Publications by authors named "Daniela Amital"

47 Publications

The risk of depression and anxiety in patients with familial mediterranean fever - a cross-sectional study.

J Affect Disord 2021 09 6;292:695-699. Epub 2021 Jun 6.

Division of Psychiatry, Barzilai Medical Center, Ashkelon, Israel.

Background: Familial Mediterranean Fever (FMF) is an autosomal recessive autoinflammatory disease associated with various systemic comorbidities. Recent research regarding the association with depression and anxiety has yielded conflicting results. The current study aims were to examine whether such an association exists using big data analysis methodology.

Methods: This study was conducted as a cross-sectional analysis based on the Clalit Health Services database. We compared the proportions of depression and anxiety in patients diagnosed with FMF and age- and sex- matched controls. We used the Chi-square test and T-test for univariate analysis. Multivariate logistic regression was then applied to control for possible confounding variables.

Results: The study included 7,670 patients with FMF and 7,670 matched controls. The prevalence of both depression and anxiety was found to be higher in the FMF group as compared to controls (6.22% and 4.58%, respectively, p<0.001, and 4.93% and 3.14%, respectively, p<0.001). These proportions remained significant after adjusting for important confounders, such as smoking and socioeconomic status.

Limitations: Temporal association does not indicate a causal relationship, the validity of the diagnoses relies on clinical records and is not based on formal classifications or diagnostic criteria, information regarding disease duration and other parameters were not accessible.

Conclusions: Our data imply that FMF is independently associated with both depression and anxiety. These findings highlight the importance of raising awareness for these comorbidities.
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http://dx.doi.org/10.1016/j.jad.2021.05.113DOI Listing
September 2021

Fibromyalgia and Its Consequent Disability.

Isr Med Assoc J 2020 Jul;22(7):446-450

Department of Medicine B and Center of Autoimmune Diseases, Sheba Medical Center, Tel Hashomer, Israel.

Background: Fibromyalgia is a common pain syndrome treated by physicians of many disciplines and presents with many co-morbidities. We reviewed the complexities in assessing disabilities in fibromyalgia patients and the complex interrelationships between patients, their working places, and the medical community regarding preserving productivity. Flexibility is essential to keep the patients functional and productive. Job loss is costly to both society and patients and joint measures are needed to prevent unemployment.
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July 2020

The impact of tocilizumab on anxiety and depression in patients with rheumatoid arthritis.

Eur J Clin Invest 2020 Sep 19;50(9):e13268. Epub 2020 Jun 19.

Department of Medicine 'B', Sheba Medical Center, Tel-Hashomer, Israel.

Background: Mood disorders, such as anxiety and depression, are extremely prevalent among patients with rheumatoid arthritis (RA). In this study, we assessed the impact of treatment with tocilizumab (TCZ), an IL-6 antagonist, upon anxiety and depressive symptoms in a cohort of RA patients.

Materials And Methods: Study participants were adults diagnosed with RA who received a weekly subcutaneous injection of tocilizumab for 24 weeks. We used the Hamilton Depression (HDRS) and Anxiety (HAMA) scores in order to assess the severity of depression and anxiety, respectively. RA disease activity indices and depression and anxiety levels were assessed at baseline, 4 weeks and study completion.

Results: Ultimately, 91 patients were included in the study. The mean age was 54 years, and the majority were female (79%). The mean score in all disease activity indices as well as depression and anxiety levels decreased dramatically from baseline to study completion. Sixty patients (66%) demonstrated a significant decrease in anxiety and/or depression levels. When logistic regression was performed, an HDRS score indicative of depression at study baseline demonstrated an independent association with a significant psychiatric response whilst older age and increased baseline weight were negatively associated. HAMA and HDRA scores correlated with the following RA disease activity parameters, respectively; HAQ-DI (r = .4, .42), DAS28 (r = .29, .32) and CDAI (0.28 and 0.33), all of them were statistically significant (P < .01).

Conclusions: This study has demonstrated a favourable impact of TCZ therapy on parameters reflecting depression and anxiety severity in patients with RA.
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http://dx.doi.org/10.1111/eci.13268DOI Listing
September 2020

The Powers of Flowers: Evaluating the Impact of Floral Therapy on Pain and Psychiatric Symptoms in Fibromyalgia.

Isr Med Assoc J 2019 Jul;21(7):449-453

Department of Medicine 'B', Sheba Medical Center, Tel Hashomer, Israel.

Background: Fibromyalgia is a syndrome of unknown etiology that is characterized by widespread pain, which severely impairs quality of life. Several forms of occupational and alternative therapy have demonstrated beneficial effects in fibromyalgia patients.

Objectives: To assess the effects of participation in a floral design course on physical and psychiatric symptoms in a cohort of fibromyalgia patients.

Methods: This study was conducted as an observational study. Women diagnosed with fibromyalgia over the age of 18 were recruited to participate in one of two 12-week flower design (floristry) courses. Demographic details, disease activity indices, and anxiety and depression scores were calculated for all participants at baseline, week 12, and study completion. Physical and mental health of the two groups were compared throughout the study time-points.

Results: The study was completed by 61 female fibromyalgia patients who were included in the final analyses; 31 patients participated in the first floristry course and 30 in the second. Significant improvements in the 36-Item Short Form Survey physical and mental health components, visual analog scale, Fibromyalgia Impact Questionnaire, Hamilton Anxiety Rating Scale, and Hamilton Depression Rating Scale scores for the entire study population and for each group separately could be seen following participation in each floristry course.

