Chitosan 95% Deacetylated by Herb Xtra

POSSIBLY EFFECTIVE

• Hypertension. Substituting table salt with a chitosan-containing table salt may reduce blood pressure in patients with hypertension. Details: Small clinical studies in patients with prehypertension or moderate hypertension show that taking a specific product (Symbiosal) containing chitosan 3% in table salt for 8 weeks decreases systolic blood pressure compared with table salt alone when used as part of a diet containing a maximum of 3 grams sodium chloride daily (97708,97715). In adults with hypertension, this product increased the number of patients with controlled blood pressure by an additional 39% when compared with table salt alone (97715). In adults with prehypertension, this product increased the number of patients with systolic blood pressure less than 130 mmHg by an additional 67% when compared with table salt alone (97708).
• Obesity. Oral chitosan may lead to slight improvements in body weight when combined with a calorie-restricted diet in patients who are overweight or obese; however, it is unclear if this weight loss is clinically significant. Details: Meta-analyses of clinical research in overweight or obese patients show that taking chitosan 1-3 grams daily for up to one year may slightly-to-modestly reduce body weight when compared with placebo; however, the average weight loss in trials lasting up to one year is only 1 kg more than placebo according to the most recent meta-analysis (41729,92781,100170). These analyses also show that taking chitosan can slightly improve systolic and diastolic blood pressure, as well as low-density lipoprotein (LDL) cholesterol and triglyceride levels, in obese or overweight patients (92781,100170). Chitosan may only be beneficial for weight loss when combined with a calorie-restricted diet. Some of the small clinical studies included in the analyses above show that combining chitosan with a calorie-restricted diet can result in modest weight loss (9610,10022,10023,10024,10025), while taking chitosan without calorie reduction does not seem to cause clinically significant weight loss (3243,3244,9986,14314,41724). It also does not seem to significantly increase fecal fat excretion, which is the suggested mechanism of action for reducing weight (9987,10020,11045,14314).
• Postoperative recovery. Application of chitosan gel dressings after endoscopic sinus surgery may improve recovery by lowering the risk of nasal adhesions. Details: A meta-analysis of three small clinical studies shows that use of chitosan gel dressing following endoscopic sinus surgery reduces the risk of nasal adhesions by 75% when compared with saline or no dressing. The chitosan dressings did not influence swelling, crusting, or infections (97713,97714).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Crohn disease. Oral chitosan has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small, uncontrolled clinical study in adults with Crohn disease shows that taking a combination of chitosan 1.05 grams and ascorbic acid daily for 8 weeks increases fecal excretion of fat, but does not improve disease activity, when compared to baseline (9609). The validity of these findings is limited by a lack of control group.
• Dental caries. While small studies suggest that use of chitosan-containing gum or mouthwash can decrease levels of cavity-causing bacteria, it is unclear if these products reduce the risk of developing dental caries. Details: One small clinical study in healthy adults shows that chewing gum supplemented with chitosan decreases the number of cariogenic bacteria in the mouth when compared with non-supplemented gum (15126). Additionally, a small crossover trial shows that rinsing with chitosan 0.5% mouthwash twice daily for 14 days can also decrease the number of cariogenic bacteria in the mouth when compared with placebo (41697). However, there is no reliable evidence that chitosan gum or mouthwash reduces the risk of developing cavities.
• Dental plaque. Small clinical studies suggest that rinsing with chitosan mouthwash may reduce plaque formation. Details: One small crossover trial shows that rinsing with chitosan 0.5% mouthwash twice daily for 14 days significantly reduces plaque formation when compared with placebo (41697). Another small clinical study in patients with dental plaque and gingivitis shows that rinsing with 10 mL of chitosan 0.5% mouthwash twice daily for 3 months reduces plaque formation when compared to baseline, with similar improvements when compared with chlorhexidine 0.2% mouthwash. However, rinsing with a combination of chitosan and chlorhexidine significantly improves plaque formation when compared with either agent alone (106521).
