UNRESTRICTED DIET IN THE TREATMENT OF DUODENAL ULCER

GASTROENTEROLOGY Copyright 1969 by The Williams & Wilkins Co. Vol. 56, No.6 Printed in U.S.A. UNRESTRCTED DET N THE TREATMENT OF DUODENAL ULCER ELWOOD BUCHMAN, M.D., DAVD T. KAUNG, M.D., KENNETH DOLAN, M.D., AND RUTH NASH KNAPP Departments of nternal Medicine and Radiology, Veterans Administration Hospital and University of owa College of Medicine, owa City, owa A controlled study is reported alternating a regular hospital diet with a bland diet in patients diagnosed as having active duodenal ulcer with crater after X-ray examination. Both diets were planned to meet nutritional requirements for normally healthy persons. All of the patients remained in the hospital for a minimum of 3 weeks after diagnosis. Accurate records were kept of food items served, with the reaction to them and the reasons for tray refusals. Clinically and radiographically there was no significant difference in the response of patients to the two diets. The patients placed on a regular diet did not eliminate foods not served on a bland or restricted diet. For over 100 years, the basic treatment of peptic ulcer has consisted in restriction of food. 1-7 The Council on Foods and Nutrition of the American Medical Association, writing about diet as related to gastrointestinal function, stated that, with a few exceptions, "All the elaborate food lists used today for treating gastrointestinal disorders must be regarded as based on unverified impressions and traditional lore." 8 Opinions still vary as to what role diet should play in the treatment of the usual patient with duodenal ulcer. 9 1o t was the intention of our group to determine whether a bland or regular diet led to differences in healing or clinical responses of patients with duodenal ulcer. Received June 21, 1968. Accepted January 3, 1969. Address requests for reprints to: Dr. Elwood Buchman, Veterans Administration Hospital, owa City, owa 52240. Special thanks are extended to Margaret Ohlson, Ph.D., formerly head of the Department of Nutrition, University of owa General Hospitals, for valuable assistance in the experimental design and to Paul E. Leaverton, Ph.D., Associate Professor of Preventive Medicine and Environmental Health, University of owa College of Medicine, for statistical analysis of the data. This investigation was limited exclusively to duodenal ulcer patients with emphasis on hospital care for several weeks with what is believed to approach optimal control of dietary management. Method All patients admitted to two wards of the Medical Service, Veterans Administration Hospital, owa City, owa, were placed in the study when duodenal ulcer craters were first reported by the radiologist. A complete medical history and physical examination were undertaken, along with a complete history of the patient's nutritional background as delineated by the research dietitian. A gastric analysis with betazole hydrochloride was accomplished and stools were examined for blood, both grossly and chemically. Patients were alternately assigned to a bland diet or to the standard hospital diet by the dietitian without bias. None of the patients received anticholinergic drugs. Milk and antacids were given to both groups of patients as outlined in table 1. The regular diet was planned to meet the nutritional requirements for normal healthy persons. Criteria for adequacy were the recommended daily dietary allowances as set forth by the National Research Council Food and Nutrition Board. ll There was no restriction in the regular hospital diet as to the foods included or their method of preparation. The 1016

June 1969 UNRESTRCTED DET N DUODENAL ULCER 1017 bland diet was planned with the same nutritional standards in mind but with the exclusion of fried foods, highly seasoned foods, raw fruits excepting ripe bananas, and all raw vegetables. Patients placed on protocol were served their assigned diet prepared by the hospital dietary personnel for a period of at least 21 days. Accurate records were kept of the amounts of food items served at each meal and of the amount actually consumed by each patient. All patients were interviewed daily to ascertain reasons for tray refusals and any subjective feelings which may have been caused by food items consumed. The information was coded, assembled, and processed by computers. Detailed information gained by the dietary examination will be the subject of another paper. At the completion of 21 days, a repeat upper gastrointestinal series, including fluoroscopy as well as appropriate films, was accomplished by the same radiologist who performed the first examination. The radiologist was not aware of the diet followed by individual patients. Patients were instructed to continue on the same diet at home as followed in the hospital. After leaving the hospital, each patient was seen at the end of the 8th week and of the 5th month, at which times he was evaluated clinically and had upper gastrointestinal roentgenograms, and his dietary history was taken by the dietitian. At the end of the 8th month, the patient had a dietary history taken and, at the end of the 12th month, when the study was completed, he had a repeat series of upper gastrointestinal X-rays, along with a dietary history and a chest X-ray. Results One hundred thirteen patients were admitted into the study beginning January 1964 and ending April 1966. Ten of the 113 patients left the study before their 3 weeks of treatment were completed, for reasons unrelated to diet. n all, there were 103 patients who completed the 21 days of in-hospital treatment, 50 of whom were given the bland diet and 53 of whom were given the regular diet. Patients on bland and regular diets were extremely well matched as to age, duration of ulcer symptoms, incidence of bleeding, pyloric obstruction and intractable pain, consumption of aspirin, alcohol, and coffee, cigarette usage, degrees of abdominal tenderness, hemoglobin values, and incidence of guaiac-positive stools. All patients had free hydrochloric acid in gastric juice after betazole hydrochloride injection. The period between admission and the time of the upper gastrointestinal series and placement into the study averaged 5 days. After 3 weeks of treatment with a bland diet, there were 50 patients who had upper gastrointestinal roentgenograms. TABLE 1. Therapy in the hospital- Group Activities Meals Antacidsb (.10 ml each dose) : aluminumper day hydroxide-magnesium trisilicate Milkb (90 ml each dose) Blanu diet Both 1st week 2nd week 3rd week and after Ad libitum on ward only 3 3 Every hr on >~ hr from 7:30 AM to retiring; also p.r.n. during night Every 2 hr from 8 AM to retiring; also, p.r.n. during night Every 4 hr from 9 AM to retiring; also p.r.n. during night Every hr on the hr from 7 AM Every 2 hr on the hr from 7 AM Every'4 hr on the hr from 7 AM _ p.r.n., As required. b Excluding meal times.

