No abstract available.
Amantadine* ; Benztropine* ; Double-Blind Method*

BACKGROUND: Pain is a common side-effect of propofol injection. A remifentanil pretreatment has been reported to decrease the incidence and intensity of pain during a propofol injection and has been suggested to act through a central or peripheral effect. This trial was designed to explore the action site of remifentanil on reducing propofol injection pain, using the venous occlusion technique and a time interval between the applications of remifentanil and propofol. METHODS: This randomized, double-blind study was designed to explore the action site of remifentanil on reducing propofol injection pain in 200 patients scheduled for elective surgery. The peripheral properties were examined using the venous occlusion technique for 30 s while a 1 min time interval between remifentanil and propofol injections was allowed for the central effect. Before the propofol injection, group A was pretreated with remifentanil (0.5 microg/ kg) with a venous occlusion, group B with remifentanil and a 1 min interval, and group C with remifentanil with a venous occlusion and a 1 min interval. Pain severity was assessed using a four-point scale. RESULTS: 40 patients (80%) complained of pain in the placebo group compared with 35 (70%) in group A, 20 (40%) in group B (p < 0.05) and 17 (34%) in group C (p < 0.05). The incidence and severity of propofol injection pain were lower in groups B and C than in group A (p < 0.05). However, there was no significant difference between groups B and C. CONCLUSIONS: The remifentanil mediated analgesic effect occurs mainly through the central effect.
Double-Blind Method ; Humans ; Incidence ; Piperidines ; Propofol

Treatment based on syndrome differentiation is an essential feature of traditional Chinese medical diagnosis. The interventions based on changes of syndrome types in randomized controlled trials are complicated, leading to the difficulty of blind method enforcement. This article described a double-blind method. It could be used in randomized controlled trials under the condition of different syndrome types and different medications. It numbered drugs in two stages, and in two phases to achieve double-blind. This method not only guaranteed investigators and subjects to be in blinded conditions, but also achieved using different medications for patients of different syndromes. It also caused no drug waste. It was scientific and feasible.
Double-Blind Method ; Humans ; Medicine, Chinese Traditional ; Randomized Controlled Trials as Topic ; Single-Blind Method

BACKGROUND/AIMS: This study assessed the efficacy and safety of high-dose multimatrix mesalazine once-daily (QD) compared to another form of high-dose mesalazine. METHODS: In this multicenter, randomized, double-blind study, 280 patients with mildly to moderately active ulcerative colitis (UC) received multimatrix mesalazine 4.8 g/day QD or pH-dependent-release mesalazine 3.6 g/day three times daily for 8 weeks. The primary endpoint was the change in the UC-Disease Activity Index (UC-DAI) at the end of the treatment period. RESULTS: The change in the UC-DAI (mean±standard deviation) in the per-protocol set was −2.6±2.47 in the multimatrix mesalazine 4.8 g/day group (n=134) and −1.8±2.64 in the pH-dependent-release mesalazine 3.6 g/day group (n=129). The difference in the mean change between the 2 groups was −0.7 (two-sided 95% confidence interval, −1.3 to −0.1). The noninferiority of multimatrix mesalazine 4.8 g/day to pH-dependent-release mesalazine 3.6 g/day was verified within the noninferiority margin (1.1). The superiority of multimatrix mesalazine 4.8 g/day to pH-dependent-release mesalazine 3.6 g/day was also investigated and confirmed in the full analysis set, according to the study protocol. In subgroup analyses, the effectiveness of multimatrix mesalazine 4.8 g/day was consistent in all subgroups. There was no difference in safety between the 2 treatment groups. CONCLUSIONS: Multimatrix mesalazine 4.8 g/day has higher efficacy and shows no difference in safety in mildly to moderately active UC, in comparison with pH-dependent-release mesalazine 3.6 g/day.
Colitis, Ulcerative* ; Double-Blind Method* ; Humans ; Mesalamine* ; Ulcer*

