The Effects of 6-Week Supplementation with Multicomponent Herbal Extract on Exercise Performance, Antioxidant Status and Telomere Length, and Self-Reported Side Effects in Healthy Men: A Randomized Controlled Pilot Trial

2020 ◽  
Vol 19 (4) ◽  
pp. 520-524
Author(s):  
Valdemar Stajer ◽  
Nikola Todorovic ◽  
Darinka Korovljev ◽  
Nebojsa Maksimovic ◽  
Suzana Miljkovic ◽  
...  
Keyword(s):  
Placebo Group ◽  
Side Effects ◽  
Antioxidant Capacity ◽  
Telomere Length ◽  
Exercise Performance ◽  
Antioxidant Status ◽  
Herbal Extract ◽  
Healthy Men ◽  
Randomized Controlled

The main aim of this study was to examine the effects of medium-term supplementation with an eight-herbs extract on running performance, biomarkers of antioxidant status and telomere length, and self-reported outcome measures of safety events in healthy men. Ten healthy young men (age 23.1±3.2 years, weight 73.7±9.9kg, and height 179.4±8.0cm) volunteered to participate in this randomized controlled trial. The participants were allocated in a double-blind cross-over design to receive either an eight-herbs extract or placebo during a 6-week intervention period. Two-way mixed analysis of variance (treatment vs. time interaction) revealed no significant differences for exercise performance outcomes and telomere length between groups (P>0.05). Compared with placebo, P-DNA provoked a significant rise in serum total antioxidant capacity (316.0±183.4µmol/mL at baseline; 792.7±68.1µmol/mL at follow-up in the eight-herbs extract group vs. 298.1±90.7µmol/mL at follow-up in the placebo group; P<0.001), and less reduction in serum superoxide dismutase levels at follow-up (150.4±5.1IU/mL at baseline; 145.5±3.0IU/mL at follow-up in the eight-herbs extract group vs. 139.3±3.3IU/mL at follow-up in the placebo group; P=0.01). No participant reported any side effects of either intervention. The eight-herbs extract can thus be recommended as a well tolerated dietary supplement that can enhance antioxidant capacity in healthy men. This trial was registered at ClinicalTrials.gov (NCT04263246).

Bone density in healthy men after cessation of calcium supplements: 20-month follow-up of a randomized controlled trial

2014 ◽  
Vol 26 (1) ◽  
pp. 173-178
Author(s):  
R. Kalluru ◽  
R. Ames ◽  
B. Mason ◽  
M. J. Bolland ◽  
G. D. Gamble ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Bone Density ◽  
Controlled Trial ◽  
Healthy Men ◽  
Calcium Supplements ◽  
Randomized Controlled

Fluoride varnish for white spot lesion prevention during orthodontic treatment: results of a randomized controlled trial 1 year after debonding

2020 ◽  
Author(s):  
Mikael Sonesson ◽  
Anna Brechter ◽  
Rolf Lindman ◽  
Salem Abdulraheem ◽  
Svante Twetman
Keyword(s):  
Randomized Controlled Trial ◽  
Placebo Group ◽  
Orthodontic Treatment ◽  
Controlled Trial ◽  
White Spot ◽  
Fluoride Varnish ◽  
White Spot Lesion ◽  
Randomized Controlled

Summary Background Topical fluorides are commonly recommended to prevent the development of white spot lesion (WSL) during treatment with fixed orthodontic appliances (FOAs), but the certainty of evidence is low, and long-term effects of fluoride preventive methods to reduce lesions seem to be rare. Objective To evaluate the long-term effectiveness of professional applications of a fluoride varnish containing 1.5% ammonium fluoride in preventing WSL development in adolescents undergoing multi-bracket orthodontic treatment. Subjects and methods We performed a randomized controlled trial in which 166 healthy adolescents (12–18 years) from three different clinics were enrolled and randomly allocated to a test or a placebo group. The randomization was performed by a computer program, generating sequence numbers in blocks of 15. The fluoride varnish or the non-fluoride placebo varnish was applied in a thin layer around the bracket base every sixth week during the course of the orthodontic treatment (mean duration 1.7 years). We scored the prevalence of WSL on the labial surfaces of the maxillary incisors, canines and premolars immediately after debonding (baseline) and approximately 1 year after debonding, from digital photos with aid of a four-step score. The examiners were not involved in the treatment of the patients and blinded for the group assignment. Results One hundred and forty-eight patients were available at debonding and 142 of them could be re-examined after 1 year (71 in the test and 71 in the placebo group). The 1-year attrition rate was 4.0%. On patient level, the prevalence of post-orthodontic WSLs (score ≥ 2) dropped by over 50% during the follow-up with no significant difference between the groups. On surface level, there were significantly fewer remaining WSLs in the test group compared with the placebo group (4.5% versus 10.4%; relative risk 0.44, 95% confidence interval 0.28–0.68). Limitations The compliance with fluoride toothpaste was not checked, and the patients’ general dentists may have instigated additional risk-based preventive measures. No cost–benefit analysis was carried out. Conclusions This follow-up study displayed a small beneficial long-term effect of fluoride varnish in reducing WSL development during treatment with FOA. Registration NCT03725020. Protocol The protocol was not published before trial commencement.

