Improvement of erectile function with Prelox: a randomized, double-blind, placebo-controlled, crossover trial

In a randomly allocated, double-blind, placebo-controlled, crossover design, 50 patients with mild to moderate erectile dysfunction (ED) were treated for 1 month with placebo or a combination of L-arginine aspartate and Pycnogenol (Prelox). Patients reported sexual function from diaries. Testosterone levels and endothelial NO synthase (e-NOS) were monitored along with routine clinical chemistry. Intake of Pycnogenol for 1 month restored erectile function to normal. Intercourse frequency doubled. e-NOS in spermatozoa and testosterone levels in blood increased significantly. Cholesterol levels and blood pressure were lowered. No unwanted effects were reported. Prelox is a promising alternative to treat mild to moderate ED.     

Molgramostim (GM-CSF) associated with antibiotic treatment in nontraumatic abdominal sepsis: a randomized, double-blind, placebo-controlled clinical trial

HYPOTHESIS: The addition of molgramostim (recombinant human granulocyte-macrophage colony-stimulating factor) to antibiotic therapy for nontraumatic and generalized abdominal sepsis is effective and has a significant impact on length of hospitalization, direct medical costs, and mortality. DESIGN: Randomized, double-blind, placebo-controlled clinical trial. SETTING: Tertiary referral center. PATIENTS: Fifty-eight patients with abdominal sepsis. INTERVENTIONS: Patients were allocated to receive, in addition to ceftriaxone sodium, amikacin sulfate, and metronidazole, molgramostim in a daily dosage of 3 microg/kg for 4 days (group 1) or placebo (group 2). Antibiotics were administered for at least 5 days and discontinued after clinical improvement had occurred and white blood cell count had been normal for 48 hours. MAIN OUTCOME MEASURES: Time to improvement, duration of antibiotic therapy, hospital stay, complications, mortality, and adverse reactions to drugs. RESULTS: Median time to improvement was 2 days in group 1 and 4 days in group 2 (P<.005). Median length of hospitalization was 9 and 13 days, respectively (P<.001), and median duration of antibiotic therapy was 9 and 13 days, respectively (P<.001). Numbers of infectious complications in the 2 groups were, respectively, 6 and 16 (P = .02); of residual abscesses, 3 and 5; and of deaths, 2 and 2. Costs per patient were 12,333 dollars and 16,081 dollars (US dollars), respectively. CONCLUSION: Addition of molgramostim to antibiotic therapy reduces the rate of infectious complications, the length of hospitalization, and costs in patients with nontraumatic abdominal sepsis.     

Cabergoline treatment in men with psychogenic erectile dysfunction: a randomized, double-blind, placebo-controlled study

The effectiveness of cabergoline in 50 men with psychogenic erectile dysfunction was investigated in a 4-month, randomized, placebo-controlled, double-blind study with validated psychological tests, and prolactin, follicle-stimulating hormone, luteinizing hormone and testosterone serum levels. Cabergoline treatment was well-tolerated and resulted in normalization of hormone levels in most cases. In the cabergoline-treated group, significant interactions between prolactin and testosterone serum concentrations were observed. Erectile function improved significantly. Sexual desire, orgasmic function, and the patient's and his partner's sexual satisfaction were also enhanced. Cabergoline may be an effective and safe alternative agent for men with psychogenic ED.     

Homeopathic treatment of mild traumatic brain injury: A randomized, double-blind, placebo-controlled clinical trial

BACKGROUND: Mild traumatic brain injury (MTBI) affects 750,000 persons in the United States annually. Five to fifteen percent have persistent dysfunction and disability. No effective, standard pharmacological treatment exists specifically for this problem. We designed a pilot research project to study the clinical effectiveness of homeopathic medicine in the treatment of persistent MTBI. METHOD: A randomized, double-blind, placebo-controlled trial of 60 patients, with a four-month follow-up (N = 50), was conducted at Spaulding Rehabilitation Hospital (SRH). Patients with persistent MTBI (mean 2.93 years since injury, SD 3.1) were randomly assigned to receive a homeopathic medicine or placebo. The primary outcome measure was the subject-rated SRH-MBTI Functional Assessment, composed of three subtests: a Difficulty with Situations Scale (DSS), a Symptom Rating Scale (SRS), and a Participation in Daily Activities Scale (PDAS). The SRH Cognitive-Linguistic Test Battery was used as the secondary measure. RESULTS: Analysis of covariance demonstrated that the homeopathic treatment was the only significant or near-significant predictor of improvement on DSS subtests (P =.009; 95% CI -.895 to -.15), SRS (P =.058; 95% CI -.548 to.01) and the Ten Most Common Symptoms of MTBI (P =.027; 95% CI -.766 to -.048). These results indicate a significant improvement from the homeopathic treatment versus the control and translate into clinically significant outcomes. CONCLUSIONS: This study suggests that homeopathy may have a role in treating persistent MTBI. Our findings require large-scale, independent replication.     

