Systematic Review Of Clinical Trials Research Articles

Intradialytic parenteral nutrition in malnourished patients with chronic kidney disease: a systematic review

Introduction: Malnutrition is a prevalent condition among patients with chronic kidney disease (CKD). Objective: To answer the question of the effect of intradialytic parenteral nutrition (IPN) on malnourished CKD patients undergoing dialysis, a systematic review of clinical trials was performed. Methods: The systematic review was performed according with PRISMA. The review was carried out between September and October 2022. The search strategy included PubMed, Web of Science and LILACS databases. The selection of articles was carried out using the Rayyan platform and to assess the chance of bias, the Rob2 instrument recommended by Cochrane was employed. Results and Conclusions: From 762 article retrieved in the initial strategy only 4 articles were included in the review. In a general view, the use of IPN increased the levels of prealbumin and albumin in the participants. Studies evaluating this topic are sparse. More studies are needed to recommend the use of IPN universally in the context of malnourished patients with CKD.

A Mediterranean diet improves glycation markers in healthy people and in those with chronic diseases: a systematic review of clinical trials.

Consumption of the Mediterranean diet (MedDiet) has beneficial effects on cardiometabolic health and aging. This systematic review aimed to critically investigate the effect of the MedDiet on glycation markers in healthy or overweight individuals with type 2 diabetes or cardiovascular disease. MEDLINE, EMBASE, Web of Science, and the Cochrane Library were searched, using the terms "Mediterranean diet" AND "glycation end products, advanced". Three randomized and 3 nonrandomized clinical trials, containing data on 2935 adult and elderly individuals with normal weight or overweight, were included. All extracted data were compiled, compared, and critically analyzed. The authors of most of the studies demonstrated a reduction in serum concentrations of advanced glycation end products (AGEs), such as εN-carboxymethyllysine and methylglyoxal, and in skin autofluorescence levels after at least 4 weeks of adherence to the MedDiet. The MedDiet also led to positive effects on gene expression of receptors for AGEs, as RAGE and AGER1, and an enzyme involved in detoxification (glyoxalase I). There is no evidence that short-term adherence affects glycation markers. Glycation markers improved in response to the MedDiet. The possible mechanisms involved may be related to the low AGE and refined sugars content of the diet, as well as its high monounsaturated fatty acid, phenolic compound, and dietary fiber contents. PROSPERO registration no. CRD42021284006.

Anticonvulsants in the Treatment of Behavioral and Psychological Symptoms in Dementia: A Systematic Review

ObjectivesBehavioral and psychological symptoms of dementia (BPSD) are common and impart a significant burden to patients, caregivers, and the health system. However, there are few pharmacological options for treating BPSD. We conducted a systematic review of clinical trials examining the efficacy of anticonvulsants in BPSD. MethodsWe searched five electronic databases through January 2023, for randomized controlled trials and systematic reviews evaluating the efficacy of non-benzodiazepine anticonvulsants for the treatment of BPSD. We used the Cochrane risk of bias tool to ascertain the risk of bias in included trials. Because statistical pooling of results using meta-analysis was not feasible, we synthesized findings using the Cochrane Synthesis Without Meta-analysis reporting guidelines. ResultsWe identified 12 studies, including randomized controlled trials (RCTs) and 1 systematic review. Five RCTs evaluating valproic acid were synthesized by a recent Cochrane review which concluded that this drug is likely ineffective for BPSD. We extracted data from 6 trials involving 248 individuals comparing non-benzodiazepine anticonvulsants to either placebo or risperidone. Four trials (n = 97 participants) evaluated carbamazepine, only one of which demonstrated an improvement in the Brief Psychiatric Rating Scale measuring agitation, hostility, psychosis, and withdrawal/depression (effect size: 1.13; 95% confidence interval [CI]: 0.54–1.73) relative to placebo. Adverse effects were more common in patients receiving carbamazepine (20/27; 74%) relative to placebo (5/24; 21%). There is low quality evidence that oxcarbazepine is likely ineffective and that topiramate may be comparable to risperidone. ConclusionAnticonvulsants are unlikely to be effective in BPSD, although the quality of existing evidence is low.

Tooth movement with dental anchorage vs. skeletal anchorage: A systematic review of clinical trials.

