Vitamin D Supplementation After Parathyroidectomy: Effect on Bone Mineral Density—A Randomized Double‐Blind Study

Patients with primary hyperparathyroidism (PHPT) have higher bone turnover, lower bone mineral density (BMD), and an increased risk of fractures. They also have a high incidence of low vitamin D levels (25‐OH‐vitamin D <50 nmol/L) that could worsen the negative effect on the bone. In this double‐blinded clinical trial, 150 patients with PHPT were randomized, after successful parathyroidectomy (PTX), to 1‐year daily treatment with either cholecalciferol 1600 IU and calcium carbonate 1000 mg (D +) or calcium carbonate alone (D–). BMD was measured in the lumbar spine, femoral neck, total hip, distal and 33% radius using dual‐energy X‐ray absorptiometry (DXA) before surgery and after 1 year of study medication. Median age was 60 (range 30–80) years and there were 119 (79%) women and 31 (21%) men; 76% had 25‐OH‐D <50 nmol/L before PTX and 50% had persistent elevated parathyroid hormone (PTH) 6 weeks after PTX. A similar increase in BMD in the lumbar spine, femoral neck, and total hip was observed in both groups (D + : 3.6%, 3.2%, and 2.7%, p < 0.001, respectively; and D–: 3.0%, 2.3%, and 2.1%, respectively, p < 0.001). Patients with vitamin D supplementation also increased their BMD in distal radius (median 2.0%; interquartile range, ?1.7% to 5.4%; p = 0.013). The changes in BMD, especially in the hips, were correlated to the baseline concentrations of PTH, ionized calcium, and bone markers (p < 0.001). A benefit from vitamin D substitution was observed among patients with a persistent postoperative PTH elevation, who also improved their BMD at 33% radius and radius ultradistal (p < 0.05). In conclusion, except for a minor improvement of radius BMD, our data show no beneficial effect on BMD or bone turnover markers of vitamin D supplementation after PTX. Preoperative PTH seems to have the strongest association with improvement in BMD. © 2014 American Society for Bone and Mineral Research.     

The Chiropractic Subluxation: Implications for Manual Medicine

Abstract

Objectives: Studies investigating the efficacy of intra-oral myofascial therapies (IMT) for chronic temporomandibular disorder (TMD) are rare. The objective of this randomized, controlled pilot study was to compare the effects of IMT and the addition of self-care and education over 6 months on four common TMD outcome measures: inter-incisal opening range, jaw pain at rest, jaw pain upon opening, and jaw pain upon clenching.

Participants: Thirty myogenous TMD participants between the ages of 18 and 50 years, experiencing chronic jaw pain of longer than 3-month duration, were recruited for the present study.

Intervention: Included patients were randomized into one of three groups: (1) IMT consisting of two treatment interventions per week for 5 weeks; (2) IMT plus 'self-care' involving education and exercises; and (3) wait list control.

Main outcome measures: Range of motion findings were measured in millimetres by vernier callipers and pain scores were quantified using an 11-point self-reported graded chronic pain scale. Measurements were taken at baseline, 6 weeks post-treatment, and 6 months post-treatment.

Results: The results showed statistically significant differences in resting, opening, and clenching pain and opening range scores (P<0.05) in both treatment groups compared to control at 6 months. No significant differences were observed between the two treatment groups during the course of the trial.

Conclusions: This study suggests that IMT alone or with the addition of self-care may be of some benefit in the management of chronic TMD over the short-medium term. A larger scale study over a longer term (1–2 years) may be of further value.     

Denosumab reduces the risk of osteoporotic fractures in postmenopausal women, particularly in those with moderate to high fracture risk as assessed with FRAX

