scholarly journals Effects of Preoperative Carbohydrate Intake on Inflammatory Markers and Clinical Outcomes in Elderly Patients Undergoing Radical Prostatectomy: A Single-Centre, Double-Blind Randomised Controlled Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Zhen Hu ◽  
Ji Liu ◽  
Fen Wang
Keyword(s):  
Drinking Water ◽  
Placebo Group ◽  
Radical Prostatectomy ◽  
Elderly Patients ◽  
Clinical Outcomes ◽  
Inflammatory Markers ◽  
Controlled Trial ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Open Radical Prostatectomy

Background: This study aimed to analyse the effects of carbohydrate (CHO) intake on inflammatory markers, comfort, and clinical outcomes in elderly patients undergoing open radical prostatectomy.Methods: Patients aged ≥65 years who underwent open radical prostatectomy were randomly divided into CHO, drinking water, and fasting groups. A total of 90 patients were enrolled in this study (CHO group, n = 28; placebo group, n = 30 and fasting group, n = 32). Patients in the CHO group were given 800 and 400 ml of carbohydrates 8 and 2–3 h before surgery, respectively. Patients in the placebo group were given 800 and 400 ml of water 8 and 2–3 h before surgery, respectively. Patients in the fasting group did not consume any liquids. The main result is levels of inflammation markers. Secondary results included cellular immunity, comfort, body weight, grip index, and clinical results.Results: Compared with the fasting group, the CHO group exhibited a decrease in interleukin 6 (IL-6) levels on days 1 and 7 (75.47 and 7.06 pg/mL, respectively), IL-8 levels on day 1 (274.61 pg/mL) and tumour necrosis factor (TNF) levels on days 1, 3, and 7 (11.16, 9.55, and 9.67 pg/mL, respectively). The placebo group exhibited a decrease in IL-8 (390.26 pg/mL) and TNF levels (13.99 pg/mL) on day 1. Compared with the placebo group, the CHO group exhibited a decrease in IL-6 levels on day 1 and TNF levels on day 3. In the CHO and placebo groups, the thirst and hunger scores decreased on the morning of surgery.Conclusion: Preoperative CHO and drinking water are associated with decreased levels of IL-6, IL-8, and TNF. CHO and water can also reduce thirst and hunger scores. Therefore, we recommend that patients without contraindications should be given 200–400 ml of fluid 2–3 h before surgery, preferably CHO.Clinical Trial Registration:http://www.chictr.org.cn/edit.aspx?pid=21783&htm=4; ChiCTR-INR-17012867.

scholarly journals Effect of preoperative carbohydrate intake on inflammatory factors and clinical outcomes in elderly patients undergoing radical prostatectomy: a single-center, double-blind randomized controlled trial

2020 ◽  
Author(s):  
Zhen Hu ◽  
Ji Liu ◽  
Wenchao Ma ◽  
Fen Wang
Keyword(s):  
Radical Prostatectomy ◽  
Elderly Patients ◽  
Clinical Outcomes ◽  
Body Mass ◽  
Inflammatory Markers ◽  
Controlled Trial ◽  
Operation Time ◽  
Inflammatory Factors ◽  
Water Group ◽  
First Time

Abstract BACKGROUND: To investigate the advantages of Carbohydrate (CHO) in inflammatory markers, comfort and clinical outcomes in elderly patients undergoing open radical prostatectomy.METHODS: Patients of ≥65 years old with radical prostatectomy who underwent open radical prostatectomy were randomized to the CHO group, water group, and fasted group. Patients in the CHO group and water group received oral CHO, 800 ml of placebo water before surgery, and oral CHO and placebo water 400 ml 2 to 3 hours before surgery; the fasted group did not drink any liquid. The main outcomes are inflammatory markers. The secondary outcomes are cellular immunity, comfort, the index of grip strength of body mass and clinical outcomes.RESULTS: A total of 90 patients were included in current study (i.e., CHO group, n=28; water group, n=30; fasted group, n=32). The three groups matched well in age, body mass index, the grade of (American Society of Anesthesiologists) ASA, operation time, blood loss, and fluid volume. CHO reduces IL-6 of Day1 and Day7 (P = 0.009, 0.005, respectively), IL-8 (P=0.005) of Day1, Day1, Day 3, and Day 7 TNF (P = 0.001, 0.006, 0.003 respectively) compared with the fasted group ; placebo water reduced Day 1 and Day 7 TNF (P = 0.005, 0.038, respectively), Day 1of IL-8 (P = 0.045). CHO reduced Day3 of TNF (P=0.026) compared to placebo water. In the CHO group and the water group, the morning thirst scores (0.68, 1.26, respectively) and starvation (0.24, 0.47, respectively) were decreased. The first time to leave bed in the fasted group (39.21 (15-93) h) was much later than in the CHO group (28.57 (10-100) h) and the water group (28.71 (12-70) h).Conclusion: Compared with routine water ban, preoperative CHO and placebo water can reduce the levels of IL-6, IL-8 and TNF in elderly patients undergoing radical prostatectomy, which can improve the patient's preoperative comfort and shorten the patient's first time to leave bed. Compared with placebo water, CHO has no significant advantage in improving inflammatory markers and clinical outcomes.

