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Effect of Baclofen in reducing alcohol craving and intake in alcoholics: Preliminary clinical evidence
141
143 EFFECT OF BACLOFBN IN REDUCING ALCOHOL CRAVING AND INTAKE IN ALCOHOLICS: PRELIMINARY CLINICAL EVIDENCE G. Addolorato, F. Caputo, E. Capristo, G. Ghittoni, C. Anwna, C. Valeri, R. Mascian& A. Scarfone, G. Valentini, R. Agabio*, G.L. Gessa’, G. Colombo$, G. Gasbarrini. Institute of Internal Medicine, Catholic University of Rome; “‘Bernard B. Brodie” Depanment of Neuroscience and 9CNR Neurophanoacology Center, University of Cagliari. Background: Baclofen, a GABAB receptor agonist, is a drug clinically used at present to control spasticity. Accumulating evidence shows the efficacy of baclofen in reducing alcohol intake in alcohol-preferring rats. The present study investigated the effect of short term baclofen administration on craving for alcohol, ethanol intake and abstinence from alcohol in alcoholic patients. Methods: A total of 10 male current alcoholic patients were admitted to the study. Baclofen was orally administered for 4 weeks, at the dose of 15 mg/day refracted in 3 times/day for the first 3 days, increasing the dose to 30 &day for the remaining 21 days. Each subject was checked as an outpatient every week for the 4 weeks; at each visit (?J%T4) craving level was evaluated by the Alcohol Craving Scale (ACS) and abstinence from alcohol
was assessed on the basis of the patient’s self-evaluation and of family member interview and on the basis of the main biologicat markers of alcohol abuse. A self-reported alcohol intake was recorded as the mean number of
standard drinks consumed per day. Results: A total of 9 subjects completed the study; of these, 2 subjects continued to drink alcohol although they
substantially reduced their daily drinks in the first week of treatment, while 7 maintained abstinence throughout the experimental period. A significanl reduction in craving was observed already from the first week of the drug administration [TO: 8 (3-14) vs Tl: 3 (O-8) p thinking about alcohol & also rep&d 6; the patients. A significant decrease in values of GGT, ALT and MCV was found at the end of the study. Tolerability 1~8sfair in all patients; headache, vertigo, nausea, constipation, abdominal pain, hypotension, increased sleepiness were present as side effects in the first stage of the treatment. No subjects showed craving for the drug. Conclusions: With the limitation of the low number of patients evaluated and of the open design, this clinical study supports the preclinical evidence on the effect of baclofen in reducing alcohol intake. The anti-craving properties of the drug suggest a possible role of baclofen in the treatment of patients with alcohol problems.
Computerized
data processing io eodoscopy:
the ELENA system.
Antonio Gmssi, M.D. Digestive Eadoscopy Unit, “Regina Elena” Cancer Institute, Rome, My The technology costs (hardware and communication) are promoting the use of computer in medicine. Clinical data in g i. endoscopy are presently managed. in the majority of Centers, by computerized systems The advantages are related to an improvement in the generation of reports, and an easy retrieval of information.The endoscopy record can also be linked to images, captured during the examination. a tinal multimedial record is therefore generated. In this scenario the possibility of data exchange behveen Centers is related to the compatibility between softwares.This basic need has been s&stied by the ESGE, under the auspices of OMED, by producing the Minimal Standards in endoscopy report generation and Minimal Standards in the Terminology (MST). We are presenting a software developed for endoscopy units named ELENA: it is compliant to the recommended standards in endoscopy reports, as well as in the terminology. The main topics are patient’s data, reasons for examination, endoscopy procedures, endoscopy reports, diagnosis, images additional procedures applied (diagnostic and therapeutic) and others. The endoscopy report is generated on a tree structure of the standard terms and their attributes, not in t?ee text The images captured can he selected and stored in the clinical record of the patient. and in an image database The basic characteristics of the ELENA system are A) a core dataset fully compliant with the standards in computer&c data processing of EXE-OMED. B) Easy to use with a Windows interface C) Generation of a multimedia record (clinical data and images) D) Possibility to customize some parts of the report The generation of clinical databses in g.i endoscopy using different reporting systems gives the unique opportunity to pool database information: but the only condition to this is that a standard core dataset is used and that terminology and definitions are common. If all these requisites are satisfied, one of the future benefit that can be foreseen is the promotion of multicentric studies among physicians by using systems complying with standaros in data recording.