No effect of enoxaparin on outcome of aneurysmal subarachnoid hemorrhage: a randomized, double-blind, placebo-controlled clinical trial

OBJECT: From the moment an intracranial aneurysm ruptures, cerebral blood flow is impaired, and this impairment mainly determines the outcome in patients who survive after the initial bleeding. The exact mechanism of impairment is unknown, but activation of coagulation and fibrinolysis correlate with clinical condition and outcome after aneurysmal subarachnoid hemorrhage (SAH). The purpose of this study was to determine whether enoxaparin, a low-molecular-weight heparin, which is a well-known anticoagulating agent, has any effect on the outcome of aneurysmal SAH postoperatively. METHODS: In this randomized, double-blind, single-center clinical trial, 170 patients (85 per group) with aneurysmal SAH were randomly assigned to receive either enoxaparin (40 mg subcutaneously once daily) or a placebo, starting within 24 hours after occlusion of the aneurysm and continuing for 10 days. Analysis was done on an intention-to-treat basis. Outcome was assessed at 3 months on both the Glasgow Outcome and modified Rankin Scales. Patients were eligible for the study if surgery was performed within 48 hours post-SAH, and no intracerebral hemorrhage was larger than 20 mm in diameter on the first postoperative computerized tomography scan. At 3 months, there were no significant differences in outcome by treatment group. Of the 170 patients, 11 (6%) died, and only 95 (56%) had a good outcome. Principal causes of unfavorable outcome were poor initial condition, delayed cerebral ischemia, and surgical complications. There were four patients with additional intracranial bleeding in the group receiving enoxaparin. The bleeding was not necessarily associated with the treatment itself, nor did it require treatment, and there were no such patients in the placebo group. CONCLUSIONS: Enoxaparin seemed to have no effect on the outcome of aneurysmal SAH in patients who had already received routine nimodipine and who had received triple-H therapy when needed. Routine use of low-molecular-weight heparin should be avoided during the early postoperative period in patients with SAH, because this agent seems to increase intracranial bleeding complications slightly, with no beneficial effect on neurological outcome.     

Beta-blocker/thiazide combination for treatment of hypertensive children: a randomized double-blind,placebo-controlled trial

Antihypertensive medications are used extensively in children despite a paucity of randomized, placebo-controlled trials. This study was among the first randomized, controlled pediatric antihypertensive medication trials, in which the combination drug bisoprolol fumarate/hydrochlorothiazide (B/HT) was compared with placebo. The study comprised a 2-week single-blind placebo screening period, a 6-week double-blind dose titration period, a 4-week double-blind dose maintenance period, and a 2-week double-blind dose-tapering period. One hundred and forty subjects were enrolled to achieve 94 randomized subjects treated either with B/HT (n=62) or placebo (n=32). B/HT induced significant reductions compared with placebo for average sitting systolic blood pressure (SiSBP) (9.3 vs. 4.9 mmHg, P<0.05) and sitting diastolic blood pressure (SiDBP) (7.2 vs. 2.7 mmHg, P<0.05). The placebo-subtracted BP reductions were greater in younger children and those with more-severe baseline hypertension. The percentage of subjects with BP less than the 90th percentile at study completion was 45% for B/HT and 34% for placebo (P=NS). Although the study demonstrated that B/HT reduced BP safely compared with placebo, the large placebo effect and failure of most subjects to achieve target BP control make it uncertain whether B/HT is appropriate first-line therapy for pediatric hypertension, particularly in adolescents with mild-to-moderate BP elevation. Received: 14 November 2001 / Revised: 3 January 2002 / Accepted: 4 January 2002     

