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BACKGROUND: Chronic low back pain affects daily activities at home and workplaces and causes a huge economic burden. Current therapeutic options are very limited and the effects of available pharmacological agents are less than satisfactory. While NSAIDs might be effective for the short term and opioids might help with urgent pain relief and improving the life quality, their long-term use is associated with significant side effects and drug misuse or abuse. To seek alternative pharmacological agents for effective treatment, we examined the therapeutic potential of the extracts of Vaccinia variola-inoculated rabbit skin (Analgecine, abbreviated as AGC) in patients with chronic low back pain due to degenerative vertebral disorders. METHODS: In this randomized multi-center double-blind placebo-controlled phase 3 clinical trial (Chinese Clinical Trial Registry number 2009L01498), we enrolled patients (aged 26-70 years) with chronic low back pain for at least 3 months due to degenerative spinal (vertebral) disorders from 7 medical centers in China, and randomly allocated 459 participants to receive oral AGC or placebo for 28 days to study the efficacy and safety of AGC. Randomization was performed according to a centralized randomization schedule, which was blocked by study sites and generated by an unmasked statistician independent of study conduct and data analysis. Both participants and staff at each study site were masked to treatment assignment. The primary efficacy endpoint was the change of the mean pain intensity, based on an 11-point numerical rating scale, between the baseline and the last week of treatment, with the primary efficacy analysis of intention to treat. The ratio between exposed and unexposed groups was designed to be 3:1 in order to increase the likelihood of demonstrating the AGC effect upon repeated measures. RESULTS: 347 patients were assigned to receive AGC (4 units/tablet; 2 tablets twice a day) and 112 patients were to take placebo. Among them, 324 patients taking AGC and 112 receiving placebo completed the assessment. Patients receiving AGC reported significant pain relief at the end of week 2 and 3 compared to those taking placebo, with mean reduction of the pain scores as 1.7 vs. 0.9 at week 2 (p < 0.0001) and 2.8 vs. 1.2 at week 3 (p < 0.0001). A total of 47 AGC-treated patients reported 85 treatment emergent adverse events while 16 patients taking placebo reported 26 events, but no serious side effects were found to be related to AGC treatment. CONCLUSION: Analgecine (AGC, 8 units twice daily) effectively alleviates chronic low back pain due to degenerative vertebral disorders when compared to placebo and is well tolerated by tested individuals, and can be considered as a first-line treatment for chronic low pain due to degenerative vertebral diseases.
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OBJECTIVE: Comorbidity is an important concern for chronic gout patients. We evaluated the relationship between comorbidity profiles and gout in Taiwan aborigines and Taiwanese Han. METHODS: We used the claims data from the Taiwan national health insurance database for 2004 to 2006. Physician-diagnosed gout and comorbidities were coded using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM). Total sampling from Pingtung County of southern Taiwan included 37,482 aborigines (gout cases, n=3906 and controls, n=33,576) and 37,451 Han (gout cases, n=1115 and controls, n=36,336). RESULTS: In 2006, the gout prevalences were 10.42% and 2.98% (prevalence ratio [PR]=3.50) in the aborigines and Han general populations, respectively. The prevalences of uric acid nephrolithiasis and tophi were higher in aborigines (0.42% and 0.30%, respectively) than in Han (0.09% and 0.04%, respectively). When stratified by comorbidity status, the prevalences of gout were 4.49% and 27.34% in aborigines and 1.52% and 9.44% in Han (approximate PR=3.00). Similarly, the prevalence ratios of gout in the comorbidity group, compared with the non-comorbidity group, were 6.09 in aborigines and 6.23 in Han. Multivariate odds ratios [ORs] showed that hypercholesterolemia, hyperglyceridemia, essential hypertension and renal insufficiency were the common comorbidities of gout (OR≥1.63); heart failure exerted a significant effect only in aborigines (OR=1.55). For five comorbidity factors, patients with multiple comorbidities had higher gout prevalence (maximum OR=12.90). CONCLUSION: Gout prevalence was higher in aborigines, both with and without comorbidities, than in Han. The comorbid diseases and comorbidity aggregations showed a substantial association with gout occurrence in both ethnicities.
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Gota/epidemiología , Adulto , Anciano , Comorbilidad , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Taiwán/epidemiología , Adulto JovenRESUMEN
BACKGROUND: Hypertriglyceridemia (HTG) is a heterogeneous metabolic disorder. The aim of this study was to examine associations among genetic polymorphisms, SstI polymorphism of apolipoprotein CIII (ApoCIII) and Hind III polymorphism of lipoprotein lipase (LPL), environmental factors and risks of HTG. METHODS AND RESULTS: Two hundred and forty-nine southern Taiwanese aborigines were recruited for a cross-sectional study, which included 90 subjects with triglyceride (TG)>150 mg/dl (HTG) and 159 with TG