A controlled, class-based multicomponent intervention to promote healthy lifestyle and to reduce the burden of childhood obesity.

BACKGROUND: Overweight and obesity prevention in childhood and adolescence represent a priority for public health; school is a privileged place for health promotion interventions. OBJECTIVES: The study aimed to test the effectiveness of a multicomponent 5-month intervention on the habits of primary school children, making the families aware of the importance of healthy choices. METHODS: Two hundred nine children attending the fourth class of primary school, divided into interventional (n = 103) and control arm (n = 106) were included in the study. In the intervention group, parents and teachers received more intense lifestyle counseling, associated with weekly motivational telephone calls to families to motivate further their lifestyle changes. Standard deviation score (SDS) body mass index (BMI) was the primary outcome measure; on open-air games and TV watching were secondary outcomes. RESULTS: At baseline, no differences were observed between groups. At 8-month follow-up, mean SDS BMI had decreased by 0.06 units in the intervention arm and increased by 0.12 in controls (time × treatment anova, P < 0.002). Outdoor activities increased from 6.23 h week(-1) to 9.93 in the intervention group (P < 0.001), not in controls. This change was associated differences in TV watching from baseline (intervention, -0.96 h week(-1); P = 0.037; controls, +1.33 h week(-1); P = 0.031). CONCLUSION: A multicomponent school-based intervention addressing the needs of children, teachers and families produced a significant and favourable short-term effect on overweight/obese schoolchildren.

Which treatment for nonalcoholic fatty liver disease?

Subjects with nonalcoholic fatty liver disease are at risk of progressive liver failure. Lifestyle changes including weight-loss strategies and increased physical activity remain the first-line approach, but a few pharmacological treatments have also been successfully tested. Several drugs improve biochemistry, only a few improve histology; in all cases, the results were not sustained after treatment stop. Pharmacological treatment is not so far indicated outside controlled clinical trials with histological outcomes.

A physical activity program to reinforce weight maintenance following a behavior program in overweight/obese subjects.

OBJECTIVE: To investigate the effects of a specific program to implement physical activity (fitness program) on weight loss maintenance, activity level and resting energy expenditure (REE). DESIGN: Observational study of subjects completing a behavioral program. SUBJECTS: In total, 200 overweight/obese subjects (36 males, aged 20-66 years; average BMI, 35.2 kg/m2). Program and measurements:The fitness program consisted of 12 bimonthly sessions, chaired by doctors and dietitians, involving groups of 8-12 subjects. Patients entered the program approximately 9 months after the end of behavioral treatment, during a weight loss maintenance period. The goal was set at a light-to-moderate daily physical activity (brisk walking), quantitatively measured by a pedometer; REE was measured before and after the fitness program by indirect calorimetry in a subset of patients. RESULTS: The fitness program restarted the process of weight loss in over 60% of subjects. At the end of the study, 84% of patients walked at least 5000 steps per day, compared with 24% at the beginning of the study. The probability of losing from 5 to 10% of initial body weight increased by 20% for any 1000 steps/day (OR, 1.20; 95% CI (confidence interval), 1.07-1.35), and that of losing more than 10% by over 30% (OR, 1.33; 95% CI, 1.19-1.49). REE increased significantly by 100 kcal/day (+7.5%), in spite of further weight loss (-1.8%). CONCLUSION: A specific fitness program in the weight maintenance phase after a behavioral program may significantly improve the long-term control of obesity.

The burden of obesity on everyday life: a role for osteoarticular and respiratory diseases.

The burden of obesity on patients' everyday life is high; obese subjects perceive a poor Health-Related Quality of Life (HRQL) in both physical and mental dimensions. We aimed to identify the areas of everyday life limited by health status and factors mainly responsible for perceived problems. The Nottingham Health Profile questionnaire (NHP) was used in 274 obese subjects seeking treatment at a university-based obesity center. Values were compared with normative Italian data, corrected for age and sex. Anthropometric and clinical data were also recorded, and correlated with health status. All domains of NHP were significantly impaired in obesity, the effect size ranging from 0.14 (Emotional Reactions; p = 0.02) to 0.99 (Physical Mobility; p < 0.0001), and varying in relation to gender, age and obesity class. Female subjects reported a higher-than-expected prevalence of problems in most areas of daily life [from 20% (Paid Employment) to 44% (Jobs around the home), compared with 14-26% in controls]. Males reported a high prevalence of problems in Sex life (31%), Holidays (37%) and Hobbies (49%), compared with 14, 14, and 16% in controls, respectively. Logistic regression analysis identified osteoarticular pain (knee and hip pain) and respiratory diseases as major factors predicting a poor HRQL in its physical dimensions, or perceived problems in everyday life. The relative importance of knee pain was higher than that of hip pain. Osteoarticular and respiratory diseases are major determinants of poor HRQL in obesity. Prevention strategies and treatment of somatic diseases are mandatory for a comprehensive approach to obesity.

