Natural Standard Bottom Line Monograph, Copyright © 2013 (www.naturalstandard.com). Commercial distribution prohibited. This monograph is intended for informational purposes only, and should not be interpreted as specific medical advice. You should consult with a qualified healthcare provider before making decisions about therapies and/or health conditions.
While some complementary and alternative techniques have been studied scientifically, high-quality data regarding safety, effectiveness, and mechanism of action are limited or controversial for most therapies. Whenever possible, it is recommended that practitioners be licensed by a recognized professional organization that adheres to clearly published standards. In addition, before starting a new technique or engaging a practitioner, it is recommended that patients speak with their primary healthcare provider(s). Potential benefits, risks (including financial costs), and alternatives should be carefully considered. The below monograph is designed to provide historical background and an overview of clinically-oriented research, and neither advocates for or against the use of a particular therapy.
214Bi, basic bismuth carbonate (BSC), basic bismuth gallate (BSG), basic bismuth nitrate (BSN), basic bismuth salicylate (BSS), Bi, Bi2O3, biscu, Bismatrol®, Bismatrol® Extra Strength, Bismed®, bismuth aluminate (BA), bismuth ammonium citrate, bismuth biskalcitrate, bismuth carbomer enemas, bismuth gallate, bismuth (III), bismuth oxynitrate, bismuth phosphate, bismuth salts, bismuth subgallate, bismuth subnitrate, bismuth subnitrate suspension (B), bismuth subsalicylate, bismuth sulfate agar (BSA), bismuth tribromophenate (Xeroform®), bismuth-207, bismuth-212, bismuth-213, bismuth-ethylenediamine tetraacetate bisodium (bi-EDTA), bismuthi subcitras colloidal, bismuth-peptide complex (BPC, bicitropeptide), BSS, calcium acexamate-light bismuth nitrate, colloidal bismuth, colloidal bismuth pectin (CBP), colloidal bismuth subcitrate (CBS), De-Nol®, Gastrin®, Gastrocaps®, GR122311X, Kaopectate®, karaya bismuth, micronized bismuth subnitrate, Pepto-Bismol®, Pepto-Bismol® Easy-to-Swallow Caplets, Pepto-Bismol® Maximum Strength, PMS-bismuth subsalicylate, Q-ULCER®, ranitidine bismuth citrate (Pylorid®, RBC, Rb, Tritec®), Rbc, Roter®, tripotassium dicitrato bismuthate (TBS, TDB, Ventrisol®), tripotassium dicitratobismuthate (De-Nol®), ulcedal, ulcerine, vicalin, wikalina, Xeroform®.
Note: This monograph focuses on bismuth and bismuth subcarbonate, subgallate, or subnitrate single-arm studies. Bismuth subsalicylate, colloidal bismuth subcitrate, bismuth aluminate, and ranitidine bismuth products are alluded to, but not expanded on.
Bismuth (Bi) is a chemical element whose atomic number is 83. Bismuth-containing compounds include cosmetics (bismuth oxychloride) and certain drugs. Bismuth is also used in some medical procedures. Bismuth has been used for approximately a hundred years for stomach and intestinal conditions and was the first drug shown to affect the progression of peptic ulcer disease. The historical use of bismuth has been discussed in various reviews.
Although the element bismuth has been used since at least the 18th Century, most bismuth-containing products available on the market now are multi-ingredient products or are used in combination with other drugs. These multi-ingredient products will be only briefly discussed in this monograph.
Examples of bismuth products used in medicine include bismuth subnitrate, bismuth subcarbonate, bismuth subsalicylate (e.g., Pepto-Bismol®, Kaopectate®), bismuth subgallate (e.g., Devrom®), colloidal bismuth subcitrate (e.g., De-Nol®), and ranitidine bismuth subcitrate.
Some preliminary evidence suggests that bismuth carbomer enemas may reduce pouchitis (inflammation in the pouch) that may occur after colon removal. Bismuth subnitrate has been used for treatment of Helicobacter pylori infection, typically in combination with antibiotics, with limited evidence of benefit. Bismuth subgallate has been studied for controlling odor after an ileostomy (a hole surgically constructed in the abdomen to eliminate waste).
These uses have been tested in humans or animals. Safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider.
Gastritis (stomach lining inflammation)
According to human research, bismuth subnitrate may reduce the acidity of the stomach, as well as increase the production of a substance that improves ulcer healing. Also, a bismuth-protein complex may coat ulcers and allow healing to occur. Bismuth therapy for gastritis has been investigated in a few preliminary clinical trials. Well-designed studies are required before conclusions can be drawn.
