scholarly journals Homoeopathic treatment of vitiligo: an open observational pilot study

2021 ◽  
Vol 12 (45) ◽  
pp. 168-177
Author(s):  
Subhasish Ganguly ◽  
Subhranil Saha ◽  
Munmun Koley ◽  
Ramkumar Mondal
Keyword(s):  
Pilot Study ◽  
Task Force ◽  
Psychological Impact ◽  
Life Quality ◽  
Feasibility Studies ◽  
Median Score ◽  
Open Label ◽  
Double Blind ◽  
Homeopathic Treatment ◽  
Intensity Spread

Background: Vitiligo is a common hypopigmentation disorder with significant psychological impact. An evaluation of homeopathic treatment was performed in individuals with vitiligo in a hospital outpatient clinic in West Bengal, India. Methods: Thirty participants (median age 27 years old, 57% female) were recruited for a prospective open-label pilot study and treated with individualized homeopathic medicines for 6 months. Efficacy was assessed after 3 months and 6 months using Vitiligo Area Scoring Index (VASI) score, Vitiligo European Task Force (VETF) score, and Dermatological Life Quality Index (DLQI) score, which are validated outcome measures evaluating the area, intensity, spread of depigmentation of vitiligo lesions, and quality of life (QoL). Results: A total of 27 participants completed the trial; 3 dropped out. After 6 months of treatment, the median VASI total score improved significantly by 0.1 units (p=0.003), from 0.8 (0.5, 1.5) to 0.7 (0.3, 0.8) on a scale from 0 (no depigmentation) to 100 (completely depigmented). Similarly, the VETF median score improved by 2 units (p=0.0001) from 1 (0, 1) to –1 (–1, 0) and the staging score changed from 1 (1, 2) to 1 (0, 1), p=0.002. The total DLQI median score exhibited significant reduction from 21 (17, 22) to 13.6 (10, 17), change 7.4 (p=0.0001), as also did its components. Conclusions: Individualized homeopathic treatment associated with significant improvement of VASI, VETF and DLQI scores. The extent to which the observed effects were due to placebo needs clarification in future randomized double-blind clinical studies preceded by feasibility studies. Trial Registration: Clinical Trials Registry, India registration number CTRI/2013/08/003879.

Evaluating Thrombin Inhibition in Alzheimer’s Disease (The BEACON Trial): Protocol for a Pilot Study (Preprint)

2019 ◽  
Author(s):  
Cláudia Yang Santos ◽  
Christine Getter ◽  
John Stoukides ◽  
Brian Ott ◽  
Stephen Salloway ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Pilot Study ◽  
Cognitive Performance ◽  
Thrombin Inhibitor ◽  
Placebo Control ◽  
Open Label ◽  
Double Blind ◽  
Thrombin Inhibition ◽  
Approved Drugs

BACKGROUND The precise mechanisms whereby cardiovascular risk factors increase the risk of Alzheimer’s disease (AD) have not been delineated. We reported that microvessels isolated from AD brains overexpress a diverse array of neurotoxic and inflammatory proteins, which is consistent with the process of vascular activation. In pre-clinical studies using AD animal models we showed that a vascular activation inhibitor reduced vascular-derived neuroinflammation and improved cognitive performance. Thrombin is a key mediator of cerebrovascular activation in AD. OBJECTIVE This study aims to investigate the safety and potential efficacy of the direct thrombin inhibitor dabigatran, in patients with mild cognitive impairment (MCI) or mild AD to decrease vascular-derived neuroinflammation and improve cognitive performance. METHODS Participants will be enrolled then evaluated quarterly throughout the 24-month study. This is a 24-month randomized-control, double-blind, placebo-controlled, multicenter, delayed-start, pilot study evaluating thrombin inhibition in people with biomarker-confirmed MCI probably due to AD or mild AD. 40 - 60 participants will be recruited between 50 - 85 years old. In the initial 9-months of study, either dabigatran or placebo will be orally administered to patients at a dose of 150 mg per day. After 9 months of the placebo-control (Phase I), the placebo arm will cross-over to an active, open-label (Phase II) where all patients will be treated with a 150 mg daily dose of dabigatran orally for an additional 12 months. A 3-month non-treatment follow-up period will assess duration of effects. RESULTS Beginning in July 2019, and concluding in August 2022, this study is expected to publish final results in January 2023. CONCLUSIONS BEACON is a first-in-kind randomized clinical trial targeting thrombin activation in AD therapeutics. This trial will stimulate translational investigations of an FDA-approved drugs in a newly defined therapeutic areas. CLINICALTRIAL Clinicaltrials.gov NCT03752294

scholarly journals A Prospective Pilot Study of Levetiracetam for Body Dysmorphic Disorder

