scholarly journals Perioperative synbiotics administration decreases postoperative infections in patients with colorectal cancer: a randomized, double-blind clinical trial

2017 ◽  
Vol 44 (6) ◽  
pp. 567-573 ◽  
Author(s):  
ALINE TABORDA FLESCH ◽  
STAEL T. TONIAL ◽  
PAULO DE CARVALHO CONTU ◽  
DANIEL C. DAMIN
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trial ◽  
Elective Surgery ◽  
Lactobacillus Rhamnosus ◽  
Control Group ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Colorectal Cancer Patients ◽  
To Receive

ABSTRACT Objective: to evaluate the effect of perioperative administration of symbiotics on the incidence of surgical wound infection in patients undergoing surgery for colorectal cancer. Methods: We conducted a randomized clinical trial with colorectal cancer patients undergoing elective surgery, randomly assigned to receive symbiotics or placebo for five days prior to the surgical procedure and for 14 days after surgery. We studied 91 patients, 49 in the symbiotics group (Lactobacillus acidophilus 108 to 109 CFU, Lactobacillus rhamnosus 108 to 109 CFU, Lactobacillus casei 108 to 109 CFU, Bifi dobacterium 108 to 109 CFU and fructo-oligosaccharide (FOS) 6g) and 42 in the placebo group. Results: surgical site infection occurred in one (2%) patient in the symbiotics group and in nine (21.4%) patients in the control group (p=0.002). There were three cases of intraabdominal abscess and four cases of pneumonia in the control group, whereas we observed no infections in patients receiving symbiotics (p=0.001). Conclusion: the perioperative administration of symbiotics significantly reduced postoperative infection rates in patients with colorectal cancer. Additional studies are needed to confirm the role of symbiotics in the surgical treatment of colorectal cancer.

Role of Centella asiatica and ceramide in skin barrier improvement: a double blind clinical trial of Indonesian batik workers

2021 ◽  
Vol 32 (4) ◽  
pp. 589-593
Author(s):  
Sylvia Anggraeni ◽  
Menul Ayu Umborowati ◽  
Damayanti Damayanti ◽  
Anang Endaryanto ◽  
Cita Rosita Sigit Prakoeswa
Keyword(s):  
Clinical Trial ◽  
Contact Dermatitis ◽  
Stratum Corneum ◽  
Skin Barrier ◽  
Centella Asiatica ◽  
Transepidermal Water Loss ◽  
Double Blind ◽  
Stratum Corneum Hydration ◽  
Double Blind Clinical Trial

Abstract Objectives Batik dyes contain irritant chemicals that increase the risk of skin barrier disruption. This study aims to determine the effect of Centella asiatica and ceramide in transepidermal water loss (TEWL), hydration of the stratum corneum and skin acidity (pH). Methods This was a double blind clinical trial of 30 Indonesian batik workers who suffered from skin dryness, but had no clinical manifestation of contact dermatitis. Subjects were given cream containing C. asiatica or ceramide that formulated and randomly labeled by manufacturer (PT Paragon Technology and Innovation). Both subjects and researchers were blinded to the type of the cream. Cream was applied to the hands and arms twice a day. Biological function of the skin (TEWL, stratum corneum hydration level, and skin acidity) was examined by Cutometer dual MP-580. Baseline was recorded in the first examination, followed by second and third examinations at two and four weeks after treatment. Results After four weeks treatment, there were significant improvement of C. asiatica application in evaluation of corneometer palmar (p=0.007; CI 95%), corneometer dorsum (p=0.001; CI 95%), and skin acidity dorsum (p=0.017; CI 95%). Ceramide application also gave significant improvement of corneometer palmar (0.038; CI 95%), skin acidity palmar (p=0.001; CI 95%), TEWL dorsum (p=0.023; CI 95%), corneometer dorsum (p=0.002; CI 95%) and skin acidity dorsum (p=0.011; CI 95%). There were no significant differences of C. asiatica effectiveness compared to ceramide in skin barrier improvement. Conclusions C. asiatica and ceramide can improve skin barrier hydration in order to prevent the risk of contact dermatitis in batik workers.

