Using IOTA terminology to evaluate fetal ovarian cysts: analysis of 51 cysts over 10-year period.

OBJECTIVES: To describe ultrasound features of fetal ovarian cysts as reported by the original ultrasound examiner, to apply International Ovarian Tumor Analysis (IOTA) terminology after retrospective analysis of the images and to describe patient management and evolution of fetal cysts during pregnancy and after delivery. METHODS: This retrospective observational study included pregnant women diagnosed on ultrasound examination with a fetal ovarian cyst at the Prenatal Diagnosis Division of the Bambino Gesù Children's Hospital, in Rome, between March 2011 and May 2020. Cysts were classified by the original ultrasound examiner as 'simple' (unilocular anechoic cyst) or 'complex' (cyst with other morphology). In addition, three ultrasound examiners, experienced in gynecologic ultrasound, classified retrospectively the fetal ovarian cysts according to IOTA terminology, by reviewing stored ultrasound images. The evolution of these fetal ovarian cysts during pregnancy and after birth was recorded. RESULTS: Included were 51 ovarian cysts in 48 fetuses. Of the 51 cysts, 29 (56.9%) had been classified by the original ultrasound examiner as 'simple', and 22 (43.1%) as 'complex'. Of the simple cysts, the majority (20/29 (69.0%)) resolved spontaneously after delivery, 2/29 (6.9%) resolved following intrauterine aspiration, 2/29 (6.9%) resolved after postnatal aspiration and 5/29 (17.2%) underwent surgery due to persistence after delivery; in all five, normal ovarian parenchyma without signs of necrosis was observed at histology. Of the complex cysts, 7/22 (31.8%) resolved spontaneously. The other 15/22 (68.2%) were removed surgically and, at histology, necrosis was observed in most (12/15 (80.0%)), while a benign epithelial cyst with normal ovarian parenchyma was observed in 3/15 (20%). After reviewing the ultrasound images and applying IOTA terminology, all 51 (100%) fetal cysts were described as unilocular; 29/51 (56.9%) cysts showed anechoic content (described as simple cysts by the original ultrasound examiner), and 10/51 (19.6%) had low-level, 1/51 (2.0%) had ground-glass, 9/51 (17.6%) had hemorrhagic, 1/51 (2.0%) had mixed and 1/51 (2.0%) had undefined content (all described as complex by the original ultrasound examiner). Among the 29 anechoic ovarian cysts, resolution was observed in most (24/29, 82.8%) cases. Similarly, resolution was observed in 7/10 (70.0%) cysts with low-level content. Resolution was not observed in any of the other 12 cysts and all of these cases underwent surgery, with evidence of necrosis being observed in 11 (91.7%). CONCLUSIONS: Applying IOTA terminology provided a more detailed and accurate description of fetal ovarian cysts compared with the original classification into 'simple' and 'complex' categories. Anechoic cysts (described as simple cysts by the original ultrasound examiner) and cysts with low-level content (described as complex by the original ultrasound examiner) frequently resolved spontaneously. Cysts with ground-glass, hemorrhagic, mixed or undefined content were frequently associated with necrosis at histology following surgery. © 2022 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Reliability of Fetal Echocardiography in Predicting Postnatal Critical Hypoxia in Patients with Transposition of Great Arteries and Intact Ventricular Septum.

Critical hypoxemia soon after birth is the most critical preoperative determinant of neurological outcomes and survival in newborns with Dextro Transposition of the Great Arteries and Intact Ventricular Septum (D-TGAIVS). Our study aimed to define fetal echocardiographic aspects that can better predict neonates with D-TGAIVS at risk for restricted interatrial communication after birth. 31 fetuses with a prenatal diagnosis of D-TGAIVS were included in our study. We divided patients with D-TGAIVS according to the timing of balloon atrial septostomy: Urgent, Not-Urgent and no BAS. We identified five fetal echocardiographic aspects of the interatrial septum (redundant, aneurysmal, flat, fixed, hypermobile). No significant differences in these fetal echocardiographic features were found between the three different groups of D-TGAIVS according to the timing of balloon atrial septostmy. However, only two patients showed flat appearance of interatrial communication: both needed Urgent balloon atrial septostomy. The prevalence of hypermobile septum primum was significantly lower in the control group compared to patients with D-TGAIVS. Fetal echocardiographic aspects cannot predict patients with D-TGAIVS who will not need Urgent balloon atrial septostomy. Therefore, we recommended a delivery in a tertiary center, equipped for Urgent balloon atrial septostomy, for all patients with D-TGAIVS regardless of fetal echocardiographic features.

