US Parents' Acceptance of Learning About Mindfulness Practices for Parents and Children: National Cross-sectional Survey.

BACKGROUND: Mindfulness practices are associated with improved health and well-being for children. Few studies have assessed parents' acceptance of learning about mindfulness practices. OBJECTIVE: This study aims to assess parents' beliefs and interest in learning about mindfulness, including from their health care provider, and differences across demographic backgrounds. METHODS: We conducted a national cross-sectional survey of parents with children aged 0-18 years in October 2018. Measures included beliefs and interest in learning about mindfulness. These measures were compared across demographic backgrounds using chi-square analysis. Multivariate linear and logistic regression analyses were used to perform adjusted comparisons between demographic backgrounds. RESULTS: Participants (N=3000) were 87% (n=2621) female and 82.5% (n=2466) Caucasian. Most (n=1913, 64.2%) reported beliefs that mindfulness can be beneficial when parenting, 56.4% (n=1595) showed interest in learning about mindfulness to help their child stay healthy, and 40.8% (n=1214) reported interest in learning about mindfulness from their health care provider. Parents with a college degree 49.6% (n=444) were more likely to report interest in learning about mindfulness from a health care provider compared to those without 37.1% (n=768; P<.001). Parents interested in learning about mindfulness were more likely to be male 62.6% (n=223; P<.001). There was no significant difference in interest in learning about mindfulness from a health care provider based on race. CONCLUSIONS: This study indicates that many parents believe mindfulness can be beneficial while parenting and are interested in learning how mindfulness could help their child stay healthy. Findings suggest there is an opportunity to educate families about mindfulness practices.

Prospective empirical test suite for energy practitioners.

OBJECTIVE: To design a set of measures which were portable and cost-effective that scientists could use to determine competence of Energy Practitioners so that qualified practitioners could be employed in improving ongoing research accuracy. DESIGN: This was a prospective study with sample of convenience. SUBJECTS: 213 subjects, 185 women and 28 men, were tested in this study. OUTCOME MEASURES: Empirical outcome measures included Triaxial Extra Low Frequency Magnetic Field meter, Data Logging Multimeter, RF Field Spectrum Analyzer, Acoustimeter, Broadcast Frequency counter, digital pH meter, digital TDS meter, GDV and physiology suite including heart rate variability, galvanic skin response, respiration, EMG, EKG, temperature and blood volume pulse. Additional questions on ethics and body reading were included in the test. RESULTS: Results suggest a range of tests which could be used to determine practitioner competence. Many of the energy practitioners tested consistently produced changes in the areas being measured past the error rate of the devices being used. Across the 13 measures, practitioner success ranged from 56.8% on the Acoustimeter to 100% on the Broadcast Frequency Counter measures with 95% CI. Tri Axial ELF magnetic field meter showed significance with practitioners producing oscillations of amplitude from the L hand at p< 0.01 with and effect size D of 1.5 and R hand p< 0.001 and an effect size D of 1.6. Practitioners demonstrated the ability to produce a change in pH beyond ±.1pH in 10 minutes at a Mean of 0.5 and a SD of 0.4 at a 95% CI of 0.48-0.58 and changes in TDS beyond+/-2% at a Mean of 36.7 and a SD of 35.2 at a 95% CI of 31.9-41.5. Other measures are discussed in detail. CONCLUSIONS: This test presents a possible way to demonstrate a level of practitioner competence and improve the selection of energy practitioners for use in scientific studies of energy healing in the areas of full spectrum healing, laying-on-of-hands healing, Reiki, Qi Gong and Tai Chi.

Parents' Acceptance of Learning about Mindfulness for Managing Pediatric Asthma.

BACKGROUND: Emerging research suggests mindfulness may reduce stress and asthma symptoms in children, yet there is a gap in understanding parental views towards learning about mindfulness. OBJECTIVE: This study aimed to compare the perceived acceptance to learn about mindfulness among parents of children with and without asthma, and to understand differences across income levels. METHODS: This was a national, cross-sectional, online survey of parents of children 0-18 years. Acceptance was measured with questions on whether parents believe mindfulness could be beneficial while parenting, and if they would be willing to learn about mindfulness. Comparisons of mindfulness acceptance between income level were conducted using chi-square and Fisher's exact test. RESULTS: Parents of children with asthma were more likely to be interested in learning about mindfulness from their health care provider compared to those without asthma (46% vs. 38%, p < 0.0001). At all income levels examined in the study, parents (63-75%) of children with asthma indicated that they agreed or strongly agreed that mindfulness can be beneficial when parenting. CONCLUSION: Findings suggest an opportunity to incorporate mindfulness teaching into asthma care for pediatric patients of all income levels.