scholarly journals Analgesic efficacy of nefopam for cancer pain: a randomized controlled study

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 378
Author(s):  
Koravee Pasutharnchat ◽  
Wichita Wichachai ◽  
Rungrawan Buachai
Keyword(s):  
Placebo Group ◽  
Side Effects ◽  
Cancer Pain ◽  
Breakthrough Pain ◽  
Analgesic Efficacy ◽  
Pain Reduction ◽  
Morphine Consumption ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Significant Pain

Background: Nefopam is a non-opioid, non-steroidal, central acting drug used effectively for postoperative pain. The efficacy of nefopam for cancer pain remains unclear. We aimed to evaluate the analgesic efficacy of nefopam for cancer pain in a randomized controlled trial. Methods: Patients with moderate to severe cancer pain (n=40) were randomly divided into two groups. The nefopam group (n=20) received three 20 mg doses of nefopam every 8 hours. The placebo group (n=20) received normal saline. Intravenous patient-controlled analgesia with morphine was given for breakthrough pain for 48 hours. The primary outcome was significant pain reduction. Secondary outcomes were morphine consumption over 48 hours and incidence of side effects. Results: The nefopam group showed pain reduction at 12 hours (65% of patients), 24 hours (80%), 36 hours (85%), and 48 hours (65%). The placebo group showed pain reduction at 12 hours (70%), 24 hours (75%), 36 hours (80%), and 48 hours (60%). However, there were no statistically significant differences between the groups (p>0.05). The median dosage of morphine consumption in 48 hours was lower in the nefopam group (25.5 mg) compared with the placebo group (37 mg), but this was not statistically significant (p=0.499). There were no statistically significant differences in blood pressure and heart rate between the groups. Side effects in both groups were comparable. Conclusions: At dosage of 60 mg in 24 hours, nefopam did not provide significant pain reduction in moderate to severe cancer pain patients. However, there was a trend of reduced opioid consumption. Further studies with larger sample sizes, longer duration, or higher doses of nefopam are warranted. Registration: Thai Clinical Trail Registry (TCTR) ID TCTR20181016001; registered on 12 October 2018.

P5383Autologous adipose-derived stromal cell treatment for patients with refractory angina (MyStromalCell Trial) - 3-years follow-up results

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A A Qayyum ◽  
A B Mathiasen ◽  
S Helqvist ◽  
E Joergensen ◽  
M H Haack-Soerensen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Exercise Performance ◽  
Left Ventricular Ejection ◽  
Refractory Angina ◽  
Bicycle Exercise ◽  
Exercise Time ◽  
Cardiac Symptoms

