A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Effects of Kamishoyosan, a Traditional Japanese Medicine, on Menopausal Symptoms: The KOSMOS Study

Objective. The KOSMOS study, a multicenter, randomized, double-blind, placebo-controlled trial, investigated the effects and safety of kamishoyosan (TJ-24), a traditional Japanese medicine, in the treatment of climacteric disorder. Methods. Japanese women with climacteric disorder were administered a placebo during a 4-week run-in period, after which they were classified as placebo responders (R group) if their score on the modified Questionnaire for the Assessment of Climacteric Symptoms in Japanese Women (m-QACS) with excitability and irritability as the primary outcome improved by ≥ 3 points and as placebo nonresponders (NR group) otherwise. Members of the NR group were randomly allocated to receive either TJ-24 or placebo. After 12 weeks, their m-QACS scores, anxiety and depression, sleep, and overall quality of life (QOL) were compared. Results. The TJ-24 and placebo arms in the NR group included 20 patients each. The change in the m-QACS scores of members of the NR group for excitability and irritability at 12 weeks versus baseline was –3.1 ± 1.7 in the TJ-24 arm, a significant decrease, but compared with –2.7 ± 2.2 in the placebo arm, no significant difference was between two arms. However, the proportion of participants whose score improved by ≥3 points was significantly higher in the TJ-24 arm. In the subgroup analysis of premenopausal women, the changes in the score for excitability and irritability were significantly larger in the TJ-24 arm. The incidence of adverse drug reactions or adverse events did not differ between the two arms, and no serious events were reported. Conclusion. Although no significant difference was identified for the primary outcome, a significantly higher proportion of patients who received TJ-24 displayed improvement. Its high level of safety and effects on excitability and irritability in premenopausal women suggest that TJ-24 may be a useful treatment.

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Randomized, Double-Blind, Placebo-Controlled Trial of Erythropoietin in Non–Small-Cell Lung Cancer With Disease-Related Anemia

Journal of Clinical Oncology ◽

10.1200/jco.2006.07.1514 ◽

2007 ◽

Vol 25 (9) ◽

pp. 1027-1032 ◽

Cited By ~ 303

Author(s):

James R. Wright ◽

Yee C. Ung ◽

Jim A. Julian ◽

Kathleen I. Pritchard ◽

Timothy J. Whelan ◽

...

Keyword(s):

Overall Survival ◽

Primary Outcome ◽

Controlled Trial ◽

Safety Analysis ◽

Small Cell ◽

Erythropoietin Receptor ◽

Epoetin Alfa ◽

Double Blind ◽

Double Blind Placebo ◽

Significant Difference

Purpose Previous trials have suggested a quality-of-life (QOL) improvement for anemic cancer patients treated with erythropoietin, but few used QOL as the primary outcome. We designed a trial to investigate the effects of epoetin alfa therapy on the QOL of anemic patients with advanced non–small-cell carcinoma of the lung (NSCLC). Patients and Methods A multicenter, randomized, double-blind, placebo-controlled trial was conducted. The proposed sample size was 300 patients. Eligible patients were required to have NSCLC unsuitable for curative therapy and baseline hemoglobin (Hgb) levels less than 121 g/L. Patients were assigned to 12 weekly injections of subcutaneous epoetin alpha or placebo, targeting Hgb levels between 120 and 140 g/L. The primary outcome was the difference in the change in Functional Assessment of Cancer Therapy–Anemia scores between baseline and 12 weeks. Results Reports of thrombotic events in other epoetin trials prompted an unplanned safety analysis after 70 patients had been randomly assigned (33 to the active arm and 37 to the placebo arm). This revealed a significant difference in the median survival in favor of the patients on the placebo arm of the trial (63 v 129 days; hazard ratio, 1.84; P = .04). The Steering Committee closed the trial. Patient numbers compromised the interpretation of the QOL analysis, but a positive Hgb response was noted with epoetin alfa treatment. Conclusion An unplanned safety analysis suggested decreased overall survival in patients with advanced NSCLC treated with epoetin alfa. Although infrequent, other similar reports highlight the need for ongoing trials evaluating erythropoietin receptor agonists to ensure that overall survival is monitored closely.

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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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Does the packaging of health information affect the assessment of its reliability? A randomized controlled trial protocol

WikiJournal of Medicine ◽

10.15347/wjm/2021.001 ◽

2021 ◽

Vol 8 (1) ◽

pp. 1

Author(s):

Leela Raj ◽

Denise Smith ◽

James Heilman

Keyword(s):

