Pricking and penetrating moxibustion therapy in patients with refractory insomnia: a randomized and controlled clinical trial

OBJECTIVE

To observe the clinical effect of pricking and penetrating moxibustion therapy on refractory insomnia.

Comparison of injection modalities in the treatment of plantar heel pain: a randomized controlled trial

In a prospective randomized study of plantar heel pain, 44 patients were treated with injection of 1 mL of 2% prilocaine using the peppering technique, 1 mL of 2% prilocaine combined with 2 mL of autologous blood, or 1 mL of 2% prilocaine mixed with 40 mg of methylprednisolone acetate. At 6-month follow-up, clinical improvement was evaluated by using a 10-cm visual analog scale and the rearfoot score of the American Orthopaedic Foot and Ankle Society. Results were analyzed using sample t-tests within groups and repeated-measures analyses of variance between groups. Mean +/- SD visual analog scale scores in the peppering technique, autologous blood injection, and corticosteroid injection groups improved from 6.4 +/- 1.1, 7.6 +/- 1.3, and 7.28 +/- 1.2 to 2.0 +/- 2.2 (P < .001), 2.4 +/- 1.8 (P < .001), and 2.57 +/- 2.9 (P < .001), respectively. Mean +/- SD rearfoot scores in the same groups improved from 64.1 +/- 15.1, 71.6 +/- 1, and 65.7 +/- 12.7 to 78.2 +/- 12.4 (P = .018), 80.9 +/- 13.9 (P = .025), and 80.07 +/- 17.5 (P = .030), respectively. There were no statistically significant differences among the groups. Good outcomes have been documented using the peppering technique and autologous blood injection for the treatment of lateral epicondylitis. Although the curative mechanisms of both injection modalities are based on a hypothesis, they seem to be good alternatives to corticosteroid injection for the treatment of plantar heel pain.     

Acupuncture for patients with migraine: a randomized controlled trial

Context  Acupuncture is widely used to prevent migraine attacks, but the available evidence of its benefit is scarce. Objective  To investigate the effectiveness of acupuncture compared with sham acupuncture and with no acupuncture in patients with migraine. Design, Setting, and Patients  Three-group, randomized, controlled trial (April 2002-January 2003) involving 302 patients (88% women), mean (SD) age of 43 (11) years, with migraine headaches, based on International Headache Society criteria. Patients were treated at 18 outpatient centers in Germany. Interventions  Acupuncture, sham acupuncture, or waiting list control. Acupuncture and sham acupuncture were administered by specialized physicians and consisted of 12 sessions per patient over 8 weeks. Patients completed headache diaries from 4 weeks before to 12 weeks after randomization and from week 21 to 24 after randomization. Main Outcome Measures  Difference in headache days of moderate or severe intensity between the 4 weeks before and weeks 9 to 12 after randomization. Results  Between baseline and weeks 9 to 12, the mean (SD) number of days with headache of moderate or severe intensity decreased by 2.2 (2.7) days from a baseline of 5.2 (2.5) days in the acupuncture group compared with a decrease to 2.2 (2.7) days from a baseline of 5.0 (2.4) days in the sham acupuncture group, and by 0.8 (2.0) days from a baseline if 5.4 (3.0) days in the waiting list group. No difference was detected between the acupuncture and the sham acupuncture groups (0.0 days, 95% confidence interval, –0.7 to 0.7 days; P = .96) while there was a difference between the acupuncture group compared with the waiting list group (1.4 days; 95% confidence interval; 0.8-2.1 days; P<.001). The proportion of responders (reduction in headache days by at least 50%) was 51% in the acupuncture group, 53% in the sham acupuncture group, and 15% in the waiting list group. Conclusion  Acupuncture was no more effective than sham acupuncture in reducing migraine headaches although both interventions were more effective than a waiting list control.      

