Two placebo-controlled crossover studies in healthy subjects to evaluate gastric acid neutralization by an alginate-antacid formulation (Gaviscon Double Action).

OBJECTIVE: To investigate the intragastric acid neutralization activity of a combined alginate-antacid formulation. SIGNIFICANCE: Published studies have investigated the reflux-suppressing alginate component of Gaviscon Double Action (Gaviscon DA; RB, UK) but intragastric acid neutralization activity of the antacid component has not been evaluated in vivo. METHODS: Intragastric pH monitoring, using a custom-made 10-electrode catheter, was evaluated in a two-part exploratory study in healthy subjects; Part I (n = 6) tested suitability of the catheter using antacid tablets (Rennie; Bayer, Germany); Part II (n = 12) evaluated gastric acid neutralization activity of Gaviscon DA liquid (20 ml) versus placebo in fasted subjects using a randomized, open-label, crossover design. The primary endpoint was the percentage of time that intragastric pH ≥4 was measured during 30 min post-treatment. A confirmatory study of identical design was subsequently conducted (n = 20). RESULTS: Monitoring pH using the multielectrode catheter was a viable approach, directly detecting changes in intragastric pH following a single dose of antacid tablets. In the exploratory study, the percentage of time that pH ≥4 during 30 minutes post-treatment was 46.8% with Gaviscon DA liquid versus 4.7% with placebo (p = 0.0004). These findings were supported by the confirmatory study, where pH ≥4 was recorded 50.8% of the time with Gaviscon DA versus 3.5% with placebo (p = 0.0051). In this study, Gaviscon DA was safe and well tolerated. CONCLUSIONS: These studies demonstrate the effective acid neutralizing capacity of Gaviscon DA versus placebo in healthy, fasted subjects. This adds to the evidence base for the combination of alginates and antacids.

The interplay between partners' responsiveness and patients' need for emotional expression in couples coping with cancer.

The central aim of this longitudinal observational study was to test whether patients with a high need for emotional expression are especially sensitive to their partners' responsive behavior, and therefore at risk for depressive symptoms when responsiveness is withheld. Patients with colorectal cancer and their partners (n = 58) participated in a longitudinal study (3, 5 and 9 months after the diagnosis). Additionally to self-report measurements (i.e., patients' need for emotional expression, patients' depressive symptoms and patients' relationship satisfaction) couples were videotaped discussing cancer-related concerns. External observers coded partners' responsiveness (i.e., understanding, validation and caring) and patients' self-disclosures. Partner responsiveness predicted lower levels of depressive symptoms over time in patients who had a relatively high need for emotional expression above and beyond the effect of relationship satisfaction. We demonstrated that partners' understanding and validation are more important in explaining patients' depressive symptoms than partners' caring behavior. Our findings highlight the importance of the relational context in improving adaptation to cancer taking into account individual differences.

Randomized Comparison of Surveillance Intervals in Familial Colorectal Cancer.

PURPOSE: Colonoscopic surveillance is recommended for individuals with familial colorectal cancer (CRC). However, the appropriate screening interval has not yet been determined. The aim of this randomized trial was to compare a 3-year with a 6-year screening interval. PATIENTS AND METHODS: Individuals between ages 45 and 65 years with one first-degree relative with CRC age < 50 years or two first-degree relatives with CRC were selected. Patients with zero to two adenomas at baseline were randomly assigned to one of two groups: group A (colonoscopy at 6 years) or group B (colonoscopy at 3 and 6 years). The primary outcome measure was advanced adenomatous polyps (AAPs). Risk factors studied included sex, age, type of family history, and baseline endoscopic findings. RESULTS: A total of 528 patients were randomly assigned (group A, n = 262; group B, n = 266). Intention-to-treat analysis showed no significant difference in the proportion of patients with AAPs at the first follow-up examination at 6 years in group A (6.9%) versus 3 years in group B (3.5%). Also, the proportion of patients with AAPs at the final follow-up examination at 6 years in group A (6.9%) versus 6 years in group B (3.4%) was not significantly different. Only AAPs at baseline was a significant predictor for the presence of AAPs at first follow-up. After correction for the difference in AAPs at baseline, differences between the groups in the rate of AAPs at first follow-up and at the final examination were statistically significant. CONCLUSION: In view of the relatively low rate of AAPs at 6 years and the absence of CRC in group A, we consider a 6-year surveillance interval appropriate. A surveillance interval of 3 years might be considered in patients with AAPs and patients with ≥ three adenomas.

