St Barbaras Main District Hospital

Sosnowiec, Poland

St Barbaras Main District Hospital

Sosnowiec, Poland
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Gonciarz M.,St Barbaras Main District Hospital | Bielanski W.,Jagiellonian University | Mularczyk A.,St Barbaras Main District Hospital | Konturek P.C.,Thuringia Clinic Saalfeld | And 2 more authors.
Journal of Physiology and Pharmacology | Year: 2012

The present study represents the follow-up of our initial observations designed to investigate whether in patients with nonalcoholic steatohepatitis (NASH) the beneficial effect of 12-week course of melatonin (MT) on liver enzymes could be maintained with prolonged period of treatment and to analyze whether biochemical treatment responses could be sustainable after melatonin discontinuation. Forty two patients with histologically proven NASH (30 treated with melatonin 2×5 mg daily, 12 controls receiving placebo) enrolled to our previous 3-month study agreed to take part of subsequent 12 weeks treatment followed by 12-week follow-up period. Enrolled patients had biochemical determinations every six weeks during the melatonin treatment period and again after 12 weeks of follow-up. Significant reduction in median alanine aminotransferase (ALT) levels between baseline and week 18, week 24 and follow-up was observed in both MT-treated and control group: 43% and 31%, 42% and 33%, 32% and 31%. Aspartate aminotransferase (AST) and gamma-glutamyl transpeptidase (GGT) levels decrease significantly only in MT-treated group. In MT-treated group mean percentage change in AST level below baseline at week 18, at week 24 and at follow-up was 45%, 33% (p<0.05) and 8% (ns), respectively. The evolution of GGT levels was as follows: the mean percentage reduction in GGT below baseline level at week 18, 24 and follow-up was: 48%, 52% and 38% (p<0.05), respectively. In both MT-treated and control group plasma cholesterol, triglicerydes and glucose concentrations as well as plasma alkaline phosphatase persisted within normal values during the prolonged study period. Plasma concentration of melatonin (pg/ml) in MT-treated group averaged 7.5±3.5 at baseline and increased to 52.5±17.5 at 24 th week. The results of our study demonstrating beneficial effect of melatonin on liver enzymes in patients with NASH would seem to encourage further controlled trials of melatonin given over a longer period of time with liver histology as end point.


Gonciarz M.,St Barbaras Main District Hospital | Bielanski W.,Jagiellonian University | Mularczyk A.,St Barbaras Main District Hospital | Konturek P.C.,Thuringia Clinic Saalfeld | And 2 more authors.
Journal of Physiology and Pharmacology | Year: 2010

The mechanism by which nonalcoholic fatty liver disease (NAFLD) progresses into nonalcoholic steatohepatitis (NASH) is unknown, however, the major process is oxidative stress with increased production of reactive oxygen species and excessive inflammatory cytokine generation. To date, there are no effective treatments for NASH and the published data with treatment using antioxidants are not satisfactory. Melatonin (MT), the potent endogenous antioxidant secreted in circadian rhythm by pinealocytes and in large amounts in the digestive system, was reported to improve oxidative status and to exert beneficial effects in NASH pathology in experimental animals, but no study attempted to determine the possible effectiveness of MT in humans with NASH. In this study, 42 patients (12 placebo controls and 30 MT-treated) with histological evidence (liver biopsy) of NASH and no history of alcohol abuse, were included. The treatment group took melatonin (2x5 mg/daily orally), while controls were treated with placebo. At baseline no significant differences between the groups were found for age, body mass index (BMI) as well as for plasma alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), alkaline phosphatase (ALP), and concentrations of cholesterol, triglycerides (TG), glucose and MT. During the study period plasma ALT level and cholesterol concentration decreased significantly in both MT-treated and control groups, however AST and GGT levels decreased significantly only in MT-treated groups. Median value of AST level at baseline was 76.5 (64.2-114.2) IU/L and its percentage decrease at 4, 8 and 12 week was 20, 36 and 38%, resp. Baseline GGT median level was 113 (75.7-210.7) IU/L and its mean percentage decrease at week 4, 8 and 12 was 46, 48 and 47%, resp. Plasma ALP levels did not change significantly during MT treatment. Median value of plasma concentrations of MT (pg/mL) in MT-treated group rose from 7.5 (5.0-14.25) at baseline to 35.5(18.8-110.0), 43.5(17.0-102.5) and 49.5(18.0-99.5) at the end of 4, 8 and 12 week of treatment, respectively. Plasma levels of TG and glucose as well as BMI in controls and MT-treated patients were not significantly different from baseline. This study demonstrates for the first time in humans that three months treatment with MT significantly improves plasma liver enzymes in patients with NASH without causing any side-effect. Plasma MT levels during the whole period of MT treatment persisted above that at baseline. Our findings show that treatment with MT significantly improves plasma liver enzymes in NASH patients, but larger cohort trials and longer treatment with MT are required before this indole could be included into the spectrum of the NASH treatment.


