Is celecoxib a useful adjunct in the treatment of post-tonsillectomy pain in the adult population? A randomised, double-blind, placebo-controlled study

2017 ◽  
Vol 131 (S1) ◽  
pp. S18-S28 ◽  
Author(s):  
T-T Ng ◽  
D Diamantaras ◽  
J Priestley ◽  
J Redman ◽  
N De Silva ◽  
...  

AbstractObjective:To evaluate the efficacy and safety of celecoxib for pain management in post-tonsillectomy adult patients.Design:A randomised, double-blind, placebo-controlled, phase 3 clinical trial was conducted in an adult population (aged 18–55 years), with a parallel group design using an allocation ratio of 1:1.Methods:Eighty patients underwent elective tonsillectomy or adenotonsillectomy, operated on by one surgeon. They were discharged home with randomly assigned celecoxib or placebo, together with regular post-tonsillectomy medications (paracetamol and Endone). Pain scores were measured from post-operative days 1 to 10. All patients were assessed on post-operative days 5, 12 and 28.Results:There were no statistically significant differences in the daily or overall pain scores, the total intake of Endone, or the time taken to achieve freedom from pain after tonsillectomy between the study arms (n = 40 each arm). The celecoxib-treated group experienced significantly more vomiting (celecoxib vs placebo p < 0.001 (Mann–Whitney test), confidence interval = 0.57 to 0.76).Conclusion:Celecoxib usage was associated with significantly more vomiting and did not reduce narcotic analgesia requirement post-tonsillectomy.

2012 ◽  
Vol 6 ◽  
pp. SART.S9706 ◽  
Author(s):  
David M. Penetar ◽  
Alison R. Looby ◽  
Elizabeth T. Ryan ◽  
Melissa A. Maywalt ◽  
Scott E. Lukas

Bupropion's (Zyban® SR) effectiveness to treat symptoms experienced in marihuana withdrawal was tested in a double-blind, placebo-controlled study with chronic, heavy marihuana users. Participants maintained their usual marihuana intake until Quit Day after which they were required to cease intake of THC products for 14 days. A Withdrawal Discomfort Score revealed that for 7 days immediately following cessation, placebo-treated subjects reported more symptoms than bupropion-treated subjects. Self-reported craving for marihuana increased for the placebo-treated group but not for those treated with bupropion. Measures of sleep and cognitive performance were not different between the two groups. Participants in the bupropion treatment arm were more likely to complete the study than those randomized to the placebo arm (50% completion for bupropion vs. 33% completion for placebo). These results suggest that bupropion may be useful for alleviating marihuana withdrawal symptoms and be useful in subject retention during long-term cessation programs.


2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Sreenivasulu Puram ◽  
Hyung Chae Suh ◽  
Seung Un Kim ◽  
Bharathi Bethapudi ◽  
Joshua Allan Joseph ◽  
...  

A randomized, double blind placebo controlled study was conducted to evaluate the efficacy of GutGard (root extract ofGlycyrrhiza glabra) in the management ofHelicobacter pylori(H. pylori) gastric load. Participants diagnosed withH. pyloriinfection were randomly assigned to two groups to orally receive 150 mg of GutGard (n=55) or placebo (n=52) once daily for 60 days.H. pyloriinfection was assessed using13C-urea breath test (13C-UBT) at days 0, 30, and 60. Stool Antigen test (HpSA) was also performed on days 0, 30, and 60. Repeated measures of analysis of variance (RMANOVA), chi-square, and Fisher's exact probability tests were used to compare the treatment outcomes. A significant interaction effect between group and time (P=0.00) and significant difference in mean Delta Over Baseline (DOB) values between GutGard (n=50) and placebo (n=50) treated groups after intervention period were observed. On day 60, the results of HpSA test were negative in 28 subjects (56%) in GutGard treated group whereas in placebo treated group only 2 subjects (4%) showed negative response; the difference between the groups was statistically significant. On day 60, the results of13C-UBT were negative in 24 (48%) in GutGard treated group and the difference between the groups was statistically significant. The findings suggest GutGard is effective in the management ofH. pylori.


