Hidradenitis suppurativa and electrocardiographic changes: a cross-sectional population study.

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disease, recently associated with metabolic syndrome, subclinical atherosclerosis and increased risk of cardiovascular disease. OBJECTIVES: To investigate the hitherto unknown electrocardiographic (ECG) changes associated with HS, which have recently been associated with significant cardiovascular burden. METHODS: Data were obtained from the cross-sectional Danish General Population Study (GESUS). HS diagnosis was based on a validated self-reported questionnaire; 404 individuals met the HS diagnosis criteria and 19 001 controls without HS were identified. Severity of HS was staged according to a modified Hurley score. The ECG parameters of heart rate (HR), PR interval, QRS duration, JTc interval and QTc interval were obtained from 12-lead resting ECGs. We investigated the difference in means by unpaired t-test or anova. RESULTS: HR was significantly higher [mean difference 2·3 beats per min (bpm), 95% confidence interval (CI) 1·2-3·4; P < 0·01] when adjusting for age and sex, but when adjusting for multivariates, there was no significant difference (0·3 bpm, 95% CI -0·7 to 1·4; P = 0·52). Severe HS was significantly associated with increased HR across all models (2·9 bpm, 95% CI 0·7-5·1; P = 0·01). Mean QRS duration was significantly shorter in the group with mild HS but not in the groups with moderate and severe HS. CONCLUSIONS: Mean resting HR in patients with severe HS was significantly higher compared with controls. Given that resting HR is associated with increased risk of all-cause and cardiovascular mortality, and that patients with HS have increased risk of cardiovascular events, this finding is potentially important, easily testable and intervenable.

Thyroid function in hidradenitis suppurativa: a population-based cross-sectional study from Denmark.

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic inflammatory disease. Numerous studies have associated HS with obesity, and recently with metabolic syndrome (MetS). Both obesity and MetS are linked with metabolic changes. Thyroid hormones play a central role in metabolism and exert pleiotropic effects on adipogenesis and the basal metabolism of lipids and glucose. We hypothesized that patients with HS have an altered or dysfunctional metabolism expressed as thyroid function. AIM: To investigate thyroid function in individuals with HS compared with healthy controls (HCs). METHODS: We conducted a retrospective comparative cross-sectional study using blood samples and questionnaire-based self-reported information to assess thyroid function. RESULTS: Our study comprised 430 patients in a population-based HS group, and 20 780 HCs. The age/sex-adjusted analysis showed a significantly lower level (P < 0.001) of thyroid-stimulating hormone (TSH) and a significantly higher level (P < 0.0001) of total triiodothyronine (tT3) for the HS compared with the HC group. The age/sex-adjusted analysis also showed a significant association between clinical hyperthyroidism and HS (an OR = 1.91, 95% CI 1.19-3.07; P = 0.02). When this analysis was adjusted further for the potential confounders of body mass index, smoking and oral contraception, the results remained significant. CONCLUSION: This study suggests that HS is associated with hyperthyroidism. Hyperthyroidism may indicate an altered or dysfunctional metabolism.

Moderate to severe hidradenitis suppurativa patients do not have an altered bacterial composition in peripheral blood compared to healthy controls.

