Treatment of idiopathic gastroparesis with injection of botulinum toxin into the pyloric sphincter muscle

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.     

Pyloric injection of botulinum toxin for treatment of diabetic gastroparesis

BACKGROUND: Diabetic gastroparesis is a common clinical problem. The pathophysiology includes prolonged pyloric contractions that may cause functional resistance to gastric outflow. Botulinum toxin was injected into the pyloric sphincter in an attempt to decrease pyloric resistance and improve gastric emptying. METHODS: Six patients with diabetic gastroparesis and an abnormal solid phase gastric emptying study underwent upper endoscopy during which 100 units of botulinum toxin were injected into the pyloric sphincter. Gastric emptying studies were obtained at 48 hours and 6 weeks after injection. Patients were questioned about symptoms of gastroparesis, and a symptom score was obtained at baseline and at 2 weeks and 6 weeks after injection. OBSERVATIONS: There was a mean improvement in the subjective symptom score at 2 weeks of 55% (range 14% to 80%). This improvement was maintained at 6 weeks. There was a 52% improvement in gastric emptying at 2 and 6 weeks. CONCLUSION: Pyloric injection of botulinum toxin can improve symptoms and gastric emptying in patients with diabetic gastroparesis. Further evaluation of pyloric injection of botulinum toxin as a treatment for diabetic gastroparesis is warranted.     

Factors Associated with Symptom Response to Pyloric Injection of Botulinum Toxin in a Large Series of Gastroparesis Patients

Case series report symptom reductions after pyloric botulinum toxin injection in gastroparesis, but small controlled trials show no benefit. Factors that enhance response to therapy are undefined. A retrospective analysis of 179 gastroparetics undergoing pyloric botulinum toxin injection from 2001 to 2007 assessed responses relating to drug dosing, demographic factors, comorbidities, and gastric function. Overall, there was a decrease in gastroparetic symptoms 1–4 months after pyloric botulinum toxin injection in 92 patients (51.4%). Increasing the botulinum toxin dose significantly improved clinical responses of patients who provided information on symptoms after therapy (100 units: 54.2%; 200 units: 76.7%; P = 0.02). Other factors that improved response to botulinum toxin included female gender, age <50 years, and nondiabetic nonpostsurgical etiology (all P < 0.05). Eighty-seven patients received 307 follow-up injections. A clinical response to a second injection was observed in 73.4% of evaluable patients. In conclusion, responses to pyloric botulinum toxin depended on dose and were maintained on repeat injection. Subgroup analyses defined subgroups likely to benefit. These findings provide the foundation for large, controlled trials of high-dose botulinum toxin in selected gastroparesis subsets.     

Long-term follow-up of achalasia patients treated with botulinum toxin

AIMS: To evaluate long-term efficacy of intrasphincteric injection of botulinum toxin in untreated achalasia patients; to analyse whether age can be a predictor of response; and to verify whether any objective measurements correlate with symptom relief MATERIALS AND METHODS: A total of 37 patients (mean age 61.4+/-17.5 years) were enrolled, all of whom injected endoscopically with 100 U of botulinum toxin. Symptom score, oesophageal manometry and oesophageal radionuclide emptying were assessed prior to treatment and 4 weeks, 3 months and 1 year after botulinum toxin. In the case of failure or relapse (symptom score >2), treatment was repeated. RESULTS: All but 6 patients (83.7%) were in clinical remission one month after botulinum toxin. At 12 months, mean symptom score was 0.9+/-0.5 (p<0.05 vs basal); mean lower oesophageal sphincter pressure was 22.0+/-6.3 (p<0.05 vs basal), and 10-min radionuclide retention was 14.0%+/-7.2 (p<0.05 vs basal). Of the 35 patients followed, 12 (34.3%) had a relapse and were re-treated; 4 out of 12 did not respond after re-treatment. Efficacy of first injection of botulinum toxin lasted for a mean period of 15.6 months (range 2-30). Up to day 31 (83.7%) patients were still in remission. We observed a trend towards a better response to botulinum toxin treatment in patients over 50 years (p=0.053). Moreover no correlation was found between any objective achalasia measurements and symptom relief (r coefficient between 0.1 and 0.5) CONCLUSIONS: Results show that: 1) one or two intrasphincteric injections of botulinum toxin result in clinical and objective improvement in about 84% of achalasia patients and are not associated with serious side-effects; 2) patients over 50 years showed better benefit than younger patients; 3) no correlation was found between any objective measurements and symptom relief.     