• Diabetic foot ulcers. It is unclear if topical chitosan is beneficial in patients with diabetic foot ulcers. Details: A small clinical study in adults with diabetic foot ulcers shows that applying a thin smear of chitosan 10% gel to the ulcer is no more effective than placebo gel for ulcer healing. Also, when chitosan 10% gel is used in combination with topical isosorbide dinitrate two sprays daily, it is no more effective than the isosorbide dinitrate spray alone (100171). It is not clear if this study was adequately powered to detect a difference between groups.
• Dry eye. It is unclear if chitosan-containing eye drops are beneficial in patients with dry eye. Details: A small clinical study in patients with dry eye shows that applying a specific eye drop (Lacrimera) containing chitosan-N-acetylcysteine 0.1% once or twice daily to the eyes for 5 days improves general symptoms of dry eye by approximately 60% when compared to baseline (97710). The validity of these findings is limited by a lack of placebo control group.
• Gingivitis. It is unclear if rinsing with chitosan mouthwash is beneficial in patients with gingivitis. Details: A small clinical study in patients with gingivitis and dental plaque shows that rinsing with 10 mL of chitosan 0.5% mouthwash twice daily for 3 months reduces gingivitis scores when compared to baseline, with similar improvements when compared with chlorhexidine 0.2% mouthwash. However, rinsing with a combination of chitosan and chlorhexidine significantly improves gingivitis scores when compared with either agent alone (106521).
• Hypercholesterolemia. Despite conflicting study results in patients with hypercholesterolemia, a meta-analysis of small clinical studies suggests that oral chitosan may slightly improve lipid levels when taken for at least 4 weeks in overweight or obese patients with or without hypercholesterolemia. Details: A meta-analysis of seven small clinical studies of obese or overweight patients with or without hypercholesterolemia shows that taking chitosan 1-4.5 grams daily for 4 weeks or longer can reduce both total cholesterol and low-density lipoprotein (LDL) cholesterol by around 6 mg/dL, increase high-density lipoprotein (HDL) cholesterol by around 1 mg/dL, and reduce triglyceride levels by around 11 mg/dL when compared with placebo (92781). However, individual studies in patients with mild hypercholesterolemia show conflicting results. Some small clinical studies show that taking chitosan 1-3 grams daily for 1-3 months does not decrease total cholesterol or LDL cholesterol (3243,9986,11044), while other studies show that taking chitosan 1.2-1.35 grams daily for 8 weeks modestly reduces total cholesterol by 4% to 10% and LDL cholesterol by about 7% when compared with placebo (11307,41693). Several clinical studies also suggest that chitosan-containing combination products seem to reduce cholesterol levels in obese patients or those with hypercholesterolemia. Combinations studied include chitosan 1.2 grams with glucomannan 1.2 grams daily for 1 month (11046); a fiber supplement containing chitosan, guar meal, ascorbic acid, and other micronutrients (10025); chitosan 240 mg, garcinia 55 mg, and chromium 19 mg once or twice daily for 4 weeks (41720); and a specific product (Tegradoc) containing chitosan 10 mg, berberine 200 mg, red yeast extract providing monacolin K 3 mg, and coenzyme Q10 10 mg daily for 12 weeks (97709). It is unclear if the positive findings associated with these combination products are due to chitosan, other ingredients, or the combination.
• Hyperphosphatemia. It is unclear if chewing chitosan-loaded gum is beneficial in patients with hyperphosphatemia who are undergoing hemodialysis. Details: One very small clinical study in patients undergoing hemodialysis with hyperphosphatemia inadequately controlled with sevelamer shows that chewing 20 mg of chitosan-loaded gum twice daily for 2 weeks reduces serum phosphorous levels by 31% when compared to baseline (92784). The validity of this finding is limited by a lack of control group. Conversely, a slightly larger, placebo-controlled clinical study in patients on hemodialysis with phosphorous levels inadequately controlled on phosphate binders shows that chewing 40 mg of chitosan-loaded gum for 30 minutes three times daily for 3 weeks does not significantly reduce serum phosphorous levels when compared with placebo (92779).
