Formula 6 GI Relief [Discontinued] by NESS Nutritional Enzyme Support System

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Celiac disease. Although there has been interest in using oral lipase for celiac disease, there is insufficient reliable information about the clinical effects of lipase for this purpose.
• Dyspepsia. It is unclear if oral lipase is beneficial for improving symptoms of postprandial distress syndrome. Details: A small clinical trial shows that taking a specific acid-resistant lipase (Amano Enzyme USA) 280 mg immediately before a high-fat meal does not reduce postprandial bloating and nausea when compared with placebo in individuals with postprandial distress syndrome (101900).
• Inflammatory bowel disease (IBD). Although there has been interest in using oral lipase for IBD, there is insufficient reliable information about the clinical effects of lipase for this purpose.
• Prematurity. It is unclear if adding a specific form of lipase, recombinant human bile salt-stimulated lipase (rhBSSL), to infant formula improves outcomes in premature infants. Some research suggests a potential increased risk for adverse effects. Details: Human breast milk contains rhBSSL, but it is inactivated when breast milk is pasteurized for donation. Clinical research in infants born before 32 weeks' gestation shows that adding rhBSSL as 8700 units per 100 mL formula or pasteurized breast milk, for 4 weeks does not increase growth velocity, body length, or head circumference over the next 12 months when compared with formula or pasteurized breast milk devoid of lipase. However, the infants who were small for gestational age (SGA), which made up approximately 15% of the study population, grew by an additional 1.9 grams/kg daily on average when compared with placebo (101940). More evidence is needed to rate lipase for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• ACE inhibitor-induced cough. It is unclear if oral marshmallow root is beneficial in patients with cough due to ACE inhibitors. Details: A small clinical study in patients with ACE inhibitor-induced cough shows that taking marshmallow root 40 mg (20 drops) three times daily for 4 weeks improves cough when compared to baseline (62027). The validity of this finding is limited by the lack of a control group.
• Atopic dermatitis (eczema). It is unclear if topical marshmallow is beneficial in children with eczema. Details: A very small clinical study in children ages 3 months to 12 years with a recent diagnosis of mild to moderate eczema shows that applying a marshmallow 1% ointment twice daily for 1 week and then three times weekly for 3 weeks seems to reduce symptoms, as measured on the SCORing Atopic Dermatitis (SCORAD) scale, when compared with applying hydrocortisone 1% ointment (105437). This finding is limited by the large number of drop-outs due to non-compliance, most of which were in the marshmallow group.
• Breast engorgement. It is unclear if topical marshmallow is beneficial in women with this condition. Details: A small clinical study in breastfeeding women with breast engorgement shows that applying a compress containing 40-50 mL of a solution made from marshmallow leaves and stems 3 times daily for 2 days in conjunction with standard treatment improves patient-reported breast engorgement scores when compared with standard treatment alone. Standard treatment consisted of massage and alternating warm and cold compresses before and after breastfeeding (92845).
• Constipation. Although there is interest in using oral marshmallow for constipation, there is insufficient reliable information about the clinical effects of marshmallow for this condition.
• Cough. Although there is interest in using oral marshmallow for cough, there is insufficient reliable information about the clinical effects of marshmallow for this condition.
• Diarrhea. Although there is interest in using oral marshmallow for diarrhea, there is insufficient reliable information about the clinical effects of marshmallow for this condition.
• Fever. It is unclear if topical marshmallow is beneficial for pediatric fever. Details: A moderate-sized clinical study in children aged 6 months-10 years with fever receiving rectal acetaminophen shows that applying marshmallow extract body wash and lukewarm water reduces the time to defervescence by 8 minutes when compared with lukewarm water alone, but does not improve the change in body temperature, number of acetaminophen doses given, or incidence of fever recurrence (112375). However, the interpretation of these findings is limited to patients without fevers greater than 40 degrees Celsius or history of febrile seizures since these patients were not studied.
• Leishmania lesions. Topical marshmallow has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research suggests that the topical application of an herbal extract containing a combination of marshmallow and Althaea rosa to affected areas for 5 days can help promote curing of Leishmania lesions (62020).
• Respiratory tract infections. Although there is interest in using oral marshmallow for respiratory tract infections, there is insufficient reliable information about the clinical effects of marshmallow for this condition.
• Vaginal candidiasis. It is unclear if vaginal marshmallow is beneficial for vulvovaginal candidiasis. Details: A small clinical study in adults with vulvovaginal candidiasis shows that applying a vaginal cream comprised of marshmallow extract 4% and clotrimazole 1% daily for 7 days improves itching, dyspareunia, and dysuria at 7 days when compared with clotrimazole 1% alone. At 30 days, the marshmallow intervention also results in fewer positive yeast cultures and sustained reduction in itching (112371). However, the validity of these results is limited by significant differences between groups at baseline for dyspareunia and dysuria, and lack of adjustment for multiple comparisons which can increase false positive findings. Additionally, all primary outcomes were patient-reported.
• Venous leg ulcers. Although there is interest in using topical marshmallow for venous leg ulcers, there is insufficient reliable information about the clinical effects of marshmallow for this condition.
• Wounds. Although there is interest in using topical marshmallow for wounds, there is insufficient reliable information about the clinical effects of marshmallow for this condition. More evidence is needed to rate marshmallow for these uses.

