scholarly journals Effect of Micronutrients on Insomnia in Adults

2016 ◽  
Vol 4 (6) ◽  
pp. 1112-1124 ◽  
Author(s):  
Joanna Lothian ◽  
Neville M. Blampied ◽  
Julia J. Rucklidge
Keyword(s):  
Rating Scale ◽  
Self Report ◽  
Multiple Baseline ◽  
Sleep Diary ◽  
Open Label ◽  
Depression Anxiety Stress Scale ◽  
Open Label Trial ◽  
Clinically Significant ◽  
Insomnia Severity

Insomnia is a debilitating condition causing psychological distress and frequently comorbid with other mental health conditions. This study examined the effect of 8 weeks of treatment by broad spectrum micronutrients (vitamins and minerals) on insomnia using a multiple-baseline-across-participants open-label trial design. Seventeen adults were randomized to 1-, 2-, or 3-week baseline periods (14 completed). Self-report measures were the Consensus Sleep Diary–Morning (CSD-M), the Pittsburgh Insomnia Rating Scale (PIRS), and the Depression, Anxiety, Stress Scale (DASS). Baselines were generally stable. Treatment completers reported reliable and clinically significant change in insomnia severity (PIRS), in depression, stress, and anxiety (DASS), and on at least two aspects of sleep measured by the CDS-M. All completers were treatment-compliant, and side effects were minimal. Nutritional supplementation is shown to be a novel, beneficial treatment for insomnia in adults. Follow-up research using placebo-controlled designs as well as comparisons to cognitive-behavioral and other treatments is recommended.

scholarly journals Behavior-analytic intervention for women with fibromyalgia and insomnia: a single subject design

2021 ◽  
Vol 34 (1) ◽  
Author(s):  
Luziane de Fátima Kirchner ◽  
Maria de Jesus Dutra dos Reis
Keyword(s):  
Clinical Status ◽  
Self Report ◽  
Multiple Baseline ◽  
Single Subject ◽  
Single Subject Design ◽  
Baseline Design ◽  
Subject Design ◽  
Interpersonal Environment ◽  
Insomnia Severity

AbstractThis study evaluated the effects in the pain and sleep, and the clinic significance after an analytic-behavioral intervention to manage the condition of the physical and interpersonal environment related to pain. Four women with fibromyalgia and insomnia participated in a study with intervention withdrawal multiple baseline design and initial, intermediate, final, and follow-up assessments. Self-report instruments were used to assess pain intensity and disability, sleep quality, and insomnia severity, besides the actigraphy. Data showed that the intervention (20 sessions) was effective in reducing the sleep and pain problems in all participants by shifting two participants from clinical to non-clinical status in sleep indicators. The gains were maintained or increased in follow-up measures. However, the results should take into consideration the clinical condition and other variables that may have individually impacted the results.

scholarly journals Trajectories of fatigue in actively treated patients with established rheumatoid arthritis starting biologic DMARD therapy

RMD Open ◽  
2020 ◽  
Vol 6 (3) ◽  
pp. e001372
Author(s):  
Sella Aarrestad Provan ◽  
Brigitte Michelsen ◽  
Joseph Sexton ◽  
Tillmann Uhlig ◽  
Hilde Berner Hammer
Keyword(s):  
Rheumatoid Arthritis ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Tender Joint Count ◽  
Tender Joint ◽  
Logistic Regression Models ◽  
Patient Reported ◽  
Biologic Dmard ◽  
Clinically Significant

ObjectivesTo define fatigue trajectories in patients with rheumatoid arthritis (RA) who initiate biological DMARD (bDMARD) treatment, and explore baseline predictors for a trajectory of continued fatigue.MethodsOne-hundred and eighty-four patients with RA initiating bDMARDs were assessed at 0, 1, 2, 3, 6 and 12 months. Swollen and tender joint counts, patient reported outcomes (PROMs), blood samples and ultrasound examinations were collected at each time point. Fatigue was assessed by the fatigue Numeric Rating Scale (0–10) from the Rheumatoid Arthritis Impact of Disease (RAID) questionnaire. Clinically significant fatigue was predefined as fatigue ≥4. Three trajectories of interest were defined according to level of RAID fatigue: no fatigue (≤3 at 5/6 visits), improved fatigue (≥4 at start, but ≤3 at follow-up) and continued fatigue (≥4 at 5/6 visits). Baseline variables were compared between groups by bivariate analyses, and logistic regression models were used to explore baseline predictors of continued vs improved fatigue.ResultsThe majority of patients starting bDMARD therapy followed one of three fatigue trajectories, (no fatigue; n=61, improved; n=33 and continued fatigue; n=53). Patients with continued fatigue were more likely to be anti–citrullinated protein antibody and/or rheumatoid factor positive and had higher baseline PROMs compared to the other groups, while there were no differences between the groups for variables of inflammation including. Patient global, tender joint count and anxiety were predictors for the continued fatigue trajectory.DiscussionA trajectory of continued fatigue was determined by PROMs and not by inflammatory RA disease activity.