Ultrasonographic assessment of mediastinal shift angle (MSA) in isolated left congenital diaphragmatic hernia for the prediction of postnatal survival.

Objectives: To quantify mediastinal shift in isolated congenital diaphragmatic hernia (CDH), by the introduction of a new ultrasonographic (US) marker, defined as mediastinal shift angle (MSA) and to evaluate its ability in predicting postnatal survival at discharge.Methods: Twenty-four consecutive fetuses from singleton pregnancies with isolated left-sided CDH were included in the study group and then subdivided into group A (16 survivors) and group B (8 nonsurvivors). The study group was matched with a control group of 95 fetuses from singleton pregnancies free from structural and/or chromosomal anomalies. On the same US stored images commonly used for lung-to-head ratio (LHR) measurement, a landmark line was drawn from a point on the posterior face of the vertebral body, splitting it into two equal parts, to the mid-posterior surface of the sternum. Another landmark line was then traced from the same point of the vertebral body to touch tangentially the lateral wall of the right atrium. The angle between these two lines was used to quantify mediastinal shift and called "mediastinal shift angle" (MSA).Results: Median MSA was significantly different between group A (34.3° range 29.3-45.9°) and group B (42.7° range 34.1-58.9°) (p < .001) and between study group as a whole and the control group (19° range 13.8-25.9°) (p < .001). Statistical analysis confirmed an inverse correlation between MSA values and survival (p = .004). The best cutoff value for MSA was 43.7°, which demonstrated the highest discriminatory power (sensitivity 63%; specificity 93.75%).Conclusions: In fetuses with isolated CDH, the mediastinal shift may be quantified using mediastinal shift angle (MSA) and this US marker, similarly to the widely accepted and used US prenatal prognostic indicators (LHR and O/E LHR), seems to reliably predict survival.

Gastric cancer prevalence in patients with liver cirrhosis.

An increased risk for gastric cancer in patients with liver cirrhosis has recently been reported in epidemiological studies. The present endoscopic study was performed to further evaluate whether people with cirrhosis are at increased risk for gastric cancer development. We reviewed the medical records of all cirrhotic patients referred to our Endoscopic Service for portal hypertension screening and, therefore, cases of latent gastric cancer were observed. For a comparison, the prevalence (age and sex standardized) of latent gastric cancer in the general population was estimated hypothesizing a latency period of 5 years. Overall, 1379 patients with cirrhosis were selected from a total of 15 791 endoscopically examined different patients observed during the period 1982-1997. Histological assessment revealed the presence of gastric cancer in 10 patients (9 males and 1 female). There was a significant 2.6-fold (P<0.01) increase in prevalence of gastric cancer compared with that expected in our cirrhotic patients. In conclusion, our findings confirm that liver cirrhosis would seem to be a risk factor for the development of gastric cancer. Other studies are needed to evaluate the pathogenic mechanisms involved.

A phase II study of gemcitabine and tamoxifen in advanced pancreatic cancer.

BACKGROUND: Advanced pancreatic cancer (APC) constitutes a poor-prognosis disease with few and disappointing therapeutic options. In recent years chemotherapy has demonstrated a positive effect on disease-related symptoms with the introduction of a novel pyrimidine analogue, gemcitabine. Moreover there is experimental and clinical evidence that endocrine therapy may play a small but unexplored role in the management of APC. Therefore we performed a phase II study to assess whether the combination of gemcitabine and tamoxifen could be an active and safe schedule for the treatment of APC in terms of response rate and clinical benefits. MATERIALS AND METHODS: Twenty-seven evaluable consecutive patients with locally advanced, unresectable or metastatic adenocarcinoma of the pancreas were treated with gemcitabine (1000 mg/mq given as a short infusion once weekly for 3 consecutive weeks out of every 4 weeks) and tamoxifen (20 mg daily starting the second day after gemcitabine). The treatment was continued until progression or unacceptable toxicity. Evaluation of efficacy included response rate, time to progression, survival and clinical benefit, an integrated measurement of pain parameters, weight and performance status. RESULTS: A partial response was achieved in 11% of patients while 48% experienced stable disease, lasting at least 8 weeks; disease progression was documented in 41% of patients. The median time of progression was 4.5 months; the median survival-time was 8 months and one-year survival was 31%. Clinical benefit was documented in 59% of patients with a median duration of 13 weeks. No gastrointestinal or haematological grade 4 toxicity was observed. In general the treatment showed a satisfactory safety profile and tamoxifen-related toxicity was not documented. CONCLUSION: The combination of gemcitabine and tamoxifen appears to be an innovative therapeutic approach in the management of APC with interesting clinical activity and a good profile of toxicity. This novel schedule of treatment deserves further investigation in large randomized trials to assess if the addition of tamoxifen could improve the therapeutic results of gemcitabine in APC, mostly in term of quality of lfe.

