A double blind, randomized, placebo controlled trial of the efficacy, quality of life and safety of food allergen‐specific sublingual immunotherapy in client owned dogs with adverse food reactions: a small pilot study

2016 ◽  
Vol 27 (5) ◽  
pp. 361 ◽  
Author(s):  
Elisa Maina ◽  
Eric Cox
Keyword(s):  
Quality Of Life ◽  
Pilot Study ◽  
Food Allergen ◽  
Sublingual Immunotherapy ◽  
Controlled Trial ◽  
Small Pilot Study ◽  
Double Blind

scholarly journals Adjunctive Garcinia mangostana Linn. (Mangosteen) Pericarp for Schizophrenia: A 24-Week Double-blind, Randomized, Placebo Controlled Efficacy Trial: Péricarpe d’appoint Garcinia mangostana Linn (mangoustan) pour la schizophrénie : un essai d’efficacité de 24 semaines, à double insu, randomisé et contrôlé par placebo

2020 ◽  
pp. 070674372098243
Author(s):  
Alyna Turner ◽  
Andrea Baker ◽  
Olivia M. Dean ◽  
Adam J. Walker ◽  
Seetal Dodd ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Schizoaffective Disorder ◽  
Negative Symptoms ◽  
Controlled Trial ◽  
Safety Data ◽  
Rate Of Change ◽  
Adjunctive Treatment ◽  
Garcinia Mangostana ◽  
Double Blind

Objectives: Garcinia mangostana Linn. (“mangosteen”) pericarp contains bioactive compounds that may target biological pathways implicated in schizophrenia. We conducted a double-blind randomized placebo-controlled trial evaluating the efficacy of adjunctive mangosteen pericarp, compared to placebo, in the treatment of schizophrenia. Methods: People diagnosed with schizophrenia or schizoaffective disorder ( Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), recruited across 2 sites (Brisbane and Victoria, Australia), were randomized to receive 24 weeks of adjunctive mangosteen pericarp (1,000 mg/day) or matched placebo. The primary outcome measure was the Positive and Negative Symptom Scale total score. Secondary outcomes included positive and negative symptoms, general psychopathology, clinical global severity and improvement, participant reported overall improvement, depressive symptoms, functioning, quality of life, and safety data at 24 and 28 weeks (4 weeks postdiscontinuation). Data were collected from July 2016 to February 2019. Results: Baseline assessments were conducted on 148 people (mangosteen = 74, placebo = 74); data analyses were conducted on 136 (92%) participants with postbaseline data. The treatment group had significantly higher symptom severity compared to placebo, and both groups significantly improved on all symptom, functioning, and quality of life measures over time. No between-group differences were found for the rate of change between baseline and 24 or 28 weeks. Conclusion: Despite promising preclinical and clinical work, our results do not support mangosteen pericarp extract as an adjunctive treatment for schizophrenia or schizoaffective disorder.

scholarly journals Amelioration of mild and moderate depression through Pranic Healing as adjuvant therapy: randomised double-blind controlled trial

2017 ◽  
Vol 26 (1) ◽  
pp. 82-87 ◽  
Author(s):  
R Rajagopal ◽  
Srikanth N Jois ◽  
Sumanth Mallikarjuna Majgi ◽  
MN Anil Kumar ◽  
HB Shashidhar
Keyword(s):  
Quality Of Life ◽  
Adjuvant Therapy ◽  
Mental Disorder ◽  
Controlled Trial ◽  
Antidepressant Drug ◽  
Double Blind ◽  
Average Decrease ◽  
Moderate Depression ◽  
Post Assessment