CNS Spectrums ◽  
2009 ◽  
Vol 14 (5) ◽  
pp. 252-260 ◽  
Author(s):  
Katharine A. Phillips ◽  
William Menard
Keyword(s):  
Pilot Study ◽  
Body Dysmorphic Disorder ◽  
Rating Scale ◽  
Primary Outcome Measure ◽  
Obsessive Compulsive ◽  
Open Label ◽  
Double Blind ◽  
The Social ◽  
Scale Scores ◽  
The Mean

ABSTRACTIntroduction: Body dysmorphic disorder (BDD) is an often severe disorder, but few treatment studies have been conducted.Objective: This pilot study explored the efficacy and safety of the antiepileptic medication levetiracetam for BDD.Methods: Seventeen subjects with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition BDD participated in a 12-week open-label levetiracetam trial. Subjects were assessed at regular intervals with standard measures.Results: In intent-to-treat analyses, scores on the Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS), the primary outcome measure, decreased from 32.5±4.7 at baseline to 21.5±11.0 at endpoint (P<.001). Approximately 60% (n=9) of subjects were responders (≥30% decrease on the BDD-YBOCS). The mean time to response was 4.6±2.8 (range: 2-10) weeks. Scores also significantly improved on the Brown Assessment of Beliefs Scale, the Hamilton Rating Scale for Depression, the Global Assessment of Functioning Scale, and the Social and Occupational Functioning Assessment Scale. Scores did not significantly improve on the Quality of Life Enjoyment and Satisfaction Questionnaire, the Beck Anxiety Inventory, or the Social Phobia Inventory. The mean endpoint dose of levetiracetam was 2,044.1±1,065.2 (range: 250–3,000) mg/day, and it was relatively well-tolerated.Conclusion: Randomized, double-blind placebo-controlled studies of levetiracetam for BDD are needed to confirm these preliminary findings.

An open label pilot study of citalopram for depression and boredom in ambulatory cancer patients

2003 ◽  
Vol 1 (1) ◽  
pp. 71-77 ◽  
Author(s):  
DALE E. THEOBALD ◽  
KENNETH L. KIRSH ◽  
ELIZABETH HOLTSCLAW ◽  
KATHLEEN DONAGHY ◽  
STEVEN D. PASSIK
Keyword(s):  
Depressive Symptoms ◽  
Pilot Study ◽  
Cancer Patients ◽  
Antidepressant Treatment ◽  
Controlled Trial ◽  
Depression Scale ◽  
Evidence Base ◽  
Open Label ◽  
Double Blind ◽  
Visual Analog Scales

Objective: Significant levels of depressive symptoms are an impediment to adjustment and affect greater than one-third of people with cancer. The clinical diagnosis of major depression is estimated to occur in 25%. Depression is dramatically underrecognized by oncologists and oncology nurses, and as a result, often undertreated. Clinical experience suggests that antidepressants of virtually all types are well tolerated and potentially efficacious. There is, however, a lack of an evidence base for the use of antidepressants in cancer patients.Methods: We undertook an open-label pilot study using citalopram in 30 cancer patients who reported a high level of depressive symptoms on the Zung Self-Rating Depression Scale (ZSDS). In addition to the ZSDS, eligible patients completed a series of visual analog scales for pain, depression, and sleep disturbance; the Functional Assessment of Cancer Therapy-General Module; and the Purposelessness, Understimulation, and Boredom Scale developed by the research team. Patients began a 2-month course of therapy with citalopram 20 mg, increasing to 40 mg at the end of the fourth week if the patient was in the same range of depressive symptoms as measured by the ZSDS.Results: Twenty-one of 30 patients completed the protocol. The average age of the sample was 57.32 years (SD = 12.6) and was comprised of 11 women (52.4%) and 10 men (47.6%). Depressive symptoms decreased and quality of life improved during the 8-week treatment period. Of special interest was the rate of improvement in boredom, and using the total boredom score of the PUB, significant improvement compared to baseline was seen in weeks 6 (F = 5.266, p < .05) and 8 (F = 9.248, p < .01).Significance of results: Overall, the positive findings suggest the need for a randomized, double-blind, placebo-controlled trial of citalopram in cancer patients. Regarding the interplay of boredom and depression, the relationship between improvements in depressive symptoms and boredom is complex. This is illustrated by the way in which the different elements respond to antidepressant treatment. Depression began to improve almost immediately upon initiation of treatment whereas improvement in boredom does not become evident until week 6.

scholarly journals 32 Early-Onset Efficacy and Safety Pilot Study of Amphetamine Extended-Release Oral Suspension (AMPH EROS) in the Treatment of Children with Attention-Deficit/Hyperactivity Disorder

CNS Spectrums ◽  
2019 ◽  
Vol 24 (1) ◽  
pp. 191-192
Author(s):  
Ann C. Childress ◽  
Antonio Pardo ◽  
Thomas R. King ◽  
Judith C. Kando ◽  
Barry K. Herman
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Extended Release ◽  
Rating Scale ◽  
Upper Respiratory Tract ◽  
Open Label ◽  
Double Blind ◽  
Hyperactivity Disorder ◽  
Laboratory Classroom ◽  
Open Label Phase

