scholarly journals Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial

2016 ◽  
Vol 30 (12) ◽  
pp. 1165-1180 ◽  
Author(s):  
Stephen Ross ◽  
Anthony Bossis ◽  
Jeffrey Guss ◽  
Gabrielle Agin-Liebes ◽  
Tara Malone ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mystical Experience ◽  
Controlled Trial ◽  
Anxiety And Depression ◽  
Double Blind ◽  
Patients With Cancer ◽  
Life Threatening ◽  
Attitudes Towards Death ◽  
Clinically Significant

Background: Clinically significant anxiety and depression are common in patients with cancer, and are associated with poor psychiatric and medical outcomes. Historical and recent research suggests a role for psilocybin to treat cancer-related anxiety and depression. Methods: In this double-blind, placebo-controlled, crossover trial, 29 patients with cancer-related anxiety and depression were randomly assigned and received treatment with single-dose psilocybin (0.3 mg/kg) or niacin, both in conjunction with psychotherapy. The primary outcomes were anxiety and depression assessed between groups prior to the crossover at 7 weeks. Results: Prior to the crossover, psilocybin produced immediate, substantial, and sustained improvements in anxiety and depression and led to decreases in cancer-related demoralization and hopelessness, improved spiritual wellbeing, and increased quality of life. At the 6.5-month follow-up, psilocybin was associated with enduring anxiolytic and anti-depressant effects (approximately 60–80% of participants continued with clinically significant reductions in depression or anxiety), sustained benefits in existential distress and quality of life, as well as improved attitudes towards death. The psilocybin-induced mystical experience mediated the therapeutic effect of psilocybin on anxiety and depression. Conclusions: In conjunction with psychotherapy, single moderate-dose psilocybin produced rapid, robust and enduring anxiolytic and anti-depressant effects in patients with cancer-related psychological distress. Trial Registration: ClinicalTrials.gov Identifier: NCT00957359

scholarly journals Effects of Melatonin on Appetite and Other Symptoms in Patients With Advanced Cancer and Cachexia: A Double-Blind Placebo-Controlled Trial

2013 ◽  
Vol 31 (10) ◽  
pp. 1271-1276 ◽  
Author(s):  
Egidio Del Fabbro ◽  
Rony Dev ◽  
David Hui ◽  
Lynn Palmer ◽  
Eduardo Bruera
Keyword(s):  
Quality Of Life ◽  
Weight Loss ◽  
Advanced Cancer ◽  
Interim Analysis ◽  
Null Hypothesis ◽  
Controlled Trial ◽  
Double Blind ◽  
Patients With Cancer ◽  
Edmonton Symptom Assessment Scale

Purpose Prior studies have suggested that melatonin, a frequently used integrative medicine, can attenuate weight loss, anorexia, and fatigue in patients with cancer. These studies were limited by a lack of blinding and absence of placebo controls. The primary purpose of this study was to compare melatonin with placebo for appetite improvement in patients with cancer cachexia. Patients and Methods We performed a randomized, double-blind, 28-day trial of melatonin 20 mg versus placebo in patients with advanced lung or GI cancer, appetite scores ≥ 4 on a 0 to 10 scale (10 = worst appetite), and history of weight loss ≥ 5%. Assessments included weight, symptoms by the Edmonton Symptom Assessment Scale, and quality of life by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire. Differences between groups from baseline to day 28 were analyzed using one-sided, two-sample t tests or Wilcoxon two-sample tests. Interim analysis halfway through the trial had a Lan-DeMets monitoring boundary with an O'Brien-Fleming stopping rule. Decision boundaries were to accept the null hypothesis of futility if the test statistic z < 0.39 (P ≥ .348) and reject the null hypothesis if z > 2.54 (P ≤ .0056). Results After interim analysis of 48 patients, the study was closed for futility. There were no significant differences between groups for appetite (P = .78) or other symptoms, weight (P = .17), FAACT score (P = .95), toxicity, or survival from baseline to day 28. Conclusion In cachectic patients with advanced cancer, oral melatonin 20 mg at night did not improve appetite, weight, or quality of life compared with placebo.

