***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: OBJECTIVE To positively reframe perceptions of menstrual cycle experiences to diminish reports of negative perimenstrual symptoms among women with premenstrual syndrome ( PMS ) . DESIGN / SAMPLE A longitudinal quasi-experimental research design ; data were collected on 28 women . SETTING Treatment sessions were conducted in a university classroom in the northeastern United States . INTERVENTION The intervention consisted of a health promotion program that provided social support and a psychoeducational intervention with a positive reframing psychotherapeutic maneuver . MAIN OUTCOME MEASURES To describe ( a ) perceptions of biologic , psychologic , and social outcomes related to perimenstrual changes and ( b ) compare biologic , psychologic , and social outcomes of women participating in a  health promotion intervention with women not participating . RESULTS Negative perimenstrual symptom reports decreased for women in the experimental group . In addition , the participants ' personal re sources increased significantly . CONCLUSIONS Participation in a peer support group that provides women with information on positive concomitants of the menstrual cycle can benefit women with PMS In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring  dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials This study assesses the efficacy of cognitive behaviour therapy ( CBT ) in treating premenstrual dysphoric changes .  The  CBT condition ( n = 24 ) aim ed to modify dysfunctional thinking as a means of impacting on negative premenstrual symptoms and changes . The components of CBT were cognitive restructuring and assertion training . A comparison condition called ' information-focused therapy ' ( IFT ) ( n = 9 ) aim ed to present information only and did not address belief restructuring . The components were relaxation training , nutritional and vitamin guidelines , dietary and lifestyle recommendations , aspects of child management training and assertion training . Results indicated that the amelioration of anxiety , depression , negative thoughts and physical changes can be effectively addressed by either CBT or IFT . The extent to which a women 's belief system is critical in the experience of premenstrual distress requires further empirical investigation CONTEXT Selective reporting of outcomes within published studies based on the nature or direction of their results has been widely suspected , but direct evidence of such bias is currently limited to case reports . OBJECTIVE To study empirically the extent and nature of outcome reporting bias in a cohort of r and omized trials . DESIGN Cohort study using protocol s and published reports of r and omized trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg , Denmark , in 1994 - 1995 . The number and characteristics of reported and unreported trial outcomes were recorded from protocol s , journal articles , and a survey of trialists . An outcome was considered incompletely reported if insufficient data were presented in the published articles for meta- analysis . Odds ratios relating the completeness of outcome reporting to statistical significance were calculated for each trial and then pooled to provide an overall estimate of bias . Protocol s and published articles were also compared to identify discrepancies in primary outcomes . MAIN OUTCOME MEASURES Completeness of reporting of efficacy and harm outcomes and of statistically significant vs nonsignificant outcomes ; consistency between primary outcomes defined in the most recent protocol s and those defined in published articles . RESULTS One hundred two trials with 122 published journal articles and 3736 outcomes were identified . Overall , 50 % of efficacy and 65 % of harm outcomes per trial were incompletely reported . Statistically significant outcomes had a higher odds of being fully reported compared with nonsignificant outcomes for both efficacy ( pooled odds ratio , 2.4 ; 95 % confidence interval [ CI ] , 1.4 - 4.0 ) and harm ( pooled odds ratio , 4.7 ; 95 % CI , 1.8 - 12.0 ) data . In comparing published articles with protocol s , 62 % of trials had at least 1 primary outcome that was changed , introduced , or omitted . Eighty-six percent of survey responders ( 42/49 ) denied the existence of unreported outcomes despite clear evidence to the contrary . CONCLUSIONS The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocol s. Published articles , as well as review s that incorporate them , may therefore be unreliable and overestimate the benefits of an intervention . To ensure transparency , planned trials should be registered and protocol s should be made publicly available prior to trial completion OBJECTIVE This study assessed cycle to cycle symptom stability in women with premenstrual syndrome ( PMS ) . METHOD Symptom ratings