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Clinical Presentation of Left Atrial Cardiac Myxoma
Introduction Cardiac myxoma is the most frequent “benign” tumor of the heart and presents an important diagnostic challenge (4,43,47). Myxomas may resemble many cardiovascular or systemic diseases, and can arise in any of the cardiac chambers, although 75% occur in the left atrium. Most cases of atrial myxomas are now diagnosed in living patients, allowing successful surgical extirpation (1,3,30,44,53). Before the introduction of angiocardiography in 1951, cardiac myxoma diagnosis was made only at autopsy (22). The first successful surgical removal of an atrial myxoma was performed in 1954 (35,47). In 1959, the first M-mode echocardiogram of a left atrial myxoma was reported (16). Indeed, the introduction of echocardiography has provided an important noninvasive means of diagnosis for cardiac myxomas (55). Thus, the diagnosis of small myxomas (less than 5 cm in size and asymptomatic) is becoming easier. We report here the experience of a French cardiovascular center in the clinical presentation of left atrial myxomas. The large number of patients in this series allowed us to perform an analytic, clinicopathologic study. Patients and Methods We reviewed the 112 cases of left atrial myxoma seen at 1 institution (Hôpital Louis Pradel, Lyons, France) over a 40-year period (1959–1998). In all cases the diagnosis was established before surgical removal. The patients’ medical records were reviewed, and data concerning clinical presentation, diagnostic methods, and postoperative course were collected. Histopathologic slides were reviewed for all cases by the same pathologist (RL). Other locations where cardiac myxoma occurred during that time period were the right atrium (15 cases), left ventricle (2 cases), and right ventricle (1 case). Follow-up information was obtained by contacting either the patients or the attending physicians, and a standardized questionnaire was completed for each case. Statistical analysis A chi-square test, or the Fisher exact test when required, was performed for all qualitative variables, and odds ratios (OR) with 95% confidence intervals (95% CI) were computed. For ordinal variables a Wilcoxon rank sum test was used. Data analysis was performed using SAS (Statistical Analysis System, SAS Institute Inc., Cary, NC). The variables studied in the statistical analysis were 1) sex and age, period of diagnosis (before or after echocardiography was available), delay to diagnosis (delay between the first symptoms and diagnosis), possible systematic (serendipitous) discovery; 2) size of the tumor (> or < 5 cm), tumor surface appearance (smooth or villous); 3) the main symptoms: cardiac (cardiac failure, malaise or syncope, chest pain or palpitations), embolic (cerebral, coronary, or peripheral artery), systemic (fever, weight loss, or pseudo-connective tissue disease signs), or neurologic (stroke, vertigo, epilepsy, coma, or other signs); 4) cardiac auscultation modifications (pseudo-mitral signs, “tumor plop”, nonspecific other signs); 5) possible chest X-ray abnormalities (left cardiac failure signs, cardiomegaly, pleural effusion, left atrium enlargement, visible myxoma when calcified), electrocardiogram (ECG) alterations (arrhythmias or conduction disturbances, ST-segment and T-wave shifts, left atrial hypertrophy, and nonspecific signs), or serologic test abnormalities (elevated erythrocyte sedimentation rate [ESR], anemia). Results Patient characteristics The study group included 72 women, (64% of the whole sample; median age, 53 yr; range, 23–84 yr) and 40 men (36% of the sample; median age, 58 yr, range, 5–77 yr). Forty-six patients (41% of the sample, 31 women, 15 men) were less than 50 years old, 47 (42%, 31 women, 16 men) were between 50 and 70 years, and 19 (17%, 10 women, 9 men) were older than 70. Age distribution was homogenous in men, but most female patients were between 40 and 60 years old (Figure 1).Fig. 1: Age distribution of 112 patients with left atrial myxoma. The clinical and laboratory features of left atrial myxoma in our series are presented in Table 1. The different frequencies of clinical and laboratory signs according to sex and age are detailed in Table 2. Male patients were more at risk than females for embolic complications and for neurologic symptoms; females were more at risk than males to develop systemic symptoms such as fever; younger patients (age <50 yr) had more neurologic symptoms and cardiac auscultation abnormalities than older patients (age >50 yr).TABLE 1: Clinical and laboratory features of left atrial myxoma (112 cases)TABLE 2: Frequencies of clinical and laboratory signs by sex and age*We divided the patients into 2 groups according to the pre-and post-echocardiography periods: 1) between 1959 and 1977, when the only diagnostic methods were angiocardiography and cardiac cathe-terization, only 14 patients (12.5%) underwent surgery; 2) since 1977, with 2-dimensional echocardiography use (transthoracic, then transesophageal), about 5 patients per year have undergone surgery for left atrial myxoma (98 patients, 87.5%). The sex ratio and age ranges are similar in these 2 patient groups, but other differences can be identified (Table 3). Before 1977, most patients were diagnosed on the basis of serologic or blood test abnormalities (particularly elevated ESR) and radiologic abnormalities; chest X-ray evidence of cardiac failure or left atrium enlargement was particularly prevalent in patients diagnosed before 1977 compared with those diagnosed after 1977 (p = 0.006 and p = 0.02, respectively).TABLE 3: Symptoms by year of diagnosis*Delay before surgery In our series, the time interval between symptoms onset and diagnosis (surgical removal) varied from 0 to 126 months (median, 4 mo). The median delay before surgery was 5.5 months before 1977, and 3 months after 1977; the difference is not significant. The median delay to diagnosis increased significantly when cardiac symptoms were present; there was no significant difference for the other symptoms (Table 4).TABLE 4: Delay to diagnosis by year and by principal clinical symptoms*Initial symptoms ( Figure 2) For 11 patients, the left atrial myxoma diagnosis was a mere chance, or serendipitous, discovery (“systematic findings” in Figure 2). Among these patients, in 9 cases echocardiography (8 cases) or computed tomography (CT) (1 case) was performed for another indication and allowed a diagnosis of myxoma. For 2 patients, echocardiography had been systematically performed during follow-up for surgery on a right atrial myxoma. Fig. 2: Initial symptoms of left atrial myxoma (112 cases).The most common initial symptoms of left atrial myxoma in our series were related to mitral valve obstruction: dizziness and occasionally syncope, palpitations, dyspnea, cough, pulmonary edema, or congestive heart failure were observed in 58 patients. Eight patients showed atypical paroxysmal clinical manifestations: chest pain, hemoptysis, limb claudication, thoracic noise, shortness of breath, or syncope when reclining. Embolic manifestations suggested myxoma in 18 patients. Constitutional or general systemic signs appeared as initial manifestations for 17 patients: myalgia, muscle weakness, arthralgia, fever, weight loss, fatigue, and Raynaud syndrome. Clinical features at diagnosis All patients presented with at least 1 or more symptoms of the classic triad: 1) obstructive cardiac signs; 2) embolic signs; and 3) constitutional or systemic manifestations (See Table 1). 1) Intracardiac obstruction signs occurred in 75 patients. Pulmonary edema or progressive congestive cardiac failure (dyspnea, orthopnea) were the most common symptoms (n = 48). Malaise or syncope occurred in 16 cases. Two patients experienced cardiac arrest before surgery and fully recovered after resuscitation. Other nonspecific cardiac symptoms were present in 34 patients: cough, thoracic pain, palpi-tations, myocardial infarction due to coronary embolism. Malaise, palpitations, or thoracic pain could vary with body postural changes. 2) Signs of embolism were present in 33 patients, either with 1 (n = 25) or several (n = 8) locations. Embolic locations were the central nervous system (n = 24), in 1 case in the retinal artery, the upper and lower extremities (n = 15), and the coronary arteries (n = 4). 3) Thirty-eight patients presented with systemic or constitutional symptoms. These symptoms were obviously nonspecific, including fever (n = 22), weight loss or fatigue (n = 20), and immunologic diseases mimicking symptoms such as myalgia, muscle weakness, arthralgia, or Raynaud syndrome (n = 6). 4) Other clinical presentations 4.1) Twenty-nine patients had neurologic symptoms, particularly transient or permanent motor or sensory neurologic deficiencies (n = 23), when cerebral emboli were present (stroke). Three of these patients developed multiple cerebral aneurysms, induced by cerebral emboli. Three patients had epileptic fits, or multilocular sclerosis mimicking symptoms. Six patients also suffered from other neurologic manifestations, such as vertigo or coma. One patient with streptococcal meningitis underwent surgery for a supposed antibiotic-resistant endocarditis suggested by echocardiographic findings, but surgery uncovered an incidental noninfected myxoma. 4.2) One patient had fever and positive blood cultures for Streptococcus viridans. 4.3) Three patients were investigated for liver abnormalities connected in fact with right cardiac failure. 4.4) For 3 patients, the main symptoms were abdominal pain or hemoptysis. Physical examination (cardiac auscultation) On cardiac auscultation 72 patients (64%) had abnormal findings, 18 (16%) of them with postural changes or with time examination modifications. These murmurs looked like significant mitral stenosis findings: apical diastolic or presystolic murmur (n = 60, 53%). A tumor plop was heard in 17 patients (15%), all before 1989. Other auscultatory features were changes in preexisting murmurs, gallops, or modification of the first (split) or second heart sound (n = 12, 11%). A significant was observed between cardiac auscultation abnormalities and 1) systemic symptoms (fever, weight loss or and 2) cardiac symptoms and signs (cardiac failure, (Table no between auscultatory signs and embolic or neurologic symptoms was between clinical The most frequent laboratory was in patients Table 1). in men, in was observed in 15 patients. blood or was present in patients. The between these serologic abnormalities and systemic manifestations was significant Table there was no significant between serologic signs and or neurologic symptoms. abnormalities of the patients (n = had abnormal Table 1). atrial was the most frequent (n = or or conduction were Other were ST-segment abnormalities (n = or nonspecific abnormalities (n = hypertrophy, The of abnormalities with systemic manifestations and cardiac signs was significant Table was no significant with embolic or neurologic symptoms. were abnormal in patients Table 1). included pulmonary or congestive heart failure signs (n = and nonspecific (n = atrial enlargement (n = that made the tumor visible (n = and pleural were (n = The of radiologic abnormalities with systemic and cardiac manifestations was significant Table X-ray abnormalities were significantly less frequent in patients with embolic or neurologic methods Before 1977, all cases were diagnosed by angiocardiography with left heart (n = 1977, echocardiography was the diagnostic (n = only M-mode echocardiography was (Figure 3). 