Abstract Background Improvements in medical and interventional therapies have transformed ischemic heart disease into a chronic illness for lot of patients. The disease is in progress and by time patients suffer from cardiac symptoms, reduced work capacity and decline in quality of life. Stem cell therapy is investigated as a treatment option for these patients. Purpose In this study, long-term safety and efficacy of autologous intra-myocardial injections of adipose-derived stromal cells (ASCs) were studied in patients with refractory angina. Methods Sixty patients were double-blinded 2:1 randomised to ASC or saline injections and followed for three years. The patients had significant angina due to ≥1 coronary artery stenosis but preserved left ventricular ejection fraction. ASCs were obtained from abdomen, ex vivo culture expanded and VEGF-A165 stimulated before delivery into the ischemic myocardium. Results The cardiac symptoms, CCS and NYHA classification, were significantly reduced in the ASC group during the three years follow-up period (2.5±0.9 to 1.8±1.2, P=0.002 and 2.4±0.6 to 2.2±0.8, P=0.007, respectively). However, no significant change was observed in CCS or NYHA in the placebo group during the follow-up period (2.5±0.8 to 2.1±1.3, P=0.186 and 2.7±0.6 to 2.4±0.8, P=0.314, respectively). Moreover, the number of weekly angina attacks reported was significantly reduced in the ASC group (P=0.017), but not in the placebo group (P=0.425). For patients in the ASC group, the bicycle exercise time (383±30s to 370±44s, P=0.052) and the exercise performance in watt were un-changed (81±6 to 78±10, P=0.123), but the performance in METs was reduced significantly (4.2±0.3 to 4.0±0.4, P=0.027) during the follow-up period. At the same time in the placebo group, there was a significant decline in bicycle exercise time (437±53s to 383±58s, P=0.001), the exercise performance measured in watt (87±12 watt to 80±12 watt, P=0.019) and in METs (4.5±0.4 to 4.1±0.4, P=0.002). In both groups, significant improved quality-of-life, angina stability, angina frequency and physical limitation score was observed but not for overall satisfaction score. Conclusion Patients receiving ASCs had improved cardiac symptoms during the three years follow-up period, which was not the case for patients in the placebo group. Moreover, patients receiving ASCs had unchanged exercise capacity, in opposition to deterioration in the placebo group. Acknowledgement/Funding Arvid Nilssons Foundation; Rigshospitalets Research Foundation; Aase and Ejnar Danielsens Foundation

scholarly journals Immunoglobulins in Neonates with Rhesus Hemolytic Disease of the Fetus and Newborn: Long-Term Outcome in a Randomized Trial

2015 ◽  
Vol 39 (3) ◽  
pp. 209-213 ◽  
Author(s):  
Jeanine M.M. van Klink ◽  
Suzanne J. van Veen ◽  
Vivianne E.H.J. Smits-Wintjens ◽  
Irene T.M. Lindenburg ◽  
Monique Rijken ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Placebo Group ◽  
Controlled Trial ◽  
Neurodevelopmental Outcome ◽  
Hemolytic Disease ◽  
Follow Up Study ◽  
Randomized Controlled ◽  
Neurodevelopmental Impairment

Objective: Prophylactic intravenous immunoglobulin (IVIg) does neither reduce the need for exchange transfusion nor the rates of other adverse neonatal outcomes in neonates with rhesus hemolytic disease of the fetus and newborn (rhesus HDFN) according to our randomized controlled trial analysis. Our objective was to assess the long-term neurodevelopmental outcome in the children included in the trial and treated with either IVIg or placebo. Methods: All families of the children included in the trial were asked to participate in this follow-up study. The long-term neurodevelopmental outcome in children at least 2 years of age was assessed using standardized tests. The primary outcome was the incidence of neurodevelopmental impairment defined as at least one of the following: cerebral palsy, severe cognitive and/or motor developmental delay (with a test score of less than -2 SD), bilateral deafness or blindness. Results: Sixty-six of the 80 children (82.5%) who had been recruited to the initial randomized controlled trial participated in the follow-up study. The children were assessed at a median age of 4 years (range 2-7). The median cognitive score was 96 (range 68-118) in the IVIg group and 97 (range 66-118) in the placebo group (p = 0.79). There was no difference in the rate of neurodevelopmental impairment between the IVIg and the placebo group [3% (1/34) vs. 3% (1/32); p = 1.00]. Conclusions: The long-term neurodevelopmental outcome in children treated with IVIg was not different from that in children treated with placebo. Standardized long-term follow-up studies with large enough case series and sufficient power are needed to replicate these findings.

scholarly journals Efficacy, Safety and Steroid-sparing Effect of Topical Cyclosporine A 0.05% for Vernal Keratoconjunctivitis in Indian Children

2019 ◽  
Author(s):  
Arkendu Chatterjee ◽  
Sabyasachi Bandyopadhyay ◽  
Samir Kumar Bandyopadhyay
Keyword(s):  
Placebo Group ◽  
Side Effects ◽  
Cyclosporine A ◽  
Controlled Study ◽  
Vernal Keratoconjunctivitis ◽  
Indian Children ◽  
Steroid Dependent ◽  
Sparing Effect ◽  
Steroid Sparing

