Placebo-Control Groups in the Study of Outpatient Depressives-Reply

1984 ◽  
Vol 41 (11) ◽  
pp. 1110
Author(s):  
George E. Murphy
2021 ◽  
Vol 2021 (1) ◽  
pp. 32-37
Author(s):  
Ol'ga Petrova

In this article were present of effectiveness Stop-cystitis® Plus drug containing the amino acids tryptophan, methionine and L-theonine and herbal. Evaluation of efficiency was carried out on the basis of a comprehensive clinical examination, analysis of physical and chemical indicators of urine, blood values (clinical and biochemical profile), ultrasound, cystocentase and microscopy, etc. Relapses after treatment, complications were monitored, and the dynamics of restoring the physiology of urination in animals was determined. For comparison, we used the indicators for placebo control groups and baseline values in healthy animals.


1981 ◽  
Vol 3 (3) ◽  
pp. 228-238 ◽  
Author(s):  
Robert S. Weinberg ◽  
Thomas G. Seabourne ◽  
Allen Jackson

The present investigation attempted to determine whether imagery combined with relaxation (VMBR) is more effective in facilitating karate performance than either imagery or relaxation alone. Each subject (N = 32) was randomly assigned to either a VMBR, relaxation, imagery, or attention-placebo control condition in a one-way design. During the first day of the karate class (which met twice a week), each group was individually provided with an explanation of how to practice their assigned strategy at home. Trait anxiety tests were administered at the beginning and the end of the 6-week test period. In addition, performance tests were administered at the end of the testing period along with precompetitive state anxiety. Trait anxiety results indicated that all subjects displayed a reduction in trait anxiety over the course of the testing period. State anxiety results indicated that the VMBR and relaxation groups exhibited lower levels of state anxiety than the imagery and attention-control groups. Performance was broken down into three subareas which consisted of skill, combinations, and sparring (actual competition). Results only showed an effect for sparring, with VMBR group exhibiting better performance than all other groups.


2020 ◽  
Author(s):  
Flavio A. Cadegiani ◽  
Andy Goren ◽  
Carlos G. Wambier ◽  
John McCoy

Abstract Background: While there was a lack of pharmacological interventions proven to be effective in early, outpatient settings for COVID-19, in a prospective, open-label observational study (pre-AndroCoV Trial) the use of nitazoxanide, ivermectin and hydroxychloroquine demonstrated similar effects, and apparent improvement of outcomes compared to untreated patients. The unexpected apparent positive results led to ethical questions on the employment of further full placebo-control studies in early stage COVID-19. The objective of the present study was to elucidate whether the conduction of a full placebo-control RCT was still ethically viable, through a comparative analysis with two control-groups.Materials and methods: Active group (AG) consisted of mild-to-moderate early stage COVID-19 patients enrolled in the Pre AndroCoV-Trial, treated with nitazoxanide ivermectin, or hydroxychloroquine in selected cases, in association with azithromycin. Vitamin D, vitamin C, zinc, glucocorticoids and anticoagulants, when clinically recommended. Control Group 1 (CG1) consisted of a retrospectively obtained group of untreated patients from the same population as those from the Pre-AndroCoV Trial, and Control Group 2 (CG2) resulted from a precise prediction of clinical outcomes, based on a thorough and structured review of articles indexed in PubMed and MEDLINE and statements by official government agencies and specific medical societies. For both CGs, patients were matched for proportion between sex, age, obesity and other comorbidities. Results: Compared to CG1 and CG2, AG showed a reduction of 31.5 to 36.5% in viral shedding (p < 0.0001), 70 to 85% and 70 to 73% in duration of COVID-19 clinical symptoms when including and not including anosmia and ageusia, respectively ((p < 0.0001 for both), and 100% in respiratory complications through the parameters of the Brescia COVID-19 Respiratory Scale (p < 0.0001). For every 1,000 confirmed cases for COVID-19, a minimum of 140 patients were prevented from hospitalization (p < 0.0001), 50 from mechanical ventilation, and five deaths, when comparing to age-, sex- and comorbidity-matched non-treated patients with similar initial disease severity at the moment of diagnosis.Conclusion: Apparent benefits of the combination between early detection and early pharmacological approaches for COVID-19 demonstrated to be consistent when when compared to different control groups of untreated patients. The potential benefits could allow a large number of patients prevented from hospitalizations, deaths and persistent symptoms after COVID-19 remission. The potential impact on COVID-19 disease course and numbers of negative outcomes and the well-established safety profile of the drugs proposed by the Pre-AndroCoV Trial led to ethical questions regarding the conduction of further placebo control randomized clinical trials (RCTs) for early COVID-19. Early pharmacological approaches including azithromycin in combination with any of the options between nitazoxanide, ivermectin or optionally hydroxychloroquine should be considered for those diagnosed with COVID-19 presenting less than seven days of symptoms. Of the three drugs, we opted for nitazoxanide, due to more extensive demonstration of in vitro and in vivoantiviral activity, proven efficacy against other viruses in humans, and steadier safety profile.