The aim of this study is to compare the time and movement of orthodontic treatment using dental anchorage and skeletal anchorage in adolescent and adult patients with dental malocclusions. A systematic search was conducted in the Embase, PubMed, Lilacs, Cochrane, Trip, and Scopus databases up to October 2022. All the articles were selected using title and abstract, applying the inclusion and exclusion criteria. Disagreements were resolved with a third author. Finally, a full-text selection took place. The data extraction was conducted by two authors who independently evaluated the risk of bias. The methodological quality of the randomized clinical trials was evaluated using the Cochrane tool for the evaluation of the randomized clinical trials. Six articles were included in the data analysis. There were four clinical trials and two randomized clinical trials. A total of 176 patients was obtained with an age range between 14 and 46 years. Four studies showed significant differences when comparing the two anchorages in retraction or distalization of tooth groups, and two showed no differences when using dental and skeletal anchorage for vertical movements; only the articles with vertical movements showed relapse. We can conclude that skeletal anchorage generates precise and stable horizontal movements without overloading or changing the position of the molar. Future studies must incorporate three-dimensional technology for greater clinical accuracy.

Effect of level of sedation on outcomes in critically ill adult patients: a systematic review of clinical trials with meta-analysis and trial sequential analysis

Sedation is routinely administered to critically ill patients to alleviate anxiety, discomfort, and patient-ventilator asynchrony. However, it must be balanced against risks such as delirium and prolonged intensive care stays. This study aimed to investigate the effects of different levels of sedation in critically ill adults. Systematic review with meta-analysis and trial sequential analysis (TSA) of randomised clinical trials including critically ill adults admitted to the intensive care unit. CENTRAL, MEDLINE, Embase, LILACS, and Web of Science were searched from their inception to 13 June 2023. Risks of bias were assessed using the Cochrane risk of bias tool. Primary outcome was all-cause mortality. Aggregate data were synthesised with meta-analyses and TSA, and the certainty of the evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. This study is registered with PROSPERO: CRD42023386960. Fifteen trials randomising 4352 patients were included, of which 13 were assessed high risk of bias. Meta-analyses comparing lighter to deeper sedation showed no evidence of a difference in all-cause mortality (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.83-1.06; p=0.28; 15 trials; moderate certainty evidence), serious adverse events (RR 0.99, CI 0.92-1.06; p=0.80; 15 trials; moderate certainty evidence), or delirium (RR 1.01, 95% CI 0.94-1.09; p=0.78; 11 trials; moderate certainty evidence). TSA showed that when assessing mortality, a relative risk reduction of 16% or more between the compared interventions could be rejected. The level of sedation has not been shown to affect the risks of death, delirium, and other serious adverse events in critically ill adult patients. While TSA suggests that additional trials are unlikely to significantly change the conclusion of the meta-analyses, the certainty of evidence was moderate. This suggests a need for future high-quality studies with higher methodological rigor. None.

Clinical Effectiveness of High-viscosity Glass Ionomer Cement and Composite Resin as a Restorative Material in Primary Teeth: A Systematic Review of Clinical Trials

Clinical Effectiveness of High-viscosity Glass Ionomer Cement and Composite Resin as a Restorative Material in Primary Teeth: A Systematic Review of Clinical Trials

Comparison of revision rates and epidemiological data of a single total knee arthroplasty system of different designs (cruciate retaining, posterior stabilized, mobile bearing, and fixed bearing): a meta-analysis and systematic review of clinical trials and national arthroplasty registries

BackgroundThis study aimed to meta-analyze epidemiological data, revision rates, and incidences of different designs of a single Total Knee Arthroplasty System and compare these factors across different countries.MethodsA systematic review was conducted on clinical studies and arthroplasty registries of ATTUNE TKA from 1999 to 2020. The main endpoints analyzed were revision rates and epidemiological data.ResultsThe average age of patients was 67.8 years, with a gender distribution of 60% female and 40% male. The pooled average BMI was 29.4 kg/m2. Eight clinical studies showed a pooled revision rate per 100 observed CY of 0.5 (n = 1343 cases). Cumulative revision rates after 1, 3, and 5 years varied among registries, with the Swiss registry having the highest revision data (after 5 years: 6.3%) and the American registry having the lowest revision data (after 5 years: 1.7%). A comparison of the revision rates of mobile bearing and fixed bearing (41,200 cases) as well as cruciate retaining and posterior stabilized (n = 123,361 cases) showed no significant advantage in the first 5 years after implantation.ConclusionIn conclusion, pooled data from 41,200 cases of TKA with a single Total Knee Arthroplasty System in two arthroplasty registries revealed that there was no significant difference in revision rates between the mobile bearing and fixed bearing design within the first 5 years after implantation. In addition, a comparison of the revision rates in n = 123,361 cases showed no significant advantage for cruciate retaining or posterior stabilized in the first 5 years after implantation.

