Acupuncture in patients with chronic low back pain: a randomized controlled trial

BACKGROUND: Acupuncture is widely used by patients with low back pain, although its effectiveness is unclear. We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with chronic low back pain. METHODS: Patients were randomized to treatment with acupuncture, minimal acupuncture (superficial needling at nonacupuncture points), or a waiting list control. Acupuncture and minimal acupuncture were administered by specialized acupuncture physicians in 30 outpatient centers, and consisted of 12 sessions per patient over 8 weeks. Patients completed standardized questionnaires at baseline and at 8, 26, and 52 weeks after randomization. The primary outcome variable was the change in low back pain intensity from baseline to the end of week 8, as determined on a visual analog scale (range, 0-100 mm). RESULTS: A total of 298 patients (67.8% female; mean +/- SD age, 59 +/- 9 years) were included. Between baseline and week 8, pain intensity decreased by a mean +/- SD of 28.7 +/- 30.3 mm in the acupuncture group, 23.6 +/- 31.0 mm in the minimal acupuncture group, and 6.9 +/- 22.0 mm in the waiting list group. The difference for the acupuncture vs minimal acupuncture group was 5.1 mm (95% confidence interval, -3.7 to 13.9 mm; P = .26), and the difference for the acupuncture vs waiting list group was 21.7 mm (95% confidence interval, 13.9-30.0 mm; P<.001). Also, at 26 (P=.96) and 52 (P=.61) weeks, pain did not differ significantly between the acupuncture and the minimal acupuncture groups. CONCLUSION: Acupuncture was more effective in improving pain than no acupuncture treatment in patients with chronic low back pain, whereas there were no significant differences between acupuncture and minimal acupuncture.     

提前使用替罗非班在急性STEMI直接PCI中的疗效及安全性研究

目的:探讨提前使用替罗非班对急性ST段抬高型心肌梗死(STEMI)直接冠状动脉介入治疗术(PCI)近期预后的影响。方法:选择我院2008-01-2010-12期间收治的急性STEMI患者共185例,根据使用替罗非班的时机将患者分为早期使用组(G1组,来院临床诊断后即刻给药)及延迟使用组(G2组,PCI术中或术后即刻给药)2组,分析2组患者的基本情况、临床资料及住院期间心脏事件及出血事件。结果:2组患者基线情况及实验室检查比较,差异均无统计学意义(P>0.05)。G1组使用替罗非班时间较G2组平均提前(2.7±0.52)h。G1组与G2组患者相比,肌酸激酶、肌酸激酶同工酶峰值明显下降[分别为(1 750±1 231)U/L与(3 256±2 430)U/L,(162±124)U/L与(360±189)U/L,P<0.05];术中慢血流/无再流明显减少(19.1%与31.9%,P<0.05);术后校正的TIMI帧数明显减少[(23.8±4.2)帧与(34.7±7.3)帧,P<0.05];2周内左室射血分数明显增加[(54.2±6.8)%与(45.3±7.1)%,P<0.05];术后TIMI 3级比例明显增加(93...     

Hemodynamic effects of propranolol with spironolactone in patients with variceal bleeds： A randomized controlled trial

AIM： To study the hemodynamic effects of spironolactone with propranolol vs propranolol alone in the secondary prophylaxis of variceal bleeding. METHODS： Thirty-five cirrhotics with variceal bleeding randomly received propranolol （n = 17： Group A） or spironolactone plus propranolol （n = 18： Group B）. Hemodynamic assessment was performed at baseline and on the eighth day. RESULTS： Spironolactone with propranolol caused a greater reduction in the hepatic venous pressure gradient than propranolol alone （26.94% vs 10.2%; P 〈 0.01）. Fourteen out of eighteen patients on the combination treatment had a reduction in hepatic venous pressure gradient to≤ 12 mmHg or a 20% reduction from baseline in contrast to only six out of seventeen （6/17） on propranolol alone （P 〈 0.05）. CONCLUSION： Spironolactone with propranolol results in a better response with a greater reduction in hepatic venous pressure gradient in the secondary prophylaxis of variceal bleeding. A greater number of patients may be protected by this combination therapy than by propranolol alone. Hence, this combination may be recommended for secondary prophylaxis in patients with variceal bleeding.     

