Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
List of bibliographic references supporting the HMPC Assessment Report on Cassia senna L. and Cassia angustifolia Vahl, folium (EMEA/HMPC/51868/2006) and the HMPC Assessment Report on Cassia senna L. , fructus and Cassia angustifolia Vahl, fructus (EMEA/HMPC/51870/2006) (27 April 2007) (1) Tarpila S et al. Efficacy of ground flaxseed on constipation in patients with irritable bowel syndrome. Current Topics in Nutraceutical Research 2004; 2: 119-25 (2) Westendorf J. Pharmakologische und toxikologische Bewertung von Anthranoiden. Pharm. Ztg. 1993; 48: 3891-3902 (3) Wichtl M. Teedrogen und Phytopharmaka. Wiss. VerlagsGmbH, Stuttgart, 3. Aufl. 1997, 225226, 388-390, 546-550. (4) Lemli J. Senna, das am besten untersuchte Laxans. Schweizer Apotherkerzeitung 1995; 133 (10): 244-245 (5) Mascolo N et al. Senna. A Safe and Effective Drug. Phytotherapy Research 1998; 12: 143 – 145 (6) Miething H et al. Densitometric method for the assay of contents of aloeemodin glycosides in Senna pods and leaves and in the aqueous preparations. Pharmazeutische zeitung 1986; 131: 747-9 (7) German monograph of Sennae folium (Sennesblätter), Bundesanzeiger Nr. 133 vom 21.07.1993 (8) Lemli J et al. Naphthalene glycosides in Cassia senna and Cassia angustifolia. Planta Medica 1981; 43: 11-17 (9) Lemli J et al. Chemical-Identification of Alexandrian and Tinnevelley Senna – Studies in the field of drugs containing anthracene-derivates. 34. Planta medica 1983; 49: 36-37 (10) Westendorf J. Pharmakologische und toxikologische Bewertung von Anthranoiden. Pharm Ztg 1993; 138; 48: 3891-3902 (=2) (11) HagerROM 2003, Springer Verlag, Heidelberg: Sennae folium (Sennesblätter) von Cassia angustifolia (12) Lemli J et al. Metabolism of sennosides and rhein in the rat. Pharmacology 1980; 20 (Suppl 1): 50-7 (13) Lemli J. Metabolism of sennosides – an overview. Pharmacology 1988; 36 (Suppl 1): 126-8 (14) De Witte P; Lemli J: Metabolism of 14C-rhein and 14C-rhein anthrone in rats. Pharmacology 1988; 36 (Suppl 1): 152-7 (15) Hietala P. et al. New Aspects on the Metabolites of Sennosides. Pharmacology 1988; 36 (Suppl 1): 138-143 ©EMEA 2007 1/8 (16) Krumbiegel G et al. Rhein and aloe-emodin kinetics from senna laxatives in man. Pharmcology 1993; 47 (Suppl 1): 120-124 (17) Hattori M et al. Metabolism of sennosides by human intestinal bacteria. Pharmacology 1988; 36 (Suppl 1): 172-9 (18) Faber P et al. Relevance of rhein excretion into breast milk. Pharmacology 1988; 36 (Suppl 1) 212-20 (19) Ewe K. Obstipation und Laxanzien. Dtsch. Apoth. Ztg. 1994; 134: 825-833 (20) Gabler F. Obstipation und Laxanzien. PTA heute 8,1994, 5, 380-388 (21) Frexinos J et al. Effects of sennosides on colonic myoelectrical activity in man. Dig Dis Sci 1989; 34, 2: 214-219 (22) Fioramonti J et al. Effects of sennosides on colon motility in dogs. Pharmacology 1988; 36 (Suppl 1: 23-30 (23) Okawa K et al. A study on the optimal time required of ingestion of polyethylene glycol electrolyte lavage solution (PEG) with sennoside and metoclopramide in preparation for colonoscopy. Gastroenterol Endosc 1990; 32, 6: 1377-1385 (24) Van Hoestenberghe A et al. The effect of rhein and rhein anthrone on intestinal fluid transport and on large intestine transit