2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Wei Xu ◽  
Yan Li ◽  
Mei Ju ◽  
Wei Lai ◽  
Xueyan Lu ◽  
...  

Background. Glycyrrhizin is widely used in skin disorders, such as psoriasis, alopecia areata, and allergic diseases, but has not been extensively studied in patients with chronic eczema. Objective. To evaluate the efficacy and safety of oral compound glycyrrhizin (OCG) plus topical corticosteroid (TCS) in adults with chronic eczema. Methods. This was a multicenter, randomized, double-blind, placebo-controlled study in patients with chronic eczema (n = 199). Randomized participants from 6 centers in China received either 75 mg OCG capsules or placebo capsules three times a day and TCS (i.e., 0.1% mometasone furoate ointment) once a day for 28 days. Efficacy was determined by analyzing the mean change from the baseline using standardized measures including the Investigator’s Global Assessment (IGA) score, Eczema Area and Severity Index (EASI), and the visual analogue scale score (VAS) of itching. Results. Decreases in absolute EASI were significantly greater in the OCG-treated group versus placebo on day 14 (−3.41 ± 1.41 vs. −2.71 ± 1.25, P<0.001) and day 28 (−7.39 ± 1.71 vs. −6.64 ± 1.75, P=0.003). OCG-treated patients also saw greater benefit in other EASI metrics including EASI-50 (96.8% vs. 87.9%, P=0.021) and EASI-75 (47.9% vs. 21.2%, P<0.001) on day 28 compared with placebo. The absolute IGA score reductions were also significantly greater in the OCG group than the placebo (all P<0.05). In addition, proportions of patients who achieve clear (0) IGA scores or almost clear (1) IGA scores were significantly higher in the treated group than placebo on day 14 (22.8% vs. 6.2%, P=0.001) and day 28 (93.5% vs. 79.4%, P=0.005). Moreover, the proportions of patients with reduced pruritus were significantly greater in the treated group than placebo on day 28 (94.7% vs. 83.8%, P=0.016) and eczema recurrence was notably less in the OCG group versus placebo (3.19% vs. 12.12%, P=0.021). Eleven patients experienced adverse events, but there was no significant difference in the proportion of patients affected (3.0% vs. 8.5%, P>0.05). The most common adverse events were edema of both lower limbs. Conclusion. For adults with chronic eczema, OCG capsules combined with TCS is an effective and well-tolerated treatment, suggesting that OCG may be a useful nonsteroidal agent with an additional effect for the treatment of chronic eczema by TCS.


2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
E. Brunel ◽  
M. Schnitzler ◽  
M. Foidart-Dessalle ◽  
J. C. Souberbielle ◽  
E. Cavalier

In this double blind, unicentre, randomized, placebo controlled study, we evaluated the changes in 25-hydroxyvitamin D (25(OH)D) serum levels in 150 young Belgian adults (18–30 years), monthly supplemented with 50,000 IU of vitamin D (VTD) or placebo for 6 months, from November 2010 to May 2011. At T0, 30% of the population presented 25(OH)D serum levels below 20 ng/mL. In the VTD-treated group, mean serum levels increased from 21.2 ± 8.2 to 30.6 ± 8.8 ng/mL (P<0.001) at T3mo and to 36.0 ± 9.2 ng/mL (P<0.001) at T6mo. Despite documented VTD intake, no changes in serum levels were, however, observed in 10% of the treated group. In the placebo group, mean 25(OH)D serum levels decreased from 22.8 ± 8.5 to 14.0 ± 6.9 ng/mL at T3mo (P<0.001) but returned to values not significantly different from those observed at T0 (23.5 ± 8.6 ng/mL) at T6mo. No difference between serum calcium levels was observed between the groups throughout the study. In conclusion, monthly supplementation with 50,000 UI of VTD in winter can warrant serum 25(OH)D levels above 20 ng/mL in 96.2% of those healthy young adults without inducing unacceptably high 25(OH)D concentration. This supplementation is safe and may be proposed without 25(OH)D testing.


Sign in / Sign up

Export Citation Format

Share Document