***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: CONTEXT The generalized type of social phobia ( social anxiety disorder ) is a severe and often disabling form of social anxiety that affects approximately 5 % of the general population . Earlier research has shown monoamine oxidase inhibitors or benzodiazepines to be effective in treating this condition , but neither has achieved widespread use . OBJECTIVE To compare the efficacy of paroxetine , a selective serotonin reuptake inhibitor , with placebo in adults with generalized social phobia . DESIGN Twelve-week , multicenter , r and omized , double-blind trial . SETTING Thirteen centers across the United States and 1 in Canada . PARTICIPANTS Between April 13 , 1995 , and February 28 , 1996 , 187 persons meeting Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition criteria for generalized social phobia were r and omized ( and 183 returned for at least 1 efficacy assessment ) to treatment . INTERVENTION After a 1-week , single-blind , placebo , run-in period , patients received a double-blind , 11-week course of either paroxetine or matching-image placebo . The initial daily dosage of paroxetine ( or placebo ) was 20 mg with increases of 10 mg/d weekly ( flexible dosing to a maximum of 50 mg/d ) permitted after the second week of treatment . MAIN OUTCOME MEASURES Number of responders based on the Clinical Global Impression Global Improvement Item ( " much improved " or " very much improved " ) ; mean change from baseline on the Liebowitz Social Anxiety Scale total score . RESULTS Fifty ( 55.0 % ) of 91 persons taking paroxetine and 22 ( 23.9 % ) of 92 persons taking placebo were much improved or very much improved at the end of treatment ( odds ratio [ OR ] , 3.88 ; 95 % confidence interval [ CI ] , 2.81 - 5.36 ) . Mean Liebowitz Social Anxiety Scale total scores were reduced by 39.1 % ( the mean baseline score of 78.0 declined by a mean of 30.5 points at follow-up ) in the paroxetine group compared with 17.4 % ( the mean baseline score of 83.5 declined 14.5 points at follow-up ) in the placebo group , a difference of 21.7 % ( 95 % CI , 8.7%-34.7 % ) favoring paroxetine . CONCLUSIONS Paroxetine is an effective treatment for patients with generalized social phobia . Short-term ( ie , 11-week ) treatment results in substantial and clinical ly meaningful reductions in symptoms and disability . Future research should test whether these may be further reduced by extended treatment or supplementation with specific educational-cognitive-behavioral techniques Rationale Seasonal affective disorder ( SAD ) is a relatively common cyclical depressive illness characterized by seasonal depressions during winter . The disorder is commonly responsive to light therapy , but antidepressant drug efficacy has not been definitely established . Serotonin selective re-uptake inhibitors are potentially efficacious treatments for SAD . Objectives The objective of this study was to evaluate the efficacy , tolerability and safety of sertraline treatment for SAD . Methods One hundred and eighty seven out patients with seasonal pattern recurrent winter depression ( DSM-III-R defined ) and a minimum 29-item Hamilton depression scale ( SIGH-SAD version ) score of 22 were r and omized to 8 weeks treatment with either sertraline or placebo in a double-blind , multi-country , multi-center , parallel-group , flexible dose ( 50–200 mg once daily ) study . Efficacy was investigated using physician and patient-rated scales measuring depression , anxiety and symptoms characteristic of seasonal affective disorder . Results Sertraline produced a significantly greater response than placebo at endpoint as measured by changes in the 29-item and 21-item Hamilton depression scales , the clinical global impression ( CGI ) severity scale , the Hamilton anxiety scale , and the hospital anxiety and depression scale . The proportion of sertraline-treated subjects achieving a response on the CGI improvement rating ( ratings of 1 or 2 ) at endpoint ( last observation carried forward ) was significantly greater than that of the placebo group . Overall sertraline was well tolerated with the most frequent placebo adjusted adverse events , being nausea , diarrhea , insomnia and dry mouth . Adverse events were mostly mild to moderate and transient . Conclusions Sertraline pharmacotherapy has been demonstrated to be an effective and well-tolerated therapy for out patients with SAD . As such , sertraline offers an important pharmacological