scholarly journals Ingestion of Exopolymers fromAureobasidium pullulansReduces the Duration of Cold and Flu Symptoms: A Randomized, Placebo-Controlled Intervention Study

2018 ◽  
Vol 2018 ◽  
pp. 1-12 ◽  
Author(s):  
Jong-Min Lim ◽  
Eunju Do ◽  
Dong-Chan Park ◽  
Go-Woon Jung ◽  
Hyung-Rae Cho ◽  
...  
Keyword(s):  
Functional Food ◽  
Intervention Study ◽  
Influenza Season ◽  
Controlled Study ◽  
Serum Cytokine ◽  
Double Blind ◽  
Food Material ◽  
Significance Level ◽  
Cytokine Levels ◽  
Primary Variable

Aim. The objective of the study was to assess the efficacy of exopolymers fromAureobasidium pullulans(EAP) on the incidence of colds and flu in healthy adults.Methods. We conducted a randomized, double-blind, placebo-controlled study at the onset of the influenza season. A total of 76 subjects (30–70 years of age) were recruited from the general population. The subjects were instructed to take one capsule per day of either EAP or a placebo for a period of 8 weeks. The duration of cold and flu symptoms, a primary variable in assessing effectiveness, and serum cytokine levels as well as WBC counts as secondary variables were also evaluated.Results. EAP was associated with a statistically significant decrease in the duration of cold and flu symptoms, a primary variable in assessing effectiveness. Although cold and flu symptom levels were not significantly different at a significance level of 5%, the cold and flu symptom levels of the EAP group were less severe compared to the placebo group. No statistically significant changes of serum cytokine levels as well as WBC counts were observed.Conclusion. The results showed that EAP is a useful pharmaceutical and functional food material for preventing and treating colds and flu.

scholarly journals A Double-Blind Placebo-Controlled Study of an Infusion of Lexipafant (Platelet-Activating Factor Receptor Antagonist) in Patients with Severe Sepsis

2000 ◽  
Vol 44 (3) ◽  
pp. 693-696 ◽  
Author(s):  
Yupin Suputtamongkol ◽  
Sunanta Intaranongpai ◽  
Michael D. Smith ◽  
Brian Angus ◽  
Wipada Chaowagul ◽  
...  
Keyword(s):  
Severe Sepsis ◽  
Receptor Antagonist ◽  
Controlled Trial ◽  
Platelet Activating Factor ◽  
Blood Cultures ◽  
Controlled Study ◽  
Double Blind ◽  
Cytokine Levels ◽  
Paf Receptor ◽  
Paf Receptor Antagonist

ABSTRACT Platelet-activating factor (PAF) is a potent endogenous proinflammatory mediator implicated in the pathogenesis of septic shock. A double-blind randomized placebo-controlled trial of an intravenous PAF receptor antagonist (lexipafant) was conducted with 131 adult Thai patients with suspected severe sepsis (66 of whom had positive blood cultures). Detailed serial clinical, biochemical, and cytokine measurements were performed. Lexipafant treatment was well tolerated. The 28-day mortality in the lexipafant group (61.4%) was similar to that in the placebo group (62.6%). There was also no evidence that lexipafant affected clinical or biochemical measures of disease severity or the profile of sequentially measured plasma cytokine levels. PAF may not have an important role in the pathogenesis of severe sepsis.

Rituximab As Second Line Treatment For Adult Immune Thrombocytopenia (ITP): A Multicentre, Randomized, Double Blind, Placebo-Controlled Study – The Ritp Study (NCT00344149)

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 449-449 ◽  
Author(s):  
Waleed Ghanima ◽  
Abderrahim Khelif ◽  
Neila Benromdhan ◽  
Anders Waage ◽  
Geir E. Tjonnfjord ◽  
...  
Keyword(s):  
Treatment Failure ◽  
Research Funding ◽  
Statistical Tests ◽  
Complete Response ◽  
Controlled Study ◽  
Logrank Test ◽  
Double Blind ◽  
Significance Level ◽  
Double Blind Placebo ◽  
Number Of Patients