[Treatment of euthyroid goiter in the elderly]. / Terapia del gozzo eutiroideo degli anziani.

PURPOSE: A study was conducted to evaluate the effectiveness of the medical therapy with synthetic hormone levothyroxine (L-T4) in the elderly subjects with multinodular euthyroid goiter. PATIENTS AND METHODS: 187 elderly subjects (34 males and 153 females) ranging between 63 and 85 years of age with multinodular euthyroide goiter were examined. For each subject has been calculated the index of body mass (BMI) which has consented the identify two groups of subjects: the elderly patients with normal weight and the obese subjects. RESULTS: In the mostly of the patients (82%), both normal weight and obese, the L-T4 therapy has not determined significant changes either of the dimensions or the number of the nodules. In the obese subjects the L-T4 therapy has not caused decrease of weight at least to the 20% of the initial body weight. CONCLUSIONS: The results of the research have proved the limited effectiveness of the suppressive therapy with levothyroxine in the reduction of the volume and/or of the number of the nodules, without however denying the usefulness in the preventing the worsening of the nodular disease of thyroid. The study also has revealed that the therapy with levothyroxine is ineffective for the body weight reduction in the obese subjects.

[Chemotherapy in the elderly patient]. / I trattamenti chemioterapici nel paziente anziano.

In the past, the clinical approach in elderly cancer patients was different than in younger ones; the natural history of neoplastic disease and the chemotherapy-related toxicity were the main reasons for this behaviour, and frequently over 65 years patients were excluded from chemotherapeutic treatments and from clinical trials. In the last years, according to clinical data, this approach changed and now there is evidence that also old patients (70-80 ys) can be treated with full dose chemotherapy, on condition that no poor performance status and no severe associated disease are present. Nevertheless, because of the increasing number of cancer patients with advanced age, in future it will be necessary to optimize the antineoplastic treatments individualizing chemotherapy and improving the clinical surveillance in this subset of patients. Moreover it will be strategic to identify optimal schedules of treatment in elderly cancer patients.

[Chemotherapy in gastroenterologic neuroendocrine tumors]. / Chemioterapia nei tumori neuroendocrini gastroenterici.

Gastrointestinal neuroendocrine tumors (carcinoids tumors and endocrine islet cell tumors) are a family of rare malignancies with many typical characteristics by a biologic, epidemiologic and clinical point of view. In this category of neoplasia an integrated clinical and therapeutic approach is mandatory, whereas for too many years these tumors were investigated and treated in an empirical way without considering an integrated approach. The singular features of this class of malignancies, with different and complex symptomatology, with enigmatic clinical presentation and outcome and with conflicting therapeutic options, oblige the clinicians to give different treatment to the patients. Chemotherapy has a marginal role in gastrointestinal neuroendocrine tumors mostly because it is used in patients with advanced disease not suitable for other therapeutic approach (surgery, thermoablation, chemoembolization, biotherapy). Unfortunately in the past it was not possible to establish the efficacy of chemotherapy in these malignancies because most of the studies pooled without distinction carcinoids, pancreatic tumors and hepatic metastases from unknown primary. The most extensively studied drugs have been streptozotocin, doxorubicin, mitoxantrone, dacarbazine, used alone or in combination; the gold standard today is considered the association of streptozotocin with doxorubicin or 5-fluorouracil, but there is strong evidence that the disappointing results in the treatment of these rare malignancies could be improved in a multidisciplinary fashion; in this field the combination of new drugs with aggressive surgery, radionuclide therapy, biotherapy and local therapeutic approach will give new opportunities to better control the symptoms and the clinical course of gastrointestinal neuroendocrine tumors.

Gastric epithelial cell proliferation in patients with liver cirrhosis.