Evaluating Glass Ionomer Cement Longevity in the Primary and Permanent Teeth-An Umbrella Review.

The aim of this umbrella review was to evaluate the longevity of glass ionomer cement (GIC) as a restorative material for primary and permanent teeth. Research in the literature was conducted in three databases (MedLine/PubMed, Web of Science, and Scopus). The inclusion criteria were: (1) to be a systematic review of clinical trials that (2) evaluated the clinical longevity of GICs as a restorative material in primary and/or permanent teeth; the exclusion criteria were: (1) not being a systematic review of clinical trials; (2) not evaluating longevity/clinical performance of GICs as a restorative material; and (3) studies of dental restorative materials in teeth with enamel alterations, root caries, and non-carious cervical lesions. Twenty-four eligible articles were identified, and 13 were included. The follow-up periods ranged from 6 months to 6 years. Different types of GICs were evaluated in the included studies: resin-modified glass ionomer cement (RMGIC), compomers, and low- and high-viscosity glass ionomer cement. Some studies compared amalgam and composite resins to GICs regarding longevity/clinical performance. Analyzing the AMSTAR-2 results, none of the articles had positive criteria in all the evaluated requisites, and none of the articles had an a priori design. The criteria considered for the analysis of the risk of bias of the included studies were evaluated through the ROBIS tool, and the results of this analysis showed that seven studies had a low risk of bias; three studies had positive results in all criteria except for one criterion of unclear risk; and two studies showed a high risk of bias. GRADE tool was used to determine the quality of evidence; for the degree of recommendations, all studies were classified as Class II, meaning there was still conflicting evidence on the clinical performance/longevity of GICs and their recommendations compared to other materials. The level of evidence was classified as Level B, meaning that the data were obtained from less robust meta-analyses and single randomized clinical trials. To the best of our knowledge, this is the first umbrella review approaching GIC in permanent teeth. GICs are a good choice in both dentitions, but primary dentition presents more evidence, especially regarding the atraumatic restorative treatment (ART) technique. Within the limitation of this study, it is still questionable if GIC is a good restorative material in the medium/long term for permanent and primary dentition. Many of the included studies presented a high risk of bias and low quality. The techniques, type of GIC, type of cavity, and operator experience highly influence clinical performance. Thus, clinical decision-making should be based on the dental practitioner's ability, each case analysis, and the patient's wishes. More evidence is needed to determine which is the best material for definitive restorations in permanent and primary dentition.

The effect of Oenothera biennis (Evening primrose) oil on inflammatory diseases: a systematic review of clinical trials

BackgroundEvening primrose oil (EPO), extracted from the seeds of Oenothera biennis, has gained attention for its therapeutic effects in various inflammatory conditions.MethodWe performed a systematic search in multiple databases and defined the inclusion criteria based on the following PICOs: P: Patients with a form of inflammatory condition, I: EPO, C: Placebo or other therapeutic interventions, O: changes in inflammatory markers or patients’ symptoms; S: randomized controlled trials. The quality of the RCTs was evaluated using Cochrane’s RoB tool.ResultsSeveral conditions were investigated in the literature. In rheumatoid arthritis, mixed results were observed, with some studies reporting significant improvements in symptoms while others found no significant impact. EPO showed some results in diabetes mellitus, atopic eczema, menopausal hot flashes, and mastalgia. However, it did not demonstrate effectiveness in chronic hand dermatitis, tardive dyskinesia, psoriatic arthritis, cystic fibrosis, hepatitis B, premenstrual syndrome, contact lens-associated dry eyes, acne vulgaris, breast cyst, pre-eclampsia, psoriasis, or primary Sjogren's syndrome. Some results were reported from multiple sclerosis after EPO consumption. Studies in healthy volunteers indicated no significant effect of EPO on epidermal atrophy, nevertheless, positive effects on the skin regarding hydration and barrier function were achieved.ConclusionSome evidence regarding the potential benefits of EPO in inflammatory disorders were reported however caution is due to the limitations of the current survey. Overall, contemporary literature is highly heterogeneous and fails to provide strong recommendations regarding the efficacy of EPO on inflammatory disorders. Further high-quality studies are necessitated to draw more definite conclusions and establish O. biennis oil effectiveness as an assuring treatment option in alleviating inflammatory conditions.

