scholarly journals Transferability to clinical practice of the results of controlled clinical trials: The case of antiemetic prophylactic treatment for cancer chemotherapy-induced nausea and vomiting

1998 ◽  
Vol 9 (7) ◽  
pp. 759-765 ◽  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Cancer Chemotherapy ◽  
Prophylactic Treatment ◽  
Nausea And Vomiting ◽  
Controlled Clinical Trials

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.

Antifungal Prophylaxis in Immunocompromised Hosts

1993 ◽  
Vol 27 (1) ◽  
pp. 53-60 ◽  
Author(s):  
Stan Reents ◽  
S. Diane Goodwin ◽  
Vipul Singh
Keyword(s):  
Clinical Trials ◽  
Antifungal Prophylaxis ◽  
Nausea And Vomiting ◽  
Fungal Colonization ◽  
Solid Organ ◽  
Renal Transplant Recipients ◽  
Efficacy And Safety ◽  
Controlled Clinical Trials ◽  
Immunocompromised Hosts ◽  
The Relationship

OBJECTIVE: To review the literature on the efficacy and safety of antifungal agents for prophylaxis of fungal infections in populations of immunocompromised hosts (key words: hematology-oncology, surgical, solid organ transplant, HIV infection), and to develop guidelines and recommendations regarding safe and effective drug regimens for antifungal prophylaxis in this patient population. DATA EXTRACTION: Comprehensive review of clinical trials of antifungal prophylaxis published in the English literature, with an emphasis on controlled trials, and discussion of key clinical trials illustrating efficacy and safety of agents for antifungal prophylaxis in immunocompromised patients. RESULTS: Much of the clinical data evaluating the efficacy and safety of antifungal prophylaxis has been generated in cancer patients. The choice of antifungal agent for prophylaxis in this population remains controversial. However, azole compounds such as clotrimazole, ketoconazole and fluconazole appear to be more effective and better tolerated than nystatin suspension. Although ketoconazole has been shown to reduce fungal colonization in surgical patients, current data do not support the routine use of antifungal prophylaxis in this population. In renal transplant recipients, clotrimazole troches have been shown to be more effective than placebo or nystatin suspension. Selective bowel decontamination with nonabsorbable antibiotics and nystatin may be useful in reducing Candida colonization in liver transplant patients but no definitive recommendations may be made at this time regarding optimal antifungal prophylaxis in these patients. In patients with advanced HIV disease or history of prior fungal disease prophylaxis for oropharyngeal candidiasis is indicated, although the agent of choice remains controversial. Fluconazole is the drug of choice for prevention of relapse of cryptococcal meningitis in patients with AIDS. Finally, only limited data exist assessing the relationship between local colonization and systemic fungal infection. Adverse effects associated with antifungal prophylaxis, generally limited to nausea and vomiting and transient elevations in hepatic transaminases, occur with similar frequency among available oral or topical agents. However, the incidence of nausea and vomiting with resultant poor patient tolerance and compliance is usually higher with nystatin. CONCLUSIONS: Based on available data from controlled clinical trials, azole agents are currently the most effective and best-tolerated drugs for antifungal prophylaxis in immunocompromised hosts. Choice of one agent in this group over another may be dictated by cost. As new antifungal treatments are released onto the market, these drugs should be compared with existing agents in controlled clinical trials. Future studies should be designed to evaluate the relationship between local colonization and disseminated infection.

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.

Antioxidants and toxicity of cancer chemotherapy: A systematic review of the evidence from randomized controlled trials

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9130-9130
Author(s):  
K. I. Block ◽  
A. C. Koch ◽  
M. N. Mead ◽  
P. Tothy ◽  
R. A. Newman ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Chemotherapy ◽  
Statistical Power ◽  
Meta Analysis ◽  
Controlled Clinical Trials ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled ◽  
Standardized Protocol ◽  
Concurrent Use ◽  
Relapsed Disease

9130 Background: Much debate has focused on whether or not antioxidants interfere with the efficacy of cancer chemotherapy. The objective of this study is to systematically review the medical literature to compile results from randomized, controlled clinical trials evaluating the effects of concurrent use of antioxidants with chemotherapy on toxic side effects. Methods: We performed a search of literature from 1966-December 2006 using MEDLINE, Cochrane, CinAhl, AMED, AltHealthWatch and EMBASE databases. Randomized, controlled clinical trials reporting mitigation of chemotherapy toxicity were included in the final tally. The searches were performed in duplicate following a standardized protocol. No meta-analysis was performed due to heterogeneity of cancers and chemotherapy regimens. Results: Of 848 articles considered, 32 trials met the inclusion criteria. Antioxidants evaluated were: glutathione (9), melatonin (6), vitamin A (1), an antioxidant mixture (3), N-acetylcysteine (3), vitamin E (5), selenium (1), L-carnitine (1), Co-Q10 (2) and ellagic acid (1). Subjects of most studies had advanced or relapsed disease. Conclusions: One of the 32 studies included reported evidence of significant increase in toxicity from the concurrent use of antioxidants with chemotherapy. In 18 studies, antioxidant groups experienced significantly lower toxicity than control groups. Statistical power and poor study quality were concerns with some of the studies. We have reported elsewhere that randomized trials of various antioxidants given with chemotherapy did not demonstrate an adverse effect on treatment response or survival. Well-designed studies evaluating larger populations of patients given antioxidants concurrently with chemotherapy are thus warranted. No significant financial relationships to disclose.

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).

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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