- Email: [email protected]
Interferon alfacon-1 in chronic active hepatitis (CAH) C: Our preliminar experience
57
59
EFFECT OF MINTOIL TREATMENT ON QUALITY OF LIFE IN PATIENTS WITH IRRITABLE BOWEL SYNDROME (IBS). PRELIMINARY RESULTS WA, Ortolani M, Herrera L, Nuti M, Casini A, Surrenti C, Surrenti E Dept. Clinical Pathopysiology, Gastroebterology Unit, University of Florence, Italy Irritable bowel syndrome (IBS) is a common chronic gastrointestinal disorder characterized by lower abdominal pain or discomfort associated with altered bowel habit. Peppermint oil is a naturally occurring carminative oil which relaxes gastrointestinal muscle both in viva and in vitro. Peppermint oil has now been incorporated in several over-thecounter remedies for the symptomatic treatment of D3S but evidence to support the use of such products is still unclear. Aim of our study was to evaluate the e effect of a new product containing peppermint oil (MINTOIL, long retarded micro-coated capsules) on the quality of life of patients with IBS. Methods. To study the efficacy of MINTOIL treatment we developed and validated a new-self reported measure of IBS-reletad quality of life questionarie, that takes into consideration not only the intensity but also the subjective relevance of physical and psychosocial distress. The items of the questionarie were conceptually related to three different areas: Symptoms (5 items), Disconfort (7 items, impact of BS on emotional status), Impact (6 items, effect of IBS on familiar relationship). For each item the patient was asked to score on the 4-point Liken scale, higher scores mean a lower quality of life. The questionarie was evaluated in twenty patients with IEID (Roma criteria) ( 13 F and 7 M) attending the Gastroenterology Unit between December 1999 and May 2000. After one month treatment with 2 cps X3/die, questionarie was administered again. Results. A highly significant correlation between test a retest scores was observed. IBD patients showed significant reduction of mean total scores after one month of treatment with MINTOlL (33.7 f 22.3 vs. 5 1.2 f 23.5 pc.01) No significant correlation of age and sex with total scores was observed. Conclusion. MINTOIL treatment provides a significant global improvement of IBS-symptoms and ameliorates quality of life of IBS patients.
THE OUTCOME OF NON-ULCER DYSPEPSIA AFTER H. PYLORI ERADICATION: A CLINICAL-HISTOLOGICAL FOLLOW-UP STUDY. P Paoluzi, P Rossi, OA Paoluzi, R Pica, F Iacopini, Crisp& P, A ConsoIaxio, *F N&i.
Department of Clinical Sciences, ‘Institute of Pathology, University Sapien&, Rome, Italy.
‘La
The clinical improvement after H.PyIori (HP) eradication in pts at&ted by mx-ulcer dyspepsia (NUD) is still debated.
Background
Aim: To evaluate w&r
NUD symptoms improve after Hp eradication in Thirty-seven p’s, 17 males and 20 females alEcted by HP+ NlJD were treated with triple therapy (omcpraz& 2Omg bid for 2 wks + claritbromycin 250 mg qid and amoxycillin I g bid for I or 2 wks) and found HP-negative at histologic control after two months were enrolled in the study. At 12 months clinical, endoscopic and histologic controls were performed to evsloate the clinical outcome, the HP status and the inflammatory changes. The pts wcrc defined as responders or non-responders according to a semiquantitative score based on frequency and severity of dyspeptic symptoms. Gastritis activity, presence of chronic
reiatiollship with gastritis. Pt&Mcthods:
inflammation superticial cpithelial
damage @ED)
and intestinal mctaplasia
(IM) were histologically evaluated (2 biopsies from antnan and 2 from the body, hacmatoxylii-cosine staining). Results: All pts remained HP- during follow-up. At 12 months 20 out of 35 pts (570/.) reported a complete recovery of symptoms, while in 15 pts (43%) symptoms did oat improve or worsened. Responders showed at entry a statistically significant higher
incidence of SED and active gastritis in comparison to non-responden. After HP eradication all parameters showed a similar behcviour in the two groups (see Table). Histoloaical
NR
changes-
(n=l5)
Activity
Inflammation IM ____-
12 (75)
16(100%)
_\--,
3(18)
at entry R (n=20)
NR
21 (100)
12 (75)
(n=ZO) 4 (19) 21 (100)
13i62j 6 (29)
1’ 2(12)
5 (24)
21 (100)
(sl5)
I2 months R
1 (6)
P co.05 n.s.
co.01 “3.
