Psycho-echo-biofeedback: a novel treatment for anismus—results of a prospective controlled study

Background

Anismus or non-relaxing puborectalis muscle (PRM), detectable with anal/vaginal ultrasound (US), is a cause of obstructed defecation (OD) and may be treated with biofeedback (BFB). Many patients with anismus are anxious and/or depressed. The aim of this prospective study was to evaluate the outcome of the novel procedure psycho-echo-BFB in patients with anismus and psychological disorders.

Methods

Patients presenting at our unit with anismus and psychological disorders between January 2009 and December 2013, and not responding to conventional conservative treatment, were enrolled in the study. All underwent four sessions of psycho-echo-BFB, carried out by two psychologists and a coloproctologist, consisting of guided imagery, relaxation techniques and anal/vaginal US-assisted BFB. A validated score for OD was used, and PRM relaxation on straining measured before and after the treatment. PRM relaxation was also measured in a control group of 7 patients with normal bowel habits.

Results

Ten patients (8 females, median age 47 years, range 26–72 years) underwent psycho-echo-BFB. The OD score, evaluated prior to and at a median of 25 months (range 1–52 months) after the treatment, improved in 7 out of 10 patients, from 13.5 ± 1.2 to 9.6 ± 2.2 (mean ± standard error of the mean (SEM)), p = 0.06. At the end of the last session, PRM relaxed on straining in all cases, from 0 to 7.1 ± 1.1 mm, i.e., physiological values, not statistically different from those of controls (6.6 ± 1.5 mm). Two patients reported were cured, 3 improved and 5, all of whom had undergone prior anorectal surgery, unchanged. No side effects were reported.

Conclusions

Psycho-echo-BFB is safe and inexpensive and allows all patients with anismus to relax PRM on straining. Previous anorectal surgery may be a negative predictor.     

Transanal rectocele repair using EndoGIA: short–term results of a prospective study

Background The surgical treatment of symptomatic rectocele may be carried out by means of endorectal techniques. Results depend on a correct etiologic evaluation of associated diseases. We report the preliminary results of an original endorectal technique applied to selected patients. Methods Fifteen women (median age, 57 years; range, 38–73 years) underwent transanal rectocele resection by a 60 mm endo–GIA and subsequent plication of the anterior rectal wall. All patients had a primary isolated anterior medium sublevator rectocele with obstructed defecation symptoms. They were prospectively evaluated by questionnaire, defecation diary, clinical examination, defecography and anal manometry were performed preoperatively. All patients had less than three weekly bowel motions. Postoperative follow–up included clinical examination and symptoms questionnaire with defecation diary at one week, one month and three months; defecography was performed at three months. Results The time required to repair the rectocele was approximately 20 min. The mean time spent in hospital after the operation was 37 h. Postoperative pain was low or moderate in all cases, one patient had acute urinary retention, 11 had minor rectal bleeding, and 5 had temporary urgency. Abolition of excessive straining, feeling of incomplete evacuation, enemas and self–digitations was achieved in all patients; stool frequency at three months was 7 per week in 10 patients, 5–6 per week in 3 patients and 4–6 in 2 patients (p<0.001). Defecography at three months did not show any rectocele recurrence. Conclusions Transanal rectocele repair with linear stapler applied in selected patients is safe and easy to perform. Short–term results are safisfactory. Complete investigations of impaired defecation and selection of patients are needed to achieve satisfactory results.     

Controlled, randomized trial of island flap anoplasty for treatment of trans–sphincteric fistula–in-ano: early results

Treatment of trans–sphincteric fistula is usually a compromise between recurrence and incontinence. Dermal island flap anoplasty has been found to be useful in the treatment of these fistulas. We performed a randomized trial to compare dermal island flap anoplasty with conventional treatment for trans–sphincteric fistula–in–ano. Seventy nine patients with fistula–in–ano were recruited; twenty patients with trans–sphincteric fistula confirmed by endoanal ultrasound were prospectively randomized to receive either dermal island flap anoplasty (IFA) or conventional treatment (CVN) for trans–sphincteric fistula–inano. Conventional treatment consisted of lay open fistulotomy or seton insertion if deemed unsuitable for fistulotomy. Dermal island flap anoplasty involved a cutaneous advancement flap into the rectum. Pain scores, fecal incontinence scores, operative complications, wound healing and recurrence rates were charted. Two patients in the CVN group required seton insertions, which were still intact at the 9–month follow–up. Two patients with similar high trans–sphincteric fistula in the IFA group avoided having a long–term seton. There were no differences in the postoperative pain score, incontinence score, complications, wound healing and recurrence rates between the two groups. IFA is a safe and useful method for treating transsphincteric fistula. It can be considered when a suprasphincteric extension is suspected, thus avoiding risk of incontinence or the discomfort of a long–term seton.     