Conclusions: Participation in a floristry course may lead to a significant improvement in pain and psychiatric symptoms in fibromyalgia patients. These findings highlight the potential benefit of utilizing occupational therapy programs, such as a floristry course, for improving quality of life in fibromyalgia.
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July 2019

[ASSOCIATION OF OBESITY, SMOKING AND SOCIOECONOMIC STRATA WITH THE FIBROMYALGIA SYNDROME].

Harefuah 2019 Sep;158(9):583-586

Department of Medicine 'B' and the Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel Hashomer, Israel.

Aims: This study aimed to examine a possible association between BMI levels, smoking and socio-economic status and the existence of fibromyalgia.

Background: Obesity is a worldwide epidemic with devastating impacts on the public's health. There are several indications that obesity might also be involved in the pathogenesis of chronic pain syndromes such as fibromyalgia.

Methods: Patients who were diagnosed with fibromyalgia were compared to population-based controls, matched in age and gender (by a ratio of 1:5). Body mass indices, smoking status and socioeconomic strata were retrieved from computerized medical records of the Clalit Health Services database. Body mass index was classified in WHO categories of underweight, normal, overweight and obese (<18.5, 18.5-<25, 25.0-<30, ≥30.0 kg/m2); χ2, t-tests, and logistic regression models were used to compare the study groups and assess the association between obesity and fibromyalgia.

Results: The study included 14,296 patients with fibromyalgia and 71,324 controls. Among patients with fibromyalgia the average BMI (body mass index) was higher than that of the controls 29.1± 6.2 vs. 28.0± 6.01, p<0.001) with every increment of 1 unit of the BMI score, there was an increment of 2.7% of the odds of having coexistent fibromyalgia. The chances of having fibromyalgia was 56% higher among subjects with obesity compared to individuals of normal weight. The data revealed that patients with fibromyalgia smoke more and belong to lower socioeconomic levels.

Conclusions: Our findings demonstrate that obesity is significantly associated with a higher proportion of fibromyalgia. This finding underlines the role that obesity plays in inflammation and chronic pain.
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September 2019

Epilepsy is not statistically associated with systemic sclerosis but significantly impacts on mortality: A real-world epidemiological survey-based study.

Best Pract Res Clin Rheumatol 2018 10 7;32(5):710-717. Epub 2019 Mar 7.

Department of Medicine 'B' and Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Sackler Faculty of Medicine, Tel Aviv University, Israel. Electronic address:

Little is known about the relationship between epilepsy and SSc. Our study included 2431 SSc patients and 12,710 age- and sex-matched controls. In 209 controls (1.6%) and 66 SSc patients (2.7%), epilepsy diagnosis was made (not significant). In the multivariate logistic regression analysis, higher age (OR 1.01 [95% CI 1.00-1.02], p = 0.0207) was associated with an increased risk of epilepsy, whereas high vs low socioeconomic status (SES) (OR = 0.62 [95% CI 0.42-0.92], p = 0.0189) was associated with a low risk of epilepsy. In the Cox multivariate survival analysis, higher age (HR = 1.06 [95% CI 1.06-1.07], p < 0.0001), epilepsy (HR = 2.28 [95% CI 1.77-2.94], p < 0.0001) and SSc (HR = 2.37 [95% CI 2.07-2.71], p < 0.0001) were independent risk factors for all-cause mortality. In contrast, BMI >30 kg/mvs BMI <20 kg/m (HR = 0.69 [95% CI 0.59-0.81, p < 0.0001]), female gender (HR = 0.73 [95% CI 0.65-0.83], p < 0.0001) and high SES (HR = 0.72 [95% CI 0.63-0.82], p < 0.0001) were protective factors for mortality. SSc-related autoantibodies were not associated with the risk of epilepsy. In conclusion, whilst epilepsy and SSc are not significantly associated, epilepsy is a predictor of mortality in SSc patients.
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http://dx.doi.org/10.1016/j.berh.2019.02.013DOI Listing
October 2018

Time to diagnosis of fibromyalgia and factors associated with delayed diagnosis in primary care.

Best Pract Res Clin Rheumatol 2018 08 4;32(4):489-499. Epub 2019 Mar 4.

Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; MK and Maccabi Research & Innovation Institute, Maccabi Healthcare Services, Tel Aviv, Israel.

Fibromyalgia is a complex disorder, and its diagnosis often comprises a challenge for physicians. We aimed to assess the time from the appearance of early symptoms to the definite diagnosis of fibromyalgia and to delineate patient and physician factors associated with this delay. The database of a large healthcare services provider was searched for all fibromyalgia patients (age 21 years or more) diagnosed during 2008-2011. Patients with a diagnosis confirmed by a physician with a relevant specialization were compared with age- and sex-matched nonfibromyalgia controls to retrospectively identify an initial complaint pattern characteristic of fibromyalgia. The time from initial complaints to fibromyalgia diagnosis, as well as the fraction of time while the patient was treated continuously by the same primary physician as at time of diagnosis, was assessed among all eligible fibromyalgia patients. An initial complaint pattern was identified in 67.9% of 2,055 patients with confirmed fibromyalgia vs. 27.6% of 9,172 controls. Among 2,369 (69.0%) of all 3,434 eligible patients with fibromyalgia, mean (SD) total time to diagnosis was 6.42 (3.57) years and mean (SD) time while treated by the same primary physician as at diagnosis was 3.75 (3.26) years. Comorbidity, younger patient, and older physician age were associated with longer time to diagnosis. By analysis of "real-world" data, fibromyalgia remains a complex and elusive diagnosis, taking years to be properly diagnosed. There is a need to increase the awareness of this syndrome among physicians, especially of older age.
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http://dx.doi.org/10.1016/j.berh.2019.01.019DOI Listing
August 2018

Cross-sectional analysis of the associations between fibromyalgia and diabetes mellitus.