Gastrointestinal conditions (stomach problems)
Bismuth has been used traditionally for stomach problems. Limited research has investigated the use of bismuth subgallate to control the odor associated with ileostomies (a surgical opening in the belly wall to allow waste to be removed). Further well-designed trials are required before conclusions can be drawn.
Helicobacter pylori infection
Bismuth has been established as a safe and well-tolerated treatment for Helicobacter pylori infections in adults and children. Limited research suggests that the addition of bismuth subnitrate to other medications, such as antibiotics, may improve the elimination of bacteria over the other medications alone. Further studies are needed before conclusions can be drawn.
Kidney disorders (renal cysts)
According to research in humans, bismuth subnitrate, ginseng, and tang-kuei ten may reduce kidney dysfunction associated with cisplatin treatment, although conflicting results exist. Furthermore, at least one case study suggests that high doses of bismuth may cause sudden and severe kidney failure. More information is needed before conclusions can be drawn.
Bismuth has been used traditionally for gastric concerns. The use of bismuth subgallate to control the odor associated with ileostomies (a surgical opening in the belly wall to allow waste to be removed) was investigated in humans. Also, limited research indicates that bismuth may prevent ulcer recurrence similarly to cimetidine. Further information is required before conclusions can be drawn.
Pouchitis (intestinal inflammation)
A limited number of studies have investigated the use of bismuth carbomer enemas for chronic pouchitis, which is the inflammation of a surgically constructed bowel pouch. However, the results from these studies were conflicting, so further information is required before conclusions can be drawn.
Tonsillitis (swelling of the tonsils)
A limited number of studies have investigated the use of bismuth subgallate for tonsillectomy (tonsil removal). Although evidence from clinical trials examining the effect of gauze containing bismuth and adrenaline suggests improved healing, only one of two trials examining the effect of bismuth alone agreed with these results. Further information is required before conclusions can be drawn.
*Key to grades:A: Strong scientific evidence for this use; B: Good scientific evidence for this use; C: Unclear scientific evidence for this use; D: Fair scientific evidence against this use (it may not work); F: Strong scientific evidence against this use (it likely does not work).
The below uses are based on tradition or scientific theories. They often have not been thoroughly tested in humans, and safety and effectiveness have not always been proven. Some of these conditions are potentially serious and should be evaluated by a qualified health care professional.
Alcohol abuse (injury), antibiotic, anti-inflammatory, antimicrobial, antioxidant, cancer, coagulation (blood clotting), colitis (swelling of the large intestine), constipation, diagnostic procedure, diarrhea (traveler's), gastroenteritis (swelling of the stomach and intestines), hemorrhoids, indigestion (nonulcer dyspepsia), nosebleed, syphilis (sexually transmitted disease).
The below doses are based on scientific research, publications, traditional use, or expert opinion. Many herbs and supplements have not been thoroughly tested, and safety and effectiveness may not be proven. Brands may be made differently, with variable ingredients, even within the same brand. The below doses may not apply to all products. You should read product labels, and discuss doses with a qualified healthcare provider before starting therapy.
Adults (18 years and older)
For most conditions, 400-800 milligrams of combined bismuth nitrate and bismuth aluminate, 200 milligrams of bismuth subgallate, 240 milligrams bismuth subcitrate, and 300-700 milligrams of bismuth subnitrate have been given by mouth.
For gastritis, 400-800 milligrams of combined bismuth nitrate and bismuth aluminate has been given by mouth for four weeks.
For gastrointestinal conditions, 200 milligrams of bismuth subgallate has been given by mouth twice daily for one week.
For Helicobacter pylori infections, 240 milligrams of bismuth subcitrate has been given by mouth twice daily for 10 days as a combination therapy. Also, 400-800 milligrams of combined bismuth nitrate and bismuth aluminate has been given by mouth for four weeks. For other infections, colloidal bismuth subcitrate (one tablet four times daily) and bismuth subnitrate (two tablets three times daily) have been given by mouth for four weeks in combination with antibiotics.
For peptic ulcers, 700 milligrams of bismuth subnitrate has been given by mouth three times daily for four weeks. For duodenal ulcers, 300 milligrams of micronized bismuth subnitrate has been given by mouth six times daily for one month.
For pouchitis, bismuth carbomer has been given as an enema for 45 days. Bismuth carbomer (containing 270 milligrams of bismuth) has been given as foam enemas for three weeks.