前列安栓治疗慢性前列腺炎的安全性和有效性:随机双盲安慰剂对照试验

目的　评价前列安栓治疗各型慢性前列腺炎的安全性、有效性和依从性。　方法　多中心随机双盲安慰剂对照研究。 12 5例慢性前列腺炎患者根据美国国立卫生院 (NIH)前列腺炎分型标准分型后随机分为治疗组和对照组 ,治疗组 (6 5例 )前列安栓 1粒 ,对照组 (6 0例 )安慰剂 1粒 ,肛内用药每晚 1次 ,疗程 1个月。以NIH慢性前列腺炎症状评分 (NIH CPSI)和前列腺按摩液 (EPS)白细胞计数为疗效评价指标。　结果　试验结束时 ,12 4例可评价病例中Ⅱ型 4 8例 (38.7% ) ,Ⅲa型 4 5例 (36 .3% ) ,Ⅲb型 31例 (2 5 .0 % )。治疗组NIH CPSI总分用药前后分别为 (2 5 .4 5± 5 .82 )和 (15 .0 8± 7.84 )分 ,平均降低 10 .37分 ,症状程度评分用药前后分别为 (16 .76± 4 .0 7)和 (9.4 2± 5 .38)分 ,平均降低 7.34分 ;对照组NIH CPSI总分用药前后分别为 (2 2 .87± 5 .79)和 (16 .2 2± 6 .2 3)分 ,平均降低 6 .6 5分 ,症状程度评分用药前后分别为 (15 .2 7± 3.86 )和 (10 .5 5± 4 .2 9)分 ,平均降低 4 .72分 ;治疗组NIH CPSI总分与症状程度评分的下降幅度均较对照组更明显 (P <0 .0 1)。治疗组总显效率2 8.1% (18/ 6 4 ) ,总有效率 71.9% (4 6 / 6 4 ) ,对照组总显效率 13.3% (8/ 6 0 ) ,总有效率 4 1.7% (2 5 / 6 0 )     

The effect of solifenacin on postvoid dribbling in women: results of a randomized,double-blind placebo-controlled trial

Introduction and hypothesis

To determine the effectiveness of the muscarinic receptor antagonist solifenacin (VESIcare®) in the treatment of postvoid dribbling (PVD).

Methods

We carried out a multicenter, 12-week, double-blind, randomized, placebo-controlled, parallel design study. Between 2012 and 2015, a total of 118 women (age 18–89 years) with PVD at least twice/weekly, were randomized to receive solifenacin (5 mg; n?=?58) or placebo (n?=?60) once daily. The primary outcome was the percentage reduction in PVD episodes. Secondary outcomes included the percentage of patients with ≥50% reduction in PVD episodes and changes in quality of life.

Results

There were no differences in either the primary or secondary outcome variables. Subgroup analysis, based on those with more severe disease (>10 PVD episodes/week), showed a greater and significant percentage reduction in the frequency of PVD episodes per day (60.3% vs 32.1%; p =?0.035) and a higher percentage of patients showing ≥50% reduction in the frequency of PVD episodes with solifenacin (68.1% vs 45.8%; p =?0.0476). A significant solifenacin effect occurred at week 2 and continued through week 12 for the subgroup. For solifenacin, PVD reduction was the same for the entire cohort and subgroup, whereas for placebo, it was 10% lower in the subgroup, declining from 42% to 32%.

Conclusion

There were no differences in PVD outcomes between the solifenacin and placebo groups. Solifenacin may play a role in treating women with the most severe symptoms. Because of the powerful placebo response seen in this study, behavior-based interventions may be useful for treating PVD.

     

Recombinant coagulation factor VIIa in major liver resection: a randomized, placebo-controlled, double-blind clinical trial

BACKGROUND: Prevention of bleeding episodes in noncirrhotic patients undergoing partial hepatectomy remains unsatisfactory in spite of improved surgical techniques. The authors conducted a randomized, placebo-controlled, double-blind trial to evaluate the hemostatic effect and safety of recombinant factor VIIa (rFVIIa) in major partial hepatectomy. METHODS: Two hundred four noncirrhotic patients were equally randomized to receive either 20 or 80 microg/kg rFVIIa or placebo. Partial hepatectomy was performed according to local practice at the participating centers. Patients were monitored for 7 days after surgery. Key efficacy parameters were perioperative erythrocyte requirements (using hematocrit as the transfusion trigger) and blood loss. Safety assessments included monitoring of coagulation-related parameters and Doppler examination of hepatic vessels and lower extremities. RESULTS: The proportion of patients who required perioperative red blood cell transfusion (the primary endpoint) was 37% (23 of 63) in the placebo group, 41% (26 of 63) in the 20-microg/kg group, and 25% (15 of 59) in the 80-microg/kg dose group (logistic regression model; P = 0.09). Mean erythrocyte requirements for patients receiving erythrocytes were 1,024 ml with placebo, 1,354 ml with 20 microg/kg rFVIIa, and 1,036 ml with 80 microg/kg rFVIIa (P = 0.78). Mean intraoperative blood loss was 1,422 ml with placebo, 1,372 ml with 20 microg/kg rFVIIa, and 1,073 ml with 80 microg/kg rFVIIa (P = 0.07). The reduction in hematocrit during surgery was smallest in the 80-microg/kg group, with a significant overall effect of treatment (P = 0.04). CONCLUSIONS: Recombinant factor VIIa dosing did not result in a statistically significant reduction in either the number of patients transfused or the volume of blood products administered. No safety issues were identified.     

