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A Laupacis  K Sullivan 《CMAJ》1996,154(11):1669-1674
OBJECTIVE: To determine the effect of the results of clinical trials on the behaviour of patients and physicians, the authors ascertained the proportion of patients participating in the Canadian Atrial Fibrillation Anticoagulation (CAFA) study who started or continued warfarin therapy at the end of the study and identified factors affecting the decision to use or not use warfarin. The CAFA study was a double-blind, randomized, placebo-controlled, multicentre study to evaluate the efficacy of warfarin in preventing stroke among patients with nonrheumatic atrial fibrillation. Recruitment and follow-up were stopped early because two other similar studies had shown a decrease in the rate of stroke among patients treated with warfarin. DESIGN: Mail survey 21 months after the end of the study. PARTICIPANTS: The personal physicians of 336 patients who had participated in the CAFA study. OUTCOME MEASURES: Type of antithrombotic therapy the patients had received since the CAFA study ended for patients who were not receiving warfarin, the reasons they were not. RESULTS: Questionnaires concerning 254 (76%) of the patients who had participated in the study were returned. Since the end of the CAFA study, 153 (60%) of these patients had been treated continually with warfarin, 14 (6%) had been treated with warfarin but had subsequently stopped taking it, 59 (23%) had taken acetylsalicylic acid (ASA) continually, 5 (2%) had been taking ASA but had subsequently stopped taking it, and 23 (9%) had not taken either drug. The responding physicians stated that 58 (67%) of the patients who were not treated with warfarin did not wish to take the drug. The patients who had received warfarin during the CAFA trial were more likely to be treated with warfarin after the trial (75%) than were those who had received a placebo (56%) (p = 0.001). The probability of the patients'' being treated with warfarin also depended on which study centre they had been treated in (p = 0.001). CONCLUSIONS: Of the patients in the CAFA study for whom questionnaires were received, only 167 (66%) had been treated with warfarin after the end of the study. The patients were more likely to have been treated with warfarin after the study if they had received warfarin during the study. The positive results of clinical trials, on their own, are not enough to fully change the behaviour of patients and physicians.  相似文献   

4.

Background

Little is known about whether atrial fibrillation is a presentation of coronary disease. There is a paucity of knowledge about their causal relationship and also the impact of different antithrombotic strategies on the subsequent presentation of symptomatic coronary disease.

Methods and Results

We studied 7,526 Chinese patients diagnosed with non-valvular atrial fibrillation and no documented history of coronary artery disease. The primary endpoint was the new occurrence of coronary artery disease—either stable coronary artery disease or acute coronary syndrome. After a mean follow-up of 3.2±3.5 years (24,071 patient-years), a primary endpoint occurred in 987 patients (13.1%). The overall annual incidence of coronary artery disease was 4.10%/year. No significant differences in age, sex, and mean CHA2DS2-VASc score were observed between patients with and without the primary endpoint. When stratified according to the antithrombotic strategies applied for stroke prevention, the annual incidence of coronary artery disease was 5.49%/year, 4.45%/year and 2.16%/year respectively in those prescribed no antithrombotic therapy, aspirin, and warfarin. Similar trends were observed in patients with acute coronary syndromes. Diabetes mellitus, smoking history and renal failure requiring dialysis were predictors for primary endpoint in all antithrombotic therapies.

Conclusion

In patients with non-valvular atrial fibrillation, there is a modest association with coronary artery disease. Patients prescribed warfarin had the lowest risk of new onset coronary artery disease.  相似文献   

5.
目的:探讨利伐沙班与华法林对高龄非瓣膜性房颤(NVAF)患者血浆D-二聚体(D-D)、N末端B型利钠肽原(NT-pro BNP)水平的影响及其临床疗效。方法:选取我院2015年1月~2016年11月收治的146例高龄NVAF患者,采取随机数字表法均分为两组。华法林组予以华法林抗栓治疗,利伐沙班组采取利伐沙班抗栓治疗。记录比较两组治疗期间栓塞、出血情况及不良反应,以及治疗前后血浆D-二聚体(D-D)、N末端B型利钠肽原(NT-pro BNP)水平的变化情况。结果:两组治疗后栓塞发生率比较,差异无统计学意义(P0.05)。利伐沙班组出血发生率(4.1%)低于华法林组(15.1%),差异具有统计学意义(P0.05)。与治疗前相比,两组治疗后血浆D-D和NT-pro BNP水平均降低,差异具有统计学意义(P0.01);治疗后,两组血浆D-D和NT-pro BNP水平比较,差异无统计学意义(P0.05)。两组不良反应发生率对比,差异无统计学意义(P0.05)。结论:与华法林相比,高龄非瓣膜性房颤应用利伐沙班抗栓治疗在患者耐受性与预防血栓栓塞方面优势相当,但利伐沙班更能有效降低患者出血风险。  相似文献   

6.