Reumatologia 2018 31;56(5):275-278. Epub 2018 Oct 31.

Tel Aviv University, Sackler School of Medicine, Tel Aviv, Israel.

Background: The fibromyalgia syndrome (FMS) is a chronic condition consisting of widespread musculoskeletal pain and tenderness together with mood and cognitive dysfunction. Diabetes mellitus (DM) is a common condition causing significant and detrimental morbidity and mortality. Data on the association between the two conditions is scarce and mainly based on small populations therefore lack solid evidence.

Objectives: To evaluate the association of FMS with DM.

Material And Methods: This cross-sectional study used the Clalit Health Services database, the largest Health Maintenance Organization in Israel, serving 4,400,000 members. FMS patients were compared to age- and sex-matched controls regarding chronic comorbid conditions. χ and student's t-tests were used for univariate analysis.

Results: The study included 14,296 FMS patients and 71,324 age- and sex-matched controls. The FMS group had a significantly higher proportion of DM patients compared to non-FMS controls (19.8% and 17.4 respectively; OR 1.17 , 95% CI: 1.12-1.23, < 0.001).

Conclusions: DM was found to be more common amongst FMS patients compared to matched controls to suggest that the pathophysiology of DM might lead a patient to develop FMS. Consequently, physicians treating DM patients should be aware of the possible risk and asses for clinical signs of FMS in order to diagnose and treat it in time to better their patients' quality of life and disease management.
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http://dx.doi.org/10.5114/reum.2018.79496DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6263302PMC
October 2018

The burden of depression in systemic sclerosis patients: a nationwide population-based study.

J Affect Disord 2019 01 21;243:427-431. Epub 2018 Sep 21.

Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel; Ness-Ziona, Mental Health Center, Beer-Yaakov, Israel.

Background: Systemic sclerosis (SSc) can clinically present with psychological symptoms, including pain, depression, and distress about disfigurement, physical and social functioning. The existing small studies have reported a prevalence of depression ranging from 36% to 65% among SSc patients, likely reflecting the disease impact on the patient's self-image and function.

Aim Of The Study: To investigate the association between SSc and depression using big data analysis methods.

Methods: We designed a nation-wide epidemiological survey relying on a large database of 2500 SSc patients and explored the relationship between SSc and depression, but also the impact of depression on the survival of SSc patients. Chi-squared and t-tests were used for univariate analysis and a logistic regression model was used for multivariate analysis.

Results: The proportion rate of depression among SSc patients was significantly higher than controls (16.2% vs 10.9%), and this proportion was even higher in female SSc patients and of low socioeconomic status. At the multivariate logistic regression, SSc was found to be an independent risk factor for depression with an OR of 1.55 (95%CI 1.29-1.88, p < 0.0001). No significant association was found between SSc-specific autoantibodies (anti-centromere, anti-Scl-70, anti-RNA polymerase III and anti-RNP) status and the risk of depression. Depression was not found to have a significant impact on the survival of SSc patients with an HR of 1.06 (0.80-1.42).

Conclusions: This study provides further support for the high prevalence of depression in SSc patients and therefore, SSc patients may benefit from a screening approach and a broad supportive care program.
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http://dx.doi.org/10.1016/j.jad.2018.09.075DOI Listing
January 2019

The relationship between serum cytokine levels and degree of psychosis in patients with schizophrenia.

Psychiatry Res 2018 10 31;268:467-472. Epub 2018 Jul 31.

Beer-Yaacov- Ness Ziona, Mental Health Center, Israel.

Several observations indicate that cytokine concentrations might also relate to the severity of the psychosis. In this study we assessed whether inflammatory and anti-inflammatory cytokine concentrations are associated with the degree of the psychotic manifestations. A group of 41 patients with schizophrenia suffering from an acute psychosis leading to hospitalization in a psychiatric ward were assessed for the intensity of their psychotic manifestations by the PANSS score. Serum IL-2R, IL-6, IL-8, IL-10 were analyzed by commercial ELISA kits. These patients were compared to controls without schizophrenia. At the univariate analysis, statistically significant elevated levels of the cytokines IL-6, IL-2R and IL-8 were detected in the sera of the patients with schizophrenia compared to controls. At the multivariate analysis, statistically significance held only for IL-2R concentration. Furthermore, positive correlation was found between symptom severity as measured by the PANSS and IL-6 levels as well as IL-2R levels. In Conclusion, our data indicate that elevated serum concentrations of IL-6, IL-8 and IL-2R are associated with severe clinical symptoms measured by the total, general, negative and positive scores of the PANSS scale.
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http://dx.doi.org/10.1016/j.psychres.2018.07.041DOI Listing
October 2018

Searching the Internet for psychiatric disorders among Arab and Jewish Israelis: insights from a comprehensive infodemiological survey.

PeerJ 2018 14;6:e4507. Epub 2018 Mar 14.

Zabludowicz Center for Autoimmune Diseases, Department of Medicine B, Sheba Medical Center, and Sackler Faculty of Medicine, Tel Aviv University, Ramat Gan, Israel.

