scholarly journals A Randomized, Double-Blind Pilot Trial of Hydrolyzed Rice Bran versus Placebo for Radioprotective Effect on Acute Gastroenteritis Secondary to Chemoradiotherapy in Patients with Cervical Cancer

2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Yoshiyuki Itoh ◽  
Mika Mizuno ◽  
Mitsuru Ikeda ◽  
Rie Nakahara ◽  
Seiji Kubota ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Acute Phase ◽  
Rice Bran ◽  
Acute Gastroenteritis ◽  
Side Effect ◽  
Oral Intake ◽  
Radioprotective Effect ◽  
Control Group ◽  
Double Blind ◽  
Assessment Score

We aimed to evaluate the radioprotective effect of hydrolyzed rice bran (HRB) on acute gastroenteritis due to chemoradiotherapy for treatment of cervical cancer. This placebo-controlled, double-blind study was conducted as an exploratory investigation of the colitis-inhibiting effects of HRB in alleviating acute-phase gastrointestinal side effects of chemoradiotherapy. The study involved 20 patients (10 in the HRB group, 10 in the control group). The patients in the control group underwent the same chemoradiotherapy regimen as those in the HRB group, but they received a placebo instead of HRB. The diarrheal side effect assessment score was lower in the HRB than control group, and a trend toward a reduction in diarrhea symptoms was observed with the oral intake of HRB. Additionally, no significant difference was observed in the administration of intestinal regulators and antidiarrheal agents, but again the assessment score was lower in the HRB than control group, and diarrhea symptoms were alleviated with the oral intake of HRB. A trend toward no need for strong antidiarrheal agents was seen. Although this study was an exploratory clinical trial, the results suggest that HRB may relieve diarrhea, an acute-phase gastrointestinal side effect of chemoradiotherapy.

scholarly journals Effect of symbiotic supplementation on fecal calprotectin levels and lactic acid bacteria, Bifidobacteria, Escherichia coli and Salmonella DNA in patients with cervical cancer

2018 ◽  
Author(s):  
Genaro Gabriel Ortiz ◽  
Luis Humberto De Loera Rodríguez ◽  
Paloma Rivero Moragrega ◽  
Irma Ernestina Velázquez Brizuela ◽  
Juan Francisco Santoscoy Gutiérrez ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Adverse Effects ◽  
Pathogenic Bacteria ◽  
The United States ◽  
Fecal Calprotectin ◽  
Control Group ◽  
Double Blind ◽  
Faecal Calprotectin ◽  
Bacterial Dna ◽  
Polymerase Chain

Background: Patients with cervical cancer (CC) receiving chemotherapy and radiotherapy have several gastrointestinal adverse effects. Objective: To evaluate the effect of dietary symbiotic supplementation on fecal calprotectin, bacterial DNA levels, and gastrointestinal adverse effects in patients with CC. Methods: Clinical, controlled, randomized, double-blind trial. Patients consumed symbiotics or placebo three times a day for 7 weeks. Fecal calprotectin was assessed by Elisa method. DNA from probiotic and pathogenic bacteria were determined by quantitative real-time polymerase chain reaction. Diarrheal evacuations were evaluated with the Bristol scale and nausea and vomiting were measured using the scale of the National Institute of Cancerology of the United States. Results: Fecal calprotectin concentration was lower in the symbiotic group compared to the control group (p <0.001). The concentrations and total proportions of the probiotic and pathogenic bacteria were similar in both groups. Nausea cases significantly diminished in both groups (p <0.001) at the end of the trial. Furthermore, the symbiotic group had a statistically significant decrease in the frequency and intensity of vomiting when compared to the control group (p <0.001). Conclusions: The symbiotic treatment decreases significantly the fecal calprotectin levels and the frequency and intensity of vomiting in patients with CC. KEYWORDS: faecal calprotectin, cervical cancer, symbiotic, qPCR.

scholarly journals Role of Dexamethasone on Reducing Post Tonsillectomy Morbidities

2009 ◽  
Vol 20 (1) ◽  
pp. 13-17 ◽  
Author(s):  
Rubina Yasmin ◽  
Zamir Hossain Khan ◽  
SM Shafiqul Alam
Keyword(s):  
Surgical Techniques ◽  
Oral Intake ◽  
Saline Control ◽  
Control Group ◽  
Double Blind Study ◽  
Double Blind ◽  
Post Operative Pain ◽  
Poor Oral Intake ◽  
Induction Of Anaesthesia

