Nearly 400 hundred years ago, Frances Gliesson first de­scribed a sphincter structure at the distal end of the common bile duct where it enters the duodenum, but it was not until 1889, when Rugero Oddi described its anatomy and physiology in detail, that the function of this structure and its role in the control of flow of bile and pancreatic juices were appreciated. Oddi also postulated that patients would experience symptoms when this sphincter, which now bears his name, malfunctions. Since these initial ob­servations, numerous studies have been conducted with the aim of understanding the way that the sphincter of Oddi (SO) functions and how its dysfunction produces a variety of clinical syndromes. As we enter into the 21st century, our knowledge of the normal function of the sphincter has been considerably enhanced by these studies, and patients with dysfunctioning sphincters that produce symptoms can be identified. Furthermore, for a number of patients, thera­pies exist that produce good long term results. However, there are still large gaps in our understanding of the mecha­nism of dysfunction, and successful therapies for a significant number of individuals with SO dysfunction are lacking.

SO FUNCTION

The SO has been shown to be predominantly made up of circular and longitudinally orientated smooth muscle fibres that are embryologically distinct from the duodenum.

The muscular connections with the duodenum are thought to act as anchoring points and not to be functionally important. The SO shows similarities to duodenal activity in that its phase 3 activity of the migrating myoelectrical complex always precedes the duodenal phase 3 activity, but for the rest of the time the SO functions independently from the duodenum with regular phasic activity and no quiescent phase.

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The differential diagnosis of small intestinal ulceration and stricture formation is extensive. This is generally classi­fied into broad groups such as congenital, mechanical, in­flammatory, vascular, neoplastic and miscellaneous. Most formations are self-evident from clinical history and are rare. Granulomatous disease, especially with broad-based stric­tures, raises the possibility of Crohn’s disease or an in­fection such as tuberculosis. Congenital duodenal stenoses, including webs and rings, may occur and are evi­dent soon after birth. Occasionally, they may be associ­ated with Down’s syndrome. Post-traumatic strictures that simulate Crohn’s disease rarely have been described in the ileum, but stricture of the duodenum and jejunum has been recorded in association with physical child abuse. Ischemic strictures may develop in the more distal small intestine, are usually broad-based and typically have iron-laden macrophages. Ulceration in the small intes­tine may be related to celiac disease, sometimes with intesti­nal lymphoma. Strictures have also been associated with celiac disease, particularly in the duodenum. Drug-induced strictures and diaphragm-like changes have been reported with a number of medications, including po­tassium chloride, ASA and other nonsteroidal anti- inflammatory medications. Usually, these occur in the distal small intestine and colon rather than the duodenum. In spite of careful, clinical and pathological evaluation, the cause of some small intestinal strictures remain unex­plained. Some of these differ from the changes seen in the present case because the strictures are broad-based and often require surgical resection to resolve symptoms. In contrast, the diaphragm-like strictures seen in the present patient were quite distinctive and multiple; they usually involve the distal small intestine or colon. Pathological features of diaphragm disease, as previously detailed in this journal, also seem quite specific and, in some instances, appear to be directly related to medication use. In the present patient, no specific cause could be defined.

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A 58-year-old, Indo-Canadian male was evaluated for recur­rent bouts of upper epigastric pain and distension that was exacerbated by meals. There was no nausea, vomiting, change in appetite or weight loss. A barium study of the stomach and duodenum showed a dilated duodenum with­out ulceration (Figure 1). Radiographic studies of the jejunum and ileum were normal. Retained food debris was also reported, possibly from delayed emptying of the duodenum. A chest radiograph was normal. Serological studies for Helicobacter pylori were negative. There was no history of potassium chloride, ASA or other nonsteroidal anti- inflammatory drug use. There was no history of abdominal trauma, rheumatological disorder or familial history of gas­trointestinal diseases such as Crohn’s disease or celiac dis­ease. An initial endoscopic examination revealed a normal esophagus and stomach, but there was retained food debris. Endoscopic examination was repeated after a 24 h fluid diet. The mucosa was normal except for two distinct membranous strictures or webs of the descending duodenum (Figure 2). Mucosal biopsies from mucosa of the descending duodenum beyond the second stricture and between strictures, and from the duodenal bulb were normal. Biopsies from the margin of the web-like membranous strictures revealed reactive epithelial cellular changes with mucin depletion. No erosive change was evident. Fibrosis in the submucosal region was present, but there were no iron-laden macrophages or granu- lomas. Gastric biopsies were normal, while silver stains for H pylori were negative. Clinical improvement and resolu­tion of his abdominal pain followed endoscopic balloon dila­tion and empirical omeprazole therapy.