Review: low caloric intake and gall-bladder motor function.

Cholelithiasis is the primary expression of obesity in the hepatobiliary system. In obese subjects the risk of developing gallstones is increased due to a higher cholesterol saturation of gall-bladder bile. During weight reduction with very low calorie diets (VLCD) the incidence of gallstones increases, but the mechanism for gallstone formation is not completely understood and several pathogenetic mechanisms have been suggested: increased saturation of bile, increased gall-bladder secretion of mucin and calcium, increased presence of prostaglandins and arachidonic acid. Alterations in gall-bladder motility may contribute to gallstone formation, but few studies have addressed the issue of gall-bladder motility during rapid weight loss and its possible role in gallstone formation. VLCD have been associated with a gall-bladder stasis, as a consequence of reduced gall-bladder stimulation by low fat content of the diets. A threshold quantity of fat (10 g) has been documented to obtain efficient gall-bladder emptying. Ursodeoxycholic acid administered during VLCD seems to have a protective role in developing a biliary cholesterol crystals. Gall-bladder emptying was lower in response to low fat meals with respect to relative higher fat meals, before as well as during the VLCD. This may account the possibility of an adaptative response of the gall-bladder motility to a given diet regimen. Adequate fat content of the VLCD may prevent gallstone formation, maintaining adequate gall-bladder motility and may be more economic and physiologically acceptable than administration of a pharmacological agent.

Sluggish small bowel motility is involved in determining increased biliary deoxycholic acid in cholesterol gallstone patients.

OBJECTIVE: Our aim was to establish whether small intestine transit time is defective in subjects with cholesterol gallstones. METHODS: We enrolled 10 patients (eight women, two men; mean age, 48.7 yr; mean body mass index [BMI], 22.4 Kg/m2) with recently diagnosed cholelithiasis, with no liver pathology, who were not taking any drugs, and 11 comparable healthy volunteers (eight women, three men; mean age, 46.2 yr; mean BMI, 22.7 Kg/m2), who served as controls. All subjects underwent orocecal (by starch breath test technique and serum assays of salazopyrin), oroileal (by serum assays of tauroursodeoxycholic acid), and duodenoileal (by serum assays of taurocholic acid) transit times; cholesterol saturation index; and bile acid composition and gallbladder motility studies (by ultrasound). For serum assays, blood samples were collected over a period of 7 h. Gallbladder motility and orocecal transit time were evaluated simultaneously. RESULTS: All four means of assessing transit time gave longer times in cholesterol gallstone patients than in controls: orocecal transit time (salazopyrin) = 366 +/- 13 vs 258 +/- 16 min, p < 0.0005; orocecal transit time (starch breath test) = 415 +/- 139 vs 290 +/- 15 min, p < 0.01; duodenoileal transit time: 272 +/- 23 vs 205 +/- 23 min, p < 0.03; and oroileal transit time: 308 +/- 18 vs 230 +/- 19 min, p < 0.009. Cholesterol gallstone patients showed an increase in percent molar biliary deoxycholic acid (30% +/- 4.5% vs 16% +/- 1.3%, p < 0.02) and a decrease in percent molar cholic acid 32% +/- 2.2% vs 40% +/- 1.3%, p < 0.03) and chenodeoxycholic acid (34% +/- 3% vs 41% +/- 1.8%, p < 0.03), compared with controls; patients also had greater percent molar biliary cholesterol. A linear relationship (r2 = 0.6324, p = 0.0012) between biliary deoxycholic acid and small bowel transit time was found. Residual gallbladder volumes were larger in cholesterol gallstone patients (11.38 +/- 1.27 vs 7.55 +/- 0.39 ml, p < 0.04), whereas basal gallbladder volumes, although higher, did not reach statistical significance (24.25 +/- 2.41 vs 19.98 +/- 1.63 ml; p = ns). CONCLUSIONS: This study confirms that patients with cholesterol gallstones have delayed small bowel transit, defective gallbladder motor function, and increased biliary deoxycholic acid. Delayed small bowel transit may contribute to supersaturation of bile with cholesterol by increasing deoxycholic acid production.

