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

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.

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Vitamin D3 repletion versus placebo as adjunctive treatment of heart failure patient quality of life and hormonal indices: a randomized, double-blind, placebo-controlled trial

BMC Cardiovascular Disorders ◽

10.1186/s12872-017-0707-y ◽

2017 ◽

Vol 17 (1) ◽

Cited By ~ 10

Author(s):

Heidi D. Moretti ◽

Vincent J. Colucci ◽

Bradley D. Berry

Keyword(s):

Quality Of Life ◽

Heart Failure ◽

Vitamin D3 ◽

Heart Failure Patient ◽

Controlled Trial ◽

Adjunctive Treatment ◽

Double Blind ◽

Double Blind Placebo

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Antidepressant Controlled Trial For Negative Symptoms In Schizophrenia (ACTIONS): a double-blind, placebo-controlled, randomised clinical trial

Health Technology Assessment ◽

10.3310/hta20290 ◽

2016 ◽

Vol 20 (29) ◽

pp. 1-46 ◽

Cited By ~ 8

Author(s):

Thomas RE Barnes ◽

Verity C Leeson ◽

Carol Paton ◽

Céire Costelloe ◽

Judit Simon ◽

...

Keyword(s):

Quality Of Life ◽

Negative Symptom ◽

Antipsychotic Medication ◽

Functional Outcomes ◽

Negative Symptoms ◽

Controlled Trial ◽

Health Technology ◽

Double Blind

BackgroundNegative symptoms of schizophrenia represent deficiencies in emotional responsiveness, motivation, socialisation, speech and movement. When persistent, they are held to account for much of the poor functional outcomes associated with schizophrenia. There are currently no approved pharmacological treatments. While the available evidence suggests that a combination of antipsychotic and antidepressant medication may be effective in treating negative symptoms, it is too limited to allow any firm conclusions.ObjectiveTo establish the clinical effectiveness and cost-effectiveness of augmentation of antipsychotic medication with the antidepressant citalopram for the management of negative symptoms in schizophrenia.DesignA multicentre, double-blind, individually randomised, placebo-controlled trial with 12-month follow-up.SettingAdult psychiatric services, treating people with schizophrenia.ParticipantsInpatients or outpatients with schizophrenia, on continuing, stable antipsychotic medication, with persistent negative symptoms at a criterion level of severity.InterventionsEligible participants were randomised 1 : 1 to treatment with either placebo (one capsule) or 20 mg of citalopram per day for 48 weeks, with the clinical option at 4 weeks to increase the daily dosage to 40 mg of citalopram or two placebo capsules for the remainder of the study.Main outcome measuresThe primary outcomes were quality of life measured at 12 and 48 weeks assessed using the Heinrich’s Quality of Life Scale, and negative symptoms at 12 weeks measured on the negative symptom subscale of the Positive and Negative Syndrome Scale.ResultsNo therapeutic benefit in terms of improvement in quality of life or negative symptoms was detected for citalopram over 12 weeks or at 48 weeks, but secondary analysis suggested modest improvement in the negative symptom domain, avolition/amotivation, at 12 weeks (mean difference –1.3, 95% confidence interval –2.5 to –0.09). There were no statistically significant differences between the two treatment arms over 48-week follow-up in either the health economics outcomes or costs, and no differences in the frequency or severity of adverse effects, including corrected QT interval prolongation.LimitationsThe trial under-recruited, partly because cardiac safety concerns about citalopram were raised, with the 62 participants recruited falling well short of the target recruitment of 358. Although this was the largest sample randomised to citalopram in a randomised controlled trial of antidepressant augmentation for negative symptoms of schizophrenia and had the longest follow-up, the power of statistical analysis to detect significant differences between the active and placebo groups was limited.ConclusionAlthough adjunctive citalopram did not improve negative symptoms overall, there was evidence of some positive effect on avolition/amotivation, recognised as a critical barrier to psychosocial rehabilitation and achieving better social and community functional outcomes. Comprehensive assessment of side-effect burden did not identify any serious safety or tolerability issues. The addition of citalopram as a long-term prescribing strategy for the treatment of negative symptoms may merit further investigation in larger studies.Future workFurther studies of the viability of adjunctive antidepressant treatment for negative symptoms in schizophrenia should include appropriate safety monitoring and use rating scales that allow for evaluation of avolition/amotivation as a discrete negative symptom domain. Overcoming the barriers to recruiting an adequate sample size will remain a challenge.Trial registrationEuropean Union Drug Regulating Authorities Clinical Trials (EudraCT) number 2009-009235-30 and Current Controlled Trials ISRCTN42305247.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 29. See the NIHR Journals Library website for further project information.

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Faculty Opinions recommendation of OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.718006591.793478312 ◽

2013 ◽

Author(s):

Francisco Cruz

Keyword(s):

Quality Of Life ◽

Urinary Incontinence ◽

Overactive Bladder ◽

Controlled Trial ◽

Double Blind ◽

Double Blind Placebo ◽

Overactive Bladder Symptoms ◽

Bladder Symptoms

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

Australasian Psychiatry ◽

10.1177/1039856217726449 ◽

2017 ◽

Vol 26 (1) ◽

pp. 82-87 ◽

Cited By ~ 4

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.

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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.

10.21203/rs.2.10758/v4 ◽

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.

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