2-dimensional and particularly echocardiography the methods in many cases. For 2 patients the diagnosis was established by or 3: A myxoma is seen in the left The diagnosis of myxoma was obtained after surgical tumor for all cases. On the tumor from 1 cm to 15 The size was for was than 5 cm in and in cases had been during The weight of the from 15 to In our series of the myxomas were with a cm), and were the left atrial myxomas in our series, the and from the left atrial with only a other left and small mitral valve The myxoma surface was studied in was or in of these (n = and (Figure 4) in the other cases (n = The less common or (Figure 5) myxomas had a surface that of multiple or and with a to (Figure 4: left atrial myxoma after left atrial were on the of myxoma in an of an The myxoma had a or an and a were the The surface of the tumor was by a of was observed in of the cases. We with a myxoma from with a and or different of 1) (Figure with or by then by 2) (Figure with many or in the of the cases were left atrial of them with and with were myxomas with All were observed in patients with myxoma and atrial myxoma with with myxoma in atrial myxoma with or myxoma in significant could be between myxoma size or 5 and diagnosis or or of or serologic symptoms or signs (Table 6). a myxoma size cm was significantly with cardiac symptoms, auscultatory signs, and and chest X-ray of myxomas appeared to be more and the delay to diagnosis was for small than for large Table of clinical features to myxoma size was significantly with neurologic symptoms, embolic and cardiac auscultation there was no significant between and or X-ray signs or symptoms; discovery; or delay in diagnosis (Table of clinical features to myxoma surface course All patients had patients during the 1 patient in during a second surgical for a of myxoma years after the first surgical a on in with cardiac and on the second postoperative from a in from mitral by a mitral and a in from meningitis with the the incidental tumor had been 1 patient a mitral valve endocarditis was with the myxoma. The most frequent postoperative was transient or atrial in patients A permanent cardiac for was for only 2 patients. Follow-up the postoperative patients were to patients to and not our Among the other patients, 4 and were during the follow-up Patients presented with peripheral fully The follow-up for patients with multiple cerebral is 14 years a In the present series, were for a median of 3 years 1 yr). Six patients had a of myxoma. Three patients with myxoma in the left and 17 years Three other patients had One of them suffered 2 in the left 16 and months The other 2 patients with had an initial myxoma in the right for 1 of them the was in the left atrium 3 years and for the other the were multiple in the left atrium and years and then in the right atrium years We report here the series of patients with left atrial myxoma diagnosed in a to our The patients presented over a 40-year ratio is with other in this ratio from to Myxomas can occur in all but are most frequent between the and of occur in although there is no for this female due in to In our series, younger age is significantly with neurologic signs or cardiac auscultation and is with neurologic or embolic symptoms in men and systemic symptoms in Clinical features The clinical features of these are by and there are no signs and symptoms that the of a myxoma In a of there are no symptoms at all in our there is no significant between the size of the tumor or 5 and the of discovery or atrial myxomas when the mitral or systemic 1) symptoms occur in of patients in our cases as mitral valve in mitral atrial and of fever are only of patients had in our study. Cardiac obstruction can be by progressive congestive cardiac failure on or or by syncope, or to mitral valve obstruction by the myxoma or coronary arteries The of obstruction may vary with body and these postural changes are particularly of myxoma (35,47). Cardiac failure the most frequent in our In our the of cardiac signs increased the diagnosis to that clinical symptoms are by another more common disease due to 2) emboli are the second of the classic in of myxoma patients in our study. than of emboli to the central nervous system in our but any may be to a of symptoms and cases emboli in the upper and lower coronary and more emboli may to aneurysms, as of cardiac myxomas as in 3 patients in our was 12, yr, We that the of an or surface is significantly with cerebral and peripheral 3) Constitutional signs are the of the classic these symptoms are may occur in to of cases The is lower in our series studied a at a cardiovascular These signs and symptoms myalgia, muscle weakness, arthralgia, fever, weight loss, and are obviously nonspecific and may occur in a of or or immunologic diseases tissue manifestations have also been reported in myxoma patients Cardiac auscultation Cardiac auscultatory may vary between and may on body presystolic or diastolic murmurs, significant mitral may be heard in more than of the patients in our The auscultatory of myxoma is “tumor is a heart sound of heard after the second heart sound may be with a heart sound or a mitral The tumor plop is in only of patients in our We established a significant between cardiac auscultation abnormalities and cardiac or systemic symptoms. and are abnormal in only of the patients those with systemic symptoms significant was in our The main but nonspecific laboratory abnormalities are and elevated or is or may occur by on the has also been common are and that the and of a by the tumor may be for systemic and manifestations has been with of in patients with myxoma that to after surgical removal A between the size of the tumor and the of has also been suggested have also been in myxoma tissue myxoma tissue in cases by and are nonspecific but observed in our atrial in of patients, the alterations by the is (less than of cases) in to the in mitral valve We observed a significant between signs and the of cardiac or systemic symptoms. also nonspecific features in the patients and are not for when the tumor is in our a left atrium enlargement and signs of pulmonary may be In our series, chest X-ray abnormalities were significantly with cardiac or systemic symptoms, but there were radiologic signs when the myxoma was by embolic or neurologic In cardiac signs or symptoms are more prevalent with large and may that embolic becoming are diagnosed before the the size 5 that to cardiac and radiologic data a positive between small tumor size and embolic Table 6). methods is the and diagnostic of is and not any risk of tumor and and cardiac examination may be by the echocardiography is less with an to but echocardiography the for surgery is only on echocardiographic evidence of the in our series angiocardiography has not been since coronary in patients over 40 years old is in to coronary disease Other diagnostic methods and The of and over echocardiography is that of and thoracic are also more in tumor and tumor and size data that most left atrial myxomas arise from the atrial or the on the of and on the appearance is or with a or or is and the surface is either or and in our myxomas with constitutional symptoms, or In the such as and surface are seen in older that In our series, there was no significant between and The size and weight of myxomas but in our the of symptoms was in patients with on could or myxomas and or myxomas according to the of the that all occurred in patients with and myxomas. the of cardiac myxomas have been The of most is that myxomas are of is no that myxomas are myxomas may have a of that at first may be the of multiple surface or is not with or any of presentation, and is important not to an on the basis of these atypical are cardiac not be with myxomas The to the tumor are to be and analysis has that myxoma as tumor = and are and may be for and cases with is as is the showed that was by is also a for the that myxomas arise from the to A study that myxomas with a between tumor size and the of this a in Myxomas may to the but these not have any The myxoma tissue emboli may may the and may or may but any cerebral tissue years the may to Three patients in our series had embolic that into the with of multiple aneurysms, any or during and follow-up The of for myxomas is surgical removal the diagnosis is of the tumor is Embolic complications or are in patients: of patients in the time of our series, not due to cardiac but 2 patients had cardiac arrest in the before surgery with successful resuscitation. surgery is a as most are can be The may according to In our series, was 3 patients during the postoperative period before and another patient in of meningitis not to myxoma. The most frequent postoperative was transient or with an of Cardiac myxomas occur but or cases have been The reported rate ranges from to in the in our are reported from as as a months to as as years after of the myxoma in our The of is not but risk or of tumor of the a of tumor in the In most cases of of the to be the of Patients with abnormalities are at risk of and from 2 or more of the cardiac and myxomas or of the with and are as or The risk of for and myxomas is about and is only for In our series, 3 cases the cardiac myxoma the time of myxoma patients are younger than myxoma patients. myxomas of the 2 patient groups are not A to has been identified The is In the the rate is and after of myxomas ranges from 0 to in our may surgical removal in our A patients may permanent cardiac for conduction 2 patients in our In of the of a tumor that with mitral valve to in heart failure, the mitral valve is In our only 1 patient mitral valve for endocarditis with left atrial myxoma. the myxoma patients to be and cases. echocardiogram is over the period at diagnosis The mitral valve other and heart more common than and occur in patients with myocardial infarction or systemic symptoms are present (fever, weight loss, the diagnosis heart and tissue disease or The of embolic and constitutional symptoms is due more to but may also myxoma. The of or syndrome to the 2 diseases, as these are in myxoma. myxomas are occasionally the clinical of myxoma and endocarditis more of cardiac myxomas reported 40 cases with a presentation similar to is no clinical between and noninfected myxoma cardiac symptoms and the rate of systemic or cerebral constitutional symptoms significantly in patients with myxoma (fever, elevated and men are more than series of 112 cases of left atrial myxoma clinical that this tumor may a of clinical symptoms not only such as cardiac but also or neurologic is made only on clinical there are no signs or symptoms. but or cases have been that and of the by the tumor may be for or including the is the of for diagnosis and follow-up of this myxomas are be in the diagnosis of mitral valve disease and congestive heart failure, in patients with is also for any patient with embolic embolic in in the of signs or symptoms of endocarditis or to a of myxoma as the embolic The obtained by be are to the clinical features of in in myxoma or be studied for embolic myxomas with of could be performed to for the ratio and age We a series of 112 cases of left atrial myxoma diagnosed in a French and 40 age range, yr) over 40 years, from 1959 to Symptoms of mitral valve the first of the classic of myxoma presentation, were present in 75 patients with cardiac failure or Symptoms of the second frequent presentation in the classic were observed in 33 cases with 1 or several cerebral emboli with are at risk than females of embolic The of the classic of constitutional symptoms with fever, weight loss, or symptoms tissue due to and patients have more neurologic symptoms, and female patients have more systemic symptoms. patients (64%) had cardiac auscultation valve disease and more the tumor plop The most frequent was left atrial were The number of myxoma patients diagnosed after 1977 the introduction of echocardiography as a noninvasive diagnostic there was no significant in the time from onset of symptoms to between patients seen in the before and after The tumor from 1 to 15 cm with a weight of between 15 and The myxoma surface was or in of the and in the other cases. Myxomas in patients with embolism have a those in patients with cardiac symptoms, auscultation signs, tumor and electrocardiogram or radiologic signs of left atrium and are significantly the The is and only 4 occurred our 112 cases over a median follow-up of 3 The rate is but follow-up and echocardiography are for patients. The surgical were performed during the 40-year period by We are to for the
Medicine · review · 878 citationsread the source →
Ponsioen CY, de Groof EJ, Eshuis EJ, Gardenbroek TJ, Bossuyt PMM, Hart A, Warusavitarne J, Buskens CJ, van Bodegraven AA, Brink MA, Consten ECJ, van Wagensveld BA, Rijk MCM, Crolla RMPH, Noomen CG, Houdijk APJ, Mallant RC, Boom M, Marsman WA, Stockmann HB, Mol B, de Groof AJ, Stokkers PC, D'Haens GR, Bemelman WA, LIR!C study group. (2017)MEDLINE-indexed journal, not yet read by usThe lancet. Gastroenterology & hepatology · randomised controlled trial Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn's disease: a randomised controlled, open-label, multicentre trial.