天麻素注射液对老年难治性高血压患者血压和血管活性物质影响的随机对照研究

目的：检测并比较老年难治性高血压患者血浆内皮素（endothelin，ET）和一氧化氮（nitric oxide，NO）含量变化．观察天麻素注射液对老年难治性高血压患者血压及血浆ET和NO含量的影响。 方法：选取老年难治性高血压患者63例，普通高血压患者30例，健康人群30例，检测并比较其血浆ET和NO含量变化；将难治性高血压患者随机分为2组：天麻素治疗组和常规治疗组。天麻素治疗组在常规治疗的基础上加用天麻素注射液1000mg静脉滴注2个疗程，共4周，常规治疗组继续常规降压药物治疗，观察治疗前和每个疗程后血压的变化，并比较血浆ET和NO含量的变化。 结果：难治性高血压患者血浆ET含量明显高于普通高血压者（t=3．27，P=0．008），NO含量明显低于普通高血压者（t=-3．81．P=0．002）。天麻素治疗组患者在治疗1个疗程后收缩压和脉压差均明显下降（t=1．85，P=0．03；t=1．74．P=0．04）。天麻素治疗组随着治疗疗程的增加，ET含量逐渐下降，但2个疗程结束后与治疗前相比，差异仍无统计学意义；而NO含量在2个疗程结束后明显升高，与治疗前相比．差异有统计学意义（t=-2．70，P=0．04）。 结论：与普通高血压患者比较，难治性高血压患者血浆ET明显升高，NO含量显著降低。天麻素注射液可以降低老年难治性高血压患者的血压，且其降低收缩压的作用相对较强。可能通过调节患者血管活性物质来实现降压，但具体机制尚需进一步研究。     

Active neck muscle training in the treatment of chronic neck pain in women: a randomized controlled trial

CONTEXT: Active physical training is commonly recommended for patients with chronic neck pain; however, its efficacy has not been demonstrated in randomized studies. OBJECTIVE: To evaluate the efficacy of intensive isometric neck strength training and lighter endurance training of neck muscles on pain and disability in women with chronic, nonspecific neck pain. DESIGN: Examiner-blinded randomized controlled trial conducted between February 2000 and March 2002. SETTING: Participants were recruited from occupational health care systems in southern and eastern Finland. PATIENTS: A total of 180 female office workers between the ages of 25 and 53 years with chronic, nonspecific neck pain. INTERVENTIONS: Patients were randomly assigned to either 2 training groups or to a control group, with 60 patients in each group. The endurance training group performed dynamic neck exercises, which included lifting the head up from the supine and prone positions. The strength training group performed high-intensity isometric neck strengthening and stabilization exercises with an elastic band. Both training groups performed dynamic exercises for the shoulders and upper extremities with dumbbells. All groups were advised to do aerobic and stretching exercises regularly 3 times a week. MAIN OUTCOME MEASURES: Neck pain and disability were assessed by a visual analog scale, the neck and shoulder pain and disability index, and the Vernon neck disability index. Intermediate outcome measures included mood assessed by a short depression inventory and by maximal isometric neck strength and range of motion measures. RESULTS: At the 12-month follow-up visit, both neck pain and disability had decreased in both training groups compared with the control group (P<.001). Maximal isometric neck strength had improved flexion by 110%, rotation by 76%, and extension by 69% in the strength training group. The respective improvements in the endurance training group were 28%, 29%, and 16% and in the control group were 10%, 10%, and 7%. Range of motion had also improved statistically significantly in both training groups compared with the control group in rotation, but only the strength training group had statistically significant improvements in lateral flexion and in flexion and extension. CONCLUSIONS: Both strength and endurance training for 12 months were effective methods for decreasing pain and disability in women with chronic, nonspecific neck pain. Stretching and fitness training are commonly advised for patients with chronic neck pain, but stretching and aerobic exercising alone proved to be a much less effective form of training than strength training.     

Rapid magnetic resonance imaging vs radiographs for patients with low back pain: a randomized controlled trial

Context  Faster magnetic resonance imaging (MRI) scanning has made MRI a potential cost-effective replacement for radiographs for patients with low back pain. However, whether rapid MRI scanning results in better patient outcomes than radiographic evaluation or a cost-effective alternative is unknown. Objective  To determine the clinical and economic consequences of replacing spine radiographs with rapid MRI for primary care patients. Design, Setting, and Patients  Randomized controlled trial of 380 patients aged 18 years or older whose primary physicians had ordered that their low back pain be evaluated by radiographs. The patients were recruited between November 1998 and June 2000 from 1 of 4 imaging centers in the Seattle, Wash, area: a university-based teaching program, a nonuniversity-based teaching program, and 2 private clinics. Intervention  Patients were randomly assigned to receive lumbar spine evaluation by rapid MRI or by radiograph. Main Outcome Measures  Back-related disability measured by the modified Roland questionnaire. Secondary outcomes included Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), pain, preference scores, satisfaction, and costs. Results  At 12 months, primary outcomes of functional disability were obtained from 337 (89%) of the 380 patients enrolled. The mean back-related disability modified Roland score for the 170 patients assigned to the radiograph evaluation group was 8.75 vs 9.34 for the 167 patients assigned the rapid MRI evaluation group (mean difference, -0.59; 95% CI, -1.69 to 0.87). The mean differences in the secondary outcomes were not statistically significant : pain bothersomeness (0.07; 95% CI -0.88 to 1.22), pain frequency (0.12; 95% CI, -0.69 to 1.37), and SF-36 subscales of bodily pain (1.25; 95% CI, -4.46 to 4.96), and physical functioning (2.73, 95% CI -4.09 to 6.22). Ten patients in the rapid MRI group vs 4 in the radiograph group had lumbar spine operations (risk difference, 0.34; 95% CI, -0.06 to 0.73). The rapid MRI strategy had a mean cost of $2380 vs $2059 for the radiograph strategy (mean difference, $321; 95% CI, -1100 to 458). Conclusions  Rapid MRIs and radiographs resulted in nearly identical outcomes for primary care patients with low back pain. Although physicians and patients preferred the rapid MRI, substituting rapid MRI for radiographic evaluations in the primary care setting may offer little additional benefit to patients, and it may increase the costs of care because of the increased number of spine operations that patients are likely to undergo.      

