17) for cardiopulmonary events in SPO-treated versus PO-treated patients after surgery, respectively, (p>0.05). The incidences of neurological deficits in the SPO-treated and PO-treated patients were respectively, 14.29%, (n=3/21) vs 17.65%, (n=3/17) immediately following surgery, (p>0.05), and 0.00%, (n=0/21) in SPO-treated vs 14.28%, (n=3/21) in PO-treated patients at ≥2 years postoperative, (p<0.05). Among the 3 patients that reported neurological deficits in the PO-treated group at ≥2 years postoperative, 2 patients had preexisting baseline neurological deficits. The ODI score in the PO-treated group was significantly inferior at a minimum 2-year follow-up, (p<0.05).

CONCLUSIONS: In the current study, both SPO-treated and PO-treated patients demonstrated statistically comparable surgical complications immediately following corrective surgery. Severe rigid kyphoscoliosis patients with preexisting baseline neurological deficits were more inclined to sustain neurological morbidity following corrective surgery. PCO corrective techniques are warranted as safe options for treating patients with severe rigid spine deformity phenotypes.

PMID:37619870 | DOI:10.1016/j.spinee.2023.08.006

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Nevin Manimala Statistics

Pharmacists’ Perceptions Regarding Feasibility, Acceptability, and Usefulness of Student-Delivered Naloxone Education Services in Community Pharmacy: A Mixed Methods Study in Alabama

J Am Pharm Assoc (2003). 2023 Aug 22:S1544-3191(23)00268-6. doi: 10.1016/j.japh.2023.08.017. Online ahead of print.

ABSTRACT

BACKGROUND: Given that Alabama has the highest opioid prescribing rate in the nation, efforts to promote safe opioid use and reduce overdose mortality are critical. To address this, the Auburn University Harrison College of Pharmacy (HCOP) developed and piloted a didactic-experiential naloxone learning model in the first-year PharmD curriculum in 2020-2021 consisting of lectures, skills laboratory, and 120-hour community pharmacy introductory pharmacy practice experience (IPPE). Student-delivered naloxone education services (SDNES), including naloxone counseling and dispensing, were incorporated into the IPPE.

OBJECTIVES: The objective of this study was to evaluate the feasibility, acceptability, and usefulness of SDNES from the perspective of community pharmacy IPPE preceptors.

METHODS: This study utilized a mixed methods design including cross-sectional online surveys and follow-up semi-structured telephone interviews. Survey measures were informed by Weiner et al (2017) and included feasibility (11-items), acceptability (13-items), and usefulness (6-items) of SDNES. Survey outcomes were assessed via 5-point Likert-type scales (1=strongly disagree, 5=strongly agree) and analyzed using descriptive statistics. Follow-up semi-structured telephone interview questions were guided by the Consolidated Framework for Implementation Research (CFIR) domains of inner and outer setting, and focused on SDNES barriers/facilitators, recommended strategies for service enhancement, and resource needs. Interview transcripts were analyzed using deductive and inductive rapid content analysis to determine themes and sub-themes.

RESULTS: Twenty-five preceptor surveys were completed (22.52% response rate). Overall, SDNES was rated as feasible (mean[SD] scale score: 4.04[0.77]), acceptable (3.95[0.83]), and useful (3.87[0.98]). Interviewees (N=8) discussed 13 barrier sub-themes, 12 facilitator sub-themes, 7 recommended strategies, and 8 resource needs across 3 overarching themes, most of which were related to the inner setting.

CONCLUSION: Community pharmacy IPPE preceptors found SDNES feasible, acceptable, and useful in their practices. The SDNES model may be used to build capacity for naloxone services delivery in community pharmacies, potentially increasing patient access to naloxone education and distribution.

PMID:37619850 | DOI:10.1016/j.japh.2023.08.017

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Real-World Use of Systemic Therapies for The Treatment of Advanced Thyroid Cancers

Endocr Pract. 2023 Aug 22:S1530-891X(23)00527-X. doi: 10.1016/j.eprac.2023.08.005. Online ahead of print.

ABSTRACT

OBJECTIVE: In the last decade, new systemic treatment options have been made available for patients with advanced thyroid cancer. However, little is known about the real-world utilization of these systemic therapies.

METHODS: We used the Optum Clinformatics database to characterize trends in the use of 15 systemic therapies that are available for treatment of advanced thyroid cancer between 2013-2021. Joinpoint regression was used to calculate annual percentage changes (APCs) in use of systemic therapy by patients’ race/ethnicity. Sequence of therapies were determined by date of prescription claims.

RESULTS: Between 2013-2021, the annual number of patients treated for advanced thyroid cancer with systemic therapy increased from 45 patients in 2013 to 114 patients in 2021 (N of total cohort = 885). Most patients were female (54.7%) and non-Hispanic White (62.1%). Between 2013 and 2021, there was a significant decrease in the proportion of non-Hispanic White patients treated for advanced thyroid cancer with systemic therapy (APC -3.9%, 95% CI -6.0% to -1.8%). Since its approval by the FDA in 2015, lenvatinib remains the most frequently prescribed first-line therapy for treatment of radioiodine-refractory thyroid cancer (48.8% of patients between 2017-2021). Between 2017-2021, most patients (79.7%) were initiated on one of the ten FDA-approved agents and 81.7% received only a first-line therapy.

CONCLUSIONS: Between 2013 and 2021, the use of systemic treatment options for advanced thyroid cancer has increased significantly, largely driven by the prescribing of lenvatinib following its approval by the FDA in 2015, with an increasing trend for use in non-White patients.

