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Tamoxifen is an important targeted endocrine therapy in breast cancer. However, side effects and early discontinuation of tamoxifen remains a barrier for obtaining the improved outcome benefits of long-term tamoxifen treatment. Biomarkers predictive of tamoxifen side effects remain unidentified. The objective of this prospective population-based study was to investigate the value of tamoxifen metabolite concentrations as biomarkers for side effects. A second objective was to assess the validity of discontinuation rates obtained through pharmacy records with the use of tamoxifen drug monitoring. Longitudinal serum samples, patient-reported outcome measures and pharmacy records from 220 breast cancer patients were obtained over a 6-year period. Serum concentrations of tamoxifen metabolites were measured by LC–MS/MS. Associations between metabolite concentrations and side effects were analyzed by logistic regression and cross table analyses. To determine the validity of pharmacy records we compared longitudinal tamoxifen concentrations to discontinuation rates obtained through the Norwegian Prescription database (NorPD). Multivariable Cox regression models were performed to identify predictors of discontinuation. At the 2nd year of follow-up, a significant association between vaginal dryness and high concentrations of tamoxifen, Z-4′-OHtam and tam-NoX was identified. NorPD showed a tamoxifen-discontinuation rate of 17.9% at 5 years and drug monitoring demonstrated similar rates. Nausea, vaginal dryness and chemotherapy-naive status were significant risk factors for tamoxifen discontinuation. This real-world data study suggests that measurements of tamoxifen metabolite concentrations may be predictive of vaginal dryness in breast cancer patients and verifies NorPD as a reliable source of adherence data.

After a cancer diagnosis, patients often change their lifestyle in order to improve health. The aim of this study was to examine whether women with breast cancer had changed their diet two years after the diagnosis, and to compare their diet with that of healthy female blood donors.Patients (n = 180), median age 58 years (range 37-78), and 101 controls, median age 57 years (age 43-75) answered questions about consumption of alcohol, 36 different food items, and information like age, body mass index (BMI), marital status, and years of education.Forty patients (22%) had changed their diet. Comparing all patients with controls, significantly more patients avoided alcohol, p = 0.0005, and 3 of 36 food items; smoked food, p = 0.04, and milk and other dairy products, p = 0.02 and p =0.0001, respectively. Based on BMI, 50% of all the patients reported overweight or obesity. Breast cancer treatment explained 5.7% of the total variance in scores for changing diet, where chemotherapy was the sole significant predictor, p = 0.04.Two years after a breast cancer diagnosis, most women (78%) maintained their diet, which was largely similar to the controls. Fifty percent of the patients reported overweight or obesity.

Objective. Patients with perceived food hypersensitivity typically present with multiple health complaints. We aimed to assess the severity of their intestinal and extra-intestinal symptoms. Materials and methods. In a prospective study, 84 patients referred to our outpatient clinic for investigation of perceived food hypersensitivity were enrolled consecutively. Irritable bowel syndrome (IBS) was diagnosed according to the Rome III criteria. Severity and impact of bowel symptoms, fatigue and musculoskeletal pain were evaluated by using the following questionnaires: The IBS Severity Scoring System (IBS-SSS), the Fatigue Impact Scale (FIS), the FibroFatigue Scale (FFS), and visual analogue scales (VAS) for scoring of musculoskeletal pain. Results. All but one patient were diagnosed with IBS, 58% with severe symptoms. Extra-intestinal symptoms suggestive of chronic fatigue and fibromyalgia were demonstrated in 85% and 71%, respectively. Neither IgE-mediated food allergy nor organic pathology could explain the patients' symptoms. Nevertheless, malabsorption of fat was demonstrated in 10 of 38 subjects. Conclusions. Perceived food hypersensitivity may be associated with severe, debilitating illness. The comorbid triad of IBS, chronic fatigue, and musculoskeletal pain is striking and may point to a common underlying cause.