Israel represents a complex and pluralistic society comprising two major ethno-national groups, Israeli Jews and Israeli Arabs, which differ in terms of religious and cultural values as well as social constructs. According to the so-called "diversification hypothesis", within the framework of e-health and in the era of new information and communication technologies, seeking online health information could be a channel to increase health literacy, especially among disadvantaged groups. However, little is known concerning digital seeking behavior and, in particular, digital mental health literacy. This study was conducted in order to fill in this gap. Concerning raw figures, unadjusted for confounding variables (time, population size, Internet penetration index, disease rate), "depression" searched in Hebrew was characterized by 1.5 times higher search volumes, slightly declining throughout time, whereas relative search volumes (RSVs) related to "depression" searched in Arabic tended to increase over the years. Similar patterns could be detected for "phobia" (in Hebrew 1.4-fold higher than in Arabic) and for "anxiety" (with the searches performed in Hebrew 2.3 times higher than in Arabic). "Suicide" in Hebrew was searched 2.0-fold more than in Arabic (interestingly for both languages search volumes exhibited seasonal cyclic patterns). Eating disorders were searched more in Hebrew: 8.0-times more for "bulimia", whilst "anorexia" was searched in Hebrew only. When adjusting for confounding variables, association between digital seeking behavior and ethnicity remained statistically significant (-value < 0.0001) for all psychiatric disorders considered in the current investigation, except for "bulimia" ( = 0.989). More in details, Israeli Arabs searched for mental health disorders less than Jews, apart from "depression". Arab and Jewish Israelis, besides differing in terms of language, religion, social and cultural values, have different patterns of usage of healthcare services and provisions, as well as e-healthcare services concerning mental health. Policy- and decision-makers should be aware of this and make their best efforts to promote digital health literacy among the Arab population in Israel.
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http://dx.doi.org/10.7717/peerj.4507DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5857171PMC
March 2018

A systematic review of precipitating physical and psychological traumatic events in the development of fibromyalgia.

Semin Arthritis Rheum 2018 08 10;48(1):121-133. Epub 2018 Jan 10.

Department of Medicine 'B', Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer 5262100, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Israel. Electronic address:

The role of physical and psychological trauma precipitating fibromyalgia is often encountered by physicians, yet a proper systematical review of this association is lacking. Literature searches identified 51 studies which examined the association of fibromyalgia with a preceding traumatic event of physical or emotional nature. The overall quality of evidence of studies included, as assessed by the GRADE criteria, was low, however the majority of studies described a significant association between prior physically traumatic events and the onset of chronic widespread pain or fibromyalgia. Elevated rates of psychological trauma in fibromyalgia patients were demonstrated across the literature and several studies indicate a mediating effect of post-traumatic stress disorder. Potential biological mechanisms for conversion of traumatic events into a chronic pain syndrome, such as fibromyalgia, are discussed.
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http://dx.doi.org/10.1016/j.semarthrit.2017.12.011DOI Listing
August 2018

[NEUROPSYCHIATRIC MANIFESTATIONS OF SYSTEMIC LUPUS ERYTHEMATOSUS].

Harefuah 2017 Dec;156(12):779-782

Department of Medicine 'B', Sheba Medical Center, Tel-Hashomer, Israel.

Introduction: This review deals with the neuropsychiatric disorders resulting from systemic lupus erythematosus (SLE). SLE is a chronic autoimmune disease that impacts all systems in the human body, including the central nervous system. Neuropsychiatric symptoms in SLE are a common complication of the disease. This complication has significant implications for the severity of the illness. In most cases no thorough psychiatric assessment is performed during initial evaluation of the disease and no protocol or clear guidelines for treating the psychiatric symptoms in SLE are available. Early diagnosis of the psychiatric symptoms in SLE is critical since absence of treatment may result in severe psychiatric complications. Clinical pharmacological studies are needed in order to develop guidelines for treating psychiatric symptoms in SLE.
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December 2017

[SERUM CYTOKINE CONCENTRATIONS ASSOCIATION WITH THE SEVERITY OF SYMPTOMS IN MAJOR DEPRESSION].

Harefuah 2017 Dec;156(12):753-756

Beer Yaacov-Ness Ziona Mental Health Center.

Background: Mounting data are indicating that major depression is related to diverse functions of the immune system. Several observations indicate that cytokine concentrations might also relate to the intensity of depressive manifestations. In this study we assessed whether inflammatory and anti-inflammatory cytokine concentrations are associated with the intensity of the depressive features in a cohort of patients with major depression and in healthy normal controls.

Methods: A group of 25 patients with major depression all suffering from an acute deterioration of their mental status and all hospitalized in a psychiatric ward were assessed for the intensity of their depressive manifestations according to the Hamilton rating scale for depression and by the clinical global impression scale (CGI). In parallel, concentrations of serum IL-2R, IL-6, IL-8, IL-10 were analyzed by commercial ELISA kits. As comparators, a group of 25 healthy controls was analyzed.

Results: The levels of IL-6 were higher among patients with depression. A high degree of correlation was found between the scores measured by the Hamilton and CGI scales by which the intensity of depressive symptoms were ranked. Interestingly, within the group of patients with depression a negative correlation was detected between the IL-6 concentrations and the CGI scores while a positive correlation was found between the IL-10 concentration and IL-6 concentration.

Conclusions: Our data indicate that the patients with depression differ from healthy individuals by their cytokine profile. Within this group of patients depressive features have a specific pattern and linkage to inflammatory and anti-inflammatory scores.
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December 2017

Stroke among Rheumatoid Arthritis Patients: Does Age Matter? A Real-Life Study.

Neuroepidemiology 2017 14;49(3-4):99-105. Epub 2017 Nov 14.

Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.

Background/aims: Rheumatoid arthritis (RA) is a chronic, debilitating autoimmune disease that affects the joints and it is known to be associated with cardiovascular morbidity. However, the association between RA and stroke among different age groups has not been explored. The objective of our study was to evaluate the association between RA and stroke in different age strata.

Methods: Cross-sectional study, utilizing the database of Israel's largest healthcare provider. The proportion of stroke was compared between patients diagnosed with RA and age- and gender-matched controls. The study sample was divided into 2 age groups: young (≤65 years) and elderly (>65 years). Multivariable analysis was performed using logistic regression.