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Proteolytic enzymes represent a wide group of enzymes that are used alone or in combination. See specific monographs for effectiveness information.

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POSSIBLY EFFECTIVE

• Osteoarthritis. When used alone or in combination with other ingredients, oral rose hip seems to reduce pain and improve function in patients with osteoarthritis. Details: Orally, rose hip seems to have beneficial effects when used to treat osteoarthritis. Most clinical research shows that taking a specific Rosa canina rose hip powder product (LitoZin/i-flex, Hyben Vital), 2.5 grams orally twice daily for 3-4 months, reduces pain and stiffness, improves function and mobility, and decreases use of rescue medication when compared with placebo (71646,71658,71660,71661). Clinical research in adults with knee osteoarthritis shows that taking a specific combination product containing Rosa canina rose hip fruit puree 24 grams, stinging nettle leaf 160 mg, devil's claw 108 mg, and vitamin D 200 IU (Rosaxan, Medagil Gesundheitsgesellschaft) daily for 12 weeks reduces pain by 66% and improves quality of life, but does not reduce analgesic use, when compared with a control group (97937). However, one crossover study shows mixed results. Rose hip was shown to be effective for osteoarthritis only when administered after, but not before, placebo treatment (71641). This inconsistency might be due to a carryover effect of rose hip or delayed activity of the supplement.
• Postoperative pain. When taken immediately prior to surgery, oral rose hip seems to reduce pain following a Cesarean section. Details: Clinical research shows that taking a single dose of Rosa damascena rose hip extract 1600 mg, 15 minutes prior to anesthesia for a Cesarean section, delays the need for postoperative analgesics and reduces their use over the next 24 hours when compared with placebo. Almost all patients taking placebo requested analgesics within 2 hours of surgery, compared with only 11% of those taking rose hip extract. In addition, this rose hip extract moderately reduced the level of pain over the 24-hour period (104556).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging skin. It is unclear if oral rose hip is beneficial for improving wrinkles. Details: Preliminary clinical research shows that taking Rosa canina rose hip powder (Hyben Vital) 1.5 grams twice daily for 8 weeks improves wrinkles, skin moisture, and elasticity when compared with baseline. However, it is unclear if these benefits are clinically significant (104557). Also, the validity of these findings is limited by the lack of a comparator group.
• Benign prostatic hyperplasia (BPH). Although there has been interest in using oral rose hip for BPH, there is insufficient reliable information about the clinical effects of rose hip for this condition.
• Cancer. Although there has been interest in using oral rose hip for cancer, there is insufficient reliable information about the clinical effects of rose hip for this condition.
• Common cold. Although there has been interest in using oral rose hip for the common cold, there is insufficient reliable information about the clinical effects of rose hip for this condition.
• Diabetes. Although there has been interest in using oral rose hip for diabetes, there is insufficient reliable information about the clinical effects of rose hip for this condition.
• Dysmenorrhea. It is unclear if oral rose hip is beneficial for reducing menstrual pain. Details: Preliminary clinical research shows that taking Rosa damascena rose hip extract 200 mg every 6 hours for 3 days is as effective as taking mefenamic acid 250 mg on the same dosing schedule for reducing pain associated with dysmenorrhea (104555).
• Gout. Although there has been interest in using oral rose hip for gout, there is insufficient reliable information about the clinical effects of rose hip for this condition.