Perceived food hypersensitivity is a prevalent, but poorly understood condition. In this review article, we summarize narratively recent literature including results of our 10 years' interdisciplinary research program dealing with such patients. The patients (more than 400) included in our studies were all adults referred to a university hospital because of gastrointestinal complaints self-attributed to food hypersensitivity. Despite extensive examinations, food allergy was seldom diagnosed. The majority of the patients fulfilled the diagnostic criteria for irritable bowel syndrome. In addition, most suffered from several extra-intestinal health complaints and had considerably impaired quality of life. However, psychological factors could explain only approximately 10% of the variance in the patients' symptom severity and 90% of the variance thus remained unexplained. Intolerance to low-digestible carbohydrates was a common problem and abdominal symptoms were replicated by carbohydrate ingestion. A considerable number of patients showed evidence of immune activation by analyses of B-cell activating factor, dendritic cells and "IgE-armed" mast cells. Multiple factors such as immune activation, disturbed intestinal fermentation, enteric dysmotility, post-infectious changes and "local" allergy in the gut as well as psychological disturbances may play a role in the pathophysiology of perceived food hypersensitivity. Hence, our results support the view that management of these patients should be interdisciplinary.

Psychological distress may be causally related to multiple, unexplained somatic symptoms. We have investigated job stress, coping strategies and subjective health complaints in patients with subjective food hypersensitivity. Sixty-four patients were compared with 65 controls. All participants filled in questionnaires focusing on job stress, job demands and control, work environment, coping strategies and subjective health complaints. Compared with controls, patients scored significantly lower on job stress and job demands, and significantly higher on authority over job decisions. Coping strategies and satisfaction with work environment did not differ significantly between the two groups, but the patients reported significantly more subjective health complaints than the controls. Scores on job stress and job demands were generally low in patients with subjective food hypersensitivity. It is unlikely, therefore, that the patients' high scores on subjective health complaints are causally related to the work situation.

Objective Self-reported food hypersensitivity (SFH) is common. Psychological factors are assumed to be associated. We assessed anxiety and depression in SFH patients, using both questionnaires and interview. Methods Consecutive patients ( n =130) and randomly selected healthy volunteers ( n =75) completed the Hospital Anxiety and Depression Scale (HADS), the neuroticism scale of the Eysenck Personality Questionnaire (EPQ-N) and the General Health Questionnaire (GHQ). Seventy-six of the patients were also interviewed by use of the Mini International Neuropsychiatric Interview and the Montgomery–Aasberg Depression Rating Scale. All patients underwent extensive allergological, gastroenterological and dietary examinations. Results According to interviews, 57% of patients fulfilled the DSM-IV criteria for at least one psychiatric disorder. Anxiety disorders (34%) and depression (16%) predominated. According to questionnaires, patients scored significantly higher than controls on all psychometric scales except for depression (HADS). We also found an underreporting of depression in HADS compared with interviews (2.5% vs. 16%, P =.001). Food hypersensitivity was rarely confirmed by provocation tests (8%). Eighty-nine percent of the patients had irritable bowel syndrome. Conclusions Anxiety and depression are common in patients with IBS-like complaints self-attributed to food hypersensitivity. Anxiety disorders predominate. In this setting, depression may be underreported by HADS.

Owing to lack of objective measures, the diagnosis of food hypersensitivity may be difficult. The aim of this study was to investigate whether the intestinal response to direct provocation in patients with food hypersensitivity could be recognized by ultrasound.Thirty-two patients with chronic abdominal complaints, self-attributed to food hypersensitivity/allergy were included in the study. Via a nasoduodenal tube, the duodenal mucosa was challenged with the suspected food item dissolved in 10 ml water or saline. Using external ultrasound, the sonographic features (wall thickness and diameter of the duodenal bulb and jejunum, peristalsis activity and luminal fluid) were recorded before and during one hour after challenge.Sonographic changes were observed after challenge in 14 (44%) of the 32 patients. A positive sonographic response (increased wall thickness, diameter, peristalsis and/or luminal fluid) was significantly related to a positive skin prick test (p = 0.008) and a positive double-blind placebo-controlled food challenge (p = 0.03). A significant correlation was found between provocation-induced symptoms and wall thickness of the duodenal bulb (r = 0.50, p = 0.004) or the jejunum (r = 0.42, p = 0.02). Intra- and interobserver variation of the tracing procedure showed low values.Responses of the proximal small intestines to direct provocation (swelling of the wall and exudation of fluid into the lumen) could be visualized by transabdominal ultrasound. This new provocation test could be helpful in the evaluation of patients with food hypersensitivity.