A digital media attention diversion improves mood and fear in patients receiving chemotherapy for recurrent gynecologic malignancies: results of a randomized trial.

BACKGROUND: Recurrent gynecologic cancer patients experience symptoms that affect psychologic, emotional, social, and physical well-being. Chemotherapy can further exacerbate these symptoms. Poor mood, pain, and fatigue are linked and are detrimental to quality of life. Interventions targeting these symptoms may improve patient-reported outcomes and performance status. OBJECTIVES: To determine the ability of a humorous digital media attention diversion to improve symptom domains of positive and negative mood during chemotherapy for patients with recurrent gynecologic cancers. STUDY DESIGN: This randomized, crossover clinical trial enrolled women with recurrent gynecologic cancers. Subjects participated over three cycles of chemotherapy. The primary outcome was the change in mood on the validated Positive and Negative Affect Scale-Extended (PANAS-X) instrument, which measures positive and negative affect domains. All subjects completed the PANAS-X after receiving chemotherapy during cycle 1 on study. In atudy arm 1, subjects watched their choice of humorous movies on a digital media device while receiving chemotherapy during cycle 2 on study. They selected from non-humorous movies during cycle 3 on study. In arm 2, the order of movies was reversed. After each cycle, mood, fatigue, and other patient-reported outcomes were assessed for comparison with baseline measurements. RESULTS: The target enrollment of 66 subjects was achieved. Subjects watched humorous content for an average of 96.0 min and non-humorous content for an average of 62.5 min. Negative mood improved after exposure to humorous (p=0.017) and non-humorous content (p=0.001). Patient-reported fear also improved after exposure to both humorous (p=0.038) and non-humorous content (p=0.002). Subjects reported higher use of affiliating and self-effacing humor types. CONCLUSIONS: Offering patients a choice of digital media during chemotherapy significantly improved negative mood and fear. This was seen with both humorous and non-humorous content. This low-cost and low-risk intervention should be implemented as an attention diversion to improve negative mood and fear for patients receiving chemotherapy.

Improvement of Health-Related Quality of Life in Children with Inflammatory Bowel Disease Receiving Routine Intravenous Iron Supplementation.

OBJECTIVES: Iron deficiency anemia (IDA) is very common in children with inflammatory bowel disease (IBD). While health-related quality of life (HRQL) is a key outcome measure, no long-term studies have evaluated the effect of correction of IDA on HRQL in children with IBD. Our goal was to prospectively study changes in HRQL in iron-deficient children with IBD receiving routine iron supplementation with periodic intravenous iron sucrose (IVIS). METHODS: Thirty-eight children with IBD treated with infliximab participated. Hematology and inflammatory markers were assessed before each infliximab treatment. Iron-deficient patients (transferrin saturation below 20% and/or ferritin below 30 ng/mL or 100 ng/mL with normal or elevated C-reactive protein, respectively) received IVIS after each infliximab infusion until iron indices stayed normal for two consecutive measurements. HRQL was assessed with Pediatric Quality of Life Inventory every 4 months. Correlation between changes in mean hemoglobin levels and HRQL scores was analyzed prospectively in 3-month periods over a period exceeding 3 years. RESULTS: At enrollment, 27 patients had already been established on infliximab; 11 had not started or completed induction. Mean iron indices and hemoglobin normalized after 3 and 6 month of starting IVIS, respectively. Multiple HRQL parameters significantly improved, regardless of the duration of infliximab treatment at the time of enrollment. There was a statistically significant positive correlation between correction of anemia and improvement in parent-reported emotional and physical HRQL scores. CONCLUSIONS: Periodic IVIS resulted in long-term correction of IDA in children with IBD. Correction of IDA contributed to some improvements in HRQL.

Why do patients die after a liver transplantation?

