A Randomized, Controlled Study Evaluating the Effects of Silymarin Addition to Deferasirox on the Liver Function of Children with Transfusion-Dependent Thalassemia

2021 ◽  
Author(s):  
Aziz Eghbali ◽  
Roghayeh Rahimi Afzal ◽  
Mojtaba Hashemi ◽  
Aygin Eghbali ◽  
Bahar Taherkhanchi ◽  
...  
Keyword(s):  
Placebo Group ◽  
Liver Function ◽  
Total Protein ◽  
Total Bilirubin ◽  
Controlled Trial ◽  
Thalassemia Major ◽  
Controlled Study ◽  
Protective Effects ◽  
Improve Liver Function ◽  
Double Blinded

Background: Frequent blood transfusion can lead to iron overload which is potentially dangerous for the heart and liver. Silymarin has well-documented protective effects on hepatocytes. The purpose of this study was to evaluate the hepatoprotective effects of silymarin addition to iron chelators in children with thalassemia. Materials and Methods: This randomized, double-blinded, and placebo-controlled trial was performed on 40 subjects with thalassemia major and intermedia in Amir Kabir Hospital, Arak, Iran. Subjects were randomized 1:1 oral to 30 mg/kg deferasirox plus placebo, or deferasirox plus oral 70-140 mg silymarin (twice daily) for 6 months. Cardiac and hepatic iron levels and levels of Gamma-glutamyltransferase (GGT), Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline phosphatase (ALP), total bilirubin, albumin, total protein, and total cholesterol were measured at baseline and after 6 months of treatment. Results: The mean age of patients was 16 years and 60% of patients were female. After 6 months, there were significant increases in the levels of ALT, AST, GGT, and TG in the placebo group as compared to the silymarin group (P < 0.05). In contrast, ALT, AST, and GGT had significant reductions compared to the silymarin group (P =0.05). Patients in the placebo group had a rise in total bilirubin (P = 0.07), but total protein and albumin did not have significant changes in the silymarin group (P > 0.05). Finally, a significant improvement was noted in cardiac iron values in patients using silymarin; 22.2 ± 6.6 ms at baseline vs 26.9 ± 7.1 ms at 6 months (P < 0.05). Conclusion: This study suggests that twice-daily addition of silymarin to deferasirox could improve liver function in children with thalassemia major and intermedia. Silymarin seems safe in pediatrics.

scholarly journals Ubiquinone Supplementation with 300 mg on Glycemic Control and Antioxidant Status in Athletes: A Randomized, Double-Blinded, Placebo-Controlled Trial

Antioxidants ◽  
2020 ◽  
Vol 9 (9) ◽  
pp. 823
Author(s):  
Chien-Chang Ho ◽  
Po-Sheng Chang ◽  
Hung-Wun Chen ◽  
Po-Fu Lee ◽  
Yun-Chi Chang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Glycemic Control ◽  
Antioxidant Capacity ◽  
Controlled Trial ◽  
Controlled Study ◽  
Model Assessment ◽  
Glycemic Profile ◽  
Homeostatic Model Assessment ◽  
Total Antioxidant ◽  
Double Blinded

The aim of this study is to investigate the glycemic profile, oxidative stress, and antioxidant capacity in athletes after 12 weeks of ubiquinone supplementation. It was a double-blinded, randomized, parallel, placebo-controlled study. Thirty-one well-trained college athletes were randomly assigned to ubiquinone (300 mg/d, n = 17) or placebo group (n = 14). The glycemic profile [fasting glucose, glycated hemoglobin (HbA1c), homeostatic model assessment-insulin resistance (HOMA-IR), quantitative insulin sensitivity check index (QUICKI)], plasma and erythrocyte malondialdehyde (MDA), total antioxidant capacity (TAC), and ubiquinone status were measured. After supplementation, the plasma ubiquinone concentration was significantly increased (p < 0.05) and the level of erythrocyte MDA was significantly lower in the ubiquinone group than in the placebo group (p < 0.01). There was a significant correlation between white blood cell (WBC) ubiquinone and glycemic parameters [HbA1c, r = −0.46, p < 0.05; HOMA-IR, r = −0.67, p < 0.01; QUICKI, r = 0.67, p < 0.01]. In addition, athletes with higher WBC ubiquinone level (≥0.5 nmol/g) showed higher erythrocyte TAC and QUICKI and lower HOMA-IR. In conclusion, we demonstrated that athletes may show a better antioxidant capacity with higher ubiquinone status after 12 weeks of supplementation, which may further improve glycemic control.