Gallbladder motility and gallstone formation in obese patients following very low calorie diets. Use it (fat) to lose it (well).

OBJECTIVE: Dieting obese subjects are at risk of developing gallstones. A gallbladder motor dysfunction could have a pathogenetic role. The principal aim of this study was to evaluate the long term effects of two very low calorie diets differing in fat content on gallbladder emptying and gallstone formation in obese subjects. DESIGN AND SUBJECTS: Gallbladder emptying in response to meals (breakfast, lunch and dinner) in two different diet regimens (3.0 vs 12.2 g of fat/d) was evaluated by ultrasonography in 32 gallstone-free obese patients on different days, before and during (at 45 d intervals) one or two 6-month weight reduction diets (for the first three months: 2.24 MJ (535.2 kcal), 3.0 g fat/d vs 2.415 MJ (577.0 kcal), 12.2 g fat/d; for the second three months, the same low calorie diet of 4.194 MJ (1002 kcal)/d for both groups). In 10 subjects, bile analysis was also performed. RESULTS: Twenty-two (69%) subjects concluded the study, eleven in each group, and a significant weight loss was achieved by all subjects. Gallstones (asymptomatic) developed in 6/11 (54.5%) (P < 0.01) of subjects following the lower fat diet, but in none with the higher fat regimen. In the dieters during the first three months (very low calorie phase) the higher fat meals always induced a significantly greater gallbladder emptying than the lower fat meals. The cholesterol saturation index initially increased significantly and then decreased, without difference between the two groups. CONCLUSION: In the obese during rapid weight loss from a very low calorie diet, a relatively high fat intake could prevent gallstone formation, probably by maintaining an adequate gallbladder emptying, which could counterbalance lithogenic mechanisms acting during weight loss.

Gastrogastric reflexes regulating gastric tone and their relationship to perception.

Our aim was to investigate in humans the gastrogastric reflexes that regulate gastric tone and their relationship to perception. In nine healthy subjects, liquid distension (in 100-ml steps), warm stimuli (in 3 degrees C increments), and cold stimuli (in 6 degrees C decrements) were randomly applied in the stomach for 3 min at 8-min intervals. Gastric tone was measured as isobaric volume changes of air by a barostat, and perception was scored by a graded (0-6) questionnaire. Liquid accommodation produced an additional expansion of isobaric air maintained by the barostat (51 +/- 13 ml with 100 ml of liquid filling, P < 0.05), but this effect became inconsistent with further filling. An accommodation-like reflex was best evidenced by warm stimulation below the discomfort threshold (58 +/- 13 ml relaxation at 47 +/- 1 degrees C, P < 0.05). By contrast, cooling below discomfort induced a reflex contraction (-62 +/- 22 ml change at 18 +/- 2 degrees C, P < 0.05). In conclusion, gastric tone, i.e., accommodation and contraction, is modulated by a net of reflexes that arise from the proper wall of the stomach below the discomfort threshold.

Perception and gut reflexes induced by stimulation of gastrointestinal thermoreceptors in humans.

1. Experimental studies in animals suggest the existence of thermoreceptors in the gastrointestinal tract. Our aim was to investigate the distribution and specificity of upper gut thermoreceptors in humans. 2. In healthy subjects, thermal stimulation of the stomach (n = 8) and the small intestine (n = 6) was produced by means of a thermostat, which recirculates water at adjusted temperatures through an ultrathin intraluminal bag. Progressively warm (42, 47 and 52 degrees C) and cold (32, 22 and 12 degrees C) stimuli of 3 min duration were alternately applied at 13 min intervals. Perception was scored on a scale of 0-6 and gastric tone responses were measured with a barostat. 3. Thermal stimuli induced specific responses: cold stimuli induced abdominal cold sensation and a reflex contraction of the stomach, whereas warm stimuli induced warm sensation and a reflex gastric relaxation. 4. Thermal stimuli induced similar stimulus-related perception in the stomach and small intestine (temperatures between 12 and 49.5 +/- 0.5 degrees C were tolerated). 5. The reflex responses were site specific. Warm and cold stimulation of the stomach induced gastric reflexes (76 +/- 26 ml isobaric expansion at 47 degrees C, and 68 +/- 10 ml contraction at 12 degrees C; P < 0.05 for both). However, only warm, not cold, stimulation of the intestine induced enterogastric reflexes. 6. These results indicate that in humans, warm and cold receptors are distributed along the gastrointestinal tract and project afferent input both into perception and reflex circuits with specific topographic organization.

