Adjunctive Therapy to Manage Neuropsychiatric Symptoms in Moderate and Severe Dementia: Randomized Clinical Trial Using an Outpatient Version of Tailored Activity Program

2021 ◽  
pp. 1-12
Author(s):  
Alexandra Martini Oliveira ◽  
Marcia Radanovic ◽  
Patricia Cotting Homem de Mello ◽  
Patricia Cardoso Buchain ◽  
Adriana Dias Barbosa Vizzotto ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sleep Disturbances ◽  
Rating Scale ◽  
Neuropsychiatric Symptoms ◽  
Caregiver Training ◽  
Controlled Clinical Trial ◽  
Post Intervention ◽  
Double Blind ◽  
Activity Program ◽  
Experimental Group

Background: Neuropsychiatric symptoms (NPS) such as aggression, apathy, agitation, and wandering may occur in up to 90%of dementia cases. International guidelines have suggested that non-pharmacological interventions are as effective as pharmacological treatments, however without the side effects and risks of medications. An occupational therapy method, called Tailored Activity Program (TAP), was developed with the objective to treat NPS in the elderly with dementia and has been shown to be effective. Objective: Evaluate the efficacy of the TAP method (outpatient version) in the treatment of NPS in individuals with dementia and in the burden reduction of their caregivers. Methods: This is a randomized, double-blind, controlled clinical trial for the treatment of NPS in dementia. Outcome measures consisted of assessing the NPS of individuals with dementia, through the Neuropsychiatric Inventory-Clinician rating scale (NPI-C), and assessing the burden on their caregivers, using the Zarit Scale. All the participants were evaluated pre-and post-intervention. Results: 54 individuals with dementia and caregivers were allocated to the experimental (n = 28) and control (n = 26) groups. There was improvement of the following NPS in the experimental group: delusions, agitation, aggressiveness, depression, anxiety, euphoria, apathy, disinhibition, irritability, motor disturbance, and aberrant vocalization. No improvement was observed in hallucinations, sleep disturbances, and appetite disorders. The TAP method for outpatient settings was also clinically effective in reducing burden between caregivers of the experimental group. Conclusion: The use of personalized prescribed activities, coupled with the caregiver training, may be a clinically effective approach to reduce NPS and caregiver burden of individuals with dementia.

scholarly journals P2-022: RANDOMIZED AND CONTROLLED CLINICAL TRIAL TO EVALUATE A BRAZILIAN OUTPATIENT VERSION OF THE TAP METHOD (TAILORED ACTIVITY PROGRAM) FOR THE TREATMENT OF NEUROPSYCHIATRIC SYMPTOMS IN INDIVIDUALS WITH DEMENTIA

2019 ◽  
Vol 15 ◽  
pp. P578-P579
Author(s):  
Alexandra Martini Oliveira ◽  
Marcia Radanovic ◽  
Patricia Cotting Homem de Mello ◽  
Patricia Cardoso Buchain ◽  
Adriana dias Vizzotto ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Neuropsychiatric Symptoms ◽  
Controlled Clinical Trial ◽  
Activity Program

scholarly journals Pramipexole in peritoneal dialysis patients with restless legs syndrome (RLS): a protocol for a multicentre double-blind randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e033815
Author(s):  
Tian-tian Ma ◽  
Zhikai Yang ◽  
Sainan Zhu ◽  
Jing-hong Zhao ◽  
Yi Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Peritoneal Dialysis ◽  
Restless Legs Syndrome ◽  
Rating Scale ◽  
Controlled Trial ◽  
Psychological Status ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Restless Legs ◽  
Peking University