• Hyperlipidemia. Although there has been interest in using oral rose hip for hyperlipidemia, there is insufficient reliable information about the clinical effects of rose hip for this condition.
• Hypertension. Although there has been interest in using oral rose hip for hypertension, there is insufficient reliable information about the clinical effects of rose hip for this condition.
• Influenza. Although there has been interest in using oral rose hip for influenza, there is insufficient reliable information about the clinical effects of rose hip for this condition.
• Obesity. It is unclear if oral rose hip is beneficial for obesity. Details: Preliminary clinical research shows that taking Rosa canina rose hip powder 40 grams daily mixed with apple juice for 6 weeks does not significantly affect weight or glucose tolerance when compared with placebo. However, it decreases total cholesterol by 5%, low-density lipoprotein (LDL) cholesterol by 6%, and systolic blood pressure by 4% when compared with placebo (18104).
• Rheumatoid arthritis (RA). It is unclear if oral rose hip is beneficial for RA. Details: Preliminary clinical research in adults with RA shows that taking a specific Rosa canina rose hip powder product (LitoZin/i-flex, Hyben Vital) 2.5 grams (5 capsules) twice daily over 6 months improves patient scores on a disability index, as well as other subjective physician- and patient-based assessments, when compared with placebo (17416).
• Sciatica. Although there has been interest in using oral rose hip for sciatica, there is insufficient reliable information about the clinical effects of rose hip for this condition.
• Sexual dysfunction. Oral rose hip has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in women with sexual dysfunction shows that taking a specific combination tablet (Lady Prelox, Horphag Research) containing a standardized extract of rose hip (Rosvita) 50 mg, maritime pine bark (Pycnogenol, Horphag Research) 20 mg, L-arginine 200 mg, and L-citrulline 200 mg orally daily for 8 weeks, in combination with a management program consisting of lifestyle, diet, exercise, and stress control changes, improves overall sexual function when compared with the management program alone (91963). Taking the same product in a dose of 2 tablets twice daily for 8 weeks, in addition to the lifestyle management program, improves vaginal dryness in pre- and post-menopausal women when compared with lifestyle management alone (103611). The effect of rose hip extract alone on sexual dysfunction is unclear.
• Stretch marks (striae gravidarum). Topical rose hip has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that applying a specific formulation containing hydroxyprolisilane C, rose hip oil, gotu kola triterpenes, and vitamin E (Velastisa Antiestrías, ISDIN) twice daily during pregnancy, beginning at week 10-14 and continuing throughout pregnancy, decreases the severity of both new and old stretch marks when compared with placebo. It also appears to decrease the incidence of stretch marks by about 84% in women without previous striae (92507).
• Urinary tract infections (UTIs). It is unclear if oral rose hip is beneficial for UTI prevention. Details: Preliminary clinical research in women who have undergone a Cesarean section shows that taking Rosa canina rose hip powder 500 mg twice daily, starting 2 days post-partum and continuing for 20 days, reduces the odds of asymptomatic, culture-positive UTIs by 68% when compared with placebo. However, rose hip does not appear to reduce the incidence of symptomatic UTIs in these patients (97938).
• Vitamin C deficiency. Although there has been interest in using oral rose hip for vitamin C deficiency, there is insufficient reliable information about the clinical effects of rose hip for this condition. More evidence is needed to rate rose hip for these uses.

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There is insufficient reliable information available about the safety of lipase.