For wounds on the roof of the mouth, bismuth subgallate paste has been applied to the skin.
For tonsillitis, 30 milligrams of bismuth subgallate has been applied to the skin as a combination therapy. An unknown dose of bismuth added to 20 milliliters of saline has been applied to the skin on swabs.
For kidney disorders (renal cysts), 0.1-0.6 grams of bismuth phosphate has been injected through the skin.
Children (under 18 years old)
For Helicobacter pylori infections, bismuth citrate has been used as a combination therapy.
The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects.
Avoid in people with a known allergy or sensitivity to products that contain bismuth.
Side Effects and Warnings
Bismuth products may cause abdominal cramping, abnormal sensations in facial skin, abnormal spots on chest radiographs, alopecia (hair loss), anxiety, aplastic anemia (low blood cell count), bad taste in the mouth, blackening of the tongue, bleeding around the kidney, body pains, brain dysfunction, confusion, constipation, dark stools, depression, diarrhea, difficulty speaking, dry mouth, effects on glutathione, fever, glandular atrophy (wasting away of the glands), hallucinations, headache, intestinal metaplasia (change in the type of cells in the intestines), kidney disorders, kidney failure, liver toxicity, long-term gastritis (inflammation of the stomach lining), lymphoid particle formation, muscle spasms, nausea, pain, pruritus (itchy skin), tinnitus ("ringing" in the ears), trembling, and vomiting.
Bismuth may lower blood sugar levels. Caution is advised in people with diabetes or hypoglycemia, and in those taking drugs, herbs or supplements that affect blood sugar. Blood glucose levels may need to be monitored by a qualified healthcare professional, including a pharmacist, and medication adjustment may be necessary.
Bismuth may increase the risk of bleeding. Caution is advised in people with bleeding disorders or taking drugs that may increase the risk of bleeding. Dosing adjustments may be necessary.
Use bismuth cautiously in individuals with abnormal bowel movements, G6PD deficiency, gastritis, or kidney disorders.
Use bismuth cautiously in individuals taking agents that bind to opiate receptors, antidiarrheal agents, certain classes of antibiotics, phenytoin, probenecid, salicylates, and sulfinpyrazone.
Avoid using bismuth in individuals with blood disorders, gastrointestinal bleeding, hearing problems, peptic ulcer disease, sensitivity to salicylate, or tinnitus ("ringing" in the ears).
Pregnancy and Breastfeeding
There is currently a lack of scientific evidence on the use of bismuth during pregnancy or breastfeeding.
Avoid using bismuth subsalicylate during breastfeeding, as it may be absorbed by the infant through breast milk.
Most herbs and supplements have not been thoroughly tested for interactions with other herbs, supplements, drugs, or foods. The interactions listed below are based on reports in scientific publications, laboratory experiments, or traditional use. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy.
Interactions with Drugs
In general, most drug interactions resulting from bismuth-containing products are caused by other ingredients in the products.
Bismuth-containing products may lower blood sugar levels. Caution is advised when using medications that may also lower blood sugar. People taking drugs for diabetes by mouth or insulin should be monitored closely by a qualified healthcare professional, including a pharmacist. Medication adjustments may be necessary.
Bismuth-containing products may increase the risk of bleeding when taken with drugs that increase the risk of bleeding. Some examples include aspirin, anticoagulants (blood thinners) such as warfarin (Coumadin®) or heparin, antiplatelet drugs such as clopidogrel (Plavix®), and nonsteroidal anti-inflammatory drugs such as ibuprofen (Motrin®, Advil®) or naproxen (Naprosyn®, Aleve®).
Bismuth-containing products may interact with agents that bind to opiate receptors, antacids, cisplatin, metronidazole, omeprazole, phenytoin, probenecid, quinolone antibiotics, salicylates, sulfinpyrazone, and tetracycline antibiotics.
Interactions with Herbs and Dietary Supplements
In general, most interactions with herbs and dietary supplements resulting from use of bismuth-containing products are caused by other ingredients in the products.
Bismuth-containing products may lower blood sugar levels. Caution is advised when using herbs or supplements that may also lower blood sugar. Blood glucose levels may require monitoring, and doses may need adjustment.
Bismuth-containing products may increase the risk of bleeding when taken with herbs and supplements that are believed to increase the risk of bleeding. Multiple cases of bleeding have been reported with the use of Ginkgo biloba, and fewer cases with garlic and saw palmetto. Numerous other agents may theoretically increase the risk of bleeding, although this has not been proven in most cases.