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease defined by recurrent nodules, tunnels and scarring involving the intertriginous skin. Patients with HS often report an array of systemic symptoms such as fatigue and malaise. The aetiology of these symptoms remains unclear. Previously, various bacteria have been associated with mature HS lesions, and bacteraemia has been reported in patients with HS using traditional culturing methods. Thus, we hypothesized that a low-grade bacteraemia contributes to the symptomatology in patients with HS. OBJECTIVE: To explore the potential presence of bacteraemia in patients with HS and healthy controls. METHOD: A case-control study. Compositions of bacteria in the blood of 27 moderate to severe HS patients and 26 healthy controls were investigated using next-generation 16S ribosomal RNA gene sequencing (NGS) and routine anaerobic and aerobic blood culturing. None of the participants received any antibiotics (systemic or topical therapy) within 1 month prior to the study. HS patients with a recent flare were randomly selected by consecutive recruitment of eligible patients from the Department of Dermatology, Zealand University Hospital, Denmark. Healthy controls were recruited from the University of Copenhagen as well as from the healthcare staff. RESULTS: The different bacterial compositions were investigated using NGS and traditional anaerobic and aerobic blood culturing. Our NGS analysis provided a previously unreported characterization of the bacterial composition in peripheral blood from patients with HS and healthy controls. Overall, our data demonstrated that patients with HS do not have a different bacterial composition in their peripheral blood than healthy controls. CONCLUSION: The study suggests that the self-reported symptoms in HS such as malaise and fatigue may not be linked to bacteraemia.

Adjunctive yoga v. health education for persistent major depression: a randomized controlled trial.

BACKGROUND: The objective of this study was to determine whether hatha yoga is an efficacious adjunctive intervention for individuals with continued depressive symptoms despite antidepressant treatment. METHOD: We conducted a randomized controlled trial of weekly yoga classes (n = 63) v. health education classes (Healthy Living Workshop; HLW; n = 59) in individuals with elevated depression symptoms and antidepressant medication use. HLW served as an attention-control group. The intervention period was 10 weeks, with follow-up assessments 3 and 6 months afterwards. The primary outcome was depression symptom severity assessed by blind rater at 10 weeks. Secondary outcomes included depression symptoms over the entire intervention and follow-up periods, social and role functioning, general health perceptions, pain, and physical functioning. RESULTS: At 10 weeks, we did not find a statistically significant difference between groups in depression symptoms (b = -0.82, s.e. = 0.88, p = 0.36). However, over the entire intervention and follow-up period, when controlling for baseline, yoga participants showed lower levels of depression than HLW participants (b = -1.38, s.e. = 0.57, p = 0.02). At 6-month follow-up, 51% of yoga participants demonstrated a response (⩾50% reduction in depression symptoms) compared with 31% of HLW participants (odds ratio = 2.31; p = 0.04). Yoga participants showed significantly better social and role functioning and general health perceptions over time. CONCLUSIONS: Although we did not see a difference in depression symptoms at the end of the intervention period, yoga participants showed fewer depression symptoms over the entire follow-up period. Benefits of yoga may accumulate over time.

Bacterial biofilm in chronic lesions of hidradenitis suppurativa.

BACKGROUND: Chronic nonhealing or recurrent inflammatory lesions, reminiscent of infection but recalcitrant to antibiotic therapy, generally characterize biofilm-driven diseases. Chronic lesions of hidradenitis suppurativa (HS) exhibit several characteristics, which are compatible with well-known biofilm infections. OBJECTIVES: To determine and quantify the potential presence of bacterial aggregates in chronic HS lesions. METHODS: In 42 consecutive patients with HS suffering from chronic lesions, biopsies were obtained from lesional as well as from perilesional skin. Samples were investigated using peptide nucleic acid-fluorescence in situ hybridization in combination with confocal laser scanning microscopy. In addition, corresponding histopathological analysis on haematoxylin and eosin slides was performed. RESULTS: Biofilms were seen in 67% of the samples of chronic lesions and in 75% of the perilesional samples. The mean diameter of aggregates in lesional skin was significantly greater than in perilesional skin (P = 0·01). Large biofilms (aggregates > 50 µm in diameter) were found in 42% of lesional samples and in only 5% of the perilesional samples (P = 0·009). The majority of the large biofilms were situated in sinus tracts (63%) or in the infundibulum (37%). The majority of the sinus tract samples (73%) contained active bacterial cells, which were associated with inflammation. CONCLUSIONS: This study suggests that biofilm formation is associated with inflammation of chronic HS lesions. The aggregates most likely occur as a secondary event, possibly due to predisposing local anatomical changes such as sinus tracts (tunnels), keratinous detritus and dilated hair follicles.

