A systematic review on clinical management of antipsychotic-induced sexual dysfunction in schizophrenia

INTRODUCTION: Sexual dysfunction frequently occurs in patients with schizophrenia under antipsychotic therapy, and the presence of sexual side effects may affect compliance. The aim of this study was to review and describe clinical findings relating to the appropriate management of such dysfunctions. MATERIAL AND METHODS: The research was carried out through Medline (from 1966 to March 2005), PsycInfo (from 1974 to March 2005), and Cochrane Library (from 1965 to March 2005) and included any kind of study, from case reports to randomized trials. RESULTS: The most common sexual dysfunctions found in the literature were libido decrease, difficulties in achieving and maintaining erection, ejaculatory dysfunction, orgasmic dysfunction, and menstrual irregularities. Thirteen papers were found: eight of them were open-label studies, four were descriptions of cases, and only one was a randomized clinical trial. All of them were short-term and had small sample sizes. The agents used were: bromocriptine, cabergoline, cyproheptadine, amantadine, shakuyaku-kanzo-to, sildenafil and selegiline. DISCUSSION: There was no evidence that those agents had proper efficacy in treating the antipsychotic-induced sexual dysfunction. An algorithm for managing sexual dysfunction induced by antipsychotics is suggested as a support for clinical decisions. Since the outcome from schizophrenia treatment is strongly related to compliance with the antipsychotics, prevention of sexual dysfunction is better than its treatment, since there is a scarcity of data available regarding the efficacy of intervention to deal with these problems.

Download Full-text

Sexual dysfunction and mood stabilizers in bipolar disorder: A review

European Psychiatry ◽

10.1016/j.eurpsy.2017.01.1682 ◽

2017 ◽

Vol 41 (S1) ◽

pp. s849-s849 ◽

Cited By ~ 1

Author(s):

C. Gómez Sánchez-Lafuente ◽

R. Reina Gonzalez ◽

M. Hernandez Abellán

Keyword(s):

Bipolar Disorder ◽

Medication Adherence ◽

Side Effects ◽

Sexual Dysfunction ◽

Clinical Studies ◽

Side Effect ◽

Small Sample ◽

Mood Stabilizers ◽

Cochrane Library ◽

Short Period

IntroductionMood stabilizers can cause many side effects. Although many of these are well known, like thyroid and renal failure after taking lithium, sexual dysfunction side effects remains unclear.MethodsWe made a systematic computerized literature search of clinical studies using MEDLINE, The Cochrane Library and Trip for clinical studies of sexual dysfunction published up to December 2015.ResultsOnly eight relevant papers were identified. All of them studied lithium sexual dysfunction in bipolar disorder patients. Valproic acid, carbamazepine and lamotrigine were not studied in patients with bipolar disorder. Nevertheless, the three were studied in epilepsy. Clinical reports usually used Arizona Sexual Experience Scale or Psychotropic Related Sexual Dysfunction Questionnaire to measure sexual dysfunction and Brief Adherence Rating Scale to measure medication adherence. They suggest lithium could decrease desire and sexual thoughts, worse arousal and cause orgasm dysfunction. In overall, those patients with sexual dysfunction had lower level of functioning and poor compliance. Taking benzodiazepines during lithium treatment may increase the risk of sexual dysfunction even more.ConclusionThere are few studies that focus on mood stabilizers sexual dysfunction. This inevitably entails a number of limitations. First, the small sample size and, in some studies, the relative short period of follow-up may underestimate the results. Besides, practical management was not treated in any study. Actually, handling this side effect have not been well established.To conclude, this revision suggest that approximately 30% patients receiving lithium experience this side effect, and it is associated with poor medication adherence.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Download Full-text

Systematic Review of Pre-Injury Migraine Disorder as a Risk Factor for Worse Outcome Following Sport-Related Concussion

