Double blind trial of ritodrine and placebo in twin pregnancy.

In a double blind trial, 25 patients with twin pregnancy were given 40 mg of ritodrine hydrochloride by mouth daily and 24 similar patients received a placebo. The ritodrine group had no significant prolongation of pregnancy nor increase in birth weight, and a high incidence of side effects occurred.     

The treatment of detrusor instability in post-menopausal women with oxybutynin chloride: a double blind placebo controlled study

Idiopathic detrusor instability is a common cause of incontinence in the elderly for which anticholinergic agents are regularly prescribed. Oxybutynin chloride combines anticholinergic action with direct muscle relaxant properties. We performed a double blind placebo controlled fixed dose cross over study of oxybutynin chloride in post-menopausal women suffering from detrusor instability. We found oxybutynin chloride significantly more effective than placebo at reducing the symptoms of urgency and urge incontinence and more effective at reducing the height of the highest unstable detrusor contraction. This was at the expense of an increased residual urine and considerable side effects.     

The treatment of detrusor instability in postmenopausal women with oxybutynin chloride: a double blind placebo controlled study

Summary. Idiopathic detrusor instability is a common cause of incontinence in the elderly for which anticholinergic agents arc regularly prescribed. Oxybutynin chloride combines anticholinergic action with direct muscle relaxant properties. We performed a double blind placebo controlled fixed dose cross over study of oxybutynin chloride in postmenopausal women suffering from detrusor instability. We found oxybutynin chloride significantly more effective than placebo at reducing the symptoms of urgency and urge incontinence and more effective at reducing the height of the highest unstable detrusor contraction. This was at the expense of an increased residual urine and considerable side effects.     

The efficacy and safety of aceclofenac versus placebo and naproxen in women with primary dysmenorrhoea

OBJECTIVE: To determine the analgesic efficacy and safety of a single oral dose of aceclofenac 100 mg and compare that with placebo and naproxen 500 mg in women with primary dysmenorrhoea. STUDY DESIGN: In this double-blind, prospective, multicentre, randomised, three-way, crossover study, women were randomly assigned to receive one of six treatment sequences, comprising single oral doses of aceclofenac 100 mg, naproxen 500 mg or placebo, when menstrual pain reached a predetermined level of severity. A single dose of the assigned study medication was taken on three menstrual periods; a different medication was taken on each treatment day. Analgesic efficacy was determined by self-reported analgesia scoring and participants' and investigators' global evaluation of treatment effectiveness. Measurements also included physical examination and adverse events. RESULTS: Total pain relief scores were not statistically significantly different for aceclofenac and naproxen, and both were statistically significantly more effective than placebo (p = 0.019 and 0.002, respectively). This finding was supported by secondary endpoints including sum of pain intensity differences (SPID/8), peak analgesia (peak pain intensity and peak pain relief), and participants' and investigators' overall evaluation of effectiveness. Both aceclofenac and naproxen were well tolerated. CONCLUSIONS: Aceclofenac (100 mg) and naproxen (500 mg) effectively treated the pain associated with primary dysmenorrhoea, and both were more effective than placebo at easing menstrual pain assessed by various pain relief criteria.     

金振口服液有效性和安全性的多中心、随机对照临床研究

摘要：目的　评价金振口服液祛痰止咳的有效性、安全性和依从性。 方法　采用前瞻性、多中心、随机双盲、平行对照临床研究。共4个中心参与研究,实际符合入选方案病例239例,其中试验组120例,口服金振口服液;对照组119例,口服急支糖浆;疗程均为5 d。比较两组咳嗽、咳痰、喘息、肺部体征、发热、鼻塞、流涕、咽部充血等各单项症状改善率以及综合症状改善率、总有效率,观察药物不良反应和依从性。结果　两组均有显效,但试验组用药后第3天、第5天除咽部充血外,其他各单项症状改善均优于对照组（P < 0.0001）。试验组综合疗效改善率第3天为60.0%、第5天为90.0%,明显优于对照组;至用药后第5天,试验组总有效率为96.67%,对照组为64.71%,两组间比较差异有统计学意义（P = 0.0000）。金振口服液依从性达98.33%,试验期间无不良事件发生。结论　金振口服液治疗小儿由急性上呼吸道感染、气管支气管炎和轻型肺炎等引起的咳嗽、咳痰、喘息、发热鼻塞、流涕等症状有显著疗效,且安全性好、依从性高,是一种适用于儿童的祛痰止咳中成药。     