142 TREATMENT OF OSTEOPENIA IN INFLAMMATORY BOWEL DISEASE (IBD) G. Luisetto, A. Martin. Dip. di Scienze Chirurgiche e -IM.Dinca Gastroenterologiche. Dip. Scienze Mediche e Chirurgiche. Dip. Endocrinologia. Universita di Padova. Italy. Osteopenia is a frequent complication of both Crohn’s Disease (CD) and Ulcerative Colitis (UC). Several data suggest that low bone mineral density (BMD) is associated with the pathogenesis of CD, whereas in UC it seems to be more related to the side effects of steroid therapy. Aim: to assess the effect of two different treatment regimes on improving BMD in IBD patients with osteopenia. Methods: BMD of the lumbar spine was measured before and afler 1 year of two different regimes: calcium 1000 mg/die and vitamin D 0.25 mcg/die (treatment A), and calcium, vitamin D (same dose) and bisphosphonates 100 mg i.m. every 2 weeks (treatment B) in 23 patients randomly divided in 2 groups: treatment A: 10 CD, 2 UC; mean age 36 i: 10; 8 M, 4 F; treatment B: 6 CD, 5 UC; mean age 39 r 10. IOM. 1 F. Clinical and biochemical features and evolution of osteopenia (DXA) were registered. Results: Mean BMD in the treatment A group before therapy was 0.847+0.070 and reached 0.851~0.070 after therapy with calcium and vitamin D (mean % variation 0.45k4.64). The BMD of the CD patients increased by 1.25% +4.31, but that of the 2 UC patients decreased by 3.52%r5.62 (one of these patients took steroids longterm). The mean BMD in the treatment B group before therapy was 0.870+0.065 and reached 0.892+0.069 after therapy with calcium, vitamin D and bisphosphonates (mean % variation 2.73t5.81). The mean BMD of the CD patients in this group remained unchanged (mean % variation -0.01% + 2.47), but that of the UC patients increased by 6.04% + 7.18. Conclusions: Treatment with calcium and vitamin D is ineffective in imoroving BMD in IBD patients. The decrease in BMD of UC patients wiih this-treatment may be due to steroid therapy. Treatment with calcium vitamin D and bisohosohonates increases BMD of IBD patients, mainly of those with ‘UC .‘The different response to therapy in CD and UC may further suggest that osteopenia has a different pathogenesis in the two diseases.
CLLLOBIOSE AUD LACTULOSE ARE SIMILARLY USEFUL PROBES rN SMALL. INTESTINAL PERMEABILITY TESTS. r!&laaistris L, Secondulfo M, Generoso M*. Fiandra R, Belletta M, De Rosa R*. Cartem M*. Carrath R. Gastroenterology Unit and (*) Institute of Pharmacology, Second University of Naples, Naples. It.dt BACKGROUND Csilobiose/mannitol and Lactulose/mannitol tests are currently used m the Investiyation of Intestinal Permeability (IP) in many gastrointestinal disedscs The use of cellobiose, however, has been criticised due to possible cellobtase activity in the small intestine (Dahlqvist A 1962;
B~amason I et al IsI’)‘i m this study was aimed to compare the two large sugar probes (cellobiose ans lactuiose) in association with mannitol, in their timction of mtestinal permeability tests. METHODS. I8 healthy volunteers were enrolled (F=6, M=12; mean as&SD = 27.94-tS.01). The subjects had not assumed NSAIDs and/or antibiotic therapy, alcohol or tobacco for at least two days before each test. The IP tests consisted of either Cellobiose (5s) and Mannitol (Zg), or Lactulose (59) and Manmtol (2g), given as oral isosmolar loads. Sugars here recovered in urine collected for 5 hrs and determined by means of HPLC-Dionex DX500. this apparatus allows carbohydrates quantification in
\erq low concentrations and without their derivatisation. The %LA, %CE, “.X1.4 recovered in urinary excretions were evaluated and their ratios (CEIMA and LA/hfA) were calculated Each subject assumed both tests, whth seven days intenal in between, moreover, each subject aIs0 collected ihrs urine in the absence of anv sugar probe administration (urine Control).