Denosumab has been shown to reduce the incidence of vertebral, nonvertebral, and hip fractures. The aim of the current study was to determine whether the antifracture efficacy of denosumab was dependent on baseline fracture probability assessed by FRAX. The primary data of the phase 3 FREEDOM study of the effects of denosumab in women with postmenopausal osteoporosis were used to compute country-specific probabilities using the FRAX tool (version 3.2). The outcome variable comprised all clinical osteoporotic fractures (including clinical vertebral fractures). Interactions between fracture probability and efficacy were explored by Poisson regression. At baseline, the median 10-year probability of a major osteoporotic fracture (with bone mineral density) was approximately 15% and for hip fracture was approximately 5% in both groups. In the simplest model adjusted for age and fracture probability, treatment with denosumab over 3 years was associated with a 32% (95% confidence interval [CI] 20% to 42%) decrease in clinical osteoporotic fractures. Denosumab reduced fracture risk to a greater extent in those at moderate to high risk. For example, at 10% probability, denosumab decreased fracture risk by 11% (p = 0.629), whereas at 30% probability (90th percentile of study population) the reduction was 50% (p = 0.001). The reduction in fracture was independent of prior fracture, parental history of hip fracture, or secondary causes of osteoporosis. A low body mass index (BMI) was associated with greater efficacy. Denosumab significantly decreased the risk of clinical osteoporotic fractures in postmenopausal women. Overall, the efficacy of denosumab was greater in those at moderate to high risk of fracture as assessed by FRAX.     

One-Year Cost-Effectiveness of Surgical Treatment of Morbid Obesity: Vertical Banded Gastroplasty versus Lap-Band®

Background: This study was designed as an economic evaluation alongside a randomized clinical trial. The object of this study was to evaluate the 1-year cost-effectiveness of surgical treatment of morbid obesity comparing two operations. Methods: 100 patients were assigned randomly to vertical banded gastroplasty (VBG) or Lap-Band^? surgery. Both medical and non-medical costs were identified and measured. Costs data were combined with percentage Excess Weight Loss (%EWL) and with Quality Adjusted Life Years (QALYs) to obtain cost per %EWL and cost per QALY ratios. Results: At 1 year, the total costs were not significantly different between both groups (95% confidence interval E5,999 - E1,765). Also, the QALY gain after surgery was not significantly different between the two groups. However, %EWL was significantly higher in the VBG group compared to the Lap-Band^? group, P-value .0001. The estimated incremental cost per %EWL was E105.83 (E1,885.91/-17.82). For the costs per QALY, the estimated ratio was dominant. The overall mortality in this study was 2%. 2 patients in the VBG group died within 30 days after surgery; 1 of these deaths was possibly related to the VBG procedure. Conclusion: At 1 year after surgery, the costs and QoL of the two treatment modalities were found to be equal. Therefore, the selection of the procedure can be based on the clinical aspects, effectivity and safety at 1 year. In addition, the results of a long-term cost-effectiveness analysis (e.g. with a follow-up of 36 months) planned in the future can also be helpful in the selection of the preferred treatment.     

Chronic Musculoskeletal Conditions

Abstract

Neural mobilization is a treatment modality used in relation to pathologies of the nervous system. It has been suggested that neural mobilization is an effective treatment modality, although support of this suggestion is primarily anecdotal. The purpose of this paper was to provide a systematic review of the literature pertaining to the therapeutic efficacy of neural mobilization. A search to identify randomized controlled trials investigating neural mobilization was conducted using the keywords neural mobilisation/mobilization, nerve mobilisation/mobilization, neural manipulative physical therapy, physical therapy, neural/nerve glide, nerve glide exercises, nerve/neural treatment, nerve/neural stretching, neurodynamics, and nerve/neural physiotherapy. The titles and abstracts of the papers identified were reviewed to select papers specifically detailing neural mobilization as a treatment modality. The PEDro scale, a systematic tool used to critique RCTs and grade methodological quality, was used to assess these trials. Methodological assessment allowed an analysis of research investigating therapeutic efficacy of neural mobilization. Ten randomized clinical trials (discussed in 11 retrieved articles) were identified that discussed the therapeutic effect of neural mobilization. This review highlights the lack in quantity and quality of the available research. Qualitative analysis of these studies revealed that there is only limited evidence to support the use of neural mobilization. Future research need store-examine the application of neural mobilization with use of more homogeneous study designs and pathologies; in addition, it should standardize the neural mobilization interventions used in the study.     

B Vitamins and Hip Fracture: Secondary Analyses and Extended Follow‐Up of Two Large Randomized Controlled Trials