-~ -. -~ ----- 1018 BUCHMAN ET AL. Vol. 56, No.6 Forty-six of the 50 patients showed absenci~ of duodenal u1cers, and the other 4 patients exhibited ulcers. These results are compared in table 2 with 52 patients on a regular diet program who had a repeat upper gastrointestinal series at 3 weeks. n 43 patients the ulcers were healed, and 9 showed ulcers. These differences between patients receiving the bland diet and those given the regular diet are not statistically significant (P > 0.2). At the 8-week level, there were 45 patients in the bland diet group who had X-rays, with no ulcers in 42 and ulcers in 3 patients. n the regular diet group, there were 48 patients at the 8-week level who had upper gastrointestinal series, with 45 showing no evidence of ulcer, and ulcers in the 3 other patients. At 1 year, the end of the study, there were 39 patients who had been on a bland diet. n 36, the ulcers had healed; ulcers were present in 3 patients. Patients on a regular diet at the end of 1 year numbered 45, of whom 43 showed no evidence of an ulcer and the other 2 showed ulcers. Clinical results have been recorded in table 3. n both groups, all except 2 of the patients were asymptomatic by the 2nd day on dietary protocol. There appeared to be no essential differences in the subjective feelings of the two groups of patients. t was also evident in reviewing the dietary intake of all of the patients that practically without exception, the patients who were on a regular diet did indeed follow that diet, at least during the 3 weeks that they were in the hospital, and did not choose only bland foods. Discussion Until the turn of the century, early workers in the field of diet as related to peptic ulcer were handicapped by not having the benefit of radiological exami- TABLE 2. X -ray results i Bland diet Time 1 Patients Ulcer Patients Ulcer ----------------------------- -------------- - ------------ lui tial. 3 wk. 8 wk. 5 mo.. 12 mo. a Gastrointestillal. ltd ' With Hd P tt d. With Healed Present ~ GO.. i" ----',,.. """ _(~;' GO "i,, ~-~. --. ~~ ~!~ ~ ~~ ~~!~ ;....... ~~ i ~~ :~ ~ :~ :~ :~ ~ TABLE 3. Clinical results Bland diet Patients Weight change Weight change Patients Time > 51b > 51b - -_. Clinical Clinical improve- improve- With ab- ment With ab- rnent n study dominal Gain Loss n study dominal Gain Loss pain pain ------ ---------- ----- ----- ----_.- nitial..... 50 48 57 48 3 wk..... 50 7 10 1 50 53 7 10 0 53 12 mo...... 39 19 18 2 37 45 9 19 3 43

