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Journal of Psychiatric Research Nov 2023The benefits of serotonin 3 receptor antagonists (5-HT3R-As) in obsessive-compulsive disorder (OCD) treatment remain unclear. Thus, this study aimed to perform a... (Meta-Analysis)
Meta-Analysis
The benefits of serotonin 3 receptor antagonists (5-HT3R-As) in obsessive-compulsive disorder (OCD) treatment remain unclear. Thus, this study aimed to perform a systematic review and a random-effects meta-analysis, including double-blind, randomized, placebo-controlled trials (DBRPCTs). The outcomes include the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score (primary), Y-BOCS obsession subscale score, Y-BOCS compulsive subscale score, treatment response, remission rate, all-cause discontinuation, and incidence of individual adverse events (nervousness/restlessness/anxiety, insomnia, headache, dizziness/lightheadedness, decreased appetite, constipation, nausea/vomiting, diarrhea, dry mouth, sweating/increased perspiration, itching/pruritus, tremor, and sexual dysfunction/decreased libido). The mean differences (MD) for continuous outcomes and risk ratios for dichotomous outcomes with 95% confidence intervals (CIs) were calculated. Our study included 10 DBRPCTs (n = 628). Pooled 5-HT3R-As outperformed placebo regarding Y-BOCS total score (MD = -5.08, 95% CI = -7.04, -3.12, N = 9, n = 560), Y-BOCS obsession subscale score, Y-BOCS compulsive subscale score, treatment response, and remission rate. Individually, all 5-HT3R-As outperformed placebo regarding Y-BOCS total score (granisetron: MD = -5.59, 95% CI = -8.79, -2.39, N = 3, n = 178, ondansetron: MD = -5.72, 95% CI = -8.06, -3.37, N = 6, n = 331, tropisetron: MD = -2.87, 95% CI = -5.19, -0.550, N = 1, n = 96). However, all-cause discontinuation and incidence of individual adverse events between pooled 5-HT3R-As and placebo were not significantly different. In conclusion, our meta-analysis suggested 5-HT3R-As as efficacious for symptom improvement in individuals with OCD. However, the number of individuals included in each study was small; thus, a replication randomized trial of 5-HT3R-As should be conducted using a larger sample size.
Topics: Humans; Obsessive-Compulsive Disorder; Serotonin 5-HT3 Receptor Antagonists; Randomized Controlled Trials as Topic; Outcome Assessment, Health Care
PubMed: 37866327
DOI: 10.1016/j.jpsychires.2023.10.029 -
The Clinical Journal of Pain Jan 2024To summarize and appraise the use of dexmedetomidine in epidural labor analgesia, we conducted a systematic review and meta-analysis of randomized controlled trials... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To summarize and appraise the use of dexmedetomidine in epidural labor analgesia, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs).
METHODS
We conducted the literature search about the RCTs of epidural labor analgesia with or without dexmedetomidine from inception until November 1, 2022, in the following databases: PubMed, Cochrane Library, and Embase. The primary outcome was visual analog scale (VAS) within 2 hours after epidural intubation. The secondary outcomes included the duration of the first and second labor stages, Apgar score, umbilical blood pH, dosage of analgesics, and side effects.
RESULTS
Eight RCTs including 846 parturients were included. The VAS score of the dexmedetomidine group was significantly lower than that of the control group at the time of 15 minutes (mean difference [MD] -1.41, 95% confidence interval [CI] -2.23, -0.59), 30 minutes (MD -1.02, 95% CI -1.70, -0.33), 60 minutes (MD -0.90, 95% CI -1.36, -0.44), and 90 minutes (MD -0.70, 95% CI -1.16, -0.23). The incidence of pruritus in the dexmedetomidine group was lower than that of the control group (MD 0.28, 95% CI 0.11, 0.74), but the incidence of maternal bradycardia was higher (MD 6.41, 95% CI 1.64, 25.04). There were no significant difference in other outcomes.
DISCUSSION
Dexmedetomidine combined with local anesthetic for epidural labor analgesia can improve the VAS score of parturients. Except for the increased incidence of maternal bradycardia, it seems to be safe for the parturients and fetuses.