Safety, Efficacy, and Immunogenicity of Therapeutic Vaccines for Patients with High-Grade Cervical Intraepithelial Neoplasia (CIN 2/3) Associated with Human Papillomavirus: A Systematic Review

Despite the knowledge that HPV is responsible for high-grade CIN and cervical cancer, little is known about the use of therapeutic vaccines as a treatment. We aimed to synthesize and critically evaluate the evidence from clinical trials on the safety, efficacy, and immunogenicity of therapeutic vaccines in the treatment of patients with high-grade CIN associated with HPV. A systematic review of clinical trials adhering to the PRISMA 2020 statement in MEDLINE/PubMed, Embase, CENTRAL Cochrane, Web of Science, Scopus, and LILACS was undertaken, with no data or language restrictions. Primary endpoints related to the safety, efficacy, and immunogenicity of these vaccines were assessed by reviewing the adverse/toxic effects associated with the therapeutic vaccine administration via histopathological regression of the lesion and/or regression of the lesion size and via viral clearance and through the immunological response of individuals who received treatment compared to those who did not or before and after receiving the vaccine, respectively. A total of 1184 studies were identified, and 16 met all the criteria. Overall, the therapeutic vaccines were heterogeneous regarding their formulation, dose, intervention protocol, and routes of administration, making a meta-analysis unfeasible. In most studies (n = 15), the vaccines were safe and well tolerated, with clinical efficacy regarding the lesions and histopathological regression or viral clearance. In addition, eleven studies showed favorable immunological responses against HPV, and seven studies showed a positive correlation between immunogenicity and the clinical response, indicating promising results that should be further investigated. In summary, therapeutic vaccines, although urgently needed to avoid progression of CIN 2/3 patients, still present sparse data, requiring greater investments in a well-designed phase III RCT.

Compositional music therapy: A systematic review of clinical trials

Purpose: Compositional music therapy involves the creation of original music by the therapist, the patient/client, or both together. The purpose of this systematic review is to examine techniques of compositional music therapy and the evidence for its therapeutic uses. Methods: PRISMA guidelines were followed in performing this systematic review. Studies published in the last 25 years from January 1998 to December 2023 were identified through the use of the PubMed, PsycInfo, and Google Scholar databases, using the following keywords: Musi*, AND Therap*, AND Compos*. Two authors independently conducted a focused analysis and reached a final consensus on nine studies that met the specific selection criteria and passed the study quality checks. Results: Review yielded four key compositional music therapy techniques: songwriting, lyric analysis, instrumental composition, and therapeutic rap and singing. Eight out of the nine studies showed positive results for compositional music therapy. These techniques were associated with reduction in anxiety levels and an enhancement of positive affective states, the development of coping strategies, and improvement of emotional regulation. Conclusion: This review shows a body of positive evidence for compositional music therapy, highlighting its potential to foster psychological and physiological well-being across various demographics, especially in terms of coping strategies and emotion regulation. Future directions include the use of digital music technology for composition in music therapy.

Transcranial Direct Current Stimulation for Improving Spasticity, Gross Motor Functions, Balance and Gait in Spastic Cerebral Palsy: Systematic Review of Clinical Trials.

Context: Cerebral palsy is known as a non-progressive neuromotor disorder that is characterized by abnormalities of muscular tonicity, gross and fine motor skills, balance, posture and gait. Transcranial direct current stimulation (tDCS) has emerged as a rather promising therapeutic tool for the management of the above-mentioned symptoms and to possibly to optimize the rehabilitation strategies. Purpose: This review study evaluates the effectiveness of tDCS on spasticity, gross motor function, balance, and gait; it also tends to summarize the beneficial protocols of tDCS for spastic cerebral palsy patients. Methods: Comprehensive searches were performed on three electronic databases including PubMed, PEDro, and Cochrane. The inclusion criteria for considered articles were (1) English-language publications available in full text between 2000 and 2023.(2), The PEDro scale, where a score of at least 5 out of 10 was acceptable, (3) Human studies using the tDCS intervention with control group , and (4) Study design (PICOS) method, where P = spastic CP; I = transcranial direct current stimulation; C = conventional physical Therapy; O = muscle strength, spasticity, , and gait kinematics; and S = RCT. Results: Nine RCTs were included based on the inclusion criteria. This systematic review showed transcranial direct current stimulation is a non-invasive safe modality, and well-tolerated brain stimulation technique with positive effects on gross motor function, spasticity, balance, muscle strength, and gait. Besides, it can be used in conjunction with different modalities as well as conventional physical therapy. Conclusion: It can be concluded that transcranial direct current stimulation is a novel, fairly simple, low cost and low risk therapeutic modality that can be easily administered in a clinic as well as at home to produce a significant change in spasticity, balance, gross motor function, and gait.