scholarly journals Oral Clonidine in reduction of postoperative nausea and vomiting after laparoscopic cholecystectomy: A double blinded placebo controlled trial

2015 ◽  
Vol 1 (2) ◽  
pp. 76-79
Author(s):  
Sandip Bhandari ◽  
Madindra Basnet ◽  
Gentle Sunder Shrestha ◽  
Modh Nath Marhatta
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Placebo Group ◽  
Controlled Trial ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Controlled Study ◽  
Oral Clonidine ◽  
Prophylactic Use ◽  
Post Operative Nausea ◽  
Double Blinded

Background: The common adverse effects of laparoscopic cholecystectomy include nausea and vomiting. Surgical pneumoperitoneum can stimulate vagal response and induce the release of various emetogenic substances such as 5-hydroxytryptamine and acetylcholine. We hypothesized that oral Clonidine administered preoperatively reduces the post operative nausea and vomiting following laparoscopic cholecystectomy.Methodology: In a randomized, double-blinded placebo controlled study, seventy patients undergoing laparoscopic cholecystectomy were assigned to receive either oral Pyridoxine (placebo) or oral Clonidine 200?g 20-30 minutes before conduction of general anaesthesia. We assessed post operative nausea and vomiting and compared its incidence following laparoscopic cholecystectomy with prophylactic use of oral Clonidine or placebo. We also found out the requirements of rescue antiemetic medication (Ondansetron and Promethazine) for post operative nausea and vomiting after prophylactic use of oral Clonidine or Placebo.Results: Three patients in Clonidine group and 12 patients in Placebo group vomited in first two hours. Likewise, 11 and 22 patients vomited in Clonidine and Placebo group over 24 hours respectively. In group Clonidine, 18 patients had nausea in first two hours and 20 patients had nausea over 24 hours. In group Placebo, 33 patients developed nausea in first two hours and over 24 hours. Ten patients in Clonidine group and 19 patients in Placebo group required Ondansetron as rescue antiemetics over 24 hours.Conclusion: Oral Clonidine given pre-operative to patients undergoing laparoscopic cholecystectomy decrease the incidence of post operative nausea and vomiting.Journal of Society of Anesthesiologists 2014 1(2): 76-79

scholarly journals Fourteen-days Evolution of COVID-19 Symptoms During the Third Wave in Non-vaccinated Subjects and Effects of Hesperidin Therapy: A randomized, double-blinded, placebo-controlled study.

2021 ◽  
Author(s):  
Jocelyn Dupuis ◽  
Pierre Laurin ◽  
Jean-Claude Tardif ◽  
Leslie Hausermann ◽  
Camille Rosa ◽  
...  
Keyword(s):  
Placebo Group ◽  
Missing Values ◽  
Controlled Trial ◽  
Controlled Study ◽  
Shortness Of Breath ◽  
Bias Analysis ◽  
Double Blind ◽  
Runny Nose ◽  
Group A ◽  
Double Blinded

