Health-Related Quality of Life and Psychosocial Variables in Women with Colorectal Pelvic Floor Dysfunction: A Cross-Sectional Study.

Pelvic floor dysfunction comprises various disorders, including urinary incontinence, fecal incontinence, pelvic organ prolapse, and chronic pelvic pain. This study aimed to evaluate health-related quality of life (HRQoL), anxiety, depression, sleep disturbance, and sexual functioning in women with pelvic floor dysfunction of colorectal etiology compared with control women. Patients were recruited from a specialized colorectal unit and controls were selected from among the patients' friends and relatives. Sociodemographic and clinical data were collected. Pelvic floor dysfunction distress and impact, HRQoL, depression, anxiety, insomnia, and sexual functioning were assessed using the following validated questionnaires: Short-Form Pelvic Floor Distress Inventory (PFDI-20), Short Form Pelvic Floor Impact Questionnaire (PFIQ-7), 36-Item Short-Form Health Survey (SF-36), Beck Depression Inventory II (BDI-II), Beck Anxiety Inventory (BAI), Insomnia Severity Index (ISI), and Changes in Sexual Functioning Scale (CSFQ). Statistical analyses included Welch's t-test, Fisher's exact test, and Spearman's correlation coefficients. Eighty-four patients and 57 controls were included. Compared with controls, patients were more likely to be obese or overweight, have had higher numbers of deliveries, more vaginal deliveries, more frequent use of forceps, and have had more associated comorbidities, mainly in the urinary, neurological, and psychiatric domains. As expected, patients scored significantly higher than controls on both the PFDI-20 and PFIQ-7 and their respective sub-scales, with the highest mean values in the patient group on the sub-scales related to the colorectal-anal domain. QoL, depression, anxiety, insomnia, and sexual functioning were significantly worse in patients than in controls (p < 0.0001 in every case). In patients, PFIQ-7 scores correlated significantly with HRQoL (p < 0.001 for the physical component and p < 0.01 for the mental component), depression (p < 0.001), anxiety (p < 0.001), insomnia (p < 0.05), and sexual functioning scores (p < 0.05). Colorectal pelvic floor dysfunction had a markedly deleterious impact on the HRQoL, depression, anxiety, sleep disturbance, and sexual functioning of patients. It is concluded that colorectal pelvic floor dysfunction exerts a considerable burden on patients' lives. Addressing these issues in clinical settings could significantly improve patients' well-being.

The Probiotic VSL#3® Does Not Seem to Be Efficacious for the Treatment of Gastrointestinal Symptomatology of Patients with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Gastrointestinal symptomatology is frequent among patients with fibromyalgia, which increases disease burden and lacks specific treatment, either pharmacological or non-pharmacological. We aimed to evaluate the efficacy and tolerability of a multi-strain probiotic, VSL#3®, for the treatment of fibromyalgia-associated gastrointestinal manifestations. This randomized, placebo-controlled trial included 12 weeks of probiotic or placebo treatment followed by 12 weeks of follow up. The primary outcome variable was the mean change from the baseline to the endpoint in the composite severity score of the three main gastrointestinal symptoms reported by patients with fibromyalgia (abdominal pain, abdominal bloating and meteorism). Secondary outcome variables were the severity of additional gastrointestinal symptoms, fibromyalgia severity, depression, sleep disturbance, health-related quality of life and patients' overall impression of improvement. No differences were found between VSL#3® (n = 54) and the placebo (n = 56) in the primary outcome (estimated treatment difference: 1.1; 95% confidence interval [CI]: -2.1, 4.2; p = 0.501), or in any of the secondary outcomes. However, responders to VSL#3 were more likely to maintain any improvement during the follow-up period compared to responders in the placebo arm. Overall, VSL#3 tolerability was good. Our data could not demonstrate any beneficial effects of VSL#3® either on the composite score of severity of abdominal pain, bloating and meteorism or in any of the secondary outcome variables. More research is needed to elucidate specific factors that may predict a favourable response to treatment in patients with fibromyalgia.

Marital Adjustment in Patients with Cancer: Association with Psychological Distress, Quality of Life, and Sleep Problems.