Pain, nausea, vomiting, oedema and poor oral intake are the most common morbidities after general anesthesia and surgery like tonsillectomy. This study was done to evaluate the effectiveness of intravenous dexamethasone (0.15mg/kg) at induction of anaesthesia on post tonsillectomy morbidities. In this prospective randomized double blind study, sixty children of age between 8-12 years, ASA I & II undergoing tonsillectomy under general anaesthesia were randomly assigned into two equal groups of 30 each. They received dexamethasone IV or saline (control) following induction of anaesthesia. Both anesthetic and surgical techniques were standardized. Post operative pain was assessed by visual analogue scale (VAS). Inj. Tramadol 1mg/kg in first 6 hrs and oral paracetamol 10mg/kg in next 24 hrs were administered as rescue analgesic. Incidence of nausea, vomiting, time and quantity of first oral intake were also noted. Patients receiving dexamethasone experienced significantly less pain, nausea and vomiting than control group throughout 24 hrs. Lesser patients required rescue analgesics (23.33% vs. 46.67%) in first 6 hrs. So, it is found that, single intravenous dose of dexamethasone (0.15mg/kg) provided significant analgesia, reduced nausea, vomiting and improved quality of oral intake in paediatric patients who underwent tonsillectomy.   Journal of BSA, Vol. 20, No. 1, January 2007 p.13-17

scholarly journals The Effect of Oral Pregabalin on Epidural-Induced Shivering and Epidural Characteristics in Gynecological Surgeries, a Prospective Randomized Double-Blind Study

2018 ◽  
Author(s):  
Tarek Al Menesy ◽  
Ghada Adel ◽  
Ahmed A. Badawy ◽  
Samaa A. Kasem ◽  
Ashraf Abd Elmawgoud ◽  
...  
Keyword(s):  
Side Effects ◽  
Epidural Anesthesia ◽  
Side Effect ◽  
Epidural Block ◽  
Control Group ◽  
Double Blind Study ◽  
Single Shot ◽  
Double Blind ◽  
Sedation Scores ◽  
And Control

Abstract Purpose: The previous reports tried to reduce shivering and improve neuraxial anesthesia characteristics by the systemic use of different drugs. This study was directed to evaluate the effect of pregabalin premedication on both shivering and epidural characteristics following single shot loading. Patients and Methods: Eighty female patients, ASA grade I and II, scheduled for gynecological surgeries under epidural anesthesia were studied. The patients were divided into two groups: Pregabalin (P) group and Control (C) group in which the patients received 150 mg of pregabalin and placebo capsules respectively sixty minutes prior to surgery. Following epidural loading, the onset and degree of shivering were compared between the two groups. Also, the epidural onset, level and duration were compared. The perioperative hemodynamics, sedation scores, meperidine consumption and side effects were followed up and registered. Results: The onset of shivering was significantly prolonged and the degree of shivering was less in pregabalin group compared to Control group. The duration of epidural shot was shorter in the control group in relation to the pregabalin treated patients. Regarding both onset and level of block, no significant changes were detected. The patients were more sedated with less meperidine consumption in the pregabalin group. The two groups were similar as regards the perioperative hemodynamics and occurrence of side effect. Conclusion: The premedication with pregabalin reduced onset and degree of shivering and prolonged the duration of single shot epidural block.

The Effects of a Caffeine Placebo and Experimenter Expectation on Blood Pressure, Heart Rate, Well-Being, and Cognitive Performance

2001 ◽  
Vol 6 (1) ◽  
pp. 15-25 ◽  
Author(s):  
Harald Walach ◽  
Stefan Schmidt ◽  
Yvonne-Michelle Bihr ◽  
Susanne Wiesch
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Cognitive Task ◽  
Well Being ◽  
Control Group ◽  
Double Blind ◽  
Main Effect ◽  
The Difference ◽  
Being There ◽  
To Receive

We studied the effect of experimenter expectations and different instructions in a balanced placebo design. 157 subjects were randomized into a 2 × 4 factorial design. Two experimenters were led to expect placebos either to produce physiological effects or not (pro- vs. antiplacebo). All subjects except a control group received a caffeine placebo. They were either made to expect coffee, no coffee, or were in a double-blind condition. Dependent measures were blood pressure, heart rate, well-being, and a cognitive task. There was one main effect on the instruction factor (p = 0.03) with the group “told no caffeine” reporting significantly better well-being. There was one main effect on the experimenter factor with subjects instructed by experimenter “proplacebo” having higher systolic blood pressure (p = 0.008). There was one interaction with subjects instructed by experimenter “proplacebo” to receive coffee doing worse in the cognitive task than the rest. Subjects instructed by experimenter “antiplacebo” were significantly less likely to believe the experimental instruction, and that mostly if they had been instructed to receive coffee. Contrary to the literature we could not show an effect of instruction, but there was an effect of experimenters. It is likely, however, that these experimenter effects were not due to experimental manipulations, but to the difference in personalities.