An increased risk for gastric cancer in patients with liver cirrhosis has recently been reported. This study was performed in order to determine gastric epithelial cell proliferation in cirrhotic patients and to evaluate the role of congestive gastropathy (CG) and Helicobacter pylori infection in this process. Thirty-six cirrhotic patients and 18 controls were enrolled in the study. All patients underwent endoscopy and three biopsies were performed in the antrum and three in the gastric body. The presence of H. pylori infection was assessed by a rapid urease test and histology. The antral biopsies were used for gastric cell proliferation assessment by an immunohistochemical analysis (Ki-67). There was no significant difference in epithelial cell proliferation between cirrhotics and controls. Gastric proliferation values were higher in patients with H. pylori infection compared with uninfected patients, both in cirrhotic (P = 0.003) and in control groups (P = 0.06). Among the cirrhotic group, we found a progressive increase in gastric cell proliferation values related to the degree of CG, the highest values being observed in cirrhotic patients with severe CG. Moreover, cirrhotics with both severe CG and H. pylori infection had the highest proliferation values when compared with all other subgroups. In conclusion, this study found that: (1) CG significantly affects epithelial cell proliferation in gastric mucosa in cirrhotic patients, (2) H. pylori infection plays a similar role in gastric cell proliferation in both cirrhotic and non-cirrhotic patients, and (3) CG and H. pylori could act synergistically in this process.

5-fluorouracil plus folinic acid with or without ifosfamide in advanced colorectal cancer: a phase II randomized trial.

AIM: This phase II trial evaluated the biomodulation of 5-fluorouracil (5-FU) plus folinic acid (FA) with or without ifosfamide (IFO) in chemotherapy-naive patients with colorectal cancer. PATIENTS AND METHODS: Forty-eight patients were randomized to receive: FA (25 mg/m2 iv bolus days 1 to 3), followed by 5-FU (750 mg/m2 iv bolus days 1 to 3), arm A; or FA (25 mg/m2 iv bolus days 1 to 3), followed by 5-FU (750 mg/m2 iv bolus days 1 to 3) plus IFO (2,000 mg/m2 in 1000 mL 5% dextrose in a 2-hr infusion, days 1 to 3), arm B. Mesna was added during and after IFO to prevent hemorrhagic cystitis. Treatment was repeated every 21 days in both arms. RESULTS: Forty-five patients were assessable for response: in arm A, 5 patients achieved a partial response (overall response, 25%), and in arm B, 2 patients achieved a complete and 1 a partial response (overall response, 12%). Time to failure was 3.5 months (range, 1-38) in patients treated with 5-FU plus FA, and 3 months (range, 1-21) in patients treated with the IFO combination. The median survival time was 13.5 months (range, 1-49 months) in arm A and 16 months (range, 1-43 months) in arm B. Diarrhea, stomatitis and vomiting were the most common nonhematologic toxicities in both arms. The most notable hematologic toxicity was leukopenia; 15% and 20% of patients experienced grade 4 in arm A and arm B, respectively. CONCLUSIONS: IFO does not increase the activity of the 5-FU plus FA combination in advanced colorectal cancer.

[Prevalence of obesity in adolescence]. / Prevalenza dell' obesità nell'adolescenza.

PURPOSE: A clinical epidemiological research was conducted in Sardinia on a sample of hig school students to survey the preminence of obesity and overweight during adolescence. PATIENTS AND METHODS: 304 normal subjects were examined, 161 males and 143 females ranging between 16 and 18 years of age. For each subject the index of body mass was considered then compared to the standard values of population using Hamil schedules. RESULTS: The survey revealed a normal weight in mostly of the teen-agers. Obesity was observed however in 23.6% of males and in 5.6% of females on what was seen the percentage of overweight or excessively fat subjects is below the percentage of underweight teen-agers (21% of males and 43% of females). CONCLUSIONS: This difference could be considered the proof of a particular adolescential attitude that seen as a positive aim and is identified with social acceptance and sexual attraction especially among girls. This is confirmed by the fact that when questioned a great number of teen-agers admitted they were or they had been on a diet to lo lose weight.

Gastric pathology in patients with common variable immunodeficiency.