BACKGROUND: As more patients achieve long-term survival, it has become important to understand mortality in liver transplantation (LT) recipients. METHODS: We conducted retrospective reviews of long-term outcome in two adult LT cohorts: 85 031 in the United Network for Organ Sharing (UNOS) database and 1458 transplanted at the University of Wisconsin (UW). RESULTS: During median follow-up of 3.2 years (UNOS) and 6.6 years (UW), 35.1% of UNOS patients and 44.2% of UW patients died; 43.1% of all UNOS deaths occurred in year 1 compared to 25.1% in the UW cohort. Deaths due to infection (other than viral hepatitis) or cardiovascular (CV) causes were most frequent in year 1 in both cohorts and then persisted at lower rates. In contrast, death from malignancy increased after year 1 to peak in years 1-5. Deaths due to rejection, hepatitis, or graft failure were infrequent. In the UW cohort, de novo malignancy was more common than recurrent tumor and correlated with smoking history. CONCLUSIONS: A coordinated holistic approach that focuses on limiting immunosuppression, infection, risky behaviors, and CV risks, while screening for cancer, is needed to extend the healthy lives of LT recipients.

Evaluation of a pharmacist-led pilot service based on the anticholinergic risk scale.

OBJECTIVES: To determine primary care physician (PCP) acceptance rates of electronic medication therapy recommendations based on anticholinergic burden for high-risk elderly patients, and to evaluate potential associations between recommendation acceptance and patient-provider characteristics. SETTING: Two medical clinics within Dean Health System, an integrated health care organization comprising ambulatory surgery centers, medical clinics, community pharmacies, specialty pharmacies, a health plan, and a pharmacy benefits management company. PRACTICE INNOVATION: In this pilot service, the medical records of patients at least 60 years old who met the following criteria were evaluated bimonthly: 1) PCP visit within 2 weeks; (2) three or more inpatient hospitalizations or emergency department visits in the past year; and (3) ten or more active medications. Anticholinergic Risk Scale (ARS) scores of eligible patients were calculated, and medication therapy recommendations were sent electronically to PCPs for patients with an ARS score greater than 3. Post-visit recommendation outcomes were recorded. EVALUATION: Descriptive statistics were utilized to characterize patients, physicians, and recommendations. A generalized linear mixed effects model with physician specific random effects was employed to evaluate recommendation acceptance rates, and odds ratios were calculated to quantify associations between baseline patient/provider characteristics and the likelihood of recommendation acceptance. Changes in aggregate ARS scores were evaluated with the use of a paired t test. RESULTS: Fifty-nine patients were included in this pilot, with 89 medication therapy recommendations made to 21 PCPs. An overall recommendation acceptance rate of 50% (95% confidence interval [CI] 37%-63%) was observed. There were no significant associations identified between baseline patient/provider characteristics and medication recommendation acceptance. CONCLUSION: High recommendation acceptance rates were achieved with the combination of objective anticholinergic risk assessment and algorithm-driven medication therapy recommendations. The lack of identified associations between patient/provider characteristics and recommendation acceptance supports the future scalability of this novel service.

A phase II study of sorafenib, oxaliplatin, and 2 days of high-dose capecitabine in advanced pancreas cancer.

PURPOSE: Fluoropyrimidines and oxaliplatin have demonstrated some efficacy against pancreatic adenocarcinoma, but survival remains brief. Sorafenib is an oral multikinase inhibitor which we sought to combine with a unique capecitabine and oxaliplatin regimen for pancreatic adenocarcinoma. METHODS: We performed a multicenter phase II study of sorafenib 200 mg orally twice daily along with oxaliplatin 85 mg/m(2) IV on days 1 and 15, followed by capecitabine 2250 mg/m(2) orally every 8 h for six doses starting on days 1 and 15 of a 28-day cycle in patients who had no more than one previous chemotherapy regimen for their pancreatic adenocarcinoma. The primary objective was response rate; secondary objectives were progression-free survival (PFS), overall survival (OS), and safety. RESULTS: Twenty-four patients were enrolled; median age was 63 years (range 48-83). The most common related toxicities were fatigue, neuropathy, anemia, thrombocytopenia, diarrhea, nausea, leukopenia, and hand-foot syndrome. Grade 3 hand-foot syndrome was rare (4 %). Other grade 4 toxicities included abdominal pain (8 %), pulmonary embolism (4 %), and anemia (4 %). Three partial responses were seen (13 %), and 11 patients had stable disease (46 %) as their best response. Median PFS was 6.0 months (range 1.5-13 months). Median OS was 8.1 months (range 1.5-13.6 months). CONCLUSIONS: Sorafenib, oxaliplatin, and capecitabine produced partial responses in patients with advanced pancreatic cancer including previously treated patients and demonstrated a PFS of 6 months with few grade 3/4 toxicities.

Effects of energy enhancer patches on cortisol production, peripheral circulation, and psychological measures: a pilot study.