• Iron deficiency anemia. Although there has been interest in using oral chitosan for iron deficiency anemia, there is insufficient reliable information about the clinical effects of chitosan for this purpose.
• Kidney failure. It is unclear if oral chitosan is beneficial in patients with kidney failure who are receiving hemodialysis. Details: One small clinical study in patients with kidney failure receiving chronic hemodialysis shows that taking chitosan 450 mg three times daily for 12 weeks reduces elevated cholesterol levels, improves anemia, and enhances physical strength, appetite, and sleep when compared with no treatment (1942).
• Minor bleeding. Small clinical studies suggest that application of chitosan gel dressings after endoscopic sinus surgery may reduce the risk of minor post-surgical bleeding, while application of chitosan-containing gauze to skin grafts does not appear to reduce bleeding risk. Details: A meta-analysis of two small clinical studies shows that use of chitosan gel dressing following endoscopic sinus surgery increases hemostasis by 70% when compared with saline or no dressing (97714). Over 60% of patients using chitosan gel achieved hemostasis within 2 minutes compared with 17.5% of patients not using chitosan gel (97713). However, one small study in patients with skin grafts shows that using chitosan gauze (AnsCare ChitoClot Gauze, BenQ Materials Corporation) with paraffin dressing for 2 weeks does not reduce the amount of blood loss when compared with paraffin dressing alone (97711). These conflicting results might be related to the form of chitosan used or the type of surgical wound to which it is applied.
• Muscle strength. Although there has been interest in using oral chitosan for increasing muscle strength, there is insufficient reliable information about the clinical effects of chitosan for this purpose.
• Periodontitis. It is unclear if topical chitosan is beneficial in patients undergoing surgery for periodontitis. Details: A very small clinical study in patients with periodontitis undergoing dental surgery shows that applying chitosan ascorbate to the gums improves tooth mobility and pocket depths when compared to baseline (1945). The validity of these findings is limited by a lack of control group.
• Wound healing. Several small clinical studies suggest that application of chitosan-containing dressings to skin grafts improves wound healing, scar formation, and nerve regeneration. Details: One small clinical study shows that applying a chitosan mesh dressing increases healing and regeneration of the skin in the first ten days after skin graft placement and reduces itching by about 50% when compared with paraffin dressing (97707). Another small clinical study in patients receiving skin grafts after surgery, burn wounds, or skin malignancy excision shows that application of a chitosan-containing dressing to the skin graft improves wound re-epithelialization and nerve regeneration, but does not improve the rate of healing, when compared with a conventional dressing (41692). Another small clinical study in patients undergoing plastic surgery shows that applying N-carboxybutyl chitosan topically seems to promote donor site tissue regeneration and reduce scar formation when compared with control donor sites (1944). A small clinical study in adults undergoing extraction of an impacted mandibular third molar shows that applying a topical gel (Bexident Post, ISDIN) containing chitosan, allantoin, dexpanthenol, and chlorhexidine as 10 mL three times daily for ten days increases the rate of good wound healing by an additional 52% and 36% after 7 and 14 days, respectively, when compared with no gel. However, this chitosan-containing gel does not appear to reduce postoperative pain or swelling (97712). It is unclear if these findings are due to chitosan, other ingredients, or the combination. More evidence is needed to rate chitosan for these uses.