Immune-related adverse events in patients with gastrointestinal cancer undergoing pembrolizumab monotherapy: A systematic review of clinical trials.

744 Background: Pembrolizumab, an immune checkpoint inhibitor targeting programmed death 1 (PD-1), is widely employed in the treatment of various gastrointestinal (GI) cancers. This systematic review aims to assess the spectrum and incidence of immune-related adverse events (irAEs) associated with pembrolizumab monotherapy in GI cancer patients. Methods: A comprehensive search of PubMed/MEDLINE was conducted to identify full-text articles of clinical trials investigating pembrolizumab monotherapy in GI cancer patients. Two independent authors reviewed the articles and extracted data, with discrepancies resolved by consensus. Primary endpoints included the incidence of grade 3 or higher irAEs and the treatment discontinuation rate due to irAEs. Secondary endpoints encompassed the incidence of any-grade irAEs and specific irAEs such as pneumonitis, colitis, hepatitis, myositis, myocarditis, nephritis, pancreatitis, peripheral neuropathy, skin toxicity, endocrine toxicity, infusion reactions, and deaths. Results: After excluding duplicates and articles not meeting inclusion criteria, data extraction and analysis were performed on 25 selected articles. Common reasons for exclusion included concomitant use of chemotherapy or targeted therapy and trials involving non-GI cancer patients. The analysis included 2866 patients with a median age of 62 years, of which 29% were female. Tumor types included colorectal (13%), esophagogastric (46%), hepatocellular carcinoma (25%), and others (16%). The aggregate incidence of grade 3 or higher irAEs was 8.7%, with reported rates ranging from 3% to 41% across different trials. The incidence of any grade irAEs varied from 39% to 98%. The treatment discontinuation rate due to irAEs was 6.8%. The most common grade 3 or higher irAEs were hepatitis (3.6%), pneumonitis (0.8%), and colitis (0.7%). irAE-related deaths were infrequent (0.9%). Detailed irAE data are summarized in the Table. Conclusions: In GI cancer patients receiving pembrolizumab monotherapy, severe irAEs are rare. Treatment discontinuation and deaths attributed to pembrolizumab-related irAEs are infrequent, underscoring the safety profile of this therapy in patients with GI cancer. [Table: see text]

The Effect of Oral Chamomile on Anxiety: A Systematic Review of Clinical Trials.

Anxiety disorder is a prevalent psychiatric issue that affects 4.05% of the global population. As complementary and alternative medicine gains popularity, many individuals with anxiety symptoms seek herbal remedies. This systematic review aims to explore the sedative efficacy of chamomile as an herbal medicine for anxiety treatment. Our search was conducted in PubMed, Google Scholar, and Scopus databases until August 2023. Among 389 papers found, after removing duplicates and irrelevant papers, 10 clinical trials investigating the effect of oral consumption of chamomile on anxiety were included. Two researchers independently completed all steps, including the screening process and data extraction. Out of the 10 articles selected, 9 studies have concluded that chamomile is effective in reducing anxiety. Even though, the exact mechanism of chamomile's anxiolytic action is not well understood, evidence suggests that its active compounds, including apigenin, may modulate the function of the hypothalamic-pituitary-adrenocortical axis by affecting neurotransmitter pathways. This systematic review showed that chamomile potentially has an anxiolytic effect. In addition, due to the side effects of drugs used to treat anxiety disorders, the use of chamomile seems to be effective and less dangerous.