PURPOSE: To investigate the effects of the intake of xylooligosaccharide-sugar mixture (XOS) on defecation frequency and symptoms in 56 young women (mean age of 22.1 years old) with constipation. METHODS: Two experiments were conducted. In experiment 1, a randomized double-blind study was performed to evaluate the effect of 6 weeks' intake of 10 g sucrose containing 7% xylooligosaccharide or 10 g sucrose on constipation. In experiment 2, 24 g coffee mixture containing 12.8 g plant cream and 11.2 g xylooligosaccharide-sugar mixture was consumed by the subjects. During the study, the clinical efficacy was assessed by using a daily diary. The subjects indicated the number of frequencies they defecated in a day and the clinical symptom scores. RESULTS: In experiment 1, the mean frequency of defecations was 2.07 in the pretreatment week and increased significantly to 4.05, 4.42, 4.84, 4.84, and 4.05 in weeks 2 to 6 of XOS intake, in comparison with the 3-3.67 with sucrose intake (sucrose, SUC). In experiment 2, the mean frequency of defecations significantly increased from 2.47 in the pretreatment week to 4.11-5.67 in weeks 1-6 of XOS intake. The occurrence of very loose or loose stools in the XOS group was significantly increased in weeks 5 and 6, compared with the pretreatment week and SUC group. XOS intake significantly alleviated the abdominal displeasure and feeling of residual stool leftness in weeks 2, 3, 5, and 6, while SUC did so in weeks 4 and 6 (p < 0.05). The coffee mixture containing xylooligosaccharide-sugar mixture reduced the abdominal displeasure and feeling of residual stool leftness from week 3 until the end of the experiment (p < 0.05). CONCLUSION: Our results suggest that xylooligosaccharide-sugar mixture intake was effective, without adverse effects, for the alleviation of constipation in the young women in this study.
Coffee ; Constipation* ; Defecation* ; Double-Blind Method ; Female ; Humans ; Plants ; Sucrose

In order to evaluate the the effectiveness of low-dose longterm Vibramycin (Doxycycline) treatment on Acne Vulgaris, a double-blind study was performed on fifty two patients with Acne Vulgaris. The patients were classified as to the severi.ty of their disease before treatment according to Wand. et al. The degree of the effcctiveness of the treatment was evaluated every other week for 12 weeks on the grounds of clinical improvement. The therapeutic results obtaincd were as follovs: araong the 19 patients who received 50 mg per day for 12 weeks, 13 cases (72.2%) showed excellent improverrent after 6 weeks; whereas in thc placebo group only 4 out of 15 patients (26. 7%) showed good response, Statistical analysis of the data revealed that there was a significant difference (p<0.05) in effectiveness between the Vibrarzycin 50mg per day group and the placebo group. Among the 19 patient who received a 100mg capsile orally per day for 4 weeks (subsequently this group received 50mg per day for 8 weeks) 13 cases.(68.4%) showed excellent improvement in 4 weeks; whereas in the placebo group only 4 cases(26, 7%) showed good respnnse Statistical analysis of this data revealed that there was a significant difference (p<0. 05) in efectivencess the Vibramycin 100mg per day group and the placebo group, It was noted that 44 out of 52 patients (83%) had a distinct family history of the disease, suggesting that there might be a predisposing hereditary factor involvcd in the manifestation of Acne Vulgaris It is concluded f rom this study that Vibramycin, when administrated in a dose of 50mg per day for more than 6 weeks is effective in the treatment of Acne Vulgaris.
Acne Vulgaris* ; Double-Blind Method* ; Doxycycline* ; Dronabinol ; Humans

BACKGROUND/AIMS: This study compared the efficacy of once-daily administration of multimatrix mesalazine 2.4 g/day with multiple-dose mesalazine for the maintenance of remission. METHODS: In this multicenter, randomized, double-blind study, 203 patients with ulcerative colitis in remission received multimatrix mesalazine 2.4 g/day once-daily or time-dependent (controlled-release) mesalazine 2.25 g/day 3 times-daily for 48 weeks. The primary efficacy endpoint was the proportion of patients without rectal bleeding. RESULTS: The proportion of patients without rectal bleeding during the 48-week treatment period in the per protocol set was 84.8% (84/99) in the multimatrix mesalazine 2.4 g/day group and 78.0% (78/100) in the controlled-release mesalazine 2.25 g/day group. The difference between the 2 treatment groups was 6.8% (two-sided 95% confidence interval, −3.9% to 17.6%). The noninferiority margin of −10% was met in the comparison of multimatrix mesalazine 2.4 g/day once-daily with controlled-release mesalazine 2.25 g/day. Multimatrix mesalazine 2.4 g/day once-daily demonstrated consistent efficacy in all subgroups. There was no difference between the 2 treatment groups with regard to safety. CONCLUSIONS: A once-daily dose of 2 multimatrix mesalazine tablets (2.4 g) was not inferior to controlled-release mesalazine 2.25 g/day 3 times-daily in maintaining absence of rectal bleeding in ulcerative colitis.
Colitis, Ulcerative* ; Double-Blind Method* ; Hemorrhage ; Humans ; Mesalamine* ; Tablets ; Ulcer*