Unsatisfactory colposcopy and the response to orally administered oestrogen: a randomized double blind placebo controlled trial

Thirty-six women with dyskaryotic cervical smears and unsatisfactory colposcopy were randomly allocated to receive either 30 micrograms ethinyl oestradiol or placebo daily by mouth for 10 days. Thirty-four women were available for review (17 women in each of the two groups), full colposcopic inspection of the transformation zone was possible in a significantly greater proportion of the oestrogen treated group (70% versus 23%, P less than 0.01). As most diagnostic conizations are currently performed on the basis of unsatisfactory colposcopy, the use of oestrogen medication followed by colposcopic reassessment should permit a reduction in the number of patients subject to operation.     

Unsatisfactory colposcopy and the response to orally administered oestrogen: a randomized double blind placebo controlled trial

Summary. Thirty-six women with dyskaryotic cervical smears and unsatisfactory colposcopy were randomly allocated to receive either 30 μg ethinyl oestradiol or placebo daily by mouth for 10 days. Thirty-four women were available for review (17 women in each of the two groups), full colposcopic inspection of the transformation zone was possible in a significantly greater proportion of the oestrogen treated group (70% versus 23%, P <0.01). As most diagnostic conizations are currently performed on the basis of unsatisfactory colposcopy, the use of oestrogen medication followed by colposcopic reassessment should permit a reduction in the number of patients subject to operation.     

Inhibition of puerperal lactation. A double blind study of bromocriptine and placebo.

Bromocriptine and placebo were randomly allocated for three weeks to 52 postpartum patients requiring lactation suppression. Bromocriptine significantly lowered plasma prolactin levels and suppressed breast milk, breast pain and engorgement quicker than placebo. No side-effects were noted and rebound lactation did not occur. Menstruation appeared to re-start sooner when Bromocriptine was given.     

Prostaglandin induced cervical ripening under tocolytic cover in primiparae: results of a double blind placebo controlled trial

Summary. In a double blind trial, 60 nulliparae with a modified Bishop score of 5 requiring induction of labour, received either 8 mg of salbutamol or an identical placebo orally, 30 min before vaginal administration of 2 mg prostaglandin E₂ gel. Women in the salbutamol group experienced less uterine activity over the subsequent 12 h compared with those given placebo, and fewer (35%) commenced labour compared with the placebo group (62%). However, the change in cervical score was significantly less in the salbutamol group (mean 3.0, SD 3.1) than that in the placebo group (mean 5.8, SD 3.2), and the prostaglandin treatment to delivery time in the salbutamol group (mean 26.1 h, SD 6.49) was significantly longer than that in the placebo group (mean 19.3 h, SD 7.95). The first stage of labour lasted >10h in 11 women in the salbutamol group compared with five in the placebo group. Side effects attributable to salbutamol occurred in 10% > of the treated women but in none of their fetuses and fetal outcome was satisfactory and similar in both groups. Our findings show that salbutamol can suppress prostaglandin-induced uterine activity during cervical ripening, which could be an advantage in induction of labour where a planned delivery is preferred. However, the poorer outcome of labour in salbutamol-treated women mitigates against this approach.     

Prostaglandin induced cervical ripening under tocolytic cover in primiparae: results of a double blind placebo controlled trial

In a double blind trial, 60 nulliparae with a modified Bishop score of less than or equal to 5 requiring induction of labour, received either 8 mg of salbutamol or an identical placebo orally, 30 min before vaginal administration of 2 mg prostaglandin E2 gel. Women in the salbutamol group experienced less uterine activity over the subsequent 12 h compared with those given placebo, and fewer (35%) commenced labour compared with the placebo group (62%). However, the change in cervical score was significantly less in the salbutamol group (mean 3.0, SD 3.1) than that in the placebo group (mean 5.8, SD 3.2), and the prostaglandin treatment to delivery time in the salbutamol group (mean 26.1 h, SD 6.49) was significantly longer than that in the placebo group (mean 19.3 h, SD 7.95). The first stage of labour lasted greater than 10 h in 11 women in the salbutamol group compared with five in the placebo group. Side effects attributable to salbutamol occurred in 10% of the treated women but in none of their fetuses and fetal outcome was satisfactory and similar in both groups. Our findings show that salbutamol can suppress prostaglandin-induced uterine activity during cervical ripening, which could be an advantage in induction of labour where a planned delivery is preferred. However, the poorer outcome of labour in salbutamol-treated women mitigates against this approach.     