Guggulipid for the treatment of hypercholesterolemia: a randomized controlled trial

Context  Herbal extracts from Commiphora mukul (guggul) have been widely used in Asia as cholesterol-lowering agents, and their popularity is increasing in the United States. Recently, guggulsterones, the purported bioactive compounds of guggul, have been shown to be potent antagonists of 2 nuclear hormone receptors involved in cholesterol metabolism, establishing a plausible mechanism of action for the hypolipidemic effects of these extracts. However, there are currently no published safety or efficacy data on the use of guggul extracts in Western populations. Objective  To study the short-term safety and efficacy of 2 doses of a standardized guggul extract (guggulipid, containing 2.5% guggulsterones) in healthy adults with hyperlipidemia eating a typical Western diet. Design  Double-blind, randomized, placebo-controlled trial using a parallel design, conducted March 2000-August 2001. Participants and Setting  A total of 103 ambulatory, community-dwelling, healthy adults with hypercholesterolemia in the Philadelphia, Pa, metropolitan area. Intervention  Oral, 3 times daily doses of standard-dose guggulipid (1000 mg), high-dose guggulipid (2000 mg), or matching placebo. Main Outcome Measures  Percentage change in levels of directly measured low-density lipoprotein cholesterol (LDL-C) after 8 weeks of therapy. Secondary outcome measures included levels of total cholesterol, high-density lipoprotein cholesterol (HDL-C), triglycerides, and directly measured very low-density lipoprotein cholesterol (VLDL-C), as well as adverse events reports and laboratory safety measures including electrolyte levels and hepatic and renal function. Results  Compared with participants randomized to placebo (n = 36), in whom levels of LDL-C decreased by 5%, both standard-dose guggulipid (n = 33) and high-dose guggulipid (n = 34) raised levels of LDL-C by 4% (P = .01 vs placebo) and 5% (P = .006 vs placebo), respectively, at 8 weeks, for a net positive change of 9% to 10%. There were no significant changes in levels of total cholesterol, HDL-C, triglycerides, or VLDL-C in response to treatment with guggulipid in the intention-to-treat analysis. While guggulipid was generally well tolerated, 6 participants treated with guggulipid developed a hypersensitivity rash compared with none in the placebo group. Conclusions  Despite plausible mechanisms of action, guggulipid did not appear to improve levels of serum cholesterol over the short term in this population of adults with hypercholesterolemia, and might in fact raise levels of LDL-C. Guggulipid also appeared to cause a dermatologic hypersensitivity reaction in some patients.      

Ipriflavone in the treatment of postmenopausal osteoporosis: a randomized controlled trial