PMID:37619826 | DOI:10.1016/j.eprac.2023.08.005

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Nevin Manimala Statistics

No observed difference in inflammatory and coagulation markers following diets rich in omega-6 polyunsaturated fat vs. monounsaturated fat in adults with untreated hypercholesterolemia: a randomized trial

J Acad Nutr Diet. 2023 Aug 22:S2212-2672(23)01490-9. doi: 10.1016/j.jand.2023.08.127. Online ahead of print.

ABSTRACT

BACKGROUND: Inflammatory and prothrombotic responses are hallmark to the progression of cardiovascular disease (CVD) and may be influenced by the type of dietary fat. Cottonseed oil (CSO) is rich in omega-6 polyunsaturated fats (n-6 PUFA) and improves traditional CVD risk factors such as cholesterol profiles. However, some clinicians are still hesitant to promote n-6 PUFA consumption despite growing evidence suggesting they may not be independently pro-inflammatory.

OBJECTIVE: To investigate the inflammatory and coagulation marker responses to an 8-week diet intervention rich in either CSO or olive oil (OO; monounsaturated fat rich) in adults with untreated hypercholesterolemia.

DESIGN: This was a secondary analysis of a parallel-arm randomized clinical trial with the main outcome of cholesterol measures.

PARTICIPANTS: /setting: Participants included in this analysis were 42 sedentary adults age 30-75 (62% female) in the Athens, GA area, between May 2018 and June 2021, with untreated hypercholesterolemia or elevated blood lipids and BMIs >18.5. Hypercholesterolemia was defined as at least two blood lipids in a “borderline undesirable/at risk” range (total cholesterol (TC) ≥ 180 mg/dL, Low-density lipoprotein cholesterol (LDL-c) ≥ 110 mg/dl, high-density lipoprotein cholesterol (HDL-c) < 50 mg/dL, or triglycerides (TG) ≥ 130), or at least one in an “undesirable” range (TC ≥ 240 mg/dL, LDL-c ≥ 160 mg/dl, HDL-c< 40 mg/dL, or TG ≥ 200).

INTERVENTION: Participants were randomly assigned to either the CSO or OO group in a partial outpatient feeding trial. Meals from the study provided approximately 60% of their energy needs with 30% of energy needs from either CSO or OO for eight weeks. Participants fulfilled their remaining energy needs with meals of their choosing.

MAIN OUTCOME MEASURES: Fasting plasma concentrations of inflammatory markers including C-reactive protein (CRP), tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-1β (IL-1β) were measured at baseline and 8-weeks. Markers of coagulation potential including plasminogen activator inhibitor-1 (PAI-1), and tissue factor (TF) were measured at the same time points.

STATISTICAL ANALYSES PERFORMED: Repeated measures linear mixed models were used with treatment and visit in the model for analyses of all biochemical markers.

RESULTS: There were no significant differences in fasting CRP (p=0.70), TNF-α (p=0.98), IL-6 (p=0.21), IL-1β (p=0.13), PAI-1 (p=0.29), or TF (p=0.29) between groups across the intervention.

CONCLUSION: Inflammation and coagulation marker responses to diets rich in CSO vs. OO were not significantly different between groups, and neither group showed changes in these markers in adults with untreated hypercholesterolemia. This provides additional evidence suggesting that dietary n-6 PUFAs may not promote inflammation compared to MUFAs, even in adults at increased risk for CVD.

PMID:37619782 | DOI:10.1016/j.jand.2023.08.127

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Efficacy of Scalp Acupuncture Combined with Conventional Therapy in the Intervention of Post-stroke Depression: a Systematic Review and Meta-analysis

Complement Ther Med. 2023 Aug 22:102975. doi: 10.1016/j.ctim.2023.102975. Online ahead of print.

ABSTRACT

BACKGROUND: Post-stroke depression (PSD) is a common complication following a stroke, significantly impacting patients’ quality of life and mental well-being. Currently, two primary approaches are employed to treat PSD: drug therapy and non-drug therapy. Among these, acupuncture, specifically scalp acupuncture (SA), has gained attention due to its cost-effectiveness and broad social benefits. SA is a precise and direct form of acupuncture that has been utilized in the treatment of PSD. Although several randomized controlled trials (RCTs) have demonstrated the efficacy of SA in treating PSD, there is a lack of comprehensive systematic reviews. Given the limitations of existing evidence, we conducted a systematic evaluation to assess the effectiveness of SA in combination with conventional therapy (CT) for intervening in PSD.

METHODS: We systematically searched five databases for articles published up until May 31, 2023, pertaining to SA treatment of PSD. A team of researchers meticulously screened and assessed these articles to identify the final included studies. After extracting relevant information and outcome indicators from the selected articles, we employed RevMan5.3 software to evaluate their quality and perform statistical analysis. Throughout our research, we strictly adhered to the PRISMA 2020 guidelines.

RESULTS: A total of 11 articles were included, and a meta-analysis was conducted to evaluate the effectiveness of SA combined with CT for treating PSD. The results revealed that SA combined with CT can effectively improve the treatment’s success rate for PSD and reduce the severity of depressive symptoms measured by the Self-Rating Depression Scale. However, SA combined with CT did not show significant reductions in depressive symptoms assessed by the Hamilton Rating Scale for Depression, which may be related to the inclusion of high heterogeneity articles. Importantly, the combination treatment did not lead to an increase in adverse reactions among PSD patients.

CONCLUSION: While the effectiveness of SA combined with CT in treating PSD still requires further validation through rigorous randomized double-blind trials, this study provides a comprehensive collection of studies that meet the criteria for SA combined with CT in PSD treatment. It objectively and systematically evaluated the impact of SA combined with CT on PSD. Consequently, the findings of this study hold certain clinical significance.

PMID:37619716 | DOI:10.1016/j.ctim.2023.102975