Purpose: To evaluate the efficacy, safety, and steroid-sparing effect of topical cyclosporine A (Cs A) 0.05% in patients with moderate to severe steroid dependent vernal keratoconjunctivitis (VKC). Methods: A prospective, comparative, placebo controlled study was carried out on 68 VKC patients, with 34 patients treated with topical Cs A 0.05% and the remaining 34 with topical carboxymethyl cellulose 0.5% (placebo). Both groups also received topical loteprednol etabonate 0.5%. Symptom (itching, photophobia, tearing, and discharge) score, sign (tarsal and limbal papillae, corneal involvement, and conjunctival hyperemia) score, and drug score (steroid drop usage/day/eye) were recorded at baseline and each followup visit. The intraocular pressure (IOP) measurement and evaluation of any ocular side effects were carried out. Results: Significant reduction in symptom score and sign score was seen in both groups. Cs A group significantly showed more reduction in symptom (P < 0.0001 in all follow-up visits) and sign (P < 0.0001 in all follow-up visits) scores compared to the placebo group. At day 7, mean steroid usage reduced from 4 to 3.44 ± 0.5 and 3.79 ± 0.4 in Cs A and placebo groups, respectively (P < 0.0001). Steroid drops completely stopped in 21 patients at day 60 in the Cs A group compared to none in the placebo group. No significant rise in IOP or any side effects were noted in either group. Conclusion: Topical Cs A 0.05% is effective and safe in patients with moderate to severe VKC with good steroid-sparing effect.

PS02.104: CLINICAL STUDY OF PROSPECTIVE RANDOMIZED CONTROLLED TRIALS ON ADJUVANT THERAPIES IN TREATMENT OF RESECTABLE PIB-III (PT2–4AN0–1M0) ESOPHAGEAL SQUAMOUS CELL CARCINOMA

2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 150-150
Author(s):  
Bin Zheng ◽  
Maohui Chen ◽  
Canxing Wu ◽  
Taidui Zeng ◽  
Shuliang Zhang ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Side Effects ◽  
Adjuvant Chemotherapy ◽  
Esophageal Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Conflicts Of Interest ◽  
Adjuvant Chemoradiotherapy ◽  
Randomized Controlled

Abstract Background Esophageal squamous cell carcinoma (ESCC) patients have relatively poor prognosis after operation. The study was designed to analyse the effect of surgery alone, surgery with adjuvant chemotherapy and surgery with chemoradiotherapy on prognosis in the patients with pathologic stage pIB-III (pT2–4aN0–1M0) who received radical esophagectomy. Methods We carried out the prospective randomized study. In this study, we analyzed 104 patients who had undergone minimally invasive esophagectomy for thoracic ESCC and been assessed as pathological stage pIB-III (pT2–4aN0–1M0) from January 2013 to October 2015 in our institute. 48 patients are treated with surgery alone (S group),33 patients received surgery and adjuvant chemotherapy (CT group), and 23 patients received surgery and adjuvant chemoradiotherapy (CRT group). We do the follow up for all the patients, collect the clilnical, patholigical data of them, and analyze the overal survival (OS) and disease-free survival (DFS) of them. Results The basic clinical characteristics of three groups were comparable. The average age was (52.1 ± 9.7) years old. The median follow‐up period was 39 months. The 3-year OS of the patients in the S group, CT group, and CRT group were 37.5%,18.8%, 65.2%, respectively. According to the follow-up data, both the 3-year OS and the 3-year DFS of the patients in the CRT group were better than those of the patients in the S group and CT group group (P < 0.05). However, the incidence rates of side effects and complications in CRT group were higher than those in S group and CT group, without signicant differences. One patient died in S group in perioperative period, because of postoperaive pulmonary embolism, and no patients died in CT group and CRT group in peri-treatment period. Conclusion Our prospective, randomized controlled trial showed that surgery with adjuvant chemoradiotherapy could improve 3-year OS and DFS compared with treatment of surgery alone or surgery with adjuvant chemotherapy.The side effects and complications of surgery with adjuvant chemoradiotherapy were acceptable. However, because our study enrolled limited patients, and the follow-up time was not long enough, we need to collect more patients and longer follow-up to further comfirm our conclusion. Disclosure All authors have declared no conflicts of interest.

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