CONTEXT: Data on the efficacy and safety of ipriflavone for prevention of postmenopausal bone loss are conflicting. OBJECTIVES: To investigate the effect of oral ipriflavone on prevention of postmenopausal bone loss and to assess the safety profile of long-term treatment with ipriflavone in postmenopausal osteoporotic women. DESIGN AND SETTING: Prospective, randomized, double-blind, placebo-controlled, 4-year study conducted in 4 centers in Belgium, Denmark, and Italy from August 1994 to July 1998. PARTICIPANTS: Four hundred seventy-four postmenopausal white women, aged 45 to 75 years, with bone mineral densities (BMDs) of less than 0.86 g/cm(2). INTERVENTIONS: Patients were randomly assigned to receive ipriflavone, 200 mg 3 times per day (n = 234), or placebo (n = 240); all received 500 mg/d of calcium. MAIN OUTCOME MEASURES: Efficacy measures included spine, hip, and forearm BMD and biochemical markers of bone resorption (urinary hydroxyproline corrected for creatinine and urinary CrossLaps [Osteometer Biotech, Herlev, Denmark] corrected for creatinine), assessed every 6 months. Laboratory safety measures and adverse events were recorded every 3 months. RESULTS: Based on intent-to-treat analysis, after 36 months of treatment, the annual percentage change from baseline in BMD of the lumbar spine for ipriflavone vs placebo (0.1% [95% confidence interval (CI), -7.9% to 8.1%] vs 0.8% [95% CI, -9.1% to 10.7%]; P =.14), or in any of the other sites measured, did not differ significantly between groups. The response in biochemical markers was also similar between groups (eg, for hydroxyproline corrected for creatinine, 20.13 mg/g [95% CI, 18.85-21.41 mg/g] vs 20.67 mg/g [95% CI, 19.41-21.92 mg/g]; P =.96); urinary CrossLaps corrected for creatinine, 268 mg/mol (95% CI, 249-288 mg/mol) vs 268 mg/mol (95% CI, 254-282 mg/mol); P =.81. The number of women with new vertebral fracture was identical or nearly so in the 2 groups at all time points. Lymphocyte concentrations decreased significantly (500/microL (0.5 x 10(9)/L]) in women treated with ipriflavone. Thirty-one women (13.2%) in the ipriflavone group developed subclinical lymphocytopenia, of whom 29 developed it during ipriflavone treatment. Of these, 15 (52%) of 29 had recovered spontaneously by 1 year and 22 (81%) of 29 by 2 years. CONCLUSIONS: Our data indicate that ipriflavone does not prevent bone loss or affect biochemical markers of bone metabolism. Additionally, ipriflavone induces lymphocytopenia in a significant number of women.     

Paroxetine controlled release in the treatment of menopausal hot flashes: a randomized controlled trial

Context  Standard therapy for hot flashes has been hormone replacement with estradiol or progestational agents, but recent data suggest that antidepressants inhibiting serotonin reuptake may also be effective. Objective  To evaluate a selective serotonin reuptake inhibitor (paroxetine controlled release [CR]) in treating the vasomotor symptoms displayed by a general cross-section of menopausal women. Design and Setting  Randomized, double-blind, placebo-controlled, parallel group study conducted across 17 US sites, including urban, suburban, and rural clinics. Patients  A total of 165 menopausal women aged 18 years or older experiencing at least 2 to 3 daily hot flashes and must have discontinued any hormone replacement therapy for at least 6 weeks. Women were excluded if they had any signs of active cancer or were undergoing chemotherapy or radiation therapy. Intervention  After a 1-week placebo run-in phase, study participants were randomized to receive placebo or receive 12.5 mg/d or 25.0 mg/d of paroxetine CR (in a 1:1:1 ratio) for 6 weeks. Main Outcome Measures  Mean change from baseline to week 6 in the daily hot flash composite score (frequency x severity). Results  Fifty-six participants were randomly assigned to receive placebo and 51 to receive 12.5 mg/d and 58 to receive 25.0 mg/d of paroxetine CR. The mean reductions in the hot flash frequency composite score from baseline to week 6 were statistically significantly greater for those receiving paroxetine CR than for those receiving placebo. By week 6, the mean daily hot flash frequency went from 7.1 to 3.8 (mean reduction, 3.3) for those in the 12.5-mg/d and from 6.4 to 3.2 (mean reduction, 3.2) for those in the 25-mg/d paroxetine CR groups and from 6.6 to 4.8 (mean reduction, 1.8) for those in the placebo group. Mean placebo-adjusted reduction in hot flash composite scores were -4.7 (95% confidence interval, - 8.1 to -1.3; P = .007) comparing 12.5-mg/d paroxetine CR with placebo; and -3.6 (95% confidence interval, -6.8 to -0.4; P = .03) comparing 25.0-mg/d paroxetine CR with placebo. This corresponded to median reductions of 62.2% for those in the 12.5-mg/d and 64.6% for those in the 25.0-mg/d paroxetine CR groups compared with 37.8% for those in the placebo group. Conclusion  Paroxetine CR may be an effective and acceptable alternative to hormone replacement and other therapies in treating menopausal hot flash symptoms.      