Effect of intravenous hyoscine-N-butyl bromide on active phase of labor progress: a randomized double blind placebo controlled trial

Introduction: Appropriate cervical dilatation and effacement are essential for the progression of labor. With the active management of labor, number of cesarean deliveries reduces and the duration of labor shortens. Cervical dilatation can be facilitated by mechanical, pharmacological and non-pharmacologic methods. Cervix is richly supplied by autonomic nerves, which may play a role in the dilatation of cervix. Hyoscine-N-butylbromide (HBB) is a muscarinic antagonist and acts as a cervical spasmolytic agent. After intravenous administration it is rapidly distributed into the tissues. We aimed to study the effects and safety of a single dose 20?mg HBB injection during the active phase of labor in both primi- and multigravid women.

Materials and method: A randomized, double-blinded, controlled trial, with healthy primigravid and multigravid women in spontaneous labor at term was considered in this study. Once the active phase of labor was achieved, either a single dose of 20?mg (1?mL) of HBB or placebo (1?mL saline) was given intravenously.

Results: The mean duration of the first stage of labor was 191.1?±?43.06?min in the primigravid patients of the HBB group, while it was 248.2?±?66.1?min in the placebo group, a statistically significant difference of 57?min (p?p?Conclusion: A single dose of 20?mg intravenous HBB is effective and safe in shortening the duration of the first stage of labor without any adverse effects on fetus and mother.     

Prospective study of the efficacy and safety of occlusive sterilization with phenol-mucilage]

A prospective study on the safety and effectiveness of female sterilization using chemical occlusion of Fallopian tubes was conducted in 2 Chinese rural townships. 471 women aged 20-35 who had 2 or more children were recruited for the study. These women were randomly assigned to 2 groups each using a different chemical solution for the sterilization. Group A used Guangdong solution and Group B used Shanghai solution. After the injection of the solution into the Fallopian tubes, X-ray examination was conducted to determined the length of blockage obtained with the solution. Those with a blockage length of 1.5 cm received another injection in 3 months. Follow-up examinations were conducted at 7-14 days and 3, 6, 12, and 24 months. The results were processed with computer and chi-square and t tests were conducted. In 231 cases that received chemical occlusion with Guangdong solution, 18 become pregnant within 2 years, with a success rate of 92.2%. Among 231 women who received Shanghai solution, 4 become pregnant in 2 years, with a success rate of 98.3%. The difference was statistically significant. No serious side effects or complications were observed after the procedure. The study result has shown that chemical occlusion of Fallopian tubes was a safe and effective method of female sterilization. The key to the success of the procedure was the skill of the service provider. The length of blockage of tubes is a very important factor affecting effectiveness. Therefore, the massive application of such a method will require the standardization of operation skills.     

A prospective placebo controlled double blind randomised study to investigate the use of indoramin to prevent post-operative voiding disorders after surgical treatment for genuine stress incontinence

A prospective placebo controlled double blind randomised study was undertaken to investigate the use of indoramin an alpha blocker to prevent post-operative voiding disorders after surgical treatment for genuine stress incontinence. Fifty-six patients were randomised to receive indoramin 20 mg orally twice a day or identical placebo from the first post-operative day until discharge from hospital. After seven exclusions, 49 patients were included in the study. There was no significant differcnce between the treatment (indoramin) group and placebo group for any of the outcomes measured. The routine use of indoramin to prevent post-operative voiding problems cannot be justified on the basis of these data.     

Randomised, double-blind, placebo controlled pilot study assessing nitroglycerin as a tocolytic

Thirty-three women in preterm labour were randomised in a double-blind fashion to receive either transdermal nitroglycerin (   n = 17  ) or placebo (   n = 16  ). Both groups had significant (   P < 0.001  ) change in the cervix prior to randomisation. The primary outcome measure was delivery within 48 hours of randomisation. Fewer women randomised to nitroglycerin treatment (6/17) were delivered within 48 hours, compared with the placebo treatment (10/16) (RR 0.56, 95% CI 0–27 to 1.19). This pilot study lends support to two case series published that suggest that transdermal nitroglycerin may be promising as a safe, effective means for tocolysis.