Effect of photobiomodulation on postoperative endodontic pain: A systematic review of clinical trials

ABSTRACT Background: This review aims to perform a complete evaluation of the impact of photobiomodulation (PMB) on postoperative endodontic pain. Materials and Methods: The PRISMA checklist was used to perform this systematic review. The electronic databases were searched, including Google Scholar, PubMed, and Embase. Sixty-three papers were obtained through a main electronic search and a hand search. Nine trials met the criteria after screening the titles, abstracts, and/or full texts. Results: Seven out of nine studies showed that PMB has a significant impact on relieving postoperative endodontic pain, with no statistically significant difference in the severity of pain between the laser and control groups in the two remaining studies. In addition, eight studies showed no adverse effects, indicating that we can remove the adverse effects of drugs such as nonsteroidal anti-inflammatory drugs. However, one study showed evidence of the consequences of PMB application on teeth with symptomatic irreversible pulpitis. Therefore, it can be concluded that PMB should not be used in teeth with pain because of irreversible pulpitis. Conclusion: Although there is some understanding from a cellular viewpoint of the effects of PMB, there is still some uncertainty about whether these cell-level modifications impact reducing the postendodontic pain.

Chordoma: A Comprehensive Systematic Review of Clinical Trials.

This systematic review aims to characterize ongoing clinical trials and therapeutic treatment options for chordoma, a rare notochordal remnant tumor that primarily affects the cranial base, mobile spine, and sacrum. While radical surgical resection remains the cornerstone for chordoma management, unique technical challenges posed by its proximity to critical neurovascular structures confer a tendency towards disease recurrence which often requires additional treatment modalities. In an attempt to better understand the current treatment landscape, a systematic review was designed to identify clinical trials directed at chordoma. A total of 108 chordoma trials were identified from four clinical trial databases; fifty-one trials were included in the final analysis, of which only 14 were designated as completed (27.5%). Aggregate data suggests most chordoma interventions are repurposed from other neoplasms that share common molecular pathways, with a recent emphasis on combination therapeutics within and across drug classes. Naturally, the publication and dissemination of clinical trial results remain a concern (n = 4, 28.6%), highlighting the need for enhanced reporting and transparency measures. Active clinical trial efforts are quite promising, with a renewed focus on novel biotherapeutic targets and deciphering the natural history, as well as survivorship of this complex disease.

The safety and efficacy of tislelizumab, alone or in combination with chemotherapy, for the treatment of non-small cell lung cancer: a systematic review of clinical trials

BackgroundTislelizumab is an anti-programmed death-1 (PD-1) monoclonal antibody with a construction that enables it to have a higher affinity to its target. We aimed to evaluate tislelizumab’s safety and efficacy for treating non-small cell lung cancer (NSCLC).MethodsEmbase, Scopus, PubMed, Web of Science, and Google Scholar were searched up to December 20, 2022. The review only included randomized controlled trials (RCTs) that evaluated the safety or efficacy of tislelizumab for treating patients with lung cancer. The revised Cochrane risk-of-bias tool (RoB2) was utilized to evaluate study quality.ResultsThere were four RCTs identified, which included 1565 patients with confirmed locally advanced or metastatic squamous and/or non-squamous types of NSCLC. Treatment with tislelizumab was associated with better progression-free survival (PFS) and objective response rate (ORR), particularly when used in combination with chemotherapy. Almost all patients in both arms reported at least one treatment-emergent adverse event (TEAE). Decreased hematologic indexes accounted for more than 20% of the grade ≥ 3 TEAEs in the tislelizumab plus chemotherapy group. The proportion of TEAE that led to death in the tislelizumab plus chemotherapy arms ranged from 3.2 to 4.2%. Hypothyroidism, pneumonitis, and hyperglycemia were the most frequently noted immune-mediated adverse events in the tislelizumab group.ConclusionsTislelizumab, whether used alone or in combination with chemotherapy, seems to demonstrate both a safety and efficacy as a treatment for NSCLC.

Eficacia de las intervenciones fisioterápicas sobre la musculatura respiratoria mediante técnicas de entrenamiento respiratorio en el postoperatorio de trasplantados pulmonares: una revisión sistemática

IntroductionRespiratory muscles are a limiter of exercise capacity in lung transplant patients. It is necessary to know the effectiveness of specific respiratory muscle training techniques carried out in the management of adult lung transplant patients in the postoperative period. Material and methodsA systematic review of clinical trials was carried out, which included adult lung transplant patients undergoing post-transplant respiratory training. A search was carried out in the databases PubMed/Medline, EMBASE, Scopus, Web of Science, Cochrane Library between January 2012 and September 2023, using the terms: “breathing exercise”, “respiratory muscle training”, “inspiratory muscle training”, “respiratory exercise”, “pulmonary rehabilitation”, “lung rehabilitation”; in combination with “lung transplantation”, “lung transplant”, “posttransplant lung”. No language limit. ResultsEleven trials were included with a total of 639 patients analyzed. Most training programs begin upon hospital discharge (more than one month post-transplant), few do so early (Intensive Care Unit). The duration varies from 1-12 months post-transplant. The interventions were based on aerobic training and peripheral muscle strength. Some of them included breathing exercises and chest expansions. The most used outcome variable was submaximal exercise capacity measured with the 6-minute walk test. ConclusionsTraining the respiratory muscles of the adult transplant patient favors the improvement of exercise capacity and quality of life. Aerobic training, as well as strength training of the rest of the peripheral muscles, contribute to the improvement of respiratory muscles.