Chemotherapy with or without irinotecan in patients with advanced or recurrent gastric cancer: a meta-analysis of randomized controlled trials

Background Studies have shown that irinotecan can improve survival in patients with advanced or recurrent gastric cancer,but the overall benefit of irinotecan in the treatment of advanced or recurrent gastric cancer remains controversial.The aim of this study was to evaluate the benefits and risks of irinotecan for survival in patients with advanced or recurrent gastric cancer.Method We searched PubMed,EmBase,the Cochrane Central Register of Controlled Trials,reference lists of articles,and proceedings of major conferences for relevant clinical trials.We included randomized controlled trials that reported on the efficacy and safety of irinotecan in patients with advanced or recurrent gastric cancer.Outcomes were analyzed by survival rate,objective response rate （ORR）,and toxicity.Furthermore,the analysis was further stratified by factors that could affect the treatment effects.Results Eight trials recruiting 1 546 patients with advanced or recurrent gastric cancer were included in the analysis.Overall,irinotecan therapy was associated with a 6％ improvement in survival rate,but this difference was not statistically significant （odds ratio （OR） 0.94; 95％ confidence interval （95％ CI） 0.70-1.27; P=-0.69）.However,irinotecan therapy had more frequent ORR than irinotecan-free arm （OR 1.70; 95％ CI 1.34-2.17; P ＜0.001）.Furthermore,irinotecan therapy was associated with a clinically and statistically significant increase in the risk for declined hemoglobin,hyponatremia,and diarrhea,but it also protected against thrombocytopenia risk when compared with irinotecan-free therapy.Conclusions There is no evidence to support the use of irinotecan therapy in patients with advanced or recurrent gastric cancer; however,given the significant advantage in ORR irinotecan therapy using combination regimens may be considered for further evaluation in subsets of patients who may benefit from this treatment.     

Integrating primary medical care with addiction treatment: a randomized controlled trial

CONTEXT: The prevalence of medical disorders is high among substance abuse patients, yet medical services are seldom provided in coordination with substance abuse treatment. OBJECTIVE: To examine differences in treatment outcomes and costs between integrated and independent models of medical and substance abuse care as well as the effect of integrated care in a subgroup of patients with substance abuse-related medical conditions (SAMCs). DESIGN: Randomized controlled trial conducted between April 1997 and December 1998. SETTING AND PATIENTS: Adult men and women (n = 592) who were admitted to a large health maintenance organization chemical dependency program in Sacramento, Calif. INTERVENTIONS: Patients were randomly assigned to receive treatment through an integrated model, in which primary health care was included within the addiction treatment program (n = 285), or an independent treatment-as-usual model, in which primary care and substance abuse treatment were provided separately (n = 307). Both programs were group based and lasted 8 weeks, with 10 months of aftercare available. MAIN OUTCOME MEASURES: Abstinence outcomes, treatment utilization, and costs 6 months after randomization. RESULTS: Both groups showed improvement on all drug and alcohol measures. Overall, there were no differences in total abstinence rates between the integrated care and independent care groups (68% vs 63%, P =.18). For patients without SAMCs, there were also no differences in abstinence rates (integrated care, 66% vs independent care, 73%; P =.23) and there was a slight but nonsignificant trend of higher costs for the integrated care group ($367.96 vs $324.09, P =.19). However, patients with SAMCs (n = 341) were more likely to be abstinent in the integrated care group than the independent care group (69% vs 55%, P =.006; odds ratio [OR], 1.90; 95% confidence interval [CI], 1.22-2.97). This was true for both those with medical (OR, 3.38; 95% CI, 1.68-6.80) and psychiatric (OR, 2.10; 95% CI, 1.04-4.25) SAMCs. Patients with SAMCs had a slight but nonsignificant trend of higher costs in the integrated care group ($470.81 vs $427.95, P =.14). The incremental cost-effectiveness ratio per additional abstinent patient with an SAMC in the integrated care group was $1581. CONCLUSIONS: Individuals with SAMCs benefit from integrated medical and substance abuse treatment, and such an approach can be cost-effective. These findings are relevant given the high prevalence and cost of medical conditions among substance abuse patients, new developments in medications for addiction, and recent legislation on parity of substance abuse with other medical benefits.     