Archives of Clinical Neuropsychology ◽

10.1093/arclin/acz026.24 ◽

2019 ◽

Vol 34 (5) ◽

pp. 754-754

Author(s):

D P Terry ◽

A J Gardner ◽

G L Iverson

Keyword(s):

Systematic Review ◽

Risk Factor ◽

Age Of Onset ◽

Small Sample ◽

Self Report ◽

Cochrane Library ◽

Clinical Recovery ◽

Other Information ◽

Sport Athlete ◽

Small Sample Sizes

Abstract Purpose This systematic review examined clinical outcomes (i.e., prognosis) following a sport-related concussion in athletes who have a pre-injury history of migraines. Clinical recovery was defined functionally as recovery from symptoms or full return to activities following injury. Data Selection All studies published prior to February 2019 that addressed pre-injury migraines as a possible predictor of clinical recovery from concussion were included. Broadly, the search included (i) sport/athlete-related terms, (ii) concussion-related terms, and (iii) diverse predictor/modifier terms. The following databases were utilized: PubMed, PsycINFO®, MEDLINE®, CINAHL, Cochrane Library, EMBASE, SPORTDiscus, Scopus, and Web of Science. After removing duplicates from the 9,372 identified articles, 5,888 abstracts were screened, 358 full-text articles were reviewed, and 15 articles examining pre-injury migraines as a predictor of recovery were included. Data Synthesis Most articles examined pre-injury migraines as an exploratory/secondary predictor of concussion outcome. Migraine history was predominantly based on self-report. Studies included minimal other information about this condition (e.g., age of onset, migraine frequency/severity, past treatment). Methodological rigor varied greatly across studies. Most studies did not find pre-injury migraines to be associated with concussion outcome, but several of these studies had small or very small sample sizes. Larger, better-designed studies suggested pre-injury migraines may be a risk factor for worse concussion outcome. Effect sizes were rarely reported or able to be calculated. Conclusion There is some evidence to suggest pre-injury migraines may be a vulnerability factor for a prolonged recovery following concussion. Future studies should focus on improving methodological quality when assessing the relationship between pre-injury migraines and concussion outcome.

Download Full-text

A Critical Review of Multimodal Interventions for Cachexia

Advances in Nutrition ◽

10.1093/advances/nmaa111 ◽

2020 ◽

Cited By ~ 1

Author(s):

Clare McKeaveney ◽

Peter Maxwell ◽

Helen Noble ◽

Joanne Reid

Keyword(s):

Body Composition ◽

Sample Size ◽

Small Sample ◽

Cochrane Library ◽

Chronic Obstructive ◽

Obstructive Pulmonary Disease ◽

Treatment Groups ◽

Small Sample Sizes

ABSTRACT Currently, there are no standardized treatments for cachexia or severe wasting. There is a growing consensus advocating multimodal interventions to address the complex pathogenesis and metabolic alterations in these conditions. This review examined multimodal treatments intended to alleviate and/or stabilize cachexia and severe wasting. The objectives of this review were to 1) identify multimodal interventions for the treatment of cachexia or associated wasting syndromes in patients with a chronic illness, 2) assess the quality of these studies, and 3) assess the effectiveness of multimodal interventions. Electronic databases including PubMed, MEDLINE, EMBASE, Scopus, Web of Science, Cochrane Library, CINAHL, PEDro, OpenGrey, and clinicaltrials.org were systematically searched using both text words and MeSH (medical subject heading) terms. The literature revealed a dearth of large, well-conducted trials in this area. Fourteen trials (n = 5 cancer, n = 5 chronic obstructive pulmonary disease, n = 4 chronic kidney disease) were included in this review. A total of 1026 patients were included across all studies; sample size ranged between 21 and 138 patients. Baseline and follow-up data were collected between 6 wk and 24 mo. All demonstrated some improvement in favor of the treatment groups, in relevant measures of body composition, nutrition, biomarkers, and functionality; however, caution should be applied due to the heterogenous nature of the interventions and small sample sizes. Overall, the evidence from this review supports the role of multimodal interventions in the treatment of severe wasting. However, randomized controlled trials with a powered sample size and sufficiently lengthy interaction period are necessary to assess if multimodal interventions are effective forms of therapy for improving body composition and nutritional and physical status in patients with cachexia and wasting. The protocol for this review is registered with Prospero (ID: CRD42019124374).