Nerve-sparing radical hysterectomy in patients with infiltrative cervical cancer

2016 ◽  
pp. 46-51
Author(s):  
T. Dermenzhy ◽  
◽  
V. Svintitskiy ◽  
S. Nespryadko ◽  
L. Legerda ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Radical Hysterectomy ◽  
Contractile Function ◽  
Major Elements ◽  
Control Group ◽  
Nerve Sparing ◽  
Group I ◽  
Hypogastric Plexus ◽  
Prognostic Indexes

The objective: to improve an effectiveness of therapy and quality of life of patients with infiltrative cervical cancer using radical hysterectomy accomplished with nerve-sparing methodology. Patients and Methods: Ninety patients with histologically verified infiltrative cervical cancer were cured with radical hysterectomy (RHE) in the Department of Oncogynecology of National Cancer Institute (Kyiv, Ukraine) in 2012-2016. The age of the patients was from 26 to 65 years (an average age of 42.61±1.06). The patients were distributed in 2 groups: group I treated with nerve-sparing radical hysterectomy (NSRHE), 45 patients, the main group; group II treated with radical hysterectomy (RHE III), the control group, 45 patients. The prognostic indexes in the groups were similar. Results. NSRHE that included the dissection of cardinal ligament, separation of dorsal and anterior layers of uterovesical ligament allowed separate uterine branch of inferior hypogastric plexus, preserve an innervation of urinary bladder and prevent the malfunction of its contractile function at postoperative period. Conclusion. The data of the urodynamic study using cystomanometry performed at pre- and early operative periods have shown that surgical treatment of patients with infiltrative cervical cancer with preservation of the major elements of pelvic autonomic plexuses allows significantly decrease the rate of postoperative urogenical malfunctions. Key words: nerve-sparing radical hysterectomy, cervical cancer, cystomanometry.

Effects of Papaya Leaf Extract (Carica papaya L.) on Cellular Proliferation and Apoptosis in Cervical Cancer Mice Model

2019 ◽  
Vol 17 (5) ◽  
pp. 265-275
Author(s):  
Y. Peristiowati ◽  
Y. Puspitasari ◽  
Indasah
Keyword(s):  
Cervical Cancer ◽  
Cell Proliferation ◽  
Hela Cells ◽  
Leaf Extract ◽  
Caspase 3 ◽  
Methanol Extract ◽  
Negative Control ◽  
Proliferation Index ◽  
Control Group ◽  
P53 Expression

This study is aimed at analyzing the anticancer properties of papaya leaf extract, specifically the inhibition of cell proliferation and apoptotic induction through nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) and p53 pathways. Twenty-five mice (Mus musculus), aged 2 months and weighing 20–30 g, was injected with 0.5 mg dexamethasone for 7 days. The mice were then injected intracutaneously with 1 ml of HeLa cells (8 × 106 HeLa cells/microliter). The mice were divided into five groups (5 each): negative control (P1) (5% CMC-Na, sodium carboxymethyl cellulose), treatment II (225 mg/kg BW (body weight) papaya leaves methanol extract), treatment III (450 mg/kg BW), treatment IV (750 mg/kg BW), and treatment PV (2 mg alcohol anticancer drug). Papaya leaf extract treatments were applied for 2 weeks. Then, the tumor tissue was isolated for hematoxylin and eosin staining. Immunohistochemical imaging was used to detect Ki-67, caspase-3, NF-κB, and p53 expression. Further analysis was undertaken using the ImmunoRatio software program. The results indicated that administration of papaya leaf methanol extract significantly increased the expression of NF-κB and p53 at a dose of 450 mg/kg BW. Our results also showed that the mice treated with 450 mg of papaya leaf extract per kg of BW (P3) had the largest increase of caspase-3 expression compared to the negative control group. Papaya leaf ethanol extract decreased the cancer cell proliferation index and increased apoptosis of cancer cells in animal models of cervical cancer; it may also work to increase NF-kB expression and expression of the p53 gene.

Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

2019 ◽  
Vol 16 (2) ◽  
pp. 223-231 ◽  
Author(s):  
Younes Najafian ◽  
Zahra M. Khorasani ◽  
Mona N. Najafi ◽  
Shokouh S. Hamedi ◽  
Marjan Mahjour ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Diabetic Foot ◽  
Intervention Group ◽  
Aloe Vera ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Control Group ◽  
Plantago Major ◽  
Double Blind ◽  
Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

Effect of Cilostazol on Cerebral Vasospasm and Outcome in Patients with Aneurysmal Subarachnoid Hemorrhage: A Randomized, Double-Blind, Placebo-Controlled Trial

2016 ◽  
Vol 42 (1-2) ◽  
pp. 97-105 ◽  
Author(s):  
Naoya Matsuda ◽  
Masato Naraoka ◽  
Hiroki Ohkuma ◽  
Norihito Shimamura ◽  
Katsuhiro Ito ◽  
...  
Keyword(s):  
Subarachnoid Hemorrhage ◽  
Cerebral Infarction ◽  
Cerebral Vasospasm ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Control Group ◽  
Independent Factor ◽  
Double Blind ◽  
End Points ◽  
Double Blind Placebo ◽  
Poor Outcome

Background: Several clinical studies have indicated the efficacy of cilostazol, a selective inhibitor of phosphodiesterase 3, in preventing cerebral vasospasm after aneurysmal subarachnoid hemorrhage (SAH). They were not double-blinded trial resulting in disunited results on assessment of end points among the studies. The randomized, double-blind, placebo-controlled study was performed to assess the effectiveness of cilostazol on cerebral vasospasm. Methods: Patients with aneurysmal SAH admitted within 24 h after the ictus who met the following criteria were enrolled in this study: SAH on CT scan was diffuse thick, diffuse thin, or local thick, Hunt and Hess score was less than 4, administration of cilostazol or placebo could be started within 48 h of SAH. Patients were randomly allocated to placebo or cilostazol after repair of a ruptured saccular aneurysm by aneurysmal neck clipping or endovascular coiling, and the administration of cilostazol or placebo was continued up to 14 days after initiation of treatment. The primary end point was the occurrence of symptomatic vasospasm (sVS), and secondary end points were angiographic vasospasm (aVS) evaluated on digital subtraction angiography, vasospasm-related new cerebral infarction evaluated on CT scan or MRI, and clinical outcome at 3 months of SAH as assessed by Glasgow Outcome Scale, in which poor outcome was defined as severe disability, vegetative state, and death. All end points were evaluated with blinded assessment. Results: One hundred forty eight patients were randomly allocated to the cilostazol group (n = 74) or the control group (n = 74). The occurrence of sVS was significantly lower in the cilostazol group than in the control group (10.8 vs. 24.3%, p = 0.031), and multiple logistic analysis showed that cilostazol use was an independent factor reducing sVS (OR 0.293, 95% CI 0.099-0.568, p = 0.027). The incidence of aVS and vasospasm-related cerebral infarction were not significantly different between the groups. Poor outcome was significantly lower in the cilostazol group than in the control group (5.4 vs. 17.6%, p = 0.011), and multiple logistic analyses demonstrated that cilostazol use was an independent factor that reduced the incidence of poor outcome (OR 0.221, 95% CI 0.054-0.903, p = 0.035). Severe adverse events due to cilostazol administration did not occur during the study period. Conclusions: Cilostazol administration is effective in preventing sVS and improving outcomes without severe adverse events. A larger-scale study including more cases was necessary to confirm this efficacy of cilostazol.

Safety evaluation of an antimalarial herbal product from Andrographis paniculata (AS201-01) in healthy volunteers

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Aty Widyawaruyanti ◽  
Arijanto Jonosewojo ◽  
Hilkatul Ilmi ◽  
Lidya Tumewu ◽  
Ario Imandiri ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Healthy Volunteers ◽  
Day Treatment ◽  
Phase 1 ◽  
Andrographis Paniculata ◽  
Control Group ◽  
Healthy Human ◽  
Double Blind ◽  
Random Blood Glucose ◽  
Significant Difference

Abstract Objectives Andrographis paniculata tablets (AS201-01) have previously been shown to have potent bioactivity as an antimalarial and to produce no unwanted side effects in animal models. Here, we present the phase 1 clinical trial conducted to evaluate the safety of AS201-01 tablets in healthy volunteers. Methods The study was a randomized, double-blind controlled cross-over, a placebo-controlled design consisting of a 4-day treatment of AS201-01 tablets. A total of 30 healthy human volunteers (16 males and 14 females) were divided into two groups, and each group was given 4 tablets, twice daily for 4 days. Group 1 received AS201-01, while group 2 received placebo tablets. Volunteers were given a physical examination before the treatment. The effects of AS201-01 on random blood glucose, biochemical, and hematological as well as urine profiles were investigated. Results There were no changes in observed parameters as a result of AS201-01 being administered. Statistical analysis showed no significant difference (p>0.05) between the test and control group regarding hematology profile, biochemical profile, and random blood glucose. Increased appetite and better sleep, which categorized as grade 1 adverse event was reported after treatment with AS201-01 tablet Conclusions The outcome supports our previous observation that the AS201-01 tablet, given twice a day for 4 days, is safe and nontoxic.

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