The role of oophorectomy for colon cancer with ovarian metastasis

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15113-e15113
Author(s):  
S. Lee ◽  
J. Lee ◽  
H. Ahn ◽  
J. Park ◽  
J. Kim ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cancer Patients ◽  
Performance Status ◽  
Poor Performance ◽  
Ovarian Metastasis ◽  
Control Group ◽  
Poor Performance Status ◽  
Ovarian Metastases ◽  
Colorectal Cancer Patients

e15113 Background: A recent study demonstrated that colorectal cancer with ovarian metastases were less responsive to chemotherapy compared to extraovarian metastases. Hence, the ovary may actually represent a “sanctuary” for metastatic cells from CRC. The aim of the study was to investigate the impact of oophorectomy on survival of colorectal cancer patients with ovarian metastasis. Methods: Between 1996 and 2008, 83 colorectal cancer patients underwent oophorectomy. For the historical control, 47 colorectal cancer patients without oophorectomy were included in the analysis. Survival and its associated factors were analyzed using Kaplan-Meier method, log-rank test and Cox-regression analysis. Results: The median age was younger (48 years) in the oophorectomy group when compared to the historical control (54 years) (P =.012). The proportion of synchronous metastasis was higher in the oophorectomy than the control group (57% vs 30%, respectively; P=.003). After a median follow-up duration of 60.8 months (range, 7.4 - 169.7 months), the median OS was significantly longer in the oophorectomy group (28.1 vs 21.2 months, oophorectomy vs non-oophoreectomy; P=.038). For ovary-specific survival (date of ovarian metastasis diagnosis to death), colorectal cancer patients with oophorectomy showed significantly favorable survival than the control group (20.8 vs 10.9 months, respectively; P<.001). At univariate analyses, no oophorectomy (P=.038), bilaterality of ovarian metastasis (P=0.032), the presence of extraovarian metastasis (P<0.001), elevated CEA (p<0.001), poor performance status (p=0.001), no palliative chemotherapy(p=0.001), no primary disease resection(p=0.005) were identified as significantly poor prognostic factors for overall survival. The no oophorectomy, no chemotherapy, extraovarian metastasis, elevated CEA, poor performance status retained statistical significance at multivariate level. (p=0.003, p=0.004, p=0.005, p=0.015, p=0.029, respectively). Conclusions: Based on this retrospective analysis, the oophorectomy significantly prolonged survival in colorectal cancer patients with ovarian metastases. A potential role of oophorectomy in the management of colorectal cancer should be prospectively studied. No significant financial relationships to disclose.

scholarly journals Tepid sponging plus dipyrone versus dipyrone alone for reducing body temperature in febrile children

2008 ◽  
Vol 126 (2) ◽  
pp. 107-111 ◽  
Author(s):  
João Guilherme Bezerra Alves ◽  
Natália Dornelas Câmara Marques de Almeida ◽  
Camila Dornelas Câmara Marques de Almeida
Keyword(s):  
Clinical Trial ◽  
Body Temperature ◽  
Randomized Clinical Trial ◽  
Primary Outcome ◽  
Control Group ◽  
Emergency Ward ◽  
Axillary Temperature ◽  
Secondary Outcomes ◽  
To Receive

CONTEXT AND OBJECTIVE: The role of tepid sponging to promote fever control in children is controversial. We did not find any studies reporting on the effectiveness of tepid sponging in addition to dipyrone. The aim of this study was to compare the effects of tepid sponging plus dipyrone with dipyrone alone for reducing fever. DESIGN AND SETTING: A randomized clinical trial was undertaken at Instituto Materno-Infantil Professor Fernando Figueira, Recife, Pernambuco. METHODS: Children from six months to five years old with axillary temperature greater than 38 ºC in the emergency ward between January and July 2006 were eligible. One hundred and twenty children were randomly assigned to receive oral dipyrone (20 mg/kg) or oral dipyrone and tepid sponging for 15 minutes. The primary outcome was mean temperature reduction after 15, 30, 60, 90 and 120 minutes. Secondary outcomes were crying and irritability. RESULTS: 106 children finished the study. After the first 15 minutes, the fall in axillary temperature was significantly greater in the sponged group than in the control group (p < 0.001). From 30 to 120 minutes, better fever control was observed in the control group. Crying and irritability were observed respectively in 52% and 36% of the sponged children and in none and only two of the controls. CONCLUSIONS: Tepid sponging plus dipyrone cooled faster during the first 15 minutes, but dipyrone alone presented better fever control over the two-hour period. Tepid sponging caused mild discomfort, crying and irritability for most of the children.

