Herbal Medicine: Expanded Commission E
Psyllium seed husk, Blonde
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Latin Name: Plantago psyllium
Pharmacopeial Name: Psyllii semen
Other Names: French psyllium
Overview
Blonde psyllium (Plantago ovata) is a low herbaceous annual plant native to Iran and India, extensively cultivated there and in other countries, including Pakistan (Kapoor, 1990; Karnick, 1994; Nadkarni, 1976; Wichtl and Bisset, 1994). Black psyllium of the P. afra species is native to the western Mediterranean region, northern Africa, and western Asia, now cultivated in southern France and Spain. Black psyllium of the P. indica species is native to southeastern Europe and Asia Minor (Braun et al., 1997; Budavari, 1996; Leung and Foster, 1996). In commerce, blonde psyllium is obtained mainly from India, Pakistan, and Iran. Black psyllium is obtained mainly from southern France (BHP, 1996; Wichtl and Bisset, 1994). Psyllium has a long history of medical use in both conventional and traditional systems of medicine throughout Asia, Europe, and North America. Blonde psyllium is official in the national pharmacopeias ofFrance, Germany, Great Britain, and the United States(BP, 1988;Bradley, 1992; DAC, 1986; DAB, 1997; Newall et al., 1996; Ph.Fr.X, 1990; USP XXII, 1990–1992; Wichtl and Bisset, 1994).Psyllium monographs also appear in the Ayurvedic Pharmacopoeia,British Herbal Pharmacopoeia, British Herbal Compendium, ESCOP Monographs, Commission E Monographs, and the German Standard License Monographs (BAnz, 1998; BHP, 1996; Bradley, 1992; Braun et al., 1997; ESCOP, 1997; Karnick, 1994). The World Health Organization (WHO) has published a monograph on psyllium seed covering P. afra, P. indica, P. ovata, and P. asiatica (WHO, 1999). Asian psyllium seed (P. asiatica Linn or P. depressa Willd.)is official in the national pharmacopeias of China and Japan (JP XII, 1993; Tu, 1992; Yen, 1992). In Germany, psyllium isofficial in the German Pharmacopoeia and approved in both the German Standard License and Commission E Monographs (BAnz, 1998; Braun et al., 1997; DAB 10, 1993; DAB, 1997; Wichtl and Bisset, 1994). It is used in laxatives by itself (e.g., Agiocur®-Granulat, Abf hr Herbagran® Granulat-Psyllium) and in combination with senna fruit extract (e.g., Agiolax®-Granulat, Kneipplax®N)(Kneipp®, 1996; Schilcher, 1997; Wichtl and Bisset, 1994).In the United States, psyllium is used as a bulk laxative OTC drug (e.g., Metamucil®) to treat chronic constipation. The ground seeds or husks are used in dietary supplements for increased fiber, cholesterol reduction, and laxative activity (Leung and Foster, 1996; Wichtl and Bisset, 1994). In 1998, the FDA amended its soluble fiber health claim regulation to include blonde psyllium husk as a source. Psyllium products of which a single dose or serving contains at least 1.7 grams of soluble fiber can be labeled, "Consumption of the product in association with a diet low in saturated fats and cholesterol may [or might] reduce the risk of coronary heart disease" (Levy, 1998; Tips, 1998). Modern human studies have investigatedpsyllium for treating irritable bowel syndrome and chronic constipation (Hotz and Plein, 1994; Tomas-Ridocci et al., 1992), maintaining remission in ulcerative colitis (Fernandez-Banares et al., 1997, 1999), its effects on serum levels of bile acids in patients with juvenile ulcerative colitis (Ejderhamm and Strandvik, 1991), hypercholesterolemia (Kwiterovich, 1995; Schectman et al., 1993; Sprecher et al., 1993; Williams et al., 1995), and its effects in the prevention of gallstones in obese patients on a reducing diet (Moran et al., 1997). In a randomized double-blind placebo study, the effect of P. ovata (PO) on 20 patients with chronic constipation (CC), 10 of whom had associated irritable bowel syndrome (IBS), was investigated. Weight of feces and intestinal transit time were measured with radiopaque markers (relative impenetrability of X-rays) at the start and after 30 days of treatment. All patients treated with PO reported good results. Frequency of stools increased from 2.5+/–1 to 8+/–2.2 stools per week. A decrease in consistency of stools was also observed in the treated group. Fecal weight and colonic transit time were not significantly modified in the placebo group, while weight increase as well as decreased transit time were observed in the treated group. No adverse effects were observed; in particular, no flatulence, as is often seen