BACKGROUND/AIMS: Common variable immunodeficiency (CVID) is an immunological disorder characterised by defective antibody production. Patients with CVID have a high risk of gastric cancer. It has been suggested that gastric cancer results from an interaction between environmental factors and a genetic predisposition. The role of Helicobacter pylori as an environmental factor in gastric carcinogenesis is of current interest. Moreover, p53 gene mutations have been reported in gastric cancer. This study focuses on the gastric pathology of patients with CVID and correlation with H pylori infection. METHODS: Thirty four consecutive dyspeptic patients with CVID (mean age 49.6 years, range 14-72; 17 men) were included in the study. An upper gastrointestinal endoscopy was performed and biopsy specimens were taken from the antrum, incisura angularis, and gastric body. Biopsies were used for histological assessment, to identify the presence of H pylori, and to evaluate p53 overexpression. RESULTS: H pylori infection was detected in 14/34 (41%) patients. Chronic active gastritis involving both antrum and body was observed more frequently in H pylori positive (79%) than H pylori negative (20%) patients (p = 0.001). Similarly, a histological feature of multifocal atrophic gastritis was found more frequently in infected (50%) than uninfected patients (10%) (p = 0.012). In addition, one case of gastric adenocarcinoma and another of notable dysplasia were observed in the H pylori positive group. Overexpression of p53 was found in six (18%) patients, including one with normal gastric mucosa. CONCLUSIONS: It can be hypothesised that both H pylori and p53 alterations play a role in the gastric carcinogenesis of patients with CVID.

[The long-term results of low-calorie diet therapy in the obese]. / Risultati a lungo termine della terapia dietetica ipocalorica negli obesi.

PURPOSE: To evaluate long-term results of hypocaloric dietetic treatment in patients with essential obesity. PATIENTS AND METHODS: The study was carried out in 1,479 woman and 320 men. Body weight was evaluated at 3 months and at 1, 2 and 3 years. RESULTS: The best results in short term reduction of weight excess were found in obesity due to sedentariness or arisen after operation or emotional stress. It has been also observed that the percentage of subjects loosing weight decreased after the first year of treatment, while the percentage of subjects gaining body weight. CONCLUSIONS: Long term hypocaloric dietetic treatment in subjects with low or moderate essential obesity should primarily be aimed preventing further gain in body weight.

[Thyroid tumors in obesity]. / Tumori della tiroide nell'obesità.

BACKGROUND: The presence of nodules in the thyroid gland is the most frequent cause of endocrinopathy. The prevalence of thyroid nodules in the United States is estimated to be between 3-10%, whereas the prevalence of thyroid nodules in European adult population is estimated to be between 4-10%. At our Clinic of Obesity, the presence of nodules in the thyroid gland of obese patients is often found, incidentally, for this reason, we decide to investigate the prevalence of this pathology in obese patients and to quatify the number of times in which the presence of nodules had not been previously diagnosed. METHODS: 3248 obese patients were examined during in the last six years (1991-1996); of these patients 747 were affected by obesity and thyropathy; of these 747 we took into consideration only those with a cold single nodule and correlated the presence of the nodule with BMI, sex and age. RESULTS AND CONCLUSIONS: The prevalence of a cold single nodule in the obese patients was 31%, of which 83% has not been previously diagnosed. Of cold nodules 8% was represented by carcinoma. The carcinoma appeared more often in females than in males (3:1). The incidence of cold nodules was more frequent in adults and in mild-medium obesity.

[Latent thyroid diseases in obesity]. / Tireopatie latenti nell'obesità.

We have investigated 2672 obese subjects (2324 females and 348 males); of these, the following two groups were considered: obese subjects with or without thyroid disease. Subjects were stratified according to age, sex, and BMI. The prevalence of thyroid disease was correlated to age, sex and BMI increased body weight. Our data showed that 22% of patients affected by essential obesity and not resident in area of iodine deficiency is affected by thyroid diseases which are not diagnosed (18%). In the obese subjects, presence of goiter is more frequent than in the normal weight subjects and affects mainly adult males. Chronic thyroiditis is typical of females (9:1 female:male ratio) with no difference between normo and overweight subjects. Prevalence of single nodule in the obese is similar to the normal weight subjects, it is more frequent in adults and in subjects with medium size obesity. However, occurrence of carcinoma (8%) in single nodules appears higher in the overweight (5-6%) as compared to the normal weight subjects.

Onset of hepatocellular carcinoma in a non-cirrhotic patient affected with haemochromatosis.

The increased incidence of hepatocellular carcinoma in patients affected with haemochromatosis has previously been attributed to cirrhosis. However, some cases of hepatocellular carcinoma without cirrhosis have recently been reported in patients with haemochromatosis, leading to reconsideration of the role of iron in the tumorigenesis of hepatocellular carcinoma. We describe a 79 year old male patient affected with haemochromatosis and with a multinodular hepatocellular carcinoma, but without any evidence of cirrhosis. The absence of any other cancer risk factor (alcohol abuse, liver viral infections, heredity) has lead us to reconsider the possible role of iron as a direct carcinogen in the onset of hepatocellular carcinoma in patients with haemochromatosis.

Analysis of p53 expression in precancerous and malignant gastric mucosa.