in germ-free rats. European journal of pharmacology 1992; 212 (1): 121-3 (25) Nijs G et al. Conventionalization of germ-free rats reverses the disability of rhein anthrone to induce laxation. European journal of pharmacology 1993; 239 (1-3): 241-3 (26) Ewe K et al. Influence of senna, fibre, and fibre + senna on colonic transit in loperamideinduced constipation. Pharmacology 1993; 47 (Suppl 1): 242-248 (27) Buhmann S et al. Funktionelle Cine-MRT des Kolon: Darstellung und Quantifizierung der Darmmotilität. RoFo Fortschritte auf dem Gebiet der Röntgenstrahlen und der Bildgebenden Verfahren 2005; 177 (1); 35-40 (28) Symposium Antrachinon-Laxantien (1985) Dtsch Apoth Ztg 125: 2745-2747 (29) German pharmacovigilance actions for anthranoid-containing laxatives of 21 June 1996 (30) Pers M, Pers B. A Crossover Comparative Study with Two Bulk Laxatives. J Int Med Res (1983) 11, 51 (31) Marlett JA et al. Comparative Laxation of Psyllium with and without Senna in an Ambulatory Constipated Population. The American Journal of Gastroenterology 1987, Vol. 82, No. 4: 333337 (32) Passmore AP et al. A Comparison of Agiolax and Lactulose in Elderly Patients with Chronic Constipation. Pharmacology 1993a; 47 (1): 249-252 (33) Passmore AP et al. Chronic constipation in long stay elderly patients: a comparison of lactulose and a senna-fibre combination. BMJ 1993b; 307: 769-771 (34) Kinnunen O et al. Safety and Efficacy of a Bulk Laxative Containing Senna versus Lactulose in the Treatment of Chronic Constipation in Geriatric Patients. Pharmacology 1993; 47 (1): 253255 ©EMEA 2007 2/8 (35) Agra Y et al. Efficacy of Senna versus Lactulose in Terminal Cancer Patients Treated with Opioids. Journal of Pain and Symptom Management 1998; 15 (1): 1-7 (36) Hübner WD, Moser EH. Charcoal tablets in the treatment of patients with irritable bowel syndrome. Advances in Therapy 2002; 19 (5): 245-252 (37) Moser EH, Hübner WD. Behandlung von Patienten mit Reizdarmsyndrom mittels EucarbonTabletten (Treatment of the irritable bowel syndrome with Eucarbon). Zeitschrift für Phytotherapie 2003; 24 (1): 15-21 (38) Francis CY et al. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther 1997; 11: 395-402 (39) Frigerio G et al. High doses of Senna for colon cleansing. Giornale italiano di Endoscopia Digestive 1996; 19 (3). 181-184 (40) Krakamp B et al. Koloskopievorbereitung: ein sicheres und einfach zu handhabendes Regime (Preparation for colonoscopy: a reliable and easily implemented regimen). Zeitschrift für Gastroenterologie 1996; 34 (10): 686-91 (41) Valverde A et al. Senna vs polyethylene glycol for mechanical preparation the evening before elective colonic or rectal resection: a multicenter controlled trial. French association for surgical research. Archives of Surgery 1999; 134 (5): 514-9 (42) Bokemeyer B et al. Koloskopievorbereitung in der ambulanten Gastroenterologie (Colonoscopy preparation in outpatient gastroenterology). Verdauungskrankheiten 2000; 18 (1): 17-24 (43) Arezzo A. Prospective randomized trial comparing bowel cleaning preparations for colonoscopy. Surgical Laparoscopy, Endoscopy & Percutaneous Techniques 2000; 10 (4): 215-7 (44) Chilton AP et al. A blinded, randomised comparison of a novel, low-dose, triple regimen with fleet phospho-soda: A study of colon cleanliness, speed and success of colonoscopy. Endoscopy 2000; 32 (1): 37-41 (45) Schanz S et al. Oral sodium phosphate solution versus polyethylene glycol-based lavage for bowel preparation for colonoscopy: a multicenter trial. Digestive Disease Week Abstracts and Itinerary Planner; Vol: 2003; p. Abstract No. S1472/2003 (46) Tasci I et al. Bowel cleansing for diagnostic colonoscopy: Which method is preferable? Istanbul experience. Techniques in Coloproctology 2003; 7 (1): 18-21 (47) Nolan T et al. Randomised trial of laxatives in treatment of childhood encopresis. The Lancet 338, 1991, 8766: 523-527 (48) Bliesner JA et al. Erfahrungen mit X-Prep® bei Kindern. Klinikarzt 1978; 7: 828-34 (49) Dahshan A et al. A randomized, prospective study to evaluate the efficacy and acceptance of three bowel preparations for colonoscopy in children. American Journal of Gastroenterology 1999; 94 (12): 3497-501 (50) Williams CL et al. A summary of conference recommendations on dietary fiber in childhood: Conference on Dietary Fiber in Childhood, New York (New York, USA), May 24, 1994. Pediatrics 1995; 96: 1023-1028 (51) Sitzmann FC et al. Lokale Nebenwirkungen an der Haut durch Anthraglykoside. Pädiatr Prax 1979; 21: 355-358 ©EMEA 2007 3/8 (52) Bundesinstitut für Arzneimittel und Medizinprodukte. Bekanntmachung über die Zulassung und Registrierung von Arzneimitteln – Abwehr von Arzneimittelrisiken, Stufe II – Humanarzneimitteln zur innerlichen Anwendung, ausgenommen nach HAB 1 hergestellte homöopathische Arzneimittel, welche Drogen, Drogenzubereitungen oder isolierte Inhaltsstoffe der Anthranoid- (Hydroxyanthracenderivat-)haltigen Pflanzengattungen Andira, Cassia, Rhamnus, Rheum oder Aloe enthalten (German pharmacovigilance actions for anthranoidecontaining laxatives) vom 21. Juni 1996, Bundesanzeiger vom 05.07.1996 Nr. 123, Seite 7581 (=29) (53) Bonapace ES Jr, Fisher RS. Constipation and diarrhea in pregnancy. Gastroenterology clinics of North America 1998; 27 (1): 197-211 (54) Garcia Villar R. Evaluation of the Effects of Sennosides on Uterine Motility in the Pregnant Ewe. Pharmacology 1988; 36: 203-11 (55) Shelton MG Standardized senna in the management of constipation in the puerperium: A clinical trial. South African Medical Journal 1980; 57 (3): 78-80 (56) Kräuterbuch von Jacobus Theodorus „Tabernaemontanus“, Anno 1625, Kassie / Gewürzrinde (57) Finley Ellingwood, M.D. American Materia Medica, Therapeutics and Pharmacognosy 1919 (58) Hagers Handbuch der Pharmazeutischen Praxis. Dr. G. Frerichs, G. Arends, Dr. H. Zörnig (Herausgeber). Verlag von Julius Springer, Berlin 1927 (59) Handbuch der praktischen und wissenschaftlichen Pharmazie. Hermann Thoms (Herausgeber). Urban & Schwarzenberg, Berlin, Wien 1927 (60) Gerhard Madaus. Lehrbuch der biologischen Heilmittel Band III 1938. Reprint Georg Olms Verlag Hildesheim New York 1976 (61) Martindale – The Extra Pharmacopoiea – 25th ed 1967. By Norman W. Blacow. London. The pharmaceutical press (62) David M.R. Culbreth, Ph.G., M.D. A Manual of Materia Medica and Pharmacology. 