CONTEXT: LifeWave Energy Enhancer (LEE) patches (LifeWave Corp, San Diego, CA, USA) on skin produce some changes that are consistent with increased energy production, but little is known about their effects on cortisol concentrations or the peripheral circulation. OBJECTIVE: The study intended to assess the effects of LEE patches on salivary cortisol, peripheral circulation, and psychological measures on healthy adults. METHODS: A double-blind, placebo-controlled, randomized pilot study was performed. SETTING/LOCATION: Measurements were made in the laboratory at Mind-Body-Science (Tucson, AZ, USA). Participants collected some of the saliva samples at work or home. PARTICIPANTS: To obtain pilot data, 20 healthy individuals with no chronic conditions were recruited-5 males and 15 females-aged 30-69 y. INTERVENTION: Participants completed baseline psychological questionnaires and provided saliva samples for hormonal analysis. The next day, fingertip microvascular perfusion was measured, LEE or placebo patches were applied to participants' wrists, and perfusion scans were repeated, first immediately after and then 10 min after application of the patch. Saliva samples were collected, and questionnaires were completed. Participants returned at noon and 4:00 PM for further scans, and at the end of that time, the patches were removed. The protocol was repeated the following day using new patches. OUTCOME MEASURES: The research team analyzed the saliva samples for levels of cortisol and measured the percentage changes in cutaneous microvascular perfusion. The participants completed the energy visual analog scales (eVASs) and the Marlowe-Crowne Social Desirability survey. RESULTS: After the first patch application, the active group showed significantly higher cortisol concentrations than the placebo group, both at noon-2.39 ± 0.17 ng/mL vs 2.15 ± 0.27 (P = .0360), respectively-and at 4:00 PM- 2.02 ± 0.24 vs 1.67 ± 0.31 (P = .0155), respectively. No consistent changes occurred in perfusion. The eVAS score decreased significantly compared with baseline in the placebo group but not in the active group. CONCLUSION: Cortisol concentrations and eVAS scores showed significant differences between groups, which is consistent with the patches increasing energy production, warranting further testing.

Yttrium 90-ibritumomab tiuxetan plus rituximab maintenance as initial therapy for patients with high-tumor-burden follicular lymphoma: a Wisconsin Oncology Network study.

INTRODUCTION: Yttrium 90-ibritumomab tiuxetan (90Y-IT) radioimmunotherapy has proved to be effective in relapsed follicular lymphoma (FL). We conducted a clinical trial in which 90Y-IT followed by maintenance rituximab (MR) was evaluated as initial therapy for high-tumor-burden FL. METHODS: Eligible patients had histologically confirmed FL and met the GELF (Groupe d'Etude des Lymphomes Folliculaires) criteria for high tumor burden. All patients received a single dose of 90Y-IT. Patients with platelet counts of 150,000/mm³ or higher received 0.4 mCi/kg, and patients with platelet counts between 100,000/mm³ and 149,000/mm³ received 0.3 mCi/kg. At 6 months, patients without progressive disease (PD) received rituximab weekly for 4 weeks at a dose of 375 mg/m² (consolidation therapy), followed by MR consisting of the same dose every 3 months for a planned 5 years. RESULTS: From January 2005 through November 2007, a total of 16 patients were enrolled. The median age was 52 years (range, 37-75). The major toxicity from 90Y-IT was myelosuppression, with 88% and 31% of the patients experiencing grade 3 and grade 4 hematologic toxicity, respectively. The responses to 90Y-IT induction therapy were as follows: 7 patients with complete response/unconfirmed complete response (CR/Cru), 4 with partial response (PR), 3 with stable disease (SD), and 2 with progressive disease (PD). We identified 6 patients with early PD (range, 4-16 months) and 10 patients with prolonged remission (range, 37-101+ months). Compared with the patients who had prolonged remission, the patients who had early PD tended to have larger baseline nodal masses. The median progression-free survival (PFS) has not been reached after a median follow-up period of 48 months. The 3-year PFS and overall survival (OS) rates were 56% (95% CI, 37%-87%) and 93% (95% CI, 80%-100%), respectively. CONCLUSION: The overall response rate (ORR) to 90Y-IT was 69% in patients who had previously untreated, high-tumor-burden FL, which is lower than what is observed with contemporary rituximab/chemotherapy combinations. MR after 90Y-IT did convert all PRs to CRs. Alternative therapies should be considered for patients who have FL with large nodal masses (>9 cm), whereas very durable responses are possible in patients who have intermediate-size masses (>9 cm).

