Background-Intrasphincteric injection of botulinum toxin (Botx) has been proposed as treatment for oesophageal achalasia. However, the predictors of response and optimal dose remain unclear. Aims-To compare the eVect of diVerent doses of Botx and to identify predictors of response. Patients/methods-A total of 118 achalasic patients were randomised to receive one of three doses of Botx in a single injection: 50 U (n=40), 100 U (n=38), and 200 U (n=40). Of those who received 100 U, responsive patients were reinjected with an identical dose after 30 days. Clinical and manometric assessments were performed at baseline, 30 days after the initial injection of botulinum toxin, and at the end of follow up (mean 12 months; range 7-24 months). Results-Thirty days after the initial injection, 82% of patients were considered responders without a clear dose related eVect. At the end of follow up however, relapse of symptoms was evident in 19% of patients who received two injections of 100 U compared with 47% and 43% in the 50 U and 200 U groups, respectively. Using Kaplan-Meier analysis, patients in the 100×2 U group were more likely to remain in remission at any time (p<0.04), with 68% (95% CI 59-83) still in remission at 24 months. In a multiple adjusted model, response to Botx was independently predicted by the occurrence of vigorous achalasia (odds ratio 3.3) and the 100×2 U regimen (odds ratio 3.2). Conclusions-Two injections of 100 U of Botx 30 days apart appeared to be the most eVective therapeutic schedule. The presence of vigorous achalasia was the principal determinant of the response to Botx.
SUMMARYAim: To decrease the intensity of dyspeptic symptoms by impairing the visceral nociceptive C-type fibres with capsaicin, contained in red pepper powder. Methods: The study was performed on 30 patients with functional dyspepsia and without gastro-oesophageal reflux disease and irritable bowel syndrome. After a 2-week washout period, 15 patients received, before meals randomly and in a double-blind manner, 2.5 g ⁄ day of red pepper powder for 5 weeks, and 15 patients received placebo. A diary sheet was given to each patient to record, each day, the scores of individual and overall symptom intensity, which subsequently were averaged weekly and over the entire treatment duration. Results: The overall symptom score and the epigastric pain, fullness and nausea scores of the red pepper group were significantly lower than those of the placebo group, starting from the third week of treatment. The decrease reached about 60% at the end of treatment in the red pepper group, whilst placebo scores decreased by less than 30%. Conclusions: Red pepper was more effective than placebo in decreasing the intensity of dyspeptic symptoms, probably through a desensitization of gastric nociceptive C-fibres induced by its content of capsaicin. It could represent a potential therapy for functional dyspepsia.
Circadian antroduodenal motor activity was studied in 40 normal subjects by means of a portable recording system consisting of a computerized data logger and a probe with microtransducers. The quantitative and qualitative characteristics of contraction events during the interdigestive and digestive periods, as well as during the awake and asleep periods, were analysed. The composition and timing of meals and night recumbence were standardized. In spite of the high interindividual variability in motor parameters, significant differences in the characteristics of interdigestive and digestive periods between waking and sleep states were found. This paper confirms the existence of a circadian variation in antroduodenal motor activity and provides reference values from a large series of normal subjects that can be used for statistical comparisons with those obtained from patients recorded with the same method.
The traditional approach to the treatment of patients with achalasia is based on stretching or cutting the muscle fibres at the oesophagogastric junction by pneumatic dilatation'6 or surgical myotomy.7 12 More recently, nitro derivatives and calcium antagonists, particularly nifedipine, have been proved to be effective in reducing lower oesophageal pressure and improving oesophageal emptying in patients with achalasia.' '7 The results obtained both with surgical or mechanical procedures, such as myotomy and dilatation, and with drug treatment are well known."'0 No prospective study, however, has been reported comparing drug treatment with nifedipine and pneumatic dilatation.The aim of our study was to perform such a prospective trial to determine whether there is a significant difference in the results of both treatments. MethodsThirty consecutive patients with clinical, radiological, endoscopic, and manometric evidence of oesophageal achalasia, stage I or II using the classification of Adams et al,2' were randomly assigned to two groups. Patients with sigmoid dilatation of the oesophagus or those who had had treatment for achalasia were excluded. Group A had 16 patients assigned to undergo pneumatic dilatation (seven men, nine women; mean age 49.5 years, range 18-82 years). The mean duration of symptoms was 4-1 years (range 6 months-8 years) and the mean oesophageal diameter 3-8 cm (range 2-6 cm). Group B had 14 patients who were treated with sublingual nifedipine (six men, eight women; mean age 51-3 years, range 17-83 years). The mean duration of symptoms was 3.5 years (range 6 months-7 years) and the mean oesophageal diameter 3.9 cm (range 2.5-6 cm). CLINICAL STUDYThe patients were examined and details of the severity of dysphagia, regurgitation, retrosternal pain, and weight loss were taken before the study and every three months for a mean follow up of 21.4
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