Elevated plasma homocysteine levels are associated with increased risk of fractures in observational studies. However, it is unsettled whether homocysteine‐lowering treatment affects fracture risk. The aim of this study was to investigate the effect of an intervention with B vitamins on the risk of hip fracture in a secondary analysis of combined data from two large randomized controlled trials originally designed to study cardiovascular diseases. Both trials had identical design, intervention, and primary objective. Based on a two‐by‐two factorial design, the intervention consisted of a daily capsule with either (1) folic acid (0.8 mg) plus vitamin B₁₂ (0.4 mg) and vitamin B₆ (40 mg); (2) folic acid (0.8 mg) plus vitamin B₁₂ (0.4 mg); (3) vitamin B₆ alone (40 mg); or (4) placebo. The participants were followed with respect to hip fracture during the trial or during an extended follow‐up (from the trial start for each patient until the end of 2012). No statistically significant association was found between folic acid plus vitamin B₁₂ treatment and the risk of hip fracture, neither during the trial (median 3.3 years; hazard ratio [HR] 0.87; 95% confidence interval [CI], 0.48 to 1.59) nor during the extended follow‐up (median 11.1 years; HR 1.08; 95% CI, 0.84 to 1.40). Nor were there significant differences in the risk of hip fracture between groups receiving versus not receiving vitamin B₆ during the trial (HR 1.42; 95% CI, 0.78 to 2.61). However, during the extended follow‐up, those receiving vitamin B₆ showed a significant 42% higher risk of hip fracture (HR 1.42; 95% CI, 1.09 to 1.83) compared to those not receiving vitamin B₆. In conclusion, treatment with folic acid plus vitamin B₁₂ was not associated with the risk of hip fracture. Treatment with a high dose of vitamin B₆ was associated with a slightly increased risk of hip fracture during the extended follow‐up (in‐trial plus post‐trial follow‐up). © 2017 American Society for Bone and Mineral Research.     

Prophylaxis of Venous Thromboembolism Using Two Different Doses of Low-Molecular-Weight Heparin (Nadroparin) in Bariatric Surgery: A Prospective Randomized Trial

Background: Obese patients undergoing bariatric surgery are at a high risk of developing fatal pulmonary embolism or post-thrombotic syndrome.The prophylactic use of low molecular weight heparins (LMWHs) is correlated with a significant reduction in post-operative venous thrombosis in patients undergoing orthopedic or general surgery. In morbidity obese patients, the limited number of comparative trials are too sparse to allow a consensus on the effective dose and dosing schedule. Methods: In a prospective study to evaluate the effect of two doses of nadroparin as prophylaxis for venous thromboembolism following bariatric surgery, 60 consecutive patients undergoing Rouxen-Y gastric bypass were randomized to receive either 0.6 ml (5700 IU) or 1.0 ml (9500 IU) of nadroparin started pre-operatively and then given once daily post-operatively until discharge. Results: No statistically significant differences between the two groups were detected in any of the measured coagulation parameters either preoperatively or at days 1, 3 and 5 postoperatively.No thrombotic events were observed pre- or post- operatively, and no patient developed meta-thrombotic syndrome at the 3 and 6 months follow-up. No bleeding events occurred in the patients given the lower dose compared with two major hemorrhages in those given the higher dose. Conclusion: Our results indicate that 0.6 ml (5700 IU) of nadroparin once daily is safe and well-tolerated, and it is as effective in prophylaxis of venous thromboembolism as the higher dose of 1 ml (9500 IU), in such high risk patients.     

中医药治疗咳嗽变异型哮喘随机对照研究文献的质量评价

【目的】对中医药治疗咳嗽变异型哮喘(CVA)的随机对照试验的文献质量进行分析,以客观评价中医药治疗CVA的疗效。【方法】按照临床流行病学/DME和循证医学的原则,采用统一编制的《中医药治疗性文献系统质量评价及信息采集表》,对1980~2006年发表的CVA中医药治疗性文献进行质量评价。【结果】检索到符合纳入标准的随机对照试验文献38篇,虽均有提及“随机对照”、“随机分组”,但只有4篇说明了具体的随机分配方法;较少采用盲法;所有文献均未说明样本含量的估算及失访、退出病例;有不良反应观察的9篇;有随访的10篇;在组间均衡性分析及疗效评价、结论推导等方面还存在一定的不足,影响了中医药随机对照试验的质量。【结论】中医药治疗CVA临床研究文献质量虽较以前有明显提高,但在科研设计和实施方面仍存在着一些问题;应提倡开展高质量的多中心前瞻性随机对照试验,以提高中医药治疗CVA研究文献的质量。     

Effects of a 12-Month Supervised,Community-Based,Multimodal Exercise Program Followed by a 6-Month Research-to-Practice Transition on Bone Mineral Density,Trabecular Microarchitecture,and Physical Function in Older Adults: A Randomized Controlled Trial

