Double Blind Placebo Controlled Evaluation of Clinical Activity and Safety of Dation 500 mg in the Treatment of Acute Haemorrhoids

1994 ◽  
Vol 9 (1_suppl) ◽  
pp. 40-43 ◽  
Author(s):  
M. Cospite
Keyword(s):  
Controlled Trial ◽  
Signs And Symptoms ◽  
Clinical Severity ◽  
University Hospital ◽  
Clinical Activity ◽  
Patient Acceptability ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Haemorrhoidal Disease ◽  
Controlled Evaluation

Objective: Efficacy of treatment of acute haemorrhoidal crisis by Daflon 500 mg (D500) in comparison to a placebo (Pl). Design: Prospective, double blind, placebo controlled trial with randomization into two parallel groups. Setting: In- and outpatients at a University Hospital. Patients: One hundred patients with a history of haemorrhoidal disease, suffering from an acute haemorrhoidal attack. Interventions: Administration of Daflon 500 mg or placebo at a dose of three tablets b.i.d. for the first 4 days and two tablets b.i.d. for the following 3 days. Main outcome measures: Improvement of symptoms and signs measured by a score and patient acceptability. Results: Overall improvements of symptoms was greater in the D500 group than in the Pl group, from day 2 up to day 7. The clinical severity of proctorrhagia, anal discomfort, pain and anal discharge diminished in both groups, but to a greater extent in the D500 group ( p <0.001). Inflammation, congestion, oedema and prolapse were more markedly improved in the D500 group than in the Pl group. Duration and severity of the current haemorrhoidal episode, as assessed by patient self-evaluation, were less important in the D500 group compared with previous episodes. Use of analgesics and topical medications diminished in both groups, with a major reduction in the D500 group from day 4 ( p <0.001). Acceptability was good in both groups: no patient experienced major side-effects. Conclusion: Treatment with D500 resulted in a quicker and more pronounced relief of signs and symptoms of acute haemorrhoids than with the placebo.

scholarly journals l-Serine and EPA Relieve Chronic Low-Back and Knee Pain in Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

2020 ◽  
Vol 150 (9) ◽  
pp. 2278-2286
Author(s):  
Ikuko Sasahara ◽  
Akiko Yamamoto ◽  
Masamichi Takeshita ◽  
Yasuyo Suga ◽  
Katsuya Suzuki ◽  
...  
Keyword(s):  
Placebo Group ◽  
Knee Pain ◽  
Medical Information ◽  
Controlled Trial ◽  
Brief Pain Inventory ◽  
University Hospital ◽  
Active Group ◽  
Low Back ◽  
Double Blind ◽  
Double Blind Placebo

ABSTRACT Background Multisite pain, including low-back and knee pain, is a major health issue that greatly decreases quality of life. Objectives This study analyzed the effects of l-serine, which provides necessary components for nerve function, and EPA, which exerts anti-inflammatory properties, on pain scores of adults with pain in at least the low back and knee for ≥3 mo. Methods This was a randomized, double-blind, placebo-controlled, parallel-group study. The Japan Low Back Pain Evaluation Questionnaire (JLEQ) and Japanese Knee Osteoarthritis Measure (JKOM) were applied as primary outcomes. The Brief Pain Inventory (BPI) and safety evaluation were secondary outcomes. We enrolled 120 participants aged ≥20 y (36 men and 84 women: mean ± SD age = 40.8 ± 10.9 y). The participants were randomly allocated to either the active group (daily ingestion of 594 mg l-serine and 149 mg EPA) or placebo group. The study period consisted of 8-wk dosing and 4-wk posttreatment observation. ANCOVA between groups for each time point was conducted using the baseline scores as covariates. Results The JLEQ scores (active compared with placebo: 14.2 ± 11.2 compared with 19.0 ± 10.2) at week 8 were lower in the active group (P &lt; 0.001). The JKOM scores at week 4 (11.7 ± 9.0 compared with 13.9 ± 7.9), week 8 (10.4 ± 7.9 compared with 13.1 ± 7.1), and week 12 (10.3 ± 7.4 compared with 13.8 ± 7.5) were lower in the active group (P ≤ 0.04). Additionally, the active group had 11–27% better scores compared with the placebo group for BPI1 (worst pain), BPI3 (average pain), and BPI5D (pain during moving) at week 4 (P ≤ 0.028) and week 8 (P ≤ 0.019), respectively, and BPI5D was 23% better in the active group at week 12 (P = 0.007). No adverse events were observed. Conclusions l-Serine and EPA were effective for pain relief in adults with low-back and knee pain after multiplicity adjustment. This trial was registered at the University Hospital Medical Information Network Clinical Trials Registry as UMIN000035056.