Sildenafil treatment of women with antidepressant-associated sexual dysfunction: a randomized controlled trial

Context  Antidepressant-associated sexual dysfunction is a common adverse effect that frequently results in premature medication treatment discontinuation and for which no treatment has demonstrated efficacy in women. Objective  To evaluate the efficacy of sildenafil for sexual dysfunction associated with selective and nonselective serotonin reuptake inhibitors (SRIs) in women. Design, Setting, and Participants  An 8-week prospective, parallel-group, randomized, double-blind, placebo-controlled clinical trial conducted between September 1, 2003, and January 1, 2007, at 7 US research centers that included 98 previously sexually functioning, premenopausal women (mean [SD] age 37.1 [6] years) whose major depression was remitted by SRIs but who were also experiencing sexual dysfunction. Intervention  Forty-nine patients were randomly assigned to take sildenafil or placebo at a flexible dose starting at 50 mg adjustable to 100 mg before sexual activity. Main Outcome Measures  The primary outcome measure was the mean difference in change from baseline to study end (ie, lower ordinal score) on the Clinical Global Impression sexual function scale. Secondary measures included the Female Sexual Function Questionnaire, the Arizona Sexual Experience scale-female version, the University of New Mexico Sexual Function Inventory-female version, a sexual activity event log, and the Hamilton Depression Rating scale. Hormone levels were also assessed. Results  In an intention-to-treat analysis, women treated with sildenafil had a mean Clinical Global Impression–sexual function score of 1.9 (95% confidence interval [CI], 1.6-2.3) compared with those taking placebo (1.1; 95% CI, 0.8-1.5), with a mean end point difference of 0.8 (95% CI, 0.6-1.0; P = .001). Assigning baseline values carried forward to the 22% of patients who prematurely discontinued resulted in a mean end point in the sexual function score of 1.5 (95% CI, 1.1-1.9) among women taking sildenafil compared with 0.9 (95% CI, 0.6-1.3) among women taking placebo with a mean end point difference of 0.6 (95% CI, 0.3-0.8; P = .03). Baseline endocrine levels were within normal limits and did not differ between groups. The mean (SD) Hamilton scores for depression remained consistent with remission in both groups (4.0 [3.6]; P = .90). Headache, flushing, and dyspepsia were reported frequently during treatment, but no patients withdrew because of serious adverse effects. Conclusion  In this study population, sildenafil treatment of sexual dysfunction in women taking SRIs was associated with a reduction in adverse sexual effects. Trial Registration  clinicaltrials.gov Identifier: NCT00375297      

针刺治疗卒中后中枢性疼痛的随机对照研究

目的探讨针刺对卒中后中枢性疼痛的临床疗效。方法将符合纳入标准的70例卒中后中枢性疼痛病人,采用数字表法随机分为针刺组(n=35)和药物组(n=35)。针刺组给予百会为主穴的调神针刺法治疗,每周5次,共治疗4周,药物组给予口服阿米替林每次25 mg,3次/d,连续治疗28 d,治疗前后进行视觉模拟评表(Visual Analogue Scale,VAS)、简明Mc Gill疼痛量表(Short-form of Mc Gill Pain Questionnaire,SF-MPQ)评定。结果针刺组总有效率为72.9%(23/32),优于药物组的51.5%(17/33,P<0.05);2组治疗后VAS、简化SF-MPQ评分较治疗前均有降低(均P<0.05),且针刺组在感觉、情感和疼痛程度方面优于药物组(P<0.05)。结论针刺对卒中后中枢性疼痛病人的疼痛症状具有缓解作用。     

Effectiveness of massage therapy for subacute low-back pain: a randomized controlled trial

BACKGROUND: The effectiveness of massage therapy for low-back pain has not been documented. This randomized controlled trial compared comprehensive massage therapy (soft-tissue manipulation, remedial exercise and posture education), 2 components of massage therapy and placebo in the treatment of subacute (between 1 week and 8 months) low-back pain. METHODS: Subjects with subacute low-back pain were randomly assigned to 1 of 4 groups: comprehensive massage therapy (n = 25), soft-tissue manipulation only (n = 25), remedial exercise with posture education only (n = 22) or a placebo of sham laser therapy (n = 26). Each subject received 6 treatments within approximately 1 month. Outcome measures obtained at baseline, after treatment and at 1-month follow-up consisted of the Roland Disability Questionnaire (RDQ), the McGill Pain Questionnaire (PPI and PRI), the State Anxiety Index and the Modified Schober test (lumbar range of motion). RESULTS: Of the 107 subjects who passed screening, 98 (92%) completed post-treatment tests and 91 (85%) completed follow-up tests. Statistically significant differences were noted after treatment and at follow-up. The comprehensive massage therapy group had improved function (mean RDQ score 1.54 v. 2.86-6.5, p < 0.001), less intense pain (mean PPI score 0.42 v. 1.18-1.75, p < 0.001) and a decrease in the quality of pain (mean PRI score 2.29 v. 4.55-7.71, p = 0.006) compared with the other 3 groups. Clinical significance was evident for the comprehensive massage therapy group and the soft-tissue manipulation group on the measure of function. At 1-month follow-up 63% of subjects in the comprehensive massage therapy group reported no pain as compared with 27% of the soft-tissue manipulation group, 14% of the remedial exercise group and 0% of the sham laser therapy group. INTERPRETATION: Patients with subacute low-back pain were shown to benefit from massage therapy, as regulated by the College of Massage Therapists of Ontario and delivered by experienced massage therapists.     