Multicomponent exercise programs are recommended to reduce fracture risk; however, their effectiveness in real-world community settings remain uncertain. This 18-month randomized controlled trial investigated the effects of a 12-month, community-based, supervised multicomponent exercise program followed by a 6-month “research-to-practice” transition on areal bone mineral density (BMD), trabecular bone microarchitecture, functional performance, and falls in older adults at increased fracture risk. One-hundred and sixty-two adults aged ≥60 years with osteopenia or at increased falls risk were randomized to the Osteo-cise: Strong Bones for Life multicomponent exercise program (n = 81) or a control group (n = 81). Exercise consisted of progressive resistance, weight-bearing impact, and balance training (3-days/week) performed at community leisure centers. Overall 148 (91%) participants completed the trial, and mean exercise adherence was 59% after 12 months and 45% during the final 6 months. After 12 months, there were significant net beneficial effects of exercise on lumbar spine and femoral neck BMD (1.0% to 1.1%, p < 0.05), muscle strength (10% to 13%, p < 0.05), and physical function (timed stair climb 5%; four-square step test 6%; sit-to-stand 16%, p ranging <0.05 to <0.001), which persisted after the 6-month transition. There were no significant effects of the 18-month intervention on distal femur or proximal tibia trabecular bone microarchitecture or falls incidence, but per protocol analysis (≥66% exercise adherence) revealed there was a significant net benefit of exercise (mean [95% confidence interval] 2.8% [0.2, 5,4]) on proximal tibia trabecular bone volume fraction (Osteo-cise 1.5% [−1.2, 4.2]; controls −1.3% [−2.6, 0.1]) after 18 months due to changes in trabecular number (Osteo-cise 1.7% [−0.9, 4.3]; controls −1.1% [−2.4, 0.2]) but not trabecular thickness (Osteo-cise − 0.2% [−0.5, 0.2]; controls −0.2% [−0.4, 0.0]). In conclusion, this study supports the effectiveness of the Osteo-cise: Strong Bones for Life program as a real-world, pragmatic, evidence-based community exercise program to improve multiple musculoskeletal health outcomes in older adults at increased fracture risk. © 2019 American Society for Bone and Mineral Research.     

Effects of a Targeted Multimodal Exercise Program Incorporating High‐Speed Power Training on Falls and Fracture Risk Factors in Older Adults: A Community‐Based Randomized Controlled Trial

Multimodal exercise programs incorporating traditional progressive resistance training (PRT), weight‐bearing impact training and/or balance training are recommended to reduce risk factors for falls and fracture. However, muscle power, or the ability to produce force rapidly, has emerged as a more crucial variable to functional decline than muscle strength or mass. The aim of this 12‐month community‐based randomized controlled trial, termed Osteo‐cise: Strong Bones for Life, was to evaluate the effectiveness and feasibility of a multimodal exercise program incorporating high‐velocity (HV)‐PRT, combined with an osteoporosis education and behavioral change program, on bone mineral density (BMD), body composition, muscle strength and functional muscle performance in older adults. Falls incidence was evaluated as a secondary outcome. A total of 162 older adults (mean ± SD; 67 ± 6 years) with risk factors for falls and/or low BMD were randomized to the Osteo‐cise program (n = 81) or a control group (n = 81). Exercise consisted of fitness center‐based HV‐PRT, weight‐bearing impact and challenging balance/mobility activities performed three times weekly. After 12 months, the Osteo‐cise program led to modest but significant net gains in femoral neck and lumbar spine BMD (1.0% to 1.1%, p < 0.05), muscle strength (10% to 13%, p < 0.05), functional muscle power (Timed Stair Climb, 5%, p < 0.05) and dynamic balance (Four Square Step Test 6%, p < 0.01; Sit‐to‐Stand, 16%, p < 0.001) relative to controls. There was no effect on total body lean mass or mobility (timed‐up‐and‐go), and no difference in falls rate (incidence rate ratio [IRR], 1.22; 95% confidence interval [CI], 0.72–2.04). In conclusion, this study demonstrates that the Osteo‐cise: Strong Bones for Life community‐based, multimodal exercise program represents an effective approach to improve multiple musculoskeletal and functional performance measures in older adults with risk factors for falls and/or low BMD. Although this did not translate into a reduction in the rate of falls, further large‐scale trials are needed to evaluate the efficacy of this multimodal approach on reducing falls and fracture. © 2014 American Society for Bone and Mineral Research.