Background: Treatment of patients with ileocaecal Crohn's disease who have not responded to conventional therapy is commonly scaled up to biological agents, but surgery can also offer excellent short-term and long-term results. We compared laparoscopic ileocaecal resection with infliximab to assess how they affect health-related quality of life.
Methods: In this randomised controlled, open-label trial, in 29 teaching hospitals and tertiary care centres in the Netherlands and the UK, adults with non-stricturing, ileocaecal Crohn's disease, in whom conventional therapy has failed were randomly allocated (1:1) by an internet randomisation module with biased-coin minimisation for participating centres and perianal fistula to receive laparoscopic ileocaecal resection or infliximab. Eligible patients were aged 18-80 years, had active Crohn's disease of the terminal ileum, and had not responded to at least 3 months of conventional therapy with glucocorticosteroids, thiopurines, or methotrexate. Patients with diseased terminal ileum longer than 40 cm or abdominal abscesses were excluded. The primary outcome was quality of life on the Inflammatory Bowel Disease Questionnaire (IBDQ) at 12 months. Secondary outcomes were general quality of life, measured by the Short Form-36 (SF-36) health survey and its physical and mental component subscales, days unable to participate in social life, days on sick leave, morbidity (additional procedures and hospital admissions), and body image and cosmesis. Analyses of the primary outcome were done in the intention-to-treat population, and safety analyses were done in the per-protocol population. This trial is registered at the Dutch Trial Registry (NTR1150).
Findings: Between May 2, 2008, and October 14, 2015, 73 patients were allocated to have resection and 70 to receive infliximab. Corrected for baseline differences, the mean IBDQ score at 12 months was 178·1 (95% CI 171·1-185·0) in the resection group versus 172·0 (164·3-179·6) in the infliximab group (mean difference 6·1 points, 95% CI -4·2 to 16·4; p=0·25). At 12 months, the mean SF-36 total score was 112·1 (95% CI 108·0-116·2) in the resection group versus 106·5 (102·1-110·9) in the infliximab group (mean difference 5·6, 95% CI -0·4 to 11·6), the mean physical component score was 47·7 (45·7-49·7) versus 44·6 (42·5-46·8; mean difference 3·1, 4·2 to 6·0), and the mean mental component score was 49·5 (47·0-52·1) versus 46·1 (43·3-48·9; mean difference 3·5, -0·3 to 7·3). Mean numbers of days of sick leave were 3·4 days (SD 7·1) in the resection group versus 1·4 days (4·7) in the infliximab group (p<0·0001), days not able to take part in social life were 1·8 days (6·3) versus 1·1 days (4·5; p=0·20), days of scheduled hospital admission were 6·5 days (3·8) versus 6·8 days (3·2; p=0·84), and the number of patients who had unscheduled hospital admissions were 13 (18%) of 73 versus 15 (21%) of 70 (p=0·68). Body-image scale mean scores in the patients who had resection were 16·0 (95% CI 15·2-16·8) at baseline versus 17·8 (17·1-18·4) at 12 months, and cosmetic scale mean scores were 17·6 (16·6-18·6) versus 18·6 (17·6-19·6). Surgical intervention-related complications classified as IIIa or worse on the Clavien-Dindo scale occurred in four patients in the resection group. Treatment-related serious adverse events occurred in two patients in the infliximab group. During a median follow-up of 4 years (IQR 2-6), 26 (37%) of 70 patients in the infliximab group had resection, and 19 (26%) of 73 patients in the resection group received anti-TNF.
Interpretation: Laparoscopic resection in patients with limited (diseased terminal ileum <40 cm), non-stricturing, ileocaecal Crohn's disease in whom conventional therapy has failed could be considered a reasonable alternative to infliximab therapy.
Funding: Netherlands Organisation for Health Research and Development.
The lancet. Gastroenterology & hepatology · randomised controlled trial · 228 citationsread the source →
The Economic Impact of Smoking and of Reducing Smoking Prevalence: Review of Evidence.
Background: Tobacco smoking is the cause of many preventable diseases and premature deaths in the UK and around the world. It poses enormous health- and non-health-related costs to the affected individuals, employers, and the society at large. The World Health Organization (WHO) estimates that, globally, smoking causes over US$500 billion in economic damage each year.
Objectives: This paper examines global and UK evidence on the economic impact of smoking prevalence and evaluates the effectiveness and cost effectiveness of smoking cessation measures.
Study selection: SEARCH METHODS We used two major health care/economic research databases, namely PubMed and the National Institute for Health Research (NIHR) database that contains the British National Health Service (NHS) Economic Evaluation Database; Cochrane Library of systematic reviews in health care and health policy; and other health-care-related bibliographic sources. We also performed hand searching of relevant articles, health reports, and white papers issued by government bodies, international health organizations, and health intervention campaign agencies. SELECTION CRITERIA The paper includes cost-effectiveness studies from medical journals, health reports, and white papers published between 1992 and July 2014, but included only eight relevant studies before 1992. Most of the papers reviewed reported outcomes on smoking prevalence, as well as the direct and indirect costs of smoking and the costs and benefits of smoking cessation interventions. We excluded papers that merely described the effectiveness of an intervention without including economic or cost considerations. We also excluded papers that combine smoking cessation with the reduction in the risk of other diseases. DATA COLLECTION AND ANALYSIS The included studies were assessed against criteria indicated in the Cochrane Reviewers Handbook version 5.0.0. OUTCOMES ASSESSED IN THE REVIEWPrimary outcomes of the selected studies are smoking prevalence, direct and indirect costs of smoking, and the costs and benefits of smoking cessation interventions (eg, "cost per quitter", "cost per life year saved", "cost per quality-adjusted life year gained," "present value" or "net benefits" from smoking cessation, and "cost savings" from personal health care expenditure).
Main results: The main findings of this study are as follows: The costs of smoking can be classified into direct, indirect, and intangible costs. About 15% of the aggregate health care expenditure in high-income countries can be attributed to smoking. In the US, the proportion of health care expenditure attributable to smoking ranges between 6% and 18% across different states. In the UK, the direct costs of smoking to the NHS have been estimated at between £2.7 billion and £5.2 billion, which is equivalent to around 5% of the total NHS budget each year. The economic burden of smoking estimated in terms of GDP reveals that smoking accounts for approximately 0.7% of China's GDP and approximately 1% of US GDP. As part of the indirect (non-health-related) costs of smoking, the total productivity losses caused by smoking each year in the US have been estimated at US$151 billion. The costs of smoking notwithstanding, it produces some potential economic benefits. The economic activities generated from the production and consumption of tobacco provides economic stimulus. It also produces huge tax revenues for most governments, especially in high-income countries, as well as employment in the tobacco industry. Income from the tobacco industry accounts for up to 7.4% of centrally collected government revenue in China. Smoking also yields cost savings in pension payments from the premature death of smokers. Smoking cessation measures could range from pharmacological treatment interventions to policy-based measures, community-based interventions, telecoms, media, and technology (TMT)-based interventions, school-based interventions, and workplace interventions. The cost per life year saved from the use of pharmacological treatment interventions ranged between US$128 and US$1,450 and up to US$4,400 per quality-adjusted life years (QALYs) saved. The use of pharmacotherapies such as varenicline, NRT, and Bupropion, when combined with GP counseling or other behavioral treatment interventions (such as proactive telephone counseling and Web-based delivery), is both clinically effective and cost effective to primary health care providers. Price-based policy measures such as increase in tobacco taxes are unarguably the most effective means of reducing the consumption of tobacco. A 10% tax-induced cigarette price increase anywhere in the world reduces smoking prevalence by between 4% and 8%. Net public benefits from tobacco tax, however, remain positive only when tax rates are between 42.9% and 91.1%. The cost effectiveness ratio of implementing non-price-based smoking cessation legislations (such as smoking restrictions in work places, public places, bans on tobacco advertisement, and raising the legal age of smokers) range from US$2 to US$112 per life year gained (LYG) while reducing smoking prevalence by up to 30%-82% in the long term (over a 50-year period).Smoking cessation classes are known to be most effective among community-based measures, as they could lead to a quit rate of up to 35%, but they usually incur higher costs than other measures such as self-help quit-smoking kits. On average, community pharmacist-based smoking cessation programs yield cost savings to the health system of between US$500 and US$614 per LYG.Advertising media, telecommunications, and other technology-based interventions (such as TV, radio, print, telephone, the Internet, PC, and other electronic media) usually have positive synergistic effects in reducing smoking prevalence especially when combined to deliver smoking cessation messages and counseling support. However, the outcomes on the cost effectiveness of TMT-based measures have been inconsistent, and this made it difficult to attribute results to specific media. The differences in reported cost effectiveness may be partly attributed to varying methodological approaches including varying parametric inputs, differences in national contexts, differences in advertising campaigns tested on different media, and disparate levels of resourcing between campaigns. Due to its universal reach and low implementation costs, online campaign appears to be substantially more cost effective than other media, though it may not be as effective in reducing smoking prevalence. School-based smoking prevalence programs tend to reduce short-term smoking prevalence by between 30% and 70%. Total intervention costs could range from US$16,400 to US$580,000 depending on the scale and scope of intervention. The cost effectiveness of school-based programs show that one could expect a saving of approximately between US$2,000 and US$20,000 per QALY saved due to averted smoking after 2-4 years of follow-up. Workplace-based interventions could represent a sound economic investment to both employers and the society at large, achieving a benefit-cost ratio of up to 8.75 and generating 12-month employer cost savings of between $150 and $540 per nonsmoking employee. Implementing smoke-free workplaces would also produce myriads of new quitters and reduce the amount of cigarette consumption, leading to cost savings in direct medical costs to primary health care providers. Workplace interventions are, however, likely to yield far greater economic benefits over the long term, as reduced prevalence will lead to a healthier and more productive workforce.