Aim

Cardioversion can rapidly and effectively restore sinus rhythm in patients with persistent atrial fibrillation. Since 2011 dabigatran has been available as an alternative to warfarin to prevent thromboembolic events in patients with non-valvular atrial fibrillation undergoing cardioversion. We studied time to cardioversion, risk of adverse events, and risk of readmission with atrial fibrillation after cardioversion according to anticoagulation therapy.

Methods and Results

Through the nationwide Danish registries we included 1,230 oral anticoagulation naïve patients with first time non-valvular atrial fibrillation and first time cardioversion from 2011 to 2012; 37% in the dabigatran group (n = 456), and 63% in the warfarin group (n = 774). Median time to cardioversion was 4.0 (interquartile range [IQR] 2.9 to 6.5) and 6.9 (IQR 3.9 to 12.1) weeks in the dabigatran and warfarin groups respectively, and the adjusted odds ratio of cardioversion within the first 4 weeks was 2.3 (95% confidence interval [CI] 1.7 to 3.1) in favor of dabigatran. The cumulative incidence of composite endpoint of stroke, bleeding or death were 2.0% and 1.0% at 30 weeks in the warfarin and dabigatran groups respectively, with an adjusted hazard ratio of 1.33 (95% CI 0.33 to 5.42). Cumulative incidence of readmission with atrial fibrillation after 30 weeks were 9% and 11% in the warfarin and dabigatran groups, respectively, and an adjusted hazard ratio of 0.66 (95% CI 0.41 to 1.08).

Conclusion

Anticoagulation treatment with dabigatran allows shorter time to cardioversion for atrial fibrillation than warfarin, and appears to be an effective and safe alternative treatment strategy to warfarin.  相似文献   

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目的:研究经食道超声心动图(TEE)评估特发性房颤左心房左心耳的临床价值。方法:选择自2015年1月到2016年8月在医院接受诊治的特发性房颤患者100例纳入本次研究,阵发性房颤92例,记为阵发性房颤组;持续性房颤8例,记为持续性房颤组。另选同期在医院进行健康体检的心功能正常志愿者90例作为对照组。利用TEE对受试者进行检查,对比房颤组与对照组的左心房及左心耳参数,是否含有自发性显影(LASEC)的房颤患者的左心房及左心耳参数,利用TEE分析对房颤患者的预后情况。结果:阵发性房颤组左心房的前后径和左右径,左心耳血流最大的排空速度(Lev)均明显小于对照组,左心耳的面积变化率及最大的充盈速度(Lfv)均明显大于对照组,差异有统计学意义(P0.05)。持续性房颤组左心房的前后径和左右径均明显大于对照组,左心耳的面积变化率、Lev及Lfv均明显小于对照组,差异有统计学意义(P0.05)。阵发性房颤组左心房的前后径和左右径均明显小于持续性房颤组,左心耳的面积变化率、Lev及Lfv均明显大于持续性房颤组,差异有统计学意义(P0.05)。有LASEC者左心房的前后径和左右径均明显大于无LASEC者,左心耳的面积变化率、Lev及Lfv均明显小于无LASEC者,差异有统计学意义(P0.05)。100例房颤患者中发现34例LASEC,占34.00%,其中有18例患者合并有左心耳血栓,占18.00%。总计有66例患者接受导管射频消融疗法,占66.00%,均未在术中及术后7d内出现血栓及栓塞并发症。结论:利用TEE对特发性房颤的患者左心房及左心耳进行评估,有利于更好的辅助患者的临床治疗,值得重视。  相似文献   