IntroductionRestless legs syndrome (RLS) is a common neurological sensorimotor disorder among patients with end stage renal disease. This clinical trial aimed to provide evidence on the efficacy and safety of pramipexole in patients with uremic RLS receiving peritoneal dialysis (PD).Methods and analysisThis is a 12-week, multicentre, randomised, double-blind, placebo-controlled clinical trial. In total, 104 patients with uremic RLS receiving PD will be enrolled from four hospitals and randomly assigned in a 1:1 ratio to either placebo or pramipexole. We will determine the efficacy of pramipexole in the improvement of International RLS Study Group Rating Scale as the primary outcome, while responder rates for other RLS scales at week 12, change from baseline to week 12 for psychological status, sleep disorder and quality of life and blood pressure represent the secondary outcomes.Ethics and disseminationThe study was approved by the ethics committees of Peking University First Hospital, Xinqiao hospital of Army Medical University, Cangzhou Center Hospital and Peking University Shenzhen Hospital. The results will be disseminated in peer-reviewed journals.Trial registration numberNCT03817554

OscillococcinumR in patients with influenza-like syndromes: A placebo-controlled double-blind evaluation

1998 ◽  
Vol 87 (02) ◽  
pp. 69-76 ◽  
Author(s):  
Rosemarie Papp ◽  
Gert Schuback ◽  
Elmar Beck ◽  
Georg Burkard ◽  
Jürgen Bengel ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Rectal Temperature ◽  
Muscle Pain ◽  
Rating Scale ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Duration Of Symptoms ◽  
Number Of Patients ◽  
Positive Effect

AbstractA controlled clinical trial was conducted to assess the effectiveness of OscillococcinumR in the treatment of patients with influenza-like syndromes. 188 patients received the test drug and 184 patients were assigned to the placebo. Data were recorded by the participating physicians at the beginning of the treatment, after 48 hours and after 7–10 days. During the first few days, the patients recorded their rectal temperature twice a day (mornings and evenings), 9 symptoms on a rating scale (cough, catarrh, sore throat, muscle pain, etc.), and use of medication. Recovery was defined as follows: ‘rectal temperature < 37.5°C and no headache or muscle pain’. Effectiveness was defined as a statistically significant greater decrease in symptoms after 48 hours in the verum group or a shorter duration of symptoms in comparison to the placebo group. After 48 hours the symptoms of the patients in the verum group were significantly milder (P=0.023) than in the placebo group. The number of patients with no symptoms was significantly higher in the verum group from the second day onwards (verum: 17.4%, placebo: 6.6%) until the end of the patients’ recording (day 5 in the evening: verum: 73.7%, placebo: 67.7%). The biggest group difference was recorded for the time between the evening of the second day (10.6% more patients with no symptoms) and the morning of the fourth day (10.2% more patients with no symptoms). The clinical trial showed that treatment of influenza-like syndromes with OscillococcinumR has a positive effect on the decline of symptoms and on the duration of the disease.

Ginger for chemotherapy-related nausea in cancer patients: A URCC CCOP randomized, double-blind, placebo-controlled clinical trial of 644 cancer patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9511-9511 ◽  
Author(s):  
J. L. Ryan ◽  
C. Heckler ◽  
S. R. Dakhil ◽  
J. Kirshner ◽  
P. J. Flynn ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Receptor Antagonist ◽  
Cancer Patients ◽  
Rating Scale ◽  
Zingiber Officinale ◽  
Time Of Day ◽  
Nausea And Vomiting ◽  
Analysis Of Covariance ◽  
Controlled Clinical Trial ◽  
Double Blind