Topics: Female; Humans; Dexmedetomidine; Bradycardia; Randomized Controlled Trials as Topic; Analgesics; Analgesia, Epidural; Analgesia, Obstetrical
PubMed: 37855310
DOI: 10.1097/AJP.0000000000001166 -
Clinics (Sao Paulo, Brazil) 2023Lipolytic substance injections to reduce localized fat have been extensively used because it is a low-invasive method. This review aimed to evaluate the efficacy and... (Meta-Analysis)
Meta-Analysis Review
Efficacy, safety, and potential industry bias in using deoxycholic acid for submental fat reduction ‒ A systematic review and meta-analysis of randomized clinical trials.
Lipolytic substance injections to reduce localized fat have been extensively used because it is a low-invasive method. This review aimed to evaluate the efficacy and safety of deoxycholic acid in submental fat reduction compared to a placebo and investigate the potential industry sponsorship bias in the results of randomized clinical trials on this topic. Ten electronic databases were extensively searched for randomized clinical trials without restriction on language and year of publication. Two reviewers extracted the data and assessed the individual risk of bias in the studies with the RoB 2.0 tool. The industry sponsorship bias was evaluated according to citations in the articles regarding industry funding/sponsorship throughout the texts. Fixed and random effects meta-analyses were performed, and the results were reported in Risk Ratio (RR) at a 95% Confidence Interval (95% CI). The initial search provided 5756 results, of which only five were included. Only two studies had a low risk of bias. All studies showed a potential industry bias. The meta-analysis showed that patients treated with deoxycholic acid had significant positive results for all efficacy outcomes and a higher risk of fibrosis, pain, erythema, numbness, swelling, edema, pruritus, nodules, headache, and paresthesia. The low to moderate certainty of evidence found allows concluding that deoxycholic acid is effective in submental fat reduction, causing well-tolerated adverse effects. However, all eligible studies showed a potential industry bias.
Topics: Humans; Randomized Controlled Trials as Topic; Pain; Deoxycholic Acid; Bias
PubMed: 37806137
DOI: 10.1016/j.clinsp.2023.100220 -
Acta Oncologica (Stockholm, Sweden) Dec 2023Patients with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors (TKIs) often experience cutaneous adverse events, such as rashes and pruritus. In... (Meta-Analysis)
Meta-Analysis
Comparison of cutaneous adverse events between second-generation tyrosine kinase inhibitors and imatinib for chronic myeloid leukemia: a systematic review and meta-analysis.
BACKGROUND
Patients with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors (TKIs) often experience cutaneous adverse events, such as rashes and pruritus. In this study, we aimed to compare the risks of cutaneous adverse events between imatinib- and second-generation TKI-treated patients with CML.
MATERIAL AND METHODS
Paired reviewers independently obtained studies from PubMed, Embase, and Cochrane Library published until 15 March 2022. The following terms were searched: (Leukemia, Myelogenous, Chronic and BCR-ABL Positive), chronic myeloid leukemia, tyrosine kinase inhibitor, TKI, imatinib, dasatinib, nilotinib, bosutinib, and radotinib. Two independent reviewers screened the results and selected articles on cutaneous adverse events. RevMan 5.4 and the Cochrane Collaboration tool were used to perform the meta-analysis and risk of bias assessment.
RESULTS AND CONCLUSION
Eleven trials involving 4502 patients were analyzed in this study. Patients treated with second-generation TKIs were significantly more likely to experience cutaneous adverse events than those treated with imatinib with a relative risk (RR) of 1.62 (95% confidence interval [CI], [1.25-2.09]). Except dasatinib (RR [95% CI], 1.39 [0.75-2.56]), the risk of adverse events was more with second-generation TKIs than with imatinib as follows: nilotinib (2.11 [1.53-2.90]), bosutinib (1.41 [1.07-1.86]), and radotinib (1.87 [1.33-2.63]). Rash was the most common cutaneous adverse event that was observed in 21.6% of cases across all grades, followed by pruritus (5.7%) and alopecia (4.3%). In conclusion, our findings suggest that cutaneous adverse events occur more frequently with second-generation TKIs than with imatinib. Therefore, effective management of the cutaneous outcome is necessary to achieve high patient adherence to medication and successful treatment with TKIs.