Prodromal symptoms in hidradenitis suppurativa.

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disease, which presents as recurrent nodules and sinus tracts (tunnels) with subsequent scarring, predominantly involving the intertriginous regions. Although prodromal symptoms (i.e. various symptoms preceding the eruption of the HS lesions) are often mentioned, there have been no formal investigations into this aspect. Insight into prodromal symptoms may enable patients with HS or dermatologists in choosing a more targeted treatment at a much earlier stage, potentially increasing treatment efficacy and quality of life. AIM: To characterize the spectrum of prodromes in patients with HS. METHODS: An extensive questionnaire that explored the frequency, type and time of occurrence of the prodromal symptom(s) and the degree of certainty of the perceived association was administered to 72 patients. RESULTS: The majority of the 72 patients (83.3%; n = 60) confirmed that they experienced one or more symptom(s) prior to the development of inflamed nodules or abscesses. These included: fatigue (32%), malaise (defined as a fever-like sensation) (23%), headache (11%) and nausea (2%). Localized symptoms included skin erythema (75%), paraesthesia (63%) and itching (20%). the majority of the patients stated that the prodromes usually occurred > 24 h (45%) or 12-24 h (20%) before the eruption. CONCLUSION: Our data suggest that the majority of patients with HS experience prodromal symptoms, heralding a flare of their HS. The findings may give rise to important new treatment approaches for the management of HS.

Meta-analyses of the relationship between conformity to masculine norms and mental health-related outcomes.

Despite theoretical postulations that individuals' conformity to masculine norms is differentially related to mental health-related outcomes depending on a variety of contexts, there has not been any systematic synthesis of the empirical research on this topic. Therefore, the authors of this study conducted meta-analyses of the relationships between conformity to masculine norms (as measured by the Conformity to Masculine Norms Inventory-94 and other versions of this scale) and mental health-related outcomes using 78 samples and 19,453 participants. Conformity to masculine norms was modestly and unfavorably associated with mental health as well as moderately and unfavorably related to psychological help seeking. The authors also identified several moderation effects. Conformity to masculine norms was more strongly correlated with negative social functioning than with psychological indicators of negative mental health. Conformity to the specific masculine norms of self-reliance, power over women, and playboy were unfavorably, robustly, and consistently related to mental health-related outcomes, whereas conformity to the masculine norm of primacy of work was not significantly related to any mental health-related outcome. These findings highlight the need for researchers to disaggregate the generic construct of conformity to masculine norms and to focus instead on specific dimensions of masculine norms and their differential associations with other outcomes. (PsycINFO Database Record

Is hidradenitis suppurativa associated with anaemia?: a population-based and hospital-based cross-sectional study from Denmark.

BACKGROUND: Chronic inflammatory diseases may be associated with anaemia of inflammation. Hidradenitis suppurativa is a chronic inflammatory dermatological disease associated with metabolic comorbidities, low quality of life and fatigue. Anaemia may cause fatigue, and it has been hypothesized that HS-related fatigue may be partly due to anaemia. OBJECTIVE: Our objective was to investigate a possible association between HS and anaemia. METHODS: We performed a hospital-based and population-based cross-sectional study investigating the red blood cell profile, i.e. haemoglobin. RESULTS: We identified a total of 32 hospital HS individuals, 430 population HS individuals and 20,780 population non-HS control individuals. The age-sex-smoking-adjusted analyses showed no differences in the haemoglobin level of the HS groups vs. the control group. Analyses of the anaemic subgroup of HS individuals revealed that 60% had normocytic anaemia and 40% microcytic anaemia, in concordance with anaemia of inflammation. CONCLUSION: In contrast to our hypothesis, this study showed that HS is not associated with anaemia. Thus, anaemia may not be the cause of the described fatigue in HS patients. Furthermore, the results indicate that if an HS patient does suffer from anaemia it is most likely to be normocytic or microcytic and thus compatible with anaemia seen in other chronic inflammatory disorders.

