***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: Background In the present study , we examined clinical and laser-evoked potentials ( LEP ) features in two groups of chronic tension-type headache ( CTTH ) patients treated with two different approaches : intra-oral appliance of prosthesis , aim ing to reduce muscular tenderness , and 10 mg daily amitriptyline . Methods Eighteen patients with diagnosed CTTH participated in this open label , controlled study . A baseline evaluation was performed for clinical features , Total Tenderness Score ( TTS ) and a topographic analysis of LEPs obtained manually and the pericranial points stimulation in all patients vs. healthy subjects . Thereafter , patients were r and omly assigned to a two-month treatment by either amitriptyline or intra-oral appliance . Results and discussion Both the intra-oral appliance and amitriptyline significantly reduced headache frequency . The TTS was significantly reduced in the group treated with the appliance . The amplitude of P2 response elicited by stimulation of pericranial zones showed a reduction after amitriptyline treatment . Both therapies were effective in reducing headache severity , the appliance with a prevalent action on the pericranial muscular tenderness , amitriptyline reducing the activity of the central cortical structures subtending pain elaboration Conclusion The results of this study may suggest that in CTTH both the interventions at the peripheral and central levels improve the outcome of headache The efficacy and safety of fluoxetine and desipramine were compared in a 6-week double-blind , parallel group study of patients with major depression . Twenty-five were studied while hospitalized for treatment , and 33 were studied as out patients . Improvement on the Hamilton Rating Scale for Depression was significant for both treatments from week 1 through the end of the study and did not differ between the two treatments at any week . Overall , 64 % of fluoxetine-treated patients and 68 % of desipramine-treated patients had at least a 50 % reduction in Hamilton Depression score . We assessed whether improvement relatively early in treatment was predictive of categorical response at 6 weeks . Among fluoxetine-treated patients , but not desipramine-treated patients , the week 3 change in the Hamilton Depression mood item was significantly predictive of the response at 6 weeks . Patients treated with fluoxetine had significantly fewer side effects than those treated with desipramine . Desipramine , but not fluoxetine , caused a persistent increase in heart rate . The results suggest that early signs of response to fluoxetine are not dependent on achieving steady-state levels of the drug To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results Antidepressants , in particular newer agents , are among the most widely prescribed medications worldwide with annual sales of billions of dollars . The introduction of these agents in the market has passed through seemingly strict regulatory control . Over a thous and r and omized trials have been conducted with antidepressants . Statistically significant benefits have been repeatedly demonstrated and the medical literature is flooded with several hundreds of " positive " trials ( both pre-approval and post-approval ) . However , two recent meta-analyses question this picture . The first meta- analysis used data that were su bmi tted to FDA for the approval of 12 antidepressant drugs .  While only half of these trials had formally significant effectiveness , published reports almost ubiquitously cl aim ed significant results . " Negative " trials were either left unpublished or were distorted to present " positive " results . The average benefit of these drugs based on the FDA data was of small magnitude , while the published literature suggested larger benefits . A second meta- analysis using also FDA -su bmi tted data examined the relationship between treatment effect and baseline severity of depression . Drug-placebo differences increased with increasing baseline severity and the difference became large enough to be clinical ly important only in the very small minority of patient population s with severe major depression . In severe major depression , antidepressants did not become more effective , simply placebo lost effectiveness . These data suggest that antidepressants may be less effective than their wide marketing suggests . Short-term benefits are small and long-term balance of benefits and harms is understudied . I discuss how the use of many small r and omized trials with clinical ly non-relevant outcomes , improper interpretation of statistical significance , manipulated study design , biased selection of study population s , short follow-up , and selective and distorted reporting of results has built and nourished a seemingly evidence -based myth on antidepressant effectiveness and how higher evidence st and ards , with very large long-term trials and careful prospect i ve meta-analyses of individual-level data may reach closer to the truth and clinical ly useful evidence SYNOPSIS CONTEXT Chronic tension-type headaches are characterized by near-daily headaches and often are difficult to manage in primary practice . Behavioral and pharmacological therapies each appear modestly effective , but data are lacking on their separate and combined effects . OBJECTIVE To evaluate the clinical efficacy of behavioral and pharmacological therapies , singly and combined , for chronic tension-type headaches . DESIGN AND SETTING R and omized placebo-controlled trial conducted from August 1995 to January 1998 at 2 outpatient sites in Ohio . PARTICIPANTS Two hundred three adults ( mean age , 37 years ; 76 % women ) with diagnosis of chronic tension-type headaches ( mean , 26 headache d/mo ) . INTERVENTIONS Participants were r and omly assigned to receive tricyclic antidepressant ( amitriptyline hydrochloride , up to 100 mg/d , or nortriptyline hydrochloride , up to 75 mg/d ) medication ( n = 53 ) , placebo ( n = 48 ) , stress management ( eg , relaxation , cognitive coping ) therapy ( 3 sessions and 2 telephone contacts ) plus placebo ( n = 49 ) , or stress management therapy plus antidepressant medication ( n = 53 ) . MAIN OUTCOME MEASURES Monthly headache index scores calculated as the mean of pain ratings ( 0 - 10 scale ) recorded by participants in a daily diary 4 times per day ; number of days per month with at least moderate pain ( pain rating > /=5 ) , analgesic medication use , and Headache Disability Inventory scores , compared by intervention group . RESULTS Tricyclic antidepressant medication and stress management therapy each produced larger reductions in headache activity , analgesic medication use , and headache-related disability than placebo , but antidepressant medication yielded more rapid improvements in headache activity . Combined therapy was more likely to produce clinical