obtained prospect ively over three or more symptomatic cycles from 16 women with PMS were analyzed . Measures of symptom severity and change were used to generate a coefficient of variation and an intraclass correlation coefficient ( ICC ) for each one of 14 symptoms across all cycles . In addition , symptoms were divided into three clusters , and the stability of the rank order of severity of symptoms within clusters and the correlation between symptom clusters were also calculated . RESULTS In the 65 cycles studied , mood symptoms were the most prevalent . Mood symptoms -- anxiety , irritability , and mood lability -- had the lowest coefficients of variation but also the lowest ICCs of all symptoms . Within their respective symptom clusters , both physical and mood symptoms showed remarkable stability across cycles of their rank order of severity , but only the mood symptom cluster was highly correlated with functional impairment . CONCLUSIONS Three mood symptoms -- anxiety , irritability , and mood lability -- were the most stable symptoms in this group of women with PMS . Mood and not somatic symptoms accounted for most of the functional impairment in this group of women . It is concluded that PMS is a stable syndrome that may best be viewed as part of the spectrum of recurrent mood disorders This study examines the relative effectiveness of cognitive behavior therapy ( CBT ) ( ten sessions ) , fluoxetine ( 20 mg daily ) and combined therapy ( CBT plus fluoxetine ) in women with premenstrual dysphoric disorder ( PMDD ) . This was a r and omized pragmatic treatment trial with three treatment cells . Treatment lasted for 6 months ; a naturalistic follow-up was undertaken 1 year post-treatment . One hundred and eight women , satisfying the DSM-IV criteria for PMDD with 2 months ' prospect i ve confirmation were recruited into the study ; sixty of these had completed 6 months of treatment and all measures before and after treatment . The main outcome measures were premenstrual scores on the Calendar of Premenstrual Experiences ( COPE ) and percentage of PMDD cases ( DSM-IV diagnostic criteria ) . Significant improvement occurred in all three treatment-groups after 6 months ' treatment , assessed by the COPE .  Fluoxetine was associated with a more rapid improvement . There were no group differences in the percentage of DSM cases of PMDD post teatment , but at follow-up CBT was associated with better maintenance of treatment effects compared with fluoxetine . In conclusion , CBT and fluoxetine are equally effective treatments for PMDD , but the treatments have some differential effects that can be considered in treatment decisions . There appears to be no additional benefit of combining the treatments OBJECTIVE This study characterizes the responses to placebo medication of patients with premenstrual syndrome ( PMS ) who were r and omly assigned in controlled treatment trials . Possible predictors of placebo response were also examined . METHOD Subjects from two r and omized controlled trials were pooled . The 101 subjects met defined criteria for severe PMS , remained eligible after 1 month of single-blind placebo lead-in treatment , and were r and omly assigned to 3 months of double-blind placebo treatment . Improvement in the current study was defined as a decrease of at least 50 % in premenstrual symptom score from the pretreatment baseline . RESULTS At endpoint , 20 ( 20 % ) of the placebo-treated subjects showed sustained improvement , 18 of these in at least 3 of the 4 months of placebo medication . Another 42 % of subjects partially improved , and 39 % were clearly unimproved throughout the study period . CONCLUSIONS Some patients with severe PMS experience significant and sustained improvement with placebo medication , but the majority report only partial or no improvement . Patients who sustain improvement for at least 2 consecutive months are likely to remain improved , indicating the importance of nondrug factors in clinical care The aim of this study was to evaluate the effectiveness of  cognitive therapy ( CT ) as a psychological treatment for premenstrual syndrome ( PMS ) , by comparison with a waitlist control group .  Women meeting selection criteria for PMS were r and omly allocated to one of two treatment groups : ( i ) an immediate treatment group , who received 12 weekly sessions of individual CT ; or ( ii ) a waiting list group who recorded symptoms of PMS for a length of time equivalent to the duration of an individual treatment in the immediate treatment group .  