P53 overexpression, detected by immunohistochemical analysis, has been reported in about 50% of gastric cancers whereas scarce data are available on the p53 oncoprotein in precancerous gastric lesions. This study focused on the p53 expression in gastric cancerous and precancerous lesions. One hundred gastric specimens obtained during endoscopy were analyzed: 14 cases of normal gastric mucosa, 53 of chronic gastritis with intestinal metaplasia and/or dysplasia and 33 gastric tumors. An immunoperoxidase technique and monoclonal anti-p53 antibodies were employed. Eleven out of 31 gastric carcinomas overexpressed p53. No correlation was observed between p53-positivity and histological type and grade of tumors. All precancerous lesions were p53-negative. Our results suggest that p53 overexpression is a relatively late event in gastric carcinogenesis.

Surgical revascularization for acute coronary insufficiency: analysis of risk factors for hospital mortality.

BACKGROUND: A retrospective study of 444 patients undergoing urgent and emergent coronary artery bypass grafting for acute coronary insufficiency was performed to identify the risk factors for hospital death specifically associated with the clinical severity of the acute coronary insufficiency syndrome. METHODS: The patients were divided into three groups-urgent, emergent A, and emergent B-on the basis of the evolution of the clinical pattern of the acute coronary insufficiency syndrome on full medical treatment. The three categories were defined as follows: urgent (257 patients), surgical revascularization could be delayed for 24 to 36 hours after surgical consultation because of adequate control of ischemia; emergent A (127 patients), prompt myocardial revascularization was required because medical treatment achieved only transient regression of an unrelenting ischemic pattern; and emergent B (60 patients), prompt myocardial revascularization was required because the acute coronary insufficiency was entirely refractory to medical treatment. RESULTS: Mortality rates were 7.4% for the urgent group, 13.4% for the emergent A group, and 31.7% for the emergent B group. Multivariate analysis identified the following as risk factors for hospital mortality: ejection fraction (p = 0.023) and aortic cross-clamp time (p = 0.10) for the urgent group; aortic cross-clamp time (p = 0.017), ejection fraction (p = 0.03), and nonuse of blood cardioplegia (p = 0.04) for the emergent A group; and cardiogenic shock (p = 0.00), preoperative ischemic interval (p = 0.00), aortic cross-clamp time (p = 0.018), and nonuse of blood cardioplegia (p = 0.012) for the emergent B group. CONCLUSIONS: A more exact definition of patient risk can be achieved when predictive outcome models are constructed using the risk factors specifically related to each level of clinical severity of the ischemic syndrome.

Vitamin E and nicotinamide have similar effects in maintaining residual beta cell function in recent onset insulin-dependent diabetes (the IMDIAB IV study)

OBJECTIVE: Protection of residual beta cell function at the time of diagnosis of insulin-dependent diabetes mellitus (IDDM) by intensive insulin therapy and the addition of nicotinamide (NA) has been established. The objective of this study was to evaluate the effect of a free oxygen radical scavenger such as vitamin E (Vit E) on residual beta cell function and parameters of metabolic control in patients with recent onset IDDM undergoing intensive insulin therapy. DESIGN: The effect of Vit E was compared with that of NA (control group) in a randomized multicentre trial. METHODS: Eighty-four IDDM patients between 5 and 35 years of age (mean age 15.8 +/- 8.4 (s.d.) years) entered a one year prospective study. One group of patients (n = 42) was treated with Vit E (15 mg/kg body weight/day) for one year; the other group (n = 42) received NA for one year (25 mg/kg body weight/day). All patients were under intensive insulin therapy with three to four injections a day. Basal and stimulated (1 mg i.v. glucagon) C-peptide secretion, glycosylated haemoglobin and insulin dose were evaluated at diagnosis and at three-monthly intervals up to one year. RESULTS: Preservation and slight increase of C-peptide levels at one year compared with diagnosis were obtained in the two treated patient groups. No statistically significant differences were observed in basal or stimulated C-peptide levels between the two groups of patients for up to one year after diagnosis. Glycosylated haemoglobin and insulin dose were also similar between the two groups; however patients receiving Vit E under the age of 15 years required significantly more insulin than NA-treated patients one year after diagnosis (P < 0.04). CONCLUSIONS: Our data indicate that Vit E and NA possess similar effects in protecting residual beta cell function in patients with recent onset IDDM. Since their putative mechanism of protection on beta cell cytotoxicity is different, combination of these two vitamins may be envisaged for future trials of intervention at IDDM onset.