Topics: Humans; Imatinib Mesylate; Dasatinib; Tyrosine Kinase Inhibitors; Protein Kinase Inhibitors; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Pyrimidines; Pruritus; Exanthema; Antineoplastic Agents
PubMed: 37787749
DOI: 10.1080/0284186X.2023.2263152 -
Dermatitis : Contact, Atopic,... 2024Atopic Dermatitis® (AD) is an inflammatory skin disease characterized by intense itching and highly visible signs, representing a great burden to the patient. Despite... (Review)
Review
Atopic Dermatitis® (AD) is an inflammatory skin disease characterized by intense itching and highly visible signs, representing a great burden to the patient. Despite its straightforward diagnosis, AD severity and burden can be underestimated in routine clinical practice. This review aims to determine the impact of AD on patients' lives, establish which domains of life are most affected, and identify symptom drivers of AD burden. A systematic literature review was conducted in Pubmed/Medline, Web of Science, and Scopus following Cochrane and PRISMA recommendations. Observational studies published in English or Spanish between January 1, 2018, and August 31, 2022, evaluating the impact of AD and its symptoms from the patient's perspective, were included. Reviewed studies were assessed for quality following the STrengthening the Reporting of OBservational studies in Epidemiology Checklist. A total of 28 observational studies evaluating the impact of AD and its symptoms from the patient's perspective were included in the review. All domains of the AD patient's life were found to be greatly affected, including health-related quality of life (HRQoL), emotional health, sleep disorders, work impairment, health care resource utilization, cognitive function, and development of comorbidities. The more severe the disease, the greater the impact, worsening in patients with moderate and severe AD. Pruritus and pain are reported to be the disease symptoms with the greatest impact. In conclusion, AD impacts several domains of patients' lives, especially HRQoL and mental health. Pruritus and pain are identified as the main drivers of AD impact, suggesting that optimal symptom control may reduce the burden and improve disease management.
Topics: Humans; Pruritus; Dermatitis, Atopic; Quality of Life; Pain; Cost of Illness; Severity of Illness Index
PubMed: 37751176
DOI: 10.1089/derm.2023.0163 -
Dermatology and Therapy Nov 2023Assessing treatment response is key to determining treatment value in atopic dermatitis (AD). Currently, response is assessed using various clinician- or... (Review)
Review
INTRODUCTION
Assessing treatment response is key to determining treatment value in atopic dermatitis (AD). Currently, response is assessed using various clinician- or patient-reported measures and response criteria. This variation creates a mismatch of evidence across trials, hindering the ability of clinicians, regulators, and payers to compare the efficacy of treatments. This review identifies which measures and criteria are used to determine response in clinical trials and health technology assessments (HTAs). Moreover, it systematically reviews the psychometric performance of those measures and criteria to understand which perform best in capturing patient-relevant symptoms and treatment benefits.
METHODS
A scoping review of clinical trials and HTAs in AD identified the following measures for inclusion: the Eczema Area and Severity Index (EASI), the Investigator's Global Assessment (IGA), the Dermatology Life Quality Index (DLQI) and the Peak Pruritus Numerical Rating Scale (PP-NRS). A systematic search was performed in MEDLINE and Embase to identify studies testing the psychometric performance of these measures in adults or adolescents with AD.
RESULTS
A lack of consistency in the assessment of response was observed across clinical trials and HTAs. Important gaps in psychometric evidence were identified. No content validations of the EASI and IGA in AD were found, while some quantitative studies suggested that these measures fail to capture itch, a core symptom. The PP-NRS and DLQI performed well. No studies compared the performance of different response criteria.