COVID-19 symptoms can cause substantial disability, yet no therapy can currently reduce their frequency or duration. We conducted a double-blind placebo-controlled trial of hesperidin 1000 mg once-daily for 14 days in 216 symptomatic non-vaccinated COVID-19 subjects. Thirteen symptoms were recorded after 3, 7, 10 and 14 days. The primary endpoint was the proportion of subjects with any of four cardinal (group A) symptoms: fever, cough, shortness of breath or anosmia. At baseline, symptoms in decreasing frequency were: cough (53.2%), weakness (44.9%), headache (42.6%), pain (35.2%), sore throat (28.7%), runny nose (26.9%), chills (22.7%), shortness of breath (22.2%), anosmia (18.5%), fever (16.2%), diarrhea (6.9%), nausea/vomiting (6.5%) and irritability/confusion (3.2%). Group A symptoms in the placebo vs hesperidin group was 88.8% vs 88.5% (day 1) and reduced to 58.5 vs 49.4 % at day 14 (OR 0.69, 95% CI 0.38–1.27, p = 0.23). At day 14, 15 subjects in the placebo group and 28 in the hesperidin group failed to report their symptoms. In an attrition bias analysis imputing ″no symptoms″ to missing values, the hesperidin group shows reduction of 14.5 % of group A symptoms from 50.9% to 36.4% (OR: 0.55, 0.32–0.96, p = 0.03). Anosmia, the most frequent persisting symptom (29.3%), was lowered by 7.3% at 25.3 % in the hesperidin group vs 32.6% in the placebo group (p = 0.29). Mean number of symptoms in placebo and hesperidin was 5.10 ± 2.26 vs 5.48 ± 2.35 (day 1) and 1.40 ± 1.65 vs 1.38 ± 1.76 (day 14) (p = 0.92). In conclusion, most non-vaccinated COVID-19 infected subjects remain symptomatic after 14 days with anosmia being the most frequently persisting symptom. Hesperidin 1g daily may help reduce group A symptoms. Earlier treatment of longer duration and/or higher dosage should be tested.

Therapeutic Effects of Hab Shabyar on Open-Angle Glaucoma: A Double-Blinded, Randomized, Placebo-Controlled Trial

2019 ◽  
Vol 8 ◽  
pp. 1218
Author(s):  
Ebrahim Khalil BaniHabib ◽  
Ali Mostafai ◽  
Seyyed Mohammad Bagher Fazljou ◽  
Ghadir Mohammdi
Keyword(s):  
Placebo Group ◽  
Intraocular Pressure ◽  
Open Angle Glaucoma ◽  
Controlled Trial ◽  
Intervention Group ◽  
Therapeutic Effects ◽  
Open Angle ◽  
The Mean ◽  
The Right ◽  
Double Blinded

Background: Open-angle glaucoma (OAG) is one of the leading causes of blindness worldwide. This study evaluates the therapeutic effects of hab shabyar in patients with open-angle glaucoma. Materials and Methods: In this clinical randomized controlled trial, 50 patients with OAG were randomized into two groups. The intervention group was received a drop of timolol plus 500 mg of hab shabyar every 12 hours. The placebo group was received a drop of timolol every 12 hours plus 500 mg of wheat germ as a placebo. The intraocular pressure in patients with OAG was measured in each group and compared at before the intervention (t1), one month (t2), and two months (t3) after the intervention. Results: The mean decrease in intraocular pressure for the right eye at three times in the intervention group was statistically significant, but the mean decrease in the placebo group was not significant. Similar results were obtained for the left eye at t1 when compared to t3. The patients in the intervention group expressed more satisfaction than the patients in the placebo group (P≤0.001). Conclusion: Our study demonstrated that consumption of timolol plus hab shabyar instead of consuming of timolol alone was probably more effective for reducing intraocular pressure in patients with OAG.[GMJ.2019;In press:e1218]

scholarly journals A Randomised Controlled Trial on the Efficacy and Safety of Oral Ketamine in Neonatal Circumcision

2021 ◽  
Author(s):  
Victor Ifeanyichukwu Modekwe ◽  
Jideofor Okechukwu Ugwu ◽  
Okechukwu Hyginus Ekwunife ◽  
Andrew Nwankwo Osuigwe ◽  
Jideofor Chukwuma Orakwe ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Controlled Study ◽  
Categorical Variables ◽  
Paediatric Surgery ◽  
Peripheral Oxygen Saturation ◽  
Double Blind ◽  
Oral Ketamine ◽  
The Mean ◽  
Neonatal Circumcision

