Effectiveness of esophageal dilation in relieving nonobstructive esophageal dysphagia and improving quality of life.
Methods: Ambulatory patients presenting with swallowing complaints were evaluated by history and physical examination, speech therapy evaluation, dynamic barium oropharyngeal swallowing study, and barium esophagram plus upper endoscopy. Patients diagnosed as having nonobstructive esophageal dysphagia were offered participation in the study. Eligible candidates were randomized to either 56-French (the study group) or 40-French (the control group) Pilling dilators. All patients were treated with proton pump inhibitors. Patients completed questionnaires for dysphagia score, diet score, and quality of life (SF-36) at baseline, at 1 month, and then at follow-up visits at 1- to 3-month intervals for up to 12 months.
Results: Of the 125 patients complaining of swallowing difficulties, 6 (5%) were diagnosed as having oropharyngeal dysphagia and 119 (95%) had esophageal dysphagia. Of the patients with esophageal dysphagia, 84 (67%) had nonobstructive dysphagia. A total of 30 patients participated in the study. Seventeen patients were randomized to the study group and 13 were randomized to the control group. The baseline dysphagia, diet, and quality-of-life scores were comparable between groups. Dysphagia in both groups improved after dilation compared with baseline; however, the difference in the degree of improvement between the two groups was not significant. In addition, there was no significant difference in improvement of the quality of life between the two groups.
Conclusion: Most patients with esophageal dysphagia have a non-obstructing esophageal lumen. Our prospective, randomized, controlled study does not support the practice of empiric esophageal dilation for patients with nonobstructive esophageal dysphagia. Improvement in both groups suggests the possibility that it occurred due to proton pump inhibitor therapy, lending credence to the hypothesis that esophageal hypersensitivity to acid contributes to symptoms in most patients with nonobstructive esophageal dysphagia, which is the predominant category of dysphagia.
Dysphagia is a symptom commonly experienced by the general population and a source of frequent referral to gastroenterologists. (1) There is a paucity of data regarding the relative prevalence of oropharyngeal versus esophageal dysphagia and nonobstructive versus obstructive dysphagia among ambulatory patients.
The management of nonobstructive esophageal dysphagia is also not clearly established. In a national survey, 50% of practicing gastroenterologists used empiric dilation in patients with nonobstructive dysphagia. (2) There is some support for treatment with empiric esophageal bougie dilation based on anecdotal (3), (4) and retrospective data. (5) Recently, two prospective studies with different study designs have yielded conflicting results with respect to efficacy of empiric dilation on relief of dysphagia. In addition, the effect of such dilation on quality of life among such patients has never been reported.
The aim of our study was to determine the relative prevalence of obstructive versus nonobstructive esophageal dysphagia and to assess the long-term effect of large-diameter esophageal dilation on symptoms and quality of life in patients with nonobstructive esophageal dysphagia. Our institutional review board approved the study, and informed consent was obtained from all patients.
Patients and Methods
Ambulatory patients seen in our institution from June 2000 to August 2001 for complaints of swallowing difficulty were evaluated by history and physical examination, speech therapy swallowing evaluation, dynamic barium oropharyngeal swallowing study, and barium esophagraphy. (6), (7) Data from the same period from patients with swallowing complaints were used to generate relative prevalence information regarding oropharyngeal and esophageal (nonobstructive versus obstructive) dysphagia. Patients with esophageal dysphagia as determined by the above evaluation were offered the opportunity to participate in the study.
Clinical characteristics of the subjects regarding age, sex, smoking, use of alcohol, nonsteroidal anti-inflammatory drugs, calcium channel blockers, nitrates, [H.sub.2]-receptor antagonists, proton pump inhibitors (PPIs), other medications, and dentures were documented (Table 1). Baseline data for validated diet, (8) dysphagia, (9) and quality-of-life SF-36 scores (10) were recorded. Patients were entered into the study if esophagogastroduodenoscopy indicated a nonobstructed esophageal lumen. Patients with head and neck or upper gastrointestinal malignancies, prior esophageal dilation, and mental retardation were excluded.
Patients were randomized to either the 56-French (study group) or the 40-French dilator group (control group) using a flip of a coin. Pilling dilators were used to dilate the esophagus. All patients were sedated for endoscopy and dilation. Subjects were blinded as to the size of the dilator.
After endoscopy and dilation, all patients were treated with daily therapy with PPIs. Diet, dysphagia, and quality-of-life scores were repeated at 1 and 3 months and then at 1-to 3-month intervals up to 12 months. Final scores were as documented at the last follow-up. Patients were also followed clinically, and any complications related to the procedures were documented. All score values were expressed as mean [+ or -] SEM. Comparisons were done using Student's t test.