Results: The study included 11,782 RA patients and 57,973 age- and gender-matched controls. RA patients, primarily young, had more cardiovascular risk factors than controls. Stroke rates were significantly elevated among young RA patients in comparison with controls (3.74 vs. 2.20%, respectively, p < 0.001). In multivariate analysis, RA was found to be independently associated with stroke (OR 1.18, 95% CI 1.09-1.28).

Conclusion: RA is independently associated with stroke, especially among RA patients under 65 years, for whom cardiovascular risk factors were more prominent. Physicians should advise RA patients to manage their risk factors strictly.
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http://dx.doi.org/10.1159/000481992DOI Listing
July 2019

High proportions of dementia among SLE patients: A big data analysis.

Int J Geriatr Psychiatry 2018 03 8;33(3):531-536. Epub 2017 Nov 8.

Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Objective: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease affecting a wide range of systems including the peripheral and central nervous system. Cognitive impairment leading to dementia is one of the harmful central nervous system afflictions of SLE. The aim of this study was to investigate the association of SLE with dementia.

Methods: A cross-sectional study was conducted using Clalit Health Care database, the largest health maintenance organization in Israel with more than 4.4 million enrollees. Systemic lupus erythematosus patients were compared in a 1:5 ratio to age- and sex-matched controls. Chi-square and t tests were used for univariate analysis, and a logistic regression model was used for multivariate analysis.

Results: The study included 4886 SLE patients and 24 430 age-frequency- and sex-frequency-matched controls without SLE. The proportion of dementia was higher among SLE patients compared to controls (1.56% and 0.51%, respectively; P < .001). This finding was consistent across all age groups by univariate analysis. In a multivariate logistic regression analysis, SLE was significantly associated with dementia (odds ratio = 1.51, 95% confidence interval, 1.11-2.04).

Conclusion: Systemic lupus erythematosus is significantly associated with dementia. This finding should give rise to search for SLE in patients with an ambiguous cause for dementia, especially those with an early onset cognitive decline.
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http://dx.doi.org/10.1002/gps.4819DOI Listing
March 2018

Adherence and Persistence with Drug Therapy among Fibromyalgia Patients: Data from a Large Health Maintenance Organization.

J Rheumatol 2017 Oct 1;44(10):1499-1506. Epub 2017 Aug 1.

From the Department of Gastroenterology, Sheba Medical Center; Department of Medicine B, Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center; Sackler Faculty of Medicine, Tel Aviv University; Maccabitech, Maccabi Healthcare Services; Department of Medicine E, Tel Aviv Sourasky Medical Center, Tel Aviv; Beer-Yaakov/Ness-Ziona, Mental Health Center, Beer-Yaakov, Israel.

Objective: To assess 1-year persistence and adherence rates with drug therapy among patients with fibromyalgia (FM) and to identify factors associated with therapy discontinuation.

Methods: This retrospective, cohort study included members ≥ 21 years old from the Maccabi Healthcare Services, a large health maintenance organization in Israel, who were diagnosed with FM from 2008 through 2011. Medications of interest included the anticonvulsant pregabalin, antidepressants [selective serotonin reuptake inhibitor (SSRI), serotonin/norepinephrine reuptake inhibitor (SNRI)], and tricyclic antidepressants (TCA). Time to treatment discontinuation and proportion of days covered (PDC) with FM-specific therapies during the year from first dispensed were analyzed. PDC < 20% was considered low adherence and PDC ≥ 80% was considered high adherence. Logistic regression models were constructed for multivariable analyses.

Results: Overall, 3932 patients with FM were included; 88.7% were female. Pre-diagnosis use of medication of interest was documented in 41% of the study population. Of the remaining 2312 patients, 56.1% were issued a prescription, 45.0% were dispensed at least 1 medication in the year following diagnosis, and only 28.8% had prescriptions filled twice within the first year from diagnosis. Among newly prescribed patients, 1-year discontinuation was highest for TCA (91.0%) and lowest for SSRI/SNRI antidepressants (73.7%). Over half of the patients (60.5%) had fewer than 20% of the days covered by any medication during the year and only 9.3% were very adherent (PDC ≥ 80%).

Conclusion: This study clearly shows that in an Israeli "real-life" population of patients with FM, persistence and adherence with FM therapy in the year following diagnosis is remarkably low.
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http://dx.doi.org/10.3899/jrheum.170098DOI Listing
October 2017

What do people search online concerning the "elusive" fibromyalgia? Insights from a qualitative and quantitative analysis of Google Trends.

Clin Rheumatol 2017 Aug 1;36(8):1873-1878. Epub 2017 May 1.

Department of Medicine "B", Sheba Medical Center, 52621, Tel HaShomer, Israel.

Fibromyalgia is a chronic disease, characterized by pain, fatigue, and poor sleep quality. Patients and mainly those with chronic diseases tend to search for health-related material online. Google Trends (GT), an online tracking system of Internet hit-search volumes that recently merged with its sister project Google Insights for Search (Google Inc.), was used to explore Internet activity related to fibromyalgia. Digital interest in fibromyalgia and related topics searched worldwide has been reported in the last 13 years. A slight decline in this interest has been observed through the years, remaining stable in the last 5 years. Fibromyalgia web behavior exhibited a regular, cyclic pattern, even though no seasonality could be detected. Similar findings have been reported among rheumatoid arthritis and depression. However, differently from rheumatoid arthritis and depression, the focus of the fibromyalgia-related queries was more concentrated on drug side effects and the "elusive" nature of fibromyalgia: is it a real or imaginary condition? Does it really exist or is it all in your head? A tremendous amount of information on fibromyalgia and related topics exist online. Still many queries have been raised and repeated constantly by fibromyalgia patients in the last 13 years. Therefore, physicians should be aware of the common concerns of people or patients regarding fibromyalgia in order to give a proper answers and education.
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http://dx.doi.org/10.1007/s10067-017-3665-yDOI Listing
August 2017

Anxiety disorder among rheumatoid arthritis patients: Insights from real-life data.