Conclusions: We conclude that the direct costs and externalities to society of smoking far outweigh any benefits that might be accruable at least when considered from the perspective of socially desirable outcomes (ie, in terms of a healthy population and a productive workforce). There are enormous differences in the application and economic measurement of smoking cessation measures across various types of interventions, methodologies, countries, economic settings, and health care systems, and these may have affected the comparability of the results of the studies reviewed. However, on the balance of probabilities, most of the cessation measures reviewed have not only proved effective but also cost effective in delivering the much desired cost savings and net gains to individuals and primary health care providers.
Tobacco use insights · review · 189 citationsread the source →
Enhanced treatment for depression in primary care: long-term outcomes of a psycho-educational prevention program alone and enriched with psychiatric consultation or cognitive behavioral therapy
BACKGROUND: The long-term outcome of major depression is often unfavorable, and because most cases of depression are managed by general practitioners (GPs), this places stress on the need to improve treatment in primary care. This study evaluated the long-term effects of enhancing the GP's usual care (UC) with three experimental interventions. METHOD: A randomized controlled trial was conducted from 1998 to 2003. The main inclusion criterion was receiving GP treatment for a depressive episode. We compared: (1) UC (n=72) with UC enhanced with: (2) a psycho-educational prevention (PEP) program (n=112); (3) psychiatrist-enhanced PEP (n=37); and (4) brief cognitive behavioral therapy followed by PEP (CBT-enhanced PEP) (n=44). We assessed depression status quarterly during a 3-year follow-up. RESULTS: Pooled across groups, depressive disorder-free and symptom-free times during follow-up were 83% and 17% respectively. Almost 64% of the patients had a relapse or recurrence, the median time to recurrence was 96 weeks, and the mean Beck Depression Inventory (BDI) score over 12 follow-up assessments was 9.6. Unexpectedly, PEP patients had no better outcomes than UC patients. However, psychiatrist-enhanced PEP and CBT-enhanced PEP patients reported lower BDI severity during follow-up than UC patients [mean difference 2.07 (95% confidence interval (CI) 1.13-3.00) and 1.62 (95% CI 0.70-2.55) respectively] and PEP patients [2.37 (95% CI 1.35-3.39) and 1.93 (95% CI 0.92-2.94) respectively]. CONCLUSIONS: The PEP program had no extra benefit compared to UC and may even worsen outcome in severely depressed patients. Enhancing treatment of depression in primary care with psychiatric consultation or brief CBT seems to improve the long-term outcome, but findings need replication as the interventions were combined with the ineffective PEP program.
Psychological Medicine · randomised controlled trial · 70 citationsread the source →
Character virtues prospectively predict responses to situational stressors in daily life in clinical and subclinical samples.
Background: Character strengths and virtues may shape responses to stressors and risk for anxious and depressive distress. However, most studies have relied on cross-sectional designs, and it remains unclear whether virtues directly predict distress in daily life or buffer context-specific stressors. We tested whether higher-order intellectual (inquisitiveness), intrapersonal (self-control), and interpersonal virtues (caring) prospectively predicted coping responses and lower symptoms, and moderated effects of specific stressors on distress.
Methods: Treatment-seeking individuals diagnosed with anxiety/depression (N = 81; Study 1) and students (N = 112; Study 2) completed the VIA Inventory of Strengths survey at baseline, then experience-sampling of daily symptoms and situational responses (perceptions and/or coping strategies) over seven days (Study 1) or five weeks (Study 2).
Results: Multilevel models generally linked virtues to more adaptive daily responses during individuals' worst and best daily events (Study 1) and worst events (Study 2), but inquisitiveness unexpectedly predicted higher symptoms in both studies. Additionally, virtues buffered against the within-person effects of specific stressor perceptions on distress (Study 2).
Conclusions: The relevance of character virtues for anxiety, stress, and coping may be complex, predicting higher or lower symptoms depending on both the virtue and the situational context.
Anxiety, stress, and coping · 2 citationsread the source →
Non-pharmacological interventions for assisting the induction of anaesthesia in children.
Background: Induction of general anaesthesia can be distressing for children. Non-pharmacological methods for reducing anxiety and improving co-operation may avoid the adverse effects of preoperative sedation.
Objectives: To assess the effects of non-pharmacological interventions in assisting induction of anaesthesia in children by reducing their anxiety, distress or increasing their co-operation.
Search methods: In this updated review we searched CENTRAL (the Cochrane Library 2012, Issue 12) and searched the following databases from inception to 15 January 2013: MEDLINE, EMBASE, PsycINFO and Web of Science. We reran the search in August 2014. We will deal with the single study found to be of interest when we next update the review.
Selection criteria: We included randomized controlled trials of a non-pharmacological intervention implemented on the day of surgery or anaesthesia.
Data collection and analysis: At least two review authors independently extracted data and assessed risk of bias in trials.
Main results: We included 28 trials (2681 children) investigating 17 interventions of interest; all trials were conducted in high-income countries. Overall we judged the trials to be at high risk of bias. Except for parental acupuncture (graded low), all other GRADE assessments of the primary outcomes of comparisons were very low, indicating a high degree of uncertainty about the overall findings. Parental presence: In five trials (557 children), parental presence at induction of anaesthesia did not reduce child anxiety compared with not having a parent present (standardized mean difference (SMD) 0.03, 95% confidence interval (CI) -0.14 to 0.20). In a further three trials (267 children) where we were unable to pool results, we found no clear differences in child anxiety, whether a parent was present or not. In a single trial, child anxiety showed no significant difference whether one or two parents were present, although parental anxiety was significantly reduced when both parents were present at the induction. Parental presence was significantly less effective than sedative premedication in reducing children's anxiety at induction in three trials with 254 children (we could not pool results). Child interventions (passive): When a video of the child's choice was played during induction, children were significantly less anxious than controls (median difference modified Yale Preoperative Anxiety Scale (mYPAS) 31.2, 95% CI 27.1 to 33.3) in a trial of 91 children. In another trial of 120 children, co-operation at induction did not differ significantly when a video fairytale was played before induction. Children exposed to low sensory stimulation were significantly less anxious than control children on introduction of the anaesthesia mask and more likely to be co-operative during induction in one trial of 70 children. Music therapy did not show a significant effect on children's anxiety in another trial of 51 children. Child interventions (mask introduction): We found no significant differences between a mask exposure intervention and control in a single trial of 103 children for child anxiety (risk ratio (RR) 0.59, 95% CI 0.31 to 1.11) although children did demonstrate significantly better co-operation in the mask exposure group (RR 1.27, 95% CI 1.06 to 1.51). Child interventions (interactive): In a three-arm trial of 168 children, preparation with interactive computer packages (in addition to parental presence) was more effective than verbal preparation, although differences between computer and cartoon preparation were not significant, and neither was cartoon preparation when compared with verbal preparation. Children given video games before induction were significantly less anxious at induction than those in the control group (mYPAS mean difference (MD) -9.80, 95% CI -19.42 to -0.18) and also when compared with children who were sedated with midazolam (mYPAS MD -12.20, 95% CI -21.82 to -2.58) in a trial of 112 children. When compared with parental presence only, clowns or clown doctors significantly lessened children's anxiety in the operating/induction room (mYPAS MD -24.41, 95% CI -38.43 to -10.48; random-effects, I² 75%) in three trials with a total of 133 children. However, we saw no significant differences in child anxiety in the operating room between clowns/clown doctors and sedative premedication (mYPAS MD -9.67, 95% CI -21.14 to 1.80, random-effects, I² 66%; 2 trials of 93 children). In a trial of hypnotherapy versus sedative premedication in 50 children, there were no significant differences in children's anxiety at induction (RR 0.59, 95% CI 0.33 to 1.04). Parental interventions: Children of parents having acupuncture compared with parental sham acupuncture were less anxious during induction (mYPAS MD -17, 95% CI -30.51 to -3.49) and were more co-operative (RR 1.59, 95% CI 1.01 to 2.53) in a single trial of 67 children. Two trials with 191 parents assessed the effects of parental video viewing but did not report any of the review's prespecified primary outcomes.
Authors' conclusions: This review shows that the presence of parents during induction of general anaesthesia does not diminish their child's anxiety. Potentially promising non-pharmacological interventions such as parental acupuncture; clowns/clown doctors; playing videos of the child's choice during induction; low sensory stimulation; and hand-held video games need further investigation in larger studies.
The Cochrane database of systematic reviews · meta-analysis · 100 citationsread the source →
Balaj M, York HW, Sripada K, Besnier E, Vonen HD, Aravkin A, Friedman J, Griswold M, Jensen MR, Mohammad T, Mullany EC, Solhaug S, Sorensen R, Stonkute D, Tallaksen A, Whisnant J, Zheng P, Gakidou E, Eikemo TA. (2021)MEDLINE-indexed journal, not yet read by usLancet (London, England) · meta-analysis Parental education and inequalities in child mortality: a global systematic review and meta-analysis.
Background: The educational attainment of parents, particularly mothers, has been associated with lower levels of child mortality, yet there is no consensus on the magnitude of this relationship globally. We aimed to estimate the total reductions in under-5 mortality that are associated with increased maternal and paternal education, during distinct age intervals.