scholarly journals The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: A randomised placebo-controlled double-blind clinical trial

2020 ◽  
Author(s):  
Naser Gharebaghi ◽  
Rahim Nejadrahim ◽  
Seyed Jalil Mousavi ◽  
Seyyed-Reza Sadat-Ebrahimi ◽  
Reza Hajizadeh
Keyword(s):  
Clinical Trial ◽  
Mortality Rate ◽  
Hospital Mortality ◽  
Intravenous Immunoglobulin ◽  
Initial Treatment ◽  
Control Group ◽  
Double Blind ◽  
Reduce Mortality Rate ◽  
Double Blind Clinical Trial ◽  
Laboratory Test Results

Abstract Background: Coronavirus disease 2019 (COVID-19) has infected people in many countries worldwide. Discovering an effective treatment for this disease, particularly in severe cases, has become the subject of intense scientific investigation. Therefore, the objective of this study was to evaluate the efficacy of intravenous immunoglobulin (IVIg) in patients with severe COVID-19 infection.Methods: This study was conducted as a randomized placebo-controlled double-blind clinical trial. Fifty-nine patients with severe COVID-19 infection who did not respond to initial treatments were randomly assigned into two groups. One group received IVIg (human)—four vials daily for three days (in addition to initial treatment), while the other group received a placebo. Patients’ demographic, clinical, and select laboratory test results, as well as the occurrence of in-hospital mortality, were recorded.Results: Among total study subjects, 30 patients received IVIg and 29 patients received a placebo. Demographics, clinical characteristics, and laboratory tests were not statistically different (P > 0.05) between the two groups. The in-hospital mortality rate was significantly lower in the IVIg group compared to the control group (6 [20.0%] vs. 14 [48.3%], respectively; P = 0.022). Multivariate regression analysis demonstrated that administration of IVIg did indeed have a significant impact on mortality rate (aOR = 0.003 [95% CI: 0.001–0.815]; P = 0.042).Conclusions: Our study demonstrated that the administration of IVIg in patients with severe COVID-19 infection who did not respond to initial treatment could improve their clinical outcome and significantly reduce mortality rate. Further multicenter studies with larger sample sizes are nonetheless required to confirm the appropriateness of this medication as a standard treatment.Trial registration: A study protocol was registered at the Iranian Registry of Clinical Trials (www.IRCT.ir), number IRCT20200501047259N1. It was registered retrospectively on May 17th, 2020.

scholarly journals The efficacy, safety, and tolerability of levofloxacin quadruple therapy for helicobacter pylori eradication: a randomized, double-blind clinical trial

2020 ◽  
Author(s):  
Fariborz Mansour-Ghanaei ◽  
Behnam Masihypour ◽  
Mohammad Fathalipour ◽  
Soheil Hassanipour ◽  
Homayoon Sokhanvar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Alternative Therapy ◽  
Double Blind ◽  
Intention To Treat ◽  
Bismuth Subcitrate ◽  
Double Blind Clinical Trial ◽  
End Of Treatment ◽  
H Pylori ◽  
To Receive

Abstract BackgroundThe incidence of microbial resistance is increasing, and new rescue regimens are needed in order to treat Helicobacter pylori (H. pylori) infection. To evaluate the efficacy, safety, and tolerability of levofloxacin based quadruple therapies in the eradication of H. pylori.MethodsIn a randomized, double-blind clinical trial, 220 patients with dyspepsia and H. pylori infection were randomly assigned to receive either bismuth subcitrate 240 mg, pantoprazole 20 mg, amoxicillin 1000 mg twice a day, and levofloxacin 500 mg daily for seven days (BPAL-7), or ten days (BPAL-10). The eradication of H. pylori was evaluated two months after the end of treatment, and adverse drug reactions (ADRs) were assessed during the intervention.ResultsAccording to intention-to-treat and per-protocol, the eradication rate was significantly lower in the BPAL-7 regimen 49.1% (95% CI: 39.3–57.8) and 47.6% (95% CI: 39.7–58.4), respectively compared to the BPAL- 10 regimen 62.7% (95% CI: 53.6–72.8) and 62.4% (95% CI: 55.1–72.8), respectively. The incidence of ADRs was not statistically significant between BPAL-7 (33.6%) and BPAL-10 (36.7%) groups.ConclusionAlthough the ADRs were negligible in both groups, these regimens could not be an ideal alternative therapy for H. pylori because of low eradication rates compared to standard regimens.Trial registration: The study reviewed and approved by the Iranian Registry of Clinical Trials (IRCT201406141155N19). This trial was retrospectively registered on July 10, 2015.