Statistical analysis showed no significant differences in any parameter. The analysis OF urine control samples excluded the presence of any cndoxenous amount of all the investigated probes. <~O~CLtJSIONS Callobiose and Lactulose give the same results in respect to the function of large probe in IP tests As a consequence, CEihJA and/or L&‘&IA tests are sm~darl? useful in the clinical investigation ofIF.
143 EFFECT OF BACLOFBN IN REDUCING ALCOHOL CRAVING AND INTAKE IN ALCOHOLICS: PRELIMINARY CLINICAL EVIDENCE G. Addolorato, F. Caputo, E. Capristo, G. Ghittoni, C. Anwna, C. Valeri, R. Mascian& A. Scarfone, G. Valentini, R. Agabio*, G.L. Gessa’, G. Colombo$, G. Gasbarrini. Institute of Internal Medicine, Catholic University of Rome; “‘Bernard B. Brodie” Depanment of Neuroscience and 9CNR Neurophanoacology Center, University of Cagliari. Background: Baclofen, a GABAB receptor agonist, is a drug clinically used at present to control spasticity. Accumulating evidence shows the efficacy of baclofen in reducing alcohol intake in alcohol-preferring rats. The present study investigated the effect of short term baclofen administration on craving for alcohol, ethanol intake and abstinence from alcohol in alcoholic patients. Methods: A total of 10 male current alcoholic patients were admitted to the study. Baclofen was orally administered for 4 weeks, at the dose of 15 mg/day refracted in 3 times/day for the first 3 days, increasing the dose to 30 &day for the remaining 21 days. Each subject was checked as an outpatient every week for the 4 weeks; at each visit (?J%T4) craving level was evaluated by the Alcohol Craving Scale (ACS) and abstinence from alcohol
was assessed on the basis of the patient’s self-evaluation and of family member interview and on the basis of the main biologicat markers of alcohol abuse. A self-reported alcohol intake was recorded as the mean number of
standard drinks consumed per day. Results: A total of 9 subjects completed the study; of these, 2 subjects continued to drink alcohol although they
substantially reduced their daily drinks in the first week of treatment, while 7 maintained abstinence throughout the experimental period. A significanl reduction in craving was observed already from the first week of the drug administration [TO: 8 (3-14) vs Tl: 3 (O-8) p
Computerized
data processing io eodoscopy:
the ELENA system.
Antonio Gmssi, M.D. Digestive Eadoscopy Unit, “Regina Elena” Cancer Institute, Rome, My The technology costs (hardware and communication) are promoting the use of computer in medicine. Clinical data in g i. endoscopy are presently managed. in the majority of Centers, by computerized systems The advantages are related to an improvement in the generation of reports, and an easy retrieval of information.The endoscopy record can also be linked to images, captured during the examination. a tinal multimedial record is therefore generated. In this scenario the possibility of data exchange behveen Centers is related to the compatibility between softwares.This basic need has been s&stied by the ESGE, under the auspices of OMED, by producing the Minimal Standards in endoscopy report generation and Minimal Standards in the Terminology (MST). We are presenting a software developed for endoscopy units named ELENA: it is compliant to the recommended standards in endoscopy reports, as well as in the terminology. The main topics are patient’s data, reasons for examination, endoscopy procedures, endoscopy reports, diagnosis, images additional procedures applied (diagnostic and therapeutic) and others. The endoscopy report is generated on a tree structure of the standard terms and their attributes, not in t?ee text The images captured can he selected and stored in the clinical record of the patient. and in an image database The basic characteristics of the ELENA system are A) a core dataset fully compliant with the standards in computer&c data processing of EXE-OMED. B) Easy to use with a Windows interface C) Generation of a multimedia record (clinical data and images) D) Possibility to customize some parts of the report The generation of clinical databses in g.i endoscopy using different reporting systems gives the unique opportunity to pool database information: but the only condition to this is that a standard core dataset is used and that terminology and definitions are common. If all these requisites are satisfied, one of the future benefit that can be foreseen is the promotion of multicentric studies among physicians by using systems complying with standaros in data recording.