OBJECTIVES: To evaluate the efficacy of trimetazidine dihydrochloride as a treatment for chronic tinnitus. METHODS: A total of 97 chronic tinnitus patients were evaluated in this randomized, prospective, double-blind, placebo-controlled trial. After assessing for eligibility, 82 patients were randomly assigned into placebo or trimetazidine groups according to the medication. The trimetazidine group received 20×3 mg/day per oral trimetazidine dihydrochloride and the placebo group received 20×3 mg/day per oral placebo for 3 months. Tinnitus handicap inventory (THI), visual analogue scale (VAS) questionnaires and audiometric results were used to determine the effectiveness of trimetazidine treatment. RESULTS: The study group comprised 82 tinnitus subjects, 42 (51%) of whom received trimetazidine dihydrochloride and 40 (49%) who received placebo. There was no significant difference between placebo and trimetazidine groups in THI grade and VAS (both pre- and posttreatment scores) (P>0.05) and no significant improvement was observed in subjective loudness score in either group (P>0.05). Additionally there was no significant difference between groups in pre- and posttreatment pure tone hearing thresholds at all measured frequencies (P>0.05). CONCLUSION: Trimetazidine dihydrochloride therapy was ineffective for relieving chronic tinnitus.
Double-Blind Method* ; Hearing ; Humans ; Prospective Studies ; Tinnitus* ; Trimetazidine*

Authors compared prospectively anterior transposition to myectomy of the inferior oblique. Thirteen patients with symmetrical +3 overaction of the inferior oblique were operated: one eye was performed with anterior transposition, the other eye of the same patient with myectomy, and evaluated with double masked method. Duration of follow up examination was from 6 to 9 months (mean 6.7 months). At 6 months following surgery, in 4 among the 13 patients the results of the two procedures were same, but in other 9 patients, those with anterior transposition were better than with myectomy (p<0.05), Inferior oblique action following myectomy was variable from -0.5 underaction to +2 overaction. but stable from -0.5 underaction to +0.5 overaction in anterior transposition cases (p<0.05). It appears that anterior transposition of the inferior oblique is superior to myectomy for the treatment of overaction of inferior obliuqe.
Double-Blind Method ; Follow-Up Studies ; Humans ; Prospective Studies

This clinical study was designed to determine the clinical and microbiological outcomes and safety of using minocycline loaded polycaprolactone strip for pericoronitis patients. 64 patients showing symptoms and signs of pericoronitis were enrolled according to the inclusion criteria in this double blind study. They were randomly assigned to two groups. 32 patients comprised control group and they received only polycaprolactone films in pericoronal spaces, and another 32 patients comprised experimental group and they received polycaprolactone films loaded with 30% minocycline. Informed consent was obtained from all the participants before beginning the study. At the initial visit, gingival index(GI), papillary bleeding index(PBI), amount of gingival crevicular fluid(GCF) were recorded, and microbiological sampling was done. Then, loaded or unloaded polycaprolactone film was inserted into the pericoronal spaces. No drug was prescribed excepting this film. After one week, clinical and microbiological exam was repeated. Presence of any side effects or inconveniences were checked. Chi-square test and t-test was performed to compare outcomes. At baseline, there were no significant differences in all the criteria between experimental group and control group. Experimental group showed significant improvement compared with control group both in GI(p<0.01) and PBI(p<0.01). The amount of GCF of the experimental group was significantly decreased compared with the control group(p<0.01) and baseline(p<0.01). In microbiological study, percentage of motile rod was prominently decreased in the experimental group. Also, aerobic(p<0.001), anaerobic(p<0.001) and black pigmented(p<0.01) bacteria were significantly decreased from the baseline. Furthermore, no side effects or inconveniences was reported in the experimental group. From this study, it was concluded that insertion of polycaprolactone film with 30% minocycline into the pericoronal spaces would be effective and safe treatment for pericoronitis.
Bacteria ; Double-Blind Method ; Hemorrhage ; Humans ; Informed Consent ; Minocycline* ; Pericoronitis*