Marital adjustment plays a key role in the physical and psychosocial wellbeing. We conducted a cross-sectional study to evaluate marital adjustment and its association with psychological distress, suicidal ideation, sleep problems, and quality of life in patients with cancer. We collected demographic and clinical information using a structured survey. We assessed marital adjustment, quality of life, psychological distress profile, and sleep problems of participants using validated instruments: the Locke and Wallace Marital Adjustment Test (LWMAT), the Short-Form Health Survey-12, the Beck's Depression Inventory (BDI), the Beck Anxiety Inventory (BAI), and the Insomnia Severity Index (ISI). Suicidal ideation was assessed with item nine of the BDI. Of the 130 patients (52.3% females, mean age 57.9 ± 12.4 years) enrolled, 20 (15%) were classified as experiencing poor marital adjustment. Moderate to severe depression, anxiety, and insomnia were found in 25.4%, 34.6%, and 24.7% of participants, respectively. Positive suicidal ideation was documented in 13.8% of participants. We found a significant association between poor marital adjustment and depression, anxiety, suicidal ideation, and poor sleep. Our study confirms the relevance of marital adjustment in relation to the psychological wellbeing of patients with cancer. Depression, anxiety, and poor sleep were found to be significantly associated with poor marital adjustment.

The Effects of a Gluten-free Diet Versus a Hypocaloric Diet Among Patients With Fibromyalgia Experiencing Gluten Sensitivity-like Symptoms: A Pilot, Open-Label Randomized Clinical Trial.

BACKGROUND AND AIMS: Patients with fibromyalgia frequently present with symptoms similar to those experienced by patients with gluten-related disorders, raising the possibility that a subgroup of these patients could be experiencing underlying gluten sensitivity. This study aimed to evaluate the effects of a gluten-free diet (GFD) compared with a hypocaloric diet (HCD) among patients with fibromyalgia. METHODS: Adult patients diagnosed with fibromyalgia were randomly allocated to receive a GFD or a HCD over a 24-week period. The primary outcome measure was the change in the number of gluten sensitivity symptoms. The following secondary outcomes were evaluated: body mass index, Revised Fibromyalgia Impact Questionnaire, Pittsburgh Sleep Quality Index, Brief Pain Inventory, Beck Depression Inventory-II, State-Trait Anxiety Inventory, Short-Form Health Survey, Patient Global Impression Scale of Severity, Patient Global Impression Scale of Improvement, and adverse events. RESULTS: Seventy-five subjects were randomly allocated to receive either a GFD (n=35) or an HCD (n=40). The least squares mean change in the total number of gluten sensitivity symptoms from baseline did not differ significantly between the GFD and HCD groups (-2.44±0.40 for the GFD; -2.10±0.37 for the HCD; P=0.343). Similarly, the 2 dietary interventions did not differ in any of the remaining measured secondary outcomes. Both dietary interventions were well tolerated. CONCLUSIONS: Both dietary interventions were associated with similar beneficial outcomes in reducing gluten sensitivity symptoms and other secondary outcomes. However, despite its specificity, GFD was not superior to HCD in reducing the number of gluten sensitivity symptoms or secondary outcomes.

[Acute abdomen due to complicated intramural duodenal haematoma. Report of a case and review of the literature]. / Abdomen agudo por hematoma duodenal intramural complicado. Presentación de un caso y revisión en la literatura.

BACKGROUND: Intramural duodenal haematoma is a rare entity that usually occurs in the context of patients with coagulation disorders. A minimum percentage is related to processes such as pancreatitis and pancreatic tumours. CLINICAL CASE: The case is presented of a 45 year-old male with a history of chronic pancreatitis secondary to alcoholism. He was seen in the emergency room due to abdominal pain, accompanied by toxic syndrome. The abdominal computed tomography reported increased concentric duodenal wall thickness, in the second and third portion. After oesophageal-gastro-duodenoscopy, he presented with haemorrhagic shock. He had emergency surgery, finding a hemoperitoneum, duodenopancreatic tumour with intense inflammatory component, as well a small bowel perforation of third duodenal portion. A cephalic duodenopancreatectomy was performed with pyloric preservation and reconstruction with Roux-Y. DISCUSSION: Treatment of a duodenal haematoma is nasogastric decompression, blood transfusion and correction of coagulation abnormalities. Surgery is indicated in the cases in which there is no improvement after 2 weeks of treatment, or there is suspicion of malignancy or major complications arise. CONCLUSIONS: Duodenal intramural haematoma secondary to chronic pancreatitis is rare, although the diagnosis should be made with imaging and, if suspected, start conservative treatment and surgery only in complicated cases.

