scholarly journals Healing of Benign Gastric and Prepyloric Ulcers: A Prospective, Endoscopy-Controlled, Randomized, Double-Blind, Canadian Multicentre Study of Omeprazole 20 and 40 mg Daily and Rantidine 150 mg Twice a Day

1990 ◽  
Vol 4 (1) ◽  
pp. 7-12
Author(s):  
Pierre Paré ◽  
Robert J Bailey ◽  
André P Archambault ◽  
Henri Navert ◽  
C Noel Williams ◽  
...  
Keyword(s):  
Ulcer Healing ◽  
Healing Rate ◽  
Smoking Status ◽  
Standard Dose ◽  
Symptomatic Relief ◽  
Randomized Study ◽  
Ulcer Recurrence ◽  
Serious Adverse Events ◽  
Double Blind

A double-blind, randomized study was conducted in 118 patients with benign gastric or prepyloric ulcers to compare the efficacy of omeprazole 20 or 40 mg daily with ranitidine 150 mg twice daily. The healing rates at four weeks were 67, 79 and 54% and at eight weeks increased to 90, 97 and 71 % for the omeprazole 20 and 40 mg groups and the ranitidine group, respectively (P< 0.03 for the differences between each of the omeprazole groups and the ranitidine group at eight weeks). Multivariate analysis showed influence on healing rate for ulcer size but not for smoking status, sex or ulcer site. Symptomatic relief was excellent and similar in the three groups. Ulcer recurrence during the six month follow-up off treatment after initial ulcer healing did not differ between the three groups. No serious adverse events could be attributed to the drugs. The authors conclude that treatment with omeprazole 20 or 40 mg daily for a period of four to eight weeks is safe and significantly more effective in ulcer healing than a standard dose of ranitidine.

scholarly journals Recurrence of Acute Duodenal Ulcer

1994 ◽  
Vol 8 (1) ◽  
pp. 21-26
Author(s):  
RJ Bailey ◽  
IG Morrison-Cleator ◽  
A Farley ◽  
A Archambault ◽  
M Oravec ◽  
...  
Keyword(s):  
Ulcer Healing ◽  
Healing Rate ◽  
Multicentre Trial ◽  
Epigastric Pain ◽  
Symptomatic Relief ◽  
Ulcer Recurrence ◽  
Double Blind ◽  
Duodenal Ulcers ◽  
Treatment Groups ◽  
Ulcer Healing Rate

Nizatidine, 300 mg once nightly, was compared with cimetidine, 800 mg once nightly, for treatment of 212 adult out-patients with acute duodenal ulcers in an eight-week randomized, double-blind, multicentre trial. Patients were endoscoped at weeks 2, 4 and 8, regardless of ulcer healing status. No significant differences in ulcer healing rates between treatment groups were seen at weeks 2 and 4, but at week 8, nizatidine had a significantly higher ulcer healing rate (P=0.036) than cimetidine (86% versus 74%, respectively). Patients with healed ulcers at either week 2 or week 4 had a final endoscopy performed at week 8. The rate of ulcer recurrence was significantly greater (P=0.021) in the cimetidine group at week 8 compared with the nizatidine group: 21% versus 7.3%, respectively. Increasing tolerance to H2receptor antagonist therapy with prolonged use may explain the higher recurrence rate of cimetidine. Both drugs provided equally rapid and effective symptomatic relief from epigastric pain after two weeks of therapy. Both were equally safe and free from treatment-related adverse effects.