Changes in biliary lipid secretion and cholic acid kinetics induced by diet, diet plus simvastatin and diet plus ursodeoxycholic acid in obese subjects.

The aim of this work was to evaluate and compare the effects of a low calorie diet (1026 kcal), simvastatin and ursodeoxycholic acid administration on biliary lipid secretion and cholic acid kinetics in dieting obese subjects. We studied 6 obese subjects before and after four weeks of a hypocaloric diet alone, after four weeks of diet plus ursodeoxycholic acid (900 mg/day) and after four weeks of diet plus simvastatin (40 mg/day), according to a Latin square design. The cholesterol saturation index was increased after diet alone, significantly reduced with diet plus ursodeoxycholic acid (p < 0.01), and unchanged during simvastatin administration. While the cholesterol output was reduced by all three regimens, diet plus ursodeoxycholic acid caused a significantly greater decrease than diet alone (p < 0.01). Cholic acid synthesis and bile acid secretion were decreased by diet and diet plus simvastatin (p < 0.05), but neither was affected by ursodeoxycholic acid. For cholic acid, all three treatments, but especially diet alone and diet plus simvastatin (p < 0.05), reduced the pool size; all three regimens also increased the turnover rate, but this was significant only for ursodeoxycholic acid (p < 0.01). Our study shows that, in obese patients, a hypocaloric diet reduces cholesterol-holding biliary lipid output and consequently increases the cholesterol saturation index. The addition of simvastatin to a hypocaloric dietary regimen reduces cholesterol secretion, but without variation in bile acid and phospholipid output thus the cholesterol saturation index remains unchanged. When ursodeoxycholic acid is added to the dietary regimen, it reduces cholesterol secretion, while maintaining bile acid output and, thus, lowers the cholesterol saturation index. Unlike simvastatin, ursodeoxycholic acid prevents the drop in cholic acid synthesis induced by a low calorie diet.

Treatment of chronic sporadic-type non-A, non-B hepatitis with lymphoblastoid interferon: gamma GT levels predictive for response.

The aim of this study was to evaluate the efficacy of human lymphoblastoid interferon-alpha treatment in chronic sporadic-type non-A, non-B hepatitis. We also aimed to determine if histological or liver function data could predict either response or relapse. Sixty patients with chronic sporadic-type non-A, non-B hepatitis were randomized in two groups of 30. One group was treated with interferon-alpha (3 MU thrice weekly) for one year; the other group was untreated controls. The treated group was followed for another year after interferon withdrawal. Liver function tests were performed during treatment. Liver biopsy was carried out before and a year after randomization. We evaluated rate of response [normalization of alanine aminotransferase (ALT) levels for at least three consecutive months] and rate of relapse (ALT rebound after therapy suspension). We also looked at possible predictive factors for response and relapse. In the treatment group the rate of response was 55% (16/29). No control patient exhibited ALT normalization. Among the responders, 31% (5/16) relapsed after interferon withdrawal. Low gamma GT and female sex are positive predictive factors of response (P < 0.01 and P < 0.02 respectively). Presence of portal and periportal inflammation at the second liver biopsy was correlated with relapse (P < 0.05). In conclusion, human lymphoblastoid interferon-alpha treatment for one year is beneficial in patients suffering from chronic sporadic-type non-A, non-B hepatitis. Low pretreatment gamma GT levels and female sex are positive predictors of response in this patient population.(ABSTRACT TRUNCATED AT 250 WORDS)

Ursodeoxycholic acid administration on bile acid metabolism in patients with early stages of primary biliary cirrhosis.

