High-Dose Neuroleptics: Uncontrolled Clinical Practice Confirms Controlled Clinical Trials

1984 ◽  
Vol 144 (1) ◽  
pp. 25-27 ◽  
Author(s):  
Paola Bollini ◽  
Amato Andreani ◽  
Fabio Colombo ◽  
Cesario Bellantuono ◽  
Paola Beretta ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
General Hospital ◽  
Adverse Reactions ◽  
Complete Recovery ◽  
Psychiatric Ward ◽  
High Dose ◽  
Benefit Analysis ◽  
Controlled Clinical Trials ◽  
Risk Benefit Analysis

SummaryThe strategy of high-dose intramuscular haloperidol as routinely applied in a general hospital psychiatric ward to 74 successive patients, 33 of whom stayed only up to seven days, and a further 34 up to 15 days, led to a complete recovery in only six, and complete lack of change in 23. Adverse reactions were recorded in 42, severe enough to stop treatment in eight; there were three deaths. In view of this risk-benefit analysis, systematic application of this high dose strategy to get a more rapid turnover of patients is unjustified.

Trends in randomized controlled trials in ENT: a 30-year review

1997 ◽  
Vol 111 (7) ◽  
pp. 611-613 ◽  
Author(s):  
K. W. Ah-See ◽  
N. C. Molony ◽  
A. G. D. Maran
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Controlled Trials ◽  
Evidence Based ◽  
Controlled Clinical Trials ◽  
Medline Search ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

AbstractThere is a growth in the demand for clinical practice to be evidence based. Recent years have seen a rise in the number of randomized controlled clinical trials (RCTS). Such trials while acknowledged as the gold standard for evidence can be difficult to perform in surgical specialities. We have recently identified a low proportion of RCTS in the otolaryngology literature. Our aim was to identify any trend in the number of published RCTS within the ENT literature over a 30-year period and to identify which areas of our speciality lend themselves to this form of study design. A Medline search of 10 prominent journals published between 1966 and 1995 was performed. Two hundred and ninety-six RCTS were identified. Only five were published before 1980. Two hundred (71 per cent) of RCTS were in the areas of otology and rhinology. An encouraging trend is seen in RCTS within ENT literature.

Response to Erythropoietin in a Multicentric Real-Life Cohort of Myelodysplastic Patients: The Grom Experience

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4958-4958
Author(s):  
Roberto Latagliata ◽  
Maria Antonietta Aloe Spiriti ◽  
Luca Maurillo ◽  
Carolina Nobile ◽  
Anna Lina Piccioni ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Transfusion Requirement ◽  
Conflicts Of Interest ◽  
Real Life ◽  
Low Risk ◽  
Controlled Clinical Trials ◽  
University Hospitals ◽  
Erythroid Response ◽  
High Doses

Abstract Abstract 4958 Erythropoietin (EPO) have been widely employed in the treatment of patients with low-risk Myelodysplastic Syndromes (MDS) and anemia, with response rates ranging from 30 to 60%. These data, however, have been derived only from controlled clinical trials or unicentric single-arm studies; it is still lacking a wider survey evaluating the use of EPO in the real-life clinical practice. To address this issue, the Gruppo Romano Mielodisplasie (GROM) revised retrospectively 394 MDS patients (M/F 225/169, median age at diagnosis 73. 9 yrs, IR 67. 0 – 79. 3) treated with EPO from 1/2002 to 12/2010 by 11 Hematological Centers (5 university hospitals and 6 community-based hospitals) in the metropolitan area of Rome. According to WHO classification, there were 81 (20. 6%) patients with RA, 7 (1. 8 %) with SA, 160 (40. 7%) with RCMD, 17 (4. 3%) with RCMD-S, 75(19. 0%) with RAEB-1, 27 (6. 8%) with RAEB-2 and 27 (6. 8%) with isolated del5q. The IPSS score was calculated in the 307 patients with an available karyotype: 145 (47. 2%) patients were low-risk, 135 (44. 0%) int-1, 24 (7. 8%) int-2 and 3 (1. 0%) high-risk. Median interval from diagnosis to EPO start was 3. 7 months (IR 0. 9 – 12. 1). At EPO start, median age was 74. 5 yrs (IR 68. 3 – 79. 9) with a median haemoglobin level of 8. 9 g/dl (IR 8. 2 – 9. 6). Creatinine level was elevated in 64 (16. 2%) cases: 138 patients (35. 3%) had a previous transfusion requirement. Median serum EPO level was 50. 0 mU/L (IR 26. 2 – 110. 0). The initial doses of EPO were ≤ 40. 000 UI/week in 259 patients (65. 7%) (standard doses, α-EPO in 104 patients, β-EPO in 143 patients, darbepoietin in 12 patients) and 80000 UI/week in 135 patients (34. 3%) (high doses, α-EPO in 130 patients, β-EPO in 5 patients). An erythroid response was observed in 228 (57. 9%) patients, with Hb increase > 1. 5 g/dl in 210 patients (53. 3%) and disappearance of transfusion requirement in 18 (4. 6%): patients receiving initial high doses had a higher response rate compared to patients receiving standard doses [94/135 (69. 6%) vs 134/259 (51. 7%), p=0. 002]. Only 5 thrombotic events (1. 2%) were reported during the treatment. Predicting factors for erythroid response were no previous transfusion requirement (p<0. 001), serum EPO levels at baseline < 50 mU/l (p<0. 001), creatinine levels above the normal values (<0. 001), ferritin levels < 250 ng/ml (p=0. 009) and hemoglobin level at baseline > 8 g/dl (p=0. 017). Median overall survival from EPO start was 70. 7 months (CI 95% 52. 5 – 88. 8) in responders versus 41. 7 months (CI 95% 27, 6 – 55, 7) in resistant patients (p= 0. 018). Our real-life data from a single homogeneous geographic area outline that EPO treatment is safe and effective also in the current clinical practice, beyond controlled clinical trials. However, this latter type of studies is warranted to define the best initial dose of EPO in such patients. Disclosures: No relevant conflicts of interest to declare.