Introduction: Procedural analgesia use in neonatal circumcision is not widespread in the developing world. An easy-to-administer, adequate and safe analgesia will encourage usage in neonatal circumcision. Orally administered ketamine may prove effective and safe, and may encourage procedural analgesia use in neonatal circumcision. Aim: To determine the analgesic efficacy of oral ketamine in Plastibell® neonatal circumcision. Materials and Methods: A hospital based randomised double blind controlled study was conducted at the paediatric surgery unit of the hospital, from March 2015 to December 2015. Total 121 neonates were sequentially recruited, and randomised into two groups. Group A received oral ketamine, and Group B received plain syrup (placebo) as procedural analgesia. Continuous pulse oximeter monitoring was done before, during and immediately after the procedure. The pre-procedural and intra-procedural peripheral oxygen saturation (SpO2) and Pulse Rate (PR) were determined at the various stages. Also, the Neonatal Infant Pain Scale (NIPS) scores were assessed during the stages of the procedure. Differences in mean scores were analysed. Mann-Whitney U test and Independent t-test were used to compare means of continuous variable, while Fisher’s exact test was used to compare categorical variables. Significance was set at p<0.05. Results: Sixty-one neonates received oral ketamine, while 60 received placebo. The intraoperative mean SpO2 were lower in the placebo group and significant at the tying stage with p=0.022. The mean intraoperative PR was higher in the placebo group and significant at dorsal-slit, tying and excision stages (p<0.05). The mean intraoperative NIPS scores were significantly higher in the placebo group. Conclusion: Oral ketamine provides effective and safe analgesia for neonatal Plastibell® circumcision in comparison to placebo.

scholarly journals Oral metoclopramide boosts lactogenesis II in mothers with preterm infants: a randomized placebo-controlled trial.

2020 ◽  
Author(s):  
Doris Fok ◽  
Yiong Huak Chan ◽  
Jiahui Ho ◽  
Mary HJ RAuff ◽  
Yah Shih Chan ◽  
...  
Keyword(s):  
Human Milk ◽  
Preterm Infants ◽  
Controlled Trial ◽  
Controlled Study ◽  
Delivery Methods ◽  
Maternal Perception ◽  
Mothers Of Preterm Infants ◽  
Term Births ◽  
Double Blinded ◽  
Breastfeeding Practice

Abstract Background: Preterm mothers at risk of delayed lactogenesis II may benefit from early pharmcological intervention to initiate breastfeeding onset. Research aim. To evaluate the effect of oral metoclopramide on lactogenesis II in mothers of preterm infants commencing within twelve hours of delivery. Methods: From April 2006 to May 2009,105 women were randomized to metoclopramide (term births, n=36;reterm n=20) or placebo (term,n=33;preterm,n=16). Mothers received 30 mg of oral metoclopramide daily for the first postnatal week in a randomized double-blinded placebo-controlled study. Primary outcome was augmentation of Lactogenesis II onset by postnatal day 3. Secondary outcomes were daily expression of breastmilk and maternal perception of lactogenesis II, breastfeeding practice and infant weight change over 6 months. Results: Metoclopramide achieved 25% augmentation in lactogenesis II onset (p=0.09) with greater expressed human milk volumes in mothers of preterm infants. Daily expressed human milk volumes was higher among preterm mothers on metoclopramide compared to term placebo mothers who served as controls, significant on day 2 (19.9 vs 2.4ml, p=0.04) and day 3 (32.6 vs 8.8ml,p=0.04),and total expressed human milk volumes had increased by 8.2 fold by the end of week one. Most mothers reported first initiation of lactogenesis II by day 6, with 95-100% of term mothers confirmed by day 5 (not significant). Conclusions: Short-term metoclopramide use starting within 12 postnatal hours boosted lactogenesisi II onset in preterm mothers, improving daily expressed human milk production and maternal perception of lactogenesis II onset.

scholarly journals Safety and efficacy of herbal medicine for acute intracerebral hemorrhage (CRRICH): a multicentre randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e024932 ◽  
Author(s):  
Liling Zeng ◽  
Guanghai Tang ◽  
Jing Wang ◽  
Jianbin Zhong ◽  
Zhangyong Xia ◽  
...  
Keyword(s):  
Placebo Group ◽  
Herbal Medicine ◽  
Adverse Events ◽  
Intracerebral Haemorrhage ◽  
Poor Prognosis ◽  
Controlled Trial ◽  
Blood Stasis ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Safety And Efficacy