General practitioners and gynecologists referred women who were complaining of distressing and disabling emotional and physical symptoms in the second half of the menstrual cycle , as verified by 2 months of prospect i ve diary recording . Assessment s of the women 's psychological and social functioning were made on entry to the study , 2 months later , and at the end of the treatment period . This design allows evaluation of the efficacy of  CT  relative to any spontaneous remission that may have occurred as a consequence of the passage of time , the keeping of menstrual diaries , interview , and self-rated assessment s. Results indicated that CT was significantly more effective than assignment to the waitlist group . Diary measures and self-report question naires indicated an almost complete remission of psychological and somatic symptoms and of impairment of functioning . It is concluded that CT for PMS is associated with substantial improvements that can not be attributed to the passage of time or the completion of the diary and other assessment This exploratory study was conducted to determine the effects of an educational program on the number and severity of premenstrual symptoms as well as the number of premenstrual days with symptoms .  Participants were a convenience sample of 47 employed women , whose scores on Abraham 's Menstrual Symptomatology Question naire were in the moderate to severe range . Women were r and omly divided into control and experimental groups , and those in the experimental groups participated in an education program . Both groups recorded daily on Abraham 's Menstrual Symptom Diary for 19 anxiety , appetite , edema , and depression symptoms . Participants in the education program had fewer occurrences of anxiety and appetite symptoms and fewer severe edema and depression symptoms , as well as fewer days with symptoms , than women who did not participate in the educational program . The findings support the idea that client education can promote self-care and improve health status A review of measures of menstrual cycle symptoms is provided . This will enable research ers and clinicians to make the appropriate choice of method for their study requirements . In recent years , these measures have taken the form of retrospective question naires ( rating severity of symptoms from memory  ) and prospect i ve diaries ( daily checklists of symptoms )  . Many of these draw on aspects of the well-known retrospective question naires , the Menstrual Distress Question naire and Premenstrual Assessment Form , in their development and validation . Each measure will be briefly described , followed by comments on its development , psychometric properties and finally an evaluation of its strengths and weaknesses . It concludes with an examination of the implication s arising from the review , and some recommendations that menstrual cycle research ers and clinicians may wish to consider , as they decide upon the most appropriate measure for their needs & NA ; Daily symptom ratings were evaluated in 31 women who met DSM III‐R criteria for a diagnosis of Late Luteal Phase Dysphoric Disorder ( LLPDD ) , and 34 women who reported no premenstrual symptomatology . Women in both groups were r and omly assigned to be aware or unaware of the menstrual cycle focus of the study . Results revealed a consistent pattern of cyclic effects , with higher ratings in the mid‐luteal , premenstrual and menstrual phases for many symptoms . Ratings of women reporting severe symptoms were not affected by knowing the purpose of the study and were higher than ratings in the asymptomatic group for many symptoms relevant to the LLPDD diagnosis . Awareness of the study focus did increase cyclicity in the ratings of asymptomatic women aware of the study focus compared with those who were unaware , but these differences were small and most were not significant . The implication s of these findings for research and clinical diagnosis of PMS/LLPDD are discussed During a 5-month study , we examined the effects of the relaxation response on  premenstrual syndrome in 46 women who were r and omly assigned to one of three groups : a charting group , a reading group , and a relaxation response group . The relaxation response group showed significantly greater improvement than the charting and the reading groups on physical symptoms ( P < .025 for both comparisons ) . There was a significant group-by-severity effect for charting versus relaxation response and for reading versus relaxation response on symptoms measured daily ( P < .01 for both comparisons ) , on emotional symptoms measured retrospectively ( P < .001 and P < .025 , respectively ) , and on symptoms of social withdrawal measured retrospectively ( P < .01 and P < .025 , respectively ) . Women with 
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Results provide much more limited support for monitoring as a form of therapy and suggest the ineffectiveness of education .
Conclusions : Low quality evidence from r and omized trials suggests that cognitive behavioural therapy may have important beneficial effects in managing symptoms associated with premenstrual syndrome