Labuzek K.,University of Silesia | Prusek K.,University of Silesia | Gonciarz M.,St Barbaras Main District Hospital | Okopien B.,University of Silesia
Polski merkuriusz lekarski : organ Polskiego Towarzystwa Lekarskiego | Year: 2013

SS Hygiene Institute provided adequate funding for research on the treatment of mycobacterial infections, and two scientists who became famous in the subject were Dr. Waldemar Hoven (KL Buchenwald) and Dr. Kurt Heissmeyer (KL Neuengamme). They conducted researches not only on adult prisoners, but also on the Jewish children. Studies of tuberculosis were also conducted under the auspices of the German Medical Association by Dr. Rudolf Brachtel. In turn, Dr. Klaus Schilling dealt with the treatment and immunoprophylaxis of malaria. He tested such substances, as pyramidon, aspirin, quinine and atebrin on more than 1200 prisoners. These sulfonamide-derived drugs, were also studied by prof. Karl Gebhardt and Dr. Fritz Fischer. They assessed the efficacy of these drugs in the treatment of "dirty" wounds incurred by German soldiers. Dr. Heinrich Schutz, Karl Babor and Waldemar Wolter they were enthusiasts in so-called biochemical therapy, based on the use of substances of natural origin, such as salt. After termination of War, during the Nuremberg Trials, many of them evaded responsibility, they were running medical practices, some were publishing. However, despite those facts, trials of Nazi war criminals were not result less, they opened world's eyes for the necessity of clarifying rudiments of human subject research, they gave foundations to define records like The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine or Good Clinical Practice.


PubMed | University of Silesia and St Barbaras Main District Hospital
Type: Biography | Journal: Polski merkuriusz lekarski : organ Polskiego Towarzystwa Lekarskiego | Year: 2013

The outbreak of World War II is considered as the inception of the pharmacology of the III Reich. Hitlers soldiers are decimated on the front lines by malaria, typhoid, gas gangrene, they need efficient and easy accessible medicines. From now on German forces are engaged into pharmacology of war. Only augmentation of Fuehrers army effectiveness is reckoned with. Research centers in the concentrations camps are being organized, prisoners are used as the human subject. In the investigations many noted and respected personages are involved. Dr. Helmut Vetter and Dr. Ding Erwing Schuler studied chemicals which may had potential use in the prevention and treatment of typhoid. Professor Eugen Haagen carried out experiments concerning the use of vaccines against typhoid. The latter, although sentenced to life imprisonment, he returned to research in 1952 as a result of the amnesty activities in the former West Germany, and then worked as a researcher. His studies were reflected in the book, and scientific publications. Professor. Eugen Haagen died of natural causes in 1972.


PubMed | University of Silesia and St Barbaras Main District Hospital
Type: Historical Article | Journal: Polski merkuriusz lekarski : organ Polskiego Towarzystwa Lekarskiego | Year: 2013

SS Hygiene Institute provided adequate funding for research on the treatment of mycobacterial infections, and two scientists who became famous in the subject were Dr. Waldemar Hoven (KL Buchenwald) and Dr. Kurt Heissmeyer (KL Neuengamme). They conducted researches not only on adult prisoners, but also on the Jewish children. Studies of tuberculosis were also conducted under the auspices of the German Medical Association by Dr. Rudolf Brachtel. In turn, Dr. Klaus Schilling dealt with the treatment and immunoprophylaxis of malaria. He tested such substances, as pyramidon, aspirin, quinine and atebrin on more than 1200 prisoners. These sulfonamide-derived drugs, were also studied by prof. Karl Gebhardt and Dr. Fritz Fischer. They assessed the efficacy of these drugs in the treatment of dirty wounds incurred by German soldiers. Dr. Heinrich Schutz, Karl Babor and Waldemar Wolter they were enthusiasts in so-called biochemical therapy, based on the use of substances of natural origin, such as salt. After termination of War, during the Nuremberg Trials, many of them evaded responsibility, they were running medical practices, some were publishing. However, despite those facts, trials of Nazi war criminals were not result less, they opened worlds eyes for the necessity of clarifying rudiments of human subject research, they gave foundations to define records like The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine or Good Clinical Practice.