R=rcspondcrs, NR=aon-responders. Number in parentheses are percentages Conclusions
The present study showed that Arc
than half of NUD pts
have a clinical improvement afier HF’ eradication but only pts with an initial active gastritis and epithclial damage show a higher clinical improvement.
58 INTERFERON ALFACON-1 (CAH) C: OUR PRELIMINAR
IN CHRONIC EXPERIENCE
ACTIVE
HEPATITIS
M. Dicillo. E Amati, D Conte U.O. di Gastroenterologia ed Endoscopia Digestiva Presidio Ospedaliero “S. Paolo” - A.U.S.L. BAI4 - Ban (Italy) Interferon alfacon-1 (consensus interferon - CIFN) IS a new recombinant interferon (IFN) whose aminoacid sequence was built by putting the most common found aminoacid of the known species of a-IFN at each position; CIFN is also 30% homologue to p-IFN. Some studies have shown CIFN efficacy as in naive as in relapsed patients in different doses, with adverse effects similar to those reported for other recombinant IFNs. (I, 2) Aim of our study was that of evaluating CIFN efficacy and adverse effects in patients who had early relapsed after 12 months therapy with a-recombinant IFN 2a or 2b (6 MU t.i.w.). 20 consecutive patients were included (9 males and 11 females, mean age 55.85 years, range 43-65); all pts. had hlstological diagnosis of CAH. ALT >xl.5-fold normal, HCV-RNA positivity (RTPCR). Study design consisted of 12 months of CIFN treatment (18 pg S.C. t.i.w.) and 12 follow-up months. Monitoring included monthly evaluation of adverse effects, routine liver and hematological tests, while HCV-RNA was tested at 61hand 12” month. The preliminar results, at the end of 3’4 month, show that adverse effects (fatigue, fever, myalgia, etc.) were present in 18 pts. (90%): 7 of them (38%) had severe side effects and 2/7 had to stop IFN (1 for severe depression). ALT normalization or reduction occurred respectively in 9 (45%) and 4 (20%) pts.; CIFN had no effect on ALT levels in 3 pts. while 2 pts. were drop-out In conclusion, though our results are still preliminary, CIFN causes frequent and severe adverse effects but it seems to be more effective in the therapy of relapsed pts., with percentages similar to a-2b IFN+ribavirin treatment (3). 1) Alberti A. BioDrugs 1999 Nov; 12 (5): 343-357. 2) Heathcote EJ et al. Hepatology 1998; 27: 1136-I 143. 3) Davis GL et al. NEJM 1998: 339: 1493.1499.
CAN BIOCHEMICAL LIVER TESTS RECOGNISE PATIENTS WITH HIGH RISK OF COMMON BILE DUCT (CBD) STONES? E. Lesiniao, L. Lodi, E. Rocca, F. Rocca UO Medicina I’ Azienda Ospedaliera “Busto A”: Busto A. (VA) Backaround: Endoscopic uitrasonography (EUS) and cholangioRM are new diagnostic techniques other then ERCP for CBD stone. They are little or no invasive methods, but without therapeutic possibility. Aim: evaluating if the changing in time of liver tests can recognise patients with high risk of CBD stones for a correct management. Materials and methods: from 6l97 to 12l99 we considered 177 patients with clinical suspicion of choledocholithiasis. They underwent biochemical liver tests (LT) (ALT: total bilirubin. TB: alkaline phosphatase, AP) at presentation of symptoms (time 1) and at diagnostic EUS and/or ERCP (time 2). The time between examinations was 6.3 * 5-3 days. Three different risk classes (RC) were i&nthIed by LT abnormality at time 1 and 2: - High (two or more abnormally: AP, ALT, TB ~2 nv) - Low (one abnormally: AP < 1.5 nv; AST and TB < 2 nv); _ Intermediate (between HRC and L RC). The prevalence of choledocboiiihias was 46.6%. Results: HR group had a prevalence of CBD stones higher than other groups (P
Time Z
1 MRC Time 1 HRC : LRC 13 HCR 96 46 ( 29 ) 1 36 (17) / ICR 82 6 (6) 1 31 (9) / 43 Total 177 54 c35) I 67 (26) I 56 Table: Change of risk class between time 1 and time 2’ number of patients patientsv&h stones (between parenthesis)
(4 ) ’ (11)
(15) and
Conclusion: the prevalence of stones depends on risk class higher. Prevalence of CBD stones is less when patients reduced the class of risk in three days and it is should when the patients change in superior risk class: in this setting they should better undergo ERCP as initial examination. Nevertheless, risk class and modification of risk class in time are not very useful to diagnostic CBD stones.