scholarly journals Effect of preoperative carbohydrate intake on inflammatory factors and clinical outcomes in elderly patients undergoing radical prostatectomy: a single-center, double-blind randomized controlled trial

2020 ◽  
Author(s):  
Zhen Hu ◽  
Ji Liu ◽  
Wenchao Ma ◽  
Fen Wang
Keyword(s):  
Placebo Group ◽  
Radical Prostatectomy ◽  
Elderly Patients ◽  
Clinical Outcomes ◽  
Operation Time ◽  
Inflammatory Factors ◽  
Blocking Group ◽  
Open Radical Prostatectomy ◽  
Water Blocking ◽  
First Time

Abstract BACKGROUND To investigate the advantages of Carbohydrate (CHO) in inflammatory factors, comfort and clinical outcomes in elderly patients with open radical prostatectomy. METHODS Patients of ≥ 65 years old with radical prostatectomy who underwent open radical prostatectomy were randomized to the CHO group, placebo group, and conventional water-blocking group. Patients in the CHO group and placebo group received oral CHO, 800 ml of placebo water before surgery,and oral CHO and placebo water 400 ml 2 to 3 hours before surgery; the water-free group did not drink any liquid. The main test indicators are inflammatory factors, comfort and clinical outcomes. RESULTS 28 patients in the CHO group, 30 in the placebo group, and 32 in the conventional water-blocking group were included in the study. The three groups matched well in age, body mass index, the grade of (American Society of Anesthesiologists)ASA, operation time, blood loss, and fluid volume.CHO reduces IL-6 of Day1 and Day7 (P = 0.009, 0.005, respectively), IL-8 (P = 0.005) of Day1, Day1, Day 3, and Day 7 TNF (P = 0.001, 0.006, 0.003 respectively) compared with the water-stopping group ; placebo water reduced Day 1 and Day 7 TNF (P = 0.005, 0.038, respectively), Day 1of IL-8 (P = 0.045). CHO reduced Day3 of TNF (P = 0.026) compared to placebo. In the CHO group and the placebo group, the morning thirst scores (0.68, 1.26, respectively) and starvation (0.24, 0.47, respectively)were decreased. The first time to leave bed in the conventional water-blocking group (39.21 (15–93) h) was much later than in the CHO group (28.57 (10–100) h) and the placebo group (28.71 (12–70) h). Conclusion Compared with routine water ban, preoperative CHO and placebo water can reduce the levels of IL-6, IL-8 and TNF in elderly patients undergoing radical prostatectomy, which can improve the patient's preoperative comfort and shorten the patient's first time to leave bed. Compared with placebo water, CHO has no significant advantage in improving inflammatory factors and clinical outcomes.

scholarly journals Effect of vitamin D supplementation on selected inflammatory biomarkers in older adults: a secondary analysis of data from a randomised, placebo-controlled trial

2015 ◽  
Vol 114 (5) ◽  
pp. 693-699 ◽  
Author(s):  
Mary Waterhouse ◽  
Bich Tran ◽  
Peter R. Ebeling ◽  
Dallas R. English ◽  
Robyn M. Lucas ◽  
...  
Keyword(s):  
Vitamin D ◽  
Placebo Group ◽  
Inflammatory Markers ◽  
Controlled Trial ◽  
Intervention Group ◽  
Vitamin D Supplementation ◽  
Post Intervention ◽  
Double Blind ◽  
Specific Patient ◽  
Significant Difference