ObjectiveTo evaluate the safety and efficacy of removing blood stasis (RBS) herbal medicine for the treatment of acute intracerebral haemorrhage (AICH) within a 6-hour time window.Study designA randomised, multicentre, double-blind, placebo-controlled study performed in 14 hospitals in China.Participants and interventionsPatients with AICH were randomly assigned to receive a placebo, the ICH-1 (Intracerebral Haemorrhage) formula (eight herbs, including the RBS herbs hirudo and tabanus) or the ICH-2 formula (six herbs without the RBS herbs hirudo and tabanus) within 6 hours of ICH onset.OutcomesThe primary safety outcome was the incidence of haematoma enlargement at 24 hours and at 10 days after treatment. The secondary outcome was the incidence of poor prognosis (mortality or modified Rankin Scale score ≥5) assessed at 90 days after symptom onset.ResultsA total of 324 subjects were randomised between October 2013 and May 2016: 105 patients received placebo; 108 patients received the ICH-1 formula; and 111 patients received the ICH-2 formula. The incidence of haematoma enlargement at 24 hours was 7.8% in the placebo group, 12.3% in the ICH-1 group and 7.5% in the ICH-2 group; the incidence of haematoma enlargement on day 10 was 1.1% in the placebo group, 1.1% in the ICH-1 group, and 3.1% in the ICH-2 group, with no significant differences among the groups (P>0.05). The mortality rates were 3.8% in the placebo group, 2.8% in the ICH-1 group, and 0.9% in the ICH-2 group; the incidences of poor prognosis were 7.1% in the placebo group, 6.0% in the ICH-1 group and 4.8% in the ICH-2 group at 3 months, with no significant differences among the groups (p>0.05). However, the overall frequency of treatment-emergent adverse events in the ICH-1 group (12.1%) was higher among the three groups (5.8% and 2.8%, respectively, p<0.05). All three cases of serious adverse events were in the ICH-1 group.ConclusionsUltra-early administration of ICH-1 formula for AICH patients did not exert significant beneficial effects on clinical outcomes but increased the risk of bleeding, which probably resulted from the inclusion of RBS herbal medicines in ICH-1.Trialregistration numberNCT01918722.

scholarly journals Randomized placebo-controlled study of the memory effects of pomegranate juice in middle-aged and older adults

2019 ◽  
Author(s):  
Prabha Siddarth ◽  
Zhaoping Li ◽  
Karen J Miller ◽  
Linda M Ercoli ◽  
David A Merril ◽  
...  
Keyword(s):  
Older Adults ◽  
Placebo Group ◽  
Visual Information ◽  
Neuronal Damage ◽  
Controlled Trial ◽  
Pomegranate Juice ◽  
Controlled Study ◽  
Middle Aged ◽  
Daily Consumption

ABSTRACT Background Antioxidant nutrients such as the polyphenols in pomegranate juice may prevent neuronal damage from the free radicals produced during normal metabolism. Previous research in animals and a short-term clinical trial in middle-aged and older adults support the potential memory benefits of pomegranate juice; however, the long-term effects of pomegranate juice consumption on cognition have not been studied. Objective In this study, we investigated the long-term effect of pomegranate juice on memory in nondemented middle-aged and older adults. Methods We performed a 12-month, randomized, double-blind, placebo-controlled trial of pomegranate juice in middle-aged and older adults. Two hundred and sixty-one subjects (aged 50–75 y) were randomly assigned to consume pomegranate juice [8 oz (236.5 mL) per day] or a placebo drink (8 oz, matched constituents of pomegranate juice except for pomegranate polyphenols). Memory measures [Brief Visuospatial Memory Test-Revised (BVMT-R) and Buschke Selective Reminding Test (SRT)] were assessed at 6 and 12 mo and analyzed using a mixed-effects general linear model. Results Twenty-eight subjects in the pomegranate juice group and 33 subjects in the placebo group dropped out before completing the study. Baseline variables in the 98 pomegranate juice and 102 placebo group subjects who completed the study did not differ significantly. Group by time interaction was statistically significant for BVMT-R Learning (F[2, 257]= 5.90, P  = 0.003; between-group effect size [ES] = 0.45): the change within the pomegranate group was not significant (ES = 0.15), whereas the placebo group showed a significant decline (ES = −0.35). Changes in the other BVMT-R scores as well as the SRT measures were not significantly different between groups. Conclusions Daily consumption of pomegranate juice may stabilize the ability to learn visual information over a 12-mo period. This trial was registered at clinicaltrials.gov as NCT02093130.