in patients ingesting bran (Tomas-Ridocci et al., 1992). In an open study, the effectiveness of psyllium seed husks in comparison with wheat bran on stool frequency and manifestations of irritable bowel syndrome (IBS) with constipation was investigated in 30 patients suffering from IBS group II to III. Patients received either 3.25g psyllium seeds or 7 g wheat bran three times daily. The study comprised two treatment phases of two weeks each, separated by two weeks without any treatment, the study lasting six weeks in all. Parameters for evaluation included stool frequency and consistency as well as symptoms of pain and abdominal distention, measured by a score (1 to 4). In both treatment groups stool frequency and consistency improved by comparison to the starting point. The improvement of stool frequency was statistically significant for both substances. However, the beneficial effects of psyllium seed exceeded those of wheat bran in weeks one, two, three, five, and six. The authors concluded that psyllium seed and wheat bran are both effective for stool frequency and consistency of patients with IBS. Psyllium seeds proved to be superior to wheat bran with respect to stool frequency and abdominal distention and therefore should be preferred in treatment of IBS and constipation (Hotz and Plein, 1994). The approved modern therapeutic applications for psyllium are supportable based on its history of use in well established systems of traditional and conventional medicines,pharmacological studies in animals, phytochemical investigations,and human clinical studies. German pharmacopeial grade blonde psyllium seed consists of the dried ripe seed of P. ovata Forssk. (syn. P. ispaghula Roxb.) The unmilled seed must have a swelling index of at least 9. Botanical identity must be confirmed by macroscopic and microscopic examinations as well as organoleptic evaluation (DAB, 1997; Wichtl and Bisset, 1994).The British Herbal Pharmacopoeia requires an additional identification test by thin-layer chromatography (TLC), although the monograph states that macroscopic examination must be used to differentiate between blonde psyllium and black psyllium seed (BHP, 1996). The ESCOP psyllium monograph requires that the material comply with the German and French pharmacopeias (ESCOP, 1997). German pharmacopeial grade black psyllium seed consists of the dried ripe whole seed of P. afra L. ("P. psyllium") or P. indica L. (syn. P. arenaria Waldstein et Kitaibel). The whole seed must have a swelling index of at least 10, contain not more than 1% foreign matter, including any green unripe seeds and/or seeds from other species of Plantago (e.g., P. lanceolata L., P. major L., P. ovata Forssk., and P. sempervirens Crantz). Botanical identity must be confirmed by macroscopic examination and organoleptic evaluation (DAB 10, 1993).
Description
Black psyllium seed consists of the dried, ripe seed of Plantago psyllium (syn. P. afra L.) and of P. indica L. (syn. P. arenaria Waldstein et Kitaibel) [Fam. Plantaginaceae] with a swelling index of at least 10, and its formulations in effective dosage. The preparation contains mucilage.
Chemistry and Pharmacology
Constituents of the seeds include 5–10% lipids with unsaturated fatty acids, sterols, and mucilaginous polysaccharide (10–15%) consisting of xylose, galacturonic acid, arabinose, and rhamnose residues (Bruneton, 1995; ESCOP, 1997). The seeds contain 15–20% protein, 5–13% fixed oil, trisaccharide planteose, and small amounts of phytosterols, triterpenes, the iridoid glucoside aucubin, and the alkaloids plantagonine, indicaine, and indicamine (ESCOP, 1997). The Commission E reported that black psyllium seed regulates intestinal peristalsis. Psyllium seed also lowers blood cholesterol levels and LDL cholesterol in hypercholesterolemic subjects without significant changes in triglycerides and HDL cholesterol. It is also believed that the seed reduces peak levels of blood glucose by delaying intestinal absorption of sugar (ESCOP, 1997).
Uses
The Commission E approved black psyllium seed for chronic constipation and irritable bowel syndrome. It is recommended where soft stool is desired, for example, in cases of anal fissures, hemorrhoids, and post-rectal surgery. WHO found these uses (noted above) supported by clinical data. WHO added restoration and maintenance of regularity, temporary constipation due to illness or pregnancy, and constipation due to duodenal ulcer or diverticulitis (WHO, 1999).