AbstractObservational studies have suggested that 25-hydroxyvitamin D (25(OH)D) levels are associated with inflammatory markers. Most trials reporting significant associations between vitamin D intake and inflammatory markers used specific patient groups. Thus, we aimed to determine the effect of supplementary vitamin D using secondary data from a population-based, randomised, placebo-controlled, double-blind trial (Pilot D-Health trial 2010/0423). Participants were 60- to 84-year-old residents of one of the four eastern states of Australia. They were randomly selected from the electoral roll and were randomised to one of three trial arms: placebo (n 214), 750 μg (n 215) or 1500 μg (n 215) vitamin D3, each taken once per month for 12 months. Post-intervention blood samples for the analysis of C-reactive protein (CRP), IL-6, IL-10, leptin and adiponectin levels were available for 613 participants. Associations between intervention group and biomarker levels were evaluated using quantile regression. There were no statistically significant differences in distributions of CRP, leptin, adiponectin, leptin:adiponectin ratio or IL-10 levels between the placebo group and either supplemented group. The 75th percentile IL-6 level was 2·8 pg/ml higher (95 % CI 0·4, 5·8 pg/ml) in the 1500 μg group than in the placebo group (75th percentiles:11·0 v. 8·2 pg/ml), with a somewhat smaller, non-significant difference in 75th percentiles between the 750 μg and placebo groups. Despite large differences in serum 25(OH)D levels between the three groups after 12 months of supplementation, we found little evidence of an effect of vitamin D supplementation on cytokine or adipokine levels, with the possible exception of IL-6.

Double-blind placebo-controlled trial of etanercept in the prevention of work disability in ankylosing spondylitis: Table 1

2010 ◽  
Vol 69 (11) ◽  
pp. 1926-1928 ◽  
Author(s):  
Nick Barkham ◽  
Laura C Coates ◽  
Helen Keen ◽  
Elizabeth Hensor ◽  
Alexander Fraser ◽  
...  
Keyword(s):  
Placebo Group ◽  
Ankylosing Spondylitis ◽  
Clinical Outcomes ◽  
Job Loss ◽  
Controlled Trial ◽  
Controlled Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Gait Parameters ◽  
Significant Difference

ObjectivesEtanercept has been shown to be rapidly effective in suppressing disease activity in ankylosing spondylitis (AS). The aim of this study was to determine whether etanercept improves work instability as measured by the Ankylosing Spondylitis Work Instability Scale (AS-WIS).MethodForty patients with active AS who were in work but were work unstable were recruited. Patients were randomised to receive 25 mg etanercept or placebo twice weekly for 12 weeks. The primary outcome was change in AS-WIS at week 12. The AS-WIS is a patient-derived outcome measure which allows stratification of the risk of job loss. Secondary outcomes included clinical outcomes and gait parameters.ResultsThe mean improvement in AS-WIS score at week 12 was 2.75 in the etanercept group and 0.68 in the placebo group (p=0.125). The risk of job loss decreased for 11 (55%) of the etanercept group compared with 7 (35%) in the placebo group. Conversely, the risk of job loss increased in 3 (15%) of the placebo group compared with 1 (5%) in the etanercept group. There was no statistically significant difference between treatment groups in change in WIS categories (Mann–Whitney U test=0.153, p=0.160). Significant improvement with etanercept was seen at week 12 in clinical outcomes and gait parameters. Etanercept was well tolerated, with no dropouts due to adverse events.ConclusionThis small study confirms the efficacy of etanercept on clinical outcome measures in patients with AS and suggests an effect on work instability which needs to be replicated in a larger controlled study.