Short-range intermittent claudication and rest pain: microcirculatory effects of pentoxifylline in a randomized, controlled trial

The efficacy of pentoxifylline (PXF) in severe intermittent claudication was studied comparing PXF and placebo. Patients were randomized into two treatment plans: PXF (2400 mg, four 600-mg tablets daily) or equivalent placebo was administered for 10 days. The exercise protocol associated with treatment was conducted under supervision. Skin flux (RF) was measured at rest and after 1 minute of exercise (AEF = after exercise flux; 3 km/hr, 12% inclination) with laser Doppler. PO2 and PCO2 were measured at the dorsum of the foot. All 20 included patients completed the study. The two groups were comparable. In the PXF group there was a significant increase in RF, AEF, and in PO2 (p<0.05); PCO2 was decreased (p<0.05). There were also changes in the placebo group, significantly lower than those observed in the PXF group (p<0.05). In conclusion high-dose PXF treatments improved all microcirculatory parameters in subjects with short-range claudication even with a short period of treatment.     

Acupuncture for chronic low back pain in older patients: a randomized,controlled trial

OBJECTIVE: To determine if acupuncture is an effective, safe adjunctive treatment to standard therapy for chronic low back pain (LBP) in older patients. METHODS: The inclusion criteria for subjects were: (i) LBP > or =12 weeks and (ii) age > or =60 yr; the exclusion criteria were (i) spinal tumour, infection or fracture and (ii) associated neurological symptoms. The subjects were randomized to two groups. The control group of subjects continued their usual care as directed by their physicians, i.e. NSAIDs, muscle relaxants, paracetamol and back exercises. Subjects in the acupuncture group in addition received biweekly acupuncture with electrical stimulation for 5 weeks. Outcome was measured by the modified Roland Disability Questionnaire (RDQ) at weeks 0, 2, 6 and 9. The primary outcome measure was change in RDQ score between weeks 0 and 6. RESULTS: Fifty-five patients were enrolled, with eight drop-outs. Twenty-four subjects were randomized to the acupuncture group and 23 were randomized to the control group. Acupuncture subjects had a significant decrease in RDQ score of 4.1 +/- 3.9 at week 6, compared with a mean decrease of 0.7 +/- 2.8 in the control group (P = 0.001). This effect was maintained for up to 4 weeks after treatment at week 9, with a decrease in RDQ of 3.5 +/- 4.4 from baseline, compared with 0.43 +/- 2.7 in the control group (P = 0.007). The mean global transition score was higher in the acupuncture group, 3.7 +/- 1.2, indicating greater improvement, compared with the score in the control group, 2.5 +/- 0.9 (P < 0.001). Fewer acupuncture subjects had medication-related side-effects compared with the control group. CONCLUSIONS: Acupuncture is an effective, safe adjunctive treatment for chronic LBP in older patients.     

The effects of acupuncture for patients with psoriasis: Study protocol for a randomized controlled trial

Introduction:Psoriasis is a common chronic relapsing inflammatory skin disease, which may have considerable detrimental effects on the quality of life. Considering high costs and side effects associated with the use of conventional medications, acupuncture, as one of complementary and alternative nonpharmacological therapies, is commonly used in the management of psoriasis for reducing itching, repairing the skin lesions, etc. However, the effects of acupuncture in the management of psoriasis are still inconsistent, especially in psychosocial abnormality due to psoriasis. Therefore, we designed a randomized controlled trials (RCT) involving a placebo control to ensure participants’ blinding to investigate the effects of acupuncture for psoriasis in improving typical clinical symptoms and psychosocial abnormality.Methods:A singlecenter RCT was designed. 220 participants who meet the eligibility criteria will be randomly allocated into manual acupuncture group or sham acupuncture group in a 1:1 ratio. Participants will respectively receive 15 minutes manual acupuncture or sham acupuncture per session, 3 sessions per week, totally 12 weeks. Psoriasis Area and Severity Index scores, body surface area (BSA), Medical Outcomes Study 36-Item Short-Form Health Survey, Montgomery-Asberg Depression Rating Scale, and Depression, Anxiety, and Stress Scale-21 will be evaluated by blinded operators at baseline and 12 weeks. All analyses will be based on an intention-to-treat principle. The results will be published in an international peer-reviewed journal.Discussion:The results of this study are expected to clarify the effects of acupuncture on improving typical clinical symptoms and psychosocial abnormality of patients with psoriasis. It will contribute to clinical practice of acupuncture in the management of psoriasis.Trial registration:Chinese Clinical Trail Registry: ChiCTR2100045481. Registration date: April 17, 2021.     