8.
BackgroundThe development of new-onset atrial fibrillation in sepsis has been associated with adverse outcomes.MethodsA systematic literature search was conducted to retrieve articles that investigated the association of new-onset atrial fibrillation in patients diagnosed with sepsis. The primary outcome of interest was the pooled risk ratio (RR) of in-hospital mortality in patients with new-onset atrial fibrillation and sepsis.ResultsSix studies included 3100 patients with new-onset atrial fibrillation in sepsis and 36,900 patients without new-onset atrial fibrillation in sepsis. The pooled RR for in-hospital mortality was 1.45 (95 % CI 1.32–1.60, p < 0.00001, I2 = 24 %). New-onset atrial fibrillation was also associated with increased ICU mortality, ICU and in-hospital length of stay and stroke. New-onset atrial fibrillation occurred more in the elderly, those with a prior history of cardiovascular and respiratory disease, and those with increased severity of illness.ConclusionProspective randomised trials are needed to clarify the significance of new-onset atrial fibrillation in sepsis, optimal treatment strategies for these patients, and the benefit of systemic anticoagulation. Physicians should be aware that new-onset atrial fibrillation in sepsis is not merely an observed temporary arrhythmia but a marker of poor prognosis and should be managed accordingly.  相似文献   

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目的:探讨与对比心房颤动对不同时间窗内急性缺血性脑卒中患者静脉溶栓疗效的影响。方法:选择2014年8月到2016年5月在我院进行诊治的急性缺血性脑卒中患者98例,其中卒中前已诊断心房颤动定义为慢性心房颤动组(n=50),入院后诊断心房颤动者为新发心房颤动组(n=48);两组都给予重组组织型纤溶酶原激活剂(rt-PA)静脉溶栓治疗,记录两组预后情况。结果:两组患者的性别、年龄、时间窗、合并疾病、血糖与甘油三酯含量对比无明显差异(P0.05)。慢性心房颤动组与新发心房颤动组的有效率分别为94.0%和95.8%,组间比较差异无统计学意义(P0.05)。慢性心房颤动组与新发心房颤动组治疗后的m RS评分分别为6.22±1.83分和6.29±1.45分,都明显低于治疗前的9.24±1.31分和9.19±1.52分(P0.05),组间对比无明显差异(P0.05)。慢性心房颤动组的症状性脑出血与非症状性脑出血发生率分别为4.0%和2.0%,都明显低于新发心房颤动组的14.6%和12.5%(P0.05)。结论:发病4.5h之内静脉溶栓急性缺血性脑卒中是安全有效的,新发心房颤动不影响患者静脉溶栓后的神经功能结局,但是会增加症状性脑出血与非症状性脑出血,需要加强预防性管理。  相似文献   

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ObjectiveTo determine whether pentoxifylline 400 mg (Trental 400) taken orally three times daily, in addition to ambulatory compression bandages and dressings, improves the healing rate of pure venous ulcers.DesignRandomised, double blind placebo controlled trial, parallel group study of factorial design, permitting the simultaneous evaluation of alternative pharmaceutical, bandaging, and dressings materials.SettingLeg ulcer clinics of a teaching and a district general hospital in southern Scotland.Participants200 patients with confirmed venous ulcers and in whom other major causal factors were excluded.InterventionsPentoxifylline 400 mg three times daily or placebo.ResultsComplete healing occurred in 65 of the 101 (64%) patients receiving pentoxifylline and 52 of the 99 (53%) patients receiving placebo.ConclusionsThe difference in the healing rates between patients taking pentoxifylline and those taking placebo did not reach statistical significance.

Key messages

  • Leg ulcers cost the NHS around £400 million per annum
  • 50%-75% of venous leg ulcers can be succesfully treated with dressings and compression bandages but take many months to heal
  • A drug that reduced the healing time of venous ulcers would be useful, although no agent has been proved to be effective to date
  • Trials with pentoxifylline, a vasoactive drug used in the treatment of peripheral vascular diseases, as an adjunct to the treatment of venous ulcers have been inconclusive
  • At the 5% level, pentoxifylline had a non-significant effect on healing rates of pure venous ulcers
  相似文献   

11.
ObjectiveTo determine patients'' preferences for a shared or directed style of consultation in the decision making part of the general practice consultation.DesignStructured interview, with video vignettes of acted consultations.Setting5 practices in Lothian, Scotland.Participants410 patients (adults and adults accompanying children) attending surgery appointments.ResultsPatients varied in their preference for involvement in decision making in the consultation. Under multiple regression analysis, patients'' preference was found to be independently predicted by the problem viewed (patients presented with physical problems preferred a directed approach), patients'' age (patients aged 61 or older were more likely to prefer the directed approach), social class (social classes I and II were more likely to prefer the shared approach), and smoking status (smokers more likely to prefer the shared approach). Those patients who were able to answer (or who thought their doctor''s style similar to those in the vignettes) were more likely to describe their own doctor''s style as similar to their preferred style. No major association in preference was found with sex, frequency of attendance, or perceived chronic ill health.ConclusionPatients may vary in their desire for involvement in decision making in consultations. Although this variation seems to depend on the presenting problem, age, social class, and smoking status, these associations are not absolute, with large minorities in each group. Doctors need the skills, knowledge of their patients, and the time to determine on which occasions, with which illnesses, and at which level their patients wish to be involved in decision making.  相似文献   