Figure 1) Barium radiographic study showing diaphragm strictures in the descending duodenum (arrows) with retained food debris. The food debris appears as filling defects in the dilated duodenum between the strictures

Figure 2) Two circumferential stenoses in the descending duodenum without erosion or ulceration
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In 1988, Bjarnason et al and Lang et al described the clinical and pathological features associated with small intestinal strictures in patients who had received non- steroidal anti-inflammatory drugs. These small intestinal strictures were very distinctive and unique to the known forms of small intestinal pathology associated with nonster- oidal anti-inflammatory drugs. Investigators used the term ‘diaphragm disease’ to describe the pathological changes. The observations were later confirmed by others detailing solitary or multiple diaphragm-like strictures, particularly in the distal small intestine and colon. In a subsequent re­port, a duodenal diaphragm-like stricture was reported in a Belgian man after consumption of an over-the-counter preparation that contained acetylsalicylic acid (ASA) and sodium bicarbonate.

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This is the first prospective, controlled study of loperamide in pregnancy to date. The results do not support the findings in the previous study with the Michigan Medicaid patients. In that study, which was a surveillance study with no personal interviews of patients (108), six major malformations were found in the first trimester, three of which were cardiac anomalies, compared with our group, which found no major malformations in the first trimester. This illustrates the im­portance of prospective, controlled studies of exposures in pregnancy, which include history and other specifics, such as concurrent drug use, smoking and alcohol use. With that be­ing the only report available before the present study, it is probable that women are advised not to take loperamide dur­ing pregnancy. This is reasonable, except that many women are not aware that they are pregnant when taking medica­tions. A large number of the women who took the drug on an acute basis did not consider whether they were pregnant, with a substantial number reporting that they were on holi­day in a foreign country. In previous studies and during the counselling process, women have informed us that they have had a therapeutic abortion of an otherwise wanted pregnancy based on fear of the consequences of the drug exposure on their fetus. We did not find an increase in the rates of preterm delivery, nor were the birth weights statistically sig­nificantly different, although the babies of chronic users were 200 g smaller than babies in the control group. However, this fact, in addition to the finding that half of the babies born to mothers who were exposed throughout the pregnancy weighed less than 3000 g, supports the results, as in other studies, that women with chronic bowel disease have smaller babies and should be encouraged to treat their condition with the appropriate medication during pregnancy, without fear of harming their babies.

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A total of 105 women from five centres were followed pro- spectively. There were 58 cases from Toronto, Ontario; 25 from Rome, Italy; 16 from Jerusalem, Israel; four from Milan, Italy; and two from Helsinki, Finland. Eighty-nine (85%) women took loperamide during organogenesis, with 21 (20%) taking it throughout their pregnancies. Indications for use were short term, for an acute case of diarrhea, or chronic, for bowel disease such as Crohn’s disease or irritable bowel syndrome. The doses varied greatly, from 4 to 6 mg in total, to 2 to 6 mg/day throughout the pregnancy.

In the study group, there were 95 live births, four thera­peutic abortions and six spontaneous abortions. There were no major malformations and three minor malformations re­ported. The malformations consisted of a heart murmur, a mild right pelviectasis (no symptoms) and a hypospadia (mi­nor). The mean birth weight was 3368 g (Table 1).

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The Motherisk Program is a counselling service for pregnant and lactating mothers, and their health professionals. Infor­mation about the safety or risk of drugs, chemicals, radiation and infectious diseases is given to approximately 35,000 call­ers per year. The other centres in Italy, Israel and Finland have similar services. The authors attempted to follow all the women who had called enquiring about the safety of this drug in pregnancy. All women who had used the drug during preg­nancy and agreed to participate were included in the study, with no exclusions. Upon contacting these women, history of exposure and pregnancy outcome were obtained, as well as other end points of interest, with the aid of a structured ques­tionnaire. Exposure history included medical indication for drug used, dosage, frequency of administration and timing of exposure. Outcomes were confirmed whenever possible by the child’s primary care physician. The primary outcome of interest was the presence or absence of a major malformation. Major malformation was defined as the presence of an anom­aly that has an adverse effect on either the function or social acceptability of the individual. Secondary outcomes of interest were spontaneous or therapeutic abortions, still­births, and presence or absence of a minor abnormality. Ex­posure was said to be during organogenesis if it occurred between the fourth and 14th week of gestation, when rates of 1% to 3% for major malformations, 10% to 15% for minor malformations and up to 15% for spontaneous abortions are expected. In addition to comparing mean birth weights be­tween the study and control groups, birth weights were com­pared between the babies whose mothers took the drug for only a few days for an acute case of diarrhea and those who took the drug throughout the pregnancy for chronic bowel disease.

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