59
EFFECT OF MINTOIL TREATMENT ON QUALITY OF LIFE IN PATIENTS WITH IRRITABLE BOWEL SYNDROME (IBS). PRELIMINARY RESULTS WA, Ortolani M, Herrera L, Nuti M, Casini A, Surrenti C, Surrenti E Dept. Clinical Pathopysiology, Gastroebterology Unit, University of Florence, Italy Irritable bowel syndrome (IBS) is a common chronic gastrointestinal disorder characterized by lower abdominal pain or discomfort associated with altered bowel habit. Peppermint oil is a naturally occurring carminative oil which relaxes gastrointestinal muscle both in viva and in vitro. Peppermint oil has now been incorporated in several over-thecounter remedies for the symptomatic treatment of D3S but evidence to support the use of such products is still unclear. Aim of our study was to evaluate the e effect of a new product containing peppermint oil (MINTOIL, long retarded micro-coated capsules) on the quality of life of patients with IBS. Methods. To study the efficacy of MINTOIL treatment we developed and validated a new-self reported measure of IBS-reletad quality of life questionarie, that takes into consideration not only the intensity but also the subjective relevance of physical and psychosocial distress. The items of the questionarie were conceptually related to three different areas: Symptoms (5 items), Disconfort (7 items, impact of BS on emotional status), Impact (6 items, effect of IBS on familiar relationship). For each item the patient was asked to score on the 4-point Liken scale, higher scores mean a lower quality of life. The questionarie was evaluated in twenty patients with IEID (Roma criteria) ( 13 F and 7 M) attending the Gastroenterology Unit between December 1999 and May 2000. After one month treatment with 2 cps X3/die, questionarie was administered again. Results. A highly significant correlation between test a retest scores was observed. IBD patients showed significant reduction of mean total scores after one month of treatment with MINTOlL (33.7 f 22.3 vs. 5 1.2 f 23.5 pc.01) No significant correlation of age and sex with total scores was observed. Conclusion. MINTOIL treatment provides a significant global improvement of IBS-symptoms and ameliorates quality of life of IBS patients.
THE OUTCOME OF NON-ULCER DYSPEPSIA AFTER H. PYLORI ERADICATION: A CLINICAL-HISTOLOGICAL FOLLOW-UP STUDY. P Paoluzi, P Rossi, OA Paoluzi, R Pica, F Iacopini, Crisp& P, A ConsoIaxio, *F N&i.
Department of Clinical Sciences, ‘Institute of Pathology, University Sapien&, Rome, Italy.
‘La
The clinical improvement after H.PyIori (HP) eradication in pts at&ted by mx-ulcer dyspepsia (NUD) is still debated.
Background
Aim: To evaluate w&r
NUD symptoms improve after Hp eradication in Thirty-seven p’s, 17 males and 20 females alEcted by HP+ NlJD were treated with triple therapy (omcpraz& 2Omg bid for 2 wks + claritbromycin 250 mg qid and amoxycillin I g bid for I or 2 wks) and found HP-negative at histologic control after two months were enrolled in the study. At 12 months clinical, endoscopic and histologic controls were performed to evsloate the clinical outcome, the HP status and the inflammatory changes. The pts wcrc defined as responders or non-responders according to a semiquantitative score based on frequency and severity of dyspeptic symptoms. Gastritis activity, presence of chronic
reiatiollship with gastritis. Pt&Mcthods:
inflammation superticial cpithelial
damage @ED)
and intestinal mctaplasia
(IM) were histologically evaluated (2 biopsies from antnan and 2 from the body, hacmatoxylii-cosine staining). Results: All pts remained HP- during follow-up. At 12 months 20 out of 35 pts (570/.) reported a complete recovery of symptoms, while in 15 pts (43%) symptoms did oat improve or worsened. Responders showed at entry a statistically significant higher
incidence of SED and active gastritis in comparison to non-responden. After HP eradication all parameters showed a similar behcviour in the two groups (see Table). Histoloaical
NR
changes-
(n=l5)
Activity
Inflammation IM ____-
12 (75)
16(100%)
_\--,
3(18)
at entry R (n=20)
NR
21 (100)
12 (75)
(n=ZO) 4 (19) 21 (100)
13i62j 6 (29)
1’ 2(12)
5 (24)
21 (100)
(sl5)
I2 months R
1 (6)
P co.05 n.s.
co.01 “3.