Download Full-text

Blood tumor mutational burden (bTMB) and tumor PD-L1 as predictive biomarkers of survival in MYSTIC: First-line durvalumab (D) ± tremelimumab (T) versus chemotherapy (CT) in metastatic (m) NSCLC.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.9016 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. 9016-9016 ◽

Cited By ~ 4

Author(s):

Naiyer A. Rizvi ◽

Byoung Chul Cho ◽

Niels Reinmuth ◽

Ki Hyeong Lee ◽

Alexander Luft ◽

...

Keyword(s):

Clinical Trial ◽

Predictive Biomarkers ◽

Predictive Biomarker ◽

Small Sample ◽

First Line ◽

Open Label ◽

Mutational Burden ◽

Tumor Mutational Burden ◽

Small Sample Sizes ◽

Clinical Trial Information

9016 Background: MYSTIC, an open-label, Ph3 trial of first-line D (anti-PD-L1) ± T (anti-CTLA-4) vs platinum-based CT, showed an improvement in OS with D vs CT in pts with tumor cell PD-L1 expression ≥25% (PD-L1 TC ≥25%; HR 0.76 [97.54% CI 0.56–1.02], p = 0.036). Exploratory analyses showed bTMB was a predictive biomarker for OS with D±T vs CT. We report further exploratory analyses of OS according to PD-L1 and bTMB. Methods: Immunotherapy/CT-naïve pts with mNSCLC were randomized (1:1:1) to D, D+T or CT. bTMB levels (mut/Mb) were evaluated with the GuardantOMNI platform (Guardant Health), and PD-L1 TC expression with the VENTANA PD-L1 (SP263) IHC assay. Results: D improved OS vs CT in pts with PD-L1 TC ≥25% across bTMB levels (PD-L1 TC ≥25%/bTMB≥20 HR 0.79 [95% CI 0.45, 1.39]; PD-L1 TC ≥25%/bTMB < 20 HR 0.64 [95% CI 0.45, 0.90]). In contrast, D+T improved OS vs CT in pts with bTMB≥20 across different PD-L1 TC expression levels (Table; PD-L1 TC ≥25%/bTMB≥20 HR 0.44 [95% CI 0.23, 0.84]; PD-L1 TC < 1%/bTMB≥20 HR 0.42 [95% CI 0.17, 0.97]). Additional cutoffs and outcomes in subgroups defined by both biomarkers will be presented. Conclusions: These exploratory analyses from MYSTIC support PD-L1 TC expression as an appropriate predictive biomarker for OS with D vs CT, while suggesting bTMB as a predictive biomarker for OS with D+T in mNSCLC. These biomarkers appear to be independent and both may be important for mNSCLC treatment decisions. Interpretation of these data may be limited by small sample sizes; further investigations are warranted. Clinical trial information: NCT02453282. [Table: see text]

Download Full-text

Effectiveness of Upper Limb Wearable Technology for Improving Activity and Participation in Adult Stroke Survivors: Systematic Review

Journal of Medical Internet Research ◽

10.2196/15981 ◽

2020 ◽

Vol 22 (1) ◽

pp. e15981 ◽

Cited By ~ 3

Author(s):

Jack Parker ◽

Lauren Powell ◽

Susan Mawson

Keyword(s):