7th edition, 1927 (63) Kirtikar KR et al. (1975) Indian Medicinal Plants, 2. Auflage, Repr., Bd. 2, Bishen Singh MS (corresponding to reference 4 in HagerROM (11)) (64) Eberhard von Koenen. Heil- und Giftpflanzen in Südwestafrika. Akademischer Verlag Windhoek, S.W.A. 1977 (65) WHO monographs on selected medicinal plants. Foilum Sennae. WHO Genf 1999 (66) Mori H et al. Carcinogenicity of naturally occuring 1-hydroxyanthraquinone in rats: induction of large bowel, liver and stomach neoplasms. Carcinogenesis 1990; 11, 5: 799-802 (67) Siegers C-P et al. Anthranoid laxatives and colorectal cancer. Trends in Pharmacological Sciences 1992; 13, 6: 229-231 (68) Brusick D et al. Assessment of the Genotoxic Risk from Laxative Senna Products. Environ. Mol. Mutagen. 1997; 29: 1-9 (69) Wölfle D et al. Hydroxyanthraquinones as tumor promoters: enhancement of malignant transformation of c3h mouse fibroblasts and growth stimulation of primary rat hepatocytes. Cancer Res 1990; 50: 6540-4 ©EMEA 2007 4/8 (70) Westendorf J et al. Genotoxicity of naturally occurring hydroxyanthraquinones. Mutat Res 1990; 240: 1-12 (71) Westendorf J. Pharmakologische und toxikologische Bewertung von Anthranoiden. Pharm Ztg. 1993; 138, 48: 3891-3902 (=2) (72) Sandnes D et al. Mutagenicity of Crude Senna and Senna Glycosides in Salmonella typhimurium. Pharmacol. Toxicol. 1992; 71: 165-172 (73) Heidemann A et al. The Genotoxicity Status of Senna. Pharmacology 1993; 47, Suppl. 1: 178186 (74) Lydén-Sokolowski A et al. Two-year carcinogenicity study with sennosides in the rat: emphasis on gastro-intestinal alterations. Pharmacology 1993; 47, Suppl. 1: 209-215 (75) Mereto E et al. Evaluation of the potential carcinogenic activity of Senna and Cascara glycosides for the rat colon. Cancer letters 1996; 101: 79-83 (76) Mascolo N et al. Does Senna Extract Promote Growth of Aberrant Crypt Foci and Malignant Tumors in Rat Colon? Digestive Disease and Science 1999; 44, 11: 2226-2230 (77) Siegers C-P et al. Anthranoid laxative abuse – A risk for colorectal cancer? Gut 1993; 34 (8): 1999-1101 (78) Kune GA et al. The role of chronic constipation, diarrhea, and laxative use in the etiology of large-bowel cancer. Data from the Melbourne Colorectal Cancer Study. Diseases of the colon and rectum 1988; 31 (7): 507-12 (79) Kune GA. Laxative use not a risk for colorectal cancer: data from the Melbourne Colorectal Cancer Study. Zeitschrift für Gastroenterologie 1993; 31 (2): 140-3 (80) Nusko G et al. Retrospective study on laxative use and melanosis coli as risk factors for colorectal neoplasma. Pharmacology 1993; 47 Suppl 1: 234-41 (81) Van Gorkom BA et al. Influence of a highly purified senna extract on colonic epithelium. Digestion 2000; 61, 2: 113-20 (82) Hallmann F. Toxicity of commonly used laxatives. Med. Sci. Monit. 2000; 6 (3): 618-28 (83) Nusko G et al. Anthranoide laxative use is not a risk factor for colorectal neoplasia: results of a prospective case control study. Gut 2000; 46: 651-55 (84) Willems M et al. Anthranoid self-medication causing rapid development of melanosis coli. The netherlands journal of medicine 2003; 61 (1): 22-4 (85) Ewing CA et al. Melanosis Coli Involving Pericolonic Lymph nodes Associated with the Herbal Laxative Swiss Kriss: A Rare and Incidental Finding in a Patient with Colonic Adenocarcinoma. Archives of Pathology and Laboratory Medicine 2004; 128 (5): 565-7 (86) Hall M, Eusebi V. Yellow-brown spindle bodies in mesenteric lymph nodes: a