Herbal treatment options for female fertility disorders: a systematic review of clinical trials

Herbal treatment options for female fertility disorders: a systematic review of clinical trials

Effectiveness and Tolerability of ICE Combinations in Relapsed/Refractory Hodgkin's Lymphoma; A Systematic Review of Clinical Trials

Background: Hodgkin's Lymphoma (HL), especially classic (cHL) subtype has a favorable prognosis and frontline therapy in almost 70-80% reach a durable complete remission. However, 10-30 % of patients relapse after achieving response, and an additional almost 14-15% will never achieve complete remission and will have refractory disease. Both groups need a second line chemotherapy regimen and possible transplantation. Among 2 nd line chemotherapy regimens, a combination of ifosfamide (I), carboplatin (C), and etoposide (E) is preferred. The aim of this systematic review is to study the efficacy and safety of combinations of ICE with other drugs in relapsed/refractory (RR) HL patients. Methods: We followed PRISMA guidelines to conduct this systematic review. A literature search was performed on PubMed, Embase, and Clinicaltrials.gov with mesh terms, “Hodgkin Lymphoma” and “ICE” from the inception of data till 07/06/2023. We screened 1412 articles and included 2 phase II randomized clinical trials (N=43) and 4 nonrandomized clinical trials (N=109), measuring the efficacy and safety of combinations of ICE in RR HL. Data was extracted for overall response rate (ORR), complete response (CR), partial response (PR), overall survival (OS) and progression free survival (PFS). Results: In the included clinical trials (N=152), ICE was combined with Immune check point inhibitors (ICIs) in two clinical trials on Pembrolizumab (PEM) and Nivolumab (N) (N=46). Panobinostat (PAN) was combined with ICE in phase I and phase I/II trials (N=32). Bortezomib (B) (N=10) and Brentuximab Vedotin (BV) (N=42) were studied in randomized phase II and phase I in combination with ICE, respectively. In 2 clinical trials (N=46) on combinations of ICE with ICIs, ORR, CR, and PR was 97-100%, 86-89%, and 11%. Grade≥3 hematological toxicity was 52% and 22% in PEM-ICE and NICE, respectively. The 2-year PFS and OS were 72% (95% CI: 56-83) and 95% (95% CI: 82-99), respectively in NICE study. BV-ICE showed ORR, CR, and PR of 76%, 60% and 16%, respectively with a 3-year OS and PFS of 100% and 64%, respectively. Combined grade ≥3 adverse events were 83.3%. PAN-ICE showed ORR, CR, and PR of 82-86%, 71-82%, 15% in phase I and II clinical trials but at the cost of greater myelosuppression depicted by thrombocytopenia's in 80-100% of patients. On the other hand, ICE alone showed ORR, CR, and PR of 75%, 67%, and 8%, respectively without causing significant myelosuppression. BICE showed ORR, CR, and PR of 70%, 30%, and 40%, respectively in comparison to ICE ORR, CR, and PR of 60%, 10% and 50%, respectively. BICE group showed the OS and PFS of 70% and 30%, respectively in comparison to 89% and 60%, respectively in ICE alone at 24 months. Grade≥3 adverse effects were also higher i.e., 37% in the BICE group in comparison to 28% in ICE alone. Table.1 Conclusion: Concurrent treatment with ICE and ICIs was well tolerated and was associated with improved effectiveness. BV-ICE achieved a greater CR regardless of frontline treatment and toxicity was manageable. PAN-ICE combination also produced high CR rate but at the cost of greater bone marrow toxicity. Investigation of PAN with less myelosuppressive agent can be considered for future trials. Due to the lack of significant improvement in outcomes of BICE as compared to ICE, this trial was stopped. More randomized double-blind large-scale phase III studies for further evaluation are needed.