A Prospective Randomised Clinical Trial of the Intra-Operative Use of 5-Fluorouracil on the Outcome of Dupuytren’s Disease

2004 ◽  
Vol 29 (1) ◽  
pp. 18-21 ◽  
Author(s):  
N. W. BULSTRODE ◽  
M. BISSON ◽  
B. JEMEC ◽  
A. L. PRATT ◽  
D. A. MCGROUTHER ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Joint Angle ◽  
Randomised Clinical Trial ◽  
Angle Measurement ◽  
Flexion Deformity ◽  
Double Blind ◽  
Significant Difference ◽  
Operative Complications

5-Fluorouracil reduces proliferation rates of fibroblasts, myofibroblast differentiation and contractility of ocular fibroblasts in vitro. This double-blind randomized clinical trial assesses whether intra-operative topical treatment with 5-fluorouracil reduces the recurrence rate after limited excision of Dupuytren’s tissue. Patients with two-digit disease were randomized to having 5-fluorouracil (25 mg/ml) treatment for 5 minutes on one digit and placebo on the other. Fifteen patients were enrolled with 18 months follow-up. There were no peri-operative complications. Wound healing was not delayed and there was no deterioration in the flexion deformity of the 5-fluorouracil treated digits. Patients were subsequently assessed by joint angle measurement at 3, 6, 12 and 18 months. There was no significant difference between control and 5-fluorouracil treated digits.

scholarly journals Effect of Vitamin D Supplementation on Faecal Microbiota: A Randomised Clinical Trial

Nutrients ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 2888 ◽  
Author(s):  
Negar Naderpoor ◽  
Aya Mousa ◽  
Luisa Fernanda Gomez Arango ◽  
Helen L. Barrett ◽  
Marloes Dekker Nitert ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vitamin D ◽  
Gut Microbiota ◽  
Randomised Clinical Trial ◽  
Vitamin D Supplementation ◽  
Faecal Microbiota ◽  
Lower Abundance ◽  
Α Diversity ◽  
Significant Difference

In animal studies, vitamin D supplementation has been shown to improve gut microbiota and intestinal inflammation. However, limited evidence exists on the effect of vitamin D supplementation on the human gut microbiota. We examined the effect of vitamin D supplementation on faecal microbiota in 26 vitamin D-deficient (25-hydroxyvitamin D (25(OH)D) ≤50 nmol/L), overweight or obese (BMI ≥25 kg/m2) otherwise healthy adults. Our study was ancillary to a community based double-blind randomised clinical trial, conducted between 2014 and 2016. The participants provided stool samples at baseline and after 100,000 international units (IU) loading dose of cholecalciferol followed by 4000 IU daily or matching placebo for 16 weeks. Faecal microbiota was analysed using 16S rRNA sequencing; V6–8 region. There was no significant difference in microbiome α-diversity between vitamin D and placebo groups at baseline and follow-up (all p > 0.05). In addition, no clustering was found based on vitamin D supplementation at follow-up (p = 0.3). However, there was a significant association between community composition and vitamin D supplementation at the genus level (p = 0.04). The vitamin D group had a higher abundance of genus Lachnospira, and lower abundance of genus Blautia (linear discriminate analysis >3.0). Moreover, individuals with 25(OH)D >75 nmol/L had a higher abundance of genus Coprococcus and lower abundance of genus Ruminococcus compared to those with 25(OH)D <50 nmol/L. Our findings suggest that vitamin D supplementation has some distinct effects on faecal microbiota. Future studies need to explore whether these effects would translate into improved clinical outcomes.

scholarly journals Efektivitas desloratadin terhadap skor gejala hidung total dan kadar interleukin-4 sekret hidung rinitis alergi

2018 ◽  
Vol 48 (1) ◽  
pp. 56
Author(s):  
Luh Putu Dhena Purwaningsih ◽  
Dwi Reno Pawarti ◽  
Bakti Surarso
Keyword(s):  
Clinical Trial ◽  
Atopic Disease ◽  
Randomised Clinical Trial ◽  
Current Treatment ◽  
Nasal Symptom ◽  
Nasal Secretion ◽  
Interleukin 4 ◽  
Control Group ◽  
Double Blind ◽  
Significant Difference