Validation and clinical utility of a bowel habit questionnaire in school-age children.

OBJECTIVES: The aim of the study was to validate a brief Bowel Habit Questionnaire (BHQ) with prospectively obtained data from a 14-day diary and to determine whether the BHQ predicts the development of medically significant constipation (MSC) during the following year. MATERIALS AND METHODS: The BHQ was distributed to parents of children ages 5 to 8 years during health supervision visits. Both the BHQ and subsequent diary were scored to indicate constipation if at least 2 of the following were reported: infrequent bowel movements, stool accidents, straining, avoidance, discomfort with defecation, or passing large stools >25% of the time. One year later, the BHQ was repeated to assess for MSC, defined as medical encounters about constipation or use of enemas, suppositories, laxatives, or stool softeners. RESULTS: MSC was reported for 57 (13.7%) of 416 children on the first BHQ. Paired BHQ and diary data were obtained for 269 children; 54 (20.1%) had diary scores indicating constipation. BHQ had a sensitivity of 59.6% (95% confidence interval [CI] 46.7%-71.4%) and a specificity of 82.6% (95% CI 77.0%-87.1%). One year later, 11 children (5.2%) had developed new-onset MSC; 7 (63.6%) of these children had initial BHQ scores of at least 2. Positive and negative predictive values for MSC were 19.4% (95% CI 9.8%-35.0%) and 97.7% (94.2%-99.1%), respectively. CONCLUSIONS: Parents often do not recognize constipation in young school-age children and most constipated children remain untreated. A brief screening questionnaire in this population proved to be valid but only moderately sensitive; efforts to improve sensitivity are needed before recommending it for routine use.

Randomized trial of adjuvant zoledronic acid in postmenopausal women with high-risk breast cancer.

PURPOSE: We present the results of a randomized multicenter clinical trial of adjuvant zoledronic acid (ZA) in postmenopausal women with high-risk breast cancer. The primary objective was change in bone mineral density (BMD) at the lumbar spine and femoral neck at 1 year. Secondary objectives included change in calcaneal BMD, disease-free survival (DFS), overall survival (OS), and toxicity. PATIENTS AND METHODS: Postmenopausal women with stage II/III breast cancer diagnosed up to 5 years previous were eligible and randomized to either observation or ZA 4 mg intravenous every 3 months. Bone mineral density testing was performed at 0, 6, and 12 months. RESULTS: Sixty-eight women were enrolled (36 ZA and 32 observation). The population was a median of 2 years from diagnosis and the majority received tamoxifen during the study. There was a significant difference in the mean change from baseline to 1 year follow-up for lumbar spine (increased by 4.28% ± 0.62%; P = .01), total femur (increased by 1.9% ± 0.4%; P = .03), trochanter (increased by 2.97% ± 0.69%; P = .03), and calcaneal BMD (increased by 2% ± 0.57%; P = .01) in favor of the ZA arm. No significant difference in the mean change for the femoral neck was seen. No significant differences in DFS or OS were observed. CONCLUSION: Zoledronic acid significantly improved the BMD at multiple skeletal sites in postmenopausal women largely on tamoxifen. No new safety signals were noted. There were insufficient events to comment on DFS or OS.

A phase II study of oxaliplatin, 5-fluorouracil, leucovorin, and high-dose capecitabine in patients with metastatic colorectal cancer.

PURPOSE: Capecitabine has shown similar efficacy to 5-fluorouracil (5-FU); a regimen containing 2 weeks of capecitabine/oxaliplatin (CapOx) has demonstrated noninferiority to infusional 5-FU/oxaliplatin/leucovorin (FOLFOX) for the treatment of metastatic colorectal cancer (mCRC). This phase II study explores the efficacy and safety of a 2-day course of oxaliplatin/capecitabine (2DOC), with oxaliplatin given on day 1 and capecitabine given orally every 8 hours in high doses over 6 doses, mimicking FOLFOX6. PATIENTS AND METHODS: This phase II study was conducted by the University of Wisconsin Carbone Cancer Center. Eligible patients with mCRC received oxaliplatin 100 mg/m2 intravenously (I.V.) over 2 hours followed by leucovorin 20 mg/m2 I.V. bolus and 5-FU 400 mg/m2 I.V. bolus on day 1 and day 15. Capecitabine was administered at 1500 mg/m2 orally every 8 hours over 6 doses starting on day 1 and day 15. RESULTS: A total of 45 patients were enrolled; 44 were evaluated for response. Seventeen patients (39%) had objective responses. Median time to progression was 6.8 months, and median overall survival (OS) was 17.5 months. The most common side effects were grade 1/2 neuropathy, fatigue, and nausea. Severe hand-foot syndrome (HFS) was rare. CONCLUSION: The overall response rate with the 2DOC regimen is similar to published CapOx regimens, and time to progression and OS are similar. The incidence of HFS, diarrhea, and mucositis were lower compared with published results of 2-week schedules of capecitabine. The 2DOC regimen merits further study as a more convenient regimen than infusional 5-FU with less HFS when compared with a 2-week administration of capecitabine.

