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Effectiveness of esophageal dilation in relieving nonobstructive esophageal dysphagia and improving quality of life.



Objectives: The role of empiric esophageal esophageal /esoph·a·ge·al/ (e-sof?ah-je´al) of or pertaining to the esophagus.

esophageal

of or pertaining to the esophagus.


esophageal achalasia
see megaesophagus.
 dilation dilation /di·la·tion/ (di-la´shun)
1. the act of dilating or stretching.

2. dilatation.


di·la·tion
n.
1.
 in improving esophageal dysphagia dysphagia /dys·pha·gia/ (-fa´jah) difficulty in swallowing.

dys·pha·gia or dys·pha·gy
n.
Difficulty in swallowing or inability to swallow.
 with nonobstructive esophageal lumen is not clear. We wished to determine the impact of esophageal dilation with a large-diameter dilator dilator /di·la·tor/ (di-lat´er)
1. a structure that dilates, or an instrument used to dilate.

2. dilator muscle.


di·la·tor
n.
1.
 on dysphagia and quality of life in such patients. We also assessed relative prevalence of esophageal versus oropharyngeal oropharyngeal /oro·pha·ryn·ge·al/ (-fah-rin´je-al)
1. pertaining to the mouth and pharynx.

2. pertaining to the oropharynx.
 dysphagia and nonobstructive versus obstructive esophageal dysphagia in ambulatory patients.

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 Upper endoscopy
A medical procedure in which a thin, lighted, flexible tube (endoscope) is inserted down the patient's throat. Through this tube the doctor can view the lining of the esophagus, stomach, and the upper part of the small intestine.
. Patients diagnosed as having nonobstructive esophageal dysphagia were offered participation in the study. Eligible candidates were randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 to either 56-French (the study group) or 40-French (the control group) Pilling dilators. All patients were treated with proton pump inhibitors Proton Pump Inhibitors Definition

The proton pump inhibitors are a group of drugs that reduce the secretion of gastric (stomach) acid. They act by binding with the enzyme H+, K(+)-ATPase, hydrogen/potassium adenosine triphosphatase
. 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 proton pump inhibitor
n.
A class of drugs that inhibit gastric acid secretion by interfering with the movement of hydrogen ions across cell membranes and are used mainly to treat peptic ulcers, gastroesophageal reflux disease, and esophagitis.
 therapy, lending credence to the hypothesis that esophageal hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen.  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 Bougie: see Bejaïa, Algeria.  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 Nonsteroidal Anti-Inflammatory Drugs Definition

Nonsteroidal anti-inflammatory drugs are medicines that relieve pain, swelling, stiffness, and inflammation.
, calcium channel blockers Calcium Channel Blockers Definition

Calcium channel blockers are medicines that slow the movement of calcium into the cells of the heart and blood vessels.
, 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 mental retardation, below average level of intellectual functioning, usually defined by an IQ of below 70 to 75, combined with limitations in the skills necessary for daily living.  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 dilate /di·late/ (di´lat) to stretch an opening or hollow structure beyond its normal dimensions.

di·late
v.
To make or become wider or larger.
 the esophagus. All patients were sedated for endoscopy endoscopy

Examination of the body's interior through an instrument inserted into a natural opening or an incision, usually as an outpatient procedure. Endoscopes include the upper gastrointestinal endoscope (for the esophagus, stomach, and duodenum), the colonoscope (for the
 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.

Results

One hundred twenty-five Adj. 1. one hundred twenty-five - being five more than one hundred twenty
125, cxxv

cardinal - being or denoting a numerical quantity but not order; "cardinal numbers"
 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 (1) (Pixels Per Inch) The measurement of the resolution of a monitor or scanner. For example, a monitor that is 16 inches wide and displays 1600 pixels across its width would have a resolution of 100 ppi (1600 divided by 16).  therapy. Esophageal manometry Esophageal manometry
A test in which a thin tube is passed into the esophagus to measure the degree of pressure exerted by the muscles of the esophageal wall.