The effect of therapeutic glucocorticoids on the adrenal response in a randomized controlled trial in patients with rheumatoid arthritis

OBJECTIVE: To measure the effect of low-dose systemic glucocorticoid treatment on the adrenal response to adrenocorticotropic hormone (ACTH) in patients with rheumatoid arthritis (RA). METHODS: Patients with RA who took part in a randomized double-blind placebo-controlled trial of budesonide (3 mg/day and 9 mg/day) and prednisolone (7.5 mg/day) underwent a short (60-minute) test with injection of ACTH (tetracosactide hexaacetate) at baseline and the day after completing the 3-month treatment program. Plasma cortisol measurements at baseline and 3 months were compared within and between the treatment groups. Individual patients were classified as normal responders to ACTH or as abnormal responders if changes were >2 SD below the pretreatment value in the entire group of study patients. RESULTS: Short tests with ACTH injection were performed on 139 patients before beginning the study medication and on 134 patients after cessation of the medication. There were no changes in the placebo group. Mean plasma cortisol levels following treatment were reduced in all active treatment groups. In addition, mean values were significantly reduced for the 30-minute and 60-minute responses to ACTH. The maximum reduction (35%) occurred in the prednisolone group at 60 minutes. Following treatment, 34% of patients taking budesonide 9 mg and 46% of those taking prednisolone 7.5 mg failed to reach the normal maximum cortisol response to ACTH. Four patients failed to achieve the normal percentage increase in cortisol levels, but only 1 patient failed to meet both criteria. CONCLUSION: Low doses of a glucocorticoid resulted in depression of baseline and ACTH-stimulated cortisol levels after 12 weeks of therapy. Although the responsiveness of the hypothalamic-pituitary-adrenal axis in individual patients generally remained within the normal range, these changes should be investigated further.     

Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease: a randomized controlled trial.

OBJECTIVES: This trial examined the relative clinical efficacy, angiographic outcomes, and safety of zotarolimus-eluting coronary stents (ZES) with a phosphorylcholine polymer versus sirolimus-eluting stents (SES). BACKGROUND: Whether a cobalt-based alloy stent coated with the novel antiproliferative agent, zotarolimus, and a phosphorylcholine polymer may provide similar angiographic and clinical benefit compared with SES is undetermined. METHODS: A prospective, multicenter, 3:1 randomized trial was conducted to evaluate the safety and efficacy of ZES (n = 323) relative to SES (n = 113) in 436 patients undergoing elective percutaneous revascularization of de novo native coronary lesions with reference vessel diameters between 2.5 mm and 3.5 mm and lesion length > or =14 mm and < or =27 mm. The primary end point was 8-month angiographic in-segment late lumen loss. RESULTS: Angiographic in-segment late lumen loss was significantly higher among patients treated with ZES compared with SES (0.34 +/- 0.44 mm vs. 0.13 +/- 0.32 mm, respectively; p < 0.001). In-hospital major adverse cardiac events were significantly lower among patients treated with ZES (0.6% vs. 3.5%, p = 0.04). In-segment binary angiographic restenosis was also higher in the ZES cohort (11.7% vs. 4.3%, p = 0.04). Total (clinically and non-clinically driven) target lesion revascularization rates at 9 months were 9.8% and 3.5% for the ZES and SES groups, respectively (p = 0.04). However, neither clinically driven target lesion revascularization (6.3% zotarolimus vs. 3.5% sirolimus, p = 0.34) nor target vessel failure (12.0% zotarolimus vs. 11.5% sirolimus, p = 1.0) differed significantly. CONCLUSIONS: Compared with SES, treatment with a phosphorylcholine polymer-based ZES is associated with significantly higher late lumen loss and binary restenosis at 8-month angiographic follow-up. (The Endeavor III CR; http://clinicaltrials.gov/ct/show/NCT00265668?order=1?).     

