Background The 5-HT 3 receptor antagonists are known to be effective for the treatment of diarrheapredominant irritable bowel syndrome (IBS), but not widely used yet. The aim of this study was to compare the efficacy and safety of ramosetron, a 5-HT 3 receptor antagonist, and mebeverine in male patients with IBS with diarrhea (IBS-D). Methods This study was performed in a multicenter, randomized, open-label design. Data of 343 male patients with IBS-D who were randomized to either a 4-week treatment of ramosetron 5 lg once daily or a 4-week treatment of mebeverine 135 mg three times daily were analyzed by the intent-to-treat analysis. The primary efficacy parameter was the proportion of patients with adequate relief of IBS symptoms at the last week of treatment. The secondary endpoints were changes in each symptom score and the safety profiles. Key Results The responder rates for global IBS symptoms, abdominal pain/discomfort and abnormal bowel habits in the ramosetron and mebeverine groups significantly increased during the treatment period. The severity scores of abdominal pain/discomfort and urgency, the stool form score, and the stool frequency in both treatment arms were significantly reduced, compared with the baselines. There were no significant differences in the responder rates (37% vs 38% on ITT analysis) and adverse event profiles between the ramosetron and mebeverine groups. Neither severe constipation nor ischemic colitis was reported by ramosetron-treated patients. Conclusions & Inferences Ramosetron 5 lg once daily is as effective as mebeverine three times daily in male patients with IBS-D.
Segmental fusion is not necessarily needed in treatment of thoracolumbar unstable burst fracture requiring surgery. Our objective was to report the results of follow-up for at least 10 years in patients with thoracolumbar unstable burst fracture requiring surgery in which fractured segment was healed following temporary posterior instrumentation without fusion, and in whom implants were subsequently removed. Retrospective Cohort Study. Nineteen patients in whom union of fractured vertebra was observed following surgery and in whom implants were removed within an average 12.2 months, and who could be followed up for at least 10 years, were enrolled. At the last follow-up, we evaluated the segmental motions, anterior body height ratio, progress of further kyphotic deformity, Oswestry Disability Index, Rolland Morris Disability Questionnaire and Short Form 36. Results: The follow-up period after implant removal surgery was 151 months on average. The local kyphotic angle was 26.89 ± 6.08 degrees at the time of injury and 10.11 ± 2.22 degrees at the last follow-up. The anterior body height ratio was 0.54 ± 0.16 at the time of injury and 0.89 ± 0.05 at the last follow-up. Thus, the fractured vertebra was significantly reduced after surgery and maintained till last follow-up. The segmental motion was 9.84 ± 3.03, Oswestry Disability Index was 7.95 ± 7.38, Rolland Morris Disability Questionnaire was 2.17 ± 2.67, short form 36 Physical Component Score was 77.50 ± 16.61, and short form 36 Mental Component Score was 79.21 ± 13.32 at last follow-up. We conducted at least 10-year follow-up and found that temporary posterior instrumentation without fusion should be considered one of the useful alternative treatments for thoracolumbar unstable burst fracture in place of the traditional posterior instrumentation and fusion.
Background The incidence of facet tropism (FT) and its correlation with low back pain (LBP) have, to our knowledge, not yet been investigated among selected community-based populations who visited departments unrelated to LBP with their chief complaints unrelated to LBP. In this study, we aimed to evaluate the prevalence of FT among selected patients in whom LBP was not the chief complaint and the correlation between FT and LBP among these patients. Methods Among patients who underwent computed tomography during 2014 for reasons unrelated to LBP, we enrolled 462 patients who satisfied the inclusion and exclusion criteria. The degree of tropism was defined as grade 0, 1, and 2 for FT, FT+, and FT++, respectively. LBP was evaluated using a modified version of the Nordic low back pain questionnaire. For additional evaluation of dynamic LBP, the question, “Did your pain go away when lying down still or standing up straight, and did it also intensify when you bend or stretch your back?,” was included in the questionnaire. Results The L4–5 intervertebral area was most frequently and severely affected by FT with an incidence rate of 46.3%, and severe FT was observed in 24.7% of the patients. FT increased with age at L2–3 and L5–S1 levels. FT at L2–3 level was correlated with LBP ( p = 0.035) and dynamic LBP ( p = 0.033). The FT grade at L2–3 level was correlated with dynamic LBP ( p = 0.022) but not with LBP ( p = 0.077). The relative risk of FT at L2–3 level was 1.614 for LBP and 1.724 for dynamic LBP. Conclusions The prevalence of FT among community-based populations was 46.3% and its severe form was more frequently observed at L4–5 level (24.7%). LBP was correlated with FT at L2–3 level. The relative FT-associated risk of LBP was 1.6 at L2–3 level, and the relative L2–3 FT-associated risk of dynamic LBP was 1.724.
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