Contraindications
Stenosis of the esophagus or the gastrointestinal tract.
Side Effects
In rare cases allergic reactions, especially with powdered or liquid preparations.
Use During Pregnancy and Lactation
No restrictions known.
Interactions with Other Drugs
None known.
Dosage and Administration
Unless otherwise prescribed: 4-20 g per day of whole seed husk as well as other galenical preparations to be taken orally. Husk: 4-5 g, one to four times daily. Presoak the husk in 150 ml of warm water for several hours. Powdered Husk: 4-5 g, one to four times daily. Stir into 150 ml water and drink immediately, followed by additional water. Note: Sufficient fluids must be taken with the preparation, e.g., 150 ml water to 5 g preparation. The dose should be taken a half hour to one hour after taking other medication. Warning: Commission E (and other authorities) require the following warning: If diarrhea lasts for more than three to four days, consult a physician (ESCOP, 1996; Newall et al., 1996; Reynolds, 1993).
References
BAnz. See Bundesanzeiger. Bradley, P.R. (ed.). 1992. British Herbal Compendium, Vol. 1. Bournemouth: British Herbal Medicine Association. Braun, R. et al. 1997. Standardzulassungen f r FertigarzneimittelText and Kommentar. Stuttgart: Deutscher Apotheker Verlag. British Herbal Pharmacopoeia (BHP). 1996. Exeter, U.K.: British Herbal Medicine Association. 114115. British Pharmacopoeia (BP). 1988. (With subsequent Addenda up to 1992.) London: Her Majesty's Stationery Office. Bruneton, J. 1995. Pharmacognosy, Phytochemistry, Medicinal Plants. Paris: Lavoisier Publishing. Budavari, S. (ed.). 1996. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 12th ed. Whitehouse Station, N.J.: Merck & Co, Inc. Bundesanzeiger (BAnz). 1998. Monographien der Kommission E (Zulassungs- und Aufbereitungskommission am BGA f r den humanmed. Bereich, phytotherapeutische Therapierichtung und Stoffgruppe). Kln: Bundesgesundheitsamt (BGA). Deutsches Arzneibuch, 10th ed., 2nd suppl. (DAB 10). 1993. Stuttgart: Deutscher Apotheker Verlag. Deutsches Arzneibuch (DAB 1997). 1997. Stuttgart: Deutscher Apotheker Verlag. Deutscher Arzneimittel-Codex (DAC). 1986. Stuttgart: Deutscher Apotheker Verlag. Ejderhamm, J. and B. Strandvik. 1991. Serum bile acids in relation to disease activity and intake of dietary fibers in juvenile ulcerative colitis. Digestion 50(34):162169. ESCOP. 1997. 'Psyllii semen,' 'Plantaginis ovatae semen,' and 'Plantaginis ovatae testa.' Monographs on the Medicinal Uses of Plant Drugs. Exeter, U.K.: European Scientific Cooperative on Phytotherapy. Fernandez-Banares, F. et al. 1997. Randomized clinical trial of Plantago ovata efficacy as compared to mesalazine in maintaining remission in ulcerative colitis. Gastroenterology 112:A971. Fernandez-Banares, F. et al. 1999. Randomized clinical trial of Plantago ovata seeds (dietary fiber) as compared with mesalamine in maintaining remission in ulcerative colitisSpanish Group for the Study of Crohn's Disease and Ulcerative Colitis (GETECCU). Am J Gastroenterol 94(2):427433. Hotz, J. and K. Plein. 1994. Wirkung von plantago-samenschalen in vergleich zu weizenkleie auf stuhlfrequenz und beschwerden beim colon-irritabile-syndrom mit obstipation [Effectiveness of plantago seed husks in comparison with wheat brain on stool frequency and manifestations of irritable colon syndrome with constipation]. Med Klin 89(12):645651. Japanese Pharmacopoeia, 12th ed. (JP XII). 