option in the clinical management of this condition The efficacy of paroxetine in the treatment of obsessive-compulsive disorder in Western population s is well established . The present study compares the efficacy and safety of paroxetine with placebo in the treatment of obsessive-compulsive disorder in Japanese patients . Patients aged 16 years or older who met Diagnostic and Statistical Manual of Mental Disorders ( 4th edn ; DSM-IV ) criteria for obsessive-compulsive disorder and had a Yale-Brown Obsessive-Compulsive Scale ( Y-BOCS ) score of > /=16 were r and omized to receive 12 weeks ' therapy in a double-blind manner . Paroxetine 20 - 50 mg/day or placebo was administered following a 1 week , placebo run-in phase . One hundred and ninety-one patients were r and omized to either paroxetine or placebo , 188 patients were assessed as the full analysis set ( FAS ) and 144 patients completed the 12 week study . After adjustment for the Y-BOCS total score at baseline , reductions in obsessive-compulsive total score at week 6 and at the end of therapy were significantly greater in the paroxetine group than the placebo group . Most of the adverse events that occurred during the study were of mild to moderate intensity . Paroxetine is effective and well tolerated in Japanese adult patients with obsessive-compulsive disorder The safety and efficacy of sertraline versus placebo were examined in a group of nondepressed out patients with obsessive-compulsive disorder ( OCD ) . Patients with moderate-to-severe OCD were recruited at 10 sites . After a 1-week placebo lead-in , patients were treated in a double-blind fashion for 12 weeks with sertraline or placebo . Sertraline was administered at a starting dose of 50 mg/day , with flexible titration up to 200 mg/day . The efficacy measures were the Yale-Brown Obsessive Compulsive Scale ( Y-BOCS ) , the National Institute of Mental Health Global Obsessive Compulsive Scale ( NIMH ) , and the Clinical Global Impression Scale ( CGI ) Severity of Illness and Improvement subscales .  One hundred sixty-seven patients were r and omly assigned and received at least one dose of double-blind medication : 86 received sertraline and 81 received placebo . All efficacy measures showed significantly greater improvement in the sertraline group from the end of week 8 until the end of week 12 . Significantly greater improvement ( p < 0.05 ) in the sertraline group first became apparent by the end of week 3 on the Y-BOCS and the CGI Improvement scale , and by the end of weeks 6 and 8 , respectively , on the NIMH and CGI Severity scale .  Sertraline was well tolerated , without serious adverse effects . In conclusion , sertraline was safe and effective in the treatment of patients with OCD One hundred and sixty patients with a primary diagnosis of obsessive compulsive disorder were enrolled in a multicentre , r and omized , double-blind , placebo-controlled study of fluvoxamine . After a placebo washout phase , patients were r and omized to treatment with placebo or fluvoxamine ( 100–300 mg/day ) for 10 weeks . Seventy-eight patients in each group were evaluable for efficacy . Fluvoxamine was significantly more effective than placebo as assessed by the Yale Brown Obsessive-Compulsive Scale ( Y-BOCS ) , the National Institute of Mental Health Obsessive Compulsive ( NIMH-OC ) scale and ( be Global Improvement item of the Clinical Global Impression ( CGI ) scale . The percentage of patients classified as “ responders ” ( much or very much improved according to the Global Improvement item ) was also significantly higher in the fluvoxamine group from Week 6 onwards , with 33.3 % of fluvoxamine-treated patients and 9.0 % of those given placebo classified as “ responders ” at : endpoint . The “ responders ” to fluvoxamine experienced a substantial clinical benefit as reflected in decreases in their Y-BOCS and NIMH-OC scores . Fluvoxamine was well tolerated with the majority of adverse events considered mild or moderate Selective serotonin reuptake inhibitors are the pharmacological treatment of choice for the treatment of  social anxiety disorder ( SAD ) . The efficacy and tolerability of fixed doses of escitalopram were compared to those of placebo in the long‐term treatment of generalised SAD , using paroxetine as an active reference . Patients with a DSM‐IV diagnosis of SAD between 18–65 years of age were r and omised to 24 weeks of double‐blind treatment with placebo ( n = 166 ) , 5 mg escitalopram ( n = 167 ) , 10 mg escitalopram ( n = 167 ) , 20 mg escitalopram ( n = 170 ) , or 20 mg paroxetine ( n = 169 ) . Based on the primary efficacy parameter , Liebowitz Social Anxiety Scale ( LSAS ) total score at Week 12 ( LOCF ) , a significantly superior therapeutic effect compared to placebo was seen for 5 and 20 mg escitalopram and for all doses for the OC analyses . Further improvement in LSAS scores was seen at Week 24 ( OC and LOCF ) , with significant superiority over placebo for all doses of escitalopram , and 20 mg escitalopram was significantly superior to 20 mg paroxetine . Response to treatment ( assessed by a Clinical Global Impression‐Improvement score ≤2 ) was significantly higher for all active treatments than for placebo at Week 12 . Clinical relevance was supported by a significant decrease in all the Sheehan disability scores , and the good tolerability  of escitalopram treatment . It is concluded that doses of 5–20 mg escitalopram are effective and well tolerated in the short‐ and long‐term treatment of generalised SAD . Depression and Anxiety 00:000–000 , 2004 . © 2004 Wiley‐Liss , BACKGROUND The serotonin selective reuptake inhibitors are increasingly being used for the treatment of panic disorder . We examined the efficacy and safety of the serotonin selective reuptake inhibitor sertraline hydrochloride in patients with panic disorder . METHODS One hundred seventy-six nondepressed out patients with panic disorder , with or without agoraphobia , from 10 sites followed identical protocol s that used a flexible-dose design . After 2 weeks of single-blind placebo , patients were r and omly assigned to 10 weeks of double-blind , flexible-dose treatment with either sertraline hydrochloride ( 50 - 200 mg/d ) or placebo . RESULTS Sertraline-treated patients exhibited significantly greater improvement ( P=.01 ) at end point than did patients treated with placebo for the primary outcome variable , panic attack frequency . Significant differences between groups were also evident for clinician and patient assessment s of improvement as measured by the Clinical Global Impression Improvement ( P=.01 ) and Severity ( P=.009 ) Scales , Panic Disorder Severity Scale ratings ( P=.03 ) , high end-state function assessment ( P=.03 ) , Patient Global Evaluation rating ( P=.01 ) , and quality of life scores ( P=.003 ) . Adverse events , generally characterized as either mild or moderate , were not significantly different in overall incidence between the sertraline and placebo groups . CONCLUSION Results support the safety and efficacy of sertraline for the short-term treatment of patients with panic disorder Background : Generalized social anxiety disorder is a highly prevalent anxiety disorder with deleterious effects on social and family relationships , as well as work performance . We report the results of a multicenter , r and omized , placebo-controlled trial comparing the efficacy , safety , and tolerability of fluvoxamine controlled release ( CR ) to placebo in patients with generalized social anxiety disorder . Methods : A total of 279 adult patients meeting all inclusion /exclusion criteria was recruited at 23 United States sites and r and omly assigned to receive either fluvoxamine CR ( 100 - 200 mg/d ) or placebo for 12 weeks . The dose could be increased , based on efficacy and tolerability , in increments of 50 mg/d at weekly intervals . The dosage remained constant during weeks 6 to 12 . Results : Treatment with fluvoxamine CR result ed in statistically and clinical ly significant improvements in symptoms associated with generalized social anxiety disorder as early as week 4 on the Liebowitz Social Anxiety Scale and the Clinical Global Impression Scale Global Improvement , and at week 6 on the Sheehan Disability Scale , Clinical Global Impression Scale Severity of Illness and the Patient Global Impression of Improvement Scale . The most frequent adverse events reported by 
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Systematic assessment led to higher rates than less systematic assessment .
Conclusion : Adverse effect profiles reported in clinical trials are strongly influenced by expectations from investigators and patients .
This difference can not be attributed to ascertainment methods .
Adverse effect patterns of the drug group are closely related to adverse effects of the placebo group .
These results question the validity of the assumption that adverse effects in placebo groups reflect the ‘ drug-unspecific effects ’