Methods: This study is a comprehensive global systematic review and meta-analysis of all existing studies of the effects of parental education on neonatal, infant, and under-5 child mortality, combined with primary analyses of Demographic and Health Survey (DHS) data. The literature search of seven databases (CINAHL, Embase, MEDLINE, PsycINFO, PubMed, Scopus, and Web of Science) was done between Jan 23 and Feb 8, 2019, and updated on Jan 7, 2021, with no language or publication date restrictions. Teams of independent reviewers assessed each record for its inclusion of individual-level data on parental education and child mortality and excluded articles on the basis of study design and availability of relevant statistics. Full-text screening was done in 15 languages. Data extracted from these studies were combined with primary microdata from the DHS for meta-analyses relating maternal or paternal education with mortality at six age intervals: 0-27 days, 1-11 months, 1-4 years, 0-4 years, 0-11 months, and 1 month to 4 years. Novel mixed-effects meta-regression models were implemented to address heterogeneity in referent and exposure measures among the studies and to adjust for study-level covariates (wealth or income, partner's years of schooling, and sex of the child). This study was registered with PROSPERO (CRD42020141731).
Findings: The systematic review returned 5339 unique records, yielding 186 included studies after exclusions. DHS data were compiled from 114 unique surveys, capturing 3 112 474 livebirths. Data extracted from the systematic review were synthesized together with primary DHS data, for meta-analysis on a total of 300 studies from 92 countries. Both increased maternal and paternal education showed a dose-response relationship linked to reduced under-5 mortality, with maternal education emerging as a stronger predictor. We observed a reduction in under-5 mortality of 31·0% (95% CI 29·0-32·6) for children born to mothers with 12 years of education (ie, completed secondary education) and 17·3% (15·0-18·8) for children born to fathers with 12 years of education, compared with those born to a parent with no education. We also showed that a single additional year of schooling was, on average, associated with a reduction in under-5 mortality of 3·04% (2·82-3·23) for maternal education and 1·57% (1·35-1·72) for paternal education. The association between higher parental education and lower child mortality was significant for both parents at all ages studied and was largest after the first month of life. The meta-analysis framework incorporated uncertainty associated with each individual effect size into the model fitting process, in an effort to decrease the risk of bias introduced by study design and quality.
Interpretation: To our knowledge, this study is the first effort to systematically quantify the transgenerational importance of education for child survival at the global level. The results showed that lower maternal and paternal education are both risk factors for child mortality, even after controlling for other markers of family socioeconomic status. This study provides robust evidence for universal quality education as a mechanism to achieve the Sustainable Development Goal target 3.2 of reducing neonatal and child mortality.
Funding: Research Council of Norway, Bill & Melinda Gates Foundation, and Rockefeller Foundation-Boston University Commission on Social Determinants, Data, and Decision Making (3-D Commission).
Lancet (London, England) · meta-analysis · 132 citationsread the source →
Predicting race performance in triathlon: the role of perfectionism, achievement goals, and personal goal setting.
The question of how perfectionism affects performance is highly debated. Because empirical studies examining perfectionism and competitive sport performance are missing, the present research investigated how perfectionism affected race performance and what role athletes' goals played in this relationship in two prospective studies with competitive triathletes (Study 1: N = 112; Study 2: N = 321). Regression analyses showed that perfectionistic personal standards, high performance-approach goals, low performance-avoidance goals, and high personal goals predicted race performance beyond athletes' performance level. Moreover, the contrast between performance-avoidance and performance-approach goals mediated the relationship between perfectionistic personal standards and performance, whereas personal goal setting mediated the relationship between performance-approach goals and performance. The findings indicate that perfectionistic personal standards do not undermine competitive performance, but are associated with goals that help athletes achieve their best possible performance.
Journal of sport & exercise psychology · 33 citationsread the source →
The Incredible Years Parents and Babies Program: A Pilot Randomized Controlled Trial.
Introduction: Infancy is an important period of life; adverse experiences during this stage can have both immediate and lifelong impacts on the child's mental health and well-being. This study evaluates the effects of offering the Incredible Years Parents and Babies (IYPB) program as a universal intervention.
Method: We conducted a pragmatic, two-arm, parallel pilot randomized controlled trial; 112 families with newborns were randomized to the IYPB program (76) or usual care (36) with a 2:1 allocation ratio. The primary outcome was parenting confidence at 20 weeks(Karitane Parenting Confidence Scale and Parental Stress Scale). Secondary outcomes include measures of parent health, parent-child relationship, infant development, parent-child activities, and network. Interviewers and data analysts were blind to allocation status. Multiple linear-regression analyses were used for evaluating the effects of the intervention.
Results: There were no intervention effects on the primary outcomes. Only one effect was detected for secondary outcomes, intervention mothers reported a significantly smaller network than control mothers (β = -0.15 [-1.85,-0.28]). When examining the lowest-functioning mothers in moderator analyses, we found that intervention mothers reported significantly higher parent stress (β = 5.33 [0.27,10.38]), lower parenting confidence (β = -2.37 [-4.45,-0.29]), and worse mental health than control mothers (β = -18.62 [-32.40,-4.84]). In contrast, the highest functioning intervention mothers reported significantly lower parent stress post-intervention (β = -6.11 [-11.07,-1.14]).
Conclusion: Overall, we found no effects of the IYPB as a universal intervention for parents with infants. The intervention was developed to be used with groups of low functioning families and may need to be adapted to be effective with universal parent groups. The differential outcomes for the lowest and highest functioning families suggest that future research should evaluate the effects of delivering the IYPB intervention to groups of parents who have similar experiences with parenting and mental health.
Trial registration: ClinicalTrials.gov NCT01931917.
PloS one · randomised controlled trial · 24 citationsread the source →
Effects of Additional Individually Tailored Interventions on Sick-Leave and Symptoms in Patients with Exhaustion Disorder: A Randomized Controlled Trial.
Objective: To evaluate the effects of adding individually tailored interventions to a standard treatment in patients with stress-related exhaustion disorder, with regard to sick-leave days and symptoms of burnout. The study design was a 2-armed randomized controlled intervention, with follow-up after 15 months. Data were obtained from patients referred to the Institute of Stress Medicine, and were collected between 2011 and 2014 in western Sweden.
Methods: Inclusion criteria were scoring above cut-off in at least 1 of 4 dimensions; mental and physical exhaustion, disturbed sleep, reduced cognitive function and perceived poor self-esteem. The total study population comprised 142 patients (112 females, 30 males) allocated through block randomization to either the intervention group (n = 71) or the control group (n = 71). The intervention group received 1-4 individually tailored interventions (physical activity, cognitive behaviour therapy for insomnia, computerized memory training, cognitive behavioural therapy for self-esteem), based on the results of screening assessments. The interventions were additional to a standard treatment. The control group received solely the standard treatment. The primary outcome measure was the proportion of participants not sicklisted at the 15-month follow-up.
Results: At the 15-month follow-up, 30% of subjects in the intervention group and 34% in the control group had 0% sick-listed (p = 0.58). No change between baseline and follow-up was seen in 42% of the intervention group and 39% of the control group, while an increased sick-leave rate was seen in 1% of the intervention group and 4% of the control group. However, no statistically significant difference was seen between groups.
Conclusion: Adding individually tailored interventions to a standard treatment in patients with stress-related exhaustion did not reduce sick-leave days or burnout symptoms.
Journal of rehabilitation medicine · randomised controlled trial · 7 citationsread the source →
Effect of MyTeen SMS-Based Mobile Intervention for Parents of Adolescents: A Randomized Clinical Trial.
Importance: There is global pressure to respond to the burden posed by adolescent mental health problems. The National Mental Health Commission has made a call for investment in mobile health services directed at prevention and early intervention to relieve the demand on targeted mental health services that are costly to provide. Parents and primary caregivers play a significant role in the lives of adolescents and are important targets for such efforts. Currently, there is no evidence for the effectiveness of programs delivered solely via text message for parents of adolescents.
Objective: To evaluate the effects of a text-messaging program (MyTeen) on promoting parental competence and mental health literacy for parents of adolescents.
Design, setting, and participants: A parallel 2-group randomized clinical trial was conducted in New Zealand. A total of 221 parents and primary caregivers of adolescents aged 10 to 15 years were recruited from March 19 to August 17, 2018, via community outreach and social media and were randomly allocated 1:1 into the control or the intervention group. Statistical analysis was performed on the principle of intention to treat with adjustment for baseline factors and ethnicity.
Intervention: A text-messaging program for parents of adolescents (age 10-15 years) to promote parental competence and mental health literacy. Participants received 1 daily text message over 4 weeks.
Main outcomes and measures: Parental competence, assessed at 1 month after randomization by the Parenting Sense of Competence Scale.
Results: In total, 221 participants (214 [96.8%] female) were randomized, 109 to the intervention group and 112 to the control group; 201 participants (91%) completed the trial at 3 months. Significant group difference was observed on the primary outcome at the end of 1 month of intervention, with participants reporting a higher level of parental competence than those in the control group (estimated mean difference, 3.33 points; 95% CI, 1.37-5.29 points; P = .002). Except for knowledge about mental health, all secondary outcomes were significant, including continued improvement in parental competence at 3 months (estimated mean difference, 4.08 points; 95% CI, 1.96-6.20 points; P < .001), knowledge of help seeking (estimated mean difference, 0.99 points; 95% CI, 0.49-1.50 points; P < .001), parental distress (estimated mean difference, -2.39 points; 95% CI, -4.37 to -0.40 points; P = .02), and parent-adolescent communication (estimated mean difference, 2.21 points; 95% CI, 0.48-3.95 points; P = .01), with participants in the intervention group reporting better parenting-related outcomes than the control group at 1 and 3 months after the intervention.
Conclusions and relevance: This text-messaging program for parents of adolescents appears to be an effective and feasible way to facilitate the implementation and delivery of evidence-based information to populations that are not easily reached with other intervention modalities. The program can be easily scaled up for delivery as an early preventive intervention and may represent a less expensive option for service delivery.
Trial registration: anzctr.org.au Identifier: ACTRN12618000117213.
JAMA network open · randomised controlled trial · 27 citationsread the source →
Hashash JG, Knisely MR, Germain A, McAuliff K, Strassburger M, Vachon A, Binion DG, Regueiro M, Wallace M, Szigethy E. (2022)MEDLINE-indexed journal, not yet read by usClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · clinical trial Brief Behavioral Therapy and Bupropion for Sleep and Fatigue in Young Adults With Crohn's Disease: An Exploratory Open Trial Study.