possible relationship with melanosis coli. Histopathology 1978; 2: 47-52 (87) Nilsson SE et al. Laxative treatment elevates plasma homocysteine: A study on a populationbased Swedish sample of old people. European Journal of Clinical Pharmacology 2004; 60 (1): 45-49 ©EMEA 2007 5/8 (88) Roth L, Daunderer M, Kormann K (1988) Giftpflanzen Pflanzengifte. Vorkommen, Wirkung, Therapie, Allergische und phototoxische Reaktionen, 3. Aufl. Ecomed, Landsberg München (89) Farah MH et al. International Monitoring of Adverse Health Effects Associated with herbal Medicines. Pharmacoepidemiology and Drug Safety 2000; 9: 105-112 (90) Anton C. Adverse effects of laxatives. Adverse Drug Reaction Bulletin 2002; 212: 811-814 (91) Beuers U et al. Hepatitis after chronic abuse of senna. Lancet (England) 1991; Vo.: 337: 372373 (92) Seybold U et al. Senna-induced hepatitis in a poor metabolizer. Annals of Internal Medicine 2004; 141 (8): 650-651 (93) Iida Y et al. Bowel preparation for the total colonoscopy by 2,000 ml of balanced lavage solution (Golytely) and sennoside. Gastroenterologica Japonica 1992; 27 (6): 728-733 (94) ESCOP monograph “SENNAE FOLIUM” 2nd edition 2003, Thieme Verlag Stuttgart, New York (95) ESCOP monograph “SENNAE FRUCTUS ACUTIFOLIAE” 2nd edition 2003, Thieme Verlag Stuttgart, New York (96) ESCOP monograph “SENNAE FRUCTUS ANGUSTIFOLIAE, 2nd edition 2003, Thieme Verlag Stuttgart, New York (97) Mengs U et al. A 13-week oral toxicity study of senna in the rat with an 8-week recovery period. Arch Toxicol 2004; 78: 269-275 (98) Michell JM, Mengs U et al. An oral carcinogenicity and toxicity study of senna (Tinnevelly senna fruits) in the rat. Arch Toxicol 2006; 80: 34-44 (99) Ishii Y et al. Studies of aloe. III. Mechanism of cathartic effect. (2). Chemical & pharmaceutical bulletin 1990; 38 (1): 197-200 (100) Hoenig J et al. Inhibition of Cl- channels as a possible base of laxative action of certain anthraquinones and anthrones. Planta Med 1992; 58 (7): A586-A587 (101) Rauwald HW et al. Different influence of certain anthraquinones/anthrones on energy metabolism: an approach for interpretation of known synergistic effects in laxative action. (Question.). Planta Med 1992; 58 (7): A587-A588 (102) Ishii Y et al. Studies of aloe. IV. Mechanism of cathartic effect. (3). Biological & pharmaceutical bulletin 1994; 17 (4): 495-7 (103) Capasso F et al. Effect of indomethacin on aloin and 1,8 dioxianthraquinone-induced production of prostaglandins in rat isolated colon. Prostaglandins 1983; 26 (4): 557-62 (104) Konsensuspapier Expertenforum: Obstipation und Laxanzien. Praxis 1999; 88: 1269-1274 (105) Haverkamp W et al. Medikamentenbedingte QT-Verlängerung und Torsade de pointes. Druginduced QT Prolongation and Torsade de Pointes. Deutsche Ärzteblatt 2002; 99: A 1972-9 [Heft 28-29] (106) Bauer H. Behandlung der Obstipation mit Laxariston in der gynäkologischen Praxis. Treatment of obstipation in gynecological practice with Laxariston. Therapie der Gegenwart 1977; 116 (12): 2305-2312 ©EMEA 2007 6/8 (107) NTP Technical Report on the Toxicology and Carcinogenesis Studies of Emodin in F344/N Rats and B6C3F1 Mice. National Toxicology Program, June 2001, NTP TR 493, NIH Publication No. 01-3952 (108) Masuda T et al. 2-Hydroxyemodin, an active metabolite