Upper Limb ◽

Complex Interventions ◽

Wearable Technology ◽

Small Sample ◽

International Classification Of Functioning ◽

Cochrane Library ◽

Stroke Survivors ◽

Sample Sizes ◽

Small Sample Sizes

Background With advances in technology, the adoption of wearable devices has become a viable adjunct in poststroke rehabilitation. Upper limb (UL) impairment affects up to 77% of stroke survivors impacting on their ability to carry out everyday activities. However, despite an increase in research exploring these devices for UL rehabilitation, little is known of their effectiveness. Objective This review aimed to assess the effectiveness of UL wearable technology for improving activity and participation in adult stroke survivors. Methods Randomized controlled trials (RCTs) and randomized comparable trials of UL wearable technology for poststroke rehabilitation were included. Primary outcome measures were validated measures of activity and participation as defined by the International Classification of Functioning, Disability, and Health. Databases searched were MEDLINE, Web of Science (Core collection), CINAHL, and the Cochrane Library. The Cochrane Risk of Bias Tool was used to assess the methodological quality of the RCTs and the Downs and Black Instrument for the quality of non RCTs. Results In the review, we included 11 studies with collectively 354 participants at baseline and 323 participants at final follow-up including control groups and participants poststroke. Participants’ stroke type and severity varied. Only 1 study found significant between-group differences for systems functioning and activity (P≤.02). The 11 included studies in this review had small sample sizes ranging from 5 to 99 participants at an average (mean) age of 57 years. Conclusions This review has highlighted a number of reasons for insignificant findings in this area including low sample sizes and the appropriateness of the methodology for complex interventions. However, technology has the potential to measure outcomes, provide feedback, and engage users outside of clinical sessions. This could provide a platform for motivating stroke survivors to carry out more rehabilitation in the absence of a therapist, which could maximize recovery. Trial Registration PROSPERO CRD42017057715; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=57715

Download Full-text

A Systematic Review of the Clinical Use of Gabapentin and Pregabalin in Bipolar Disorder

Pharmaceuticals ◽

10.3390/ph14090834 ◽

2021 ◽

Vol 14 (9) ◽

pp. 834

Author(s):

Qin Xiang Ng ◽

Ming Xuan Han ◽

Seth En Teoh ◽

Clyve Yu Leon Yaow ◽

Yu Liang Lim ◽

...

Keyword(s):

Systematic Review ◽

Bipolar Disorder ◽

Significant Proportion ◽

Evidence Base ◽

Small Sample ◽

Long Term Outcomes ◽

Open Label ◽

Related Drug ◽

Small Sample Sizes

Despite its prevalence and disease burden, several chasms still exist with regard to the pharmacotherapy of bipolar disorder (BD). Polypharmacy is commonly encountered as a significant proportion of patients remain symptomatic, and the management of the depressive phase of the illness is a particular challenge. Gabapentin and pregabalin have often been prescribed off-label in spite of a paucity of evidence and clinical practice guidelines to support its use. This systematic review aimed to synthesize the available human clinical trials and inform evidence-based pharmacological approaches to BD management. A total of six randomized, controlled trials (RCTs) and 13 open-label trials involving the use of gabapentin and pregabalin in BD patients were reviewed. Overall, the studies show that gabapentin and its related drug pregabalin do not have significant clinical efficacy as either monotherapy or adjunctive therapy for BD. Gabapentin and pregabalin are probably ineffective for acute mania based on the findings of RCT, with only small open-label trials to support its potential adjunctive role. However, its effects on the long-term outcomes of BD remain to be elucidated. The evidence base was significantly limited by the generally small sample sizes and the trials also had heterogeneous designs and generally high risk of bias.