J Affect Disord 2017 Apr 6;213:30-34. Epub 2017 Feb 6.

Sackler Faculty of Medicine, Tel-Aviv University, Israel; Ness Ziona-Beer Yaacov Mental Health Center, Beer-Yaacov, Israel.

Background: Psychiatric disorders occur in a considerable proportion of patients with rheumatoid arthritis (RA), often reflecting the difficulties of these patients in coping with a chronic debilitating disorder.

Aim Of The Study: To evaluate the proportion of anxiety disorder in RA patients using a large database analysis.

Methods: The study was designed as a case-control population-based study using data from the Clalit Health Services (CHS) database. Patients were defined as having RA or anxiety disorder when there was at least one documented diagnosis identified by the International Classification of Diseases-9 (ICD-9) from the medical records. The proportion of anxiety disorder was compared between RA patients and controls. A logistic regression model was used to estimate the association between RA and anxiety disorder in a multivariate analysis adjusted for age, gender and socioeconomic status (SES).

Results: The study included 11,782 patients with RA and 57,973 age- and sex-frequency matched controls. The proportion of anxiety in RA patients was higher than in controls (7.1% vs 6.3%, p=0.001). In multivariate analysis, RA was found to be independently associated with anxiety (OR 1.11 [95%CI 1.03-1.20], p=0.01). Our study has some shortcomings, as its cross-sectional nature does not allow to make inferences about a causal relationship between RA and anxiety.

Conclusion: Our study confirms the higher proportion of anxiety in RA patients, especially young women with low SES. Physicians should be aware of such findings and, therefore, apply proper screening strategies.
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http://dx.doi.org/10.1016/j.jad.2017.02.007DOI Listing
April 2017

Self-Perceived Emotional Distress and Diabetes Risk Among Young Men.

Am J Prev Med 2016 06 22;50(6):737-745. Epub 2016 Jan 22.

The Dr. Pinchas Bornstein Talpiot Medical Leadership Program, Sheba Medical Center, Tel Hashomer, Israel; Department of Endocrinology, Sheba Medical Center, Tel Hashomer, Israel; Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

Introduction: There are mixed data regarding the effect of emotional distress on diabetes risk, especially among young adults. This study assessed the effect of self-perceived emotional distress on diabetes incidence among young men.

Methods: Incident diabetes during a mean follow-up of 6.3 (4.3) years was assessed among 32,586 men (mean age, 31.0 [5.6] years) of the Metabolic, Lifestyle, and Nutrition Assessment in Young Adults cohort with no history of diabetes between 1995 and 2011. Emotional distress was assessed by asking participants as part of a computerized questionnaire: Are you preoccupied by worries or concerns that affect your overall wellbeing? Time-dependent Cox models were applied. Data analysis took place between 2014 and 2015.

Results: There were 723 cases of diabetes during 206,382 person-years. The presence of distress was associated with a 53% higher incidence of diabetes (95% CI=1.08, 2.18, p=0.017) after adjustment for age, BMI, fasting plasma glucose, family history of diabetes, triglyceride and high-density lipoprotein cholesterol levels, education, cognitive performance, white blood cell count, physical activity, and sleep quality. These results persisted when distress, BMI, physical activity, and smoking status were treated as time-dependent variables (hazard ratio=1.66, 95% CI=1.21, 2.17, p=0.002). An adjusted hazard ratio of 2.14 (95% CI=1.04, 4.47, p=0.041) for incident diabetes was observed among participants persistently reporting emotional distress compared with those persistently denying it.

Conclusions: Sustained emotional distress contributes to the development of diabetes among young and apparently healthy men in a time-dependent manner. These findings warrant awareness by primary caregivers when stratifying diabetes risk.
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http://dx.doi.org/10.1016/j.amepre.2015.12.006DOI Listing
June 2016

Bipolar disorder associated with rheumatoid arthritis: A case-control study.

J Affect Disord 2016 Jan 30;189:287-9. Epub 2015 Sep 30.

Sackler Faculty of Medicine, Tel-Aviv University, Israel; Ness Ziona Beer-Yaacov Mental Health Center, Israel.

Background: Rheumatoid arthritis (RA) is a chronic inflammatory disease associated with systemic comorbidities. Recent data suggests that patients with RA have increased prevalence of the bipolar disorder. The current study investigates the association between RA and bipolar disorder.

Methods: A case-control study was conducted as Patients with RA were compared with age- and gender-matched controls regarding the prevalence of bipolar disorder. Pearson χ(2) test was used for univariate analysis and a logistic regression model was used for multivariate analysis. The study was performed utilizing the medical database of Clalit Health Services.

Results: The study included 11,782 patients with RA and 57,973 age- and gender-matched controls. The prevalence of Bipolar disorder in patients with RA was increased compared with the prevalence in controls (0.6% and 0.4% respectively, p=0.036). However, in a multivariate analysis the association between RA and Bipolar disorder was not significant, whereas smoking is positively correlated with Bipolar disorder (p<0.001).