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目的:探究胺碘酮治疗老年急性心肌梗死(AMI)伴心房颤动的疗程疗效。方法:选取于2014年1月-2016年6月来我院诊治的AMI且合并心房颤动患者74例为研究对象,采用随机数字表法分为观察组和对照组,每组各37例;观察组采用胺碘酮治疗,对照组采用毛花苷丙治疗,评价两组治疗效果,比较两组房颤动控制率、窦性心律维持率、病死率及不良反应发生率。结果:观察组的显效率、总有效率分别为73.0%(18/37)、94.6%(27/37),明显高于对照组的48.6%(27/37)、73.0%(35/37),差异有统计学意义(P=0.032,P=0.021);房颤动控制率及窦性心律维持率分别为67.6%(25/37)、81.1%(30/37)明显高于对照组的43.2%(16/37)、45.9%(17/37),差异有统计学意义(P=0.035,P=0.002);病死率及不良反应发生率分别为5.4%(2/37)、10.8%(4/37)明显低于对照组的21.6%(8/37)、51.8%(19/37),差异有统计学意义(P=0.041,P0.001)。结论:胺碘酮治疗老年AMI伴心房颤动的临床疗效显著,药物不良反应的发生率较低,安全有效,值得在临床应用推广。  相似文献   

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Background and objectivesThe prevalence of atrial fibrillation (AF) and ischaemic heart disease (IHC) increases with age. They coexist in up to 20% of octogenarian patients, a situation that poses a therapeutic challenge. Trials that have addressed this scenario, which included a low percentage of octogenarians, showed that double therapy (single antiplatelet + anticoagulation) compared to triple therapy (double antiplatelet + anticoagulation) was associated with less bleeding events, especially with direct oral anticoagulants. These studies did not have sufficient power to detect differences in ischaemic events. On the other hand, prevalent characteristics in the elderly, such as geriatric syndromes, were not assessed in these studies, and are not usually evaluated in clinical practice. Accordingly, their prognostic impact remains unknown in this clinical context.MethodsObservational, prospective, and multicentre study that will include patients ≥ 80 years with AF and IHC in Spain. Baseline characteristics and geriatric syndromes will be assessed, as well as the choice of antithrombotic treatment. The primary endpoint is cardiovascular and overall mortality at one and three years follow-up.ResultsThis study will assess both characteristics and prognosis of octogenarian patients with AF and IHC in Spain, the factors involved in the choice of antithrombotic treatment, and the incidence of ischaemic and haemorrhagic events during the short- and long-term follow-up.ConclusionThis study will contribute to improve the knowledge in terms of safety and efficacy of the different therapeutic options in older patients with AF and IHC, as well as their prognostic impact.  相似文献   

15.

Background:

Although warfarin has been extensively studied in clinical trials, little is known about rates of hemorrhage attributable to its use in routine clinical practice. Our objective was to examine incident hemorrhagic events in a large population-based cohort of patients with atrial fibrillation who were starting treatment with warfarin.

Methods:

We conducted a population-based cohort study involving residents of Ontario (age ≥ 66 yr) with atrial fibrillation who started taking warfarin between Apr. 1, 1997, and Mar. 31, 2008. We defined a major hemorrhage as any visit to hospital for hemorrage. We determined crude rates of hemorrhage during warfarin treatment, overall and stratified by CHADS2 score (congestive heart failure, hypertension, age ≥ 75 yr, diabetes mellitus and prior stroke, transient ischemic attack or thromboembolism).

Results:

We included 125 195 patients with atrial fibrillation who started treatment with warfarin during the study period. Overall, the rate of hemorrhage was 3.8% (95% confidence interval [CI] 3.8%–3.9%) per person-year. The risk of major hemorrhage was highest during the first 30 days of treatment. During this period, rates of hemorrhage were 11.8% (95% CI 11.1%–12.5%) per person-year in all patients and 16.7% (95% CI 14.3%–19.4%) per person-year among patients with a CHADS2 scores of 4 or greater. Over the 5-year follow-up, 10 840 patients (8.7%) visited the hospital for hemorrhage; of these patients, 1963 (18.1%) died in hospital or within 7 days of being discharged.