Bismuth-containing products may also interact with antibacterial herbs and supplements, anticancer herbs and supplements, antioxidants, salicylates, sarsaparilla, and vitamin C.
This information is based on a systematic review of scientific literature edited and peer-reviewed by contributors to the Natural Standard Research Collaboration (www.naturalstandard.com).
Natural Standard developed the above evidence-based information based on a thorough systematic review of the available scientific articles. For comprehensive information about alternative and complementary therapies on the professional level, go to www.naturalstandard.com. Selected references are listed below.
Cengiz N, Uslu Y, Gok F, Anarat A. Acute renal failure after overdose of colloidal bismuth subcitrate. Pediatr Nephrol 2005;20(9):1355-1358. View Abstract
DuPont HL, Ericsson CD, Johnson PC, Bitsura JA, DuPont, MW, de la Cabada FJ. Prevention of travelers' diarrhea by the tablet formulation of bismuth subsalicylate. JAMA 3-13-1987;257(10):1347-1350. View Abstract
Gionchetti P, Rizzello F, Venturi A, et al. Long-term efficacy of bismuth carbomer enemas in patients with treatment-resistant chronic pouchitis. Aliment.Pharmacol Ther 1997;11(4):673-678. View Abstract
Holmberg G. Diagnostic aspects, functional significance and therapy of simple renal cysts: a clinical, radiologic and experimental study. Scand J Urol.Nephrol.Suppl 1992;145:1-48. View Abstract
Mishkin S. Intriguing gastrointestinal properties of bismuth: a folk remedy brought into the realm of clinical and investigative medicine. Can J Gastroenterol. 1998;12(8):569-570. View Abstract
Noach LA, Eekhof JL, Bour LJ, Posthumus Meyjes FE, Tytgat GN, and Ongerboer de Visser BW. Bismuth salts and neurotoxicity. A randomised, single-blind and controlled study. Hum.Exp Toxicol 1995;14(4):349-355. View Abstract
Pugh S, Lewin MR. Mechanism of action of Roter (bismuth subnitrate) in patients with duodenal ulcer disease and healthy volunteers. J Gastroenterol Hepatol 1990;5(4):382-386. View Abstract
Slikkerveer, A. and de Wolff, F. A. Bismuth poisoning and chelation. J Toxicol.Clin Toxicol. 1993;31(2):365-366. View Abstract
Sorensen WT, Henrichsen J, Bonding P. Does bismuth subgallate have haemostatic effects in tonsillectomy? Clin Otolaryngol.Allied Sci 1999;24(1):72-74. View Abstract
Sparberg M. Correspondence: Bismuth subgallate as an effective means for the control of ileostomy odor: a double blind study. Gastroenterology 1974;66(3):476. View Abstract
Topfmeier P, Eberhardt R, Mateblowski M, Kuhn D. Ulcer relapse rates following initial treatment with bismuth subnitrate as compared with cimetidine respectively. Int J Clin Pharmacol Ther Toxicol 1991;29(11):437-440. View Abstract
Tremaine WJ, Sandborn WJ, Wolff BG, Carpenter HA, Zinsmeister AR, Metzger PP. Bismuth carbomer foam enemas for active chronic pouchitis: a randomized, double-blind, placebo-controlled trial. Aliment.Pharmacol Ther 1997;11(6):1041-1046. View Abstract
Wagstaff AJ, Benfield P, Monk JP. Colloidal bismuth subcitrate. A review of its pharmacodynamic and pharmacokinetic properties, and its therapeutic use in peptic ulcer disease. Drugs 1988;36(2):132-157. View Abstract
Whitehead MW, Phillips RH, Sieniawska CE, et al. Double-blind comparison of absorbable colloidal bismuth subcitrate and nonabsorbable bismuth subnitrate in the eradication of Helicobacter pylori and the relief of nonulcer dyspepsia. Helicobacter. 2000;5(3):169-175. View Abstract
Xia HH, Yu Wong BC, Talley NJ, Lam SK. Alternative and rescue treatment regimens for Helicobacter pylori eradication. Expert.Opin.Pharmacother. 2002;3(9):1301-1311. View Abstract
Copyright © 2013 Natural Standard (www.naturalstandard.com)
The information in this monograph is intended for informational purposes only, and is meant to help users better understand health concerns. Information is based on review of scientific research data, historical practice patterns, and clinical experience. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions.
March 22, 2017