Background/aims: Sleep disturbances and fatigue are common symptoms amongst patients with Crohn's disease (CD). The aim of this study was to test the feasibility and effects of a pragmatic, stepped-care intervention for the treatment of poor sleep quality and fatigue in adolescents and young adults with CD.
Methods: This study is a two-phase open trial exploring interventions for sleep and fatigue. After the initial comprehensive assessment which included quantitative measures and an interview to evaluate sleep and physical and mental health, the 12-week intervention consisted of two sequential steps: 1) a brief behavioral therapy for sleep in inflammatory bowel disease (IBD) (BBTS-I; 4 weeks) and 2) adding the psychotropic medication, bupropion sustained release (BUP-SR; 8 weeks), for the subset of subjects continuing to experience fatigue.
Results: 232 CD patients (median age=24, median sex=female) were approached over 18 months, of whom 112 screened positive on the Pittsburgh Sleep Quality Index (PSQI) and multi-dimensional fatigue inventory (MFI), with 68 CD patients completing the more comprehensive baseline assessment. Of the 68 patients, 52 participated in Phase I of the BBTS-I intervention. Following 4-weeks of the BBTS-I, there were significant improvements in sleep quality (p < .001) and fatigue (p < .001). As part of Phase II, of the 52 patients who met fatigue threshold criteria, 33 patients participated in the BUP-SR+BBTS-I arm while 19 participated in the BBTS-I only intervention group. After 8 weeks of Phase II, both intervention groups saw significant further improvement in sleep, fatigue, anxiety and depressive symptoms, but without significant differences between the two intervention groups.
Conclusions: A stepped-care approach shows that we can improve sleep disturbance with BBTS-I in CD patients, but fatigue only partially improves. For a subset of patients who chose to add BUP-SR to their behavioral therapy, fatigue improves further but not to a statistically significant effect compared to behavioral therapy alone.
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · clinical trial · 25 citationsread the source →
Evaluation of a structured skills training group for adolescents with attention deficit/hyperactivity disorder (ADHD) - study protocol of a randomised controlled trial.
Background: Attention deficit/hyperactivity disorder (ADHD) has a negative impact on several domains of life. However, there is a shortage of evidence-based non-pharmacological treatments for adolescents with ADHD. A structured skills training group (SSTG) based on dialectical behaviour therapy (DBT) has been used in adult patients with ADHD with some promising results, although the treatment has not yet been adapted or evaluated for adolescents with ADHD. This study protocol describes how this treatment was adapted for an adolescent population and how the efficacy of the SSTG will be evaluated using a randomised controlled trial (RCT) design.
Methods: A sample of 184 adolescents (15-18 years of age) with a diagnosis of ADHD has been recruited from seven child and adolescent psychiatric outpatient units and randomised to either the SSTG or an active control group based on psychoeducation. Measures are conducted weekly during the treatment, as well as 2 weeks before treatment and 2 weeks and 6 months after treatment. The primary outcome measures are ADHD symptoms, functional impairment, quality of life and mindfulness. Secondary outcome measures are symptoms of comorbid psychopathology, perceived stress and sleep problems. This article describes the design, methods and analysis plan for evaluating the efficacy of the SSTG.
Discussion: The study will be the first RCT to examine the acceptability and efficacy of a SSTG based on DBT adapted for adolescents with ADHD. We believe that the study will extend the current knowledge base about psychological treatment for adolescents with ADHD.
Trial registration: ISRCTN registry ( ISRCTN17366720 ). Retrospectively registered May 112,016.
BMC psychiatry · clinical trial · 6 citationsread the source →
The impact of substance use, sexual trauma, and intimate partner violence on sexual risk intervention outcomes in couples: a randomized trial.
Background: Few HIV prevention interventions focus on sexual risk reduction as mutual process determined by couple members, though risk behaviors are inter-dependent.
Purpose: This trial examined the impact of substance use, history of sexual trauma, and intimate partner violence on sexual risk associated with participation in a risk reduction intervention.
Methods: HIV seroconcordant and serodiscordant multicultural couples in Miami, Florida (n = 216) were randomized to group (n = 112) or individual (n = 104) couple-based interventions.
Results: Group intervention participants increased condom use in couples in which women had a history of sexual trauma [F(2,221) = 3.39, p = 0.036] and by partners of alcohol users. History of sexual trauma was a determinant of conflict resolution, predicting negative communication and intimate partner violence.
Conclusions: Results emphasize the need for group sexual risk reduction interventions targeting sexual trauma, partner violence, and substance use among HIV seroconcordant and serodiscordant couples.
Annals of behavioral medicine : a publication of the Society of Behavioral Medicine · randomised controlled trial · 17 citationsread the source →
Labarere J, Gelbert-Baudino N, Ayral AS, Duc C, Berchotteau M, Bouchon N, Schelstraete C, Vittoz JP, Francois P, Pons JC. (2005)MEDLINE-indexed journal, not yet read by usPediatrics · randomised controlled trial Efficacy of breastfeeding support provided by trained clinicians during an early, routine, preventive visit: a prospective, randomized, open trial of 226 mother-infant pairs.
Background: Despite growing evidence of the benefits of prolonged breastfeeding for mother and infant health, the rate of breastfeeding at infant age of 6 months remains below the Healthy People 2010 goal. The greatest decrease in the breastfeeding rate occurs during the first 4 postpartum weeks. Mothers who discontinue breastfeeding early are more likely to report lack of confidence in their ability to breastfeed, problems with the infant latching or suckling, and lack of individualized encouragement from their clinicians in the early postdischarge period. Observational studies suggest that primary care physicians can increase breastfeeding rates through specific advice and practices during routine preventive visits. However, robust scientific evidence based on randomized, controlled trials is currently lacking.
Objective: The purpose of this study was to determine whether attending an early, routine, preventive, outpatient visit delivered in a primary care physician's office would improve breastfeeding outcomes.
Design: The study was a prospective, randomized, parallel-group, open trial.
Setting: Participants were recruited at a level 3 maternity facility, with an average of 2000 births per year, in France.
Participants: A total of 231 mothers who had delivered a healthy singleton infant (gestational age: > or =37 completed weeks) and were breastfeeding on the day of discharge were recruited and randomized (116 were assigned to the intervention group and 115 to the control group) between October 1, 2001, and May 31, 2002; 226 mother-infant pairs (112 in the intervention group and 114 in the control group) contributed data on outcomes.
Intervention: Support for breastfeeding in the control group included the usual verbal encouragement provided by the maternity ward staff members, a general health assessment and an evaluation for evidence of successful breastfeeding behavior by the pediatrician working in the obstetrics department on the day of discharge, provision of the telephone number of a peer support group, mandatory routine, preventive, outpatient visits at 1, 2, 3, 4, 5, and 6 months of infant age, and 10 weeks of paid maternity leave (extended to 18 weeks after the birth of the third child). In addition to the usual predischarge and postdischarge support, the mothers in the intervention group were invited to attend an individual, routine, preventive, outpatient visit in the office of 1 of the 17 participating primary care physicians (pediatricians or family physicians) within 2 weeks after the birth. The participating physicians received a 5-hour training program on breastfeeding, delivered in 2 parts in 1 month, before the beginning of the study.
Outcome measures: The primary outcome was the prevalence of exclusive breastfeeding reported at 4 weeks (defined as giving maternal milk as the only food source, with no other foods or liquids, other than vitamins or medications, being given). The secondary outcomes included any breastfeeding reported at 4 weeks, breastfeeding duration, breastfeeding difficulties, and satisfaction with breastfeeding experiences. Classification into breastfeeding categories reported at 4 weeks was based on 24-hour dietary recall.
Results: Ninety-two mothers (79.3%) assigned to the intervention group and 8 mothers (7.0%) assigned to the control group reported that they had attended the routine, preventive, outpatient visit in the office of 1 of the 17 primary care physicians participating in the study. Mothers in the intervention group were more likely to report exclusive breastfeeding at 4 weeks (83.9% vs 71.9%; hazard ratio: 1.17; 95% confidence interval [CI]: 1.01-1.34) and longer breastfeeding duration (median: 18 weeks vs 13 weeks; hazard ratio: 1.40; 95% CI: 1.03-1.92). They were less likely to report any breastfeeding difficulties (55.3% vs 72.8%; hazard ratio: 0.76; 95% CI: 0.62-0.93). There was no significant difference between the 2 groups with respect to the rate of any breastfeeding at 4 weeks (89.3% vs 81.6%; hazard ratio: 1.09; 95% CI: 0.98-1.22) and the rate of mothers fairly or very satisfied with their breastfeeding experiences (91.1% vs 87.7%; hazard ratio: 1.04; 95% CI: 0.95-1.14).
Conclusions: Although we cannot exclude the possibility that findings might differ in other health care systems, this study provides preliminary evidence of the efficacy of breastfeeding support through an early, routine, preventive visit in the offices of trained primary care physicians. Our findings also suggest that a short training program for practicing physicians might contribute to improving breastfeeding outcomes. Multifaceted interventions aiming to support breastfeeding should involve primary care physicians.
Pediatrics · randomised controlled trial · 111 citationsread the source →
Omega-3 augmentation of sertraline in treatment of depression in patients with coronary heart disease: a randomized controlled trial.
Context: Studies of depressed psychiatric patients have shown that antidepressant efficacy can be increased by augmentation with omega-3 fatty acids.
Objective: To determine whether omega-3 improves the response to sertraline in patients with major depression and coronary heart disease (CHD).
Design, setting, and participants: Randomized controlled trial. Between May 2005 and December 2008, 122 patients in St Louis, Missouri, with major depression and CHD were randomized.
Interventions: After a 2-week run-in period, all patients were given 50 mg/d of sertraline and randomized in double-blind fashion to receive 2 g/d of omega-3 acid ethyl esters (930 mg of eicosapentaenoic acid [EPA] and 750 mg of docosahexaenoic acid [DHA]) (n=62) or to corn oil placebo capsules (n=60) for 10 weeks.
Main outcome measures: Scores on the Beck Depression Inventory (BDI-II) and the Hamilton Rating Scale for Depression (HAM-D).