ObjectiveTo determine whether amphetamine extended-release oralsuspension (AMPH EROS) has an onset of effect at 30minutes postdose inchildren with ADHD.MethodsThis randomized, double-blind, 2-treatment, 2-sequence, placebo-controlled crossover pilot study enrolled subjects aged 6 to 12 years withattention-deficit/hyperactivity disorder (ADHD) and ADHD-Rating Scale-5 scores of ≥90th percentile for sex and age. A dose of 5 to 20mg/day of AMPH EROS was determined during a 1-week open-label phase based on medication history, symptom control, and tolerability. Subjects completed a practice laboratory classroom then received one day of double-blind active drug or placebo each in random sequence during 2 double-blind laboratory classroom days. Subjects completed the first double-blind laboratory classroom session, returned to open label drug for 5days then crossed over on day 6 during a second double-blind laboratory classroom session. DB dose was fixed at AMPH EROS 15, 17.5, or 20mg . The primary endpoint was change from predose in the Swanson, Kotkin, Agler, M-Flynn, Pelham rating scale-combined score (SKAMP-C) at 30minutes postdose on two DB days. The key secondary endpoint was change from predose in the SKAMP-C score at 3hours postdose for AMPH EROS compared with placebo. Safety assessments included vital signs and adverse events.ResultsEighteen subjects were enrolled in the study (14 males and 4 females) with a mean age of 9 years. At both 30minutes and 3hours postdose, changes from baseline in SKAMP-C for AMPH EROS vs. placebo were statistically significant (p<0.01 and p=0.0002, respectively) with corresponding effect sizes of 0.96 and 1.57. Adverse events (>10%) during the open-label phase included upper respiratory tract infection, fatigue, upper abdominal pain, headache, decreased appetite, and affect lability.ConclusionsAMPH EROS was effective in reducing ADHD symptoms at 30minutes postdose. AEs were mild or moderate and consistent with those of other extended-release amphetamines.Funding Acknowledgements: Support was provided by Tris Pharma, Inc.

Rivastigmine in Vascular Dementia

2003 ◽  
Vol 15 (S1) ◽  
pp. 201-205 ◽  
Author(s):  
Shoona Vincent ◽  
Roger Lane
Keyword(s):  
Pilot Study ◽  
Vascular Dementia ◽  
Selective Inhibition ◽  
Behavioral Symptoms ◽  
Functional Abilities ◽  
Mixed Dementia ◽  
Open Label ◽  
Small Pilot Study ◽  
Double Blind ◽  
Efficacious Treatment

Vascular dementia (VaD), like Alzheimer's disease (AD), is associated with cholinergic deficits. Rivastigmine provides sustained, brain-selective inhibition of acetylcholinesterase and butyrylcholinesterase. Preliminary data suggest that rivastigmine may provide significant benefits in patients with AD and cerebrovascular disease (mixed dementia), and in patients with VaD. Open-label rivastigmine treatment has been associated with improved cognitive and functional abilities, behavioral symptoms, and reduced caregiver stress in a small pilot study in these patients. Larger, prospective, double-blind studies of rivastigmine in patients with VaD are under way. These studies will confirm whether rivastigmine is an efficacious treatment option for a range of patients for whom, until now, there have been few symptomatic therapies.

Pilot Study of Droxidopa With Carbidopa in Adults With ADHD

2015 ◽  
Vol 23 (2) ◽  
pp. 189-198 ◽  
Author(s):  
Lenard A. Adler ◽  
Stephen W. Gorny
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Adult Adhd ◽  
Adhd Symptoms ◽  
Efficacy And Safety ◽  
Open Label ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Symptom Report ◽  
Pilot Investigation

Objective: We conducted a two-period (open-label and double-blind) pilot investigation of droxidopa, with and without carbidopa, for ADHD. Method: Twenty adult ADHD patients received open-label droxidopa titrated from 200 to 600 mg 3 times per day (TID; Weeks 1-3), then open-label droxidopa plus carbidopa titrated from 25 or 50 mg TID (Weeks 4-6). In Weeks 7 to 8, patients were randomized to continued co-treatment or matching placebo substitution. Results: Improvements in mean total Adult ADHD Investigator Symptom Report Scale (AISRS) scores were seen at Week 1 ( p < .0001) and Week 3 ( p < .0001). Improvements were maintained but not increased with carbidopa. Thirteen of 20 patients completed open-label treatment. In the double-blind period, mean total AISRS scores were similar between the co-treatment ( n = 6) and placebo ( n = 5) groups. No serious adverse events were reported. Conclusion: These preliminary findings indicate that droxidopa can improve adult ADHD symptoms. Further studies are warranted to examine the efficacy and safety of droxidopa in ADHD.

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