1993. Tokyo: Government of Japan Ministry of Health and WelfareYakuji Nippo, Ltd. 214. Kapoor, L.D. 1990. Handbook of Ayurvedic Medicinal Plants. Boca Raton: CRC Press. 267. Karnick, C.R. 1994. Pharmacopoeial Standards of Herbal Plants, Vol. 1. Delhi: Sri Satguru Publications. 273276. Kneipp. 1996. Wegweiser zu den Kneipp Mitteln [Guide to Kneipp Remedies]. W rzburg: Sebastian Kneipp Gesundheitsmittel Verlag. 7075. Kwiterovich, P.O. Jr. 1995. The role of fiber in the treatment of hypercholesterolemia in children and adolescents. Pediatrics 96(5 Pt 2):10051009. Leung, A.Y. and S. Foster. 1996. Encyclopedia of Common Natural Ingredients Used in Food, Drugs, and Cosmetics, 2nd ed. New York: John Wiley & Sons, Inc. Levy, B. 1998. New FDA Regulations on Antioxidants and Psyllium Seed. HerbClip060388. Austin, TX: American Botanical Council. Moran, S. et al. 1997. Efecto de la administracion de fibra en la prevencion de litiasis vesicular en obesos sometidos a dieta de reduccion. Ensayo [Effects of fiber administration in the prevention of gallstones in obese patients on a reducing diet. A clinical trial]. Rev Gastroenterol Mex 62(4):266272. Nadkarni, K.M. 1976. Indian Materia Medica. Bombay: Popular Prakashan. 960967. Newall, C.A., L.A. Anderson, J.D. Phillipson. 1996. Herbal Medicines: A Guide for Health-Care Professionals. London: The Pharmaceutical Press. Pharmacope Franaise Xe dition (Ph.Fr.X). 19831990. Moulins-les-Metz: Maisonneuve S.A. Schectman, G., J. Hiatt, A. Hartz. 1993. Evaluation of the effectiveness of lipid-lowering therapy (bile acid sequestrants, niacin, psyllium and lovastatin) for treating hypercholesterolemia in veterans. Am J Cardiol 71(10):759765. Schilcher, H. 1997. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart: Medpharm Scientific Publishers. 5253. Sprecher, D.L. et al. 1993. Efficacy of psyllium in reducing serum cholesterol levels in hypercholesterolemic patients on high- or low-fat diets. Ann Intern Med 119(7 pt. 1):545554. Comment on: 627628. Tips, S. 1998. How Changes in FDA Regulations Affect Antioxidant, Psyllium Claims. Whole Foods Mag May:3233. Tomas-Ridocci, M. et al. 1992. Eficacia del Plantago ovata como regulador del transito intestinal. Estudio doble ciego comparativo frente a placebo [The efficacy of Plantago ovata as a regulator of intestinal transit. A double-blind study compared to placebo]. Rev Esp Enferm Dig 82(1):1722. Tu, G. (ed.). 1992. Pharmacopoeia of the People's Republic of China (English Edition 1992). Beijing: Guangdong Science and Technology Press. 231. The United States Pharmacopoeia, 22nd rev.(USP XXII). 19901992. Rockville, MD: U.S. Pharmacopoeial Convention. WHO. See World Health Organization. Wichtl, M. and N.G. Bisset (eds.). 1994. Herbal Drugs and Phytopharmaceuticals. Stuttgart: Medpharm Scientific Publishers. Williams, C.L., A. Bollella, A. Spark, D. Puder. 1995. Soluble fiber enhances the hypocholesterolemic effect of the step I diet in childhood. J Am Coll Nutr 14(3):251257. World Health Organization (WHO). 1999. 'Semen Plantaginis.' WHO Monographs on Selected Medicinal Plants, Vol. 1. Geneva: World Health Organization. Yen, K.Y. 1992. The Illustrated Chinese Materia MedicaCrude and Prepared. Taipei: SMC Publishing, Inc. 180.