Pyloric Injection of Botulinum Toxin for the Treatment of Refractory GERD Accompanied with Gastroparesis: A Preliminary Report

Gastroesophageal reflux disease (GERD) refractory to conventional medical treatment is frequently associated with gastroparesis, a complex condition with no definitive treatment to date. We first developed a scoring system to assess the severity and frequency of both reflux- and gastroparesis-related symptoms. We then tested, for the first time, the hypothesis that endoscopic pyloric botulinum toxin injection alleviates both of these symptom types. Eleven patients (four males) with GERD (confirmed by esophageal pH monitoring) plus gastroparesis (confirmed by gastric emptying study) underwent toxin injection. Patients had no concomitant disease and were not allowed to use prokinetics before or after treatment. Injection significantly improved both gastroparesis- and reflux-related symptoms in the majority of patients but the duration of symptom relief was relatively short. Responders to treatment had significantly higher total reflux symptom scores (before injection) than nonresponders. All but one of the patients in whom gastroparesis symptoms improved also showed response in reflux symptoms, which supports our hypothesis. We believe that response to toxin injection is a reliable predictor of response to subsequent surgery following the recurrence of symptoms.     

Endoscopic Pyloric Injection of Botulinum Toxin-A for the Treatment of Postvagotomy Gastroparesis

ObjectivesTo evaluate the efficacy of botulinum toxin-A in the treatment of postvagotomy gastroparesis.MethodsThis open-labeled trial identified and recruited 11 subjects who developed symptomatic gastroparesis after a vagotomy (9 fundoplication, 1 trauma, and 1 exploratory laparotomy). Gastroparesis was defined as an abnormal solid-phase gastric emptying test using the standardized 4-hour radionuclide eggbeater meal method and vagotomy was confirmed with a sham meal challenge test. To complete the study, subjects should have completed the 6-month follow-up visit after their pylorus was injected with botulinum toxin-A injection in a 4-quadrant manner. Patients either received 100 (n = 2) or 200 (n = 9) units of botulinum toxin. Questionnaires recorded symptom severity of gastroparesis at baseline and at monthly intervals for 6 months after the therapy was completed by the patients.ResultsOf the 11 subjects initially recruited, 10 finished the 6-month follow-up visit (7 women). Mean age was 51 years (range, 31–84 years). Mean symptom score at baseline was 16 (95% CI 13–19) and showed a numerical decline to 9 (P > 0.05) over the 6-month period after the procedure (95% CI 5–13). Seven (70%) patients observed >30% improvement in the total symptom score. No complications were recorded.ConclusionsIn conclusion, this open-label study in patients with postvagotomy gastroparesis patients reveals a reduction of gastroparetic symptoms at 1 and 3 months after treatment with pyloric injection of botulinum toxin-A, with return of symptoms by 6 months. Thus, botulinum toxin treatment does not produce a sustained reduction in gastroparetic symptoms in this clinical setting.     

Treatment of chest pain in patients with noncardiac,nonreflux, nonachalasia spastic esophageal motor disorders using botulinum toxin injection into the gastroesophageal junction