Effectiveness of amoxicillin/clavulanate potassium in the treatment of acute bacterial sinusitis in children.

OBJECTIVE: The role of antibiotic therapy in managing acute bacterial sinusitis (ABS) in children is controversial. The purpose of this study was to determine the effectiveness of high-dose amoxicillin/potassium clavulanate in the treatment of children diagnosed with ABS. METHODS: This was a randomized, double-blind, placebo-controlled study. Children 1 to 10 years of age with a clinical presentation compatible with ABS were eligible for participation. Patients were stratified according to age (<6 or >or=6 years) and clinical severity and randomly assigned to receive either amoxicillin (90 mg/kg) with potassium clavulanate (6.4 mg/kg) or placebo. A symptom survey was performed on days 0, 1, 2, 3, 5, 7, 10, 20, and 30. Patients were examined on day 14. Children's conditions were rated as cured, improved, or failed according to scoring rules. RESULTS: Two thousand one hundred thirty-five children with respiratory complaints were screened for enrollment; 139 (6.5%) had ABS. Fifty-eight patients were enrolled, and 56 were randomly assigned. The mean age was 66 +/- 30 months. Fifty (89%) patients presented with persistent symptoms, and 6 (11%) presented with nonpersistent symptoms. In 24 (43%) children, the illness was classified as mild, whereas in the remaining 32 (57%) children it was severe. Of the 28 children who received the antibiotic, 14 (50%) were cured, 4 (14%) were improved, 4 (14%) experienced treatment failure, and 6 (21%) withdrew. Of the 28 children who received placebo, 4 (14%) were cured, 5 (18%) improved, and 19 (68%) experienced treatment failure. Children receiving the antibiotic were more likely to be cured (50% vs 14%) and less likely to have treatment failure (14% vs 68%) than children receiving the placebo. CONCLUSIONS: ABS is a common complication of viral upper respiratory infections. Amoxicillin/potassium clavulanate results in significantly more cures and fewer failures than placebo, according to parental report of time to resolution of clinical symptoms.

Self-expanding metal stents versus plastic prostheses in the palliation of malignant dysphagia: long-term outcome of 153 consecutive patients.

BACKGROUND: Malignant dysphagia due to esophagogastric cancer is associated with poor overall prognosis. Placements of self-expandable metal stents or plastic tubes are established methods as palliative treatment options. As an alternative and/or complementary therapy, radiologic techniques (external beam radiation/brachytherapy) and locally endoscopic techniques (laser, APC-beamer, PDT) are often used. STUDY AND GOALS: Retrospective trial of 153 patients treated in our department between 1993 and 2001. Forty-five patients received a plastic tube (Group A) and 108 patients were treated with metal stents (Group B). Both groups were compared for improvement of dysphagia score, survival, recurrent dysphagia and complications. RESULTS: Stent placement was successful in 41 of 45 (93%) patients of Group A and 107 of 108 (99%) of Group B. The median dysphagia score improved significantly in Group A (from 3.03 to 1.55, P = 0.010) and Group B (from 2.77 to 1.44, P = 0.009). Recurrent dysphagia was noted in 12 of 45 (27%) patients of Group A and 27 of 108 (25%) patients of Group B. Median survival time after stent insertion was 78 days (Group A) and 113 days (Group B). Overall complications occurred in 15 of 45 (33%) patients of Group A and 28 of 108 (26%) patients of Group B. However, significantly (P = 0.05) more major complications were seen in Group A than in Group B (22% vs. 9%). CONCLUSIONS: Our results indicate a marginal clinical benefit for metal stents versus plastic tubes in malignant dysphagia in the long run. However, metal stents seem to be safer and associated with a prolonged improvement of dysphagia score.