A randomized, double-blind, placebo-controlled trial of sclerosing injections in patients with chronic low back pain

OBJECTIVE: To determine the clinical efficacy of sclerosing injections in patients with chronic low back pain. METHODS: Randomized, double-blind, placebo-controlled trial of three, once weekly injections of dextrose-glycerine-phenol with lignocaine vs saline plus lignocaine in patients with mechanical back pain of more than 6 months' duration. All patient assessments were performed blind by an experienced physiotherapist. The injections to the ligaments of the L4-5 and L5-S1 lumbar motion segments were given by an orthopaedic physician experienced in the technique, blinded to the nature of the injection solution according to a standard protocol. Demographic and clinical data, the short-form McGill Pain Questionnaire, the modified Somatic Pain Questionnaire, the Zung Depression Inventory, Oswestry Disability Scale and the modified Schober method of measuring spinal flexion were undertaken at 0, 1, 3 and 6 months. RESULTS: Seventy-four patients [mean (S.D.) age 45(11) yr, female:male ratio 1:1, median pain duration >10 yr] were recruited and there were no drop-outs over the study period. There were no statistically significant differences in patient characteristics between the placebo and treatment groups at baseline or for any measure at follow-up. CONCLUSIONS: Three, weekly sclerosant injections alone may not be effective treatment in many patients with undifferentiated chronic back pain. Patient selection and combination with other treatment modalities may be factors in determining treatment success.     

Benefit of treatment interruption in HIV-infected patients with multiple therapeutic failures: a randomized controlled trial (ANRS 097)

BACKGROUND: Both highly potent antiretroviral drug rescue therapy and treatment interruption have been suggested to be effective in patients with multiple treatment failure. OBJECTIVE: To assess both the benefits and risks of an 8-week treatment interruption associated with a six to nine-drug rescue regimen in patients with multiple treatment failures. DESIGN: A randomized comparative controlled trial in 19 university hospitals in France. PATIENTS: Sixty-eight HIV-infected patients with multiple previous treatment failures and CD4 cell counts less than 200 x 10(6) cells/l and plasma HIV-1-RNA levels of 50,000 copies/ml or greater. MEASUREMENTS: The primary efficacy outcome was the proportion of patients with at least a 1 log10 decrease (copies/ml) in the plasma HIV-1-RNA level after 12 weeks of therapy. RESULTS: Treatment interruption followed by multidrug salvage therapy led to a greater proportion of patients achieving virological success (i.e. 1 log10 decrease) at 12 weeks compared with patients receiving multidrug therapy alone (62 versus 26%, intent-to-treat analysis; P = 0.007). The median decrease in the HIV-1-RNA level was -1.91 and -0.37 log10 copies/ml (P = 0.008), respectively. Treatment interruption led to an increase in the number of sensitive drugs of the multidrug regimen (71 versus 35% of regimen with at least two sensitive drugs; P = 0.004). Factors associated with virological success were treatment interruption, the reversion of at least one mutation to wild type, adequate plasma drug concentration, and the use of lopinavir. CONCLUSION: Treatment interruption was beneficial for treatment-experienced HIV-infected patients with advanced HIV disease and multidrug-resistant virus.     