Download Full-text

The Effect of Prebiotic Products on Decreasing Adiposity Parameters in Overweight and Obese Individuals: A Systematic Review and Meta- Analysis

Current Medicinal Chemistry ◽

10.2174/0929867327666191230110128 ◽

2020 ◽

Vol 28 (2) ◽

pp. 419-431

Author(s):

Hua Qu ◽

Lei Song ◽

Ying Zhang ◽

Zhu-ye Gao ◽

Da-zhuo Shi

Keyword(s):

Body Weight ◽

Fat Mass ◽

Animal Studies ◽

Weighted Mean Difference ◽

Meta Analysis ◽

Small Sample ◽

Inflammatory Biomarkers ◽

Cochrane Library ◽

Small Sample Sizes ◽

Factor Α

Background: Prebiotics are substrates selectively utilized by host microorganisms to confer health benefits. The potential of prebiotics to decrease body weight in overweight/obese individuals was suggested by some clinical and animal studies. However, these studies were based on relatively small sample sizes and the precise effects of prebiotic products have not yet been evaluated. Therefore, the present meta-analysis of Randomized Controlled Trials (RCTs) was designed to comprehensively assess the effects of prebiotic products on overweight and obese individuals. Methods: PubMed, EMBASE and Cochrane Library were searched to identify RCT investigating the effects of prebiotic products on overweight and obese individuals. We calculated the pooled weighted mean difference (WMD) to assess the effects of prebiotic products on Body Mass Index (BMI), body weight, fat mass and inflammatory biomarkers. Results: Twelve RCTs with a total of 535 overweight and obese individuals were enrolled. Compared with placebo, prebiotic products decreased C reactive protein (WMD, -1.06 mg/L; 95%CI, -1.72 to - 0.40; p=0.002), tumour necrosis factor-α(WMD, -0.64 pg/mL; 95%CI, -1.11 to -0.18; p=0.006) and other inflammatory markers, such as interleukin-1β，lipopolysaccharide (p<0.05); whereas no reductions in BMI (WMD, -0.20 kg/m2; 95%CI, -0.58 to 0.19; p=0.32), body weight (WMD, -0.51 kg; 95%CI, -1.18 to 0.16; p=0.14) and fat mass (WMD, 0.11 kg; 95%CI, -0.04 to 0.25; p=0.15) were observed. Conclusion: In the present analysis, comprehensive evidence suggested that prebiotic products did not decrease adiposity parameters (BMI, body weight and body fat mass), but they could decrease the levels of systemic inflammatory biomarkers, implying adherence to prebiotic products might be a promising complementary approach to managing inflammatory states in overweight and obese individuals.

Download Full-text

History, Present, and Progress of Frontotemporal Dementia in China: A Systematic Review

International Journal of Alzheimer s Disease ◽

10.1155/2012/587215 ◽

2012 ◽

Vol 2012 ◽

pp. 1-6 ◽

Cited By ~ 2

Author(s):

Ru-Jing Ren ◽

Yue Huang ◽

Gang Xu ◽

Chun-Bo Li ◽

Qi Cheng ◽

...

Keyword(s):

Frontotemporal Dementia ◽

Age Of Onset ◽

Case Reports ◽

Small Sample ◽

Current Status ◽

Future Research ◽

Clinical Presentations ◽

Neuropathological Diagnosis ◽

Future Research Directions ◽

Small Sample Sizes

We aim to provide an overview of clinical and demographical features and neuropathological research on frontotemporal dementia (FTD) from China over the past decade. We reviewed the demographic features, clinical presentations, and neuropathology of the FTD-spectrum disorders from the 49 cases in China published since 1998. On the basis of these findings, we retrospect the history and speculate on future progress in terms of FTD in China. We found that most published papers comprise case reports with a few retrospective studies with small sample sizes. Behavior variant FTD (bvFTD) was the most common diagnostic subtype, of which 35% were associated with amyotrophic lateral sclerosis or Parkinsonian syndrome. More than 47% patients with FTD had age onset before 65. There were no differences in age of onset and sex distribution between diagnostic subtypes. The spectrum of neuropathological diagnosis of bvFTD was frontotemporal lobe degeneration (FTLD) with tau protein or ubiquitin-immunopositive inclusions, and FTLD without intracellular inclusions. Median survival in bvFTD was 14 years. This paper provides an overview of the current status and pointers for future research directions of FTD in China.