OBJECTIVE: The aim of this study was to determine if botulinum toxin injection in the gastroesophageal junction improves symptoms in patients with noncardiac chest pain with a spastic esophageal motility disorder. METHODS: Twenty-nine noncardiac chest pain patients with nonachalasia, nonreflux-related spastic esophageal motility disorders were enrolled in this open label trial of botulinum toxin injection at the gastroesophageal junction. Chest pain was the major complaint in all patients. Symptoms of chest pain, dysphagia, regurgitation, and heartburn were scored before and 1 month after botulinum toxin injection. A response to botulinum toxin was defined as at least a 50% reduction in the symptom score with a possible total chest pain score of 4. The duration of response was defined as the time period, between the time of injection and the point in time, at which the severity of the symptoms returned to the preinjection score. RESULTS: Seventy-two percent of the patients responded with at least 50% reduction in chest pain. In these responders, there was a 79% reduction in the mean chest pain score from a preinjection score of 3.7 to a postinjection score of 0.78 (p < 0.0001). The mean duration of the response for chest pain in these patients was 7.3+/-4.1 months (range 1-18 months). There was also a significant reduction in the mean regurgitation score, dysphagia score, and total symptom score (p < 0.0001). CONCLUSIONS: Botulinum toxin injection at the gastroesophageal junction leads to significant symptomatic improvement in patients with spastic esophageal motility disorders whose major complaint is chest pain.     

Manometrically-guided endoscopic injection of botulinum toxin for esophageal achalasia: a pilot trial

AIMS: Some patients gained only short-term response (< 6 months) after botulinum toxin (BTX) injection for achalasia. This may be due to an incorrect site of injection when targeting the lower esophageal sphincter by using endoscopic landmarks only. PATIENTS AND METHODS: 7 elderly patients (4 females, 67 +/- 20 years) with classical achalasia received manometrically-guided botulinum toxin injection by means of a double-channel endoscope. Thereafter, they were clinically re-evaluated at 6 weeks and later on at bi-monthly intervals. RESULTS: The mean symptom score decreased 6 weeks after the manometrically-guided BTX-treatment from 12 +/- 2 (before BTX) to 6 +/- 2 points (p = 0.02). However, according to the study criteria one patient did not respond to BTX-injection and underwent subsequent cardiomyotomy. The LES-resting pressure was found not to be altered in this patient (6 weeks after BTX-injection) but manometry revealed a marked decrease of the LES-tone in 3 other patients who benefitted from BTX-injection. 5 of the 6 patients, who initially benefited from BTX-injection, relapsed 10 months (range, 6-13 months) after their initial BTX-treatment. They all were treated with repeated BTX-injections. At completion of the study (1.5-year follow-up) the mean symptom score of the 6 patients was still significantly lower (6 +/- 2 points) than before study entry (p = 0.03). CONCLUSION: Manometrically-guided endoscopic BTX-injection is a simple, safe and highly effective (during 1.5-year follow-up) technique for treatment of esophageal achalasia. With the manometrically-guided injection technique one may obtain a longer lasting symptomatic response than with the traditional method of BTX-application.     

Botulinum toxin A for the treatment of delayed gastric emptying

BACKGROUND: Observational data suggest that intrapyloric injection of botulinum toxin A (BoTN/A) reduces symptoms and accelerates gastric emptying in idiopathic and diabetic gastroparesis. Our purpose was to determine whether botulinum toxin improves symptoms to a significantly greater extent than placebo. An additional objective was to determine whether there is an acceleration of gastric emptying after injection. METHODS: A single-institution, randomized, double-blind, placebo-controlled trial* was done. Eligible patients had a Gastroparesis Cardinal Symptom Index score > or = 27 with randomization to intrapyloric botulinum toxin, 200 U (units), or saline placebo. Reassessment of symptoms and repeat gastric emptying scan at 1-month follow-up were done. RESULTS: Thirty-two patients were randomized to botulinum toxin (N = 16) and placebo (N = 16). At 1-month follow-up, 37.5% randomized to botulinum toxin and 56.3% randomized to placebo achieved improvement as defined by this study. There were no identifiable clinical predictors of response. The botulinum toxin group demonstrated improvement in gastric emptying; however, this was not superior to placebo. No serious adverse events were attributable to botulinum toxin. CONCLUSIONS: Intrapyloric injection of botulinum toxin improves gastric emptying in patients with gastroparesis, although this benefit was not superior to placebo at 1 month. Also, in comparison to placebo, symptoms do not improve significantly by 1 month after injection. Overall, we are unable to recommend botulinum toxin therapy for widespread use in the treatment of delayed gastric emptying until more data are available.     

