scholarly journals Effects of 4-Week Intervention withUlmus macrocarpaHance Extract on Immune Function Biomarkers in Healthy Adults: A Randomized Controlled Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-6
Author(s):  
A Ra Cho ◽  
Sang Yeoup Lee ◽  
Young Hye Cho ◽  
Cheol Min Kim ◽  
Sung Goo Kim
Keyword(s):  
Placebo Group ◽  
Immune Function ◽  
Human Subjects ◽  
Controlled Trial ◽  
Interleukin 2 ◽  
Optimal Dosage ◽  
Short Term ◽  
Double Blind ◽  
Randomized Controlled ◽  
Term Administration

Ulmus macrocarpaextract has been shown to have immune-related effects in animals, but no studies have yet been performed in humans. This randomized, double-blind, placebo-controlled trial was conducted to determine the effect of short-term administration ofUlmus macrocarpaHance extract (UME) on immune function biomarkers and its safety in human subjects. Fifty-eight subjects were randomly assigned to a UME group or a placebo group. Subjects in the UME group were given 500 mg per day of UME orally for 4 weeks. Mean fluorescence intensity (MFI) of tumor necrotic factor-αincreased only in the UME group at 1 week(P=0.027). The MFI of interleukin-2 decreased less significantly in the UME group than in the placebo group at 1 week(P=0.028). However, unfortunately, at 4 weeks, no intergroup differences were detected in MFIs of cytokine. In conclusion, administration of UME for 1 week increased serum TNF-αand sustains IL-2 in human, which suggests that UME increases Th1-related immune function in the short term in healthy people. However, additional studies are needed to confirm the results of this first-stage study and further trials are required to decide on optimal dosage and duration of administration. This trial is registered with ClinicalTrials.gov Identifier:NCT02414412.

scholarly journals The Effect of a Transdermal Scopolamine Patch on Postoperative Nausea and Vomiting after Retromastoid Craniectomy with Microvascular Decompression: A Preliminary Single Center, Double-Blind, Randomized Controlled Trial

2020 ◽  
Vol 9 (1) ◽  
pp. 156 ◽  
Author(s):  
Hyun Hee Lee ◽  
Hyun-Mi Kim ◽  
Ji Eun Lee ◽  
Young-Tae Jeon ◽  
Sanghon Park ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Placebo Group ◽  
Microvascular Decompression ◽  
Postoperative Nausea ◽  
Controlled Trial ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Double Blind ◽  
Randomized Controlled ◽  
The Mean

Background: We performed this prospective double-blind randomized controlled trial to identify the effect of a preoperative prophylactic transdermal scopolamine (TDS) patch on postoperative nausea and vomiting (PONV) after retromastoid craniectomy with microvascular decompression (RMC-MVD). Methods: We recruited 38 patients undergoing RMC-MVD and randomized them into two groups: the TDS group (n = 19, application of the TDS patch) and placebo group (n = 19, application of a sham patch). Nausea (as a self-reported 100-mm visual analog scale (VAS) score; range, 0 (no nausea) to 10 (worst nausea)), vomiting, and the use of antiemetics were the primary endpoints. Results: There was no significant difference in terms of the incidence of PONV (73.7% in the TDS group and 78.9% in the placebo group; p = 1.00) between the groups. However, the mean nausea VAS score was significantly different at arrival to the general ward (0.93 ± 1.71 in the TDS group vs. 2.52 ± 2.85 in the placebo group; p = 0.046), and throughout the study period (0.03 ± 0.07 in the TDS group vs. 0.44 ± 0.71 in the placebo group; p = 0.029). Rescue antiemetics were more frequently used in the placebo group than in the TDS group (9 (47.4%) vs. 2 (10.5%), respectively; p = 0.029). The mean number of antiemetics used throughout the study period was significantly higher in the placebo group than in the TDS group (1.37 ± 2.19 vs. 0.16 ± 0.50, respectively; p = 0.029). Conclusions: The preoperative prophylactic use of a TDS patch was safe and effective in the management of PONV after RMC-MVD in terms of the severity of PONV and the use of rescue antiemetics.

scholarly journals Premedication with Oral Paracetamol for Reduction of Propofol Injection Pain: A Randomized Placebo-Controlled Trial

2019 ◽  
Author(s):  
Sasikaan Nimmaanrat ◽  
Manasanun Jongjidpranitarn ◽  
Sumidtra Prathep ◽  
Maliwan Oofuvong
Keyword(s):  
Placebo Group ◽  
Intravenous Injection ◽  
Controlled Trial ◽  
Injection Pain ◽  
Rating Score ◽  
Double Blind ◽  
Randomized Controlled ◽  
Numerical Rating ◽  
Injection Methods ◽  
Different Doses

