S-adenosylmethionine versus ursodeoxycholic acid in the treatment of intrahepatic cholestasis of pregnancy: preliminary results of a controlled trial

Floreani, Annarosa; Paternoster, Delia Maria; Melis, Alessandro; Grella, P.

doi:10.1016/0301-2115(96)02442-6

Cited by 70 publications

(42 citation statements)

References 16 publications

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“…In addition, other studies require the use of additional biochemical markers such as elevated transaminases as inclusion criteria for ICP. 26,27 Rioseco et al 28 diagnosed ICP based on clinical criteria alone. Our decision to use a total serum bile acid concentration of 20 mmol/l or greater is the highest threshold to our knowledge for the diagnosis of ICP.…”

Section: Resultsmentioning

confidence: 99%

The prevalence of intrahepatic cholestasis of pregnancy in a primarily Latina Los Angeles population

et al. 2006

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Objective: To establish the prevalence of intrahepatic cholestasis of pregnancy (ICP) in a primarily Latina population in the United States.Study design: Over a period of 16 months, a convenience sample of subjects admitted to labor and delivery in the third trimester was enrolled. Each subject completed a questionnaire rating their severity of pruritus on a numeric scale of 1 to 10. Serum was analyzed via radioimmunoassay for total bile acid concentration. ICP was defined as pruritus score >4 and a total serum bile acid concentration of X20 mmol/l. Ethnicity was determined from hospital record demographic data.Results: All invited participants enrolled in the study. Three hundred and forty subjects were enrolled. Three hundred and sixteen subjects (93%) were identified as Latina. The serum bile acid concentration range for the entire study population was 1 to 580 mmol/l with a mean of 10.4±34.9 mmol/l. Twenty-four (7.1%) subjects had a serum bile acid concentration X20 mmol/l. A pruritus score >4 was found in 19.7% (67/ 340). Of the 24 subjects with a bile acid concentration X20 mmol/l, 19 also had a pruritus score >4. Thus, the prevalence of ICP in this population was 5.6% (19/340). In subjects with ICP, the mean serum bile acid concentration was 89.5±124.0 mmol/l. When controlling for confounders, women with ICP were associated with higher rates of chorioamnionitis (P ¼ 0.043) and their fetuses had higher rates of thick meconium (P ¼ 0.053). Conclusions:The overall prevalence of ICP in this population was 5.6%, 10 to 100 times higher than previously reported data from the United States. Larger studies of perinatal morbidity examining the diagnostic criteria of cholestasis need to be conducted.

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Section: Resultsmentioning

confidence: 99%

The prevalence of intrahepatic cholestasis of pregnancy in a primarily Latina Los Angeles population

et al. 2006

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“…Results similar to ours have been reported by the two other randomised trials comparing ursodeoxycholic acid and S-adenosyl-L-methionine. 8,9 In addition, two small randomised trials comparing ursodeoxycholic acid and placebo also showed a significant improvement in laboratory measurements with ursodeoxycholic acid. 3,10 Previous studies compared the effects of therapy only in women who completed at least 10 days of therapy; however, in our study duration of therapy did not seem to be related to the effect on the S-adenosyl-L-methionine concentrations of serum bile acid.…”

Section: Discussionmentioning

confidence: 97%

“…3,10,11 At variance with our findings, a small trial in which 20 women were randomised to ursodeoxycholic acid or S-adenosyl-L-methionine reported greater efficacy with ursodeoxycholic acid on pruritus. 8 It is possible that the variable results on the efficacy of the two therapies on maternal pruritus may reflect different dosages and routes of administration of S-adenosyl-L-methionine, as well as the difficulty in grading pruritus in a reproducible fashion.…”

Section: Discussionmentioning

confidence: 99%

A randomised controlled trial of ursodeoxycholic acid and S‐adenosyl‐l‐methionine in the treatment of gestational cholestasis

Roncaglia

Locatelli

Arreghini

et al. 2003

BJOG

108

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Objective To compare the efficacy of S-adenosyl-L-methionine and ursodeoxycholic acid in improving serum biochemical abnormalities in gestational cholestasis. Design Randomised clinical trial.Setting University hospital.Population All women at <36 weeks of gestation with severe gestational cholestasis during June 1996 to December 2001. Methods Enrolled women were randomly assigned oral S-adenosyl-L-methionine 500 mg twice daily or oral ursodeoxycholic acid 300 mg twice daily until delivery. Main outcome measures Reduction in the concentration of serum bile acids. Other variables considered included obstetric and neonatal outcome, clinical symptoms and other laboratory measurements (serum levels of transaminases and bilirubin). The two groups were compared using Student's t test, Wilcoxon's signed rank sum test and Fisher's exact test, with a two-tailed P < 0.05 being considered significant. Results Of the 46 women enrolled, 24 received ursodeoxycholic acid and 22 S-adenosyl-L-methionine. At enrolment, gestational age, duration of therapy, rate of nulliparity, pruritus score and biochemical characteristics were similar between the groups. Both therapies significantly and equally improved pruritus. Women receiving ursodeoxycholic acid had a significantly greater improvement in the concentration of serum bile acids ( P ¼ 0.001), aspartate aminotransferase ( P ¼ 0.01), alanine aminotransferase (<0.001) and bilirubin ( P ¼ 0.002) compared with those receiving S-adenosyl-L-methionine. Duration of therapy was significantly greater in women receiving ursodeoxycholic acid compared with S-adenosyl-Lmethionine ( P ¼ 0.04), whereas gestational age at delivery and rate of prematurity were similar in the two groups. Conclusions In women with intrahepatic cholestasis of pregnancy, ursodeoxycholic acid is more effective than S-adenosyl-L-methionine at improving the concentration of serum bile acids and other tests of liver function, whereas both therapies are equally effective at improving pruritus.