Alpha-blockers impact stent-related symptoms: a randomized, double-blind, placebo-controlled trial

Abstract Background and Purpose: Ureteral stents are indispensable tools in endourology, although they often are associated with bothersome lower urinary tract symptoms. This study was conducted to evaluate the effect of alfuzosin on urinary symptoms, quality of life, and pain in patients after Double-J ureteral stent placement in a randomized, placebo-controlled trial. Patients and Methods: This study was conducted from July 2008 to May 2009. A total of 130 patients underwent placement of a Double-J stent after retrograde semirigid ureteroscopy for ureteral stones. They were randomized in two groups. Group 1 (n=65) received alfuzosin 10?mg once daily and group 2 (n=65) received placebo for 1 week. Both groups also received standardized analgesia. The stent symptoms were measured and recorded 1 week after the procedure. Statistical analyses were performed using the chi-square test and Student t test with P<0.05 considered significant. Results: The demographic profile including patient and stone-related parameters were comparable. Group 1 had significantly less urinary symptoms (P<0.05). The quality-of-life assessment was better in the alfuzosin arm than in the placebo arm (P<0.001). The mean pain score was 1.15 in group 1 and 3.89 in the placebo group (P<0.001). None of the patients in either of the arms withdrew from treatment; there were minimal adverse effects in the treatment arm. The limitation of the current work includes relatively smaller sample size and use of single type of stent. Conclusions: Alfuzosin 10?mg once daily in patients with a Double-J stent significantly decreases the bothersome urinary symptoms, besides decreasing significantly the pain associated with the stent.     

Prophylactic isradipine treatment after kidney transpIantation: a prospective double-blind placebo-controlled randomized trial

Abstract There is evidence that calcium antagonists may have a beneficial effect on cyclosporineinduced nephropathy after transplantation. We treated 50 consecutive non-diabetic patients receiving their first cadaveric transplant with isradipine, a dihydropyridine calcium antagonist, or placebo in a double-blind, randomized, placebocontrolled trial. There were no significant differences between the two groups as regards age, weight, sex, HLA matching and ischaemic periods. To achieve optimal vasodilation, treatment was started intravenously 2 h before the transplantation procedure, and continued orally afterwards for 3 months. The immunosuppressive treatment included rabbit antithymocyte globulin on day 0, and oral cyclosporine from day 5. In both groups 7 patients had primary non-functioning grafts, but the incidence of never functioning kidneys due to vascular and thrombotic complications was significantly higher in the placebo group (0 vs 4 patients, P < 0.05). Hypertension was treated with oral labetolol in combination with guanfacine if necessary. In the placebo group antihypertensive medication had to be prescribed significantly more often (67% vs 33% of patients, P < 0.05), but resulted in similar blood pressure recordings in the two study groups. Cyclosporin A (CsA) plasma concentrations were also comparable but in the isradipine group a significantly higher dose of CsA was needed to achieve adequate levels (8.0 ± 0.5 vs 6.2 ± 0.5 mg/kg per day, P < 0.01). However, in the isradipine-treated patients creatinine clearance was significantly higher (66.1 ± 4.5 vs 55.6 ± 6.2 ml/min, P < 0.05) after 3 months. We conclude that isradipine is an effective antihypertensive agent after kidney transplantation. Isradipine ameliorates CsA-induced nephropathy and seems to protect against early postoperative vascular complications.     

Topical vasoactive cream in the treatment of erectile failure: a prospective, randomized placebo-controlled trial.

OBJECTIVE: To repeat a previous study on the use of a topical treatment for erectile failure using a vasoactive cream. PATIENTS AND METHODS: Fourteen patients with erectile failure who had previously responded to intracorporeal injection therapy were enrolled in a randomized placebo-controlled trial. They were given two topical applications, comprising either a cream containing aminophylline, isosorbide dinitrate and co-dergocrine mesylate, or a placebo cream of similar appearance containing no pharmacologically active ingredients. Each patient received 16 applications, eight of the active cream and eight placebo. The creams were applied alternatively on successive occasions and the results recorded. RESULTS: The active cream, applied on 77 occasions, resulted in three good and 13 partial erections. The placebo cream, applied on 76 occasions, yielded four good and 13 partial erections. CONCLUSIONS: We were unable to reproduce the successful results reported by others; in the present study the active cream performed no better than placebo.     

