BACKGROUND:Botulinum toxin A injected into the pyloric sphincter has been reported in small case series to treat gastroparesis. This study reviews the use of this treatment in a large number of patients with gastroparesis.METHODS:Patients who underwent pyloric botulinum injection for treatment of gastroparesis were identified. Response was defined as improvement or resolution of the patient's major symptom and/or two minor symptoms for 4 weeks.RESULTS:Of 115 patients treated, 63 patients met the study criteria. There were 53 women, 10 men, mean age 42 years. Most patients (56%) had idiopathic gastroparesis. Twenty-seven of 63 (43%) patients experienced a symptomatic response to treatment. By stepwise logistic regression, male gender was associated with response to treatment (OR 3.27: 95% CI[1.31, 8.13], p = 0.01). Vomiting as a major symptom was associated with a lack of response (OR 0.16: 95% CI[0.04, 0.67], p = 0.01). Despite the association of male gender with response, the mean duration of response for those patients responding, with a minimum of 3 months' follow-up was 4.9 months (+/-2.7 months) for women and 3.5 months (+/-0.71 months) for men (p = 0.59). The corresponding medians and interquartile ranges (IQR) were 5 (IQR 3-6) for females and 3.5 (IQR 3-4) for males.CONCLUSIONS:Of the patients, 43% had a response to botulinum toxin treatment that lasted a mean of approximately 5 months. Male gender was associated with a response to this therapy; however, durability of response was unrelated to gender. Vomiting as a major symptom predicted no response.
Purpose: To evaluate the efficacy and durability of pyloric injection with botulinum toxin A (Botox) for the treatment of refractory gastroparesis. To determine which variables predict response to treatment. Methods: We identified all patients who underwent EGD with Botox injection into the pylorus between 1/1/00 and 3/1/04 for documented gastroparesis. Patient's were included if follow-up data were available either by chart review or phone call. For each patient we determined: demographic data, etiology of gastroparesis, GES results, prior surgical history, and prokinetic therapy before injection. We also determined each patient's major and minor symptoms prior to treatment. “Complete response” = elimination of all symptoms for at least 4 weeks. “Partial response” = improvement but not resolution of major symptom or 2 minor symptoms for at least 4 weeks. “No response” = no improvement in symptoms or improvement lasting less than 4 weeks. Results: 63 of 115 patients had sufficient data for study inclusion. There were 53 females and 10 males. Mean age was 41.8 ± 13.5 (range 14–70). Mean follow-up was 9.3 months (range 1–37). Etiologies of gastroparesis were diabetic (41.3%), post-op (3.2%), and idiopathic (55.6%). Mean baseline GES results (% retention) were 68.2 ± 20.2% (normal <50%) at 2 hr and 41.2 ± 25.3% (normal <10%) at 4 hr. 14 patients (22%) had a complete response and 13 (21%) had a partial response for a mean of 5.1±2.8 and 2.9±2.2 months, respectively. 36 patients (57%) had no response. Both response categories were combined for further analysis. By stepwise logistic regression main symptom, GES result, age, and concurrent use of prokinet-ics were not associated with a response. Only female gender was associated with a response (OR = 8.6, 95% CI 1.8-40, p = 0.006). Moreover, females who responded had a longer response (4.4 ± 2.8 vs. 2.5 ±1.3 months, p = 0.036) than males who responded. Only females responded for >5 months after injection. Conclusions: This represents the largest report to date on the use of Botoxfor treatment of gastroparesis. Approximately 43% of patients had a response to this treatment. Of responders, over half had a complete response with elimination of symptoms for ≥ 4 weeks. Female gender was associated with a response which was more durable in comparison to males who responded. Controlled trials appear warranted based on these results.