R=rcspondcrs, NR=aon-responders. Number in parentheses are percentages Conclusions
The present study showed that Arc
than half of NUD pts
have a clinical improvement afier HF’ eradication but only pts with an initial active gastritis and epithclial damage show a higher clinical improvement.
58 INTERFERON ALFACON-1 (CAH) C: OUR PRELIMINAR
IN CHRONIC EXPERIENCE
ACTIVE
HEPATITIS
M. Dicillo. E Amati, D Conte U.O. di Gastroenterologia ed Endoscopia Digestiva Presidio Ospedaliero “S. Paolo” - A.U.S.L. BAI4 - Ban (Italy) Interferon alfacon-1 (consensus interferon - CIFN) IS a new recombinant interferon (IFN) whose aminoacid sequence was built by putting the most common found aminoacid of the known species of a-IFN at each position; CIFN is also 30% homologue to p-IFN. Some studies have shown CIFN efficacy as in naive as in relapsed patients in different doses, with adverse effects similar to those reported for other recombinant IFNs. (I, 2) Aim of our study was that of evaluating CIFN efficacy and adverse effects in patients who had early relapsed after 12 months therapy with a-recombinant IFN 2a or 2b (6 MU t.i.w.). 20 consecutive patients were included (9 males and 11 females, mean age 55.85 years, range 43-65); all pts. had hlstological diagnosis of CAH. ALT >xl.5-fold normal, HCV-RNA positivity (RTPCR). Study design consisted of 12 months of CIFN treatment (18 pg S.C. t.i.w.) and 12 follow-up months. Monitoring included monthly evaluation of adverse effects, routine liver and hematological tests, while HCV-RNA was tested at 61hand 12” month. The preliminar results, at the end of 3’4 month, show that adverse effects (fatigue, fever, myalgia, etc.) were present in 18 pts. (90%): 7 of them (38%) had severe side effects and 2/7 had to stop IFN (1 for severe depression). ALT normalization or reduction occurred respectively in 9 (45%) and 4 (20%) pts.; CIFN had no effect on ALT levels in 3 pts. while 2 pts. were drop-out In conclusion, though our results are still preliminary, CIFN causes frequent and severe adverse effects but it seems to be more effective in the therapy of relapsed pts., with percentages similar to a-2b IFN+ribavirin treatment (3). 1) Alberti A. BioDrugs 1999 Nov; 12 (5): 343-357. 2) Heathcote EJ et al. Hepatology 1998; 27: 1136-I 143. 3) Davis GL et al. NEJM 1998: 339: 1493.1499.
CAN BIOCHEMICAL LIVER TESTS RECOGNISE PATIENTS WITH HIGH RISK OF COMMON BILE DUCT (CBD) STONES? E. Lesiniao, L. Lodi, E. Rocca, F. Rocca UO Medicina I’ Azienda Ospedaliera “Busto A”: Busto A. (VA) Backaround: Endoscopic uitrasonography (EUS) and cholangioRM are new diagnostic techniques other then ERCP for CBD stone. They are little or no invasive methods, but without therapeutic possibility. Aim: evaluating if the changing in time of liver tests can recognise patients with high risk of CBD stones for a correct management. Materials and methods: from 6l97 to 12l99 we considered 177 patients with clinical suspicion of choledocholithiasis. They underwent biochemical liver tests (LT) (ALT: total bilirubin. TB: alkaline phosphatase, AP) at presentation of symptoms (time 1) and at diagnostic EUS and/or ERCP (time 2). The time between examinations was 6.3 * 5-3 days. Three different risk classes (RC) were i&nthIed by LT abnormality at time 1 and 2: - High (two or more abnormally: AP, ALT, TB ~2 nv) - Low (one abnormally: AP < 1.5 nv; AST and TB < 2 nv); _ Intermediate (between HRC and L RC). The prevalence of choledocboiiihias was 46.6%. Results: HR group had a prevalence of CBD stones higher than other groups (P
Time Z
1 MRC Time 1 HRC : LRC 13 HCR 96 46 ( 29 ) 1 36 (17) / ICR 82 6 (6) 1 31 (9) / 43 Total 177 54 c35) I 67 (26) I 56 Table: Change of risk class between time 1 and time 2’ number of patients patientsv&h stones (between parenthesis)
(4 ) ’ (11)
(15) and
Conclusion: the prevalence of stones depends on risk class higher. Prevalence of CBD stones is less when patients reduced the class of risk in three days and it is should when the patients change in superior risk class: in this setting they should better undergo ERCP as initial examination. Nevertheless, risk class and modification of risk class in time are not very useful to diagnostic CBD stones.