Soluble thrombomodulin as a predictor of type 2 diabetes: results from the MONICA/KORA Augsburg case–cohort study, 1984–1998

Aims/hypothesis Previous studies have shown an inverse association between soluble thrombomodulin (sTM) and incident CHD, but there is a lack of data on the association between sTM and type 2 diabetes. Since CHD and type 2 diabetes share many risk factors, the aim of this study was to assess whether elevated sTM levels are associated with a lower incidence of type 2 diabetes. Materials and methods A case–cohort study was performed in initially healthy middle-aged men and women based on data from the Monitoring of Trends and Determinants in Cardiovascular Disease/Cooperative Health Research in the Region of Augsburg (MONICA/KORA) studies conducted between 1984 and 1998. Levels of sTM were measured with an ELISA in serum samples from 138 men and 86 women who developed type 2 diabetes during follow-up (cases) and 534 men and 446 women who did not develop type 2 diabetes (non-cases). Results An inverse association was found between sTM and type 2 diabetes risk after multivariable adjustment for diabetes risk factors, including several other markers of inflammation and endothelial dysfunction. Markers of inflammation and endothelial dysfunction were particularly strong confounders of the observed association. In the fully adjusted model, a 1 SD increase in sTM was associated with a 27% decrease in the risk of type 2 diabetes (hazard ratio = 0.73, 95% CI 0.58–0.91) in the total study population. We did not observe significant risk differences between men and women. Conclusions/interpretation These data suggest that, in initially healthy middle-aged men and women, levels of sTM are inversely associated with the risk of type 2 diabetes. Electronic supplementary materials Supplementary material is available in the online version of this article at and is accessible to authorised users.     

Medical history and risk of lymphoma: results of a European case–control study (EPILYMPH)

Introduction  Lymphomas are a heterogeneous group of immune-cell malignancies. Immunology-related conditions are among the few factors for which consistent evidence exists relating them to lymphoma risk. Materials and methods   We used the data from the European case–control study Epilymph on 2,362 lymphoma cases and 2,458 controls to investigate associations between a medical history of infectious and non-infectious diseases with overall and subentity-specific lymphoma risk. Results   As key results, we observed an increased odds ratio (OR) for self-reported infections with hepatitis B virus (HBV, OR = 1.91, 95% CL = 1.24–2.94) and a null result for rheumatoid arthritis. Additionally, we found an increased OR for infectious mononucleosis (OR = 1.68, 95% CL = 1.14–2.48), an inverse association to frequency of sickness in childhood (OR = 0.68, 95% CL = 0.55–0.84), and—as casual finding—an increased OR with acetaminophen intake (OR = 2.29, 95% CL = 1.49–3.51). Conclusion   Our results are consistent with the current knowledge about the association with mononucleosis as indicator of Epstein–Barr-virus infection, suggest serological study of the association to HBV infection and do not support the view of a positive association between rheumatoid arthritis and lymphoma risk.     

Sargramostim in patients with Crohn’s disease: results of a phase 1–2 study

Background  We aimed to assess the tolerability, pharmacokinetics, safety, and efficacy of sargramostim in Japanese patients with active Crohn’s disease (CD). Methods  Patients with moderately to severely active CD were enrolled. Step 1 was an open-label, phase 1 study of 2 μg/kg per day sargramostim administered subcutaneously (SC) for 4 weeks, with an optional 8-week extension with 6 μg/kg per day. Step 2 was an open-label, phase 1–2 study of the tolerability and pharmacokinetics of SC sargramostim 6 μg/kg per day over 4 weeks and of 8-week efficacy and safety. Efficacy variables were the proportion of patients achieving a clinical response [≥100-point decrease from baseline in the CD activity index (CDAI)] and the proportion achieving clinical remission (CDAI ≤ 150 points). Results  Six patients participated in Step 1; five in Step 2. Serum concentrations of sargramostim peaked within 1 h of administration; mean terminal half-life was 2 h. Maximal serum concentrations increased with the dose. Mean accumulation ratios were 0.998 in Step 1 and 0.673 in Step 2. One of the six patients in the Step-1 extension and none of the five in Step 2 achieved a clinical response. Clinical remission was reported in one patient in each step. A notable decrease in median CDAI scores was observed in the extension and Step 2. In responders, improvement tended to be maintained through the 30-day follow-up. Drug-related adverse events included injection-site reaction, pyrexia, back pain, and bone pain. Conclusion  The systemic exposure of sargramostim increased dose-dependently. No accumulation in systemic exposure was associated with the repeated once-daily administration. SC sargramostim at 6 μg/kg per day improved median CDAI scores. A minority of patients experienced clinical remission or clinical response.     