Results: Adherence to the medication regimen was 97% or more in both groups for both medications. There were no differences in weekly BDI-II scores (treatment x time interaction = 0.02; 95% confidence interval [CI], -0.33 to 0.36; t(112) = 0.11; P = .91), pre-post BDI-II scores (placebo, 14.8 vs omega-3, 16.1; 95% difference-in-means CI, -4.5 to 2.0; t(116) = -0.77; P = .44), or HAM-D scores (placebo, 9.4 vs omega-3, 9.3; 95% difference-in-means CI, -2.2 to 2.4; t(115) = 0.12; P = .90). The groups did not differ on predefined indicators of depression remission (BDI-II < or = 8: placebo, 27.4% vs omega-3, 28.3%; odds ratio [OR], 0.96; 95% CI, 0.43-2.15; t(113) = -0.11; P = .91) or response (> 50% reduction in BDI-II from baseline: placebo, 49.0% vs omega-3, 47.7%; OR, 1.06; 95% CI, 0.51-2.19; t(112) = 0.15; P = .88).
Conclusions: Treatment of patients with CHD and major depression with sertraline and omega-3 fatty acids did not result in superior depression outcomes at 10 weeks, compared with sertraline and placebo. Whether higher doses of omega-3 or sertraline, a different ratio of EPA to DHA, longer treatment, or omega-3 monotherapy can improve depression in patients with CHD remains to be determined.
Trial registration: clinicaltrials.gov Identifier: NCT00116857.
JAMA · randomised controlled trial · 91 citationsread the source →
Sprong S, Jetten J, Wang Z, Peters K, Mols F, Verkuyten M, Bastian B, Ariyanto A, Autin F, Ayub N, Badea C, Besta T, Butera F, Costa-Lopes R, Cui L, Fantini C, Finchilescu G, Gaertner L, Gollwitzer M, Gómez Á, González R, Hong YY, Jensen DH, Jasinskaja-Lahti I, Karasawa M, Kessler T, Klein O, Lima M, Mégevand L, Morton T, Paladino P, Polya T, Renvik TA, Ruza A, Shahrazad W, Shama S, Smith HJ, Torres AR, van der Bles AM, Wohl MJA. (2019)MEDLINE-indexed journal, not yet read by usPsychological science "Our Country Needs a Strong Leader Right Now": Economic Inequality Enhances the Wish for a Strong Leader.
Societal inequality has been found to harm the mental and physical health of its members and undermine overall social cohesion. Here, we tested the hypothesis that economic inequality is associated with a wish for a strong leader in a study involving 28 countries from five continents (Study 1, N = 6,112), a study involving an Australian community sample (Study 2, N = 515), and two experiments (Study 3a, N = 96; Study 3b, N = 296). We found correlational (Studies 1 and 2) and experimental (Studies 3a and 3b) evidence for our prediction that higher inequality enhances the wish for a strong leader. We also found that this relationship is mediated by perceptions of anomie, except in the case of objective inequality in Study 1. This suggests that societal inequality enhances the perception that society is breaking down (anomie) and that a strong leader is needed to restore order (even when that leader is willing to challenge democratic values).
Psychological science · 51 citationsread the source →
Prevalence of anemia and its associated factors among children under five years of age attending at Guguftu health center, South Wollo, Northeast Ethiopia.
Background: Anemia during childhood adversely affects mental, physical and social development of the children. This study is aimed to assess the prevalence of anemia and its associated factors among children less than five years of age in Guguftu, South Wollo, Northeast Ethiopia.
Method: A cross-sectional health facility based study was conducted among 404 children aged 6 to 59 months. Systematic random sampling technique was used to include the participants. Pretested and structured questionnaires were used to collect socioeconomic and demographic characteristics of the family and child. Data on nutritional status, capillary blood and stool samples were collected from each child. Multivariate logistic regression was used to calculate adjusted odds ratios and the corresponding 95% confidence intervals.
Result: The overall prevalence of anemia was 41.1% (95% CI;36.6% - 45.8%). Of the anemic under five children, 112 (67.5%) had mild anemia, 52(31.3%) had moderate anemia, and 2(1.2%) had severe anemia. Children who were in the age group of 6-11(AOR = 4.52; 95% CI: 1.67-12.34) and 12-23 (AOR = 2.79; 95% CI: 1.04-7.51) months, living in an urban (AOR = 1.83; 95% CI: 1.05-3.18), with no formal education mothers (AOR = 7.05; 95% CI: 2.93-17.01) and primary education mothers (AOR = 3.26; 95% CI: 1.29-8.24), with a family monthly income of <750 ETB(AOR = 5.19; 95% CI: 1.24-21.75) and 750-1500 ETB(AOR = 5.89; 95% CI: 1.45-23.98), with early (<6 months) introduction of complementary foods (AOR = 3.53; 95% CI: 1.23-10.18), Underweight (AOR = 2.11; 95% CI: 1.21-3.69) were more likely to become anemic.
Conclusion: This study has revealed that the prevalence of anemia in children less than five years is high and a severe public health problem in the study area. Therefore, the policymakers should make a strategy that can reduce poverty and increase the awareness of women on breastfeeding, nutrition, and other associated factors to reduce anemia.
PloS one · 71 citationsread the source →
Written Exposure Therapy vs Prolonged Exposure Therapy in the Treatment of Posttraumatic Stress Disorder: A Randomized Clinical Trial.
Importance: Evidence-based treatments for posttraumatic stress disorder (PTSD) exist, but all require 8 to 15 sessions and thus are less likely to be completed than brief treatments. Written exposure therapy (WET) is a brief and efficacious treatment that has not been directly compared with prolonged exposure therapy (PE), a more time-intensive, exposure-based treatment.
Objective: To determine whether WET is noninferior to PE in treating PTSD among veterans.
Design, setting, and participants: A randomized noninferiority clinical trial was conducted between September 9, 2019, and April 30, 2022. Participants were 178 veterans with PTSD presenting to 1 of 3 Veterans Affairs medical centers. Inclusion criteria consisted of a primary diagnosis of PTSD and stable medication. Exclusion criteria included current psychotherapy for PTSD, high suicide risk, active psychosis, unstable bipolar disorder, and severe cognitive impairment. Independent evaluations were conducted at baseline and 10, 20, and 30 weeks after the first treatment session. Data were analyzed from January 1 to March 31, 2023.
Interventions: Participants assigned to WET (n = 88) received five to seven 45- to 60-minute sessions. Participants assigned to PE (n = 90) received eight to fifteen 90-minute sessions. The WET sessions included 30 minutes of writing-based imaginal exposure conducted in session, whereas PE sessions included 40 minutes of in-session imaginal exposure and between-session in vivo exposures.
Main outcomes and measures: The primary outcome was change in PTSD symptom severity measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) from baseline to the 20-week assessment; noninferiority was defined as a less than 10-point difference between the 2 treatment groups. Difference in treatment dropout was also examined.
Results: Of the 178 participants, 134 (75.3%) were men, and the mean (SD) age was 44.97 (13.66) years. In terms of race, 37 participants (20.8%) were Black, 112 (62.9%) were White, 11 (6.2%) were more than 1 race, and 18 (10.1%) were of other race (including American Indian or Alaska Native, Asian, and Native Hawaiian or Other Pacific Islander [some participants did not specify their race when selecting the category "other"]); in terms of ethnicity, 19 participants (10.7%) were Hispanic. Changes in PTSD symptom severity from baseline to all subsequent assessments among individuals randomized to WET were noninferior relative to individuals randomized to PE. The largest difference between treatments was observed at 10 weeks and was in favor of WET (mean difference, 2.42 [95% CI, 0.35-1.46] points). Participants were significantly less likely to drop out of WET compared with PE (11 [12.5%] vs 32 [35.6%]; χ2 = 12.91; Cramer V = 0.27).
Conclusions and relevance: In this study, WET was noninferior to PE in PTSD symptom change and was associated with significantly less attrition. Findings suggest that WET may transcend previously observed barriers to PTSD treatment for both patients and clinicians.
Trial registration: ClinicalTrials.gov Identifier: NCT03962504.
JAMA psychiatry · 48 citationsread the source →
The impact of adolescents' voice through an online school radio: a socio-emotional learning experimental project.
Universal school-based socio-emotional learning (SEL) programs for adolescents have shown their efficacy in producing positive outcomes. The aim of the current study is to present an original school-based program and project for adolescents-Semear Valores On-air - and to assess the relationship between participation in the project and students' socio-emotional skills. Based on the character strengths and virtues model, this online school radio project aimed at promoting communication, creative thinking, adaptability, and resilience skills in adolescents and giving them the opportunity to become influential agents of well-being and citizenship. As part of the school curriculum, students were invited to create and record radio shows and podcasts. An online school radio was thus created, and it continues to broadcast all over the world, with music, daily shows, and interviews 24/7. It was developed within the framework of the Gulbenkian Academies for Knowledge, a nationwide Portuguese program, that seeks to prepare children and youth for change, to enable them to deal with complex problems, and to expand their opportunities for achievement. A quasi-experimental design, with a mixed qualitative-quantitative approach was used to analyze data collected from 112 adolescents in the second year of its implementation, in 2020-2021. Results suggest that (1) teachers' perceptions of student's socio-emotional skills in the post test showed more positive associations with the participation in the project, than participant's perceptions; (2) students identified eight types of lessons learned, the one most referred was the improvement of socio-emotional skills and learning about themselves; and (3) the combined opportunities for adolescents to learn more about themselves, to express themselves and to practice socio-emotional skills are important ingredients for their motivation and active engagement in the project. Overall, these results indicate that participation in the project is associated with positive outcomes for the adolescents and that both monitoring and evaluation data are very important to interpret the outcomes in a more comprehensive manner.
Frontiers in psychology · 2 citationsread the source →
Protective Factors associated with Resilience in Women Exposed to Intimate Partner Violence.
Objective: Research on adversity is often skewed toward assessing problematic functioning; yet many women display resilience following traumatic experiences. Examining individual, relational, community, and cultural variables can provide new knowledge about protective factors associated with resilience in women exposed to intimate partner violence (IPV). Controlling for demographics and circumstances of the violence, this study evaluated predictors of resilience, including spirituality, social support, community cohesion, and ethnic identity.