scholarly journals The Efficacy, Safety, And Tolerability of Levofloxacin Quadruple Therapy For Helicobacter Pylori Eradication: A Randomized, Double-Blind Clinical Trial

2021 ◽  
Author(s):  
Fariborz Mansour-Ghanaei ◽  
Behnam Masihypour ◽  
Mohammad Fathalipour ◽  
Soheil Hassanipour ◽  
Homayoon Sokhanvar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Alternative Therapy ◽  
Double Blind ◽  
Intention To Treat ◽  
Bismuth Subcitrate ◽  
Double Blind Clinical Trial ◽  
End Of Treatment ◽  
H Pylori ◽  
To Receive

Abstract The incidence of microbial resistance is increasing, and new rescue regimens are needed in order to treat Helicobacter pylori (H. pylori) infection. To evaluate the efficacy, safety, and tolerability of levofloxacin based quadruple therapies in the eradication of H. pylori. In a randomized, double-blind clinical trial, 220 patients with dyspepsia and H. pylori infection were randomly assigned to receive either bismuth subcitrate 240 mg, pantoprazole 20 mg, amoxicillin 1000 mg twice a day, and levofloxacin 500 mg daily for seven days (BPAL-7), or ten days (BPAL-10). The eradication of H. pylori was evaluated two months after the end of treatment, and adverse drug reactions (ADRs) were assessed during the intervention. According to intention-to-treat and per-protocol, the eradication rate was significantly lower in the BPAL-7 regimen 49.1 % (95 % CI: 39.3-57.8) and 47.6 % (95 % CI: 39.7-58.4), respectively compared to the BPAL- 10 regimen 62.7 % (95 % CI: 53.6-72.8) and 62.4 % (95 % CI: 55.1-72.8), respectively. The incidence of ADRs was not statistically significant between BPAL-7 (33.6 %) and BPAL-10 (36.7 %) groups. Although the ADRs were negligible in both groups, these regimens could not be an ideal alternative therapy for H. pylori because of low eradication rates compared to standard regimens.Trial registration: The study reviewed and approved by the Iranian Registry of Clinical Trials (IRCT201406141155N19).

Effect of Nebulized Eucalyptus for Preventing Ventilator-Associated Pneumonia in Patients under Mechanical Ventilation: A Randomized Double Blind Clinical Trial

2018 ◽  
Author(s):  
HasanAli Karimpour ◽  
Behzad Hematpour ◽  
Saeed Mohammadi ◽  
Javad Aminisaman ◽  
Maryam Mirzaei ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intensive Care Unit ◽  
Intensive Care ◽  
Intervention Group ◽  
Control Group ◽  
Pulmonary Infections ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
And Control ◽  
And Staphylococcus Aureus

Abstract Background: Pneumonia caused by the ventilator is the most common acquired infection in the intensive care unit, which increases the morbidity and mortality of the patients. Eucalyptus plant has antiseptic properties. Therefore, the present study investigates the effect of eucalyptus incense on prevention of pneumonia in patients with endotracheal tube in the intensive care unit. Methods: This clinical trial study was performed on 100 patients under ventilation in two intervention and control groups in Imam Reza Hospital, Kermanshah, Iran in 2018. The patients in the intervention group, Eucalyptus solution 2% and in the control group received 10 cc distilled water as an inhaler three times a day. The results of the two groups were compared to the incidence of pulmonary infections based on CPIS criteria and compared with SPSS version 19 software. Results: The incidence of late pneumonia was significantly lower in the intervention group (P=0.02). The onset of pneumonia significantly later in the intervention group than the control group (P=0.01). The prevalence of Klebsiella, Candida albicans, and Staphylococcus aureus was significantly decreased in the intervention group (P=0.02) (P=0.04) (P=0.01). Conclusion: The results of this study showed that eucalyptus inhalation is effective in reducing the incidence of pulmonary infection in patients under ventilation. It is recommended that these products be used to prevent pulmonary infections in these patients.