Effects of Baduanjin on patients with chronic nonspecific low back pain: A randomized controlled trial

Background:Chronic low back pain (CLBP) is 1 of the common clinical diseases, and many treatment methods can only improve the symptoms of pain in the short term. Traditional Chinese sports - Baduanjin has been proven to have a positive effect on chronic low back pain. However, the quality of the research is low, the sample size is small, and safety observations are lacking. We describe the protocol of a randomized controlled trial to study the efficacy and safety of Baduanjin chronic low back pain.Methods:This randomized, controlled, evaluator-blind, two-arm, parallel clinical trial will include 90 outpatients with chronic low back pain recruited from the First Hospital of Nanping City, Fujian Province. The patients were randomly assigned to the intervention group (Baduanjin exercise training) and the control group (not receiving any special exercise training) at a ratio of 1:1. Patients in the intervention group will receive Baduanjin exercise training 3 times a week for 24 weeks. The 2 groups received a 4- week follow-up observation at 24 weeks. The main result from the intervention before intervention to 24 weeks later, and the follow-up of 4 changes the visual analog scale score at weeks, and by independent t are tested groups. It will also review the Pain-related disability index, The Quebec Back Pain Disability Scale, Health-related quality of life, Roland Morris (Roland Morris) Disability Questionnaire, Overall Perceived Effect (OPE) and safety Compare. Cost data for cost-benefit and cost-benefit analysis will be collected.Discussion:This will be the first study to compare the effectiveness and safety of Baduanjin for patients with chronic low back pain. The results may help healthcare professionals make clinical decisions and may reduce the cost of treatment for this disease.Trial registration:ChiCTR2000033908     

Safety of intramuscular influenza vaccine in patients receiving oral anticoagulation therapy: a single blinded multi-centre randomized controlled clinical trial

Background  

Influenza vaccines are recommended for administration by the intramuscular route. However, many physicians use the subcutaneous route for patients receiving an oral anticoagulant because this route is thought to induce fewer hemorrhagic side effects. Our aim is to assess the safety of intramuscular administration of influenza vaccine in patients on oral anticoagulation therapy.     

Patient pain and tissue trauma during syringe procedures: a randomized controlled trial

OBJECTIVE: To investigate the relationship of needle control to tissue trauma and hemorrhage during syringe procedures. METHODS: Forty-seven subjects with a palpable knee effusion underwent needle and syringe aspiration. Subjects were randomized to the conventional syringe or a safety technology, the reciprocating procedure device (RPD). This trial was registered at clinicaltrials.gov. Pain was measured with the Visual Analog Pain Scale (VAPS). Cell count, crystal examination, culture, and aspirated fluid volume were determined. Red blood cell (RBC) counts were used to measure blood in aspirated fluid. RESULTS: Patient pain during the syringe procedure significantly predicted blood (RBC) in aspirated fluid (r = 0. 53, p = 0.001). When compared to the conventional syringe, the RPD safety device reduced blood in aspirated fluid by 66.7% (RBC, 10(3)/ml: RPD 8.9 +/- 11.4; syringe 26.7 +/- 90.2; p 0.01), reduced patient pain by 73.9% (VAPS: RPD 1.68 +/- 2.34; syringe 6.44 +/- 2.86; p < 0.01), and improved fluid aspirate yield by 132% (aspirate volume: RPD 20.9 +/- 19.7 ml; syringe 9.00 +/- 6.58 ml; p < 0.01). CONCLUSION: Inadequate control of needle and syringe during physician-performed syringe procedures is an important cause of trauma to patient tissues resulting in hemorrhage, increased patient pain, and decreased aspirate yield. The RPD -- a safety device that improves needle control and decreases needle trauma to tissues -- reduces hemorrhage and improves the safety, outcome, and aspirate yield of physician-performed syringe procedures.     