142 TREATMENT OF OSTEOPENIA IN INFLAMMATORY BOWEL DISEASE (IBD) G. Luisetto, A. Martin. Dip. di Scienze Chirurgiche e -IM.Dinca Gastroenterologiche. Dip. Scienze Mediche e Chirurgiche. Dip. Endocrinologia. Universita di Padova. Italy. Osteopenia is a frequent complication of both Crohn’s Disease (CD) and Ulcerative Colitis (UC). Several data suggest that low bone mineral density (BMD) is associated with the pathogenesis of CD, whereas in UC it seems to be more related to the side effects of steroid therapy. Aim: to assess the effect of two different treatment regimes on improving BMD in IBD patients with osteopenia. Methods: BMD of the lumbar spine was measured before and afler 1 year of two different regimes: calcium 1000 mg/die and vitamin D 0.25 mcg/die (treatment A), and calcium, vitamin D (same dose) and bisphosphonates 100 mg i.m. every 2 weeks (treatment B) in 23 patients randomly divided in 2 groups: treatment A: 10 CD, 2 UC; mean age 36 i: 10; 8 M, 4 F; treatment B: 6 CD, 5 UC; mean age 39 r 10. IOM. 1 F. Clinical and biochemical features and evolution of osteopenia (DXA) were registered. Results: Mean BMD in the treatment A group before therapy was 0.847+0.070 and reached 0.851~0.070 after therapy with calcium and vitamin D (mean % variation 0.45k4.64). The BMD of the CD patients increased by 1.25% +4.31, but that of the 2 UC patients decreased by 3.52%r5.62 (one of these patients took steroids longterm). The mean BMD in the treatment B group before therapy was 0.870+0.065 and reached 0.892+0.069 after therapy with calcium, vitamin D and bisphosphonates (mean % variation 2.73t5.81). The mean BMD of the CD patients in this group remained unchanged (mean % variation -0.01% + 2.47), but that of the UC patients increased by 6.04% + 7.18. Conclusions: Treatment with calcium and vitamin D is ineffective in imoroving BMD in IBD patients. The decrease in BMD of UC patients wiih this-treatment may be due to steroid therapy. Treatment with calcium vitamin D and bisohosohonates increases BMD of IBD patients, mainly of those with ‘UC .‘The different response to therapy in CD and UC may further suggest that osteopenia has a different pathogenesis in the two diseases.
CLLLOBIOSE AUD LACTULOSE ARE SIMILARLY USEFUL PROBES rN SMALL. INTESTINAL PERMEABILITY TESTS. r!&laaistris L, Secondulfo M, Generoso M*. Fiandra R, Belletta M, De Rosa R*. Cartem M*. Carrath R. Gastroenterology Unit and (*) Institute of Pharmacology, Second University of Naples, Naples. It.dt BACKGROUND Csilobiose/mannitol and Lactulose/mannitol tests are currently used m the Investiyation of Intestinal Permeability (IP) in many gastrointestinal disedscs The use of cellobiose, however, has been criticised due to possible cellobtase activity in the small intestine (Dahlqvist A 1962;
B~amason I et al IsI’)‘i m this study was aimed to compare the two large sugar probes (cellobiose ans lactuiose) in association with mannitol, in their timction of mtestinal permeability tests. METHODS. I8 healthy volunteers were enrolled (F=6, M=12; mean as&SD = 27.94-tS.01). The subjects had not assumed NSAIDs and/or antibiotic therapy, alcohol or tobacco for at least two days before each test. The IP tests consisted of either Cellobiose (5s) and Mannitol (Zg), or Lactulose (59) and Manmtol (2g), given as oral isosmolar loads. Sugars here recovered in urine collected for 5 hrs and determined by means of HPLC-Dionex DX500. this apparatus allows carbohydrates quantification in
\erq low concentrations and without their derivatisation. The %LA, %CE, “.X1.4 recovered in urinary excretions were evaluated and their ratios (CEIMA and LA/hfA) were calculated Each subject assumed both tests, whth seven days intenal in between, moreover, each subject aIs0 collected ihrs urine in the absence of anv sugar probe administration (urine Control).
Statistical analysis showed no significant differences in any parameter. The analysis OF urine control samples excluded the presence of any cndoxenous amount of all the investigated probes. <~O~CLtJSIONS Callobiose and Lactulose give the same results in respect to the function of large probe in IP tests As a consequence, CEihJA and/or L&‘&IA tests are sm~darl? useful in the clinical investigation ofIF.