OBJECTIVES:The aim of this study was to determine whether specialized intestinal metaplasia recurs after complete laser ablation and to evaluate the persistence of colon epithelial protein in esophageal mucosa after laser ablation as a predictor of recurrence.METHODS:A total of 31 patients with specialized intestinal metaplasia (Barrett's esophagus) underwent laser photoablation. Investigators without knowledge of treatment status evaluated serial hematoxylin and eosin–stained slides, Alcian blue–stained slides, and immunohistochemistry for the detection of colon epithelial protein (mAb Das-1).RESULTS:Endoscopic ablation of specialized intestinal epithelium was accomplished in 21 patients after 6.5 ± 1.2 laser sessions. Complications included one perforation, one UGI bleed and one stricture. Of eight post-laser recurrences, seven were successfully re-ablated; one developed adenocarcinoma requiring esophageal resection. Cardia-type mucosa was present by biopsy at the time of complete ablation in all eight recurrent cases despite a normal endoscopic appearance. Colon epithelial protein was detected in all 31 patients before ablation, six of 21 completely ablated patients before they recurred and all eight recurrences. Only two of 15 patients, colon epithelial protein negative at the time of complete ablation, developed recurrent Barrett's esophagus. Thus, cardia-type mucosa and persistent colon epithelial protein staining after complete ablation of specialized intestinal epithelium were predictors of future recurrence (p < 0.001).CONCLUSION:Specialized intestinal epithelium was ablated by neodymium:yttrium-aluminum-garnet laser but recurred in eight of 21 (38%) of patients. Colon epithelial protein was present in all primary (31 of 31) and all recurrent (eight of eight) Barrett's esophagus. Recurrent specialized intestinal metaplasia may be deep to squamous epithelium. Replacement of specialized intestinal mucosa by cardia-type mucosa and persistence of colonic epithelial protein are predictors of recurrent specialized intestinal mucosa before its endoscopic or histological detection. Laser ablation of Barrett's epithelium is an investigational intervention that should be restricted to research protocols.
OBJECTIVES:We aimed to determine if botulinum toxin injection into the pyloric sphincter improves gastric emptying and reduces symptoms in patients with idiopathic gastroparesis. METHODS:Patients with idiopathic gastroparesis not responding to prokinetic therapy underwent botulinum toxin (80-100 U, 20 U/ml) injection into the pyloric sphincter. Gastric emptying scintigraphy was performed before and 4 wk after treatment. Total symptom scores were obtained from the sum of eight upper GI symptoms graded on a scale from 0 (none) to 4 (extreme). RESULTS:Ten patients were entered into the study. The mean percentage of solid gastric retention at 4 h improved from 27+/-6% (normal < 10%) before botulinum toxin injection into the pylorus to 14+/-4% (p = 0.038) 4 wk after treatment. The symptom score decreased from 15.3+/-1.7 at baseline to 9.0+/-1.9 (p = 0.006) at 4 wk, a 38+/-9% decrease. Improvement in symptoms tended to correlate with improved gastric emptying of solids (r = 0.565, p 0.086). CONCLUSIONS:This initial pilot study suggests that botulinum toxin injection into the pylorus in patients with idiopathic gastroparesis improves both gastric emptying and symptoms.
To identify factors which improve glycaemic control measured as HbA1c in children and adolescents with diabetes treated at paediatric departments.Through data from the Swedish paediatric diabetes quality registry, SWEDIABKIDS, five centres respectively with the lowest, highest, and largest decrease in centre mean HbA1c (Low, High, Decrease HbA1c centres) were identified. Diabetes team members completed questionnaires (109 of 128 responsed) and reported team structure, process and policy. Open-ended questions were analysed with summative content analysis.Compared to the High HbA1c centres, the Low and Decrease HbA1c centres showed higher compliance with guidelines, although they had shorter professional experience and lower proportion of special diabetes-educated team members. A clear message was given and the centres aimed at a lower HbA1c target value. Team members were devoted, had a positive attitude and perception of a well-functioning team. Trends for higher mean insulin dose and larger centre size were found. High HbA1c centres gave a vague message and had a perception of lack of cooperation in the team.Team members’ policy and approaches affect glycaemic control in children and adolescents. Team members need to be aware of their approach and of the importance of using resources within the team.