Treatment of symptomatic nonachalasia esophageal motor disorders with botulinum toxin injection at the lower esophageal sphincter

The purpose of this study was to determine if botulinum toxin injection at the lower esophageal sphincter improves symptoms in patients with nonachalasia spastic esophageal motility disorders. Fifteen patients with nonachalasia spastic esophageal motility disorders (diffuse esophageal spasm, nonspecific esophageal motility disorders, and lower esophageal sphincter dysfunction) unresponsive to medical therapy underwent endoscopic injection of botulinum toxin at the level of the gastroesophageal junction. Symptoms were scored (0=no symptoms, 1=mild, 2=moderate, 3=severe and 4=very severe) before treatment, at seven days and every 30 days after treatment. There was significant improvement in chest pain, dysphagia, and regurgitation at 7, 30, 60 and 90 days after treatment. At one month after treatment, 11 of 15 (73%) patients had a good or excellent response to treatment. At the last patient interview (mean follow-up of 10.6 months), five (33%) patients continued to have a good to excellent response, whereas 10 (67%) underwent subsequent treatment with repeat botulinum toxin, pneumatic dilation, or bougienage. We conclude that botulinum toxin injection at the gastroesophageal junction leads to significant symptom improvement in patients with nonachalasia esophageal motility disorders. These results suggest that botulinum toxin may be an effective treatment option in some of these patients not responsive to conventional medical therapy.     

Controlled trial of botulinum toxin injection versus placebo and pneumatic dilation in achalasia

BACKGROUND & AIMS: Intrasphincteric injection of botulinum toxin has been suggested as an alternative treatment modality in esophageal achalasia. A controlled trial comparing botulinum toxin, placebo, and pneumatic dilation is reported. METHODS: Sixteen patients received random intrasphincteric injections of either botulinum toxin or saline. The efficacy of treatment was assessed by symptom score, esophageal manometry, and scintigraphy. In case of failure, pneumatic dilation was performed. RESULTS: One month after injection, symptoms had improved in all patients treated with botulinum toxin (symptom score, 0.9 +/- 0.6 vs. 5.5 +/- 1.4; P < 0.02). In the placebo group, symptoms were unchanged in all patients, who were all dilated. Lower esophageal sphincter pressure decreased by 49% after treatment with botulinum toxin (P < 0.03) and by 72% after dilation (P < 0.01). Similarly, esophageal retention decreased by 47% after treatment with botulinum toxin (P < 0.02) and by 59% after dilation (P < 0.02). No significant difference in symptom score and esophageal function test results was found between patients treated with botulinum toxin injections and those undergoing dilation. However, 7 of the 8 patients in the botulinum toxin group required a second injection because of recurrent dysphagia. CONCLUSIONS: Treatment of achalasia with botulinum toxin was as effective as pneumatic dilation in relieving symptoms and improving esophageal function. The effect of the first injection was temporary, but the effect of the second injection lasted longer. (Gastroenterology 1996 Dec;111(6):1418-24)     

A randomized trial of botulinum toxin vs lidocain pomade for chronic anal fissure

PURPOSE: As lateral sphincterotomy and anal dilatation causes complications, a reversible chemical sphincterotomy method has been recently proposed as an alternative treatment in patients with anal fissure. In this study, the effect of botulinum toxin causing temporary paralysis in internal anal sphincter was compared with that of lidocaine in patients with chronic anal fissure. METHOD: A total of 62 outpatients were randomly assigned to receive botulinum toxin or lidocaine pomade. The patients were evaluated before and after two months of treatment with physical examination and anal manometry. Pain and nocturnal pain were scored. RESULTS: In an evaluation period of two months, in 24 of 34 patients of botulinum group (70.58%), and in six of 28 patients of lidocaine group (21.42%) showed complete epithelization (p = 0.006). All patients who had previously reported nocturnal pain became symptom free in botulinum group and in four patients of lidocaine group. Pain following defecation disappeared in 24 patients of botulinum group and in 20 patients of control group (p = 0.959). There was no adverse effect in both groups. While resting anal pressure and maximum voluntary pressure were significantly low in botulinum toxin group, both parameters did not change in lidocaine group. CONCLUSIONS: Botulinum toxin is a reliable and effective method for patients with chronic anal fissure. It can be applied easily without any anesthesia and instrumentation. It is cheaper in comparison with surgical methods and it can be a good alternative treatment in patients with risk of incontinence.     

