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Background: Pruritus is a distressing hallmark of the uremic condition, affecting approximately 60% of hemodialysis patients. Abnormal endogenous opioid ligand activity at μ and κ-opioid receptors has been postulated as a mechanism in uremic pruritus. Nalbuphine is a μ-opioid antagonist and κ-opioid agonist. Methods: In this multicenter, randomized, double-blind, placebo-controlled trial, 373 hemodialysis patients with moderate or severe uremic pruritus were randomized in a 1: 1:1 ratio to nalbuphine extended-release tablets 120 mg (NAL 120), 60 mg (NAL 60), or placebo and treated for 8 weeks. Three hundred seventy-one were analyzed for efficacy. The primary endpoint was the change from baseline to treatment weeks 7 and 8 in itching intensity on a Numerical Rating Scale (NRS, 0 [no itching]; 10 [worst possible itching]) using an intent-to-treat approach. The aim was to evaluate the safety and antipruritic efficacy of NAL. Results: The mean duration of itching was 3.2 years. From a baseline NRS of 6.9 (1.5), the mean NRS declined by 3.5 (2.4) and by 2.8 (2.2) in NAL 120 mg and the placebo groups, respectively (p = 0.017). There was no evidence of tolerance. A trend for less sleep disruption due to itching (p = 0.062, NAL 120 vs. placebo) was also observed. There were no significant differences between NAL 60 vs. placebo. Serious adverse events occurred in 6.7, 12.7, and 15.4% in the NAL 120, NAL 60, and placebo groups respectively. Conclusions: In this largest-to-date randomized controlled trial in uremic pruritus, NAL 120 durably and significantly reduced the itching intensity among hemodialysis patients.

PurposeTo compare the safety and efficacy of tamsulosin and tamsulosin with the phosphodiesterase-5 inhibitor tadalafil in combination with prednisolone as medical expulsive therapies for lower ureteric stones.Materials and MethodsBetween July 2011 and December 2012, 62 adult patients presenting with distal ureteric stones sized 5 to 10 mm were randomized equally to treatment with tamsulosin (group A) or tamsulosin with tadalafil (group B). Therapy was given for a maximum of 6 weeks. In addition, patients in groups A and B were given 5-mg prednisolone once daily (maximum 1 week). The stone expulsion rate, time to stone expulsion, analgesic use, number of hospital visits for pain, follow-up and endoscopic treatment, and adverse effects of the drugs were noted. Statistical analyses were done by using Student t-test and chi-square test.ResultsThere was a higher expulsion rate (83.9% in group B and 74.2% in group A) and a lower time to expulsion in both treatment groups than in historical controls used in earlier studies. However, these results were not statistically significant (p=0.349, p=0.074, respectively). Statistically significant differences were noted in hospitalization for colic and analgesic requirement, which were less in group B than in group A. There were no serious adverse events. Another important finding was improvement in erectile function in group B.ConclusionsMedical expulsive therapy for distal ureteric stones using tamsulosin and tadalafil with prednisolone is safe and efficacious. Also, the prescription of tadalafil in cases of erectile dysfunction with the development of lower ureteric stones may provide additional advantages.

Objectives: Threatened miscarriage is the most common complication of pregnancy, occurring in 20%-25% of ongoing pregnancies. The purpose is to study maternal and perinatal outcome in women with threatened miscarriage. Methods: A prospective study was conducted over a period of 20 months in the Department of Obstetrics and Gynaecology, Pannadhay Mahila Chikitsalaya, a tertiary care center in Udaipur, India. It included a cohort of pregnant patients with a history of threatened miscarriage during the first twenty weeks of pregnancy. They were registered, followed up prospectively at antenatal clinics and delivered in the same hospital. For the purpose of comparison, another group of booked patients (controls) without a history of threatened miscarriage were recruited, similarly scanned and followed throughout pregnancy and labour. All women were matched for age, parity, social class, BMI and gestational age at booking. Discrete variables were taken as counts (or frequencies) and were evaluated by Chi-square test. Continuous variables with normal distribution were presented as mean ± standard deviation (SD) and were compared by unpaired Student's t test. Data were fed into a Microsoft Excel worksheet and were analyzed by using the SPSS ver.17 (SPSS Inc., Chicago, IL, USA). p-value > 0.05 was considered statistically significant. Results: Out of 62 cases, 13 (21%) patients spontaneously aborted after diagnosis of threatened miscarriage. Women with threatened miscarriage had a significantly higher incidence of low lying placenta (p = 0.02) when compared with those without firsttrimester bleeding. They were more likely to experience PROM (p = 0.02), preterm delivery (p = 0.02) and to have babies with low Birthweight (p = 0.03). Conclusion: Pregnancies complicated by threatened miscarriage are at a higher risk for obstetric complications.

Both tadalafil and combination of Tadalafil + Pentoxifylline improve erectile function in patients of ED. Patients with severe ED showed much significant improvement in erectile function with combination therapy.