Memantine treatment in patients with moderate to severe Alzheimer disease already receiving donepezil: a randomized controlled trial

Context  Memantine is a low- to moderate-affinity, uncompetitive N-methyl-D-aspartate receptor antagonist. Controlled trials have demonstrated the safety and efficacy of memantine monotherapy for patients with moderate to severe Alzheimer disease (AD) but no controlled trials of memantine in patients receiving a cholinesterase inhibitor have been performed. Objective  To compare the efficacy and safety of memantine vs placebo in patients with moderate to severe AD already receiving stable treatment with donepezil. Design, Setting, and Participants  A randomized, double-blind, placebo-controlled clinical trial of 404 patients with moderate to severe AD and Mini-Mental State Examination scores of 5 to 14, who received stable doses of donepezil, conducted at 37 US sites between June 11, 2001, and June 3, 2002. A total of 322 patients (80%) completed the trial. Interventions  Participants were randomized to receive memantine (starting dose 5 mg/d, increased to 20 mg/d, n = 203) or placebo (n = 201) for 24 weeks. Main Outcome Measures  Change from baseline on the Severe Impairment Battery (SIB), a measure of cognition, and on a modified 19-item AD Cooperative Study–Activities of Daily Living Inventory (ADCS-ADL₁₉). Secondary outcomes included a Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus), the Neuropsychiatric Inventory, and the Behavioral Rating Scale for Geriatric Patients (BGP Care Dependency Subscale). Results  The change in total mean (SE) scores favored memantine vs placebo treatment for SIB (possible score range, 0-100), 0.9 (0.67) vs –2.5 (0.69), respectively (P<.001); ADCS-ADL₁₉ (possible score range, 0-54), –2.0 (0.50) vs –3.4 (0.51), respectively (P = .03); and the CIBIC-Plus (possible score range, 1-7), 4.41 (0.074) vs 4.66 (0.075), respectively (P = .03). All other secondary measures showed significant benefits of memantine treatment. Treatment discontinuations because of adverse events for memantine vs placebo were 15 (7.4%) vs 25 (12.4%), respectively. Conclusions  In patients with moderate to severe AD receiving stable doses of donepezil, memantine resulted in significantly better outcomes than placebo on measures of cognition, activities of daily living, global outcome, and behavior and was well tolerated. These results, together with previous studies, suggest that memantine represents a new approach for the treatment of patients with moderate to severe AD.      

Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer: a randomized controlled trial

Context  The role of adjuvant therapy in resectable pancreatic cancer is still uncertain, and no recommended standard exists. Objective  To test the hypothesis that adjuvant chemotherapy with gemcitabine administered after complete resection of pancreatic cancer improves disease-free survival by 6 months or more. Design, Setting, and Patients  Open, multicenter, randomized controlled phase 3 trial with stratification for resection, tumor, and node status. Conducted from July 1998 to December 2004 in the outpatient setting at 88 academic and community-based oncology centers in Germany and Austria. A total of 368 patients with gross complete (R0 or R1) resection of pancreatic cancer and no prior radiation or chemotherapy were enrolled into 2 groups. Intervention  Patients received adjuvant chemotherapy with 6 cycles of gemcitabine on days 1, 8, and 15 every 4 weeks (n = 179), or observation ([control] n = 175). Main Outcome Measures  Primary end point was disease-free survival, and secondary end points were overall survival, toxicity, and quality of life. Survival analysis was based on all eligible patients (intention-to-treat). Results  More than 80% of patients had R0 resection. The median number of chemotherapy cycles in the gemcitabine group was 6 (range, 0-6). Grade 3 or 4 toxicities rarely occurred with no difference in quality of life (by Spitzer index) between groups. During median follow-up of 53 months, 133 patients (74%) in the gemcitabine group and 161 patients (92%) in the control group developed recurrent disease. Median disease-free survival was 13.4 months in the gemcitabine group (95% confidence interval, 11.4-15.3) and 6.9 months in the control group (95% confidence interval, 6.1-7.8; P<.001, log-rank). Estimated disease-free survival at 3 and 5 years was 23.5% and 16.5% in the gemcitabine group, and 7.5% and 5.5% in the control group, respectively. Subgroup analyses showed that the effect of gemcitabine on disease-free survival was significant in patients with either R0 or R1 resection. There was no difference in overall survival between the gemcitabine group (median, 22.1 months; 95% confidence interval, 18.4-25.8; estimated survival, 34% at 3 years and 22.5% at 5 years) and the control group (median, 20.2 months; 95% confidence interval, 17-23.4; estimated survival, 20.5% at 3 years and 11.5% at 5 years; P = .06, log-rank). Conclusions  Postoperative gemcitabine significantly delayed the development of recurrent disease after complete resection of pancreatic cancer compared with observation alone. These results support the use of gemcitabine as adjuvant chemotherapy in resectable carcinoma of the pancreas. Trial Registration  isrctn.org Identifier: ISRCTN34802808      