Efficacy and Safety of Lamotrigine in Pediatric Patients

2002 ◽  
Vol 17 (2_suppl) ◽  
pp. 2S34-2S42 ◽  
Author(s):  
John Messenheimer
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Pediatric Patients ◽  
Efficacy And Safety ◽  
Controlled Clinical Trials ◽  
Regulatory Authorities ◽  
Treatment Of Epilepsy

Accumulating data suggest that lamotrigine, which has been available for adult use in epilepsy for more than a decade in clinical practice, also confers effective, well-tolerated control of a range of childhood epilepsies. Lamotrigine is currently approved for the treatment of epilepsy by regulatory authorities in 93 countries, more than 70 of which have approved its use in pediatric patients on the basis of data from well-controlled clinical trials. The controlled clinical trials data have been supplemented over the years by clinical practice data, primarily from uncontrolled studies, confirming or demonstrating additional efficacy of lamotrigine for a range of seizure types. This article reviews the data from well-controlled clinical trials and studies conducted in clinical practice to present an updated perspective on the efficacy and safety of lamotrigine in pediatric patients. (J Child Neurol 2002;17:2S34—2S42).

scholarly journals Applying a Risk-benefit Analysis to Outcomes in Tuberculosis Clinical Trials

2019 ◽  
Vol 70 (4) ◽  
pp. 698-703 ◽  
Author(s):  
Sachiko Miyahara ◽  
Ritesh Ramchandani ◽  
Soyeon Kim ◽  
Scott R Evans ◽  
Amita Gupta ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Systematic Approach ◽  
Composite Outcome ◽  
Efficacy And Safety ◽  
Benefit Analysis ◽  
Prevention Study ◽  
Design Considerations ◽  
The Mean ◽  
Risk Benefit Analysis ◽  
Noninferiority Margin

Abstract Although it is common to analyze efficacy and safety separately in clinical trials, this could yield a misleading study conclusion if an increase in efficacy is accompanied by a decrease in safety. A risk-benefit analysis is a systematic approach to examine safety and efficacy jointly. Both the “rank-based” and “partial-credit” methods described in this paper allow researchers to create a single, composite outcome incorporating efficacy, safety, and other factors. The first approach compares the distribution of rankings between arms. In the second approach, a score can be assigned to each outcome category, considering its severity and comparing the mean or median scores of arms. The methods were applied to the A5279/Brief Rifapentine-Isoniazid Efficacy for TB Prevention study, and design considerations for future clinical trials are discussed, including the challenge of arriving at a consensus on rankings/scorings. If well designed, a risk-benefit analysis may allow for a superiority comparison and, therefore, avoid setting a noninferiority margin. Clinical Trials Registration. NCT01404312 (A5279).

Treatment of menstrual migraine

Cephalalgia ◽  
1997 ◽  
Vol 17 (20_suppl) ◽  
pp. 35-38 ◽  
Author(s):  
F Granella ◽  
G Sances ◽  
G Messa ◽  
M De Marinis ◽  
Gc Manzoni
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Menstrual Cycle ◽  
Ad Hoc ◽  
Acute Attack ◽  
Menstrual Migraine ◽  
Controlled Clinical Trials ◽  
Ergot Derivatives ◽  
Definition Of ◽  
Oestrogen Supplementation

Because of its pathophysiological and clinical peculiarities, true menstrual migraine (MM) (i.e. migraine starting exclusively between the days immediately before and immediately after the first day of the menstrual cycle) requires an ad hoc management different from that of other migraines. The paucity of well-conducted, controlled clinical trials and the lack of a universally accepted definition of MM have meant that the treatment of MM is still largely empirical. In our clinical practice, we adopt a sequential therapeutic approach, including the following steps: (i) acute attack drugs (sumatriptan, ergot derivatives, NSAIDs); (ii) intermittent prophylaxis with ergot derivatives or NSAIDs; (iii) oestrogen supplementation with percutaneous or transdermal oestradiol (100 Lig patches); (iv) antioestrogen agents (danazol, tamoxifen).

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