The effects of gluten-free diet versus hypocaloric diet among patients with fibromyalgia experiencing gluten sensitivity symptoms: protocol for a pilot, open-label, randomized clinical trial.

BACKGROUND: Fibromyalgia is a chronic musculoskeletal pain syndrome characterized by a broad spectrum of manifestations. Patients with fibromyalgia frequently suffer from manifestations similar to those experienced by patients with gluten-related disorders raising the possibility that some patients with fibromyalgia could suffer from underlying gluten sensitivity. OBJECTIVE: This study aims to assess whether avoiding gluten among patients with fibromyalgia and gluten sensitivity is beneficial. METHODS: Adult patients with fibromyalgia presenting gluten sensitivity symptoms are randomly allocated to receive gluten-free diet or hypocaloric diet for 24 weeks. The primary outcome measure is the mean change in the number of experienced gluten sensitivity symptoms. Secondary outcome measures include the mean changes in the body mass index, Revised Fibromyalgia Impact Questionnaire, Pittsburgh Sleep Quality Index, Brief Pain Inventory, Beck Depression Inventory-II, State-Trait Anxiety Inventory, Short-Form Health Survey and Patient Global Impression Scale of Severity. Other secondary outcome measures include the frequency of potential adverse events and the proportion of responders according to the Patient Global Impression Scale of Improvement. DISCUSSION: Previous studies assessing dietary interventions in fibromyalgia primarily evaluated their effects on the severity and impact of fibromyalgia symptoms and pain. The current study is the first to evaluate the effects of gluten-free diet on the gluten sensitivity symptoms experienced by patients with fibromyalgia. The results of this study will contribute to a better understanding of the potential role of gluten sensitivity in fibromyalgia.

Widespread pressure pain hypersensitivity and ultrasound imaging evaluation of abdominal area after colon cancer treatment.

OBJECTIVE: To investigate the presence of widespread pressure pain sensitivity in cancer patients following partial colorectal resection in the abdominal and lower back area and to describe the presence of abnormalities in abdominal and lower back muscle morphology. METHODS: Twenty colon cancer survivors (eight females, mean age 56.60 ± 7.76 years) and 20 matched healthy controls (10 females, mean age 54.22 ± 8.12 years) participated. Abdominal and lower back pain was assessed after undergoing surgery using a Visual Analogue Scale (VAS) and Brief Pain Inventory (BPI). Pressure pain thresholds (PPTs) were bilaterally assessed over the supraumbilical, infraumbilical, and lower back areas and the second metacarpal. Ultrasound imaging was used to measure the depth of the abdominal muscles, the width of the midline abdominal fascia and the width of the lumbar multifidus. RESULTS: Ten months after finishing oncological treatments, patients who underwent partial colorectal resection reported significantly higher pain levels in the low-back area (P = 0.003) but not in the abdominal area (P = 0.426) compared with the matched controls. After surgery, the colon patients reported significantly higher BPI-intensity (P < 0.001) and BPI-interference scores (P = 0.009) compared with the matched controls. An analysis of variance (ANOVA) revealed significant between-groups difference in dominant-side lumbar, supraumbilical and infraumbilical (P ≥ 0.01), and second-metacarpal (P < 0.05) PPT levels. A significant between-groups difference was found by the ANOVA in ultrasound imaging of the depth of the internal oblique muscle (F = 4.887, P = 0.035) but not in the other ultrasound imaging measurements. CONCLUSIONS: Ten months after oncology treatment, colon cancer survivors show widespread pressure pain muscle hyperalgesia and reduced depths of dominant-side internal oblique muscles compared with matched controls.

Quetiapine extended-release (Seroquel-XR) versus amitriptyline monotherapy for treating patients with fibromyalgia: a 16-week, randomized, flexible-dose, open-label trial.