Interpretation:

In this large cohort of older patients with atrial fibrillation, we found that rates of hemorrhage are highest within the first 30 days of warfarin therapy. These rates are considerably higher than the rates of 1%–3% reported in randomized controlled trials of warfarin therapy. Our study provides timely estimates of warfarin-related adverse events that may be useful to clinicians, patients and policy-makers as new options for treatment become available.Atrial fibrillation is a major risk factor for stroke and systemic embolism, and strong evidence supports the use of the anticoagulant warfarin to reduce this risk.13 However, warfarin has a narrow therapeutic range and requires regular monitoring of the international normalized ratio to optimize its effectiveness and minimize the risk of hemorrhage.4,5 Although rates of major hemorrhage reported in trials of warfarin therapy typically range between 1% and 3% per person-year,611 observational studies suggest that rates may be considerably higher when warfarin is prescribed outside of a clinical trial setting,1215 approaching 7% per person-year in some studies.1315 The different safety profiles derived from clinical trials and observational data may reflect the careful selection of patients, precise definitions of bleeding and close monitoring in the trial setting. Furthermore, although a few observational studies suggest that hemorrhage rates are higher than generally appreciated, these studies involve small numbers of patients who received care in specialized settings.1416 Consequently, the generalizability of their results to general practice may be limited.More information regarding hemorrhage rates during warfarin therapy is particularly important in light of the recent introduction of new oral anticoagulant agents such as dabigatran, rivaroxaban and apixaban, which may be associated with different outcome profiles.1719 There are currently no large studies offering real-world, population-based estimates of hemorrhage rates among patients taking warfarin, which are needed for future comparisons with new anticoagulant agents once they are widely used in routine clinical practice.20We sought to describe the risk of incident hemorrhage in a large population-based cohort of patients with atrial fibrillation who had recently started warfarin therapy.  相似文献   

16.

Background  

Chronic atrial fibrillation is a prevalent cardiac disorder. The literature indicates varying proportions of those treated with anticoagulants, and varying intensity of anticoagulation. Electronic patient records are providing us with clinical data concerning management of anticoagulant treatment in real-life practice that is useful for audits. We aimed to assess warfarin treatment for chronic atrial fibrillation in primary health care with regard to prevalence, incidence, the proportion treated and the quality of anticoagulation control.  相似文献   

17.
摘要 目的:探讨右室Tei指数、血清醛固酮水平对慢性阻塞性肺病(COPD)患者发生房颤的预测价值。方法:根据房颤的发生情况,将200例COPD患者分为房颤发生组和无房颤发生组。比较两组的病程、COPD严重程度、血清醛固酮(ALD)水平及右室Tei指数、肺动脉压、右心室横径的差异,分析右室Tei指数和ALD预测房颤发生的ROC曲线下面积、截断值、灵敏度及特异度。结果:房颤发生组病程(8.48±1.3和7.59±1.75)、右心室横径(40.52±2.74和36.27±2.4)、血清ALD(137.64±42.77和98.61±15.39)、右室Tei指数(0.37±0.12和0.31±0.07)、COPD、肺动脉高压的严重程度与无房颤发生组比较差异都有统计学意义(P<0.05)。logistic回归分析结果显示ALD、右室Tei指数、病程、和肺动脉高压程度为影响COPD患者发生房颤的独立影响因素。右室Tei指数预测房颤发生的ROC曲线下面积AUC=0.645,截断值为0.420,灵敏度为38.0%,特异度达到93.33%;ALD预测房颤发生的ROC曲线下面积为0.792,截断值为122.72 pg/mL,灵敏度为66.0%,特异度可达到98.0%。结论:右室Tei指数和血清醛固酮水平可作为慢性阻塞性肺病患者发生房颤的预测参考指标。  相似文献   