scholarly journals Estimating the minimum important difference in the DEMQOL instrument in people with dementia

2021 ◽  
Author(s):  
Ellen C. Lee ◽  
Jessica Wright ◽  
Stephen J. Walters ◽  
Cindy L. Cooper ◽  
Gail A. Mountain
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Minimum Important Difference ◽  
Absolute Change ◽  
People With Dementia ◽  
Related Quality ◽  
Registration Number ◽  
Clinically Significant ◽  
Randomised Controlled

Abstract Purpose The Dementia-Related Quality of Life (DEMQOL) measure and the DEMQOL-Utility Score (DEMQOL-U) are validated tools for measuring quality of life (QOL) in people with dementia. What score changes translate to a clinically significant impact on patients’ lives was unknown. This study establishes the minimal important differences (MID) for these two instruments. Methods Anchor-based and distribution-based methods were used to estimate the MID scores from patients enrolled in a randomised controlled trial. For the anchor-based method, the global QOL (Q29) item from the DEMQOL was chosen as the anchor for DEMQOL and both Q29 and EQ-5D for DEMQOL-U. A one category difference in Q29, and a 0.07 point difference in EQ-5D score, were used to classify improvement and deterioration, and the MID scores were calculated for each category. These results were compared with scores obtained by the distribution-based methods. Results A total of 490 people with dementia had baseline DEMQOL data, of these 386 had 8-month data, and 344 had 12-month DEMQOL data. The absolute change in DEMQOL for a combined 1-point increase or decrease in the Q29 anchor was 5.2 at 8 months and 6.0 at 12 months. For the DEMQOL-U, the average absolute change at 8 and 12 months was 0.032 and 0.046 for the Q29 anchor and 0.020 and 0.024 for EQ-5D anchor. Conclusion We present MID scores for the DEMQOL and DEMQOL-U instruments obtained from a large cohort of patients with dementia. An anchored-based estimate of the MID for the DEMQOL is around 5 to 6 points; and 0.02 to 0.05 points for the DEMQOL-U. The results of this study can guide clinicians and researchers in the interpretation of these instruments comparisons between groups or within groups of people with dementia. Trial Registration Number and date of registration: ISRCTN17993825 on 11th October 2016.

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.

P–504 A randomised controlled trial comparing expectant management or intrauterine-insemination in couples with unexplained subfertility and a poor prognosis for natural conception: the impact on health-related-quality-of-life

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
F Mol ◽  
J Wessel ◽  
H A Verhoeve ◽  
J Maas ◽  
J P D Bruin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Poor Prognosis ◽  
Intrauterine Insemination ◽  
Controlled Trial ◽  
Expectant Management ◽  
Mean Difference ◽  
Anxiety And Depression ◽  
Depression Disorders ◽  
The Impact