Case management for patients with poorly controlled diabetes: a randomized trial

PURPOSE: To evaluate the effects of a collaborative case management intervention for patients with poorly controlled type 2 diabetes on glycemic control, intermediate cardiovascular outcomes, satisfaction with care, and resource utilization. METHODS: We conducted a randomized controlled trial at two Department of Veterans Affairs Medical Centers involving 246 veterans with diabetes and baseline hemoglobin A(1C) (HbA(1C)) levels >or=7.5%. Two nurse practitioner case managers worked with patients and their primary care providers, monitoring and coordinating care for the intervention group for 18 months through the use of telephone contacts, collaborative goal setting, and treatment algorithms. Control patients received educational materials and usual care from their primary care providers. RESULTS: At the conclusion of the study, both case management and control patients remained under poor glycemic control and there was little difference between groups in mean exit HbA(1C) level (9.3% vs. 9.2%; difference = 0.1%; 95% confidence interval: -0.4% to 0.7%; P = 0.65). There was also no evidence that the intervention resulted in improvements in low-density lipoprotein cholesterol level or blood pressure control or greater intensification in medication therapy. However, intervention patients were substantially more satisfied with their diabetes care, with 82% rating their providers as better than average compared with 64% of patients in the control group (P = 0.04). CONCLUSION: An intervention of collaborative case management did not improve key physiologic outcomes for high-risk patients with type 2 diabetes. The type of patients targeted for intervention, organizational factors, and program structure are likely critical determinants of the effectiveness of case management. Health systems must understand the potential limitations before expending substantial resources on case management, as the expected improvements in outcomes and downstream cost savings may not always be realized.     

Clarithromycin therapy for patients with cystic fibrosis: a randomized controlled trial

The clinically significant actions of oral azithromycin in modifying progressive cystic fibrosis (CF) lung disease have been well documented. In vitro and clinical data suggests that clarithromycin has immunomodulatory properties similar to other 14-member macrolides, however two previously reported short term, open label trials of clairthromycin in small numbers of patients with CF failed to show significant benefits in modifying lung function or inflammation. We performed an international double blind, cross-over trial in which 63 subjects with CF were studied while receiving either placeo or 500 mg oral clarithromycin twice daily for 5 months, with a 1-month wash-out. The primary efficacy end point was the change in lung function (FEV(1) and FVC) during the clarithromycin treatment period compared to placebo treatment. Secondary efficacy end points included; quality of life, number of pulmonary exacerbations, height and weight, sputum inflammatory mediator content, sputum transportability and surface properties, bacterial flora, nasal potential difference, and breath condensate. No significant difference in either the primary efficacy end point or any secondary end point was seen during the period of clarithromycin treatment compared to those seen during placebo administration. We conclude that clarithromycin is not effective in treating CF lung disease.     

Ceruminolytic effects of docusate sodium: a randomized, controlled trial

STUDY OBJECTIVE: Assessment of the tympanic membrane is often impeded by the presence of cerumen. We compared the ceruminolytic effects of triethanolamine polypeptide and docusate sodium in patients with cerumen. METHODS: We conducted a prospective, randomized, controlled, double-blind trial on a convenience sample of cooperative adult and pediatric patients presenting to a university-based emergency department who required removal of cerumen to visualize the tympanic membrane. Structured data collection was performed, and the physician determined whether visualization of the tympanic membrane was partially or totally obscured by cerumen (interobserver agreement, rho=0.79). Patients received intra-aural instillation of 1mL of either docusate sodium or triethanolamine polypeptide in a liquid form. If not completely cleared within 15 minutes, the external ear canal was irrigated with 50 or 100 mL of normal saline solution and additional attempts to visualize the tympanic membrane were made. The main outcome was the proportion of ears in which the tympanic membrane could be totally visualized after ceruminolytic instillation with or without irrigation. This study had 80% power to detect a 40% difference between groups in the proportion of totally visualized tympanic membranes (chi(2) test, alpha=.05). RESULTS: Of 50 enrolled patients, 23 received triethanolamine polypeptide and 27 received docusate sodium. Mean patient age was 40 years (range 1 to 81 years); 35% were female. Groups were similar in age, sex, and proportion of completely obscured tympanic membranes at presentation (78%). The ability to completely visualize the tympanic membrane was significantly greater after treatment with docusate sodium versus triethanolamine polypeptide (81% versus 35%; difference in proportions 47%; 95% confidence interval [CI], 22 to 71) particularly in children aged 5 or less (90% versus 0%; difference in proportions 89%; 95% CI 50 to 100). CONCLUSION: Docusate sodium solution is a more effective ceruminolytic than triethanolamine polypeptide, allowing complete or partial visualization of the tympanic membrane in most patients after a single application when followed with irrigation. Use of docusate sodium as a ceruminolytic should be encouraged, particularly in children.