The aim of this study was to investigate quality of life and applicability of the 10-item short form of the Nepean Dyspepsia Index (SF-NDI) in patients with subjective food hypersensitivity. Fifty-two adult patients and 120 controls were examined using three questionnaires: Quality of life Nepean Dyspepsia Index (NDI), Gastrointestinal Symptom Rating Scale (GSRS), and Ulcer Esophagitis Subjective Symptoms Scale (UESS). To document psychometric properties, 20 of the patients filled in the SF-NDI questionnaire once more 4 weeks later. Patients had poor quality of life compared with controls from health care workers or general population (P < 0.001). Scores on SF-NDI were significantly correlated with scores on the GSRS (r = 0.34, P = 0.02) and UESS (r = 0.41, P = 0.003). The SF-NDI performed very satisfactorily, with a high reliability, construct validity, and responsiveness. Patients with subjective food hypersensitivity have considerably reduced quality of life. The SF-NDI provides reliable, responsive, and clinically valid measures of quality of life in these patients.

Background: Rheumatic joint pain is a common extra-intestinal complication of inflammatory bowel disease (IBD). Because the high ratio of n-6 to n-3 fatty acids (FAs) of the Western diet might promote rheumatic disorders, we sought to compare the effects of short-term duodenal administration of n-3-rich seal oil and n-6-rich soy oil on IBD-related joint pain. Methods: Nineteen patients with IBD-related joint pain were included in the study; 9 had Crohn disease and 10 had ulcerative colitis. Ten millilitres seal oil (n = 10) or soy oil (n = 9) was self-administered through a nasoduodenal feeding tube 3 times daily for 10 days. Results: Compared with soy oil treatment, seal oil significantly reduced the duration of morning stiffness (P = 0.024), number of tender joints (P = 0.035), intensity of pain (P = 0.025) and the doctor’s scoring of rheumatic disease activity (P = 0.025) at the end of the 10-day treatment period. Analysis of the effects as area under the curve (area between the curve and baseline, zero) for the entire period from start of treatment until 6 months’ post-treatment suggested a long-lasting beneficial effect of seal oil administration on joint pain, whereas soy oil tended (not significantly) to aggravate the condition. Consistently, the serum ratios of n-6 to n-3 FAs (P 0.01) and arachidonic acid to eicosapentaenoic acid (P 0.01) were reduced after treatment with seal oil. Conclusion: The results suggest distinctive, differential prolonged effects on IBD-related joint pain of short-term duodenal administration of n-3-rich seal oil (significant improvement) and n-6-rich soy oil (tendency to exacerbation).

We examined whether psychological factors such as general and gastrointestinal symptom-specific anxiety and depression could predict symptom severity in patients with unexplained, self-reported (subjective) food hypersensitivity. For the purpose, we translated and validated the Visceral Sensitivity Index (VSI).Seventy consecutive patients completed questionnaires for Hospital Anxiety and Depression Scale, VSI, Irritable Bowel Syndrome Symptom Questionnaire, and Subjective Health Complaints Inventory. Relationship between scores on psychological factors and scores on somatic symptoms were studied by multiple regression analyses.Most patients reported non-gastrointestinal symptoms in addition to their irritable bowel syndrome complaints, but general and symptom-specific anxiety, and depression could not explain a significant amount of the variance in somatic complaints. Gastrointestinal symptom-specific anxiety was a significant predictor of gastrointestinal complaints (p = 0.02), and age was the sole significant predictor of non-gastrointestinal complaints (p = 0.01). Approximately 90% of the total variance in symptom severity remained unexplained by the psychological factors. The Norwegian version of the VSI had satisfactory validity (Cronbach alfa = 0.93). Symptom-specific and general anxiety were significantly correlated (r = 0.48, por = 0.0001).Psychological factors were not major predictors of symptom severity in patients with subjective food hypersensitivity. The Norwegian version of VSI had satisfactory validity.