CONCLUSION
Content validation of the PP-NRS confirmed the importance of itch as a core symptom and treatment priority in AD; however, itch is not well covered in the EASI or IGA. Including the PP-NRS in clinical trials and HTAs will better capture patient-relevant benefit and response. Although various response criteria were used, no studies compared the performance of different criteria to inform which were most appropriate to compare treatments in clinical trials and HTAs.
PubMed: 37747670
DOI: 10.1007/s13555-023-01038-3 -
Therapeutic Advances in Medical Oncology 2023Immune checkpoint inhibitors (ICIs) have shown remarkable therapeutic outcomes among cancer patients. Durvalumab plus tremelimumab (DT) is under investigation as a new... (Review)
Review
BACKGROUND
Immune checkpoint inhibitors (ICIs) have shown remarkable therapeutic outcomes among cancer patients. Durvalumab plus tremelimumab (DT) is under investigation as a new ICI combination therapy, and its efficacy has been reported in various types of cancer. However, the safety profile of DT remains unclear, especially considering rare adverse events (AEs).
OBJECTIVE
We aimed to assess the frequency of AEs associated with DT.
DESIGN
This study type is a systematic review and meta-analysis.
DATA SOURCES AND METHODS
Four databases were searched for articles. Randomized trials, single-arm trials, and prospective and retrospective observational studies were included. The type of cancer, previous treatment, and performance status were not questioned. Major AE indicators such as any AE and the pooled frequency of each specific AE were used as outcomes. As a subgroup analysis, we also compared cases in which DT was performed as first-line treatment with those in which it was performed as second-line or later treatment. The protocol for this systematic review was registered on the University Hospital Medical Information Network (UMIN) Center website (ID: UMIN000046751).
RESULTS
Forty-one populations including 3099 patients were selected from 30 articles. Pooled frequencies of key AE indicators are shown below: any AEs, 77.8% [95% confidence interval (CI): 67.9-87.6]; grade ⩾ 3 AEs, 29.3% (95% CI: 24.2-34.4); serious AEs, 34.9% (95% CI: 28.1-41.7); AE leading to discontinuation, 13.3% (95% CI: 9.3-17.4); treatment-related deaths, 0.98% (95% CI: 0.5-1.5). AEs with a frequency exceeding 15% are shown below: fatigue, 30.1% (95% CI: 23.8-36.3); diarrhea, 21.7% (95% CI: 17.8-25.6); pruritus 17.9% (95% CI: 14.4-21.3); decreased appetite, 17.7% (95% CI: 13.7-22.0); nausea, 15.6% (95% CI: 12.1-19.6). There were no significant differences in these pooled frequencies between subgroups.
CONCLUSIONS
The incidence of any AE in DT therapy was approximately 78%, and the incidence of grade 3 or higher AEs was approximately 30%, which was independent of prior therapy.
PubMed: 37720498
DOI: 10.1177/17588359231198453 -
Cureus Aug 2023Oral spironolactone has been proposed as a potential treatment for hair loss due to its antiandrogenic properties. However, the efficacy and safety of spironolactone for... (Review)
Review
Oral spironolactone has been proposed as a potential treatment for hair loss due to its antiandrogenic properties. However, the efficacy and safety of spironolactone for treating hair loss are not well-established. The objective of this study was to conduct a systematic review of the current literature on the use of oral spironolactone in female pattern hair loss. We conducted a systematic review and meta-analysis of randomized controlled trials and observational studies that assessed the efficacy and safety of oral spironolactone for treating hair loss. We searched for eligible papers in PubMed, Web of Science (ISI), Embase, and Scopus. All analyses were done using R software version 4.2.3 (R Foundation for Statistical Computing, Vienna, Austria). The overall rate of improved hair loss was 56.60%, with a higher rate of improvement (65.80%) observed in the combined therapy group compared to the monotherapy group (43.21%). However, there was significant heterogeneity in the efficacy outcomes, and hair loss did not improve or showed a modest improvement in 37.80% of all patients. The rates of adverse events reported in at least two studies were scalp pruritus or increased scurf (18.92%), menstrual disorders (11.85%), facial hypertrichosis (6.93%), and drug discontinuation (2.79%). The overall adverse events rate was 3.69%, but there was significant heterogeneity in the rates of different adverse events. In conclusion, the present study suggests that spironolactone is an effective and safe treatment option for hair loss. However, further research is needed to fully understand the heterogeneity of treatment response and adverse events and identify factors that may predict treatment response.