Mentioned in: Achalasia
 revealed effective peristalsis peristalsis: see digestive system.
peristalsis

Progressive wavelike muscle contractions in the esophagus, stomach, and intestines, and sometimes in the ureters and other hollow tubes.
 but findings consistent with nutcracker esophagus nutcracker esophagus Corkscrew esophagus, see there  with incomplete lower esophageal sphincter lower esophageal sphincter
n.
A ring of smooth muscle fibers at the junction of the esophagus and stomach. Also called cardiac 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 Nissen fundoplication Neonatology A laparoscopic procedure for treating reflux esophagitis and GERD. See Gastroesophageal reflux disease, 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.

Discussion

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 retrospective study,
a study in which a search is made for a relationship between one phenomenon or condition and another that occurred in the past (e.g.
 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 confounding

when the effects of two, or more, processes on results cannot be separated, the results are said to be confounded, a cause of bias in disease studies.


confounding factor
 effects of acid reflux acid reflux
n.
See heartburn.
 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 placebo effect
n.
A beneficial effect in a patient following a particular treatment that arises from the patient's expectations concerning the treatment rather than from the treatment itself.
 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 Tending to cause a delay in judicial proceedings.

Dilatory tactics are methods by which the rules of procedure are used by a party to a lawsuit in an abusive manner to delay the progress of the proceedings.
 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 heartburn, burning sensation beneath the breastbone, also called pyrosis. Heartburn does not indicate heart malfunction but results from nervous tension or overindulgence in food or drink. .

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 tertiary care Managed care The most specialized health care, administered to Pts with complex diseases who may require high-risk pharmacologic regimens, surgical procedures, or high-cost high-tech resources; TC is provided in 'tertiary care centers', often  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 gastroenterology

Medical specialty dealing with digestion and the digestive system. In the 17th century Jan Baptista van Helmont conducted the first scientific studies in the field; William Beaumont published his own observations in 1833.
 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.

Key Points

* 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

References

(1.) Lindgren S, Janzon L. Prevalence of swallowing complaints and clinical findings among 50-79-year-old men and women in an urban population. Dysphagia 1991;6:187-192.

(2.) Shaukat M, Ramirez FC, Sanowski RA. Community experience in esophageal dilation: Techniques and complications. Am J Gastroenterol 1994; 89:1627 (abstract).

(3.) Graham DY. Treatment of benign and malignant strictures of the esophagus, in Silvis SE (ed): Therapeutic Gastrointestinal Endoscopy gastrointestinal endoscopy Endoscopy A diagnostic procedure in which a flexible fiberoptic endoscope is passed into the esophagus, stomach, and upper small intestine–depending on the level at which lesions are anticipated Indications Dyspepsia, persistent . New York New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of
, Igaku-Shoin, 1990, ed 2, pp 1-41.

(4.) Webb WA, McDaniel L, Jones L. Endoscopic en·do·scope  
n.
An instrument for examining visually the interior of a bodily canal or a hollow organ such as the colon, bladder, or stomach.



en
 evaluation of dysphagia in two hundred and ninety-three patients with benign disease. Surg Gynecol Obstet 1984;158:152-156.

(5.) Marshall JB, Chowdhury TA. Does empiric esophageal dilation benefit dysphagia when endoscopy is normal? Dig Dis Sci 1996;41:1099-1101.

(6.) Castell DO. Approach to the patient with dysphagia, in Yamada T (ed): Textbook of Gastroenterology. Philadelphia, J.B. Lippincott, 1995, ed 2, pp 638-648.

(7.) Richter JE. Dysphagia, odynophagia, heartburn and other esophageal symptoms, in Feldman M, Scharschmidt B, Sleisinger M (eds): Gastrointestinal and Liver Disease Liver Disease Definition

Liver disease is a general term for any damage that reduces the functioning of the liver.
Description

The liver is a large, solid organ located in the upper right-hand side of the abdomen.
. Philadelphia, W.B. Saunders, 1998, ed 6, pp 97-105.