scholarly journals Endothelial Function is improved by Inducing Microbial Polyamine Production in the Gut: A Randomized Placebo-Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (5) ◽  
pp. 1188 ◽  
Author(s):  
Mitsuharu Matsumoto ◽  
Yusuke Kitada ◽  
Yuji Naito
Keyword(s):  
Placebo Group ◽  
Endothelial Function ◽  
Controlled Trial ◽  
Reactive Hyperemia ◽  
Intestinal Bacteria ◽  
Bifidobacterium Animalis ◽  
Parallel Group ◽  
Peripheral Arterial ◽  
Double Blinded ◽  
Arterial Tone

Recently, it was demonstrated that spermidine-induced autophagy reduces the risk of cardiovascular disease in mice. Intestinal bacteria are a major source of polyamines, including spermidine. We previously reported that the intake of both Bifidobacterium animalis subsp. lactis (Bifal) and arginine (Arg) increases the production of putrescine, a spermidine precursor, in the gut. Here, we investigated the effects of Bifal and Arg consumption on endothelial function in healthy subjects. Healthy individuals with body mass index (BMI) near the maximum value in the “healthy” range (BMI: 25) (n = 44) were provided normal yogurt containing Bifal and Arg (Bifal + Arg YG) or placebo (normal yogurt) for 12 weeks in this randomized, double-blinded, placebo-controlled, parallel-group comparative study. The reactive hyperemia index (RHI), the primary outcome, was measured using endo-peripheral arterial tone (EndoPAT). The change in RHI from week 0 to 12 in the Bifal + Arg YG group was significantly higher than that in the placebo group, indicating that Bifal + Arg YG intake improved endothelial function. At week 12, the concentrations of fecal putrescine and serum putrescine and spermidine in the Bifal + Arg YG group were significantly higher than those in the placebo group. This study suggests that consuming Bifal + Arg YG prevents or reduces the risk of atherosclerosis.

Physical Therapy for Patellofemoral Pain

2002 ◽  
Vol 30 (6) ◽  
pp. 857-865 ◽  
Author(s):  
Kay Crossley ◽  
Kim Bennell ◽  
Sally Green ◽  
Sallie Cowan ◽  
Jenny McConnell
Keyword(s):  
Placebo Group ◽  
Physical Therapy ◽  
Therapy Group ◽  
Controlled Trial ◽  
Placebo Treatment ◽  
Quadriceps Muscle ◽  
Patellofemoral Pain ◽  
Therapy Regimen ◽  
Average Pain ◽  
Double Blinded

Background Although physical therapy forms the mainstay of nonoperative management for patellofemoral pain, its efficacy has not been established. Hypothesis Significantly more pain relief will be achieved from a 6-week regimen of physical therapy than from placebo treatment. Study Design Multicenter, randomized, double-blinded, placebo-controlled trial. Methods Seventy-one subjects, 40 years of age or younger with patellofemoral pain of 1 month or longer, were randomly allocated to a physical therapy or placebo group. A standardized treatment program consisted of six treatment sessions, once weekly. Physical therapy included quadriceps muscle retraining, patellofemoral joint mobilization, and patellar taping, and daily home exercises. The placebo treatment consisted of sham ultrasound, light application of a nontherapeutic gel, and placebo taping. Results Sixty-seven participants completed the trial. The physical therapy group (N = 33) demonstrated significantly greater reduction in the scores for average pain, worst pain, and disability than did the placebo group (N = 34). Conclusions A six-treatment, 6-week physical therapy regimen is efficacious for alleviation of patellofemoral pain.

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