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POSSIBLY INEFFECTIVE

• Diarrhea. Oral gelatin tannate does not seem to be beneficial for diarrhea treatment in infants and young children. Details: A pooled analysis of three clinical trials shows that taking gelatin tannate 250-500 mg four times daily for 5 days does not reduce the duration of diarrhea or stool frequency in infants and young children with acute diarrhea and gastroenteritis when compared with placebo (103296).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging skin. Although there has been interest in using oral gelatin for aging skin, there is insufficient reliable information about the clinical effects of gelatin for this purpose.
• Beta-thalassemia. It is unclear if oral gelatin is beneficial for beta-thalassemia. Details: Preliminary clinical research in pregnant adults with minor or intermediate beta-thalassemia and mild iron-deficiency anemia shows that taking a specific form of gelatin made from donkey hide, colla corii asini, 15 grams daily for 4 weeks, increases hemoglobin by 11%, compared with a 5% reduction in those receiving no treatment (97634).
• Brittle nails. Although there has been interest in using oral gelatin for brittle nails, there is insufficient reliable information about the clinical effects of gelatin for this purpose.
• Exercise-induced muscle soreness. Although there has been interest in using oral gelatin for exercise-induced muscle soreness and damage, there is insufficient reliable information about the clinical effects of gelatin for this purpose.
• Joint pain. Although there has been interest in using oral gelatin for general joint pain, there is insufficient reliable information about the clinical effects of gelatin for this purpose.
• Obesity. Although there has been interest in using oral gelatin for weight loss, there is insufficient reliable information about the clinical effects of gelatin for this purpose.
• Osteoarthritis. Although there has been interest in using oral gelatin for osteoarthritis, there is insufficient reliable information about the clinical effects of gelatin for this purpose.
• Osteoporosis. Although there has been interest in using oral gelatin for osteoporosis, there is insufficient reliable information about the clinical effects of gelatin for this purpose.
• Rheumatoid arthritis (RA). Although there has been interest in using oral gelatin for RA, there is insufficient reliable information about the clinical effects of gelatin for this purpose.
• Ulcerative colitis. Rectal gelatin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults admitted to the hospital in China with mild to moderate ulcerative colitis lesions shows that administering a 1-gram suppository containing a specific form of gelatin made from donkey hide, colla corii asini, and multiple other ingredients rectally for 3 months improves diarrhea and bloody stool symptom scores when compared with an 0.8-gram suppository containing the same ingredients. Recurrence at 12 months occurred in approximately 10% of the patients who received the higher-dose combination product compared with 47% of patients who received the lower dose. Patients in each group received 2 suppositories twice daily for the first month, 1 suppository twice daily for the second month, and 1 suppository once daily for the third month (109673). The interpretation of these results is limited by the lack of comparison to placebo or active control with known effectiveness for ulcerative colitis.
• Uterine fibroids. Oral gelatin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Meta-analyses of a small number of preliminary clinical trials show that taking traditional Chinese medicines containing multiple ingredients including ejiao, a gelatin made from donkey hide, modestly reduces the volume of uterine fibroids and fibroid-related symptoms more effectively than mifepristone. When used in combination with mifepristone, benefits exceed those of mifepristone alone (106850). It is unclear whether any benefits are related to gelatin, one or more of the other ingredients, or their combination.
• Wrinkled skin. Although there has been interest in using oral gelatin for wrinkled skin, there is insufficient reliable information about the clinical effects of gelatin for this purpose. More evidence is needed to rate gelatin for these uses.

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POSSIBLY SAFE. ..when used orally, short-term. Chitosan has been used with apparent safety in clinical studies at a dose of up to 1.35 grams daily for up to 3 months (1942,9609,9610,10022,10023,10024,10025,11307,13171,14314)(15126,92781,97708). ...when used topically, short-term (1944,1945,4269,4270,97712,106521).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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LIKELY SAFE ...when used orally in amounts commonly found in foods. Gelatin has Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts, short-term . A specific type of gelatin from donkey hide, called colla corii asini, has been safely used in doses of 6-10 grams orally daily for 6-8 weeks. Higher doses of 15 grams daily have been associated with an increased risk of inflammatory adverse effects, including sore throat, swollen gums, local eczema, and oral ulcers (97634,107011). Since gelatin is often derived from bovine bones and skin, there is some concern about contamination with diseased animal parts (1825). So far, there are no reports of disease transmission to humans due to use of contaminated gelatin preparations.

CHILDREN: POSSIBLY SAFE
when gelatin tannate is used orally and appropriately in medicinal amounts, short-term. In children under 15 kg or under 3 years of age, gelatin tannate has been used with apparent safety at doses up to 250 mg four times daily for up to 5 days. In children over 15 kg or over 3 years of age, it has been used with apparent safety at doses up to 500 mg four times daily for up to 5 days (103296). There is insufficient reliable information available about the safety of other forms of gelatin in children.

PREGNANCY: LIKELY SAFE
when used orally in the amounts commonly found in foods.

PREGNANCY: POSSIBLY SAFE
when a specific type of gelatin from donkey hide, called colla corii asini, is used orally in doses of 10 grams daily for 6 weeks. Higher doses of 15 grams daily have been associated with an increased risk of inflammatory adverse effects, including sore throat, swollen gums, local eczema, and ulcers in the oral cavity (97634). There is insufficient reliable information available about the safety of other types of gelatin when used during pregnancy in medicinal amounts.

LACTATION: LIKELY SAFE
when used orally in the amounts commonly found in foods. There is insufficient reliable information available about the safety of using larger amounts of gelatin during lactation; avoid using.