(8.) Dakkak M, Bennett JR. A new dysphagia score with objective validation. J Clin Gastroenterol 1992;14:99-100.

(9.) Chotiprasidhi P, Minocha A. Effectiveness of single dilation with Maloney dilator versus endoscopic rupture of Schatzki's ring Schatzki's ring Esophageal web, see there, aka lower esophageal ring  using biopsy forceps biopsy forceps Surgery A disposable forceps used during minimally invasive GI and urologic endoscopy for collecting biopsies . Dig Dis Sci 2000;45:281-284.

(10.) Stewart AL, Hays RD, Ware JE Jr. The MOS (1) (Metal Oxide Semiconductor) See MOSFET.

(2) (Mean Opinion Score) The quality of a digitized voice line. It is a subjective measurement that is derived entirely by people listening to the calls and scoring the results from
 short-form general health survey: Reliability and validity in a patient population. Med Care 1988;26:724-735.

(11.) Colon VJ, Young MA, Ramirez FC. The short- and long-term efficacy of empirical esophageal dilation in patients with nonobstructive dysphagia: A prospective, randomized study. Am J Gastroenterol 2000;95:910-913.

(12.) Scolapio JS, Gostout CJ, Schroeder KW, et al. Dysphagia without endoscopically evident disease: To dilate or not? Am J Gastroenterol 2001;96:327-330.

(13.) Webb WA. Esophageal dilation: Personal experience with current instruments and techniques. Am J Gastroenterol 1988;83:471-475.

(14.) Triadafilopoulos G. Nonobstructive dysphagia in reflux esophagitis reflux esophagitis
n.
Inflammation of the lower esophagus from regurgitation of acid gastric contents, characterized by substernal pain and usually due to malfunction of the lower esophageal sphincter. Also called peptic esophagitis.
. Am J Gastroenterol 1989;84:614-618.

(15.) Jacob P, Kahrilas PJ, Vanagunas A. Peristaltic peristaltic

pertaining to or emanating from peristalsis.


peristaltic reflex
onward movement of a bolus of ingesta in the intestine is preceded by a reflex dilation of the intestine.
 dysfunction associated with nonobstructive dysphagia in reflux disease. Dig Dis Sci 1990;35:939-942.

(16.) Kahrilas PJ. Gastroesophageal reflux disease gastroesophageal reflux disease (GERD)

Disorder characterized by frequent passage of gastric contents from the stomach back into the esophagus. Symptoms of GERD may include heartburn, coughing, frequent clearing of the throat, and difficulty in swallowing.
 and its complications, in Feldman M, Scharschmidt B, Sleisinger M (eds): Gastrointestinal and Liver Disease. Philadelphia, W.B. Saunders, 1998, ed 6, pp 498-517.

Kalyana Lavu, MD, Thomas P. Mathew, MD, and Anil Minocha, MD

From the Department of Medicine, University of Mississippi Medical Center University of Mississippi Medical Center (UMC) is the health sciences campus of the University of Mississippi (Ole Miss). Located in Jackson, Mississippi (USA), it houses the Schools of Medicine, Dentistry, Nursing, Health Related Professions, and Graduate Studies in the Health , and the VA Medical Center, Jackson, MS; and the University of Illinois University of Illinois may refer to:
  • University of Illinois at Urbana-Champaign (flagship campus)
  • University of Illinois at Chicago
  • University of Illinois at Springfield
  • University of Illinois system
It can also refer to:
, 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: docwrite@aol.com
COPYRIGHT 2004 Southern Medical Association
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Title Annotation:Original Article
Author:Minocha, Anil
Publication:Southern Medical Journal
Date:Feb 1, 2004
Words:2764
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