Objectives: Depression is a mental disorder, affecting the quality of life. Our study explores the efficacy of Pranic Healing (PH), as an adjuvant therapy in treating depression Methods: In this randomised double-blind controlled trial, 52 participants with a mean age of 34.4 years, with mild to moderate depression were assessed using the Hamilton Depression Rating (HAM-D) scale during the 5-week study. Both Medication + PH (MedPH) and Medication + Mock PH (MedMockPH) groups comprising 26 members received Pranic and mock healing lasting 20 minutes per session respectively once a week for 4 weeks, along with the antidepressant drug. Results: The average decrease in HAM-D score in MedPH was median 11 (Interquartile Range (IQR) 7–12) and was significantly higher compared with the MedMockPH group median 6.5 (IQR 3–9). At pre-assessment, both groups had 8 cases of mild and 18 cases of moderate depression. At post-assessment, HAM-D showed that the improvement in depression category was seen in 69.2% of participants in the MedMockPH group and 100% in MedPH group. Conclusions: These results give first the evidence that PH can aid as an adjuvant therapy for depressed people.

scholarly journals The Effect of Coaching on Physical Activity and Quality of Life in Children and Adolescents with Cystic Fibrosis: A Quality Improvement Pilot Study

2010 ◽  
Author(s):  
Anne Swisher ◽  
Kathryn Moffett
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Cystic Fibrosis ◽  
Pilot Study ◽  
Children And Adolescents ◽  
Life Questionnaire ◽  
Activity Levels ◽  
Small Pilot Study ◽  
Phone Calls

Purpose: Physical activity is well known to improve or maintain exercise capacity and overall health in patients with cystic fibrosis (CF). However, many patients do not meet recommended guidelines for physical activity. The purpose of this study was to determine if individualized, targeted coaching could improve the levels of physical activity and quality of life in children and adolescents with CF. Subjects: Twelve children with CF, ages 7 to 17, participated in this study.Method: Each participant completed a physical activity questionnaire (PAQ) and a disease-specific quality of life questionnaire (CFQ) at baseline and three months later. The participants were given pedometers and a 10,000 step per day target. Participants also participated in discussions regarding ways to increase physical activity appropriate for their interest, abilities and age. Weekly follow-up phone calls were made to obtain pedometer counts and discuss physical activities performed. Results: Physical activity scores (PAQ) improved in 6 of 12 participants. Quality of life improved in many dimensions of the CFQ, particularly in vitality (3 of 5 improved); emotional (8 of 12 improved) and respiratory (7 of 12 improved). Conclusions: The results of this small pilot study suggest that an individualized coaching approach to physical activity in children and adolescents with CF may improve physical activity levels and improve important aspects of quality of life in some children with CF.

scholarly journals Effects of Dog-Assisted Therapy in Adolescents with Eating Disorders: A Study Protocol for a Pilot Controlled Trial

Animals ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. 2784
Author(s):  
Ana Myriam Lavín-Pérez ◽  
Cristina Martín-Sánchez ◽  
Beatriz Martínez-Núñez ◽  
Luis Lucio Lobato-Rincón ◽  
Santos Villafaina ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Eating Disorders ◽  
Pilot Study ◽  
Handgrip Strength ◽  
Controlled Trial ◽  
Self Esteem ◽  
Control Group ◽  
Physical And Mental Health ◽  
Anxiety Depression

Background: Eating disorders are characterized by a persistent disturbance that alters food intake and it is often accompanied by anxiety, depression, low self-esteem, or reduced functional capacity and quality of life. Animal-assisted therapies (AAT) have shown benefits in these variables in children and adult populations. Thus, the present pilot study will aim to evaluate the effects of a dog-assisted therapy on the eating disorders symptoms, mental, psychosocial, and physical health, quality of life, and handgrip strength of adolescents suffering from eating disorders. Methods: The current pilot study will involve 32 patients, who will be assigned to a control or an experimental group. Intervention will be conducted once a week for seven weeks. Neither the experimental nor the control group will discontinue their usual care. The main outcome measures will be the eating disorder symptoms and the health-related quality of life measured with standardized questionnaires, while the secondary variables will be anxiety, depression, character, behavior, strength, and body mass. Conclusions: This pilot-controlled trial will be the first to evaluate the effects of dog-assisted therapy on the physical and mental health of adolescents with eating disorders. Significant improvements, in the primary and secondary outcomes, may be expected based on the known benefits of AAT on self-esteem, stress, and self-control in different populations. Finally, although the program is focused on the improvement of adolescents’ health, animal welfare will be a priority in this study.

scholarly journals Ropivacaine 75mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women- The ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trial.