RATIONALE: Previous open-label studies have suggested that quetiapine could be a valuable alternative for treating fibromyalgia. OBJECTIVE: This study aims to compare the efficacy and tolerability of extended-release quetiapine with amitriptyline for treating fibromyalgia. METHODS: This study was a randomized, open-label, flexible-dose, non-inferiority trial. Patients with fibromyalgia were randomized to receive quetiapine extended-release (XR) (N = 45) (50 to 300 mg daily) or amitriptyline (N = 45) (10 to 75 mg daily) for 16 weeks. The primary endpoint was the change from baseline to endpoint in the Fibromyalgia Impact Questionnaire (FIQ) total score; the non-inferiority threshold was established at 8 points. The secondary outcomes included sleep quality, anxiety, depression, and quality of life. RESULTS: Twenty-two (49%) patients in the quetiapine group and 34 (76%) patients in the amitriptyline group completed the study. We found a reduction of 9.8 points in the total FIQ score at the endpoint for the quetiapine-treated patients compared to 13.9 points for the amitriptyline-treated patients, for a difference of 4.14 points (80% confidence interval (CI) -0.70 to 8.98). No significant differences were found between the quetiapine XR and amitriptyline groups for any of the secondary outcomes. The proportion of patients discontinuing treatment due to adverse events was higher in the quetiapine group (n = 14, 31.1%) than the amitriptyline group (n = 3, 6.6%). CONCLUSIONS: Our results appear to indicate that quetiapine XR does not provide similar efficacy to amitriptyline for treating patients with fibromyalgia. Quetiapine XR had a worse tolerability than amitriptyline in this population, possibly due to a relatively high starting dose.

Lobular breast cancer metastasis to the colon, the appendix and the gallbladder.

BACKGROUND: Metastases of lobular breast cancer are commonly encountered at the level of lungs, bones, brain and liver, whereas lesions in the gastrointestinal tract are rarely seen. CASE REPORT: A case of a patient with metastases in the right colon and gallbladder originating from an invasive lobular carcinoma is described. CONCLUSION: Adequate diagnostic procedures should be performed in patients with a history of breast cancer and who show gastrointestinal symptoms to rule out the potential presence of gastrointestinal metastases.

Suicide attempts and risk of suicide in patients with fibromyalgia: a survey in Spanish patients.

OBJECTIVES: Depression, chronic pain and sleep disturbances frequently co-exist in FM and have shown to be independently related with suicidal behaviours. The present survey was performed to evaluate the prevalence of previous suicide attempts in patients with FM and its potential relationship with sociodemographic and clinical characteristics of the disease. METHODS: A concise survey was sent to patients of seven associations of patients with FM. In addition to the inquiry concerning the number, if any, and characteristics of suicide attempts, the survey included questions about sociodemographic and clinical data of patients as well as the revised FM impact questionnaire (FIQR) and the Plutchik suicide risk scale. RESULTS: One hundred and eighty patients answered the survey. Thirty (16.7%) of them reported one to three previous suicide attempts. Drug poisoning was the most frequently employed method for suicide attempt (70%). No relevant differences were found between suicide attempters and non-attempters in relation to age, education and marital status, but a significant difference was found in relation to employment status. Plutchik's scale scores, both in suicide attempters and non-attempters, were higher than those found in the literature. FIQR scores were significantly higher in suicide attempters than in non-attempters. A high-positive correlation was found between FIQR and Plutchik suicide risk scale scores. Pain, poor sleep quality, anxiety and depression were positively correlated with suicide risk. CONCLUSIONS: FM is associated with an increased risk of suicide and suicide attempts. Suicidal behaviour seems to be related with the global severity of the disease.

Trazodone plus pregabalin combination in the treatment of fibromyalgia: a two-phase, 24-week, open-label uncontrolled study.