Latar belakang: Rinitis alergi (RA) adalah penyakit atopi yang umum terjadi, namun terapi yangtersedia mempunyai keterbatasan baik dalam penggunaan maupun angka keberhasilan. Desloratadinberperan sebagai terapi alternatif RA yang dapat menghilangkan keseluruhan gejala RA dan menurunkankadar interleukin-4 (IL-4) sekret hidung. Tujuan: Menganalisis efektivitas desloratadin dibandingkandengan loratadin dalam menurunkan skor gejala hidung total dan IL-4 sekret hidung pada penderita RA.Metode: Merupakan double blind randomised clinical trial with pre-post test design. Analisis data denganindependent sample t-test. Sebanyak 24 penderita RA dibagi menjadi 2 kelompok terapi yaitu kelompokstudi (desloratadin), dan kelompok kontrol (loratadin). Evaluasi berdasarkan skor gejala hidung total danIL-4 sekret hidung, pra dan pasca 15 hari terapi. Hasil: Penelitian yang dilakukan sejak bulan Juli sampaiOktober 2016 menunjukkan hasil berupa perbedaan bermakna rerata persentase penurunan skor gejalahidung total kelompok desloratadin dibandingkan kelompok loratadin (p=0,000). Perbandingan penurunankadar IL-4 sekret hidung antara kelompok desloratadin dengan loratadin adalah berbeda tidak bermakna(p=0,236). Kesimpulan: Penurunan skor gejala hidung total desloratadin lebih besar dibandingkan denganloratadin, dan tidak didapatkan perbedaan penurunan pada kadar IL-4 sekret hidung. ABSTRACTBackground: Allergic rhinitis (AR) is a common atopic disease but its current treatment is limitedboth in usage, as well as in the success rate. Desloratadine is an alternative choice in the treatment ofAR, and it could reduce the Interleukin (IL-4) nasal secretion level. Purpose: To assess the effectivenessof desloratadine compared to loratadine in decreasing total nasal symptom score (TNSS) and levels ofIL-4 nasal secretions in AR patients. Method: A double blind randomized clinical trial (RCT). Twentyfour AR patients were divided into two treatment groups: study group (desloratadin) and control group(loratadine). Evaluation was based on TNSS and IL-4 nasal secretion level pre and post 15 days oftreatment. Result: Conducted from July to October 2016, this study showed the mean of TNSS reductionpercentage between desloratadine group compared to loratadine group was significant (p=0.000).The comparison of reduction of IL-4 nasal secretion level between desloratadine group and loratadinegroup was not significantly different (p=0.236). Conclusion: The TNSS decreased more in desloratadinecompared to loratadine, but there was no significant difference between both groups in the levels of IL-4nasal secretions

Evidence-based mixture containing Lactobacillus strains and lactoferrin to prevent recurrent bacterial vaginosis: a double blind, placebo controlled, randomised clinical trial

2019 ◽  
Vol 10 (1) ◽  
pp. 19-26 ◽  
Author(s):  
R. Russo ◽  
E. Karadja ◽  
F. De Seta
Keyword(s):  
Clinical Trial ◽  
Bacterial Vaginosis ◽  
Randomised Clinical Trial ◽  
Vaginal Microbiota ◽  
Bovine Lactoferrin ◽  
Induction Phase ◽  
Adult Women ◽  
Double Blind ◽  
Nugent Score

Bacterial vaginosis (BV) is the most common cause of vaginal discomfort in women. It is characterised by abnormal vaginal microbiota with a depletion of lactobacilli and predominance of anaerobic microorganisms, mainly Gardnerella vaginalis and Atopobium vaginae. Although antibiotics represent an effective therapeutic option in the short-term, recurrent infections still remain a serious problem. Nowadays, evidence exists about the efficacy of probiotics for the management of BV. The aim of the current double blind, randomised clinical trial was to assess the efficacy of a probiotic mixture, including Lactobacillus acidophilus GLA-14 and Lactobacillus rhamnosus HN001, in combination with bovine lactoferrin, as adjuvant therapy to metronidazole in women with recurrent BV. In particular, normalisation of Nugent score, remission of symptoms and recurrences during a six-months follow-up were assessed. 48 adult women received metronidazole (500 mg twice daily) for 7 days and randomly assigned to take simultaneously either probiotics plus lactoferrin or placebo (2 capsules/day for 5 days followed by 1 capsule/day for 10 consecutive days; induction phase). The verum or placebo administration (1 capsule/day for 10 consecutive days) was repeated each month (maintenance phase) during the six months of follow-up starting the first day of menstrual cycle since the menstrual blood increases the vaginal pH and contributes to increase the risk of recurrences. The results showed that symptoms (vaginal discharge and itching), Nugent score and recurrence rate were significantly improved by probiotics mixture in association with lactoferrin. This alternative approach may represent a safe and effective remedy for the restoration of healthy vaginal microbiota in preventing recurrent BV.