Introduction Splenectomy is recommended by ASH and other guidelines as the main 2nd line therapy for ITP in patients who fail to respond or relapse after initial treatment with steroids. However, because of the possible peri- and postoperative complications, irreversibility and unpredictable response of splenectomy, medical alternatives that lead to avoidance of splenectomy are of great interest. Despite the lack of evidence-based data, rituximab (RTX) is now commonly used to manage ITP. RTX has not been properly evaluated in randomized placebo-controlled trials to determine its role as a splenectomy-sparing agent in ITP. This study aimed to assess the efficacy of RTX against placebo in steroid- unresponsive ITP patients. Methods In this multi center (n=14) international, double blind placebo-controlled study, patients were randomly allocated to receive 4 weekly infusions of 375mg/m2 RTX or placebo. Steroids were allowed throughout the study. Main inclusion criteria were: 1- unsplenectomized patients with primary ITP with platelet count (PC) <30 or 30-50 x109/L if a higher PC was required, 2- failure to achieve sustained response to 1-2 mg/kg prednisone/prednisolone given ≥ 2 weeks (w) or relapse during steroid-tapering or after discontinuation. Exclusion criteria included previous administration of 2nd line treatments for ITP. The Primary endpoint was the rate of treatment failure within 78 w; treatment failure was defined as splenectomy or meeting criteria for splenectomy after w 12 if splenectomy was not be performed because of contraindication or patient's refusal. Criteria for splenectomy were defined as either PC <20 x109/L or a need of dose increment > 7.5 mg/day of Prednisone/prednisolone to maintain PC ≥20 x109/L. Secondary endpoints were rate of complete response (CR) at 24 w (PC >100 x109/L without administration of any platelet elevating therapy except steroids within the last 2 w) and safety. Analysis was performed on intention to treat basis. The Kaplan-Meier method and logrank test were used for efficacy outcomes; all statistical tests were 2-sided with a significance level of 5%. The study was approved by National Ethics Committees. Written informed consent was obtained from all patients. Results Characteristics, response and safety outcomes of the 109 randomized patients are shown in the table. Treatment with RTX did not reduce the rate of treatment failure at 78 w (logrank test p=0.6). However, there was a trend toward a reduction in the rate of splenectomy in the RTX-arm. Seventeen (31%) in the RTX-arm vs 6 (11%) in the placebo-arm achieved CR at 24 w (p=0.01). CR continued to occur after 24 w, figure. Although a number of patients in both arms relapsed during the follow-up, the difference in CR between the 2 arms remained significant throughout the study (p=0.02). RTX was associated with a higher rate of infections compared to placebo; one infection in each arm was evaluated as severe. Conclusions This is the first randomized placebo-controlled study aiming to assess both short and long-term efficacy and safety of RTX in steroid-unresponsive ITP patients. The study shows that treatment of steroid-unresponsive ITP with RTX did not reduce the rate of treatment failure, which was defind as a composite of splenectomy or meeting the predefined criteria for splenectomy if spenectomy was not performed. However, there was a trend toward a lower rate of splenectomy in the RTX-arm. Conversely, RTX resulted in a significnatly higher rate of CR at 24 w compared to Placebo - a difference that remained significant throughout the study. In conclusion, monotherapy with RTX in steroid unresponsive patients did not alter the rate of treatment failure but yielded a significantly higher rates of CR as compared to placebo, which seems to be the main benift of treatment with RTX . Disclosures: Ghanima: Roche: Honoraria, Research Funding; Amgen: Honoraria, Research Funding; GSK: Honoraria. Off Label Use: Rituximab is not approved for the treatment of ITP. Michel:Roche: Honoraria, Research Funding; Amgen: Honoraria. Holme:Roche: Research Funding.

Carbohydrate and the cytokine response to 2.5 h of running

1997 ◽  
Vol 82 (5) ◽  
pp. 1662-1667 ◽  
Author(s):  
S. L. Nehlsen-Cannarella ◽  
O. R. Fagoaga ◽  
D. C. Nieman ◽  
D. A. Henson ◽  
D. E. Butterworth ◽  
...  
Keyword(s):  
Significant Interaction ◽  
Plasma Cortisol ◽  
Interleukin 1 ◽  
Cytokine Response ◽  
Controlled Study ◽  
Double Blind ◽  
Marathon Runners ◽  
Carbohydrate Ingestion ◽  
Cytokine Responses ◽  
Cytokine Levels

Nehlsen-Cannarella, S. L., O. R. Fagoaga, D. C. Nieman, D. A. Henson, D. E. Butterworth, R. L. Schmitt, E. M. Bailey, B. J. Warren, A. Utter, and J. M. Davis. Carbohydrate and the cytokine response to 2.5 h of running. J. Appl. Physiol. 82(5): 1662–1667, 1997.—This randomized, double-blind, placebo-controlled study was designed to determine the influence of 6% carbohydrate (C) vs. placebo (P) beverage ingestion on cytokine responses (5 total samples over 9 h) to 2.5 h of high-intensity running (76.7 ± 0.4% maximal O2uptake) by 30 experienced marathon runners. For interleukin-6 (IL-6), a difference in the pattern of change between groups was found, highlighted by a greater increase in P vs. C immediately postrun (753 vs. 421%) and 1.5 h postrun (193 vs. 86%) [ F(4,112) = 3.77, P = 0.006]. For interleukin-1-receptor antagonist (IL-1ra), a difference in the pattern of change between groups was found, highlighted by a greater increase in P vs. C 1.5 h postrun (231 vs. 72%) [ F(2,50) = 6.38, P = 0.003]. No significant interaction effects were seen for bioactive IL-6 or IL-1β. The immediate postrun plasma glucose concentrations correlated negatively with those of plasma cortisol ( r = −0.67, P < 0.001); postrun plasma cortisol ( r = 0.70, P < 0.001) and IL-6 levels ( r = 0.54, P = 0.003) correlated positively with levels of IL-1ra. Taken together, the data indicate that carbohydrate ingestion attenuates cytokine levels in the inflammatory cascade in response to heavy exertion.

884: Phase I, Double-Blind, Placebo-Controlled Study in Healthy Male Subjects to Investigate the Safety, Tolerability, and Pharmacokinetics of DA-8159

2004 ◽  
Vol 171 (4S) ◽  
pp. 234-234 ◽  
Author(s):  
Harin Padma-Nathan ◽  
Jae Seung Pacik ◽  
Byoung Ok Ahn ◽  
Kyung Koo Kang ◽  
Mi Young Bahng ◽  
...  
Keyword(s):  
Phase I ◽  
Controlled Study ◽  
Healthy Male ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Male Subjects
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