Mirtazapine: only for depression?

2006 ◽  
Vol 18 (3-4) ◽  
pp. 130-143 ◽  
Author(s):  
Luis San ◽  
Belen Arranz
Keyword(s):  
Randomized Controlled Trials ◽  
Case Reports ◽  
Sexual Disorders ◽  
Sufficient Evidence ◽  
Controlled Trials ◽  
Open Label ◽  
Compulsive Disorder ◽  
Off Label ◽  
Randomized Controlled ◽  
Tension Type Headaches

Background:Mirtazapine is an antidepressant first approved in the Netherlands in 1994 for the treatment of major depressive disorder. However, evidence suggests its effectiveness in a variety of other psychiatric disorders and non-psychiatric medical conditions.Objective:The present paper reviews the published literature on the off-label indications of Mirtazapine.Methods:A search of the relevant literature from MEDLINE, PsycLIT and EMBASE databases, included in the Science Citation Index and available up to March 2006, was conducted using the terms mirtazapine, case-reports, open-label trials and randomized controlled trials. Only articles referring to conditions other than major depression were included in this present review.Results:Off-label use of mirtazapine has been reported in panic disorder, post-traumatic stress disorder, generalized anxiety disorder, social phobia, obsessive-compulsive disorder, dysthymia, menopausal depression, poststroke depression, depression as a result of infection with human immunodeficiency virus, elderly depression, Methylenedioxymethamphetamine (MDMA)-induced depression, hot flashes, alcohol and other substance use disorders, sleep disorders, sexual disorders, tension-type headaches, cancer pain, fibromyalgia, schizophrenia and other less frequent conditions.Conclusions:So far, data on the off-label usefulness of mirtazapine are limited and mainly based on observations from case reports or open-label studies. However, positive cues suggest that confirmation of these preliminary data with randomized controlled trials may give sufficient evidence to warrant the use of mirtazapine in a broad range of disorders.

Impact of Blinding on Patient-Reported Outcome Differences Between Treatment Arms in Cancer Randomized Controlled Trials

2021 ◽  
Author(s):  
Fabio Efficace ◽  
David Cella ◽  
Neil K Aaronson ◽  
Melanie Calvert ◽  
Francesco Cottone ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Experimental Treatment ◽  
Patient Reported Outcome ◽  
Controlled Trials ◽  
Open Label ◽  
Multivariable Logistic Regression Model ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Independent Variable ◽  
Outcome Differences

Abstract Some concerns have been raised about potential bias in patient-reported outcome (PRO) results from open-label cancer randomized controlled trials (RCTs). We investigated if open-label trials favor the experimental treatment over the standard treatment more frequently than blinded trials. We also examined if the effect of blinding differs for distal vs more proximal PROs. We assessed 538 RCTs with a PRO endpoint conducted in the most prevalent cancers, of which 366 (68.0%) were open-label, 148 (27.5%) were blinded, and 24 (4.5%) were categorized as unclear. In our multivariable logistic regression model, we did not observe a statistically significant association of the independent variable treatment concealment (blinded vs open-label) on the dependent variable measuring the proportion of trials favoring the experimental treatment (adjusted odds ratio = 1.19, 95% confidence interval = 0.79 to 1.79; 2-sided P = .40). This was also the case when comparing distal and proximal PROs. Our findings provide novel evidence-based data that support the validity of PRO results from open-label cancer RCTs.

scholarly journals Characteristic of Clinical Studies on Baduanjin during 2000–2019: A Comprehensive Review

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Jing Zhou ◽  
Yunyang Yu ◽  
Biwei Cao ◽  
Xiaoya Li ◽  
Miao Wu ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Clinical Studies ◽  
Methodological Quality ◽  
Case Reports ◽  
Case Series ◽  
Small Sample ◽  
Chronic Obstructive ◽  
Controlled Trials ◽  
Randomized Controlled

