OICPC Therapeutic Highlights

We continue the series of basic information on therapies, summarised from the Oxford International Centre for Palliative Care Advanced Courses on Pain and Symptom Management held in Newcastle and Oxford during June-July 1999.     

Outcome of Gastric Bypass Patients

Background: The authors analyzed previously studied outcomes of Roux-en-Y gastric bypass (RYGBP), examined pre-surgical factors of post-surgical outcomes, and examined some of the psychosocial benefits. Methods: A retrospective chart review was conducted of 138 patients who underwent RYGBP between 1997 and 2000. Pre-surgical BMI, cholesterol, blood pressure, creatinine, number of antidepressant/glycemic drugs, and hemoglobin were recorded. Post-surgical follow-up was reviewed to examine changes. Results: Statistically significant changes were found in BMI, hypertension, cholesterol and glycemic control. Surgery was found to reduce creatinine from a pre-surgery average of 1.14 to 1.01 (n=11, p=.0015)). Patients with early post-operative complications (defined as length of stay >6 days or re-hospitalization within 1 month following surgery) had an average BMI of 57.58 (n=23) vs a BMI of 49.9 (n=103) in those who did not experience any complications (p = 0.0004).There was a statistically significant decrease in the rate of anti-depressant use following surgery. 49 patients were on antidepressants before surgery vs 38 following surgery (p=.0016). Conclusion: RYGBP significantly improves hypertension, hyperlipidemia and type II diabetes, and may also improve kidney function. Patients with higher pre-surgical BMIs are at greater risk for postsurgical complications. Postoperative antidepressant use appears to decrease.     

中医药临床疗效评价中结局指标的选择与应用

论述中医药临床疗效评价中结局评价指标的选择和应用。总结了我国临床试验中结局指标选择的现状及与国外的差距,阐述了主要结局指标与 次要结局指标的联系与区别,介绍了临床试验中结局指标的选择方法。指出只有选择对患者有直接影响的主要结局指标才能够证实干预措施的真正疗效,吧实验室检验为主的生物学指标只是一种次要结局指标,只有在主要结局指标不可行、且次要结局指标被证实与主要结局指标具有因果关系的情况下才能够作为代替主要结局指标的替代指标使用;并提出了临床研究中亟需注意的三点事项;①应尽快引进与完善功能与生存质量评价;②寻找能发扬中医药优势的证候相关指标;③分清主要结局指标与次要结局指标的临床意义,严格进行结论的推导。     

Impact of Psychosocial Stress and Symptoms on Indication for Bariatric Surgery and Outcome in Morbidly Obese Patients

Background: Obese patients often suffer from physical and psychiatric co-morbidity. Bariatric surgery has been widely used to treat morbid obesity. The present study addresses the issues of the impact of psychosocial stress and symptoms on indication for and outcome of bariatric surgery. Methods: A sample of 131 morbidly obese patients applying for bariatric surgery underwent assessment via the Psychosocial Stress and Symptom Questionnaire (PSSQ). Patients were categorized as under little/no (below cut-off) or great (above cut-off) psychosocial stress. 2 years after their first assessment and 1 year after potential bariatric surgery, 119 patients (90.8% participation rate), 69 of whom were treated surgically, were followed up by a telephone interview asking for outcome variables such as BMI, employability, medication, doctor consultations, and physical/psychological well-being. Results: 86 patients (72.3%) scored above the cutoff in the PSSQ.There was no correlation between the result of the PSSQ and the surgeons' indication for bariatric surgery. 69 patients (58.0%) underwent bariatric surgery, of whom 48 had PSSQ scores above the cut-off. Individuals under great psychosocial stress experienced the same positive physical and psychological well-being after surgery as subjects under little or no stress. Psychosocially stressed patients (n = 38) who did not undergo surgery showed the worst outcome. Conclusion: Great psychosocial stress in morbidly obese subjects should not be a contraindication for bariatric surgery. However, those patients should receive pre- and post-surgical counseling, to reduce anxiety before surgery and increase compliance after surgery.     

Does transcutaneous electrical nerve stimulation (TENS) produce 'dose-responses'? A review of systematic reviews on chronic pain

Abstract

Background: This review aimed to examine existing systematic reviews regarding the clinical efficacy of transcutaneous electrical nerve stimulation (TENS) in reducing pain in patients with chronic pain conditions.