of emodin in the hepatic microsomes of rats. Mutation Research 1985; 149: 327-332 (109) Jacobs EJ et White E. Constipation, laxative use, and colon cancer among middle-aged adults. Epidemiology 1998; 9: 385-91 (110) Roberts MC et al. Constipation, laxative use, and colon cancer in a North Carolina population. Am J Gastroenterol 2003; 98: 857-64 (111) Müller-Lissner S. Myths and misconceptions about chronic constipation. Am J Gastroenterol 2005; 100: 232-242 (112) Smith B. Effect of irritant purgatives on the myentric plexus in man and mouse. Gut 1968; 9: 139-45 (113) Riemann JF et al. The fine structure of colonic submucosal nerves in patients with chronic laxative abuse. Scand J Gastroenterol 1980; 15: 761-8 (114) Riemann JF et al. Ultrastructural changes in the gut autonomic nervous system following laxative abuse and in other conditions. Scand J Gastroenterol 1982; 71: 11-24 (115) Berkelhammer C et al. Low-volume oral colonoscopy bowel preparation: sodium phosphate and magnesium citrate. Gastrointest Endosc 2002; 56: 89-94 (116) Meisel JL et al. Human rectal mucosa: proctoscopic and morphological changes caused by laxatives. Gastroenterology 1977; 72: 1274-9 (117) Pockros PJ et al. Golytely lavage versus a standard colonoscopy preparation. Effect on normal colonic mucosal histology. Gastroenterology 1985; 88: 545-8 (118) Riecken EO et al. The effect of an anthraquinone laxative on colonic nerve tissue: A controlled trial in constipated women. Z Gastroenterol 1990; 28: 660-4 (119) Hoppe HA. Drogenkunde. 6th edition Hamburg: Cram, de Gruyter & Co: 1949 (120) Pharmacopoeia Austriaca 1812 (121) Dr. K. M. Nadkarni’s Indian material medica, Volume one, Bombay Popular Prakashan 1976 (122) Vanderperren B et al. Acute liver failure with renal impairment related to the abuse of senna anthraquinone glycosides. Ann Pharmacotherapy 2005; 39: 1353-7 (123) Danan G and Benichou C. Causality assessment of adverse reactions to drugs – I. A novel method based on the conclusions of international consensus meetings: application to druginduced liver injuries. J Clin Epidemiology 1993; Vol 46 (11):1323-1330 (124) Benichou C et al. Causality assessment of adverse reactions to drugs – II. An original model for validation of drug causality assessment methods: case reports with positive rechallenge. J Clin Epidemiology 1993; Vol.46 (11): 1331-1336 (125) Brunton LL. Agents affecting gastrointestinal water flux and motility; emesis and antiemetics; bile acids and pancreatic enzymes. Chapter 38. In Goodman & Gilman's Ed. ©EMEA 2007 7/8 (126) The pharmacological basis of Therapeutics. Ninth Edition. McGraw-Hill, 1996:917-937 (127) Silk DBA et al. Reversible finger clubbing in a case of purgative abuse. Gastroenterology 1975; Vol. 68, No. 4: 790-4 (128) Prior J, White I. Tetany and clubbing in patient who ingested large quantities of senna. Lancet 1978; ii: 947 (129) Malmquist J et al. Finger clubbing and aspartylglucosamine excretion in a laxative-abusing patient. Postgrad Med J 1980; 56: 862-4 (130) Levine D et al. Purgative abuse associated with reversible cachexia, hypogammaglobulinaemia, and finger clubbing. Lancet 1981; i: 919-20 (131) Armstrong RD et al. Hypertrophic osteoarthropathy and purgative abuse. BMJ 1981; 282: 1836 ©EMEA 2007 8/8