To date, a growing number of clinical studies have demonstrated the safety and health benefits from Baduanjin intervention. Based on this, our objective is to systematically retrieve and summarize the clinical studies on Baduanjin, with a view to providing more evidence-based evidence in support of the application of Baduanjin for healthcare, and to identify the shortcomings of existing research and provide feasibility suggest for further clinical research. Both four English language and four Chinese language electronic databases were used to search articles related to Baduanjin during 2000–2019. SPSS 22.0 software was used to analyze the data, and the risk of bias tool in the RevMan 5.3.5 software was used to evaluate the methodological quality of randomized controlled trials. A total of 810 publications were identified, including 43 (5.3%) systematic reviews, 614 (75.8%) randomized controlled trials, 66 (8.1%) nonrandomized controlled clinical studies, 84 (10.4%) case series, and 3 (0.4%) case reports. The top 10 diseases/conditions included diabetes, chronic obstructive pulmonary disease, hypertension, low back pain, neck pain, stroke, coronary heart disease, cognitive impairment, insomnia, and osteoporosis or osteopenia. The style of State General Administration of Sport of China in 2003 was the most commonly used version of Baduanjin, and Baduanjin was practiced with an average of 35 minutes, 1 or 2 times a day, 3–5 days per week, and a 18-week average duration. It is also worth noting that there were no serious adverse events related to Baduanjin intervention. Most studies were small sample size research, and the methodological quality of randomized controlled trials is generally low. The clinical studies of Baduanjin have a substantial quantity and evidence base. However, there are significant differences among different studies in the specific intervention measures such as style, intensity, duration, learning, and practice methods, which need to be further standardized and unified. Further high-quality designed and reporting studies are recommended to further validate the clinical benefits of Baduanjin.

scholarly journals Liver-related safety assessment of green tea extracts in humans: a systematic review of randomized controlled trials

2016 ◽  
Vol 70 (11) ◽  
pp. 1221-1229 ◽  
Author(s):  
T Isomura ◽  
S Suzuki ◽  
H Origasa ◽  
A Hosono ◽  
M Suzuki ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Green Tea ◽  
Case Reports ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomized Controlled

Abstract There remain liver-related safety concerns, regarding potential hepatotoxicity in humans, induced by green tea intake, despite being supposedly beneficial. Although many randomized controlled trials (RCTs) of green tea extracts have been reported in the literature, the systematic reviews published to date were only based on subjective assessment of case reports. To more objectively examine the liver-related safety of green tea intake, we conducted a systematic review of published RCTs. A systematic literature search was conducted using three databases (PubMed, EMBASE and Cochrane Central Register of Controlled Trials) in December 2013 to identify RCTs of green tea extracts. Data on liver-related adverse events, including laboratory test abnormalities, were abstracted from the identified articles. Methodological quality of RCTs was assessed. After excluding duplicates, 561 titles and abstracts and 119 full-text articles were screened, and finally 34 trials were identified. Of these, liver-related adverse events were reported in four trials; these adverse events involved seven subjects (eight events) in the green tea intervention group and one subject (one event) in the control group. The summary odds ratio, estimated using a meta-analysis method for sparse event data, for intervention compared with placebo was 2.1 (95% confidence interval: 0.5–9.8). The few events reported in both groups were elevations of liver enzymes. Most were mild, and no serious liver-related adverse events were reported. Results of this review, although not conclusive, suggest that liver-related adverse events after intake of green tea extracts are expected to be rare.

scholarly journals Treatment of Tinnitus in Children—A Systematic Review

2021 ◽  
Vol 12 ◽  
Author(s):  
Max J. Dullaart ◽  
Marijn Kip ◽  
Adriana L. Smit ◽  
Inge Stegeman
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Observational Studies ◽  
Case Reports ◽  
Case Series ◽  
Controlled Trials ◽  
Eligibility Criteria ◽  
Subjective Tinnitus ◽  
Randomized Controlled