18.
Background: Atrial fibrillation (AF) is the most common arrhythmia encountered in both male and female patients.Objective: This evidence-based update attempts to address the advances in the science of AF management in light of key gender issues.Methods: In October 2009, 2 investigators (H.I.M. and B.D.P.) independently searched MEDLINE (PubMed [1950–2009] and Ovid [2000–2009]) for all publication types in the English language, using database-specific controlled vocabulary describing the concepts of AF and gender (atrial fibrillation, gender, women, and men for PubMed; atrial fibrillation and gender for Ovid). The reference sections from the identified publications were also used. The methodologic quality of publications, their content relevance, and the authors' expert opinions guided publication inclusion in this evidence-based narrative review. Articles relevant to gender differences in pathophysiology, outcomes, and treatment of AF are summarized and discussed.Results: Based on current available data, mortality is greater for women with AF than for men with AF. Women with AF have a higher risk of stroke compared with their male counterparts. Women derive the greatest benefit from anticoagulation in AF. There are no significant sex differences in major bleeding risk from warfarin. Women tend to be more symptomatic from AF than are men, but fare worse than men when a rhythm-control strategy is utilized with antiarrhythmic medications. Women have an increased risk for torsades de pointes when taking sotalol or dofetilide, and have a higher risk of bradyarrhythmias when taking antiarrhythmics. AF catheter ablation is successful and beneficial for selected patients of both sexes, although women may incur higher procedural bleeding complications. Women tend to be referred for AF ablation less and later than are men.Conclusions: The past decade has witnessed significant progress in the understanding and management of AF. Awareness of key sex-specific differences in AF allows for a more safe, effective, and personalized approach to the management of this disorder.  相似文献   

19.
摘要 目的:探究永久起搏器程控在心房颤动诊断中的临床应用及意义。方法:选择78例我院收治的心房颤动患者随机分为程控组和非程控组2组,其中观察组患者给与永久起搏器程控诊断,非程控组则仅给植入永久起搏器,但非程控。对比分析两组患者基本资料、房颤负荷、心房与心室起搏比、心房结构重构及左心功能、P波结果;比较永久起搏器程控诊断与临床诊断结果的差异,分析永久起搏器程控在心房颤动诊断敏感度。结果:程控组和非程控组患者的男女比例、年龄、心率失常的类型、存在的基础性疾病以及使用过的治疗药物比较,差异均无统计学意义(P>0.05);程控组和非程控组患者的房颤负荷、VP值和P波最小时限均显著小于非程控组,AP值、P波最大时限和P波离散度则显著大于非程控组(P<0.05);程控组和非程控组患者的LAD、RAD、LVEDD和LVEF值在植入前和植入后均不存在显著性差异(P>0.05)。与临床诊断结果比较可以发现,永久起搏器程控对心房颤动检出率为97.44 %,且永久起搏器程控应用于诊断心房颤动敏感度高达98.72 %。结论:对心房颤动患者采用永久起搏器程控进行诊断,可以在心电图检查的各项指标结果上对患者的心房颤动给与准确的判断,具有较高的临床应用价值,值得临床推广使用。  相似文献   

20.
ObjectivesTo assess the efficacy and safety of hypericum extract (STEI 300, Steiner Arzneimittel, Berlin) compared with imipramine and placebo in patients in primary care with a current episode of moderate depression.DesignRandomised, double blind, multicentre, parallel group trial for 8 weeks.SettingTrained panel of 18 general practitioners from four German states: Bavaria, Berlin, Rhineland Palatinate, and Saxony.Participants263 patients (66 men, 197 women) with moderate depression according to ICD-10 (international classification of diseases, 10th revision) codes F32.1 and F33.1.Interventions1050 mg hypericum extract (350 mg three times daily), 100 mg imipramine (50 mg, 25 mg, and 25 mg daily), or placebo three times daily.ResultsHypericum extract was more effective at reducing Hamilton depression scores than placebo and as effective as imipramine (mean −15.4 (SD 8.1), −12.1 (7.4), and –14.2 (7.3) respectively). Comparable results were found for Hamilton anxiety and clinical global impressions scales and were most pronounced for the Zung self rating depression scale. Quality of life was more improved in the standardised mental component scale of the SF-36 with both active treatments than with placebo but in the physical component scale was improved only by hypericum extract compared with placebo. The rate of adverse events with hypericum extract was in the range of the placebo group but lower than that of the imipramine group (0.5, 0.6, and 1.2 events per patient respectively).ConclusionsAt an average dose of 350 mg three times daily hypericum extract was more effective than placebo and at least as effective as 100 mg imipramine daily in the treatment of moderate depression. Treatment with hypericum extract is safe and improves quality of life.

Key messages

  • Hypericum extract (STEI 300) was effective after 4, 6, and 8 weeks of treatment in patients with moderate depression
  • Simultaneous analysis confirmed hypericum extract to be at least as efficacious as imipramine 100 mg daily after eight weeks of treatment
  • Besides better antidepressive efficacy both hypericum extract and imipramine improved quality of life
  • Patients tolerate hypericum extracts much better than they do tricyclics and therefore by improving patients'' compliance hypericum extracts are promising drugs for long term treatment
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