Exercise plus behavioral management in patients with Alzheimer disease: a randomized controlled trial

Context  Exercise training for patients with Alzheimer disease combined with teaching caregivers how to manage behavioral problems may help decrease the frailty and behavioral impairment that are often prevalent in patients with Alzheimer disease. Objective  To determine whether a home-based exercise program combined with caregiver training in behavioral management techniques would reduce functional dependence and delay institutionalization among patients with Alzheimer disease. Design, Setting, and Patients  Randomized controlled trial of 153 community-dwelling patients meeting National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer Disease and Related Disorders Association criteria for Alzheimer disease, conducted between June 1994 and April 1999. Interventions  Patient-caregiver dyads were randomly assigned to the combined exercise and caregiver training progam, Reducing Disability in Alzheimer Disease (RDAD), or to routine medical care (RMC). The RDAD program was conducted in the patients' home over 3 months. Main Outcome Measures  Physical health and function (36-item Short-Form Health Survey's [SF-36] physical functioning and physical role functioning subscales and Sickness Impact Profile's Mobility subscale), and affective status (Hamilton Depression Rating Scale and Cornell Depression Scale for Depression in Dementia). Results  At 3 months, in comparison with the routine care patients, more patients in the RDAD group exercised at least 60 min/wk (odds ratio [OR], 2.82; 95% confidence interval [CI], 1.25-6.39; P = .01) and had fewer days of restricted activity (OR, 3.10; 95% CI, 1.08-8.95; P<.001). Patients in the RDAD group also had improved scores for physical role functioning compared with worse scores for patients in the RMC group (mean difference, 19.29; 95% CI, 8.75-29.83; P<.001). Patients in the RDAD group had improved Cornell Depression Scale for Depression in Dementia scores while the patients in the RMC group had worse scores (mean difference, -1.03; 95% CI, -0.17 to -1.91; P = .02). At 2 years, the RDAD patients continued to have better physical role functioning scores than the RMC patients (mean difference, 10.89; 95% CI, 3.62-18.16; P = .003) and showed a trend (19% vs 50%) for less institutionalization due to behavioral disturbance. For patients with higher depression scores at baseline, those in the RDAD group improved significantly more at 3 months on the Hamilton Depression Rating Scale (mean difference, 2.21; 95% CI, 0.22-4.20; P = .04) and maintained that improvement at 24 months (mean difference, 2.14; 95% CI, 0.14-4.17; P = .04). Conclusion  Exercise training combined with teaching caregivers behavioral management techniques improved physical health and depression in patients with Alzheimer disease.      

伤柏膏治疗急性踝关节外侧副韧带损伤患者疼痛的临床效果

目的 探讨伤柏膏在治疗急性踝关节外侧副韧带损伤患者疼痛的临床治疗效果.方法 选取我院单侧踝关节损伤患者50例随机分为治疗组和对照组,每组各25例,分别在入院治疗前及治疗第3,7,14天对患者进行疼痛度视觉模拟评分(VAS)和kofoed评分,同时测量患者踝关节周径,以及踝关节损伤后下肢功能自我功能评定.结果 两组患者治疗前一般临床资料差异均无统计学意义,在治疗第3,7,14天后,治疗组在VAS评分及肿胀消除上均优于对照组,差异具有统计学意义(P＜0.05);两组患者在治疗前和治疗第3天后Kofoed踝关节评分无显著性差异(P＞0.05),在治疗7,14d后,治疗组在Kofoed踝关节评分显著高于对照组(P＜0.05).在自我功能评定上,治疗前和治疗第3天,两组患者评分均无统计学差异,治疗7,14d后,治疗组评分显著高于对照组(P＜0.01).结论 伤柏膏外敷治疗能够较快改善急性踝关节外侧副韧带损伤患者的疼痛,并改善相关功能性评分.