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Context: Although opioids and pregabalin are widely used for cancer-related neuropathic pain (CNP), no clinical trials exist to determine which medications are effective when an opioid-pregabalin combination therapy fails.Objectives: We investigated the efficacy of duloxetine for CNP nonresponsive or intolerant to opioid-pregabalin combination therapy.Methods: A multicenter, randomized, double-blind, placebo-controlled trial was performed at 12 specialized palliative care services in Japan. Patients with CNP average pain scores (Brief Pain Inventory [BPI]-Item 5) ≥ 4 in the previous 24 hours and nonresponsive or intolerant to opioid-pregabalin combination therapy were eligible. Patients with chemotherapy-induced peripheral neuropathies were excluded. Patients were administered duloxetine 20 mg/day titrated to 40 mg/day or placebo for 10 days. The primary endpoint was BPI-Item 5 on Day 10. Responder analysis measured proportions of patients with 30% and 50% pain decreases.Results: Seventy patients were enrolled. Complete case analysis revealed mean BPI-Item 5 on Day 10 of 4.03 for Group D vs. 4.88 for Group P (P = 0.053). Baseline observation carried forward analysis revealed mean BPI-Item 5 on Day 10 of 4.06 and 4.91 for Groups D and P, respectively (P = 0.048). Clinically meaningful pain improvement (≥30%) was reported by 44.1% (n = 15) of patients in Group D vs. 18.2% (n = 6) in Group P (P = 0.02); 32.4% (n = 11) vs. 3.0% (n = 1) of patients in Groups D and P, respectively, reported pain reduction ≥ 50% (P = 0.002).Conclusion: Adding duloxetine to opioid-pregabalin therapy might have clinical benefit in alleviating refractory CNP. Further studies are needed to conclude the efficacy of adding duloxetine. [ABSTRACT FROM AUTHOR]

Background: No existing Web-based nutrition education interventions have been evaluated in light of socioeconomic status just in Japan.Objective: The aim was to investigate the effect of a Web-based intervention program on reducing vegetable intake disparities between low- and middle-income Japanese adults.Methods: In this randomized controlled trial, participants were assessed at three time points-baseline, postintervention (5 weeks later), and a follow-up after 3 months-from October 2015 to March 2016. We collected data via a Japanese online research service company from 8564 adults aged 30 to 59 years. Participants were stratified according to national population statistics for gender and age, and randomly selected. They were then randomly allocated into intervention (n=900) and control (n=600) groups such that both groups contained an equal number of individuals with low and middle income. The intervention program encouraged behavior change using behavioral theories and techniques tailored to their assumed stage of change. The outcome was vegetable intake servings per day (1 serving being approximately 70 g).Results: Out of 900 participants who started, 450 were from the middle income group (of which 386 or 85.7% completed the intervention), and 450 were from the low income group (of which 371 or 82.4% completed). In the intervention group, vegetable intake increased in the low-income participants from baseline to postintervention (0.42 servings, 95% CI 0.11-0.72). A two-way analysis of variance showed that low-income participants had significant main effects of group (η2=0.04, P=.01) and time (η2=0.01, P<.001), and a significant interaction (η2=0.01, P=.009). Middle-income participants also had a significant main effect of time (η2=0.01, P=.006) and a significant interaction (η2=0.01, P=.046).Conclusions: This Web-based nutritional education intervention could fill the vegetable intake gap between low- and middle-income adults in Japan, and is expected to prevent noncommunicable and lifestyle-related diseases. Further intervention program improvements are necessary to maintain and increase vegetable intake for other groups.Trial Registration: Current Controlled Trials (UMIN-ICDR): UMIN000019376; https://upload.umin.ac.jp/cgi-open-bin/ icdr_e/ctr_view.cgi?recptno=R000022404 (Archived by WebCite at http://www.webcitation.org/6u9wihBZU). [ABSTRACT FROM AUTHOR]