Gonciarz M.,St Barbaras Main District Hospital | Bielanski W.,Jagiellonian University | Partyka R.,St Barbaras Main District Hospital | Brzozowski T.,Jagiellonian University | And 5 more authors.
Journal of Pineal Research | Year: 2013

Insulin resistance, oxidative stress, and an abnormal production of adipokines and cytokines are implicated in the pathogenesis of nonalcoholic steatohepatitis (NASH). Recently, we reported a significant improvement in plasma liver enzymes among patients with NASH treated with melatonin. In this study, we investigated the effect of melatonin, administered at a dose of 10 mg/day for 28 days to 16 patients with histologically proven NASH on insulin resistance (HOMA-IR), on the plasma levels of adiponectin, leptin, ghrelin, and resistin. Additionally, plasma levels of aminotransferases and gamma glutamyltranspeptidase as well as plasma concentrations of melatonin were evaluated. Median baseline values of HOMA-IR, leptin (ng/mL), and resistin (pg/mL) in patients with NASH were significantly higher in comparison with controls: 4.90 versus 1.60, 10.70 versus 4.30, and 152 versus 91, respectively. Median adiponectin level (μg/mL) was decreased in patients compared to controls: 6.40 versus 16.25; no significant difference in ghrelin levels between patients and controls was found. After melatonin treatment, the median value of HOMA-IR was significantly reduced by 60% as compared to baseline values, whereas adiponectin, leptin, and ghrelin plasma levels rose significantly by 119%, 33%, and 20%, respectively; the difference between pre-/posttreatment in plasma resistin levels was not significant. These findings make melatonin a suitable candidate for testing in patients with NASH in the large controlled clinical trials. © 2012 John Wiley & Sons A/S.


Mularczyk A.,St Barbaras Main District Hospital | Gonciarz M.,St Barbaras Main District Hospital | Bartnik W.,Center of Oncology of Poland | Durlik M.,Polish Academy of Sciences | And 11 more authors.
Przeglad Gastroenterologiczny | Year: 2014

Biological medical products are drugs whose active components are produced only by living, genetically modified organisms or live cell cultures. Patents and exclusivity for most biopharmaceuticals has either expired or will expire soon, which enables biotechnological companies to introduce similar biological products. The problem of replacing a biological medicine with a biosimilar in the course of therapy remains open. In this statement, the Working Group of the Polish National Consultant in Gastroenterology, in the absence of data regarding bioequivalence in patients with inflammatory bowel disease, does not recommend switching from original biological medicine to its biosimilar analogue in the course of treatment in inflammatory disease patients; however, this may change after receiving the results of controlled studies regarding bioequivalence in this group.


Szkudlapski D.,Medical University of Silesia, Katowice | Labuzek K.,Medical University of Silesia, Katowice | Pokora Z.,Medical University of Silesia, Katowice | Smyla N.,Medical University of Silesia, Katowice | And 3 more authors.
Journal of Physiology and Pharmacology | Year: 2014

The problem of immune-mediated diseases, such as inflammatory bowel disorders (IBDs), still remains a significant clinical and therapeutic problem. Therefore, the tendency to search for safer and more effective methods of reducing their incidence and increasing the efficiency of therapy of this group of diseases is understandable. Recently, attention has been drawn to the potential therapeutic influence of intestinal helminths on the inflammatory process induced by the immune response, as well as the observed significant potential of these organisms for modulating the host immune response, which is beneficial both for the dwelling parasite and the host with an IBD. It has been proven that the effects of certain intestinal helminths on the host immune system are complex and omni-directional. They involve the modulation of TLRs expression, causing proliferation and activation of TH2 lymphocytes, leading to proliferation of regulatory T cells (TREG), and production of immunomodulatory proteins, such as cystatins and glycoprotein ES-62. In the developing countries of Africa, South America and Asia, where the level of personal and environmental hygiene is relatively low, the incidence of autoimmune diseases is also significantly lower. Limited exposure to common bacterial and parasitic pathogens in populations of very highly developed countries has probably contributed to depletion of immunological memory and the development of hypersensitivity mechanisms. Thus, reasonable suggestions have been made that the host-parasite biocenotic relationship between humans and nematodes of the gastrointestinal tract can be considered as a mutualism, rather than a typical parasitism, and may in the future be used as an alternative therapeutic model for IBD patients. © 2014, Polish Physiological Society. All rights reserved.