Objectives: To systematically review studies on the effect of treatment of subjective tinnitus in children.Data Sources: We searched for studies in MEDLINE and EMBASE databases, after which additional studies were hand searched using Scopus databases. The methods are described in the study protocol, which has been registered in the PROSPERO register. PRISMA guidelines were followed in the reporting of this study.Eligibility Criteria: We considered for inclusion randomized controlled trials (RCTs), observational studies, case reports, and case series, with tinnitus as primary outcome in children (0–18 years old) with acute or chronic subjective tinnitus. We excluded studies in which both children and adults participated but outcomes were not specifically reported for children, as well as animal studies, studies with a non-original study design and studies about children with pulsatile or objective tinnitus.Data Selection: Two reviewers independently assessed studies for eligibility and quality, collected and extracted data. Statistical analyses were performed in case of homogeneous outcomes.Results: The search yielded a total of 4,447 studies. Of these, 147 eligible studies were selected. One case report and five observational studies met the eligibility criteria. Three studies applied counseling and (simplified-)TRT and reported improvement in tinnitus outcome in 68 out of 82 children after 3–6 months of treatment. Two studies used pharmacological treatments and reported improvement in 74 out of 86 patients after 10 days to 3 months of treatment. One study reported the outcome of biofeedback therapy, describing an improvement in tinnitus loudness and annoyance after 2 months of treatment.Conclusion: Due to the high risk of bias of the included studies, we cannot determine the effectiveness of the treatment of subjective tinnitus in children. Also, owing to brief follow-up periods, it is not possible to draw conclusions regarding long-term effects. Randomized controlled trials with longer follow-up periods are necessary to provide substantial evidence of the effects of therapies for children affected by tinnitus. https://www.crd.york.ac.uk/prospero/Systematic Review Registration:https://www.crd.york.ac.uk/prospero/, identifier [CRD42020178134].

scholarly journals Perspectives on the Use of Ninjin’yoeito in Modern Medicine: A Review of Randomized Controlled Trials

2019 ◽  
Vol 2019 ◽  
pp. 1-15 ◽  
Author(s):  
Shin Takayama ◽  
Ryutaro Arita ◽  
Minoru Ohsawa ◽  
Akiko Kikuchi ◽  
Hiromichi Yasui ◽  
...  
Keyword(s):  
Side Effects ◽  
Randomized Controlled Trials ◽  
Western Medicine ◽  
Case Reports ◽  
Experimental Studies ◽  
Kampo Medicine ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Medicinal Treatment

Background. Ninjin’yoeito (NYT), a traditional Japanese (Kampo) medicine that originates from China, has been used to treat qi and blood deficiency based on its original concept. Kampo medicine has been widely used to treat many conditions and disorders combined with western medicine or Kampo medicine alone in modern situation. Aims. We reviewed randomized controlled trials (RCTs) of NYT and discussed various standpoints regarding its use in modern situation. Methods. We searched PubMed, Cochrane Library, and Evidence Reports of Kampo Treatment (EKAT) for articles written in English, and Ichushi, J-Stage, and EKAT for those written in Japanese. Articles published before January 1, 2019, were retrieved using the keywords “ninjinyoeito” and “ninjin’yoeito,” and RCTs were selected from these extracted articles. Result. Of 734 articles, 13 were RCTs, 46 were non-RCTs or studies of other designs, 15 were case reports, and 36 were experimental studies using NYT. NYT was evaluated for its use as a treatment for cancer and related conditions, refractory blood diseases and conditions, and otorhinolaryngologic symptom in 13 RCTs. Based on the use of Kampo medicine in modern situation called as Yasui’s classification, 10 of 13 RCTs were categorized as “the side effects of Western medicinal treatment are mitigated when combined with Kampo treatment” and the remaining 3 were categorized as “treatment effect of Kampo medicine is increased in combination with standard Western medicinal treatment.” Conclusion. Several studies demonstrated the efficacy of NYT in refractory diseases and other conditions, and the accompanied side effects of treatment with western medicine.

scholarly journals Investigating the impact of open label design on patient‐reported outcome results in prostate cancer randomized controlled trials

2020 ◽  
Vol 9 (20) ◽  
pp. 7363-7374
Author(s):  
Guillaume Mouillet ◽  
Fabio Efficace ◽  
Antoine Thiery‐Vuillemin ◽  
Emilie Charton ◽  
Mieke Van Hemelrijck ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Randomized Controlled Trials ◽  
Patient Reported Outcome ◽  
Controlled Trials ◽  
Open Label ◽  
Randomized Controlled ◽  
Patient Reported ◽  
The Impact
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