One hundred twenty-five patients with complaints of swallowing difficulty were seen during the enrollment period. Six patients were diagnosed with oropharyngeal dysphagia and 119 (95%) were diagnosed with esophageal dysphagia. In the esophageal dysphagia group, 84 (67%) patients had a nonobstructing lumen (Fig. 1). Of these, 30 patients were enrolled in our study after excluding patients not meeting study criteria or those declining participation.
Seventeen patients were randomized to the study group and 13 patients were randomized to the control group. Table 1 lists the demographic characteristics of the subjects. Use of prior PPIs and other medications before entry into the study was similar between the groups. There was no significant difference for the duration of follow-up between the experimental group and the control group (10.23 [+ or -] 0.95 months versus 10.18 [+ or -] 0.68 months).
[FIGURE 1 OMITTED]
One patient in the control group demanded to know the type of dilator used at Month 1 into the study and thus was excluded from further data collection. One patient in the study group had continued reflux and dysphagia. His 24-hour esophageal pH study was abnormal despite twice-a-day PPI therapy. Esophageal manometry revealed effective peristalsis but findings consistent with nutcracker esophagus with incomplete lower esophageal sphincter relaxation. He underwent Heller's myotomy and Nissen surgery at 7 months into the study. Another patient in the study group had continued reflux symptoms and an abnormal pH study at 6 months into the study and underwent Nissen fundoplication. Another patient in the study group felt initial improvement with dilation but had recurrent symptoms at 11 months into the study. This resulted in exclusion from further data collection from these patients. An additional patient in the study group was lost to follow-up at 6 months.
The initial and final diet score, dysphagia score, and quality-of-life scores are listed in Tables 2, 3 and 4, respectively. Compared with the baseline, symptoms and quality of life improved in both the treatment and control groups. However, there was no significant difference in the degree of improvement between the two groups.
Although there is no shortage of opinions, there are scant data to suggest how best to manage esophageal dysphagia in patients with nonobstructive esophageal lumen. Particularly, the benefit of empiric esophageal dilation is unclear. A retrospective study by Marshall and Chowdhury (5) reported improvement of solid food dysphagia, whereas patients with combined solid and liquid dysphagia had minimal relief after dilation. However, the dilators used in this study were of variable size. Effect on diet and quality-of-life scores were not evaluated.
Two recent prospective trials came up with conflicting conclusions. Colon et al (11) treated 23 patients with nonobstructive solid and liquid dysphagia with either a 50-French or a 26-French Maloney dilator. They reported significant improvement in diet scores with the 50-French dilator but no improvement in the dysphagia score. However, the follow-up was only 2 weeks. The study was done only in men and the dilators used in this study were smaller than in our study. Patients were not treated with antireflux medication and impact on quality of life was not evaluated.
Another prospective study by Scolapio et al (12) randomized 83 patients with nonobstructive solid food dysphagia to either a through-the-scope 18-mm balloon dilation or sham dilation. They reported no significant difference in the improvement of dysphagia between the balloon and sham dilation groups. However, the balloon was used to dilate the distal esophagus only. Patients with dysphagia frequently modify their diet without complaining of dysphagia, and a diet score can measure only subtle differences in severity of dysphagia. Effect on diet score and quality-of-life scores were not assessed in this study. In addition, antireflux medication use was less than 20% in both groups.
Ours is the first study to use PPIs in every patient to minimize the confounding effects of acid reflux with respect to swallowing difficulty. In addition to dysphagia and diet scores, we also assessed impact on quality of life, which has not been previously studied. We chose to use a 40-French dilator in the control group, because it has the potential to give enough central, esophageal sensation to be used as sham dilation. The placebo effect may be compromised with a much smaller dilator, which may coil in the throat and not pass into the esophagus. (13) A 40-French dilator overcomes this problem and is unlikely to have any dilatory effect on the nonobstructing esophageal lumen.
Both groups in our study got better to the same degree. This improvement may be explained by the beneficial effect of the PPIs. As there was no significant difference in improvement of diet score, dysphagia score, or quality-of-life scores between study and control groups, our results do not support the empiric use of large-diameter dilation to relieve nonobstructive esophageal dysphagia. Acid reflux may result in enhanced esophageal sensation, contributing to the complaint of dysphagia. (7), (14-16) Thus, patients probably may benefit from aggressive acid suppression.
