Gastroenterologia Japonica Copyright 9 1990 by The Japanese Society of Gastroenterology

Vol. 25, No. 4 Printed in Japan

Comparative studies on the usefulness of phosphate versus glycerin enema in preparation for colon examinations Fumiaki S U G I M U R A 1, Hiroichi R Y O H 1, Taijiroh W A T A N A B E 1, Nobuaki K A N E D A 1, Kyoko YONEMITSU 1, Tuguaki AOKI 1, Yasufumi MOTOKI 1, Fumio K A W A M U R A 1, Hisayuki A R I G A 1, Yutaka MATSUO 1, and Toshio H O N D A 2

1Third Department of Internal Medicine, Nihon University School of Medicine, Tokyo 173, Japan; and 2University Research Center, Nihon University, Tokyo 102, Japan Summary: Fifty of 100 persons who had undergone health screening received phosphate enema while the other 50 received glycerin enema prior to proctoscopy and barium enema, and their usefulness for preparation for colon examination was compared by a double-blind test. There was no significant difference in the degree of colonic cleansing achieved by proctoscopy and barium enema. In the subjects who received phosphate enema, the incidence of abdominal pain was less than that in those who received glycerin enema, while the effect of phosphate enema on defecation appeared later than that of glycerin enema, indicating prolonged stool retention in the subjects given phosphate enema. To study the safety of the two enemas, either phosphate enema, glycerin enema or physiological saline solution as a control was administered at 0.35 ml/ animal in the rectum by 4-h closure of the anus in 10 male 7-week-old Wistar rats, and the rectal mucosa was observed for irritation macroscopically and histophathologically. Glycerin enema produced less irritation than phosphate enema diffusely in the entire area of the rectum, while phosphate enema produced more local irritation at the end of the rectum than glycerin enema. The differences in the extent of irritation and injury between phosphate and glycerin enemas were considered to be derived from differences in the pharmacologic actions of these drugs. If the extent of injury were included in the extent of irritation, the difference in irritation between phosphate and glycerin enemas would not be significant. As described above, no specific difference seem to exist in the usefulness of phosphate and glycerin enemas as preparation for colon examination. Gastroenterol Jpn 1990;25:437-450 Key words:

barium enema; glycerin enema; proctoscopy; rectal irritation test; sodium phosphate enema

Introduction Colon examinations are increasingly being performed in Japan because of the increase in the incidence of diseases of the large intestine in recent years. As such examinations b e c o m e m o r e important, so does the type of preparation used, since this can greatly influence the quality of the examination. Glycerin e n e m a has conventionally b e e n used in japan as preparation for colon examinations in order to facilitate defecation and cleanse the inside of the large intestine. In contrast, phos-

phate e n e m a is frequently used in Western countries. W e compared the usefulness of p h o s p h a t e and glycerin enemas as preparation for colon examinations.

Subjects and Methods In the first stage of the study, 50 persons were randomly selected for administration of phosphate e n e m a out of 100 persons w h o received health screening at a clinic associated with our department during the period b e t w e e n July and N o v e m ber 19, 1987. The other 50 persons received glyc-

Received January 11, 1990. Accepted February 16, 1990. Address for correspondence: Fumiaki Sugimura, M.D., The Third Department of Internal Medicine, Nihon Univ~*rsitySchool of Medicine, 30-1 Ohyaguchi KamimachL Itabashi-ku, Tokyo 173, Japan.

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erin enema. The two enema agents were compared in terms of the response of subjects and the degree of cleansing of the large intestine as revealed by proctoscopy and barium enema. These subjects had been instructed to eat an enema diet and consume a low level of fat on the day before the enema, and to take one tablet of bisoxatin acetate (Laxonalin) as a laxative on the night before the enema. The prescription described in the USPXXI (1985), the U.S. pharmacopeia, was applied according to the composition of the phosphate enema, which was used prior to the colonic examination, as follows: 18.1g of sodium biphosphate (NaHzPO4 9 2H20) as a buffer, 0.01g of ethylis parahydroxybenzoas, and 0.005g of buthyl parahydroxybenzoate as antiseptics, and 0.2g of propylene glycol as a resolvent were added to 8.0g of the major agent, sodium phosphate (NaHzPO4 9 2H20), and the mixture was dissolved in 100 ml of distilled water. The glycerin enema used as a control agent was a commercially available 50% glycerin enema ( O H T A 120, Ohta Phamaceutical Co., Tokyo, Japan). The phosphate and glycerine enemas were each filled, in amount of 120 ml, into a plastic collapsible container that was easy to grip. Since both agents were transparent, it was difficult to differentiate one from the other in terms of appearance. The thus-prepared enema containers were numbered, and pieces of paper on which the contents of the agent were described were placed in envelopes for the double-blind test. The subjects, doctors, nurses and x-ray technicians were all unaware of the type of enema being used. After receiving an enema from the nurse, the subject was asked to defecate, and was then interviewed regarding his or her response. Then, personnel skilled in gastrointestinal diseases performed proctoscopy using plastic disposable proctoscopes, and the effects of the enemas were studied. Subsequently, 200 ml of 60% barium was injected into the large intestine of each subject using a handy disposable enema apparatus, B A R I - E N E M A . All the subject were examined by barium enema by the same x-ray technician, and the doctor who performed the proctoscopy