Ursodeoxycholic acid has been proposed for the treatment of primary biliary cirrhosis. The aim of this study was to evaluate the effect of ursodeoxycholic acid administration on bile acid metabolism in patients with early-stage primary biliary cirrhosis. Biliary bile acid composition, primary bile acid pool sizes, synthesis, and fractional turnover rate were measured before and after four weeks of ursodeoxycholic acid administration (600 mg/day) in nine patients with biopsy-proven primary biliary cirrhosis (stages I-III). Molar percentages of chenodeoxycholic, cholic, and deoxycholic acids in bile were significantly decreased by ursodeoxycholic acid administration, while its biliary concentration increased to 34.2% at the end of the same four-week period. The cholic and chenodeoxycholic acid pools decreased, although not significantly, while the deoxycholic acid pool was reduced by 60% (from 0.7 +/- 0.12 to 0.29 +/- 0.07 mmol, P < 0.002). Primary bile acid synthesis was slightly increased, and fractional turnover rate was significantly increased. The conversion rate of cholic to deoxycholic acid was measured and found to be significantly increased (P < 0.05) after ursodeoxycholic acid administration; however, serum levels of both free and conjugated deoxycholic acid were significantly decreased (from 23.2 +/- 9.7 to 3.8 +/- 1.9 mumol/liter, P < 0.001). We conclude that in patients with primary biliary cirrhosis, ursodeoxycholic acid administration replaces endogenous bile acids in the enterohepatic circulation by increasing bile acid fractional turnover rate without significant increments of their hepatic synthesis.

Comparative evaluation of chenodeoxycholic and ursodeoxycholic acids in obese patients. Effects on biliary lipid metabolism during weight maintenance and weight reduction.

Obesity is a condition associated with an increased frequency of gallstone disease. This study attempted to evaluate the comparative effects of two gallstone-dissolving agents, chenodeoxycholic acid and ursodeoxycholic acid, on bile acid metabolism and biliary lipid secretion in obese subjects in order to identify the bile acid of choice in preventing and treating gallstone disease in obesity. Twenty obese subjects (greater than 120% ideal body wt) were randomly treated with ursodeoxycholic acid (10 mg.kg-1.day-1.1 mo-1) and then with chenodeoxycholic acid (15 mg.kg-1.day-1.1 mo-1) or with chenodeoxycholic acid first and then with ursodeoxycholic acid. Patients 1-10 were studied while eating an unrestricted weight-maintenance diet, whereas patients 11-20 were eating a 1080-kcal/d hypocaloric diet. Biliary lipid composition, cholesterol saturation index, and biliary bile acid pattern were evaluated in all subjects before and after each treatment period; in subjects 6-10 and 16-20, biliary lipid secretion rates and bile acid pool size were also evaluated. Both ursodeoxycholic acid and chenodeoxycholic acid decreased cholesterol outputs and cholesterol saturation index. However, during the weight-maintenance period the decrease induced by chenodeoxycholic acid was not significant. Biliary cholesterol outputs and cholesterol saturation index were always lower during ursodeoxycholic acid administration than during chenodeoxycholic acid therapy. Ursodeoxycholic acid levels during ursodeoxycholic acid administration and chenodeoxycholic acid levels during chenodeoxycholic acid administration increased in bile to 50% and 77%, respectively, of total bile acid levels. Bile acid pool size remained unchanged during chenodeoxycholic acid administration and was significantly reduced by ursodeoxycholic acid administration during the weight-reduction period. In conclusion, ursodeoxycholic acid in obese subjects seems more effective than chenodeoxycholic acid, at least during weight maintenance, in reducing cholesterol saturation of bile. This effect is related to a significant decrease of biliary cholesterol output.

Effect of gemfibrozil administration on biliary lipid secretion in hyperlipidemic patients. A crossover study with clofibrate.

Gemfibrozil, like clofibrate, is effective in lowering both serum cholesterol and triglycerides and in increasing high-density lipoproteins. The information available about its effects on biliary lipids is still limited, and conflicting results have been reported. In this study we evaluated the effect of gemfibrozil (1.2 g/day) and clofibrate (2.0 g/day), in a single-blind crossover design for 6 weeks with a 4-week washout period, on the biliary cholesterol saturation index (SI) in stimulated hepatic bile and on the hepatic secretion rate of biliary lipids in patients with hyperlipidemia. Clofibrate increased cholesterol SI (from 1.70 +/- 0.14 to 2.05 +/- 0.24), whereas gemfibrozil decreased it (from 1.70 +/- 0.14 to 1.54 +/- 0.16). The results were not statistically significant. The hepatic secretion rate of cholesterol was significantly (p less than 0.04) increased by clofibrate therapy, whereas it was significantly (p less than 0.04) decreased after gemfibrozil; a significant (p less than 0.04) decrease in the hepatic secretion rate of bile acids, bile acid pool size, and bile acid fecal excretion (p less than 0.04) was also found after gemfibrozil administration. Gemfibrozil interferes extensively with bile acid metabolism, but it does not increase biliary cholesterol secretion, as clofibrate does. These results suggest that gemfibrozil does not seem to increase the risk of gallstone formation in patients with hyperlipidemia.