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ACYCLOVIR (Zovirax) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Chitosan can reduce the absorption of acyclovir, potentially increasing the risk for treatment failure.  Details Clinical research in humans shows that taking chitosan along with acyclovir 200 mg reduces acyclovir absorption. Concomitant administration of chitosan 400 mg or 1000 mg reduced the acyclovir area under the curve (AUC) and peak plasma concentration by about 30% and 40%, respectively, compared with control. Concomitant administration with chitosan 1000 mg also increased time to peak concentration from 1 hour to 2 hours (92780). In vitro research suggests that the mechanism for reduced absorption is due to acyclovir entrapment in chitosan-mucus complexes, which reduces intestinal absorption (112352).

WARFARIN (Coumadin) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, chitosan might increase the risk of bleeding when taken with warfarin.  Details In a case report, a patient taking warfarin had a significantly increased international normalized ratio (INR) after starting chitosan 1200 mg daily. The INR normalized after chitosan was discontinued and vitamin K was administered. The patient once again started taking chitosan and again had a significant increase in INR. The INR stabilized again once chitosan was discontinued (15909). Researchers theorize that this interaction might occur because chitosan decreases absorption of fat-soluble vitamins, including vitamin K, which could increase the anticoagulant effect of warfarin.

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General ...Orally and topically, chitosan seems to be well tolerated, short-term.
Most Common Adverse Effects:
Orally: Constipation, diarrhea, flatulence, epigastric discomfort, and nausea.

Dermatologic ...In one clinical trial, a subject with kidney failure reported itching during 12 weeks of oral chitosan treatment (1942). It is not clear if this was related to the underlying renal failure or the use of oral chitosan.

Gastrointestinal ...Orally, chitosan has been reported to cause epigastric discomfort, constipation, flatulence, diarrhea, nausea, and dryness of the throat (1942,3243,9986,11307,14314,41688,92781,100170). Excessive discharge of fat in the feces, also known as steatorrhea, has been reported with chitosan therapy (41724,41726). Theoretically, chitosan may alter the normal intestinal flora via antimicrobial activity, which could interfere with lipid digestibility and bile acid metabolism, leading to the growth of resistant pathogens (41687,41709,41725).

Musculoskeletal ...Orally, chitosan has been reported to cause swollen heels and wrists in two patients (41688).

Neurologic/CNS ...Headaches have been reported in patients taking oral chitosan (41688).

Ocular/Otic ...Topically, an eye drop containing chitosan-N-acetylcysteine has been reported to cause itching and irritation of the eyes (97710).

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General ...Orally, gelatin seems to be well tolerated.
Most Common Adverse Effects:
Oral: Belching, bloating, and dyspepsia.
Serious Adverse Effects (Rare):
Injection: IgE-mediated allergic reactions, Kounis syndrome.

Gastrointestinal ...Orally, gelatin can cause unpleasant taste, sensation of heaviness in the stomach, bloating, dyspepsia, and belching (7704).

Immunologic ...Gelatin can cause allergic reactions. Gelatin in foods can cause initial sensitization (7703). Gelatin-containing medicines including oral medications, suppositories, vaccines, and injectable products can cause IgE-mediated allergic reactions, including urticaria, angioedema, wheezing, hypotension, and anaphylaxis (7708,7709,7710,97633,111345). In the US, gelatin is used as a stabilizer in some vaccines such as measles, mumps, and rubella (MMR), and diphtheria, pertussis, tetanus (DPT) (7711). In one case report, a 73-year-old male experienced anaphylactic symptoms within 10 minutes of receiving gelatin lysate as a plasma expander during a routine surgery. The patient proceeded to develop heart, respiratory, and kidney failure and died 76 days after receiving the gelatin infusion (97633). At least 12 case reports describe life-threatening anaphylaxis after administration of gelatin-containing hemostatic agents during surgery. In these cases, hypotension, tachycardia, and increased airway pressure occurred shortly after injection of the agent into the pedicle tract (111345).
There are at least two cases of Kounis syndrome, an acute coronary syndrome related to a massive mast cell activation, after the use of a gelatin infusion during general anesthesia. In one case, immediate symptoms included bradycardia and hypotension, followed by myocardial ischemia and coronary vasospasm (97631).

Other ...Since gelatin is sometimes produced from bovine bones and skin, there is some concern about the potential risk of contamination with diseased animals and transmission of bovine spongiform encephalopathy (BSE, mad cow disease) and other diseases (1825). So far, there are no reports of BSE or other disease transmission to humans from gelatin products.

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