Body composition and basal metabolic rate in Hidradenitis Suppurativa: a Danish population-based and hospital-based cross-sectional study.

BACKGROUND: Several studies have suggested an association between Hidradenitis Suppurativa (HS) and obesity. Obesity is often expressed as Body Mass Index (BMI). However, BMI lacks information on body composition. General obesity is a predictor of health status and cardiovascular risk, but body composition (e.g. abdominal fat) may be more so. Basal metabolic rate (BMR) is an expression of resting metabolism and may serve as a complementary tool when assessing the possibly underlying metabolism behind a persons' body composition. OBJECTIVE: To investigate the body composition and basal metabolic rate in individuals with HS compared with healthy controls. METHODS: We performed a cross-sectional study on both a hospital-based and population-based HS group and compared with controls using Bioelectrical Impedance Analysis to assess body composition. RESULTS: We identified a hospital-based HS group of 32 hospital HS patients, a population-based HS group of 430 population HS patients, and 20 780 controls. Age- and sex-adjusted analyses showed a 10.12% (P < 0.0001) significantly higher fat percentage in the hospital-based HS group and 3.11% (P < 0.0001) significantly higher fat percentage for the population-based HS group compared to controls. Correspondingly, the HS groups had a lower muscle percentage (P < 0.0001) and lower bone mass percentage (P < 0.0001). Furthermore, visceral fat rating (P < 0.0001), Body Mass Index (P < 0.0001), waist circumference (P < 0.0001), and Waist/Hip Ratio (P < 0.0001) was significantly higher in HS patients compared with controls. Additionally, age and sex-adjusted analyses showed a higher predicted estimate of BMR for the HS groups compared with controls (154.56 kcal/day (95% CI 54.96-254.16) (P = 0.0031) for the hospital-based HS group, and 82.63 kcal/day (95%CI 59.70-105.56) (P < 0.0001) for the population-based HS group). CONCLUSION: Hidradenitis Suppurativa is associated with a high fat percentage, high visceral fat, and low muscle percentage adding to the morbidity of HS. The higher predicted estimate of basal metabolic rate (BMR) in HS patients may reflect a dysfunctional metabolism contributing to the high-fat-body composition.

The association of metabolic syndrome and psoriasis: a population- and hospital-based cross-sectional study.

BACKGROUND: Psoriasis (PS) has been suggested to be associated with the metabolic syndrome (MetS) in numerous studies with conflicting results. The vast majority of previous data were based on PS subjects from hospitals, and when based on data from the general population the PS subjects were often identified in insurance health databases. Furthermore, many studies used a single method approach, e.g. self-reported diagnosis. OBJECTIVE: We have therefore investigated a possible association between PS and MetS on PS subjects from the hospital as well as the general population using combined methods, i.e. self-reported diagnosis, physical examinations and blood samples. METHODS: A population- and hospital-based cross-sectional study of the possible association between PS and MetS. RESULTS: Thirty-six hospital PS subjects, 860 population PS subjects and 14,016 non-PS subjects were identified. The odds ratios (ORs) for hospital PS subjects and population PS subjects vs. population non-PS subjects, respectively, were 5.14 (2.47-10.69) and 1.29 (1.09-1.53) for MetS, 4.55 (1.91-10.85) and 1.16 (0.85-1.59) for diabetes, 1.92 (0.87-4.22) and 1.00 (0.86-1.17) for hypertension, 4.34 (1.86-10.10) and 1.15 (1.00-1.34) for hypertriglyceridaemia, 3.88 (1.96-7.69) and 1.19 (1.01-1.42) for hypoHDL, 5.77 (2.89-11.52) and 1.19 (1.00-1.41) for general obesity and 2.92 (1.45-5.88) and 1.34 (1.16-1.55) for abdominal obesity. Obesity acted as a possible confounder. A uniform pattern of higher ORs for hospital PS subjects when compared to population PS subjects was observed. The severity and duration of PS did not seem to affect the results. As this is a cross-sectional study we cannot demonstrate causality. CONCLUSION: The data suggested an association between PS and MetS as well as its individual parameters on a hospital-based level, with the exception of hypertension. On a population-based level the associations were only significant for MetS, hypoHDL and abdominal obesity.

