BackgroundLower urinary tract symptoms (LUTS) in aging men are often associated with benign prostatic hyperplasia (BPH). While regulatory evaluations of treatment benefit require an assessment of specific symptoms, a simpler approach to measuring patients’ perceptions of severity and symptom change may be particularly useful for clinical practice. The aim of this study was to provide evidence of the validity of the 1-item Patient Global Impression of Severity (PGI-S) and Improvement (PGI-I) questionnaires for use as outcome measures in the treatment of BPH-LUTS.MethodsThis was a secondary analysis of data from 4 randomized placebo-controlled 12-week trials evaluating tadalafil for the treatment of BPH-LUTS (N=1694). Visit 2 (V2 [beginning of a 4-week placebo lead-in period]) and endpoint assessments included International Prostate Symptom Score (IPSS), IPSS Quality of Life Index (IPSS-QoL), BPH Impact Index (BII), and peak urine flow (Qmax). PGI-S was only administered at V2 and PGI-I only at endpoint. Associations between the PGI-S or the PGI-I and the other assessments were analyzed by calculating Spearman rank correlation coefficients and performing analysis of variance (ANOVA).ResultsSpearman correlation coefficients were 0.43, 0.43, 0.53, and −0.09, between the PGI-S and IPSS, IPSS-QoL, BII, and Qmax baseline results (all P<0.001). Similar results were seen across race, ethnicity, and baseline severity (moderate LUTS versus severe LUTS). IPSS, IPSS-QoL, BII baseline scores (P <0.001) and Qmax values (P=0.003) were significantly different among the 4 PGI-S severity levels. Spearman correlation coefficients were 0.56, 0.53, 0.47 and −0.15 between the PGI-I and change in IPSS, IPSS-QoL, BII scores, and Qmax values from baseline to endpoint (all P<0.001). Similar results were seen across race, ethnicity, and baseline severity. Change in IPSS, IPSS-QoL, BII scores, and Qmax values (P<0.001) were significantly different among the PGI-I levels (i.e., patient perception of change in urinary symptoms).ConclusionsThis study demonstrated patients’ overall perceptions of their severity and change in BPH-LUTS can be captured in a way that is simple, valid, and easily administered in a research setting or clinical practice. Clinical parameters are weakly associated with patients’ perception of urinary symptoms, emphasizing the importance of a patient-reported assessment in the evaluation of BPH-LUTS treatment benefit.

BackgroundOptimal nutrition for lactating mothers is importance for mother and infants’ health and well-being. We determined the nutrient intake and dietary changes during the first 3-month of lactation, and its potential effect on health and disease risk.MethodPersonal interviews were conducted to collect a 24h diet recall questionnaire from 199 healthy lactating women in the postpartum days 2, 7, 30, 90 and healthy 58 non-pregnant women served as the controls.ResultsWe found in lactating women (1) the mean daily energy and carbohydrate intake was lower than that of the Chinese Recommended Nutrient Intake (RNI, 2600 Kcal, 357.5 ~ 422.5g) by 11% ~ 17% and 33% ~ 49%, respectively; (2) the fat intake increased from 3% to 13%, which was 9 ~ 77% higher than the RNI (57 ~ 86.7g); (3) the protein intake exceeded the RNI of 85g by 32 ~ 53%; (4) the total calories consumed from carbohydrate (39%-44%), fat (34% ~ 42%) and protein (20%-23%) failed to meet Chinese RNI (5) the intake of vitamin C, B1, folate, zinc, dietary fiber, and calcium was 5% ~ 73% lower than the RNI while vitamin B2, B3, E, iron and selenium intake was 20% to 3 times higher than the RNI. Nutrient intake in the control group was lower for all nutrients than the recommended RNI.ConclusionLactating women on a self-selected diet did not meet the Chinese RNI for many important micronutrients, which may influence the nutritional composition of breast milk and thus impact the potential health of mothers and infants. RNI should consider the regional dietary habits and culture. A single national RNI is not applicable for all of China. Nutritional education into the community is needed.

BackgroundOmega-3 fatty acids are important in treatment of severe primary hypertriglyceridemia (HTG). In 15 patients with severe primary HTG (TG >500 mg/dl despite conventional TG lowering therapy), we assessed efficacy-safety of sequential monthly treatment with Lovaza, 4 to 8 to 12 g/day.MethodsWith TG >500 mg/dl despite Type V diet, hyperinsulinemia and diabetes control, and fibric acids, Lovaza (4 g/d) was added for 1 month, and if TG remained >500 mg/dl, increased to 8 g/d for 1 month, and then to 12 g/d for 1 month, and subsequently reduced to 4 g/day for 4 months.ResultsPrimary HTG, median TG 884 mg/dl, 14 men, 1 woman, all white, age 50 ± 7 years, 12 non-diabetic, 3 with stable diabetes control. Weight and diet held stable throughout. In 5 patients, after 1, 2, and 3 months on 4 g/day, TG fell <500, mean 1390 to 234 (−83%, p<.0001), to 135 (−90%, p<.0001), and 158 mg/dl (−89%, p<.0001), with a negative TG slope, p=.0013. Non-HDLC fell from 320 to 177 (−45%, p=.001), to 152 (−53%, p=.0002), and to 163 (−49%, p=.0004), with a negative slope, p=.01. In 10 patients, with Lovaza increased from 4 to 8 to 12 g, 3 failed to respond. In 7 of these 10 patients, TG fell 37% from 1075 to 672 on 4 g (p=.006), to 577 on 8 g (−46%, p=.0009), and to 428 mg/dl (−60%, p<.0001) on 12 g/day, with a negative TG slope, p=.0018. TG on 12 g/day was lower than on 8 g/day, p =.03. Non-HDLC fell from 245 to 217 mg/dl (−11%) on 4 g/day, to 203 (−17%, p=.01) on 8 g/day, and to 192 (−22%, p=.003) on 12 g/day, with a negative slope, p=.016. Compared to pre-Lovaza baseline, no abnormal measures developed in safety tests. The 4, 8, and 12 g/d Lovaza doses were well tolerated.ConclusionTitration of Lovaza from 4 to 8 to 12 g/d safely offers an effective way to lower TG beyond conventional 4 g therapy.