scholarly journals The Effect of Acupressure at PC6 and REN12 on Vomiting in Patients Undergoing Inguinal Hernia Repair: A Double-Blind Randomized Clinical Trial

2019 ◽  
Vol 7 (9) ◽  
pp. 1461-1465
Author(s):  
Seyyed Roohollah Najjari ◽  
Habib Shareinia ◽  
Seyyed Javad Mojtabavi ◽  
Mohammad Mojalli
Keyword(s):  
Clinical Trial ◽  
Inguinal Hernia ◽  
Hernia Repair ◽  
Inguinal Hernia Repair ◽  
Postoperative Nausea And Vomiting ◽  
Randomised Clinical Trial ◽  
Hernia Surgery ◽  
Double Blind ◽  
Inguinal Hernia Surgery ◽  
Significant Difference

BACKGROUND: Inguinal hernia surgery is one of the most commonly performed surgeries with complications such as postoperative nausea and vomiting (PONV). AIM: This study aimed to evaluate the effect of acupressure at PC6 and REN 12 points on vomiting of patients undergoing inguinal hernia repair. MATERIAL AND METHODS: This is a double-blind, randomised clinical trial performed on 60 patients undergoing inguinal hernia repair. Using permutation blocks, patients were allocated in two groups (acupressure at PC6 and REN12 points). After the surgery and full patient consciousness, acupressure was applied on PC6 and REN 12 points separately in each group for 5 minutes; 2, 4 and 6 hours later, acupressure was repeated on those points. Two hours after each acupressure, frequency and severity of vomiting were determined. RESULTS: The results showed that there was no significant difference between the frequency of vomiting before the intervention and 2 hours after the intervention in the two intervention groups (P ≥ 0.05). Additionally, none of the two intervention groups experienced vomiting at 4, 6, and 8 hours after the intervention. CONCLUSION: It seems that acupressure at PC6 and REN 12 points are not effective in reducing the frequency and severity of vomiting in patients after inguinal hernia surgery.

scholarly journals Long Term Evaluation of the Efficacy And And Safety of Nd:Yag Laser Vitreolysis for Symptomatic Vitreous Floaters

2021 ◽  
Author(s):  
Guilherme Nunes ◽  
Gustavo Ludwig ◽  
Henrique Gemelli ◽  
Pedro D Serracarbassa ◽  
Márgara Zanotele
Keyword(s):  
Clinical Trial ◽  
Adverse Effects ◽  
Similar Proportion ◽  
Life Questionnaire ◽  
Double Blind ◽  
Vitreous Floaters ◽  
Significant Difference ◽  
Late Adverse Effects

Abstract PURPOSE: this study evaluates the long-term safety and efficacy of Nd:YAG vitreolysis for symptomatic vitreous floaters, as it remains a controversial procedure due to the lack of robust evidence in the literature for its maintenance of the results and absence of adverse effects. METHODS: this is an observational extension to the previously presented prospective, randomized, double-blind clinical trial study. Eight of thirteen subjects who underwent vitreolysis with YAG laser returned for a late reevaluation, 18 months after the procedure, to evaluate the efficacy and safety of the procedure.RESULTS: all patients maintained the improvement in symptomatology noted after the procedure, with 25% showing complete improvement, and a similar proportion (37.5%) reporting significant or partial improvement. Objective improvement in opacity was similar to that found at 6 months follow-up. The NEI-VFQ 25 quality of life questionnaire showed no statistically significant difference in responses between the sixth and eighteenth month. No adverse effects were noted on clinical examination or reported by patients.CONCLUSION: vitreolysis efficacy observed at 6 months of follow-up was maintained until the eighteenth month, with all patients reporting improvement from the pre-procedure state. No late adverse effects were noted. A larger randomized clinical trial is needed to confirm the safety of the procedure.

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.

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