Methods: Data concerning the methods and conclusions of the reviews and individual trials were extracted. The data from the individual trials were subcategorised according to the validity of outcome measures, methodological quality, sample size, and 'dose response' (if any) of TENS.

Results: Two of the six reviews concerning TENS and chronic pain reported that high intensity TENS applications were more effective compared to placebo than low intensity applications. However, the reviews and the authors' conclusions were based on a total of eight high quality trials which reported positive findings on a visual analogue scale or numeric rating scale which measured pain relief/intensity.

Discussion: Data from chronic pain trials that use these outcome measures show that any dose-related responses of TENS cannot be conclusively demonstrated as a result of the number of confounding variables (e.g. inadequate design, low statistical power and the many differences in TENS protocols such as repeated versus single treatments).

Conclusion: To address these issues, recommendations are made for future systematic reviews and randomised controlled trials. Such recommendations include the need for more comprehensive and rigorous tools in assessing substantive trials within systematic reviews.     

Vertebral Fracture Risk in Diabetic Elderly Men: The MrOS Study

Type 2 diabetes (T2DM) is associated with a significant increase in risk of nonvertebral fractures, but information on risk of vertebral fractures (VFs) in subjects with T2DM, particularly among men, is lacking. Furthermore, it is not known whether spine bone mineral density (BMD) can predict the risk of VF in T2DM. We sought to examine the effect of diabetes status on prevalent and incident vertebral fracture, and to estimate the effect of lumbar spine BMD (areal and volumetric) as a risk factor for prevalent and incident morphometric vertebral fracture in T2DM (n = 875) and nondiabetic men (n = 4679). We used data from the Osteoporotic Fractures in Men (MrOS) Study, which enrolled men aged ≥65 years. Lumbar spine areal BMD (aBMD) was measured with dual‐energy X‐ray absorptiometry (DXA), and volumetric BMD (vBMD) by quantitative computed tomography (QCT). Prevalence (7.0% versus 7.7%) and incidence (4.4% versus 4.5%) of VFs were not higher in T2DM versus nondiabetic men. The risk of prevalent (OR, 1.05; 95% CI, 0.78 to 1.40) or incident vertebral‐fracture (OR, 1.28; 95% CI, 0.81 to 2.00) was not higher in T2DM versus nondiabetic men in models adjusted for age, clinic site, race, BMI, and aBMD. Higher spine aBMD was associated with lower risk of prevalent VF in T2DM (OR, 0.55; 95% CI, 0.48 to 0.63) and nondiabetic men (OR, 0.66; 95% CI, 0.5 to 0.88) (p for interaction = 0.24) and of incident VF in T2DM (OR, 0.50; 95% CI, 0.41 to 0.60) and nondiabetic men (OR, 0.54; 95% CI, 0.33 to 0.88) (p for interaction = 0.77). Results were similar for vBMD. In conclusion, T2DM was not associated with higher prevalent or incident VF in older men, even after adjustment for BMI and BMD. Higher spine aBMD and vBMD are associated with lower prevalence and incidence of VF in T2DM as well as nondiabetic men. © 2017 American Society for Bone and Mineral Research.     

Cognitive and Guided Mastery Therapy of Agoraphobia: Long-Term Outcome and Mechanisms of Change

The aims of this study were to compare thelong-term efficacy of cognitive and guided masterytherapy of panic disorder with moderate to severeagoraphobia and to analyze cognitive mechanisms ofchange. Patients (N = 46) suffering from panic disorderwith moderate or severe agoraphobia, who regardedagoraphobia as their main problem, were randomlyassigned to receive either cognitive therapy or guided mastery therapy in a 6-week inpatient groupprogram. At 1-year follow-up, more of the cognitivetherapy patients were behavioral responders, were freeof spontaneous panic attacks, were able to work, and did not use anxiolytic medication. Oncontinuous outcome measures, overall tests revealed nodifferences between the patients in the two treatmentconditions. Results of path analyses of cognitivevariables were consistent with the cognitive model ofpanic with agoraphobia which is based on catastrophicbeliefs and inconsistent with the guided mastery modelwhich is based on self-efficacy.