Additional Resources
Bruneton, L.L. 1996. In: Hardman, J.G. et al. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed. New York: McGraw-Hill. Burton, R. and V. Manninen. 1982. Influence of a psyllium-based fibre preparation on faecal and serum parameters. Acta Med Scand Suppl 668:9194. Deutsches Arzneibuch, 10th ed. Vol. 16. (DAB 10). 1991. Kommentar. Stuttgart: Wissenschaftliche Verlagsgesellschaft. Forman, D.T., J.E. Garvin, J.E. Forestner, C.B. Taylor. 1968. Increased excretion of fecal bile acids by an oral hydrophilic colloid. Proc Soc Exp Biol Med 127(4):10601063. Frati-Munari, A.C., M.A. Flores-Garduno, R. Ariza-Andraca, S. Islas-Andrade, A. Chavez Negrete. 1989. Efecto de diferentes dosis de mucilago de Plantago psyllium en la prueba de tolerancia a la glucosa [Effect of different doses of Plantago psyllium mucilage on the glucose tolerance test]. Arch Invest Med (Mex) 20(2):147152. Hamouz, W. 1984. Therapy of acute and chronic diarrhoea with Agiocur. Med Klin (79):3233. Hnsel, R., K. Keller, H. Rimpler, G. Schneider (eds.). 1994. Hagers Handbuch der Pharmazeutischen Praxis, 5th ed. Vol. 6. Berlin-Heidelberg: Springer Verlag. Heckers, H. and D. Zielinsky. 1984. Fecal composition and colonic function due to dietary variables. Results of a long-term study in healthy young men consuming 10 different diets. Motility (Lisbon) 2429. Karawya, M.S., S.I. Balbaa, M.S. Afifi. 1971. Investigation of the carbohydrate contents of certain mucilaginous plants. Planta Med 20(1):1423. Kay, R.M. and S.M. Strasberg. 1978. Origin, chemistry, physiological effects and clinical importance of dietary fibre. Clin Invest Med 1(1):924. Kies, C. 1983. In: Furda, I. (ed.). Unconventional sources of dietary fiber. Physiological and in vitro functional properties. ACS Symposium Series 214. Washington DC: American Chemical Society. Kovar, F. 1983. Was tun bei akuter, nicht bacteriell bedingter diarrh? Symptomatische behandlung mit einem quellmittel verringert rasch die stuhlfrequenz, ohne die toxin-elimination zu stren [In German]. Artzl Praxis (35):1498. Leng-Peschlow, E. 1991. Plantago ovata seeds as dietary fibre supplement: physiological and metabolic effects in rats. Br J Nutr 66(2):331349. Marlett, J.A., B.U. Li, C.J. Patrow, P. Bass. 1987. Comparative laxation of psyllium with and without senna in an ambulatory constipated population. Am J Gastroenterol 82(4):333337. Pharmacopoeia Helvetica, 7th ed. Vol. 14.(Ph.Helv.VII). 1987. Bern: Office Central Fdral des Imprims et du Matriel. Qvitzau, S., P. Matzen, P. Madsen. 1988. Treatment of chronic diarrhoea: loperamide versus ispaghula husk and calcium. Scan J Gastroenterol 23(10):12371240. Slter, H. and D. Lorenz. 1983. Summary of clinical results with prodiem plain, a bowel-regulating agent. Today's Therapeutic Trends (1):4559. Stevens, J., P.J. VanSoest, J.B. Robertson, D.A. Levitsky. 1988. Comparison of the effects of psyllium and wheat bran on gastrointestinal transit time and stool characteristics. J Am Diet Assoc 88(3):323326. USP Drug Information, 14th ed., Vol. 2. (USP 1994). 1994. Rockville, MD: U.S. Pharmacopoeial Convention. This material was adapted from The Complete German Commission E MonographsTherapeutic Guide to Herbal Medicines. M. Blumenthal, W.R. Busse, A. Goldberg, J. Gruenwald, T. Hall, C.W. Riggins, R.S. Rister (eds.) S. Klein and R.S. Rister (trans.). 1998. Austin: American Botanical Council; Boston: Integrative Medicine Communications.
1) The Overview section is new information. 2) Description, Chemistry and Pharmacology, Uses, Contraindications, Side Effects, Interactions with Other Drugs, and Dosage sections have been drawn from the original work. Additional information has been added in some or all of these sections, as noted with references. 3) The dosage for equivalent preparations (tea infusion, fluidextract, and tincture) have been provided based on the following example: - Unless otherwise prescribed: 2 g per day of [powdered, crushed, cut or whole] [plant part]
- Infusion: 2 g in 150 ml of water
- Fluidextract 1:1 (g/ml): 2 ml
- Tincture 1:5 (g/ml): 10 ml
4) The References and Additional Resources sections are new sections. Additional Resources are not cited in the monograph but are included for research purposes. This monograph, published by the Commission E in 1994, was modified based on new scientific research. It contains more extensive pharmacological and therapeutic information taken directly from the Commission E.
Excerpt from Herbal Medicine: Expanded Commission E Monographs
Copyright 2000 American Botanical Council
Published by Integrative Medicine Communications
Available from the American Botanical Council.
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