PubMed | St Barbaras Main District Hospital
Type: Journal Article | Journal: Journal of physiology and pharmacology : an official journal of the Polish Physiological Society | Year: 2011

The mechanism by which nonalcoholic fatty liver disease (NAFLD) progresses into nonalcoholic steatohepatitis (NASH) is unknown, however, the major process is oxidative stress with increased production of reactive oxygen species and excessive inflammatory cytokine generation. To date, there are no effective treatments for NASH and the published data with treatment using antioxidants are not satisfactory. Melatonin (MT), the potent endogenous antioxidant secreted in circadian rhythm by pinealocytes and in large amounts in the digestive system, was reported to improve oxidative status and to exert beneficial effects in NASH pathology in experimental animals, but no study attempted to determine the possible effectiveness of MT in humans with NASH. In this study, 42 patients (12 placebo controls and 30 MT-treated) with histological evidence (liver biopsy) of NASH and no history of alcohol abuse, were included. The treatment group took melatonin (2x5 mg/daily orally), while controls were treated with placebo. At baseline no significant differences between the groups were found for age, body mass index (BMI) as well as for plasma alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), alkaline phosphatase (ALP), and concentrations of cholesterol, triglycerides (TG), glucose and MT. During the study period plasma ALT level and cholesterol concentration decreased significantly in both MT-treated and control groups, however AST and GGT levels decreased significantly only in MT-treated groups. Median value of AST level at baseline was 76.5 (64.2-114.2) IU/L and its percentage decrease at 4, 8 and 12 week was 20, 36 and 38%, resp. Baseline GGT median level was 113 (75.7-210.7) IU/L and its mean percentage decrease at week 4, 8 and 12 was 46, 48 and 47%, resp. Plasma ALP levels did not change significantly during MT treatment. Median value of plasma concentrations of MT (pg/mL) in MT-treated group rose from 7.5 (5.0-14.25) at baseline to 35.5(18.8-110.0), 43.5(17.0-102.5) and 49.5(18.0-99.5) at the end of 4, 8 and 12 week of treatment, respectively. Plasma levels of TG and glucose as well as BMI in controls and MT-treated patients were not significantly different from baseline. This study demonstrates for the first time in humans that three months treatment with MT significantly improves plasma liver enzymes in patients with NASH without causing any side-effect. Plasma MT levels during the whole period of MT treatment persisted above that at baseline. Our findings show that treatment with MT significantly improves plasma liver enzymes in NASH patients, but larger cohort trials and longer treatment with MT are required before this indole could be included into the spectrum of the NASH treatment.


PubMed | St Barbaras Main District Hospital
Type: Clinical Trial | Journal: Journal of physiology and pharmacology : an official journal of the Polish Physiological Society | Year: 2012

The present study represents the follow-up of our initial observations designed to investigate whether in patients with nonalcoholic steatohepatitis (NASH) the beneficial effect of 12-week course of melatonin (MT) on liver enzymes could be maintained with prolonged period of treatment and to analyze whether biochemical treatment responses could be sustainable after melatonin discontinuation. Forty two patients with histologically proven NASH (30 treated with melatonin 2x5 mg daily, 12 controls receiving placebo) enrolled to our previous 3-month study agreed to take part of subsequent 12 weeks treatment followed by 12-week follow-up period. Enrolled patients had biochemical determinations every six weeks during the melatonin treatment period and again after 12 weeks of follow-up. Significant reduction in median alanine aminotransferase (ALT) levels between baseline and week 18, week 24 and follow-up was observed in both MT-treated and control group: 43% and 31%, 42% and 33%, 32% and 31%. Aspartate aminotransferase (AST) and gamma-glutamyl transpeptidase (GGT) levels decrease significantly only in MT-treated group. In MT-treated group mean percentage change in AST level below baseline at week 18, at week 24 and at follow-up was 45%, 33% (p<0.05) and 8% (ns), respectively. The evolution of GGT levels was as follows: the mean percentage reduction in GGT below baseline level at week 18, 24 and follow-up was: 48%, 52% and 38% (p<0.05), respectively. In both MT-treated and control group plasma cholesterol, triglicerydes and glucose concentrations as well as plasma alkaline phosphatase persisted within normal values during the prolonged study period. Plasma concentration of melatonin (pg/ml) in MT-treated group averaged 7.53.5 at baseline and increased to 52.517.5 at 24th week. The results of our study demonstrating beneficial effect of melatonin on liver enzymes in patients with NASH would seem to encourage further controlled trials of melatonin given over a longer period of time with liver histology as end point.

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