Pain Medicine ◽  
2020 ◽  
Vol 21 (12) ◽  
pp. 3301-3313
Author(s):  
Daniel E Hilleman ◽  
Mark A Malesker ◽  
Sarah J Aurit ◽  
Lee Morrow

Abstract Background Intravenous (IV) acetaminophen is used in multimodal analgesia to reduce the amount and duration of opioid use in the postoperative setting. Methods A systematic review of published randomized controlled trials was conducted to define the opioid-sparing effect of IV acetaminophen in different types of surgeries. Eligible studies included prospective, randomized, double-blind trials of IV acetaminophen compared with either a placebo- or active-treatment group in adult (age ≥18 years) patients undergoing surgery. Trials had to be published in English in a peer-reviewed journal. Results A total of 44 treatment cohorts included in 37 studies were included in the systematic analysis. Compared with active- or placebo-control treatments, IV acetaminophen produced a statistically significant opioid-sparing effect in 14 of 44 cohorts (32%). An opioid-sparing effect was more common in placebo-controlled comparisons. Of the 28 placebo treatment comparisons, IV acetaminophen produced an opioid-sparing effect in 13 (46%). IV acetaminophen produced an opioid-sparing effect in only 6% (one out of 16) of the active-control groups. Among the 16 active-control groups, opioid consumption was significantly greater with IV acetaminophen than the active comparator in seven cohorts and not significantly different than the active comparator in eight cohorts. Conclusions The results of this systematic analysis demonstrate that IV acetaminophen is not effective in reducing opioid consumption compared with other adjuvant analgesic agents in the postoperative patient. In patients where other adjuvant analgesic agents are contraindicated, IV acetaminophen may be an option.


PEDIATRICS ◽  
1994 ◽  
Vol 93 (5) ◽  
pp. 871-871
Author(s):  
Mary C. Theroux ◽  
David West

We thank Drs Lopez and Urbansky for their comments. Their observation that the placebo group may have sufficiently biased the combined placebo/control group to account for the significant findings noted is reasonable, despite no significant differences being found between the placebo group and the control group. Analysis of variance among the three groups was carried out for the objective outcome variables. Differences in mean heart rate changes and maximum heart rate changes remained significant, and differences between study versus control groups and study versus placebo groups were both found to be significant, accounting for multiple comparisons.


1976 ◽  
Vol 43 (3_suppl) ◽  
pp. 1317-1318 ◽  
Author(s):  
Alex Weinberger ◽  
Roland S. Engelhart

Conditions of group systematic desensitization ( n = 8), group flooding ( n = 7), and a group discussion-placebo control treatment ( n = 4) were employed to reduce anxiety about public-speaking in university students. Three 90-min. sessions were provided. Pre- and posttreatment assessments employed self-report and behavioral measures. The desensitization group showed significant pre- to posttreatment change across all self-report measures, whereas the flooding and control groups showed similar improvement on only one such measure. No group showed significant improvement on the behavioral measure. Groups did not exhibit significant intergroup differences in improvement on any measure.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
G J Coghlan ◽  
S Gaine ◽  
R N Channick ◽  
K M Chin ◽  
C Du Roure ◽  
...  

Abstract Background In PAH clinical practice, drugs targeting the prostacyclin pathway, including the oral prostacyclin receptor agonist selexipag, are often initiated years after diagnosis. The GRIPHON (NCT01106014) and TRITON (NCT02558231) randomised controlled trials examined the impact of selexipag on disease progression, primary and secondary endpoints, respectively. In GRIPHON, selexipag significantly reduced the risk of disease progression (composite primary endpoint) in a PAH population (N=1156) with a mean time from diagnosis of 2.4 years, as part of an oral triple, double or monotherapy regimen versus placebo. In TRITON, a potential signal for reduced risk of disease progression was observed with initial triple oral therapy (selexipag, macitentan, tadalafil) versus initial double oral therapy (placebo, macitentan, tadalafil) in a population of 247 newly diagnosed, treatment naïve patients. Purpose To investigate the impact of initiating selexipag within 6 months of diagnosis on disease progression in a large PAH population. Methods We selected patients from GRIPHON and TRITON diagnosed within 6 months of randomization and compared those on active therapy with selexipag (selexipag group) versus those on control therapy with placebo (control group). Disease progression endpoints were defined as in the GRIPHON and TRITON studies, respectively. Hazard ratios (HR) and 95% CI for time to first disease progression event up to end of double-blind treatment (selexipag/placebo) + 7 days were estimated using a Cox regression model which included treatment as a factor, and baseline prognostic factors and study as covariates. Results Overall, 649 patients met the criteria (diagnosis ≤6 months) for these analyses: 329 in the selexipag group (207 from GRIPHON and 122 from TRITON) and 320 in the control group (197 from GRIPHON and 123 from TRITON). Patient characteristics at baseline and treatment regimens were balanced between the treatment groups. With respect to treatment regimen, selexipag/placebo was given as part of triple therapy in 44%, double therapy in 32% and monotherapy in 24% of patients. The median (range) exposure to study treatment was 510 (4–1280) and 409 (3–1318) days in the selexipag and control groups, respectively. There were 67 (20%) and 116 (36%) patients who experienced a disease progression event in the selexipag and control groups, respectively. Selexipag reduced the risk of disease progression (first event) by 52% compared to control (HR 0.48 [95% CI 0.35, 0.66]) (Figure). Conclusions This post-hoc pooled analysis of GRIPHON and TRITON patients diagnosed within 6 months suggests that targeting the prostacylin pathway with selexipag within a short time after diagnosis may reduce the risk of disease progression in a broad PAH population. FUNDunding Acknowledgement Type of funding sources: Other. Main funding source(s): Actelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson & Johnson


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