Effect of ursodeoxycholic acid administration on biliary lipid secretion in primary biliary cirrhosis.

Ursodeoxycholic acid (UDCA) has been reported to improve liver function tests when administered to patients with cholestatic liver diseases, such as primary biliary cirrhosis (PBC). However, its effects on biliary lipid metabolism in patients with PBC are still unknown. In this study we report the effect that UDCA (600 mg/day, for four weeks) had on biliary cholesterol saturation index, biliary bile acid pattern and pool size, and biliary lipid output in seven female patients (ages 34-58 years) with PBC, stages I to III. A significant improvement of liver function tests was observed after four weeks of treatment. Saturation index was significantly decreased from 1.23 +/- 0.1 to 0.7 +/- 0.08 (P less than 0.02); this effect was due to the significant decrease of biliary cholesterol concentration from 6.7 +/- 0.36 to 3.6 +/- 0.37 percent molar (P less than 0.02). A significant decrease of cholesterol output (from 88 +/- 9 to 55 +/- 10 mumol/hr, P less than 0.02) was also observed. The amount of cholic acid, the predominant bile acid in bile, significantly decreased (from 47.3 +/- 3.5 to 35.4 +/- 2.6 percent molar, P less than 0.02), as did amounts of chenodeoxycholic and deoxycholic acids, while the amount of UDCA rose from 1.6 +/- 1.0 to 34.0 +/- 1.3 percent molar (P less than 0.02). Total bile acid pool size was not affected by UDCA, but the evaluation of individual bile acid pool sizes showed an increased proportion of UDCA relative to the endogenous bile acids.(ABSTRACT TRUNCATED AT 250 WORDS)

Gallstone recurrence after successful oral bile acid treatment. A 12-year follow-up study and evaluation of long-term postdissolution treatment.

Recurrence is a major problem in the medical treatment of gallstones but its extent is still uncertain. The aim of this study was to determine the magnitude of this event and to assess the effectiveness of a postdissolution treatment in preventing it. We evaluated the long-term recurrence rate after 96 confirmed dissolutions observed in 86 subjects (71 women, 15 men) over a 12-yr follow-up period. A low-dose postdissolution treatment (ursodeoxycholic acid, 300 mg/day) was administered to 36 subjects, whereas in the remaining 60 cases no postdissolution treatment was given. By actuarial life-table analysis, the cumulative proportion of gallstone recurrence was 12.5% at the first year, rising to 61% at the 11th year. Postdissolution treatment was effective in reducing the frequency of gallstone recurrence (p = 0.0067), but this was mainly related to its effect on younger subjects (less than or equal to 50 yr old). In older subjects the recurrence rate was unaffected by treatment. The probability of gallstone recurrence was significantly higher in subjects with multiple stones before dissolution treatment than in those who had had solitary stones (p = 0.0091). No other factor predictive of gallstone recurrence could be identified.

Treatment of chronic hepatitis B with human lymphoblastoid interferon: results of a controlled trial.

The aim of this study was to evaluate the efficacy of human lymphoblastoid interferon (Wellferon) in the treatment of chronic hepatitis B virus (HBV) infection. To date 70 patients have entered the study, 33 randomized to receive interferon at doses of 5 MU/m2 i.m. daily for the first 4 weeks and three times weekly for 5 months thereafter and 31 acted as controls. Seventy-nine per cent of the treated group permanently cleared HBV DNA compared with 48% of the control group (p = 0.01): 69% of the treated patients and 38% of the controls who eliminated HBV DNA cleared HBeAg, HBeAb (p = 0.02). Twenty-four per cent of the treated patients and 3% (p = 0.01) of the control group had clearance of HBsAg and seroconversion to HBsAb. From these results it was concluded that interferon had a therapeutic effect on Italian heterosexual patients with chronic hepatitis B viral replication.