Neuroprotective Effect of Reduced Glutathione on Oxaliplatin-Based Chemotherapy in Advanced Colorectal Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial

2002 ◽  
Vol 20 (16) ◽  
pp. 3478-3483 ◽  
Author(s):  
Stefano Cascinu ◽  
Vincenzo Catalano ◽  
Luigi Cordella ◽  
Roberto Labianca ◽  
Paolo Giordani ◽  
...  
Keyword(s):  
Saline Solution ◽  
Neuroprotective Effect ◽  
Controlled Trial ◽  
Sensory Nerve ◽  
Clinical Activity ◽  
Double Blind ◽  
Double Blind Placebo ◽  
To Receive ◽  
Infusion Period ◽  
Toxicity Criteria

PURPOSE: We performed a randomized, double-blind, placebo-controlled trial to assess the efficacy of glutathione (GSH) in the prevention of oxaliplatin-induced neurotoxicity. PATIENTS AND METHODS: Fifty-two patients treated with a bimonthly oxaliplatin-based regimen were randomized to receive GSH (1,500 mg/m2 over a 15-minute infusion period before oxaliplatin) or normal saline solution. Clinical neurologic evaluation and electrophysiologic investigations were performed at baseline and after four (oxaliplatin dose, 400 mg/m2), eight (oxaliplatin dose, 800 mg/m2), and 12 (oxaliplatin dose, 1,200 mg/m2) cycles of treatment. RESULTS: At the fourth cycle, seven patients showed clinically evident neuropathy in the GSH arm, whereas 11 patients in the placebo arm did. After the eighth cycle, nine of 21 assessable patients in the GSH arm suffered from neurotoxicity compared with 15 of 19 in the placebo arm. With regard to grade 2 to 4 National Cancer Institute common toxicity criteria, 11 patients experienced neuropathy in the placebo arm compared with only two patients in the GSH arm (P = .003). After 12 cycles, grade 2 to 4 neurotoxicity was observed in three patients in the GSH arm and in eight patients in the placebo arm (P = .004). The neurophysiologic investigations (sural sensory nerve conduction) showed a statistically significant reduction of the values in the placebo arm but not in the GSH arm. The response rate was 26.9% in the GSH arm and 23.1% in the placebo arm, showing no reduction in activity of oxaliplatin. CONCLUSION: This study provides evidence that GSH is a promising drug for the prevention of oxaliplatin-induced neuropathy, and that it does not reduce the clinical activity of oxaliplatin.

A phase 3 (COSMIC-311), randomized, double-blind, placebo-controlled study of cabozantinib in patients with radioiodine (RAI)-refractory differentiated thyroid cancer (DTC) who have progressed after prior VEGFR-targeted therapy.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS6097-TPS6097 ◽  
Author(s):  
Marcia S. Brose ◽  
Bruce Robinson ◽  
Candy Bermingham ◽  
Soham Puvvada ◽  
Anne E. Borgman ◽  
...  
Keyword(s):  
Thyroid Cancer ◽  
Targeted Therapy ◽  
Differentiated Thyroid Cancer ◽  
Controlled Trial ◽  
Objective Response ◽  
Controlled Study ◽  
Clinical Activity ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo

TPS6097 Background: Treatment options are limited for patients with RAI-refractory DTC that is resistant to VEGFR-targeted therapy. Cabozantinib inhibits receptor tyrosine kinases including VEGFR2, MET, AXL, and RET, which are implicated in the development of DTC, and has shown clinical activity in early-phase studies of patients with RAI-refractory DTC. This study evaluates the efficacy and safety of cabozantinib in patients with RAI-refractory DTC who have progressed during or after prior VEGFR-targeted therapy. Methods: This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial (NCT03690388). The co-primary endpoints are progression-free survival and objective response rate evaluated by blinded independent radiology committee (BIRC) per RECIST v 1.1. Additional endpoints include safety, overall survival, quality of life, and changes in relevant biomarker levels (eg, thyroglobulin). Approximately 300 patients will be randomized in a 2:1 ratio to receive either cabozantinib (60 mg QD orally) or placebo. Randomization is stratified by prior treatment with lenvatinib and age (≤ 65 yrs vs > 65 yrs). Eligible patients must have a pathologic diagnosis of DTC and must have been previously treated with or deemed ineligible for treatment with iodine-131 for DTC. Patients must have received lenvatinib or sorafenib for DTC and progressed during or following treatment with a VEGFR inhibitor. Up to 2 prior VEGFR-targeting TKI agents are allowed. Patients randomized to placebo may be eligible for real time on-study crossover to cabozantinib based on BIRC confirmation of disease progression. Unblinded patients randomized to cabozantinib may continue on study treatment if there is clinical benefit per investigator. Key words: Radioiodine-refractory differentiated thyroid cancer, cabozantinib, VEGFR-targeted therapy, trial-in-progress. Clinical trial information: NCT03690388.

A Randomized, Double-Blind, Placebo-Controlled Trial of Selective Digestive Decontamination Using Oral Gentamicin and Oral Polymyxin E for Eradication of Carbapenem-Resistant Klebsiella pneumoniae Carriage

2012 ◽  
Vol 33 (1) ◽  
pp. 14-19 ◽  
Author(s):  
Lisa Saidel-Odes ◽  
Hana Polachek ◽  
Nehama Peled ◽  
Klaris Riesenberg ◽  
Francisc Schlaeffer ◽  
...  
Keyword(s):  
Klebsiella Pneumoniae ◽  
Controlled Trial ◽  
Tertiary Care ◽  
Selective Digestive Decontamination ◽  
Control Measures ◽  
University Hospital ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Carbapenem Resistant ◽  
Polymyxin E

Objective.To assess the effectiveness of selective digestive decontamination (SDD) for eradicating carbapenem-resistant Klebsiella pneumoniae (CRKP) oropharyngeal and gastrointestinal carriage.Design.A randomized, double-blind, placebo-controlled trial with 7 weeks of follow-up per patient.Setting.A 1,000-bed tertiary-care university hospital.Patients.Adults with CRKP-positive rectal swab cultures.Methods.Patients were blindly randomized (1:1) over a 20-month period. The SDD arm received oral gentamicin and polymyxin E gel (0.5 g 4 times per day) and oral solutions of gentamicin (80 mg 4 times per day) and polymyxin E (1 × 106 units 4 times per day for 7 days). The placebo arm received oral placebo gel 4 times per day and 2 placebo oral solutions 4 times per day for 7 days. Strict contact precautions were applied. Samples obtained from the throat, groin, and urine were also cultured.Results.Forty patients (mean age ± standard deviation, 71 ± 16 years; 65% male) were included. At screening, greater than or equal to 30% of oropharyngeal, greater than or equal to 60% of skin, and greater than or equal to 35% of urine cultures yielded CRKP isolates. All throat cultures became negative in the SDD arm after 3 days (P< .0001). The percentages of rectal cultures that were positive for CRKP were significandy reduced at 2 weeks. At that time, 16.1% of rectal cultures in the placebo arm and 61.1% in the SDD arm were negative (odds ratio, 0.13; 95% confidence interval, 0.02–0.74; P<.0016). A difference between the percentages in the 2 arms was still maintained at 6 weeks (33.3% vs 58.5%). Groin colonization prevalence did not change in either arm, and the prevalence of urine colonization increased in the placebo arm.Conclusions.This SDD regimen could be a suitable decolonization therapy for selected patients colonized with CRKP, such as transplant recipients or immunocompromised patients pending chemotherapy and patients who require major intestinal or oropharyngeal surgery. Moreover, in outbreaks caused by CRKP infections that are uncontrolled by routine infection control measures, SDD could provide additional infection containment.Infect Control Hosp Epidemiol 2012;33(1):14-19

Sign in / Sign up

Export Citation Format

Share Document