Endoscopic full-thickness plication for the treatment of GERD: 12-month follow-up for the North American open-label trial

2005 ◽  
Vol 61 (6) ◽  
pp. 643-649 ◽  
Author(s):  
Douglas Pleskow ◽  
Richard Rothstein ◽  
Simon Lo ◽  
Robert Hawes ◽  
Richard Kozarek ◽  
...  
Keyword(s):  
North American ◽  
Full Thickness ◽  
Open Label ◽  
The North ◽  
Open Label Trial

TPExtreme randomized trial: TPEx versus Extreme regimen in 1st line recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6002-6002 ◽  
Author(s):  
Joel Guigay ◽  
Jerome Fayette ◽  
Ricard Mesia ◽  
Cedrik Lafond ◽  
Esma Saada-Bouzid ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Phase Ii ◽  
Open Label ◽  
Locoregional Treatment ◽  
Significance Level ◽  
Hpv Dna ◽  
Open Label Trial ◽  
Clinical Trial Information

6002 Background: After promising results from the GORTEC TPEx phase II trial, the role of taxane instead of 5FU in 1st-line R/M HNSCC chemotherapy (CT) remained to be confirmed by comparing TPEx to the reference EXTREME regimen. Methods: Randomized (1:1), open-label trial. Main inclusion criteria were R/M HNSCC not suitable for locoregional treatment, age 18-70 years, PS <2, creatinine clearance >60ml/min, prior cisplatin <300 mg/m². Reference EXTREME regimen (arm A: 6 cycles every 3 weeks (Q3W) of 5FU–cisplatin-cetuximab (cetux) followed by weekly cetux maintenance) was compared to TPEx regimen (arm B: 4 cycles Q3W of docetaxel 75mg/m²–cisplatin 75mg/m²- cetux 250mg/m² with mandatory G-CSF support followed by every 2W cetux 500mg/m² maintenance). The primary endpoint was Overall Survival (OS). To detect a hazard ratio (HR) of 0.72 (median OS increase from 10.1 to 14.0 months (mo) with 88% power, 2-sided significance level of 0.05, 374 deaths were required. 540 patients (pts) were planned to enroll. Results: 539 pts were enrolled in 37 mo. Median age was 60 years, 93% were smokers, 40% had oropharyngeal tumor (p16 or HPV DNA was done in 85%, positive in 28%). In arm A, 44% of pts received all CT cycles vs 72% in arm B. Delays in administration were more frequent in arm A (27% vs 10%). Cisplatin was more frequently switched to carboplatin in arm A (34% vs 9%). Toxicity was lower in arm B: 34% pts had grade ≥4 adverse events during CT in arm B vs 50% in arm A (p<0.001). Less pts in arm A started maintenance than in arm B (53% vs 73%). At time of analysis, the median follow-up duration was 30 mo and 406 pts had died. OS was not significantly different between arms: HR=0.87 (95%CI: 0.71-1.05), p=0.15. Median OS was 13.4 mo in arm A vs 14.5 in arm B. 2-year OS rate was 21.0% in arm A vs 28.6% in arm B. Conclusions: This large randomized trial confirmed the encouraging survival results of the TPEx regimen observed in the first phase II. OS in both arms was higher than observed in previous randomized CT or immunotherapy combination trials. Despite lack of significant OS increase, taxane based TPEx regimen appears to be a new option in 1st line R/M HNSCC, with a shorter time on CT and significantly lower toxicity than the EXTREME regimen. Clinical trial information: NCT02268695.