Health Information ◽

Controlled Trial ◽

Online Health Information ◽

Plain Language ◽

Double Blind ◽

University Campuses ◽

University Of Oxford ◽

Written Information ◽

Significant Difference

Background Wikipedia is frequently used as a source of health information. However, the quality of its content varies widely across articles. The DISCERN tool is a brief questionnaire developed in 1996 by the Division of Public Health and Primary Health Care of the Institute of Health Sciences of the University of Oxford. They claim it provides users with a valid and reliable way of assessing the quality of written information. However, the DISCERN instrument’s reliability in measuring the quality of online health information, particularly whether or not its scores are affected by reader biases about specific publication sources, has not yet been explored. Methods This study is a double-blind randomized assessment of a Wikipedia article versus a BMJ literature review using a modified version of the DISCERN tool. Participants will include physicians and medical residents from four university campuses in Ontario and British Columbia and will be randomized into one of four study arms. Inferential statistics tests (paired t-test, multi-level ordinal regression, and one-way ANOVA) will be conducted with the data collected from the study. Outcomes The primary outcome of this study will be to determine whether a statistically significant difference in DISCERN scores exists, which could suggest whether or not how health information is packaged influences how it is assessed for quality. Plain Language Summary The internet, and in particular Wikipedia, is an important way for professionals, students and the public to obtain health information. For this reason, the DISCERN tool was developed in 1996 to help users assess the quality of the health information they find. The ability of DISCERN to measure the quality of online health information has been supported with research, but the role of bias has not necessarily been accounted for. Does how the information is packaged influence how the information itself is evaluated? This study will compare the scores assigned to articles in their original format to the same articles in a modified format in order to determine whether the DISCERN tool is able to overcome bias. A significant difference in ratings between original and inverted articles will suggest that the DISCERN tool lacks the ability to overcome bias related to how health information is packaged.

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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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Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study

Gut ◽

10.1136/gutjnl-2018-316434 ◽

2018 ◽

Vol 67 (12) ◽

pp. 2107-2115 ◽

Cited By ~ 96

Author(s):

Sofie Ingdam Halkjær ◽

Alice Højer Christensen ◽

Bobby Zhao Sheng Lo ◽

Patrick Denis Browne ◽

Stig Günther ◽

...

Keyword(s):

Gut Microbiota ◽

Controlled Trial ◽

Symptom Relief ◽

Controlled Study ◽

Faecal Microbiota ◽

Double Blind ◽

Double Blind Placebo ◽

Faecal Microbiota Transplantation ◽

Faecal Samples ◽

Significant Difference

ObjectiveIBS is associated with an intestinal dysbiosis and faecal microbiota transplantation (FMT) has been hypothesised to have a positive effect in patients with IBS. We performed a randomised, double-blind placebo-controlled trial to investigate if FMT resulted in an altered gut microbiota and improvement in clinical outcome in patients with IBS.DesignWe performed this study in 52 adult patients with moderate-to-severe IBS. At the screening visit, clinical history and symptoms were assessed and faecal samples were collected. Patients were randomised to FMT or placebo capsules for 12 days and followed for 6 months. Study visits were performed at baseline, 1, 3 and 6 months, where patients were asked to register their symptoms using the IBS-severity scoring system (IBS-SSS) and IBS-specific quality of life (IBS-QoL). Prior to each visit, faecal samples were collected.ResultsA significant difference in improvement in IBS-SSS score was observed 3 months after treatment (p=0.012) favouring placebo. This was similar for IBS-QoL data after 3 months (p=0.003) favouring placebo. Patients receiving FMT capsules had an increase in faecal microbial biodiversity while placebos did not.ConclusionIn this randomised double-blinded placebo-controlled study, we found that FMT changed gut microbiota in patients with IBS. But patients in the placebo group experienced greater symptom relief compared with the FMT group after 3 months. Altering the gut microbiota is not enough to obtain clinical improvement in IBS. However, different study designs and larger studies are required to examine the role of FMT in IBS.Trial registration numberNCT02788071.

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PND150 - IMPACT OF INOTERSEN ON CONDITION-SPECIFIC QUALITY OF LIFE (QOL) FOR PATIENTS WITH HATTR AMYLOIDOSIS: RESULTS FROM A DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL

Value in Health ◽

10.1016/j.jval.2018.09.2898 ◽

2018 ◽

Vol 21 ◽

pp. S354

Author(s):

A Sikora Kessler ◽

A Yarlas ◽

A Lovley ◽

S Guthrie ◽

M Pollock ◽

...

Keyword(s):

Quality Of Life ◽

Controlled Trial ◽

Double Blind ◽

Double Blind Placebo

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An evidence-based review of hyperbaric oxygen for children with cerebral palsy

South African Journal of Physiotherapy ◽

10.4102/sajp.v57i4.519 ◽

2001 ◽

Vol 57 (4) ◽

pp. 21-22

Author(s):

F. M. Bischof

Keyword(s):

Cerebral Palsy ◽

Pilot Study ◽

Motor Function ◽

Controlled Trial ◽

Evidence Based ◽

Level Of Evidence ◽

Double Blind ◽

Double Blind Placebo ◽

Children With Cerebral Palsy ◽

High Level

This paper reviews the evidence in the literature for the use of hypebaric oxygen (HBO) in the treatment of cerebral palsy (CP). To date there are only two published studies on the outcome of HBO administration in CP. A pilot study showed significant improvement in gross motor function but provided a low level of evidence. A recent multicentre, double blind, placebo controlled trial reported similar improvements in both HBO and placebo groups, but no difference between the groups. This study had a high level of evidence. The results suggest that participation in the trial produced clinically important gains in function. The outcome of the study implies that HBO may have a placebo effect in CP.

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