9511 Background: Despite the widespread use of antiemetics, post-chemotherapy nausea and vomiting continue to be reported by up to 70% of patients receiving chemotherapy. Ginger (Zingiber Officinale), an ancient spice, is used by practitioners worldwide to treat nausea and vomiting. We conducted a multi-site, phase II/III randomized, placebo-controlled, double-blind clinical trial to assess the efficacy of ginger for chemotherapy-related nausea in cancer patients at the University of Rochester-affiliated Community Clinical Oncology Program (CCOP) member sites. Methods: Cancer patients who experienced nausea following any chemotherapy cycle and were scheduled to receive at least three additional cycles were eligible. Patients were randomized into four arms: 1) placebo, 2) 0.5g ginger, 3) 1.0g ginger, or 4) 1.5g ginger. All patients received 5-HT3 receptor antagonist antiemetics on Day 1 of all cycles and took three 250mg capsules of ginger or placebo twice daily for six days starting three days before the first day of the next two cycles. Patients reported the severity of nausea during the morning, afternoon, evening, and night on a 7-point semantic rating scale (‘1' = ‘Not at all Nauseated' and ‘7' = “Extremely Nauseated”) for Days 1–4 of each cycle. The goal was to determine if ginger was more effective than placebo in controlling chemotherapy-related nausea in participants given a 5-HT3 receptor antagonist antiemetic. Results: A total of 644 patients were accrued (90% female, mean age = 53). Breast (66%), alimentary (6.5%), and lung (6.1%) cancers were the most common cancer types. Analysis of covariance (ANCOVA) examined change in nausea in the four study arms on Day 1 of cycles 2 and 3. All doses of ginger significantly reduced nausea (p=0.003). The largest reduction in nausea occurred with 0.5g and 1.0g of ginger. Also, time of day had a significant effect on nausea (p<0.001) with a linear decrease over 24 hours for patients using ginger. Conclusions: Ginger supplementation at daily dose of 0.5g-1.0g significantly aids in reduction of nausea during the first day of chemotherapy. Supported by NCI PHS grants 1R25CA10618 and U10CA37420. No significant financial relationships to disclose.

scholarly journals A clinical efficacy of 30% ethenolic extract of Indian propolis and Recaldent TM in management of dentinal hypersensitivity: A comparative randomized clinical trial

2013 ◽  
Vol 07 (04) ◽  
pp. 461-468 ◽  
Author(s):  
Nilesh Arjun Torwane ◽  
Sudhir Hongal ◽  
Pankaj Goel ◽  
B. R. Chandrashekar ◽  
Manish Jain ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Rating Scale ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Sterile Water ◽  
Double Blind ◽  
Treatment Groups ◽  
Casein Phosphopeptide ◽  
Group B ◽  
Dentinal Hypersensitivity

ABSTRACT Objective: The aim of this study is to evaluate the efficacy of 30% ethenolic extract of Indian propolis compared with Recaldent TM (casein phosphopeptide-amorphous calcium phosphate) in reduction of dentinals hypersensitivity, a randomized, double-blind, split mouth, controlled clinical trial was conducted among the patients residing in Central Jail. Materials and Methods: A sample of 73 teeth from 13 patients having at least three teeth with dentinal hypersensitivity (DH) were randomly allocated into three treatment groups: Group A: 30% ethenolic extract of Indian propolis, Group B: Recaldent TM , Group C: Sterile water. Verbal rating scale was used to record the degree of hypersensitivity based on patient′s response to tactile and air blast stimuli. The baseline scores were obtained. Each intervention group received applications of their respective agents consecutively on 1 st , 7 th , 14 th , and 21 st day. After each application the scores were recorded. Results: Both the 30% Indian propolis and Recaldent TM showed significant reduction in DH. Conclusions: Recaldent TM was found to be significantly better in reducing the DH compared to propolis and sterile water (P < 0.01).

scholarly journals The validity and internal structure of the Bipolar Depression Rating Scale: data from a clinical trial of N-acetylcysteine as adjunctive therapy in bipolar disorder

2010 ◽  
Vol 22 (5) ◽  
pp. 237-242 ◽  
Author(s):  
Michael Berk ◽  
Seetal Dodd ◽  
Olivia M Dean ◽  
Kristy Kohlmann ◽  
Lesley Berk ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bipolar Disorder ◽  
Internal Structure ◽  
Adjunctive Therapy ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Rating Scale Data ◽  
Scale Data