Yoga based cardiac rehabilitation after coronary artery bypass surgery: One-year results on LVEF,lipid profile and psychological states – A randomized controlled study

Objective

To compare the long term effects of yoga based cardiac rehabilitation program with only physiotherapy based program as an add-on to conventional rehabilitation after coronary artery bypass grafting (CABG) on risk factors.

Methods

In this single blind prospective randomized parallel two armed active control study, 1026 patients posted for CABG at Narayana Hrudayalaya Institute of Cardiac Sciences, Bengaluru (India) were screened. Of these, 250 male participants (35–65 years) who satisfied the selection criteria and consented were randomized into two groups.Within and between group comparisons were done at three points of follow up (i.e. 6th week, 6th month, and 12th month) by using Wilcoxon''s signed ranks test and Mann Whitney U test respectively.

Results

Yoga group had significantly (p = 0.001, Mann Whitney) better improvement in LVEF than control group in those with abnormal baseline EF (<53%) after 1 year. There was a better reduction in BMI in the yoga group (p = 0.038, between groups) in those with high baseline BMI (≥23) after 12 months. Yoga group showed significant (p = 0.008, Wilcoxon''s) reduction in blood glucose at one year in those with high baseline FBS ≥110 mg/dl. There was significantly better improvement in yoga than the control group in HDL (p = 0.003), LDL (p = 0.01) and VLDL (p = 0.03) in those with abnormal baseline values. There was significantly better improvement (p = 0.02, between groups) in positive affect in yoga group. Within Yoga group, there was significant decrease in perceived stress (p = 0.001), anxiety (p = 0.001), depression (p = 0.001), and negative affect (p = 0.03) while in the control group there was reduction (p = 0.003) only in scores on anxiety.

Conclusion

Addition of yoga based relaxation to conventional post-CABG cardiac rehabilitation helps in better management of risk factors in those with abnormal baseline values and may help in preventing recurrence.     

Management of periprocedural anticoagulant therapy: a novel individualized approach—a transeusophageal echocardiographic study

Journal of Thrombosis and Thrombolysis - Patients with non-valvular atrial fibrillation who are under chronic oral anticoagulant therapy (OAC) treatment frequently require interruption of OAC...     

Development assessment of HIV exposed children aged 6–18 months: a cohort study from North India

HIV exposed children are vulnerable to developmental delay irrespective of their HIV status due to combined effect of risk factors like poverty, prenatal drug exposure, stress and chronic illness in family and malnutrition. This cohort study assessed the development of 50 HIV exposed children aged 6–18 months at a Pediatric Centre of Excellence in HIV care in India. The development was assessed using Development Assessment Scale for Indian Infants (DASII) at enrolment, 3 and 6 months later. The development quotient (DQ) scores and proportion of children with developmental delay (DQ?≤?70) were compared among two sub-groups, HIV infected (HI) and HIV exposed uninfected (HEU) children. The various social and clinical factors affecting development were studied by univariate and multivariate analysis. Prevalence of developmental delay was 2.4% in the HEU (n?=?41), and 33.3% in HI (n?=?9). The DQ of HI was significantly lower than that of HEU at all three assessments. The DQ of HI were also significantly lower compared to the HEU at ages 12.1–18 months (83.37?±?20.73 vs 94.68?±?5.13, p?=?0.005) and 18.1–24 months (84.55?±?15.35 vs 94.63?±?5.86, p?=?0.006) respectively. The development of HEU was adversely affected by lower socioeconomic status and presence of wasting. In addition, development of HI was also adversely influenced by presence of stunting and opportunistic infections, advanced disease stage and shorter ART duration. We conclude that with optimum care, HEU can have a normal development, while a considerable proportion of HI may continue to have delayed development.     

Overweight,obesity and the risk of LADA: results from a Swedish case–control study and the Norwegian HUNT Study

Aims/hypothesis

Excessive weight is a risk factor for type 2 diabetes, but its role in the promotion of autoimmune diabetes is not clear. We investigated the risk of latent autoimmune diabetes in adults (LADA) in relation to overweight/obesity in two large population-based studies.

Methods

Analyses were based on incident cases of LADA (n?=?425) and type 2 diabetes (n?=?1420), and 1704 randomly selected control participants from a Swedish case–control study and prospective data from the Norwegian HUNT Study including 147 people with LADA and 1,012,957 person-years of follow-up (1984–2008). We present adjusted ORs and HRs with 95% CI.

