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Purpose: To characterize patient outcomes following visually directed high-intensity focused ultrasound (HIFU) for focal treatment of localized prostate cancer. Methods: We performed a systematic review of cancer-control outcomes and complication rates among men with localized prostate cancer treated with visually directed focal HIFU. Study outcomes were calculated using a random-effects meta-analysis model. Results: A total of 8 observational studies with 1,819 patients (median age 67 years; prostate-specific antigen 7.1 mg/ml; prostate volume 36 ml) followed over a median of 24 months were included. The mean prostate-specific antigen nadir following visually directed focal HIFU was 2.2 ng/ml (95% CI 0.9–3.5 ng/ml), achieved after a median of 6 months post-treatment. A clinically significant positive biopsy was identified in 19.8% (95% CI 12.4–28.3%) of cases. Salvage treatment rates were 16.2% (95% CI 9.7–23.8%) for focal- or whole-gland treatment, and 8.6% (95% CI 6.1–11.5%) for whole-gland treatment. Complication rates were 16.7% (95% CI 9.9–24.6%) for de novo erectile dysfunction, 6.2% (95% CI 0.0–19.0%) for urinary retention, 3.0% (95% CI 2.1–3.9%) for urinary tract infection, 1.9% (95% CI 0.1–5.3%) for urinary incontinence, and 0.1% (95% CI 0.0–1.4%) for bowel injury. Conclusion: Limited evidence from eight observational studies demonstrated that visually directed HIFU for focal treatment of localized prostate cancer was associated with a relatively low risk of complications and acceptable cancer control over medium-term follow-up. Comparative, long-term safety and effectiveness results with visually directed focal HIFU are lacking. [ABSTRACT FROM AUTHOR]

The objective of this review was to compare the efficacy and safety of conservative surgery with or without adjunctive presacral neurectomy (PN) for chronic endometriosis-related pelvic pain. In a systematic review with meta-analysis, randomized or nonrandomized controlled studies of conservative endometriosis surgery with or without adjunctive PN were included. Main outcomes were treatment failure (the proportion of women in which surgery failed to adequately resolve midline pain) and the frequency of operative and postoperative complications. A total of 7 studies with 8 group comparisons (3 randomized) representing 503 women (250 PN; 253 Control) were included. Over 34 months median follow-up, crude rates of treatment failure were 15.0% with PN and 40.9% with Controls (risk ratio = 0.43, 95% CI = 0.30 to 0.60, p < 0.001). The risk of postoperative constipation was higher with PN vs. Controls (12.5% vs. 0%, p = 0.024). No treatment group differences were observed for the risk of operative complications (0.6% vs. 0%, p = 0.498), reoperation (4.1% vs. 3.0%, p = 0.758) or urinary incontinence (5.0% vs. 0%, p = 0.195). Overall, in well-selected patients, conservative surgery with adjunctive PN may provide greater relief from midline pain and a similarly low rate of operative complications relative to conservative surgery alone but may increase the risk of constipation postoperatively. However, results were derived from mainly older and lower quality studies. Since then, surgical techniques to treat endometriosis have been improved and the effect of PN observed in prior studies should be confirmed in future studies in women in whom radical excision of deep infiltrating lesions is obtained. [ABSTRACT FROM AUTHOR]

Purpose: To determine the safety and effectiveness of limited lumbar discectomy with additional implantation of an annular closure device (ACD) among patients at high risk of herniation recurrence treated in routine clinical practice.Methods: This was a prospective, single-center study of lumbar discectomy for sciatica caused by intervertebral disc herniation with adjunctive ACD implantation to reduce herniation recurrence risk among high-risk patients with large annular defects. Patients returned for follow-up visits at 6 weeks, 12 weeks, 26 weeks, 1 year, and 2 years. Main outcomes included reoperation, herniation recurrence, back pain severity, leg pain severity, and Oswestry Disability Index (ODI). The minimum important difference was defined as ≥ 20 mm decrease relative to baseline for leg pain severity, ≥ 20 mm decrease for back pain severity, and ≥ 15-point decrease for ODI.Results: Among 75 high-risk patients (mean age 45 years, 59% female), the cumulative event incidence through 2 years was 4.0% for reoperation and 1.4% for herniation recurrence. Mean leg pain severity decreased from 73 to 6 (p < 0.001), back pain severity decreased from 51 to 13 (p < 0.001), and ODI decreased from 49 to 7 (p < 0.001). The percentage of patients achieving the minimum important difference was 91% for leg pain, 65% for back pain, and 94% for ODI.Conclusion: In patients at high risk of herniation recurrence following limited lumbar discectomy in routine clinical practice, additional implantation of an ACD was safe and reherniation recurrence rates were low at 2-year follow-up, which is favorably compared to reported rates in high-risk patients. [ABSTRACT FROM AUTHOR]

