Rating of four different foods in women with hyperemesis gravidarum: a randomised controlled trial.

OBJECTIVE: To evaluate four foods in women with hyperemesis gravidarum (HG) on their agreeability and tolerability. DESIGN: Prospective, randomised, within-subject cross-over trial. SETTING: Single-centre, tertiary, university hospital in Malaysia. PARTICIPANTS: 72 women within 24-hour of first admission for HG who were 18 years or above, with confirmed clinical pregnancy of less than 16 weeks' gestation were recruited and analysed. Women unable to consume food due to extreme symptoms, known taste or swallowing disorder were excluded. INTERVENTIONS: Each participant chewed and swallowed a small piece of apple, watermelon, cream cracker and white bread in random order and was observed for 10 min after each tasting followed by a 2 min washout for mouth rinsing and data collection. OUTCOME MEASURES: Primary outcome was food agreeability scored after 10 min using an 11-point 0-10 Visual Numerical Rating Scale (VNRS). Nausea was scored at baseline (prior to tasting) and 2 and 10 min using an 11-point VNRS. Intolerant responses of gagging, heaving and vomiting were recorded. RESULTS: On agreeability scoring, apple (mean±SD 7.2±2.4) ranked highest followed by watermelon (7.0±2.7) and crackers (6.5±2.6), with white bread ranked lowest (6.0±2.7); Kruskal-Wallis H test, p=0.019. Apple had the lowest mean nausea score and mean rank score, while white bread had the highest at both 2 and 10 min; the Kruskal-Wallis H test showed a significant difference only at 10 min (p=0.019) but not at 2 min (p=0.29) in the ranking analyses. The intolerant (gagged, heaved or vomited) response rates within the 10 min study period were apple 3/72 (4%), watermelon 7/72 (10%), crackers 8/72 (11%) and white bread 12/72 (17%): χ2 test for trend p=0.02. CONCLUSION: Sweet apple had the highest agreeability score, the lowest nausea severity and intolerance-emesis response rate when tasted by women with HG. White bread consistently performed worst.

Higher quality of life after metal stent placement compared with plastic stent placement for malignant extrahepatic bile duct obstruction: a randomized controlled trial.

OBJECTIVE: For palliation of extrahepatic bile duct obstruction, self-expandable metal stents (SEMS) are superior to plastic stents in terms of stent patency and occurrence of stent dysfunction. We assessed health-related quality of life (HRQoL) after stent placement to investigate whether this also results in a difference in HRQoL between patients treated with a plastic stent or SEMS. PATIENTS AND METHODS: This randomized multicenter trial included 219 patients who were randomized to receive plastic stent (n=73) or SEMS [uncovered (n=75) and covered (n=71); n=146] placement. HRQoL was assessed with two general questionnaires (EQ-5D-3L and QLQ-C30) and one disease-specific questionnaire (PAN-26). Scores were analyzed using linear mixed model regression and included all patients with baseline and at least one follow-up measurement. RESULTS: HRQoL data were available in 140 of 219 patients (64%); 71 patients (32%) declined participation and in eight patients (4%) only baseline questionnaires were available. On the QLQ-C30, the interaction between follow-up time and type of stent was significantly different on two of five functional scales [physical functioning (P=0.004) and emotional functioning (P=0.01)] in favor of patients with a SEMS. In addition, patients with SEMS reported significantly less frequent symptoms of fatigue (P=0.01), loss of appetite (P=0.02), and nausea and vomiting (0.04) over time. The EQ-VAS score decreased with time in both treatment groups, indicating a statistically significant decrease in HRQoL over time. CONCLUSION: In patients with inoperable malignant extrahepatic bile duct obstruction, SEMS placement results in better scores for general and disease-specific HRQoL over time compared with plastic stent placement.

Cost Efficacy of Metal Stents for Palliation of Extrahepatic Bile Duct Obstruction in a Randomized Controlled Trial.

BACKGROUND & AIMS: Endoscopic stents are placed for palliation of extrahepatic bile duct obstruction. Although self-expandable metal stents (SEMS) remain patent longer than plastic stents, they are more expensive. We aimed to evaluate which type of stent (plastic, uncovered SEMS [uSEMS], or partially covered SEMS [pcSEMS]) is the most effective and we assessed costs. METHODS: We performed a multicenter randomized trial in 219 patients at 18 hospitals in The Netherlands from February 2008 through February 2013. Patients were assigned randomly for placement of a plastic stent (n = 73), uSEMS (n = 75), or pcSEMS (n = 71) during endoscopic retrograde cholangiopancreatography. Patients were followed up for up to 1 year. Researchers were not blinded to groups. The main study end points included functional stent time and costs. RESULTS: The mean functional stent times were 172 days for plastic stents, 288 days for uSEMS, and 299 days for pcSEMS (P < .005 for uSEMS and pcSEMS vs plastic). The initial placement of plastic stents (€1042 or $1106) cost significantly less than placement of SEMS (€1973 or $2094) (P = .001). However, the total cost per patient at the end of the follow-up period did not differ significantly between plastic stents (€7320 or $7770) and SEMS (€6932 or $7356) (P = .61). Furthermore, in patients with short survival times (≤3 mo) or metastatic disease, the total cost per patient did not differ between plastic stents and SEMS. No differences in costs were found between pcSEMS and uSEMS. CONCLUSIONS: Although placement of SEMS (uncovered or partially covered) for palliation of extrahepatic bile duct obstruction initially is more expensive than placement of plastic stents, SEMS have longer functional time. The total costs after 1 year do not differ significantly with stent type. Dutch Clinical Trial Registration no: NTR1361.