ly significant ( > /=50 % ) reductions in headache index scores ( 64 % of participants ) than antidepressant medication ( 38 % of participants ; P = .006 ) , stress management therapy ( 35 % ; P = .003 ) , or placebo ( 29 % ; P = .001 ) . On other measures the combined therapy and its 2 component therapies produced similar outcomes . CONCLUSIONS Our results indicate that antidepressant medication and stress management therapy are each modestly effective in treating chronic tension-type headaches . Combined therapy may improve outcome relative to monotherapy Chronic tension type headache ( CTTH ) has a strong impact on the Quality Of Life ( QOL ) . We carried out an open – label r and omized clinical trial on 18 patients with CTTH in order to compare two different regimens of pharmacological prophylaxis : the first provided for the use of amitriptyline 20 mg/d during 3 months , while in the second we combined amitriptyline with tizanidine ( 4 mg/d ) in the first 3 weeks of treatment . Our hypothesis is that the combination therapy may guarantee an improvement of QOL even in the early stages of treatment . In fact , it 's as well – known , there is a delay of 2–3 weeks in the prophylactic effect of amitriptyline , with a consequent persistence , in the first phases of therapy , of the headache and its negative impact . We assessed the following outcome measures : frequency , pain intensity , duration of headache and the Headache Impact Test ( HIT ) score , used as headache – related QOL measure . The combination therapy was effective since the first month of treatment , with a significant reduction of the headache , greater than one obtained with amitriptyline alone , in terms of frequency ( –52,3 % vs. –40,7 % ) , intensity ( –59,51 % vs. –20,39 % ) and duration ( –53,17 % vs. –36,16%).This trend was confirmed by the HIT . Our data suggest that the combination of tizanidine with amitriptyline is faster than the amitriptyline alone in providing an improvement in the headache pattern and correlated QOL Abstract Patients with chronic tension- type headache ( CTTH ) are the most difficult to treat . Tricyclic antidepressants are the first-line therapeutic agents , but their anticholinergic side effects limit their usage . Selective serotonin reuptake inhibitors ( SSRI ) with fewer side effects than tricyclic antidepressants have also been used in treatment of CTTH , but the results are conflicting . In this study , prophylactic action of sertraline in treatment of nondepressed patients with CTTH was investigated and compared with amitriptyline in a prospect i ve , r and omized , open label , parallel-group study . A 4-week baseline period was followed by a 12-week treatment period with either 50 mg sertraline  ( n=41 patients ) or 25 mg amitriptyline  ( n=44 patients ) . Efficacies of treatments were determined by using a headache diary , in which patients recorded the occurrence , number , intensity and duration of headaches in days , analgesic drug consumption and any adverse events . Both drugs reduced headache symptoms and analgesic drug consumption at the first , second and third months of treatment compared to baseline values . There was significant superiority of amitriptyline in the headache symptoms and drug consumption reductions versus sertraline at the second and third months of treatment . Side effects were more favorable in the sertraline-treated patients , but dropouts were similar in both groups . These results suggest that both drugs were effective in the treatment of non-depressed patients with CTTH , but in comparison between groups , amitriptyline was more effective than sertraline The tricyclic anti-depressant amitriptyline is widely used in the treatment of chronic tension-type headache . The aim of the present study was to investigate whether the analgesic effect is caused by a reduction of muscle pain or by a general reduction of pain sensitivity . Thirty-three non-depressed patients with chronic tension-type headache were treated with amitriptyline 75 mg/day and with the highly selective serotonin reuptake inhibitor citalopram 20 mg/day in a 32-week , double-blind , placebo-controlled , three-way crossover study . At the end of each treatment period , actual headache intensity and pericranial myofascial tenderness were recorded , pressure pain detection and tolerance thresholds were measured in the finger and in the temporal region and the electrical pain threshold was measured at the labial commissure . Amitriptyline reduced tenderness and headache intensity significantly more than placebo ( P = 0.01 and P = 0.04 , respectively ) . The reduction in tenderness could be ascribed solely to the group of patients who responded to amitriptyline treatment by at least 30 % reduction in headache while tenderness was unchanged in non-responders . Amitriptyline did not affect pressure or electrical pain thresholds at any of the examined locations . Citalopram had no significant effect on any of the examined parameters . These findings indicate that amitriptyline elicits its analgesic effect in chronic myofascial pain by reducing the transmission of painful stimuli from myofascial tissues rather than by reducing overall pain sensitivity . We suggest that this effect is caused by a segmental reduction of central sensitization in combination with a peripheral anti-nociceptive action Amitriptyline , which is a noradrenaline reuptake and 5-HT reuptake inhibitor , has an established role in the management of  chronic tension-type headaches .  In a single-blind study , patients with chronic tension-type headache were r and omized to either fluoxetine 20 mg ( a selective 5-HT reuptake inhibitor ) or desipramine 75 mg ( a selective noradrenaline reuptake inhibitor ) and followed for 12 weeks to compare the effectiveness of the two drugs in improving headache , and to assess whether pain control is related to changes in depression . Patients were evaluated at weekly intervals on an analog pain-rating scale and at 4-weekly intervals on the Montgomery 
    Output:
    
Overall , antidepressants were no more effective than placebo , and there were no significant differences between different types of antidepressants .
There was conflicting evidence about the effectiveness of benzodiazepines and vasodilator agents compared with placebo .
Furthermore , there was limited evidence that propranolol had negative effects on depression in TTH patients , when compared with placebo or biofeedback .
There was no evidence concerning the effectiveness of muscle relaxants alone or 5-HT receptor agonist compared with placebo .
CONCLUSIONS Overall , antidepressants were no more effective on headache intensity or frequency and analgesic use than placebo .
Propranolol seemed to have negative effects on depression in TTH patients when compared with placebo or biofeedback .
No evidence was found for the use of muscle relaxants alone or 5-HT receptor agonist