Abstract Study question Is health-related quality of life (HRQoL) in women with unexplained subfertility and a poor prognosis influenced by expectant management or intrauterine insemination with ovarian stimulation? Summary answer HRQoL did not differ, except for the relational domain which was lower after expectant management. Anxiety and depression disorders occurred frequently in both groups. What is known already In couples with unexplained subfertility and a poor prognosis, IUI with ovarian stimulation (IUI-OS) is a first line treatment. Not much is known about quality of live or depression and anxiety in these couples. The Fertility Quality of Life (FertiQoL) is reliable for assessment within relational and social domains, the Hospital Anxiety and Depression Scale (HADS) is a reliable tool to detect anxiety and depression disorders. Study design, size, duration We performed a multicentre RCT in couples with unexplained subfertility with a poor prognosis of conceiving naturally within one year. Women were allocated 1:1 to six months expectant management or to six months IUI-OS. HRQoL was assessed with standard self-administered psychometric measures with established reliability and validity: FertiQol and HADS. We intended to include 1091 couples but after almost 4 years, the study had to stop due to slow inclusion and therefore lack of funding. Participants/materials, setting, methods Between June 2017 and September 2020, we recruited 178 women of wich 92 were assigned expectant management and 86 IUI-OS. All women who participated and could read Dutch were eligible for the HRQoL measurements because HRQoL questionnaires in foreign languages were not yet available online. Women completed the questionnaires before randomisation, 3 and 6 months after randomisation. We used mixed model analyses to assess differences between treatment groups and the effect of time. Main results and the role of chance One hundred sixty-two women could read Dutch and were invited (162/178 (91%)). Analyzable data of the FertiQol questionnaire were available for 80% (130/162). Compared to women allocated to IUI-OS, women allocated to expectant management had a lower FertiQol score in the relational domain (mean difference –4.3 (95% CI –7.3 to –1.3) but not in the social domain (mean diff van –0.8 (95% CI –4.5 to 2.9). Data of the HADS questionnaire were available of 156 women (96% (156/162)). Both groups had comparable scores in the Anxiety (mean difference –0.20; 95% CI 0.63; –0.99 to 0.6) and Depressions score (mean difference 0.002; 95% CI –0.67 to 0.67) at all three moments. At baseline, the incidence of an anxiety disorder (definition score 8 or higher) was 19% (30/156) and increased to 30% and 29% at 3 months and 6 months respectively. The incidence of a depression disorder (definition score 8 or higher) was 5% (7/156) and increased to 16% and 18% at 3 months and 6 months respectively. The incidences of anxiety or depression disorders did not differ significantly between expectant management and IUI. Limitations, reasons for caution Our randomized controlled trial did not reach the planned sample size. The results are only applicable to women with unexplained subfertility and a poor prognosis and not to all women with unexplained subfertility. Wider implications of the findings: Although often assumed, IUI-OS does not improve HRQoL compared to expectant management in all domains. IUI might prevent loss of quality of the relationship, but the impact seems small. Future studies should look into the high incidence of anxiety and depression disorders in these women and how to support them. Trial registration number Trial register NL5455 (NTR5599)

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 Impact of Anxiety and Depression on Quality of Life among Patients Undergoing Hemodialysis: A Scoping Review

2020 ◽  
Vol 2 (3) ◽  
pp. 14
Author(s):  
Fatima I. AlNashri ◽  
Hayfa H. Almutary ◽  
Elham A. Al Nagshabandi
Keyword(s):  
Quality Of Life ◽  
Scoping Review ◽  
Short Form ◽  
Hemodialysis Patients ◽  
Anxiety And Depression ◽  
Depression And Anxiety ◽  
Life Threatening ◽  
Anxiety Depression ◽  
The Impact

Context: Chronic kidney disease (CKD) is a life-threatening problem of global concern. Living with CKD is associated with many psychological problems, including depression and anxiety, which can directly or indirectly affect the quality of life. Only one review in the existing literature has assessed these associations among CKD patients using different dialysis modalities. However, the experience of these symptoms could be higher among patients on hemodialysis therapy. In this purview, there is a need to narrow the previous work to be more focused on hemodialysis patients. Aim: This scoping review aims to determine the gaps in the knowledge about the impact of anxiety and depression concerning QOL among people undergoing hemodialysis. Methods: The studies selected were those examined the relationships between depression or/and anxiety with quality of life in adult patients on hemodialysis. The CINAHL, MEDLINE, and Pub Med databases were searched for literature published between January 2012 and December 2019. The quality of the included studies was also apprised. Eleven studies met the inclusion criteria. Results: Six studies examined the impact of depression and anxiety on the quality of life. Five studies identified from the review have examined the relationships between depression and quality of life. It was established that the prevalence of anxiety and depression was high among hemodialysis patients, and the same was associated with low quality of life. Conclusion: The literature review highlights the negative associations between anxiety, depression, and quality of life among hemodialysis patients. It is, therefore, essential to screen hemodialysis patients frequently for anxiety and depression using a short-form questionnaire. This screening would allow for providing early interventions, and the potential deterioration of quality of life could be prevented. Further longitudinal studies are needed to assess these relationships. Additionally, further research is needed to determine effective interventional programs to improve the overall quality of life.

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