Long-term efficacy of Botulinum toxin in classical achalasia: a prospective study

OBJECTIVE: We sought to examine the long-term efficacy of intrasphincteric Botulinum toxin A injection in a prospective cohort study of 30 patients with achalasia. METHODS: Thirty patients with classical achalasia were treated with intrasphincteric Botulinum toxin A injection. Follow-up consisted of clinical assessment, symptom scoring, and postinjection manometry. RESULTS: Symptomatic improvement for >3 months was seen in 23 of 30 patients (77%). Of the 23 initial responders, seven (30%) experienced a sustained symptomatic response after a single Botulinum toxin injection (mean follow-up, 21 months). The remaining 16 initial responders (70%) eventually relapsed (mean initial response, 11 months). Nine received a 2nd Botulinum toxin injection, and seven experienced an ongoing response (mean duration, 9 months); two patients eventually required a 3rd injection with good effect (mean duration, 22 months). The remaining seven patients who relapsed after Botulinum toxin opted for pneumatic dilation or surgical myotomy. Five of the seven patients who had no initial response received a 2nd injection but again did not respond. A residual lower esophageal sphincter pressure <18 mm Hg after the first Botulinum toxin injection predicted a good response to Botulinum therapy (single or multiple injections, p < 0.002, positive predictive value = 0.71, negative predictive value = 1.0). Neither initial nor sustained response to Botulinum toxin could be predicted based on gender, age, duration of illness, previous pneumatic dilation, or esophageal motility before treatment. CONCLUSIONS: We found that 77% of patients with classical achalasia experienced a good symptomatic response after Botulinum toxin and 30% of initial responders achieve sustained symptomatic relief after a single treatment with Botulinum toxin. The initial responders who relapsed did well with subsequent Botulinum toxin A. Lack of an initial symptomatic response and residual lower esophageal sphincter pressure > or =18 mm Hg after Botulinum toxin are associated with a poor response.     

Botulinum toxin versus pneumatic dilatation in the treatment of achalasia: a randomised trial

Background—Intrasphinctericinjection of botulinum toxin is a new treatment option for achalasia.
Aims—To compare the immediate andlong term efficacy of botulinum toxin with that of pneumatic dilatation.
Methods—Symptomatic patients withachalasia were randomised to botulinum toxin (22 patients, median age57 years) or pneumatic dilatation (20 patients, median age 56 years).Symptom scores were assessed initially, and at one, three, six, nine,and 12months after treatment. Objective assessment includedoesophageal manometry initially and at one month, and bariumoesophagram initially and at one, six, and 12 months post-treatment.
Results—Pneumatic dilatationresulted in a significantly (p=0.02) higher cumulative remission rate.At 12 months, 14/20 (70%) pneumatic dilatation and 7/22 (32%)botulinum toxin treated patients were in symptomatic remission(p=0.017). Failure rates were similar initially, but failure over timewas significantly (p=0.01) higher after botulinum toxin (50%) thanpneumatic dilatation (7%). Pneumatic dilatation resulted insignificant (p<0.001) reduction in symptom scores, and loweroesophageal sphincter pressure, oesophageal barium column height, andoesophageal diameter. Botulinum toxin produced significant reduction insymptom scores (p<0.001), but no reduction in objective parameters.
Conclusions—At one year pneumaticdilatation is more effective than botulinum toxin. Symptom improvementparallels objective oesophageal measurements after pneumatic dilatationbut not after botulinum toxin treatment for achalasia.