癃清片治疗慢性前列腺炎多中心双盲安慰剂对照试验研究

目的 评价癃清片治疗慢性前列腺炎的有效性和安全性.方法 多中心、随机、双盲、安慰剂对照临床设计.480例湿热兼瘀血型慢性前列腺炎患者按3:1的比例随机分为治疗组、安慰剂对照组.治疗组360例,口服癃清片,一次6片,每日2次.安慰剂对照组120例,服用安慰剂,一次6片,每日2次,疗程为4周.以美国国立卫生院前列腺炎症状评分(NIH-CPSI)、慢性前列腺炎中医证候评分作为主要疗效评价指标.结果 (1)治疗4周后,治疗组和对照组CPSI评分分别为(11.9±5.04)和(17.66±4.92),(P<0.05).治疗组和对照组治疗前后CPSI评分差值分别为(10.44±5.91)和(4.18±3.50),治疗组降幅大于对照组(P<0.05).治疗组在降低NIH-CPSI评分疗效优于对照组.(2)治疗4周后,治疗组和对照组中医证候评分分别为(9.87±3.95)和(14.43±4.14),治疗组低于对照组(P<0.05);治疗组和对照组治疗前后差值分别为(9.17±4.82)和(4.64±4.36),治疗组降幅大于对照组(P<0.05).(3)治疗组总有效率为82.4%,对照组为40.6%,总有效率治疗组优于对照组(P<0.05).(4)两组间不良事件发生率比较无差异(P>0.05).结论 癃清片治疗慢性前列腺炎安全、有效,值得在临床推广.     

Effects of different photobiomodulation dosimetries on temporomandibular dysfunction: a randomized,double-blind,placebo-controlled clinical trial

Changes involving temporomandibular joint, masticatory musculature, and associated structures characterize temporomandibular dysfunction (TMD). The analgesic and anti-inflammatory effect produced by photobiomodulation has contributed to pain relief and functional improvement. However, the parameters to be used have not yet been well established. The aim of this study is to compare the efficacy of three different photobiomodulation dosimetries in the treatment of patients with TMD. A randomized, double-blind, placebo-controlled clinical trial with 44 subjects divided into the groups 8 J/cm² (n?=?11), 60 J/cm² (n?=?11), 105 J/cm² (n?=?11), and control (n?=?11). Pain, symptom severity, and joint mobility were evaluated before and after a ten-session protocol of photobiomodulation with AlGaAs laser (830 nm), at a power density of 30 mW/cm². The mouth opening increased in the 8-J/cm² group from 10.49?±?4.68 to 15.40?±?6.43 degrees, and in the right protrusion from 9.80?±?4.2 to 12.56?±?5.40 degrees after the intervention protocol (p?<?0.05). All groups significantly decreased pain (p?<?0.05). 830-nm laser photobiomodulation was effective in reducing TMD pain and symptoms at all doses tested. Only the doses of 8 J/cm² were effective regarding maximal opening and protrusion of the mandible.     

Efficacy and safety of once-daily dosing of udenafil in the treatment of erectile dysfunction: results of a multicenter, randomized, double-blind, placebo-controlled trial

Background

A once-daily dosing regimen with a phosphodiesterase type 5 inhibitor is needed for the treatment of erectile dysfunction (ED), in part because of the behavioral complexities associated with sexual intimacy. Many patients prefer spontaneous rather than scheduled sexual activities or they anticipate frequent sexual encounters. The pharmacokinetic profiles of udenafil with a time of maximal concentration of 1.0-1.5 h and a terminal half-life of 11-13 h make udenafil a good candidate for once-daily dosing.

Objective

To evaluate the efficacy and safety of once-daily dosing of udenafil in the treatment of ED.

Design, setting, and participants

This multicenter randomized double-blind, placebo-controlled, fix-dosed clinical trial involved 237 patients with ED. The subjects, who were treated with placebo or udenafil (25 mg, 50 mg, or 75 mg) once daily for 12 wk, were asked to complete the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and the Global Assessment Questionnaire (GAQ) during the study.

Measurements

The primary outcome parameter was the change from baseline for the IIEF erectile function domain (EFD) score. The secondary outcome parameters were SEP questions 2 and 3, the shift to normal rate (EFD ≥26), and the response to the GAQ.

Results and limitations

Compared with placebo, patients who took 50 mg or 75 mg of udenafil had a significantly improved IIEF-EFD score. Similar results were observed in comparing questions 2 and 3 in the SEP diary and the GAQ. Flushing was the most common treatment-related adverse event, which was transient and mild to moderate in severity.

Conclusions

Udenafil significantly improved erectile function among ED patients when administered in doses of 50 mg or 75 mg once daily for 12 wk. Daily administration of udenafil (50 mg) may be another treatment option for ED.