The prevalence of inverse recurrent suppuration: a population-based study of possible hidradenitis suppurativa.

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic inflammatory disease involving inverse recurrent suppuration (IRS). The epidemiology of the disease is not well described, with previous studies reporting prevalence estimates from 0·00033% to 4%. OBJECTIVE: To determine the prevalence of IRS in a large population-based survey. METHODS: Data were obtained from a general cross-sectional population study in Denmark. A validated self-administered questionnaire was used to identify IRS. Persons with the combination of outbreaks of 'boils' during the last 6 months in predefined areas and a minimum of two boils were identified. RESULTS: A total of 16 404 adults aged 30-89 years provided data and the overall prevalence of IRS was found to be 2·10% [95% confidence interval (CI) 1·88-2·32]; in men it was 1·58% (95% CI 1·29-1·86) and in women 2·56% (95% CI 2·21-2·86). No data for adults aged 20-29 years were included. The prevalence declined with age. The majority of cases (72·9%) had a body mass index of ≥ 25 kg m(-2) and 77·7% were current or ex-smokers. The mean number of inflamed lesions was 6·5 (range 2-67) during the last 6 months. The lesions affected mostly the genitalia (43·4%) and groin (39·8%) for women and 'other places' (not specified) (78·8%) for men. CONCLUSIONS: Data on IRS suggest that HS may be more prevalent than previously suggested, and the prevalence may be comparable to other major dermatoses, e.g. psoriasis. However, as no physician examination was done, the risk of recall and information bias is a major limitation.

The added value of proteomics for toxicological studies.

Proteomics has the potential to elucidate complex patterns of toxic action attributed to its unique holistic a posteriori approach. In the case of toxic compounds for which the mechanism of action is not completely understood, a proteomic approach may provide valuable mechanistic insight. This review provides an overview of currently available proteomic techniques, including examples of their application in toxicological in vivo and in vitro studies. Future perspectives for a wider application of state-of-the-art proteomic techniques in the field of toxicology are discussed. The examples concern experiments with dioxins, polychlorinated biphenyls, and polybrominated diphenyl ethers as model compounds, as they exhibit a plethora of sublethal effects, of which some mechanisms were revealed via successful proteomic studies. Generally, this review shows the added value of including proteomics in a modern tool box for toxicological studies.

Chronic stressors and trauma: prospective influences on the course of bipolar disorder.

BACKGROUND: Exposure to life stress is known to adversely impact the course of bipolar disorder. Few studies have disentangled the effects of multiple types of stressors on the longitudinal course of bipolar I disorder. This study examines whether severity of chronic stressors and exposure to trauma are prospectively associated with course of illness among bipolar patients. METHOD: One hundred and thirty-one participants diagnosed with bipolar I disorder were recruited through treatment centers, support groups and community advertisements. Severity of chronic stressors and exposure to trauma were assessed at study entry with in-person interviews using the Bedford College Life Event and Difficulty Schedule (LEDS). Course of illness was assessed by monthly interviews conducted over the course of 24 months (over 3000 assessments). RESULTS: Trauma exposure was related to more severe interpersonal chronic stressors. Multiple regression models provided evidence that severity of overall chronic stressors predicted depressive but not manic symptoms, accounting for 7.5% of explained variance. CONCLUSIONS: Overall chronic stressors seem to be an important determinant of depressive symptoms within bipolar disorder, highlighting the importance of studying multiple forms of life stress.