Method: The sample consisted of 112 women (Mage =32.12, SD=5.78) exposed to physical, psychological, and/or sexual intimate partner violence in the past 6 months. Approximately 70% of participants were Black. Hierarchical linear regression modeling was conducted to examine factors related to resilience. Model 1 included demographics (age, education, and socioeconomic status) and stressful life experiences. Model 2 added circumstances of the violence: IPV severity, IPV perpetration by participant, and number of violent partners. The third and final model added spirituality, social support, community cohesion, and ethnic identity.
Results: The final model was significant, F(11, 97)=6.63; p<.001, adj. R2 =36.5%; with greater social support (β=.24; p=.009), more spirituality (β=.28; p=.002), and fewer violent relationships (β= -.25; p=.003) predicting higher resilience among women exposed to IPV.
Conclusion: While risk factors associated with IPV are well-researched, little is known about factors related to resilient functioning, especially among minority populations. Knowledge gained from this study can advance the field of violence research by its identification of potentially mutable variables related to resilience. Such research could be applied to developing strength-based interventions for at-risk populations of violence-exposed women.
Psychology of violence · 52 citationsread the source →
Age, gender, and socioeconomic gradients in metabolic syndrome: biomarker evidence from a large sample in Taiwan, 2005-2013.
Purpose: To examine the age and gender heterogeneities in the association between socioeconomic status (SES) and the risk of metabolic syndrome (MetS) with biomarker data from Taiwan.
Methods: Subjects included 102,201 men and 112,015 women aged 25 and above, from the 2005-2013 MJ Health Survey in Taiwan. SES was measured by education and family income. MetS was defined by the Adult Treatment Panel III criteria for Asian population. Logistic regression analyses were performed by age and gender groups.
Results: (1) Higher education level was associated with significantly lower risk of MetS. (2) Higher income was associated with lower MetS risk among women aged under 65, but no association among men of all ages. (3) SES gradients were generally much stronger among women than among men of the same age group. (4) SES gradients reduced over the life course with the exception that income gradient remains flat among men of all ages.
Conclusions: Among Chinese in Taiwan, the gender and age heterogeneities in the SES gradients in MetS are similar to those reported for Western societies. This cross-cultural convergence is broadly consistent with the general hypothesis that social conditions are fundamental causes of diseases and health disparities.
Annals of epidemiology · 24 citationsread the source →
Co-Benefits to Children's Health of the U.S. Regional Greenhouse Gas Initiative.
Background: While various policies have been implemented globally to mitigate climate change and reduce exposure to toxic air pollutants, policy assessments have considered few if any of the benefits to children.
Objective: To comprehensively assess the co-benefits of climate change mitigation to children, we expanded the suite of adverse health outcomes in the U.S. Environmental Protection Agency's Benefits Mapping and Analysis Program (BenMAP) to include additional outcomes associated with prenatal and childhood exposure to ambient fine particulate matter (PM2.5). We applied this newly expanded program to an assessment of the U.S. Regional Greenhouse Gas Initiative (RGGI), the United States' first regional market-based regulatory program designed to reduce greenhouse gas emissions from the electric power sector within the Northeast.
Methods: We used calculated changes in ambient PM2.5 concentrations for the period 2009-2014, with newly incorporated concentration-response (C-R) functions to quantify changes in the incidence of preterm birth (PTB), term low birth weight (TLBW), autism spectrum disorder (ASD), and asthma. These outcomes are causally or likely to be causally related to PM2.5 exposure. Cost per case estimates were incorporated to monetize those changes in incidence.
Results: The estimated avoided cases of adverse child health outcomes included 537 asthma cases, 112 preterm births, 98 cases of ASD, and 56 cases of TLBW, with an associated avoided cost estimate ranging from $191 to $350 million. In a previous analysis of health benefits of RGGI, the only benefits accruing to children were limited to prevented cases of infant mortality and respiratory illnesses, with a monetized impact of $8.1 million-only 2-4% of the new results attributable to RGGI.
Conclusion: The results of this innovative analysis indicate that RGGI has provided substantial child health benefits beyond those initially considered. Moreover, those health benefits had significant estimated economic value. https://doi.org/10.1289/EHP6706.
Environmental health perspectives · 29 citationsread the source →
Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data.
Context: HIV patients treated with antiretroviral therapy (ART) often develop increased visceral adipose tissue (VAT).
Objective: Our objective was to perform a pooled analysis of two phase-3 studies of tesamorelin in ART-treated HIV patients with excess abdominal fat.
Design and setting: Two multicenter, international studies were conducted; a 26-wk randomized, placebo-controlled primary intervention phase was followed by a 26-wk safety extension.
Patients: A total of 806 ART-treated HIV patients with excess abdominal fat were randomized in a 2:1 fashion to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) sc daily. At wk 26, patients initially on tesamorelin were rerandomized to 2 mg tesamorelin (T-T group, n = 246) or placebo (T-P, n = 135) for an additional 26 wk, whereas patients on placebo were switched to tesamorelin (P-T, n = 197).
Interventions: Tesamorelin (GHRH(1-44)) at a dose of 2 mg or identical placebo, sc, was given daily.
Main outcome measure: We evaluated percent change in VAT by computed tomography scan at wk 26.
Results: At wk 26, VAT decreased significantly in tesamorelin-treated patients (-24 +/- 41 vs. 2 +/- 35 cm(2), tesamorelin vs. placebo, P < 0.001; treatment effect, -15.4%). No significant changes were observed in abdominal sc adipose tissue (-2 +/- 32 vs. 2 +/- 29 cm(2), P = 0.08; treatment effect, -0.6%). Treatment with tesamorelin resulted in significant decreases in triglycerides (-37 +/- 139 vs. 6 +/- 112 mg/dl, P < 0.001; treatment effect, -12.3%) and cholesterol to high-density lipoprotein ratio (-0.18 +/- 1.00 vs. 0.18 +/- 0.94, P < 0.001; treatment effect, -7.2%) vs. placebo. Tesamorelin improved body image [belly appearance distress (P = 0.002)], patient rating of belly profile (P = 0.003), and physician rating of belly profile (P < 0.001). Mean IGF-I increased 108 +/- 112 vs.-7 +/- 64 ng/ml (P < 0.001 vs. placebo). At wk 52, decreases in VAT [-35 +/- 50 cm(2) (-17.5 +/- 23.3%)], waist circumference (-3.4 +/- 6.0 cm), triglycerides (-48 +/- 182 mg/dl), cholesterol (-8 +/- 38 mg/dl), and non-high-density lipoprotein (-7 +/- 38 mg/dl) were maintained (all P < 0.001 vs. original baseline) in the T-T group. Treatment with tesamorelin was generally well tolerated. No clinically meaningful differences were observed between groups in glucose parameters at wk 26 and 52.
Conclusions: Treatment with tesamorelin reduces VAT and maintains the reduction for up to 52 wk, preserves abdominal sc adipose tissue, improves body image and lipids, and is overall well tolerated without clinically meaningful changes in glucose parameters.
The Journal of clinical endocrinology and metabolism · 74 citationsread the source →
Long chain omega-3 fatty acids intake, fish consumption and mental disorders in the SUN cohort study.
Background: Very long chain omega-3 fatty acids (w-3 PUFA) intake and fish consumption have been suggested as protective factors against neuropsychiatric disorders but there is scarcity of large cohort studies assessing this association.
Aim of the study: To assess the association between w-3-PUFA intake and fish consumption and mental disorders.
Methods: A prospective cohort study was performed in 7,903 participants. W-3 PUFA intake and fish consumption were ascertained through a validated semi-quantitative food frequency questionnaire. The outcomes after 2 years of follow-up were: (1) Incident mental disorder (depression, anxiety, or stress), (2) incident depression, and (3) incident anxiety. Logistic regression models and generalized additive models were fit to assess the relationship between w-3 PUFA intake or fish consumption and the incidence of these outcomes. Odds ratios (OR) and their 95% confidence intervals (CI) were calculated.
Results: 173 cases of depression, 335 cases of anxiety, and 4 cases of stress were observed during 2-year follow-up. ORs (95% CI) of mental disorder for successive quintiles of energy-adjusted w-3 PUFA intake were 1 (reference), 0.72 (0.52-0.99), 0.79 (0.58-1.08), 0.65 (0.47-0.90), and 1.04 (0.78-1.40). Subjects with a moderate consumption of fish (third and fourth quintiles of consumption: median of each quintile 83.3 and 112 g/day, respectively) had a relative risk reduction higher than 30%.
Conclusions: A potential benefit of w-3 PUFA intake on total mental disorders is suggested, although no linear trend was apparent.
European journal of nutrition · 117 citationsread the source →
Stigmatizing attitudes toward mental illness among racial/ethnic older adults in primary care.
Objective: The current study applies the perceived stigma framework to identify differences in attitudes toward mental health and mental health treatment among various racial/ethnic minority older adults with common mental health problems including depression, anxiety disorders, or at-risk alcohol use. Specifically, this study examines to what extent race/ethnicity is associated with differences in (1) perceived stigma of mental illness and (2) perceived stigma for different mental health treatment options.
Methods: Analyses were conducted using baseline data collected from participants who completed the SAMHSA Mental Health and Alcohol Abuse Stigma Assessment, developed for the PRISM-E (Primary Care Research in Substance Abuse and Mental Health for the Elderly) study, a multisite randomized trial for older adults (65+ years) with depression, anxiety, or at-risk alcohol consumption. The final sample consisted of 1247 non-Latino Whites, 536 African-Americans, 112 Asian-Americans, and 303 Latinos.
Results: African-Americans and Latinos expressed greater comfort in speaking to primary care physicians or mental health professionals concerning mental illness compared with non-Latino Whites. Asian-Americans and Latinos expressed greater shame and embarrassment about having a mental illness than non-Latino Whites. Asian-Americans expressed greater difficulty in seeking or engaging in mental health treatment.
Conclusions: Racial/ethnic differences exist among older adults with mental illness with respect to stigmatizing attitudes toward mental illness and mental health treatment. Results of this study could help researchers and clinicians educate racial/ethnic minority older adults about mental illness and engage them in much needed mental health services.
International journal of geriatric psychiatry · 95 citationsread the source →