Conclusions: By univariate analysis our data implied that patients with RA have a greater prevalence of bipolar disorder than matched controls. However, our analysis suggests that this association may have been confounded by smoking status. Further research is warranted before making inferences about this association in the level of clinical practice.
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http://dx.doi.org/10.1016/j.jad.2015.09.058DOI Listing
January 2016

Olfactory impairment in patients with the fibromyalgia syndrome and systemic sclerosis.

Immunol Res 2014 Dec;60(2-3):201-7

Sackler Faculty of Medicine, Tel-Aviv University, 52621, Tel Aviv, Israel,

Patients with autoimmune diseases often present with olfactory impairment. The aim of the study was to assess the olfactory functions of female patients with fibromyalgia (FM) compared with patients with systemic sclerosis (SSc) and with healthy female controls. Olfactory functions were assessed in 24 patients with FM, 20 patients with SSc and 21 age-matched healthy controls. The sense of smell was evaluated using the Sniffin' Sticks test including the three stages of smell: threshold, discrimination, and identification (TDI) of the different odors. The severity of fibromyalgia was assessed using the fibromyalgia impact questionnaire (FIQ). The short form 36 (SF-36) questionnaire was also completed in order to seek a relationship between the patients perception of quality of life and the different aspects of the smell sense. Depression was evaluated in both FM and SSc patients utilizing the Beck depression inventory-II (BDI-II) questionnaire. Patients with FM had significantly lower TDI smell scores compared with both SSc patients and healthy controls (p < 0.005, One-Way ANOVA). Hyposmia (defined as TDI scores below 30) were observed in 14 of 24 (42 %) patients with FM compared to 3 of 20 (15 %) patients with SSc and 1 of the healthy controls (4.3 %) (p < 0.02). FM patients had significantly lower thresholds of smell compared to both healthy controls and patients with SSc (p < 0.001), whereas for patients with SSc only the ability to discriminate between odors was impaired (p < 0.006). We could not detect any statistical correlation between smell abilities and clinical manifestation of SSc or the FIQ and SF-36 scores among FM patients. However the correlation between depression, defined by the BDI-II score, and the sense of smell differed between patients with FM and patients with SSc. As only among SSc patients a lower sense of smell correlated with a higher BDI-II score (p = 0.02). Our findings suggest that there is a decrease in the sense of smell both in FM and SSc patients compared with healthy controls. However these impairments differ between patients group and might represent different mechanisms that affect the sense of smell.
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http://dx.doi.org/10.1007/s12026-014-8573-5DOI Listing
December 2014

[Guidelines for the diagnosis and treatment of the fibromyalgia syndrome].

Harefuah 2013 Dec;152(12):742-7, 751, 750

Department of Medicine H, Soroka Medical Center and Faculty of Health Sciences, Ben Gurion University, Beer Sheva, Israel.

Over the past years, considerable progress has been made in understanding the pathogenesis of the fibromyatgia syndrome and the evidence based approach to the diagnosis and management has been significantty extended. The purpose of the current project is to develop practicat and evidence based guidetine recommendations for the Israeli health care system. A panet of physicians with clinical and research experience in the fibromyalgia field was convened under the auspices of the Israeli Rheumatology Association. A systematic review was performed on the current literature regarding the diagnosis and treatment of fibromyalgia. Using an interactive discussion procedure, recommendations were reached and expert opinion was introduced where evidence was considered incomplete. The panel recommendations underline the importance of concomitant and integrated medical therapy, such as serotonin and noradrenaline reuptake inhibitor (SNRI) anti-depressants or gamma-aminobutyric acid (GABA) related anti-epileptics, with regular aerobic physical exercise.
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December 2013

Family history of major depression and residual symptoms in responder and non-responder depressed patients.

Compr Psychiatry 2014 Jan 21;55(1):51-5. Epub 2013 Oct 21.

Institute of Psychiatry, University of Bologna, Viale Carlo Pepoli 5, 40123 Bologna, Italy. Electronic address:

Background: Little is known about the extent to which a family history of major depression (MD) affects residual depressive symptoms in responder and non-responder patients suffering from MD.

Methods: Nine hundred eighty-six patients with MD were recruited within the context of a large multicenter project. Information about the family history of MD, as well as about total depressive symptoms and specific depressive clusters, was collected and analyzed.

Results: No significant difference was observed in overall depressive symptoms between patients with and those without a family history of MD. However, non-responder patients with a family history of MD showed significantly higher scores in core symptoms as compared with responder patients without a family history of MD.

Conclusions: Non-responder MD patients with a positive family history of MD could represent a slightly different sub-group of MD patients with more consistent core depressive symptoms as compared with responder patients without a family history of MD. However, taking into account the retrospective assessment of data, the use of positive or negative family history as a dichotomous indicator of familial loading and the cross-sectional design of the present study, further research is needed to draw more definitive conclusions.
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http://dx.doi.org/10.1016/j.comppsych.2013.08.002DOI Listing
January 2014

Social adjustment among treatment responder patients with mood disorders.

J Affect Disord 2013 Sep 10;150(3):961-6. Epub 2013 Jun 10.

Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.

Background: Patients with major depression (MD) show reduced social adjustment when compared with healthy controls. However, even among treatment responders, significant differences in social adjustment occur. The main aim of the present work is to study several socio-demographic and clinical variables possibly influencing social adjustment in MD patients who responded to treatment.

Methods: Two hundred and eleven MD patients experiencing a depressive episode who responded to their current treatment were recruited within the context of a large European multicentre project. Our primary outcome measure was the association between 19 socio-demographic and clinical variables and total social adjustment scores, as measured with the Social Adjustment Scale (SAS). Secondary outcome measures included the associations between the same variables and SAS sub-scales, and the associations between these variables and self-esteem, as measured with the Rosenberg Self-Esteem Scale.