Quantifying cardiovascular disease risk factors in patients with psoriasis: a meta-analysis.

BACKGROUND: In a previous meta-analysis on categorical data we found an association between psoriasis and cardiovascular disease and associated risk factors. OBJECTIVES: To quantify the level of cardiovascular disease risk factors in order to provide additional data for the clinical management of the increased risk. METHODS: This was a meta-analysis of observational studies with continuous outcome using random-effects statistics. A systematic search of studies published before 25 October 2012 was conducted using the databases Medline, EMBASE, International Pharmaceutical Abstracts, PASCAL and BIOSIS. RESULTS: We included 59 studies with up to 18 666 cases and 50 724 controls. Psoriasis cases had a higher total cholesterol [weighted mean difference 8·83 mg dL(-1) , 95% confidence interval (CI) 2·94-14·72, P = 0·003 (= 0·23 mmol L(-1) )], higher low-density lipoprotein cholesterol [9·90 mg dL(-1) , 95% CI 1·56-18·20, P = 0·020 (= 0·25 mmol L(-1) )], higher triglyceride [16·32 mg dL(-1) , 95% CI 12·02-20·63, P < 0·001 (= 0·18 mmol L(-1) )], a higher systolic blood pressure (4·77 mmHg, 95% CI 1·62-7·92, P = 0·003), a higher diastolic blood pressure (2·99 mmHg, 95% CI 0·60-5·38, P = 0·014), higher body mass idex (0·73 kg m(-2) , 95% CI 0·37-1·09, P < 0·001), higher waist circumference (3·61 cm, 95% CI 2·12-5·10, P < 0·001), higher fasting glucose [3·52 mg dL(-1) , 95% CI 0·64-6·41, P = 0·017 (= 0·20 mmol L(-1) )], higher nonfasting glucose [11·70 mg dL(-1) , 95% CI 11·24-12·15, P < 0·001 (= 0·65 mmol L(-1) )] and a higher HbA1c [1·09 mmol mol(-1) , 95% CI 0·87-1·31, P < 0·001 (= 2·2%)]. CONCLUSIONS: From a preventive medicine perspective, the weighted mean differences between cases and controls are significant, and therefore relevant to the clinical management of patients with psoriasis.

Is there an increase in the incidence of uterine carcinosarcoma in north-east Scotland? A 19 years population-based cohort study.

BACKGROUND AND AIMS: The incidence of uterine carcinosarcoma and factors associated with its survival are little known and this study helps to address this question for women residing in north-east Scotland. METHODS AND RESULTS: Data were collected from women diagnosed with carcinosarcoma of the uterus residing in north-east of Scotland from 1991 to 2009. Kaplan-Meier plots and Cox regression analysis were used for analysis. A total of 43 women were analysed during this period. The median survival was 25 months. The estimated five-year survival for stage I/II disease was 52.5% (95% CI: 30.5-74.5%). The 2-year survival rate for stage III/IV disease was 46% (95% CI: 16-75%). There was an increase in the incidence during this period. Improved survival was seen in early-stage disease (FIGO stages I and II) and in the absence of lymphovascular space invasion (LVSI; p = 0.015). A total of 26% of the women had a history of tamoxifen usage with no effect seen on survival. Multivariate analysis showed that when treatment modality and LVSI were adjusted for FIGO staging, there was no statistical significance in the survival outcomes. CONCLUSION: The incidence of uterine carcinosarcomas is increasing parallel with endometrial carcinomas with no significant effect of tamoxifen on survival.

The biological correlates of macroscopic breast tumour structure measured using fractal analysis in patients undergoing neoadjuvant chemotherapy.