2020 ◽  
Author(s):  
Claire CARDAILLAC ◽  
Stéphane Ploteau ◽  
Aurélie Le Thuaut ◽  
Vincent Dochez ◽  
Norbert Winer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Perineal Pain ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Mediolateral Episiotomy ◽  
The Impact

Abstract Background Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have already investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and mid- and long-term quality of life before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. Methods The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (mid-term), defined by the numerical rating scale of pain (ENS NRS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS NRS), the impact of pain on daily behavior, on the quality of life (36-Item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale) and on sexuality (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show approximately 30% relative risk reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. Discussion Ropivacaine is a promising candidate drug, inexpensive, easy to administer, and would be suitable to include in the routine management of deliveries in labor ward. This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy.

scholarly journals Fermented Soy Supplementation Improves Quality of Life Indicators: A Randomized, Placebo-Controlled, Double-Blind Trial in Adults Experiencing Heartburn

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1124-1124
Author(s):  
Asmaa Fatani ◽  
Kadi Vaher ◽  
Karima Alabasi ◽  
Wendy Dahl
Keyword(s):  
Quality Of Life ◽  
Pilot Study ◽  
Rating Scale ◽  
Gastrointestinal Symptoms ◽  
Lactobacillus Delbrueckii ◽  
Soy Flour ◽  
Life Questionnaire ◽  
Double Blind ◽  
Symptom Intensity

Abstract Objectives The aim of this pilot study was to determine the effects of a fermented soy supplement on heartburn relief, gastrointestinal symptoms, and quality of life. Methods A 5-week, randomized, double-blind pilot study was conducted with adults (n = 51; 37F/14 M, 31 ± 12y) experiencing mild or moderate heartburn. Following a 1-week baseline, participants self-treated heartburn symptoms with up to 3, 1 g sachets of a non-GMO soy flour fermented by Lactobacillus delbrueckii ssp. delbrueckii Rosell-187 or placebo (maltodextrin) sachets per incident for 3 weeks followed by a 1-week washout. Differences from baseline between treatments were compared using the Wilcoxon Signed Rank test (alpha 0.05). Symptom intensity at 5, 15 and 30-min post administration was assessed using a Likert-like scale (1, no symptoms to 5, severe discomfort). The Gastrointestinal Symptoms Rating Scale (GSRS) (1-no discomfort to 7-very severe discomfort) and Gastro-oesophageal Reflux Disease Quality of Life Questionnaire (GERD-QOL) (4-strongly disagree to 0-strongly agree) were administered during baseline, intervention, and washout. Results No significant differences between intervention groups were seen for heartburn severity or frequency, GSRS syndromes or GERD-QOL domains. However, individual QOL items related to inconvenience of taking medications (−1.0 ± 1.3 vs −0.04 ± 1.8, P < 0.05), fear of eating (−1.4 ± 1.3 vs −0.2 ± 1.7, P < 0.05), inability to concentrate at work (−0.9 ± 1.6 vs −0.3 ± 1.0, P < 0.05), and disturbance of after-meal activities and rest (−1.6 ± 1.5 vs −0.7 ± 1.5, P < 0.05) significantly improved with fermented soy compared to control. In addition, the frequency of heartburn (0.3 ± 0.3 vs 0.1 ± 0.3, P < 0.05) and the GSRS symptoms of diarrhea (0.3 ± 1.4 vs −0.3 ± 1.2, P < 0.05) and bloating (0.7 ± 1.7 vs 0.1 ± 1.3, P < 0.05) were significantly improved during washout vs. baseline for the fermented soy group, demonstrating a possible carryover effect over time. Conclusions Further research is suggested to test the effect of daily supplementation of fermented soy on heartburn frequency, gastrointestinal symptoms and QOL in a trial of longer duration. Funding Sources Lallemand Bio-Ingredients

Sign in / Sign up

Export Citation Format

Share Document