Surgical methods and clinical results of subfascial endoscopic perforator surgery in Japan

2018 ◽  
Vol 33 (10) ◽  
pp. 678-686 ◽  
Author(s):  
Hitoshi Kusagawa ◽  
Naoki Haruta ◽  
Ryo Shinhara ◽  
Yuji Hoshino ◽  
Atsushi Tabuchi ◽  
...  
Keyword(s):  
Ulcer Healing ◽  
Healing Rate ◽  
Clinical Results ◽  
Clinical Severity ◽  
Ulcer Recurrence ◽  
Surgical Methods ◽  
Venous Clinical Severity Score ◽  
Ulcer Healing Rate ◽  
Subfascial Endoscopic Perforator Surgery

Objectives To clarify the surgical methods and the clinical results of subfascial endoscopic perforator surgery in Japan. Methods This study included 1287 limbs of 1091 patients who underwent subfascial endoscopic perforator surgery in 14 hospitals. Simultaneous saphenous vein treatment was performed in 1079 limbs (83.8%), and 118 limbs (9.2%) had deep venous lesions. The venous clinical severity score was calculated before and 6 to 12 months after surgery. The ulcer healing rate and ulcer recurrence rate were calculated cumulatively. Results Preoperative venous clinical severity score was significantly decreased from 10.0 ± 6.6 to 3.1 ± 3.4 ( P < .0001) postoperatively. The primary ulcer healing rate was 96.2% (332/345 C6 limbs) at an average follow-up of 47.7 months, and the ulcer recurrence rate was 12.0% (49/393 C5, C6 limbs) at the average follow-up of 46.0 months after the ulcer healed. Conclusion These results indicate that subfascial endoscopic perforator surgery is an alternative to improve the long-lasting disease severity and/or clinical outcome.

scholarly journals Standard-dose versus high-dose radiotherapy with concurrent chemotherapy in esophageal cancer: A prospective randomized study

2018 ◽  
Vol 07 (01) ◽  
pp. 27-30 ◽  
Author(s):  
Navin Nayan ◽  
M. Bhattacharyya ◽  
Vikas K. Jagtap ◽  
A. K. Kalita ◽  
R. Sunku ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Total Dose ◽  
Standard Dose ◽  
Randomized Study ◽  
Complete Response ◽  
Concurrent Chemotherapy ◽  
Prospective Randomized Study ◽  
High Dose ◽  
Large Sample Size

Abstract Objective: The objective of this study is comparision of local and distant control rates with high-dose versus standard-dose radiotherapy along with concurrent chemotherapy in esophageal cancer – a prospective randomized study. Materials and Methods: Histologically proven Stage I–III patients with carcinoma esophagus were randomized into two groups. One group has been treated with standard-dose radiotherapy, i.e., a total dose of 50.4 Gy (1.8 Gy/day, 28#, 5 days/week). The other group (study arm) has received high-dose radiotherapy, i.e. a total dose of 64.8 Gy (1.8 Gy/day, 36#, 5 days/week). Both groups have received 2 cycles of 3 weekly concurrent chemotherapy (cisplatin 75 mg/m[2] on day 1 and 5-fluorouracil 750 mg/m[2] continuous intravenous infusion over 24 h on day 1–4). Follow-up response evaluation was done by both endoscopy and computed tomography scan after 6–8 weeks and after 2 months thereafter. Results: Out of a total of 28 patients, 68% showed a complete response, 14% showed partial response, and 18% patients developed progressive disease at first and subsequent follow up (median follow-up of 21 months). Among the complete response patients, rates were higher in high-dose group compared to standard-dose radiotherapy group (71% vs. 64%, P = 0.38). Treatment-related toxicities were acceptable in both groups. Conclusion: High-dose radiotherapy with concurrent chemotherapy seems to be more effective with acceptable toxicity in our study. However, further follow-up and large sample size may be required to validate the current study conclusion.

scholarly journals Skin grafting in the treatment of hard-to-heal leg ulcers

2018 ◽  
Vol 2 (1) ◽  
Author(s):  
Giovanni Mosti ◽  
Vincenzo Mattaliano ◽  
Pietro Picerni ◽  
Costantino Christou
Keyword(s):  
Ulcer Healing ◽  
Healing Rate ◽  
Skin Grafting ◽  
Leg Ulcers ◽  
Clinical Routine ◽  
Ulcer Size ◽  
Donor Skin ◽  
Post Traumatic ◽  
Chronic Leg Ulcers