[Endoscopists under examination]. / Endoscopisten de maat genomen.

In 2013 a nationwide screening for colorectal cancer in the Netherlands will start. As a consequence, the number of colonoscopies per year will rise and this will increase the demands for transparency concerning the individual skills of endoscopists and the endoscopy centres themselves. Quality indicators such as the percentage of colonoscopies in which the caecum was intubated, the adenoma detection rate (ADR), endoscope withdrawal time and the level of colon preparation should be monitored and controlled. A recent study in the Netherlands showed that the percentage of caecal intubation was close to or above the proposed standard of screening. The ADR was within quality limits, but the withdrawal time was not estimated. The colon preparation level surprisingly had no influence on ADR. When the national screening program starts, all participating endoscopists and centres must be sufficiently equipped to monitor their quality. This implies that audits should start in 2012.

Is self-disclosure in couples coping with cancer associated with improvement in depressive symptoms?

OBJECTIVE: This study examined associations between the degree of self-disclosure and changes in depressive symptoms in couples coping with colorectal cancer. METHOD: Sixty-four newly diagnosed patients and their partners completed a measure of depressive symptoms (Center of Epidemiologic Studies Depression Scale) 3 and 9 months postdiagnosis. Furthermore, approximately 2 months after the first assessment, they engaged in a cancer-related conversation in which the patient was asked to introduce a concern. Each partner's verbalizations of emotions, thoughts, and wishes (i.e., self-disclosures) were coded by independent observers. RESULTS: Patients who reported more depressive symptoms at baseline showed more self-disclosures. Mutual self-disclosure was not associated with lower levels of depressive symptoms in patients and partners as compared with one-sided self-disclosure or low disclosure in both patients and partners. It is important to note that decreases in depressive symptoms over time were least prominent in couples in which the partner disclosed a lot whereas the patient disclosed little. CONCLUSION: These results suggest that mere disclosure of emotions and thoughts to one's intimate partner is not beneficial in reducing distress. Partners' self-disclosure toward patients who disclose few emotions and concerns even appears to be harmful both for patients and partners, given that it reduces the decrease of depressive symptoms over time. If there is a mismatch in the need for self-disclosure within couples, partners with a strong need to talk about their emotions and concerns may be recommended to confide in someone else in their social network or to consult a health care professional.

Spousal support and changes in distress over time in couples coping with cancer: the role of personal control.

This longitudinal study has examined the associations between perceived supportive and unsupportive spousal behavior and changes in distress in couples coping with cancer. We tested whether people relatively low in their sense of personal control were more responsive to spousal supportive and unsupportive behavior than were people relatively high in personal control. Patients with colorectal cancer and their partners (n = 70) completed questionnaires at two assessment points: 3 (at baseline) and 9 months (at follow-up) after the diagnosis. We assessed perceived spousal supportive (SSL) and unsupportive (SSL-N) behavior, sense of personal control (Pearlin & Schooler's Mastery), and depressive symptoms (CES-D) in both patients and partners. Multilevel analysis (MLwiN) was used to examine changes in distress over time in a dyadic context. Patients and partners who perceived more spousal support reported less distress over time, but this only applied to those relatively low in personal control. Moreover, partners who perceived more unsupportive spousal behavior reported more distress, again only if they were relatively low in personal control. Patients and partners relatively high in personal control reported relatively low levels of distress, regardless of spousal behavior. In conclusion, people relatively low in personal control may be more adversely affected by unsupportive behavior and benefit more from supportive behavior than people relatively high in personal control.