The effects of a multispecies probiotic supplement on inflammatory markers and episodic and chronic migraine characteristics: A randomized double-blind controlled trial

Cephalalgia ◽  
2019 ◽  
Vol 39 (7) ◽  
pp. 841-853 ◽  
Author(s):  
Fahimeh Martami ◽  
Mansoureh Togha ◽  
Maryam Seifishahpar ◽  
Zeinab Ghorbani ◽  
Hossein Ansari ◽  
...  
Keyword(s):  
Placebo Group ◽  
Chronic Migraine ◽  
Inflammatory Markers ◽  
Controlled Trial ◽  
Double Blind ◽  
Necrosis Factor Alpha ◽  
Probiotic Group ◽  
Mean Frequency ◽  
The Mean ◽  
Episodic Migraineurs

Background The current study was designed to assess the effect of supplementation with a 14-strain probiotic mixture on episodic and chronic migraine characteristics. Methods Forty episodic and 39 chronic migraine patients who completed this randomized double-blind controlled trial received two capsules of multispecies probiotic or placebo. The migraine severity was assessed by visual analog scale (VAS). The number of abortive drugs consumed, migraine days, frequency and duration of attacks were recorded on paper-based headache diaries. Serum tumor necrosis factor alpha (TNF-α) and C- reactive protein (CRP) levels were measured at baseline and the end of the intervention. Results After a 10-week intervention, among episodic migraineurs the mean frequency of migraine attacks significantly reduced in the probiotic group compare to the placebo group (mean change: −2.64 vs. 0.06; respectively, p < 0.001). A significant reduction was also evident in the migraine severity (mean decrease: −2.14 in the probiotic group and 0.11 in the placebo group; p < 0.001). Episodic migraineurs who received the probiotic also showed significant reduction in abortive drug usage per week (mean change: −0.72; p < 0.001) compare to baseline, while there was no significant changes within the placebo group. In chronic migraine patients, after an 8-week intervention, the mean frequency of migraine attacks significantly reduced in the probiotic compared to the placebo group (mean change: −9.67 vs. −0.22; p ≤ 0.001). In contrast to the placebo, probiotic supplementation significantly decreased the severity (mean changes: −2.69; p ≤ 0.001), duration (mean changes: −0.59; p ≤ 0.034) of attacks and the number of abortive drugs taken per day (mean changes: −1.02; p < 0.001), in chronic migraine patients. We failed to detect any significant differences in the serum levels of inflammatory markers at the end of the study either in chronic or in episodic migraineurs. Discussion The results of this study showed that the 14-strain probiotic mixture could be an effective and beneficial supplement to improve migraine headache in both chronic and episodic migraineurs. Further research is required to confirm our observations.

scholarly journals Effects of Melatonin on Postoperative Delirium After PCI in Elderly Patients: A Randomized, Single-Center, Double-Blind, Placebo-Controlled Trial

2021 ◽  
Vol 24 (5) ◽  
pp. E893-E897
Author(s):  
Yicheng Shi
Keyword(s):  
Placebo Group ◽  
Elderly Patients ◽  
Postoperative Delirium ◽  
Controlled Trial ◽  
Coronary Intervention ◽  
Assessment Method ◽  
Double Blind ◽  
Significant Difference ◽  
Hospitalization Costs ◽  
To Receive

Background: Experimental evidence has indicated the benefits of melatonin (Mel) for the treatment of delirium. Clinical trials had no definite conclusions concerning Mel on delirium after percutaneous transluminal coronary intervention (PCI) in elderly patients. The present study explored whether acute Mel treatment could reduce the incidence of delirium. Methods: This trial enrolled patients over the age of 60, who were admitted to intensive care units (ICUs) after PCI. A computer-generated randomization sequence (in a 1:1 ratio) was used to randomly assign patients to receive Mel (3 mg/day) or placebo once daily for up to 7 days. The primary endpoint was the incidence of delirium, assessed twice daily with the Confusion Assessment Method (CAM) during the first 7 postoperative days. Analyses were performed using intention-to-treat and safety populations. Results: A total of 297 patients randomly were assigned to receive either placebo (N = 149) or Mel (N = 148). The incidence of postoperative delirium was significantly lower in the Mel group than in the placebo group (27.0% vs. 39.6%, respectively, P = 0.02). There was no significant difference between 30-day all-cause mortality (12.2% vs. 14.1%, P = 0.62) and drug reactions (0 vs. 2.0%, P = 0.25). The length of stay and hospitalization costs in the Mel group were significantly decreased compared with those in the placebo group (P > 0.05). Conclusion: The current study suggests that Mel is safe and effective in the treatment of delirium after PCI. Further investigation is necessary to fully understand the potential usefulness of Mel in older patients via larger randomized, multicenter, double-blind, and placebo-controlled trials.

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