Keywords:achalasia; pneumatic dilatation; botulinum toxin; barium oesophagram

     

Achalasia treatment in the elderly: is botulinum toxin injection the best option?

BACKGROUND : Achalasia treatment in elderly patients is a matter of controversy. Botulinum toxin injection has been proposed as the best option in this group of patients as it is a safe procedure. However, concern persists regarding its short-term effect. AIMS : To analyse the clinical and economic effectiveness of botulinum toxin injection in the treatment of achalasia patients who are elderly. METHODS : Seventeen consecutive achalasia patients older than 65 years were treated with 80 units of botulinum toxin. Clinical follow-up at 1, 6 and 12 months was performed. Control manometry when symptoms recurred was carried out. Results were compared with those of an historical control group of 16 achalasia patients also older than 65 years and who had been treated with endoscopic dilation. The costs of both procedures were compared. RESULTS : Twenty-nine botulinum toxin injections were performed in the 17 patients of the botulinum toxin group (follow-up, 12-36 months). In the dilation group only two patients had to be retreated (follow-up, 12-108 months). No major complications were observed in either group. The average duration of symptom alleviation was 48 +/- 33 months for endoscopic dilation and 13.8 +/- 9.5 months for botulinum toxin injection. Maintaining a patient free of symptoms cost E348.31 per year for botulinum toxin injection, whilst if endoscopic dilation was chosen the cost was only E117.47 per year. CONCLUSIONS : The effect of botulinum toxin injections wanes with time in elderly patients, necessitating repeated injections to keep the patients symptom-free. Due to the required repeated injections this procedure is more expensive than endoscopic dilation.     

Características del esfínter pilórico utilizando EndoFLIP® en gastroparesia

Introduction and aims

Pyloric sphincter abnormalities may be detected in gastroparesis. Botulinum toxin A (BoNT/A) injection into the pylorus has been used to treat gastroparesis with varying results. The aim of the present article was to assess whether pyloric sphincter characteristics using the endoscopic functional lumen imaging probe (EndoFLIP^®) with impedance planimetry in patients with gastroparesis correlated with symptoms, gastric emptying, and therapeutic response to pyloric sphincter BoNT/A injection.

Short- and medium-term clinical efficacy of three endoscopic therapies for achalasia: a single-blinded prospective study.

OBJECTIVE: to compare the efficacy of three endoscopic therapies for achalasia and to identify predictors of response. DESIGN: prospective, single-blinded study at short and medium term. MATERIAL AND METHODS: 22 patients (9M/13 F; mean age: 47.45 +/- 21.01 years) with confirmed clinical and manometric achalasia were randomised in three groups: intrasphincteric injections of botulinum toxin (group 1: 10 patients ), injections of 1% polidocanol (group 2:6 patients), and a combined therapy with both of them (group 3: 6 patients). Clinical response was evaluated by a score (0-5) of tested symptoms (dysphagia, regurgitation and chest pain) at 1 and 24 weeks post-treatment. RESULTS: at 24 weeks post-treatment group 2 had the best complete response (CR) rate (33.33%), whereas CR in both the botulinum toxin and combined therapy groups was 10 and 0%, respectively. Groups 1 and 2 got an overall improvement in clinical score at 1 (p= 0.02) and 24 weeks (p= 0.04). Five patients (50%) in group 1, two patients (33.33%) in group 2, and three patients (50%) in group 3 needed other therapies (dilation or surgery) because of treatment failure. Separately, neither age nor sex, time from diagnosis or type of therapy could distinguish responders from non-responders in these three groups. However, absence of response within the first week, and an initial clinical score above 7 were predictive factors of poor response at six months. CONCLUSIONS: short- and medium-term clinical response to these endoscopic therapies was limited. The absence of response at seven days and a severe initial clinical score were predictive factors of poor medium-term response.     