Some risk factors or comorbidities may make Chronic Leg Ulcers (CLU) very difficult to heal. These ulcers are usually defined refractory ulcers and may require an in-hospital intensive care to increase the healing rate. Aim of this retrospective study was to assess if our clinical routine in hospitalized patients, made up with surgical debridement followed by donor skin grafting (allografts), may favor the ulcer healing. The records of 120 patients (55 males and 65 females; mean age 73.9±11.3 years) with ulcers greater than 100 cm2 and lasting for more than 1 year were analyzed. The median ulcer size was 165 cm2 (IQR 130-250 cm2; range 100-1000 cm2). The median ulcer duration was 24 months (IQR 16-32 months; range 12-300 months). The ulcer pathophysiology was venous in 74 patients, arterial in 21, mixed in 12, vasculitis in 5 and post-traumatic in 8 patients. After debridement the patients were submitted to allograft procedures (single or multiple) up to the ulcer healing. When allograft was able to create an effective granulation tissue and reduce the ulcer size an autograft was performed to get the ulcer closure. 109 patients healed and 11 were lost at follow-up. 65 patients healed just with one allograft in 16 weeks (IQR 13-21 weeks). 42 patients healed with 2 procedures in 20 weeks (IQR 18-23 weeks). 31 of them received a final autograft while 11 healed with two allografts. 2 patients with an ulcer surface of 200 cm2, both affected by CLI, healed with 3 allografts procedures in 40 and 33 weeks, respectively. Pain and exudate amount were significantly decreased and even disappeared after the first allograft. Allografts alone or followed by an autograft are able to get the ulcer healing also in case of extensive and long lasting ulcers refractory to all previous treatments.

Efficacy of Phenazone in the Treatment of Acute Migraine Attacks: A Double-Blind, Placebo-Controlled, Randomized Study

Cephalalgia ◽  
2004 ◽  
Vol 24 (10) ◽  
pp. 888-893 ◽  
Author(s):  
H Göbel ◽  
A Heinze ◽  
U Niederberger ◽  
T Witt ◽  
V Zumbroich
Keyword(s):  
Adverse Events ◽  
Randomized Study ◽  
Controlled Study ◽  
Acute Migraine ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Number Of Patients ◽  
Significant Difference ◽  
Main Target

In this study we compared the efficacy of 1000 mg phenazone with that of placebo in the treatment of acute migraine attacks in a randomized double-blind, placebo-controlled study of 208 patients. The main target criterion was the number of patients with a pain reduction from severe or moderate to slight or no pain 2 h after taking the pain medication. The percentage of patients satisfying the main target criterion was 48.6% for phenazone and 27.2% ( P < 0.05) for placebo. Freedom from pain after 2 h was reported by 27.6% with phenazone treatment and 13.6% ( P < 0.05) with placebo. Compared with placebo, the phenazone treatment also resulted in a significant improvement in the associated migraine symptoms of nausea, phonophobia and photophobia. Of patients treated with phenazone 11.4%, and 5.8% of those treated with placebo reported adverse events. There was no significant difference between the groups with regard to numbers of patients with adverse events. No serious adverse events occurred. The results show that phenazone at a dosage of 1000 mg is effective and well tolerated in the treatment of acute migraine attacks.

scholarly journals Near-Infrared Transcranial Radiation for Major Depressive Disorder: Proof of Concept Study

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Paolo Cassano ◽  
Cristina Cusin ◽  
David Mischoulon ◽  
Michael R. Hamblin ◽  
Luis De Taboada ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Near Infrared ◽  
Randomized Study ◽  
Proof Of Concept ◽  
Major Depressive ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Sham Treatment ◽  
New Treatment