June 1969 UNRESTRCTED DET N DUODENAL ULCER 1019 nation in diagnosis and follow-up examination. Later, Nicol studied a mixed group of duodenal and gastric ulcer patients fed "a full diet consisting of four meals a day, the only precaution taken being to sieve any rough articles of food," finding that the immediate results were as good as those obtained with stricter methods of dieting. " The exact number of duodenal ulcer patients is not clear, and sieved foods are not considered part of a "regular" diet today. t would also appear that the strict diet group received antacids, whereas the sieved diet group did not. Lawrence compared results obtained by feeding the patients with duodenal, gastric, or jejunal ulcer a "full" diet with the results found by feeding a more restricted diet consisting of milk and eggs the 1st week, with progression to other foods when the patient had remained free of symptoms for at least 4 days during the previous stage. 13 t was his conclusion t:,at dietetic treatment of peptic ulcer did not hasten healing or pain disappearance. Doll et al. studied 50 duodenal ulcer outpatients, of whom some were randomly given the standard hospital ulcer diet while others were ~iven an "almost normal" diet. 14 There was a slight but statistically insignificant advantage to the patients on the "almost normal" diet in ulcer healing. Doll et al. appreciated the vagaries and capriciousness associated with outpatient therapeutics. Truelove also followed duodenal ulcer outpatients, 40 of whom were on an "ordinary diet." 15 Forty other radiologically proven duodenal ulcer patients were given a "gastric" diet. No significant difference was found in radiological healing of the ulcer or in clinical response during the 6-month follow-up period. t is to be noted that 19 patients (11 on bland diet and 8 on regular diet) were lost from the present study after the 3 weeks of hospitalization. t may appear that asymptoraatic patients might be more likely to drop out of the bland diet group, whereas symptomatic patients might be more apt to drop out of the regular diet group. The breakdown of the 11 patients on a bland diet lost to the study after discharge from the hospital was as follows: 6 were lost without any further information obtained; 1 patient died after the 8th month of an acute myocardial infarction (without further ulcer difficulty after the 3 weeks in the hospital); 1 had a perforated ulcer and was operated upon, and another had a symptomatic new duodenal ulcer. Two patients were having symptoms and were placed on anticholinergic drugs, which automatically removed them from the study. The distribution of the 8 patients on a regular diet leaving the protocol before completion of the study was as follows: 3 were lost without further details; 4 patients had recurrent symptoms, and 2 of the 4 had recurrent ulcers, proven in both at the 5th month, and were given a bland diet and anticholinergic drugs by their local physicians. One additional patient was inadvertently given a bland diet for home use after leaving the hospital, although up until that time he had no difficulty with the regular diet. nterestingly, he developed evidence of an ulcer at 8 weeks while on the bland diet. Our data show that duodenal ulcers in humans heal as rapidly with a regular diet as with a restricted diet. n addition, X-ray recurrences of duodenal ulcers were not more frequent while the patient was following a regular, unrestricted diet during a -year follow-up. Symptoms, too, were not materially different in inpatients with duodenal ulcer whether the bland or regular diet was eaten. Most gratifying to the patient and clinician alike was the sense of relief from burdensome and inconvenient dietary restrictions which was often voluntarily expressed by the patients on the unrestricted diet. t behooves physicians to consider carefully the limitations of design of any study dealing with diet or drugs in the therapy of duodenal ulcer. The fact that patients were alternately rather than randomly selected is not believed to alter significantly the validity of the results obtained. n fact, attempts were made to

1020 BUCHMAN ET AL. Vol. 56, No.6 eliminate bias by having every patient who satisfied the criteria for inclusion placed into the study; and the initial selection as to the type of diet was made by the dietitian upon receiving word of a duodenal ulcer crater being present. t should also be apppreciated that craters in the duodenum may be missed by good radiologists. Unfortunately, duodenoscopy still leaves something to be desired. Perhaps the most serious defect in a study of this type is related to follow-up after discharge from the hospital. As with most drug studies, what happens to a patient at home is always open to discussion. t is hoped that future studies can obviate the latter criticism. REFERENCES 1. Abercrombie, J. 1828. Pathological and practical researches on disease of the stomach, the intestinal canal, the liver, and other viscera of the abdomen, p. 67-99. Waugh and nnes, Edinburgh. 2. Cruvielhier, J. 1829. Anatomie pathologique du corps humain, Vol. 1, Fascicle 10. J. B. Bail liere et fils, Paris. 3. Leube, O. W. 1876. n H. V. Ziemssen [ed.], Handbuch der speciellen Pathologie und Therapie, Vol. 7, No. 2, p. 106-117. Verlag Von F. C. Vogel, Leipzig. 4. Lenhartz, H. 1904. Eine neue Behandlung des Ulcus Ventriculi. Deutsch. Med. Wschr. 30: 412-413. 5. Sippy, B. W. 1915. Gastric and duodenal ulcer. J. A. M. A. 64: 1625-1630. 6. Meulengracht, E. 1934. Treatment of hematemesis and melaena with food. Acta Med. Scand. Suppl. 59: 375-385. 7. Meulengracht, E. 1935. Treatment of hematemesis and melaena with food. Lancet 2: 1220-1222. 8. Weinstein, L., R. E. Olson, T. B. Van tallie, E. Caso, D. Johnson, and F. J. ngelfinger. 1964. Diet as related to gastrointestinal function. J. A. M. A. 176: 935-941. 9. Roth, J. L. A. 1966. The ulcer patient should watch his diet. n F. J. ngelfinger, A. S. Reman, and M. Finland [eds.], Controversy in internal medicine, p. 161-170. W. B. Saunders Company, Philadelphia. 10. ngelfinger, F. J. 1966. Let the ulcer patient enjoy his food. n F. J. ngelfinger, A. S. Reiman, and M. Finland [eds.], Controversy in internal medicine, p. 171-179. W. B. Saunders Company, Philadelphia. 11. Report of the Food and Nutrition Board, National Academy of Sciences, National Research Council, 1964. Recommended dietary allowances, Rev. Ed. 6. Publication 1146, p. 1-59. National Academy of Sciences, Washington, D. C. 12. Nicol, B. M. 1942. Peptic ulceration- results of modern treatment. Lancet 1: 466-469. 13. Lawrence, J. S. 1952. Dietetic and other methods in the treatment of peptic ulcer. Lancet 1: 482-485. 14. Doll, R., P. Friedlander, and F. Pygott. 1956. Dietetic treatment of peptic ulcer. Lancet 1: 5-8. 15. Truelove, S. C. 1960. Stilboestrol, phenobarbitone, and diet in chronic duodenal ulcer. Brit. Med. J. 2: 559-566.