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read the barium enema films. The cleansing effect of the agent on the inside of the large intestine was also studied. As the second stage of the study, phosphate and glycerin enemas were compared with regard to injury of the rectal mucosa in rats in order to study the safety of phosphate enema. Seven-week-old male Wistar rats weighing 134-156 g were subjected to fasting for 48 hours, followed by administration of enema in the rectum by 4-hour closure of the anus. Irritation of the rectal mucosa caused by the enema was observed macroscopically and histophathologically. Each group, phosphate enema, glycerin enema and control (physiological saline solution), consisted of 10 rats. Prior to administration, the feces at the end of the rectum were forced out, and 0.35 ml (per animal) of an agent or physiological saline solution was injected into the rectum using a disposable 1ml syringe provided with a disposable oral sound. Immediately after administration the anus was closed with an adhesive agent to prevent leakage. The rats were sacrificed by exsanguination from the abdominal aorta under ether anesthesia 4 hours after administration, and the rectum was excised. After the presence or absence of feces in the rectum was observed, the rectum was incised along the dorsal side. The mucosa was lightly rinsed with physiological saline solution, expanded and fixed on a cork board on which a filter paper was placed, and observed macroscopically for redness, swelling and cloudiness. In addition, injury distance from the anus was measured. The redness, swelling and cloudiness of the mucosa were evaluated according to 5 stages: unchanged (score 0), slight (score 1), mild (score 2), moderate (score 3), and marked (score 4). After macroscopic observation, the specimens were fixed in 10% formalin solution. According to the usual method, they were e m b e d d e d in paraffin, and the longitudinal sections of the mucosal specimens, which included the largest site of injury (about 3 cm on the oral side from the anus) were prepared. After hematoxylin-eosin staining, the sections were examined histophathologically for degeneration and desquamation of the surface epithelium, e d e m a , hyperemia, hemorrhage and

Usefulness o f phosphate versus glycerin enema

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Table 1 Demographic data on subjects Parameters Sex

Age (years)

Classes

P group

G group

male female

42 8

40 10

82 18

total

50

50

100

2 7 17 13 8 3

2 5 14 26 3 0

4 12 31 39 11 3

20 30 40 50 60 70 -

29 39 49 59 69 79

Mean_+SE Bowel movements

Constipation

Bowel movement on the day of examination

Pretreatment taking the prescribed meal

Pretreatment taking a cathartic

Total

49.4+1.7

49.5+1.3

more than twice a day twice a day once a day every other day every two to three days every three days more than once every three days irregular

4 12 28 3 1 2 0

5 9 30 2 0 2 1

9 21 58 5 1 4 1

total

50

50

100

no yes

45 5

44 6

89 11

total

50

50

100

yes no

48 2

45 5

93 7

total

50

50

100

complete incomplete

47 3

48 2

95 5

total

50

50

100

yes no

43 7

38 12

81 19

total

50

50

100

cell infiltration of the lamina propria and submucosa, and evaluated according to 5 grades: unchanged ( - ) , slight (_+), mild (+), moderate ( + + ) , and marked ( + + + ) . According to Ito's method of using degeneration and desquamation of the mucosal epithelium as an index, the severity of injury in the specimens was also classified according to 5 grades: unchanged (grade 0), slight (grade 1), mild (grade 2), moderate (grade 3) and severe (grade 4) 1. Mean scores and standard deviations were calculated from the data obtained by macroscopic observation-the score for redness, swelling and cloudiness, the sum of these scores and injury distance-and from the severity of injury obtained by histological observation. Intergroup compari-

Statistical analysis Xo2 = 0.068 NS NS

(U-test) NS (t-test)

NS

(U-test)

xo~ = o.ooo

NS Xo 2 : 0.614 NS Xo~ = o o o o

NS X2 = 0.1.04 NS

son of injury distance was performed by t-test, and other comparisons were performed by the Mann-Whitney U-test. A level of less than 5% was regarded as significant. Rats with feces retained in the rectum were excluded from the comparison because they showed increased severity of injury due to fecal retention. Hence, the phosphate enema group consisted of 9 rats, the glycerin enema group 10 rats, and the control group with physiological saline solution 8 rats. Results

1. Study of background factors Table 1 shows the presence or absence of significant differences for each of the various back-

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Table 2 Efficacy of enemas Parameters Defecating effect

Time to onset of action (mins)

P group

G group

Total

yes no

Classes

43 5

39 9

92 14

Xo2 = 0.753

total

48

48

96

NS

1 1.5 2 2.5 3 3.5 4 4.5 5 5.5

5 0 15 7 11 3 1 1 3 2

9 1 26 1 8 1 1 0 0 0

14 1 41 8 19 4 2 1 3 2

0 (1) 12

(1)

6 6.5Mean_+SE Abdominal pain

Description of stools

2.1+0.1

no slight yes

35 11 2

22 16 10

total

48

48

96

watery soft normal hard other (only fluid)

26 13 4 2 3

16 22 3 0 7

42 35 7 2 10

total

48

48

96

2. Findings on the effects of enemas Table 2 shows results of the comparison of the responses of group P and G subjects to administration of enemas in terms of the presence/absence of effect on defecation, time of the effect, presence/absence and degree of abdominal pain, and fecal properties. The period between the ad-

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Comparative studies on the usefulness of phosphate versus glycerin enema in preparation for colon examinations.

Fifty of 100 persons who had undergone health screening received phosphate enema while the other 50 received glycerin enema prior to proctoscopy and b...
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