Abstract Background: To compare the effect of premedication with 2 different doses of oral paracetamol to prevent pain at propofol intravenous injection. Methods: We conducted a double-blind randomized controlled trial in which patients scheduled for induction of general anesthesia with intravenous propofol received either a placebo, 500 mg or 1000 mg of oral paracetamol (P500 and P1000, respectively) 1 hr prior to induction. Two mg/kg of propofol was injected at a rate of 600 ml/hr. After 1/4 of the full dose had been injected, the syringe pump was paused, and patients were asked to rate pain at the injection site using a verbal numerical rating score (VNRS) from 0-10. Results: Three hundred and twenty-four patients were included. Pain intensity was lower in both P500 and P1000 groups (median VNRS [interquartile range] = 2 [0-3] and 4 [2-5], respectively) than in the placebo group (8 [7-10]; P<0.001)*. The rate of pain was lower in the P1000 group (70.4%) than in both the P500 and the placebo group (86.1% and 99.1%, respectively; P<0.001)*. The respective rates of mild (VNRS 1-3), moderate (VNRS 4-6) and severe pain (VNRS 7-10) were 47.2, 23.2 and 0% in the P1000 group, 28.7, 50 and 7.4% in the P500 group, and 0, 22.2 and 76.9% in the placebo group (P<0.001* for between group comparisons). Tolerance was similar in the 3 groups. Conclusions: A premedication with oral paracetamol can dose-dependently reduce pain at propofol intravenous injection. To avoid this common uncomfortable concern for the patients, this well-tolerated, available and cheap treatment appears as an option to be implemented in the current practice.

scholarly journals Levothyroxine versus Levothyroxine with Iodine in Reduction of Thyroid Nodule Volume: A Double-Blind Randomized Controlled Trial

2019 ◽  
Vol 34 (1) ◽  
pp. 14-19
Author(s):  
Donnie Jan D. Segocio ◽  
Joseph E. Cachuela
Keyword(s):  
Randomized Controlled Trial ◽  
Placebo Group ◽  
Thyroid Nodule ◽  
Controlled Trial ◽  
Therapeutic Use ◽  
Volume Reduction ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Nodule Volume

Objective: To compare levothyroxine alone and in combination with iodine on thyroid nodule volume reduction. Methods:           Design:           Double-Blind Randomized Controlled Trial           Setting:           Tertiary Government Hospital           Participants: Nineteen (19) euthyroid patients age 19­-54 with at least 1 cytologically benign thyroid nodule were randomized to receive either levothyroxine + iodine or levothyroxine + placebo, taken once a day for 6 months with ultrasound and thyroid stimulating hormone monitoring on the 3rd and 6th month of intervention. Results: Main outcome measures included thyroid nodule volume reduction after six months of intervention. The mean change in volume from baseline to six months of levothyroxine + iodine group showed no statistically significant difference in nodule volume across time between  levothyroxine + placebo group, -0.010 ± 1.250 (CI -0.521 - 0.501) versus 0.507 ± 1.128 (CI 0.025 - 0.990), p=.158.  There were also new nodules (4 nodules) in the placebo group and none in the iodine group. No major adverse events were noted during the study. Conclusion: The two groups did not significantly differ in terms of nodule volume reduction. Keywords: thyroid nodule, prevention and control; drug therapy; iodine compounds, therapeutic use; levothyroxine, therapeutic use

scholarly journals Premedication with Oral Paracetamol for Reduction of Propofol Injection Pain: A Randomized Placebo-Controlled Trial

2019 ◽  
Author(s):  
Sasikaan Nimmaanrat ◽  
Manasanun Jongjidpranitarn ◽  
Sumidtra Prathep ◽  
Maliwan Oofuvong
Keyword(s):  
Placebo Group ◽  
Intravenous Injection ◽  
Controlled Trial ◽  
Injection Pain ◽  
Rating Score ◽  
Double Blind ◽  
Randomized Controlled ◽  
Numerical Rating ◽  
Injection Methods ◽  
Different Doses

Abstract Background: To compare the effect of premedication with 2 different doses of oral paracetamol to prevent pain at propofol intravenous injection. Methods: We conducted a double-blind randomized controlled trial in which patients scheduled for induction of general anesthesia with intravenous propofol received either a placebo, 500 mg or 1000 mg of oral paracetamol (P500 and P1000, respectively) 1 hr prior to induction. Two mg/kg of propofol was injected at a rate of 600 ml/hr. After 1/4 of the full dose had been injected, the syringe pump was paused, and patients were asked to rate pain at the injection site using a verbal numerical rating score (VNRS) from 0-10. Results: Three hundred and twenty-four patients were included. Pain intensity was lower in both P500 and P1000 groups (median VNRS [interquartile range] = 2 [0-3] and 4 [2-5], respectively) than in the placebo group (8 [7-10]; P<0.001)*. The rate of pain was lower in the P1000 group (70.4%) than in both the P500 and the placebo group (86.1% and 99.1%, respectively; P<0.001)*. The respective rates of mild (VNRS 1-3), moderate (VNRS 4-6) and severe pain (VNRS 7-10) were 47.2, 23.2 and 0% in the P1000 group, 28.7, 50 and 7.4% in the P500 group, and 0, 22.2 and 76.9% in the placebo group (P<0.001* for between group comparisons). Tolerance was similar in the 3 groups. Conclusions: A premedication with oral paracetamol can dose-dependently reduce pain at propofol intravenous injection. To avoid this common uncomfortable concern for the patients, this well-tolerated, available and cheap treatment appears as an option to be implemented in the current practice.

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