PubMed · 10140135
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M King. 1995. Minimum data set, maximum aggravation.. https://pubmed.ncbi.nlm.nih.gov/10140135/
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Anxiety and depression have significant and widespread effects on daily function and symptoms of patients with coronary artery disease over a 5-year period. This may partially explain why results of treadmill stress testing and angiography poorly predict the daily functioning of patients with coronary artery disease.
STUDY DESIGN: A systematic review within the Cochrane Collaboration Back Review Group. OBJECTIVES: To assess the effects of advice to rest in bed for patients with acute low back pain (LBP) or sciatica. SUMMARY OF BACKGROUND DATA: Low back pain is a common reason for consulting a health care provider, and advice on daily activities constitutes an important part in the primary care management of low back pain. METHODS: All randomized studies available in systematic searches (electronic databases, contact with authors, and reference lists) were included. Two reviewers independently selected trials for inclusion, assessed the validity of included trials, and extracted data. Investigators were contacted to obtain missing information. RESULTS: Nine trials with a total of 1435 patients were included. Four trials compared bed rest with advice to stay active, and the overall results were heterogeneous. Overall, results from two high-quality studies indicate no difference in pain intensity at the 3-week follow-up (standardized mean difference 0.0; 95% confidence interval [CI] -0.3, 0.2]), and a small difference in functional status in favor of staying active (weighted mean difference 3.2 [on a 0-100 scale] 95% CI 0.6, 5.8). In two high-quality trials no differences were reported in pain intensity between 2-3 days of bed rest and 7 days of bed rest. In another two high-quality trials, no differences were found between bed rest and exercises in pain intensity or functional status. CONCLUSION: Bed rest compared with advice to stay active at best has no effect, and at worst may have slightly harmful effects on LBP. There is not an important difference in the effects of bed rest compared with exercises in the treatment of acute low back pain, or 7 days compared with 2-3 days of bed rest in patients with low back pain of different durations with and without radiating pain.
CONTEXT: Nerve growth factor is a neurotrophic factor that promotes the survival of small fiber sensory neurons and sympathetic neurons in the peripheral nervous system. Recombinant human nerve growth factor (rhNGF) has demonstrated efficacy as treatment for peripheral neuropathy in experimental models and phase 2 clinical trials. OBJECTIVE: To evaluate the efficacy and safety of a 12-month regimen of rhNGF in patients with diabetic polyneuropathy. DESIGN: Randomized, double-blind, placebo-controlled phase 3 trial conducted from July 1997 through May 1999. SETTING: Eighty-four outpatient centers throughout the United States. PATIENTS: A total of 1019 men and women aged 18 to 74 years with either type 1 or type 2 diabetes and a sensory polyneuropathy attributable to diabetes. INTERVENTIONS: Patients were randomly assigned to receive either rhNGF, 0.1 microg/kg (n = 504), or placebo (n = 515) by subcutaneous injection 3 times per week for 48 weeks. Patients were assessed at baseline, 12 weeks, 24 weeks, and 48 weeks. MAIN OUTCOME MEASURES: The primary outcome measure was a change in neuropathy between baseline and week 48, demonstrated by the Neuropathy Impairment Score for the Lower Limbs, compared between the 2 groups. Secondary outcome measures included quantitative sensory tests using the CASE IV System, the Neuropathy Symptom and Change questionnaire, the Patient Benefit Questionnaire (PBQ), and a global symptom assessment, as well as nerve conduction studies and occurrence of new plantar foot ulcers. Patients also were evaluated for presence of adverse events. RESULTS: Among patients who received rhNGF, 418 (83%) completed the regimen compared with 461 (90%) who received placebo. Administration of rhNGF was safe, with few adverse events attributed to treatment apart from injection site pain/hyperalgesia and other pain syndromes. However, neither the primary end point (P =.25) nor most of the secondary end points demonstrated a significant benefit of rhNGF. Exceptions were the global symptom assessment (P =.03) and 2 of 32 comparisons within the PBQ, which showed a modest but significant benefit of rhNGF (P =.05 for severity of pain in the legs and P =.003 for 6-month symptoms in the feet and legs). CONCLUSION: Unlike previous phase 2 trials, this phase 3 clinical trial failed to demonstrate a significant beneficial effect of rhNGF on diabetic polyneuropathy. JAMA. 2000;284:2215-2221.