The potential drawbacks of our study include a mismatch in the gender proportion in the two groups. It could be argued that the use of a 40-French dilator is not the proper control. Thus, the results could also be interpreted to suggest that dilation with the 40-French dilator is as effective as the 56-French dilator. However, we believe that is unlikely because the 40-French dilator is unlikely to stretch any normal-lumen esophagus, whereas the 56-French dilator may impact on subtle narrowing anywhere from the upper to the lower esophageal sphincter. We believe that the advantage of using a 40-French dilator for sham dilation outweighs its possible dilatory effects. The addition of PPIs in both groups could potentially confound the results. In contrast, it would be unethical to withhold a potentially effective therapy from patients, because most of them did have heartburn.
To our knowledge, our study is the first to provide epidemiologic data on the relative prevalence of different kinds of dysphagia among patients evaluated for presumed esophageal dysphagia at a community-based tertiary care medical center. Our results also provide an insight into the relatively predominant occurrence of nonobstructive dysphagia compared with obstructive dysphagia among ambulatory patients seen in a busy gastroenterology practice. There are no comparable studies reported in the literature.
We conclude that most patients with complaints of esophageal type dysphagia have a nonobstructing esophageal lumen. Our study, using an adequate sample size to detect a clinically significant result, suggests that empiric dilation has no impact on the relief of symptoms in nonobstructing dysphagia or quality of life. Further studies specifically designed to assess the impact of aggressive acid suppression to relieve nonobstructive esophageal dysphagia are warranted.
* Nonobstructive esophageal dysphagia is the most prevalent form of esophageal dysphagia.
* Empiric esophageal dilation with large-diameter dilators is of no benefit for patients with nonobstructive esophageal dysphagia.
* Aggressive acid suppression appears to benefit such patients.
Table 1. Demographic characteristics of control and study groups (a) Control group Study group Age (mean [+ or -] SEM) 54.9 [+ or -] 3.79 49.6 [+ or -] 2.73 Sex (male:female) 1:12 7:10 Smoker (%) 23 47 Alcohol use (%) 7.7 11.8 NSAID use (%) 53.8 41.2 Ca blocker use (%) 30.8 11.8 Nitrate use (%) 15.4 11.8 Denture (%) 38.5 23.5 Follow-up (mean [+ or -] SEM) 10.23 [+ or -] 0.95 10.18 [+ or -] 0.68 (a) NSAID, nonsteroidal anti-inflammatory drug; Ca, calcium. Fig. 1 Relative prevalence of various forms of dysphagia in ambulatory patients. Nonobstructive Esophageal 67% Obstructive Esophageal 28% Oropharyngeal 5% Note: Table made from pie chart. Table 2. Effect of empiric dilation on diet score (higher score indicates improved diet score) (a) Study group Control group P value Diet-baseline 27.94 [+ or -] 4.14 30.00 [+ or -] 3.63 NS Diet-1 mo 35.19 [+ or -] 3.65 (b) 38.23 [+ or -] 3.55 (b) NS Diet-final 35.94 [+ or -] 3.21 (b) 39.08 [+ or -] 2.73 (b) NS (a) NS, not significant. (b) Statistically significant difference between baseline and follow-up within the study group. Table 3. Effect of empiric dilation on dysphagia score (lower score indicates reduced severity of dysphagia) (a) Study group Control group Dysphagia-baseline 2.12 [+ or -] 0.31 1.88 [+ or -] 0.33 Dysphagia-1 mo 0.88 [+ or -] 0.40 (b) 0.96 [+ or -] 0.25 (b) Dysphagia-final 1.00 [+ or -] 0.29 (b) 0.65 [+ or -] 0.26 (b) P value Dysphagia-baseline NS Dysphagia-1 mo NS Dysphagia-final NS (a) NS, not significant. (b) Statistically significant difference between baseline and follow-up within the group. Table 4. Effect of empiric dilation on quality of life (SF-36) score (a) Quality of Study group Control group P value life Baseline 91.34 [+ or -] 5.35 88.32 [+ or -] 5.99 NS 1 mo 94.26 [+ or -] 6.33 93.10 [+ or -] 6.72 NS Final 95.36 [+ or -] 5.75 94.04 [+ or -] 6.54 NS (a) NS, not significant.
Accepted June 24, 2003.
Copyright [c] 2004 by The Southern Medical Association 0038-4348/04/9702-0137
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Kalyana Lavu, MD, Thomas P. Mathew, MD, and Anil Minocha, MD
From the Department of Medicine, University of Mississippi Medical Center, and the VA Medical Center, Jackson, MS; and the University of Illinois, Chicago, IL.
Reprint requests to Anil Minocha, MD, Division of Digestive Diseases, Department of Medicine, University of Mississippi Medical Center, 2500 N. State Street, Jackson, MS 39216-4505. Email: firstname.lastname@example.org
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|Title Annotation:||Original Article|
|Publication:||Southern Medical Journal|
|Date:||Feb 1, 2004|
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