Berk M, Dodd S, Dean OM, Kohlmann K, Berk L, Malhi GS. The validity and internal structure of the Bipolar Depression Rating Scale: data from a clinical trial of N-acetylcysteine as adjunctive therapy in bipolar disorder.Background:The phenomenology of unipolar and bipolar disorders differ in a number of ways, such as the presence of mixed states and atypical features. Conventional depression rating instruments are designed to capture the characteristics of unipolar depression and have limitations in capturing the breadth of bipolar disorder.MethodThe Bipolar Depression Rating Scale (BDRS) was administered together with the Montgomery Asberg Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) in a double-blind randomised placebo-controlled clinical trial of N-acetyl cysteine for bipolar disorder (N = 75).Results:A factor analysis showed a two-factor solution: depression and mixed symptom clusters. The BDRS has strong internal consistency (Cronbach's alpha = 0.917), the depression cluster showed robust correlation with the MADRS (r = 0.865) and the mixed subscale correlated with the YMRS (r = 0.750).Conclusion:The BDRS has good internal validity and inter-rater reliability and is sensitive to change in the context of a clinical trial.

scholarly journals A Preliminary Study on the Safety, Efficacy and Acceptability of the Community Preparation of Siling Labuyo (Capsicum frutescens) Liniment in the Management of Knee Osteoarthritis in a Six-Week, Active-Controlled Community-Based Clinical Trial

2019 ◽  
Vol 53 (4) ◽  
Author(s):  
Elizabeth R. Paterno ◽  
Clarisse A. Pangilinan ◽  
Erna C. Arollado ◽  
Rachael Marie B. Rosario
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Control Agent ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Control Groups ◽  
Double Blind ◽  
The Difference ◽  
And Control ◽  
Experimental Group

Objective. The study determined the safety, efficacy and acceptability of a Philippine community preparation of Siling Labuyo liniment in the management of knee osteoarthritis. Methods. A 6-week randomized, double-blind, active-controlled clinical trial was conducted in three municipalities of Cavite from 2017-2018. The municipalities were randomly assigned to either the control or experimental group, using a commercially available Diclofenac 1% gel as the control agent. Knee Injury and Osteoarthritis Outcome Score (KOOS) and Pain Visual Analogue Scale (VAS) were used to measure the outcomes. Results. Forty-seven participants completed the study. Statistically significant improvement (p<0.05) in pain relief, reduction of symptoms and increase in knee functionality was reported by participants in both the experimental and control groups. Across the dimensions measured, at least 30% improvement in scores was reported by the experimental group, and at least 40% by the control group. The difference was statistically not significant (p>0.05). Itching (13%), burning sensation (11%) and reddening of the skin (15%) were experienced in both the experimental and the active control groups. Conclusion. Use of the liniment led to a modest therapeutic effect and was well-tolerated by the participants.

scholarly journals Neurodynamic mobilization and foam rolling improved delayed-onset muscle soreness in a healthy adult population: a randomized controlled clinical trial

PeerJ ◽  
2017 ◽  
Vol 5 ◽  
pp. e3908 ◽  
Author(s):  
Blanca Romero-Moraleda ◽  
Roy La Touche ◽  
Sergio Lerma-Lara ◽  
Raúl Ferrer-Peña ◽  
Víctor Paredes ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Muscle Soreness ◽  
Pain Perception ◽  
Rating Scale ◽  
Adult Population ◽  
Rectus Femoris ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Maximum Voluntary Isometric Contraction ◽  
Significant Difference

Objectives Compare the immediate effects of a Neurodynamic Mobilization (NM) treatment or foam roller (FR) treatment after DOMS. Design Double blind randomised clinical trial. Setting The participants performed 100 drop jumps (5 sets of 20 repetitions, separated by 2 min rests) from a 0.5-m high box in a University biomechanics laboratory to induce muscle soreness. The participants were randomly assigned in a counter-balanced fashion to either a FR or NM treatment group. Participants Thirty-two healthy subjects (21 males and 11 females, mean age 22.6 ± 2.2 years) were randomly assigned into the NM group (n = 16) or the FR group (n = 16). Main Outcome Measures The numeric pain rating scale (NPRS; 0–10), isometric leg strength with dynamometry, surface electromyography at maximum voluntary isometric contraction (MVIC) and muscle peak activation (MPA) upon landing after a test jump were measured at baseline, 48 h after baseline before treatment, and immediately after treatment. Results Both groups showed significant reduction in NPRS scores after treatment (NM: 59%, p < .01; FR: 45%, p < .01), but no difference was found between them (p > .05). The percentage change improvement in the MVIC for the rectus femoris was the only significant difference between the groups (p < 0.05) at post-treatment. After treatment, only the FR group had a statistically significant improvement (p < 0.01) in strength compared to pre-treatment. Conclusion Our results illustrate that both treatments are effective in reducing pain perception after DOMS whereas only FR application showed differences for the MVIC in the rectus femoris and strength.