Long-term outcomes of endoluminal gastroplication: a U.S. multicenter trial

BACKGROUND: Endoluminal gastroplication has shown promise for the treatment of GERD in short-term studies. Until now, long-term outcome data have been lacking. METHODS: A prospective, multicenter trial enrolled 85 patients with GERD to be treated with endoluminal gastroplication. Inclusion criteria were 3 or more heartburn or regurgitation episodes per week, >4.2% time in 24 hours with esophageal pH < 4, and dependency on antisecretory medications. Exclusion criteria were the presence of varices, achalasia, aperistalsis, or previous gastric resection. Patients underwent manometry, 24-hour pH monitoring, and symptom severity scoring before and after the procedure. Patient diaries were used to assess medication use and to estimate annual medication cost. RESULTS: At 1- and 2-year follow-up, patients had significant reductions in median heartburn symptom scores (72 at baseline [interquartile range (IQR) 90-48] vs. 4 at 12 months [IQR 43-0] and 16 at 24 months [IQR 53-3.5]; p < 0.0001 vs. baseline) and median regurgitation symptoms (2 at baseline [IQR 3-1] vs. 0 at 12 months (IQR 1-0) and 1 at 24 months [IQR 1-0]; p < 0.0001 vs. baseline). Of all patients, 59% and 52% showed heartburn symptom resolution at 12 and 24 months, respectively ( p < 0.0001 vs. baseline). Also, 83% and 77% had regurgitation symptom resolution at 12 and 24 months, respectively (p < 0.0001 vs. baseline). Proton pump inhibitor use also was significantly reduced at 12 and 24 months after the procedure. At 2-year follow-up, median annualized medication costs were reduced by 88% (1381 US dollars) (p < 0.0001). Endoluminal gastroplication significantly reduced the duration and the number of episodes of esophageal acid exposure (p < 0.0001 vs. baseline). Only 7 patients experienced adverse events. CONCLUSIONS: Endoscopic gastroplication is safe and effective, and is associated with symptom reductions in patients with GERD for at least 24 months.     

Botulinum toxin for achalasia in children

BACKGROUND: Injection of botulinum toxin (BTx) into the lower esophageal sphincter (LES) of adult patients with achalasia results in the effective relief of symptoms. The aim of the present study was to examine the effectiveness of BTx in pediatric patients suffering from achalasia. METHODS: Seven patients suffering from achalasia with or without prior treatment were treated with intrasphincteric injection of BTx. The median duration of follow up was 15 months. RESULTS: All seven patients improved. The median interval before recurrence of symptoms was 4 months (range 1-14 months). There was an inverse relationship between the pretreatment LES pressure and the duration of response (r=-0.6). The mean pretreatment LES pressure in the subgroup with a response greater than 6 months was 38+/-10 mmHg compared with 61+/-12 mmHg in the other four patients (P= 0.05). All seven patients required retreatment. CONCLUSION: Botulinum toxin is effective in relieving symptoms in pediatric patients suffering from achalasia, producing a sustained response beyond 6 months in 43% of patients.     

贲门失弛缓症内镜下注射肉毒毒素与气囊扩张术疗效比较的系统评价

目的 系统评价内镜下注射肉毒毒素与气囊扩张治疗贲门失弛缓症的有效性和安全性.方法 应用国际Cochrane协作网系统评价方法进行评价.结果 共纳人12个试验包括559例患者.Meta分析显示:(1)短期总有效率内镜下气囊扩张治疗优于内镜下注射肉毒毒素治疗(83.21%比71.27%,P<0.01).(2)长期总有效率内镜下气囊扩张治疗优于内镜下注射肉毒毒素治疗(54.59%比27.60%,P<0.01).(3)临床复发率内镜下注射肉毒毒素治疗高于内镜下气囊扩张治疗(55.66%比18.84%,P<0.01).(4)副作用及并发症发生率内镜下气囊扩张治疗高于内镜下注射肉毒毒素治疗(13.01%比1.35%,P<0.01).结论 目前的证据表明:内镜下注射肉毒毒素与气囊扩张均有较好的短期疗效和安全性,内镜下气囊扩张治疗在长期疗效上更优于内镜下注射肉毒毒素.