The course of neuropsychiatric symptoms in nursing-home patients with dementia over a 53-month follow-up period

2013 ◽  
Vol 26 (1) ◽  
pp. 81-91 ◽  
Author(s):  
Geir Selbæk ◽  
Knut Engedal ◽  
Jūratė Šaltytė Benth ◽  
Sverre Bergh
Keyword(s):  
Nursing Home ◽  
Rating Scale ◽  
Neuropsychiatric Symptoms ◽  
Clinical Dementia Rating ◽  
Severe Dementia ◽  
Persistent Symptoms ◽  
Nursing Home Patients ◽  
Affective Symptoms ◽  
Clinically Significant

ABSTRACTBackground:Neuropsychiatric symptoms (NPS) are prevalent in nursing-home (NH) patients with dementia, but little is known about the long-term course of these symptoms.Methods:In this study, 931 NH patients with dementia took part in a prospective cohort study with four assessments over a 53-month follow-up period. NPS and level of dementia were assessed with the Neuropsychiatric Inventory scale and the Clinical Dementia Rating scale, respectively.Results:Mild, moderate, and severe dementia was present in 25%, 33%, and 42%, respectively. There was an increase in the severity of the dementia from the first to the fourth assessment. Agitation, irritability, disinhibition, and apathy were the most prevalent and persistent symptoms during the study period. The affective subsyndrome (depression and anxiety) became less severe, whereas the agitation subsyndrome (agitation/aggression, disinhibition, and irritability) and apathy increased in severity during the follow-up period. More severe dementia was associated with more severe agitation, psychosis, and apathy, but not more severe affective symptoms. Mild dementia was associated with an increase in the severity of psychosis, whereas moderate or severe dementia was associated with decreasing severity of psychosis over the follow-up period.Conclusion:Nearly all the patients experienced clinically significant NPS, but individual symptoms fluctuated. Affective symptoms became less severe, while agitation and apathy increased in severity. An increase in dementia severity was associated with an increase in the severity of agitation, psychosis, and apathy, but not affective symptoms. The results may have implications when planning evaluation, treatment, and the prevention of NPS in NH patients.

Deep brain stimulation of the subcallosal cingulate for treatment-refractory anorexia nervosa: 1 year follow-up of an open-label trial

2017 ◽  
Vol 4 (4) ◽  
pp. 285-294 ◽  
Author(s):  
Nir Lipsman ◽  
Eileen Lam ◽  
Matthew Volpini ◽  
Kalam Sutandar ◽  
Richelle Twose ◽  
...  
Keyword(s):  
Anorexia Nervosa ◽  
Deep Brain Stimulation ◽  
Brain Stimulation ◽  
Open Label ◽  
Open Label Trial ◽  
Treatment Refractory ◽  
Deep Brain ◽  
Stimulation Of

Combined treatment with reboxetine in depressed patients with no response to venlafaxine: a 6-week follow-up study

2007 ◽  
Vol 19 (5) ◽  
pp. 291-296 ◽  
Author(s):  
Cecilio Álamo ◽  
Francisco López-Muñoz ◽  
Gabriel Rubio ◽  
Pilar García-García ◽  
Antonio Pardo
Keyword(s):  
Adverse Events ◽  
Rating Scale ◽  
Combined Treatment ◽  
Open Label ◽  
Serious Adverse Events ◽  
Multicentric Study ◽  
Intent To Treat ◽  
Events Data ◽  
Clinical Global Impression Improvement

Objective:The purpose of present study was to evaluate the efficacy of the addition of reboxetine in patients that had not previously responded, or had done so only partially, over 6 weeks of conventional pharmacological treatment with venlafaxine.Methods:This open-label, prospective and multicentric study included 40 outpatients diagnosed with major depressive disorder according to the DSM-IV criteria. Efficacy was assessed using the 21-item Hamilton Depression Rating Scale (HAMD) and the Clinical Global Impression-Improvement (CGI-I). Safety was evaluated by recording spontaneously reported adverse events. Data were analysed on an intent-to-treat basis, using the last-observation-carried-forward method.Results:Mean HAMD reduction was 34.9% (P < 0.0001). The percentages of responders (≥50% reduction in HAMD) and patients considered as benefiting from complete remission (HAMD ≤ 10 points) at week 6 were 27.5 and 12.5%, respectively. By the end of the treatment, the score of CGI-I decreased 24.8% (P < 0.0001). Percentage of patient improving (CGI < 4 points) was 47.5%. The most common non-serious adverse events were constipation, nervousness, anxiety and insomnia.Conclusion:These findings suggest that the combined treatment of reboxetine and venlafaxine, in venlafaxine-resistant patients, may be an effective and well-tolerated strategy.

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