Breast cancers are evolving, multi-scale systems that are characterized by varied complex spatial structures. In this study, we measured the structural characteristics of 33 breast tumours in patients who were to receive neoadjuvant chemotherapy using dynamic contrast enhanced MRI and fractal geometry. The results showed a significant association between fractal measurements and tumour characteristics. The fractal dimension was associated with receptor status (ER and PR) and the fractal fit was associated with response to chemotherapy, measured using a validated pathological response scale, tumour grade and size. This study describes structure measures that may be a consequence of known prognostic factors during the initial and/or maturation phase of tumour growth. These results suggest that measuring tumour structure in this way can predict an individual's response to neoadjuvant therapy and may identify those who will benefit least from neoadjuvant chemotherapy, allowing alternative treatment options to be selected in those patients.

Mental Health Disclosure Questions on Medical Licensure Applications: Implications for Medical Students, Residents, and Physicians.

Medical trainees and physicians experience high rates of depression, anxiety, suicidal ideation, and burnout. The stigma surrounding mental health may deter help-seeking behaviors and increase informal treatment to maintain anonymity. Invasive health history questions on state medical licensure applications regarding mental health diagnoses and treatment likely increase stigma, reduce help-seeking, and consequently may motivate some applicants to report an inaccurate history to the state medical board. Research on physician mental health, suicide rates, and lack of help-seeking have led to recommendations for changes to licensure questions. In this article, the authors review the language of health history questions, disclosure requirements for applicants, and the potential consequences of disclosing mental health or substance abuse history on state medical licensure applications. They review recent changes to some states' health history questions, using the changes to Florida's licensure application in 2021 as an example, and explore the implications of these changes for reducing stigma and encouraging help-seeking. The authors recommend that state medical boards review and refine licensure applications' health history questions regarding mental health disclosure in ways that strategically address concerns related to stigma, bias, and unwarranted scrutiny. They call for research to examine the impact of such question changes on applicant response accuracy, help-seeking behaviors, and mental health outcomes and stigma. They also recommend that medical schools offer and promote access to mental health services, encourage faculty to normalize help-seeking behaviors, and provide students with information about state licensure processes. Reducing stigma, normalizing trainee and physician experiences, and promoting help-seeking are preliminary steps to promote a culture in academic medicine that prioritizes mental health. In turn, this will encourage trainees and physicians to care for themselves and cultivate physicians who are better equipped to heal and support their patients.

A double-blind placebo-controlled randomized trial of adalimumab in the treatment of hidradenitis suppurativa.

BACKGROUND: Hidradenitis suppurativa (HS) has an impact on patients' quality of life. Treatment of HS is generally unsatisfactory, thus new treatments are needed. OBJECTIVES: To test the efficacy of adalimumab in HS. METHODS: This was a prospective, randomized, double-blinded, placebo-controlled, two-centre clinical trial conducted in Denmark. Inclusion criteria were age above 18 years and a clinical diagnosis of moderate to severe HS defined as Hurley stage II or III for at least 6 months. The patients were randomized 1:2 (placebo/active). Actively treated patients received adalimumab 80 mg subcutaneously (s.c.) at baseline followed by 40 mg s.c. every other week for 12 weeks. Placebo-treated patients received identical-looking injections with no active ingredient. The medicine was dispensed in sequentially numbered computer-randomized containers. Participants, care givers and those assessing the outcomes were blinded to group assignment. The primary efficacy endpoints were changes in the HS scores (Sartorius and Hurley scoring systems). Secondary efficacy endpoints included changes in pain (visual analogue scale), days with lesions and Dermatology Life Quality Index, and evaluation of scarring. Recruitment was terminated early due to expiry date of trial medication. RESULTS: Twenty-one patients were included, of whom 15 received adalimumab and six received placebo. All participants were analysed according to the intention to treat principle. A significant reduction was seen in Sartorius score after 6 weeks and an almost significant reduction was seen after 12 weeks of active treatment (-10·7 vs. 7·5, P = 0·024 and -11·3 vs. 5·8, P = 0·07) when compared with the placebo group. CONCLUSIONS: A significant reduction in HS severity was gained after 6 weeks. No long-term curative effect was uniformly seen.