Transcranial near-infrared radiation (NIR) is an innovative treatment for major depressive disorder (MDD), but clinical evidence for its efficacy is limited. Our objective was to investigate the tolerability and efficacy of NIR in patients with MDD. We conducted a proof of concept, prospective, double-blind, randomized study of 6 sessions of NIR versus sham treatment for patients with MDD, using a crossover design. Four patients with MDD with mean age 47 ± 14 (SD) years (1 woman and 3 men) were exposed to irradiance of 700 mW/cm2and a fluence of 84 J/cm2for a total NIR energy of 2.40 kJ delivered per session for 6 sessions. Baseline mean HAM-D17scores decreased from 19.8 ± 4.4 (SD) to 13 ± 5.35 (SD) after treatment (t=7.905;df=3;P=0.004). Patients tolerated the treatment well without any serious adverse events. These findings confirm and extend the preliminary data on NIR as a novel intervention for patients with MDD, but further clinical trials are needed to better understand the efficacy of this new treatment. This trial is registered with ClinicalTrials.govNCT01538199.

The lack of sustained effect of bright light in non-seasonal major depression

2006 ◽  
Vol 36 (9) ◽  
pp. 1247-1252 ◽  
Author(s):  
KLAUS MARTINY ◽  
MARIANNE LUNDE ◽  
MOGENS UNDÉN ◽  
HENRIK DAM ◽  
PER BECH
Keyword(s):  
Major Depression ◽  
Randomized Study ◽  
Bright Light ◽  
Light Therapy ◽  
Treated Group ◽  
Bright Light Therapy ◽  
Double Blind ◽  
Sustained Effect ◽  
The Difference

Background. Recently accumulated evidence has demonstrated that bright-light therapy in combination with antidepressants is effective in patients with non-seasonal major depression. Whether bright light has a sustained effect after discontinuation is, however, poorly investigated.Method. In this double-blind randomized study we report the results from a 4-week follow-up period in patients with major non-seasonal depression who had been treated for 5 weeks with sertraline combined with bright-light therapy or sertraline combined with dim-light therapy. At the beginning of the follow-up period the light therapy was stopped while sertraline treatment continued for 4 weeks.Results. Depression scores decreased substantially in both groups, resulting in high response and remission rates in both groups after 9 weeks of treatment. The difference in depression scores at week 5, favouring the bright-light-treated group, disappeared gradually in the 4-week follow-up period, resulting in similar end-point scores.Conclusions. Bright light did not have a sustained effect after discontinuation. The offset of effect was complete after 4 weeks.

Updated results of BICC-C study comparing first-line irinotecan/fluoropymidine combinations with or without celecoxib in mCRC: Updated efficacy data

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4027-4027 ◽  
Author(s):  
C. Fuchs ◽  
J. Marshall ◽  
E. Mitchell ◽  
R. Wierzbicki ◽  
V. Ganju ◽  
...  
Keyword(s):  
Survival Rate ◽  
Randomized Study ◽  
Progression Free Survival ◽  
First Line ◽  
Double Blind ◽  
Period 2 ◽  
Common Grade ◽  
Grade 3 ◽  
One Year

4027 Background: This multicenter, randomized study assessed efficacy & safety for irinotecan/fluoropyrimidines combinations in previously untreated mCRC. Methods: Pts were randomized to: infusional FOLFIRI, modified bolus IFL (mIFL), or CapeIri; and concurrent celecoxib or placebo in a double-blind fashion. The protocol was amended in April 2004: bevacizumab (bev) was added to the FOLFIRI and mIFL arms, whereas CapeIri was discontinued. Period 1 (P1) and Period 2 (P2) designate subjects enrolled before or after the amendment. Initial efficacy & safety analyses were reported at ASCO ’06. We now report follow-up of 46 months for P1 and 31 months for P2. Results: 430 pts were treated in P1 and 117 pts in P2. Baseline characteristics and post-study treatment were balanced. P1 results: Median progression free survival (PFS) was 7.6 mos for FOLFIRI; 5.9 mos for mIFL (p=0.004); and 5.8 mos for CapeIri (p=0.015). Median overall survival (OS) was 23.1 mos for FOLFIRI; 17.6 mos for mIFL (p=0.087); and 18.9 mos for CapeIri (p=0.27). One-year survival rate favored FOLFIRI (75%) compared to either mIFL (65%) or CapeIri (66%). Overall Response Rate (ORR) was 47% in FOLFIRI, 43% in mIFL, 39% in CapeIri (not significantly different). P2 results: Median PFS was 11.2 mos for FOLFIRI+bev and 8.3 mos for mIFL+bev (p=0.28). Median OS was not reached for FOLFIRI+bev but was 19.2 mos for mIFL+bev (p=0.007). One-year survival rate favored FOLFIRI+bev (87%) when compared to mIFL+bev (61%). ORR was 58% for FOLFIRI+bev and 54% for mIFL+bev (p=0.73). Common grade = 3 AEs are listed below. Celecoxib did not impact safety or efficacy. Conclusions: First line FOLFIRI or FOLFIRI+bev were superior to their comparators and show favorable results in survival and tolerability in untreated mCRC. Median survival for FOLFIRI+bev has not been reached. [Table: see text] No significant financial relationships to disclose.