BACKGROUND: Although trazodone is frequently used by fibromyalgia patients, its efficacy on this disease has not been adequately studied. If effective, pregabalin, whose beneficial effects on pain and sleep quality in fibromyalgia have been demonstrated, could complement the antidepressant and anxiolytic effects of trazodone. The aim of the present study was to assess the effectiveness of trazodone alone and in combination with pregabalin in the treatment of fibromyalgia. METHODS: This was an open-label uncontrolled study. Trazodone, flexibly dosed (50-300 mg/day), was administered to 66 fibromyalgia patients during 12 weeks; 41 patients who completed the treatment accepted to receive pregabalin, also flexibly dosed (75-450 mg/day), added to trazodone treatment for an additional 12-week period. Outcome measures included the Fibromyalgia Impact Questionnaire (FIQ), the Pittsburgh Sleep Quality Index (PSQI), the Beck Depression Inventory (BDI), the Hospital Anxiety and Depression Scale (HADS), the Brief Pain Inventory (BPI), the Short-Form Health Survey (SF-36), and the Patients' Global Improvement scale (PGI). Emergent adverse reactions were recorded. Data were analyzed with repeated measures one-way ANOVA and paired Student's t test. RESULTS: Treatment with trazodone significantly improved global fibromyalgia severity, sleep quality, and depression, as well as pain interference with daily activities although without showing a direct effect on bodily pain. After pregabalin combination additional and significant improvements were seen on fibromyalgia severity, depression and pain interference with daily activities, and a decrease in bodily pain was also apparent. During the second phase of the study, only two patients dropped out due to side effects. CONCLUSIONS: Trazodone significantly improved fibromyalgia severity and associated symptomatology. Its combination with pregabalin potentiated this improvement and the tolerability of the drugs in association was good. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00791739.

Subgrouping patients with fibromyalgia according to the results of the Fibromyalgia Impact Questionnaire: a replication study.

Fibromyalgia is a complex and heterogeneous disease, and several attempts have been made in order to identify different subgroups of patients sharing a common symptomatology. The purpose of the present study has been to replicate a subgroup classification proposed by de Souza et al. based in the Fibromyalgia Impact Questionnaire (FIQ) in a large sample of patients with a cultural and clinical setting different from the original one. Four hundred twenty-one patients were classified, according to the results of the visual analog FIQ subscales in type I o type II subgroups. Demographic and clinical data, as well as results of scales assessing disease's severity, quality of life, sleep quality, anxiety and depression, were compared between the two groups. The profiles of type I and type II patients from our sample strikingly paralleled those of the original study, demonstrating the reproducibility of the classification. In our sample, 18.8% of the patients appertained to type I subgroup and 81.2% to type II subgroup. Patients from this later subgroup had higher comorbidity and received more drugs than those of the former. They were also more physically ill, with higher FIQ total scores and worse sleep quality, and more psychologically distressed, with higher levels of anxiety and depression and lower scores in the mental component summary of the Short-Form Health Questionnaire (SF-12). Our study shows that the proposed fibromyalgia classification is reliable and easy to perform and could be applied in further studies.

Trazodone for the treatment of fibromyalgia: an open-label, 12-week study.

BACKGROUND: Despite its frequent use as a hypnotic, trazodone has not been systematically assessed in fibromyalgia patients. In the present study have we evaluated the potential effectiveness and tolerability of trazodone in the treatment of fibromyalgia. METHODS: A flexible dose of trazodone (50-300 mg/day), was administered to 66 fibromyalgia patients for 12 weeks. The primary outcome measure was the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome measures included the Fibromyalgia Impact Questionnaire (FIQ), the Beck Depression Inventory (BDI), the Hospital Anxiety and Depression Scale (HADS), the Brief Pain Inventory (BPI), the Short-Form Health Survey (SF-36), and the Patients' Global Improvement Scale (PGI). Trazodone's emergent adverse reactions were recorded. Data were analyzed with repeated measures one-way ANOVA and paired Student's t test. RESULTS: Trazodone markedly improved sleep quality, with large effect sizes in total PSQI score as well on sleep quality, sleep duration and sleep efficiency. Significant improvement, although with moderate effect sizes, were also observed in total FIQ scores, anxiety and depression scores (both HADS and BDI), and pain interference with daily activities. Unexpectedly, the most frequent and severe side effect associated with trazodone in our sample was tachycardia, which was reported by 14 (21.2%) patients. CONCLUSIONS: In doses higher than those usually prescribed as hypnotic, the utility of trazodone in fibromyalgia management surpasses its hypnotic activity. However, the emergence of tachycardia should be closely monitored. TRIAL REGISTRATION: This trial has been registered with ClinicalTrials.gov number NCT-00791739.