Download Full-text

Special considerations of DMCs for oncology studies.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e20071 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e20071-e20071

Author(s):

David Kerr ◽

Kent Koprowicz

Keyword(s):

Vital Signs ◽

Small Sample ◽

Scientific Integrity ◽

Open Label ◽

Extensive Experience ◽

Contract Research Organization ◽

Primary Endpoints ◽

Small Sample Sizes ◽

Immune Oncology ◽

Trial Participants

e20071 Background: Data Monitoring Committees (DMCs) are an important component of the clinical trial process. They are charged with reviewing interim data and making recommendations to protect the safety of trial participants and ensure the scientific integrity of the study. Oncologists may be involved with the DMC process in a number of ways – as a DMC member, as an investigator, as a sponsor, or in a regulatory role. This presentation will discuss novel aspects of the DMC review process that are particularly relevant for oncology trials. Methods: The authors are leaders of a Contract Research Organization (CRO) that specializes in providing independent DMC services for government and industry sponsored trials. They have worked with hundreds of unique DMCs and facilitated approximately 1,000 DMC meetings. The proposed methodologies for maximizing the efficiency and thoroughness of DMC reviews are based on extensive experience and well-established principles. Results: Topics that will be covered include: Discrepant trends in PFS vs. OS PFS results that are inconsistent between local and central assessment, or are not yet centrally assessed Co-primary endpoints – OS, PFS, ORR, CR Multiple populations of interest – ITT and a biomarker subgroup Interim analyses – overwhelming efficacy and statistical futility Program-wide DMCs – interpreting trends across multiple studies and logistical details Safety assessment in a study with thousands of AEs – novel graphics and tables Laboratory values and vital signs – novel graphics and tables Multiple comparisons and/or multiple p-values Non-standard tables, listings, figures that are particularly useful for DMC review Open-label studies – immediate withdrawals for those randomized to control arm and other potential biases Single-arm studies – how to interpret safety with no control arm Novel therapies – immune-oncology, CAR-T, small sample sizes CIOMS reports or patient narratives Conclusions: DMCs will perform a more thorough and efficient review of accumulating data upon adapting the guidance provided. A more thorough review will enhance the protection of the trial participants while a more efficient review will allow DMCs to focus their efforts appropriately.

Download Full-text

l-arginine and Erectile Dysfunction

Journal of Psychosexual Health ◽

10.1177/2631831818822018 ◽

2019 ◽

Vol 1 (1) ◽

pp. 37-43 ◽

Cited By ~ 1

Author(s):

Arpit Koolwal ◽

Shivananda Manohar J. ◽

T. S. Sathyanarayana Rao ◽

Ghanshyam D. Koolwal

Keyword(s):

Nitric Oxide ◽

Erectile Dysfunction ◽

Review Article ◽

Small Sample ◽

Cochrane Library ◽

Sample Sizes ◽

Positive Evidence ◽

Small Sample Sizes ◽

Larger Sample ◽

Natural Precursor

l-arginine, being a natural precursor of nitric oxide, is one of the more commonly used adjuvants to regular medicines in the treatment of erectile dysfunction. Objectives: Here, in this review article, we aim to highlight various studies and the research studies done on l-arginine in the treatment of erectile dysfunction. Method: Reviewing the databases such as Medline (PubMed), Cochrane Library, Excerpta Medica dataBASE, Trip, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, the Allied and Complementary Medicine Database, and the British Nursing Index. Results:l-arginine has been studied alone as well as in combination with various other molecules for the treatment of erectile dysfunction, but the studies are very limited in number and have very small sample sizes. Conclusion: Positive evidence is available for the efficacy of l-arginine and its various combinations. Further research with larger sample sizes and standardized tools are required to recommend the routine use of these products in erectile dysfunction.

Download Full-text