The Efficacy of The Administration of BifidobacteriumLactis For Treatment of Infantile Colic: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

2021 ◽  
Author(s):  
Mohammad Ali Pourmirzaiee ◽  
Fatemeh Famouri ◽  
Akram Kahid ◽  
Silva Hovsepian ◽  
Roya Kelishadi
Keyword(s):  
Clinical Trial ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Infantile Colic ◽  
Double Blind ◽  
Bifidobacterium Lactis ◽  
Bifidobacterium Animalis ◽  
Significant Difference ◽  
Study Offer

Abstract The aim of this trial was to evaluate the efficacy of Bifidobacterium Lactis administration on infantile colic (IC). In this double blind randomized, placebo‐controlled clinical trial, infants with IC diagnosis, exclusive breastfeeding, gestational age more than 37 weeks and birth weight more than 2500 gram were included. The selected infants randomly allocated in the two groups of BBcare group, treated with Bifidobacterium animalis subsp. lactis and the control group treated with placebo, 5 drops per day, for 6 weeks. The mean of crying, vomiting episodes and defecation number at baseline and during follow ups (40 and 60 days after intervention) were compared between the two studied groups. In this study from initially enrolled neonates, 40 and 38 neonates in BB-12 and placebo groups completed the study. In BB-12 group number of defecation, crying and vomiting episodes decreased significantly during intervention till 60 days after probiotic administration(P<0.05).In the placebo group there was significant decrease for crying and vomiting episodes between baseline and 60 days after intervention(P<0.05). Between group analyses indicated that there was significant difference between groups regarding mean of crying and vomiting episodes and number of defecation ,60 days after intervention(P<0.05).Conclusion: Findings of our study offer compelling signals for the effectiveness of Bifidobacterium animalis subsp. lactis BB‐12 in the management of some intestinal problems. These findings could be supportive evidences for the important role of gut microbiota as goal of intervention to improvement in bowel movement and comfortable defecation in IC.

scholarly journals Effects of an iron supplementation trial on the Fe status of Thai schoolchildren

1992 ◽  
Vol 68 (1) ◽  
pp. 245-252 ◽  
Author(s):  
Phongjan Hathirat ◽  
Aree Valyasevi ◽  
Nittaya J. Kotchabhakdi ◽  
Nipa Rojroongwasinkul ◽  
Ernesto Pollitt
Keyword(s):  
Clinical Trial ◽  
Serum Ferritin ◽  
Iron Supplementation ◽  
Transferrin Saturation ◽  
Control Group ◽  
Iron Supplement ◽  
Double Blind ◽  
Free Erythrocyte Protoporphyrin ◽  
Double Blind Clinical Trial ◽  
Hb H Disease

A double-blind clinical trial was conducted among 9- to 11-year-old children in sixteen schools in the Chon Buri province of Thailand to assess the effects of an iron supplement combined with an anthelminthic agent (i.e. albendazole). In addition to the albendazole, Fe or placebo tablets were distributed to 2268 children enrolled in grades three to five without knowledge of the Fe status of the children. Criteria for case inclusion were: (a) absence of A E Bart's or haemoglobin (Hb) H disease, (b) absence of abnormal Hb EE, and (c) age, 108–144 months. The results showed a significant improvement in the Fe status of the children after 16 weeks of treatment. The increments were: Hb from 124 to 128 g/l, serum ferritin from 34.54 to 104.72 μg/l, transferrin saturation from 24.09 to 35.05%; free erythrocyte protoporphyrin decreased from 444.7 to 281.4 μg/l erythrocytes. These changes were significantly greater than in the control group that received only the anthelminthic agent. However, the administration of albendazole only also resulted in significant changes in the same Fe indicators.

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