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“…37 Some characteristics of ICP suggest that exoge-in 20 patients with ICP, UDCA was more effective than Sadenosylmethionine in controlling pruritus and serum total nous factors might be associated with the genetic factors 1 : 1) ICP is recurrent in only 60% to 70% of pregnancies in bile acid levels. 52 In the third study comprising 19 patients treated for at least 2 weeks with UDCA (10 mg/kg/d up to multiparous women. 1 In our study, ICP recurred in only 45% of multiparous patients and the patient with a stillbirth 1 g/d) or placebo, UDCA improved pruritus but not biochemical tests.…”

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confidence: 99%

Intrahepatic cholestasis of pregnancy: A French prospective study

et al. 1997

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The prevalence of ICP varies greatly according to country. The aim of this prospective study was to analyze the charac-The prevalence is high in Scandinavian countries (1%-teristics of intrahepatic cholestasis of pregnancy (ICP) in a 1.5%), 3,4 in Bolivia (9.2%), 5 and in Chile, with a prevalence French population. From 1989 to 1995 we studied 50 consecof between 11.8% and 27.6% according to ethnic origin. 6 In utive pregnant women with ICP (41 single, 7 twin, and 2Santiago the prevalence of ICP was recently evaluated at 4%. 7 triplet pregnancies) referred for hepatologic consultation. All In contrast, the prevalence is reported to be low in the United patients suffered from pruritus and/or jaundice associated States, 8 Canada, 9 and Switzerland. 10 In France the prevalence with elevated fasting serum levels of total bile acids (mean has been assessed to be 0.2% to 0.5% 11,12 and ICP has not 49 mmol/L, range 7-290). No patients had concomitant liver often been studied. disease and all recovered normal liver function after delivery.The aim of this prospective study was to analyze characterOverall prematurity rate was 60%: 100% in multiple pregnanistics of ICP in France. rently treated with cholestyramine), after decrease in dose ofSigns of pre-eclampsia, fever, and urinary or endocervical infection progesterone in 1 patient, and spontaneously in 2 patients.were exclusion criteria. In cases of recurrent ICP the first occurrence During the same period, the percentage of pregnant women during the period under study was taken into account for the dewithout ICP who had been treated with progesterone during scription of characteristics. pregnancy was statistically lower than the percentage of patients treated with progesterone before the onset of pruritus Methods in our group of patients with ICP (36% vs. 64%, P õ .01, Biological Tests. Fasting blood samples were taken and serum TBA odds ratio 3.16, 95% CI:1.29-7.80). These results suggest that and total bilirubin and conjugated bilirubin concentrations, and orally administered progesterone might be an exogenous fac-serum ALT, alkaline phosphatase (AP), and g-glutamyl transpeptitor which triggers ICP in predisposed women. (HEPATOLOGY dase (GGT) activity, were measured at least twice, for each patient. 1997;26:358-364.)In fact, this was usually once or twice a week until delivery. Serum aspartate aminotransferase (AST) and 5 nucleotidase activity was measured in 19 and 44 patients, respectively. Prothrombin time, Intrahepatic cholestasis of pregnancy (ICP) is a liver discreatininemia, and uricemia were also regularly monitored. For each ease unique to pregnancy, which occurs in the second or patient, the most abnormal values, i.e., the highest values for LFTs, third trimesters and disappears spontaneously after delivery. uricemia, creatininemia, and the lowest values for prothrombin timeThe occurrence of ICP carries a risk for the fetus and pruritus were retained for the calculation of the biological characteristics. is a very uncomfortable symptom for the mother. ...

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S-adenosylmethionine versus ursodeoxycholic acid in the treatment of intrahepatic cholestasis of pregnancy: preliminary results of a controlled trial

Cited by 70 publications

References 16 publications

The prevalence of intrahepatic cholestasis of pregnancy in a primarily Latina Los Angeles population

The prevalence of intrahepatic cholestasis of pregnancy in a primarily Latina Los Angeles population

A randomised controlled trial of ursodeoxycholic acid and S‐adenosyl‐l‐methionine in the treatment of gestational cholestasis

Intrahepatic cholestasis of pregnancy: A French prospective study

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