Phase II, randomized, double blind, placebo-controlled study comparing siltuximab plus bortezomib versus bortezomib alone in pts with relapsed/refractory multiple myeloma.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 8018-8018 ◽  
Author(s):  
Robert Z. Orlowski ◽  
Liana Gercheva ◽  
Cathy Williams ◽  
Heather J Sutherland ◽  
Tadeusz Robak ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Response Rate ◽  
Randomized Study ◽  
Controlled Study ◽  
High Dose ◽  
Double Blind ◽  
Disease Characteristics ◽  
Dose Oral ◽  
Secondary Endpoints

8018^ Background: Preclinical studies of siltuximab (S), a chimeric anti-IL-6 mAb, in combination with bortezomib (B) indicate an additive to synergistic effect in multiple myeloma (MM) cell lines. This randomized study evaluated the safety and efficacy of S+B compared with placebo (plc)+B in pts with relapsed/refractory MM after 1−3 prior tx lines, measurable disease but no prior B exposure. Methods: 286 pts were randomized 1:1 to S+B: B+plc. S 6 mg/kg or plc was given IV q2w. B 1.3 mg/m2 was given IV on d 1, 4, 8, 11, 22, 25, 29, 32 for a max of 4 of 42-d cycles and then reduced to q1w for 35-d cycles. B was stopped for pts with PD/intolerability, and high dose oral dexamethasone (dex) 40 mg could then be started qd on d 1−4, 9−12, 17−20 for a max of 4 of 28-d cycles and on d 1−4 of subsequent cycles until PD, while S/plc continued. Primary endpoint was PFS by EBMT criteria censored at the start of dex/subsequent tx. Secondary endpoints included overall response rate (ORR), OS, and safety before dex. Results: 142 and 144 pts received S+B and B+plc, respectively. Baseline demographics and disease characteristics were well balanced across S+B and B+plc, except for age (median 64 vs. 61 yrs) and myeloma type (IgG 65 vs. 71%, IgA 27 vs. 20%). Median tx duration was 5.1 mo in both grps. Median PFS was 8.1 mo in S+B and 7.6 mo in B+plc (HR 0.869, p = 0.345). ORR (CR+PR) was 55% in pts on S+B and 47% on B+plc (p = 0.213); CR rates were 11 and 7% (p = 0.342), respectively. With 24.5 mo median follow up, median OS was 30.8 mo for S+B and 36.9 mo for B+plc (HR 1.353 for S+B, p = 0.103). Fewer pts on S+B than B+plc moved to dex (23 vs. 31%) and had subsequent SCT (5 vs. 11%). Gr ≥3 AEs occurred in 91% on S+B and 74% on B+plc. Common gr ≥3 AEs in S+B were neutropenia (49%), thrombocytopenia (48%), leukopenia (14%). SAEs occurred in 29% on S+B and 24% on B+plc. Death occurred within 30 d of last study agent administration pre-dex in 8% on S+B and 5% on B+plc. Conclusions: The combination of S+B had higher response rates but did not prolong survival compared with B+plc. A negative survival trend heavily influenced by differences in dex and SCT rescue was noted. S+B appears to be generally well tolerated but had a higher incidence of hematologic AEs.

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