PubMed: 37719557
DOI: 10.7759/cureus.43559 -
Journal of the European Academy of... Jan 2024Treat-to-target (T2T) is a pragmatic therapeutic strategy being gradually introduced into dermatology after adoption in several other clinical areas. Atopic dermatitis... (Review)
Review
Treat-to-target (T2T) is a pragmatic therapeutic strategy being gradually introduced into dermatology after adoption in several other clinical areas. Atopic dermatitis (AD), one of the most common inflammatory skin diseases, may also benefit from this structured and practical therapeutic approach. We aimed to evaluate existing data regarding the T2T approach in dermatology, with a specific focus on AD, as well as the views of International Eczema Council (IEC) members on the potential application of a T2T approach to AD management. To do so, we systematically searched for peer-reviewed publications on the T2T approach for any skin disease in the PubMed and Scopus databases up to February 2022 and conducted a survey among IEC members regarding various components to potentially include in a T2T approach in AD. We identified 21 relevant T2T-related reports in dermatology, of which 14 were related to psoriasis, five to AD, one for juvenile dermatomyositis and one for urticaria. In the IEC member survey, respondents proposed treatable traits (with itch, disease severity and sleep problems getting the highest scores), relevant comorbidities (with asthma being selected most commonly, followed by anxiety and depression in adults), recommended specialists that should define the approach in AD (dermatologists, allergists and primary care physicians were most commonly selected in adults), and applicable assessment tools (both physician- and patient-reported), in both adult and paediatric patients, for potential future utilization of the T2T approach in AD. In conclusion, while the T2T approach may become a useful tool to simplify therapeutic goals and AD management, its foundation in AD is only starting to build. A multidisciplinary approach, including a wide range of stakeholders, including patients, is needed to further define the essential components needed to utilize T2T in AD.
Topics: Adult; Humans; Child; Dermatitis, Atopic; Dermatology; Pruritus; Surveys and Questionnaires; Eczema; Quality of Life
PubMed: 37700595
DOI: 10.1111/jdv.19506 -
Journal of Burn Care & Research :... Mar 2024Despite advancements in burn care, evidence estimates that pathological scarring occurs in 32%-75% of cutaneous burns. Scar massage therapy is an under researched method...
Despite advancements in burn care, evidence estimates that pathological scarring occurs in 32%-75% of cutaneous burns. Scar massage therapy is an under researched method of management for hypertrophic burn scars which has scope to be a low-cost treatment alternative. The aim of this systematic review was to determine the efficacy of scar massage techniques for common hypertrophic burn scar symptoms such as contraction, pruritus, pain and visibility. The keywords and corresponding MeSH terms were inputed into PubMed, EMBASE, Cochrane database of Systematic Reviews, University Library of Hull, York and Queen Mary, University of London. Following the implementation of predetermined inclusion and exclusion criteria, ten papers were included for data extraction. Quality assessment of all papers was performed using the Cochrane Risk of Bias tool and ROBINS-I tool. Data pertaining to the nature of the participant demographics, scar massage treatment, and study outcomes was extracted. Nine of the ten studies showed a significant improvement for scar massage treatment of hypertrophic burn scar symptoms despite using different massage techniques. Friction and oscillation massage was used in partnership to improve scar function, whereas effleurage and petrissage used in longer sessions was seen to improve scar visibility and pain. Scar pruritus was improved by each massage technique. Scar massage has been shown to be effective at improving scar outcomes. This paper suggests massage techniques should be tailored to the patients' symptoms. A large, randomized control trial is required to advance this area of research.
Topics: Humans; Burns; Cicatrix, Hypertrophic; Hypertrophy; Massage; Pain; Pruritus
PubMed: 37698247
DOI: 10.1093/jbcr/irad140