Results: A co-morbidity with anxiety disorders and the severity of residual depression symptoms were the strongest independent factors associated with poorer social adjustment, in terms of total and most sub-areas' SAS scores. Other variables associated with total and sub-areas' SAS scores were identified as well, although some variations across different areas were observed.

Limitations: The cross-sectional design, the retrospective assessment of data and the lack of a placebo control group.

Conclusions: Our results confirm that a co-morbidity with anxiety disorders and higher residual depression symptoms could reduce social adjustment among responder MD patients. Further longitudinal studies are needed to confirm our results.
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http://dx.doi.org/10.1016/j.jad.2013.05.021DOI Listing
September 2013

Variation in the HTR1A and HTR2A genes and social adjustment in depressed patients.

J Affect Disord 2013 Sep 26;150(2):649-52. Epub 2013 Mar 26.

Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.

Background: Social adjustment is impaired in depressed patients. The difficulty to adjust to social circumstances has been hypothesized to be one of the causes of depression, as well as a consequence of the disorder. Genetic variation in the serotonin transporter gene has been previously associated with social adjustment levels in patients with mood disorders.

Methods: We investigated whether variations on the HTR1A (rs6295) and HTR2A (rs7997012) genes were associated with levels of social adjustment using the Social Adjustment Scale in two samples of depressed patients (total n=156).

Results: Patients carrying the GG genotype of the HTR2A-rs7997012 showed better social adjustment in areas of work and family unit bonding.

Limitations: These findings did not survive correction for multiple testing and should be interpreted with caution.

Conclusion: Our finding is in line with previous observations that have associated the G allele of the HTR2A-rs7997012 with higher rate of antidepressant response. The HTR2A-rs7997012 is worthy of further investigation in studies examining factors that are related to depression course and outcome.
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http://dx.doi.org/10.1016/j.jad.2013.02.036DOI Listing
September 2013

Evaluation of the role of MAPK1 and CREB1 polymorphisms on treatment resistance, response and remission in mood disorder patients.

Prog Neuropsychopharmacol Biol Psychiatry 2013 Jul 26;44:271-8. Epub 2013 Mar 26.

IRCCS Centro S. Giovanni di Dio, Fatebenefratelli, Brescia, Italy.

Treatment resistant depression (TRD) is a significant clinical and public health problem. Among others, neuroplasticity and inflammatory pathways seem to play a crucial role in the pathomechanisms of antidepressant efficacy. The primary aim of this study was to investigate whether a set of single nucleotide polymorphisms (SNPs) within two genes implicated in neuroplasticity and inflammatory processes (the mitogen activated protein kinase 1, MAPK1 (rs3810608, rs6928, rs13515 and rs8136867), and the cyclic AMP responsive element binding protein 1, CREB1 (rs889895, rs6740584, rs2551922 and rs2254137)) was associated with antidepressant treatment resistance (according to two different definitions), in 285 Major Depressive Disorder (MDD) patients. As secondary aims, we investigated the genetic modulation of the same SNPs on response, remission and other clinical features both in MDD patients and in a larger sample including 82 Bipolar Disorder (BD) patients as well. All patients were screened in the context of a European multicenter project. No association between both the investigated genes and treatment resistance and response was found in MDD patients. However, considering remission, higher rates of CREB1 rs889895 GG genotype were reported in MDD patients. Moreover, MAPK1 rs8136867 AG genotype was found to be associated with remission in the whole sample (MDD and BD). Present results suggest that some genetic polymorphisms in both CREB1 and MAPK1 could be associated with treatment remission. Although further research is needed to draw more definitive conclusions, such results are intriguing since suggest a potential role of two genes implicated in neuroplasticity and inflammatory processes in symptom remission after antidepressant treatment.
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http://dx.doi.org/10.1016/j.pnpbp.2013.03.005DOI Listing
July 2013

Retraumatization eliciting the presentation of fibromyalgia.

Isr Med Assoc J 2013 Feb;15(2):123-4

Department of Medicine B, Sheba Medical Center, Tel Hashomer, Israel.

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February 2013

The impact of adverse life events on clinical features and interaction with gene variants in mood disorder patients.

Psychopathology 2013 13;46(6):384-9. Epub 2013 Feb 13.

Department of Biomedical and NeuroMotor Sciences, University of Bologna, Bologna, Italy.

Background: Adverse life events are precipitating and maintenance factors for mood and anxiety disorders. However, the impact of such events on clinical features and treatment response is still unclear.

Sampling And Methods: The aim of this study was to investigate whether specific adverse events (early parental loss and physical abuse) influence clinical features in a sample of 1,336 mood disorder patients, and whether genetic parameters interact with adverse events to influence treatment outcomes in a subsample of 252 subjects. Participants were collected in the context of a European multicenter study and treated with antidepressants at adequate doses for at least 4 weeks. We focused on two genes (BDNF and CREB1) due to prior evidence of association with treatment outcomes in the same sample.

Results: Patients with a history of physical abuse had higher suicidal risk (including history of attempts), comorbid panic disorder, posttraumatic stress disorder and alcohol dependence compared to non-abused patients. Experience of early parental loss was a less detrimental type of life stressor. Treatment response was not affected by adverse events. No gene-environment interaction was found with genetic variations, using a corrected significance level.

Conclusions: A limitation of the present study is that the subsample is too small for detecting gene-environment interactions. The clinical message of our findings is that mood disorder patients with a history of physical abuse showed a worse clinical profile, characterized by higher comorbid Axis I psychopathology and increased suicidal behavior.
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http://dx.doi.org/10.1159/000345358DOI Listing
March 2014
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