Background: A larger defect in the annulus fibrosus following lumbar discectomy is a well-known risk factor for reherniation. Procedures intended to prevent reherniation by sealing or occluding the annular defect warrant study in high-risk patients. This study sought to determine 3-year results of lumbar discectomy with a bone-anchored annular closure device (ACD) or lumbar discectomy only (controls) in patients at high risk for reherniation. Methods: This multicenter randomized trial enrolled patients with sciatica due to lumbar intervertebral disc herniation who failed conservative treatment. Patients with large annular defects after lumbar limited microdiscectomy were intraoperatively randomly assigned to receive ACD or control. Clinical and imaging follow-up was performed at routine intervals over 3 years. Main outcomes included rate of reherniations, reoperations, and endplate changes; leg and back pain scores on a visual analogue scale; Oswestry Disability Index (ODI); Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36; and adverse events adjudicated by a data safety monitoring board. Results: Among 554 randomized patients, the modified intent-to-treat population consisted of 272 patients in which ACD implantation was attempted and 278 receiving control; device implantation was not attempted in 4 patients assigned to ACD. Outcomes at 3 years favored ACD for symptomatic reherniation (14.8% vs. 29.5%; P < 0.001), reoperation (11.0% vs. 19.3%; P = 0.007), leg pain (21 vs. 30; P < 0.01), back pain (23 vs. 30; P = 0.01), ODI (18 vs. 23; P = 0.02), PCS (47 vs. 44; P < 0.01), and MCS (52 vs. 49; P < 0.01). The frequency of all-cause serious adverse events was comparable between groups (42.3% vs. 44.5%; P = 0.61). Conclusions: The addition of a bone-anchored ACD in patients with large annular defects following lumbar discectomy reduces the risk of reherniation and reoperation, and has a similar safety profile over 3-year follow-up compared with lumbar limited discectomy only. Trial registration: ClinicalTrials.gov NCT01283438 [ABSTRACT FROM AUTHOR]

Intra-articular injection of hyaluronic acid (HA) is a controversial treatment for knee osteoarthritis (OA). While clinical efficacy of HA relative to saline injections has been demonstrated in many studies, these results are of limited value in real-world clinical practice since saline injection is not a knee OA treatment. Instead, rigorous postmarket comparative studies of HA versus approved knee OA treatments are encouraged. The conduct of such studies is particularly important given the paucity and heterogeneous nature of current evidence regarding nonsurgical knee OA treatment. Key Points: • Societal guidelines recommend nonsteroidal anti-inflammatory drugs and corticosteroid injections, but not hyaluronic acid injections, for knee osteoarthritis (OA) despite inconsistent supportive data. • This article encourages rigorous comparative post-approval studies to clarify the role of nonsurgical treatments used in clinical practice for knee OA. [ABSTRACT FROM AUTHOR]

OBJECTIVES:Standard therapies for antibiotic-associated diarrhea (AAD) and Clostridium difficile-associated diarrhea (CDAD) have limited efficacy. Probiotic prophylaxis is a promising alternative for reduction of AAD and CDAD incidence.METHODS:In this single-center, randomized, double-blind, placebo-controlled dose-ranging study, we randomized 255 adult inpatients to one of three groups: two probiotic capsules per day (Pro-2, n=86), one probiotic capsule and one placebo capsule per day (Pro-1, n=85), or two placebo capsules per day (n=84). Each probiotic capsule contained 50 billion c.f.u. of live organisms (Lactobacillus acidophilus CL1285® +Lactobacillus casei LBC80R® Bio-K+ CL1285). Probiotic prophylaxis began within 36 h of initial antibiotic administration, continued for 5 days after the last antibiotic dose, and patients were followed for an additional 21 days.RESULTS:Pro-2 (15.5%) had a lower AAD incidence vs. Pro-1 (28.2%). Each probiotic group had a lower AAD incidence vs. placebo (44.1%). In patients who acquired AAD, Pro-2 (2.8 days) and Pro-1 (4.1 days) had shorter symptom duration vs. placebo (6.4 days). Similarly, Pro-2 (1.2%) had a lower CDAD incidence vs. Pro-1 (9.4%). Each treatment group had a lower CDAD incidence vs. placebo (23.8%). Gastrointestinal symptoms were less common in the treatment groups vs. placebo and in Pro-2 vs. Pro-1.CONCLUSIONS:The proprietary probiotic blend used in this study was well tolerated and effective for reducing risk of AAD and, in particular, CDAD in hospitalized patients on antibiotics. A dose-ranging effect was shown with 100 billion c.f.u., yielding superior outcomes and fewer gastrointestinal events compared to 50 billion c.f.u. (ClinicalTrials.gov number NCT00958308). [ABSTRACT FROM AUTHOR]

Bone mineral content (BMC) and bone mineral density (BMD) are common but imperfect surrogate measures of bone strength. The mechanical response tissue analyzer is a device that measures long bone bending stiffness ( EI), which strongly predicts bone breaking strength. We hypothesized that isokinetic resistance training of the knee flexor and extensor muscles would increase tibial EI, BMC, and BMD in young women. Fifty-two women, aged 18–26 years, performed concentric (CON, n = 30) or eccentric (ECC, n = 22) isokinetic resistance training with the nondominant leg three times per week for 20 weeks. Before and after the training period, subjects were tested for CON and ECC peak torque of the knee flexor and extensor muscles with isokinetic dynamometry, tibial BMC and BMD using dual-energy X-ray absorptiometry, and tibial EI using mechanical response tissue analysis. Both training groups increased CON (15–21%) and ECC (17–31%) peak torque vs. the untrained leg. Tibial EI increased in the entire cohort (26%) and in each training group (CON 34%, ECC 16%) vs. the untrained tibia. Tibial BMC and BMD increased in the trained and untrained tibiae, with no significant differences between limbs. No differential tibial EI or bone mineral outcomes were observed between the CON and ECC training groups. In summary, CON and ECC isokinetic resistance training increased tibial EI, but not BMC or BMD, in young women. [ABSTRACT FROM AUTHOR]