Antidepressant Efficacy and Safety of Low-Dose Sertraline and Standard-Dose Imipramine for the Treatment of Depression in Older Adults: Results From a Double-Blind, Randomized, Controlled Clinical Trial

2001 ◽  
Vol 13 (1) ◽  
pp. 75-84 ◽  
Author(s):  
Orestes V. Forlenza ◽  
Osvaldo P. Almeida ◽  
Alberto Stoppe ◽  
Edson S. Hirata ◽  
Rita C. R. Ferreira
Keyword(s):  
Older Adults ◽  
Clinical Trial ◽  
Rating Scale ◽  
Standard Dose ◽  
Later Life ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Intention To Treat ◽  
Full Remission ◽  
Antidepressant Efficacy

This study compared the efficacy and tolerability of 150 mg/day imipramine and 50 mg/day sertraline for the treatment of a major depressive episode (DSM-IV) in older adults (N = 55) in an 8-week, randomized, double-blind, controlled clinical trial. Intention-to-treat analysis (last observation carried forwards) showed a reduction of 50% or more on the baseline scores of the Montgomery-Åsberg Rating Scale (MADRS) in 60.7% and 55.6% of patients receiving imipramine and sertraline, respectively (p = .698). Full remission of symptoms (MADRS < 9) was observed in 50.0% and 51.8% of patients, respectively (p = .891). Side effects were more frequent among patients treated with imipramine (86.7%) than among patients treated with sertraline (42.1%) (p = .008). Dropout rates were high in both groups (46.4% and 29.6% respectively, p = .200). These results indicate that imipramine and sertraline are equally effective for the treatment of major depression in later life, although adverse reactions are more frequent among subjects treated with imipramine than with sertraline.

scholarly journals Lovastatin as an Adjuvant to Lithium for Treating Manic Phase of Bipolar Disorder: A 4-Week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Ahmad Ghanizadeh ◽  
Motahhar OmraniSigaroodi ◽  
Ali Javadpour ◽  
Mohammad Hossein Dabbaghmanesh ◽  
Sara Shafiee
Keyword(s):  
Clinical Trial ◽  
Bipolar Disorder ◽  
Placebo Group ◽  
Adverse Effects ◽  
Rating Scale ◽  
Clinical Symptoms ◽  
Controlled Clinical Trial ◽  
Young Mania ◽  
Double Blind ◽  
Significant Difference

Objectives. Many patients with bipolar disorder suffer from metabolic disorder. Lovastatin is effective for treating major depression. This double-blind randomized placebo controlled clinical trial investigates whether lovastatin is a useful adjuvant to lithium for treating mania.Methods. Fifty-four patients with bipolar disorder-manic phase were randomly allocated into lovastatin or placebo group. The clinical symptoms were assessed at baseline, week 2, and week 4 using Young Mania Rating Scale. Adverse effects were checked.Results. Forty-six out of 54 patients completed this trial. The mania score in the lovastatin group decreased from 40.6 (11.1) at baseline to 12.9 (8.7) and 4.1 (5.4) at weeks 2 and 4, respectively. The score in the placebo group decreased from 41.0 (11.2) at baseline to 12.8 (8.07) and 5.8 (4.6) at weeks 2 and 4, respectively. However, there was no significant difference between groups at week 2 and week 4. The adverse effects rates were comparable between the two groups. No serious adverse effect was found. Tremor and nausea were the most common adverse effects.Conclusions. Lovastatin neither exacerbated nor decreased the symptoms of mania in patients with bipolar disorder. Current results support that the combination of lovastatin with lithium is tolerated well in bipolar disorder. The trial was registered with the Iranian Clinical Trials Registry (IRCT201302203930N18).

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