Results

In the Swedish data, obesity was associated with an increased risk of LADA (OR 2.93, 95% CI 2.17, 3.97), which was even stronger for type 2 diabetes (OR 18.88, 95% CI 14.29, 24.94). The association was stronger in LADA with low GAD antibody (GADA; <median) (OR 4.25; 95% CI 2.76, 6.52) but present also in LADA with high GADA (OR 2.14; 95% CI 1.42, 3.24). In the Swedish data, obese vs normal weight LADA patients had lower GADA levels, better beta cell function, and were more likely to have low-risk HLA-genotypes. The combination of overweight and family history of diabetes (FHD) conferred an OR of 4.57 (95% CI 3.27, 6.39) for LADA and 24.51 (95% CI 17.82, 33.71) for type 2 diabetes. Prospective data from HUNT indicated even stronger associations; HR for LADA was 6.07 (95% CI 3.76, 9.78) for obesity and 7.45 (95% CI 4.02, 13.82) for overweight and FHD.

Conclusions/interpretation

Overweight/obesity is associated with increased risk of LADA, particularly when in combination with FHD. These findings support the hypothesis that, even in the presence of autoimmunity, factors linked to insulin resistance, such as excessive weight, could promote onset of diabetes.

     

Cardiometabolic assessment of lamin A/C gene mutation carriers: a phenotype–genotype correlation

AimsMutations of the LMNA gene encoding lamin A/C induce heterogeneous phenotypes ranging from cardiopathies and myopathies to lipodystrophies. The aim of this study was to compare cardiometabolic complications in patients with heterozygous LMNA mutations at the 482nd codon, the ‘hotspot’ for partial lipodystrophy, with carriers of other, non-R482 LMNA mutations.Methods and resultsThis study included 29 patients with R482 LMNA mutations, 29 carriers of non-R482 LMNA mutation and 19 control subjects. Cardiac and metabolic phenotypes were compared between groups. A family history of either cardiac implantable electronic devices (CIEDs; P < 0.001) or sudden death (P < 0.01) was more frequent in non-R482 than R482 carriers. The non-R482 carriers also had more abnormalities on electrocardiography and received CIEDs more often than R482 carriers (P < 0.001). On cardiac ultrasound, non-R482 patients had greater frequencies of left atrial enlargement (P < 0.05) and lower left ventricular ejection fractions (P < 0.01) than R482 carriers. In contrast, R482 carriers had lower BMI (P < 0.05), leptin (P < 0.01) and fat mass (P < 0.001), but higher intra-/total abdominal fat-mass ratios (P < 0.001) and prevalences of diabetes (P < 0.01) and hypertriglyceridaemia (P < 0.05) than non-R482 carriers, with a trend towards more coronary artery disease. However, non-R482 carriers had higher intra-/total abdominal fat-mass ratios (P < 0.02) and prevalences of diabetes (P < 0.001) and hypertriglyceridaemia (P < 0.05) than the controls.ConclusionNon-R482 carriers present more frequently with arrhythmias than R482 carriers, who twice as often have diabetes, suggesting that follow-up for laminopathies could be adjusted for genotype. Non-R482 mutations require ultra-specialized cardiac follow-up, and coronary artery disease should not be overlooked. Although overlapping phenotypes are found, LMNA mutations essentially lead to tissue-specific diseases, favouring genotype-specific pathophysiological mechanisms.     

Discontinuation of etanercept after achievement of sustained remission in patients with rheumatoid arthritis who initially had moderate disease activity—results from the ENCOURAGE study,a prospective,international, multicenter randomized study

Objectives: To investigate the efficacy and safety of etanercept (ETN) in patients with rheumatoid arthritis (RA) with moderate disease activity and the possibility to discontinue ETN after achieving remission.

Methods: Multicenter, randomized, and open-label study was conducted in Japan and Korea. RA patients (disease duration?<5 years) with moderate disease activity despite methotrexate (MTX) treatment were allocated to either MTX or ETN?+?MTX (Period 1) for 12 months. Patients who achieved sustained remission defined as DAS28?<?2.6 at both 6 and 12 months in the ETN?+?MTX group, were randomized to either continue or discontinue ETN for 12 months (Period 2).

Results: A total of 222 patients were enrolled in Period 1 and clinical remission was achieved in 106/157 (67.5%) and 5/28 (17.9%) patients in the ETN?+?MTX and MTX groups, respectively. In Period 2, sixty-seven patients were randomized and finally 28/32 (87.5%) and 15/28 (53.6%) patients who continued or discontinued ETN maintained clinical remission. Baseline disease activity and the presence of comorbid diseases influenced the maintenance of remission after ETN discontinuation.

Conclusions: ETN?+?MTX was efficient for RA patients with moderate disease activity into remission. After achieving sustained remission, a half of the patients who discontinued ETN could maintain remission for 1 year.     

Predictors of coronary stent thrombosis: a case–control study

Journal of Thrombosis and Thrombolysis - To verify the frequency and predictors associated with stent thrombosis (ST) in a developing country. Observational, case–control study including 2535...