CHILDREN: POSSIBLY UNSAFE
when recombinant human bile salt-stimulated lipase (rhBSSL) is used orally by premature infants. Adding rhBSSL to infant formula or pasteurized breast milk increases the risk for serious gastrointestinal adverse effects in premature infants (101940).

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

(Read more about LIPASE)

LIKELY SAFE ...when marshmallow root and leaf are used in amounts commonly found in foods. Marshmallow root has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).

POSSIBLY SAFE ...when marshmallow root and leaf are used orally in medicinal amounts (4,12). ...when used topically (4,62020). There is insufficient reliable information available about the safety of marshmallow flower.

PREGNANCY AND LACTATION:
Insufficient reliable information available.

(Read more about MARSHMALLOW)

POSSIBLY SAFE ...when used orally and appropriately. Various proteolytic enzymes have been safely used orally in clinical research (716,964,965,968,969,6252,6253,10622,11457,18281,18284) (91104,91105,91106,91111,96449). Side effects are typically mild to moderate and most often include gastrointestinal effects. See specific monographs for more detailed information related to the safety of individual proteolytic enzymes. ...when used topically and appropriately. Various proteolytic enzymes have been safely used topically in clinical research (67835,67843,67845,91113). Some proteolytic enzymes might cause allergic reactions when used topically. See specific monographs for more detailed information related to the safety of individual proteolytic enzymes.

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

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LIKELY SAFE ...when rose hip extract is used orally in the amounts found in foods. Rose hip extract has Generally Recognized as Safe (GRAS) status in the US (4912). ...when rose hip from Rosa canina is used orally and appropriately in medicinal amounts. A specific formulation of rose hip powder from Rosa canina (LitoZin/i-flex, Hyben Vital), taken in doses of up to 2.5 grams (5 capsules) twice daily, has been safely used for up to 6 months (17416,71641,71646,71658,71660,71661,104557). Rose hip powder from Rosa canina, 40 grams daily mixed in apple juice, has been used safely for up to 6 weeks (18104). Rose hip powder from Rosa canina, 500 mg twice daily for 20 days, has also been safely used (97938).

POSSIBLY SAFE ...when rose hip from Rosa damascena is used orally and appropriately in medicinal amounts. Rose hip extract from Rosa damascena has been used safely in doses of 200 mg every 6 hours for 3 days (104555). There is insufficient reliable information available about the safety of medicinal amounts of rose hip from other Rosa species. There is also insufficient reliable information available about the safety of rose hip when used topically.

PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of rose hip when used orally or topically in medicinal amounts; avoid using in amounts greater than those found in foods.

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, marshmallow flower might have antiplatelet effects.  Details Animal research suggests that marshmallow flower extract has antiplatelet effects (92846). However, the root and leaf of marshmallow, not the flower, are the plant parts most commonly found in dietary supplements. Theoretically, use of marshmallow flower with anticoagulant/antiplatelet drugs can have additive effects, and might increase the risk for bleeding in some patients.

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, due to potential diuretic effects, marshmallow might reduce excretion and increase levels of lithium.  Details Marshmallow is thought to have diuretic properties. To avoid lithium toxicity, the dose of lithium might need to be decreased when used with marshmallow.

ORAL DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, mucilage in marshmallow might impair absorption of oral drugs.  Details Marshmallow contains mucilage which can affect oral drug absorption (1,11,12,19). To avoid changes in absorption, take marshmallow 30-60 minutes after oral medications.

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ALKYLATING AGENTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, the antioxidant effects of rose hip might reduce the effectiveness of alkylating agents but might also reduce the oxidative damage caused by certain alkylating agents.  Details Rose hip contains vitamin C. The use of antioxidants like vitamin C during chemotherapy is controversial. There is concern that antioxidants could reduce the activity of chemotherapy drugs that generate free radicals, such as cyclophosphamide, chlorambucil, carmustine, busulfan, and thiotepa (391). In contrast, some researchers theorize that antioxidants might make chemotherapy more effective by reducing oxidative stress that could interfere with apoptosis (cell death) of cancer cells (14012,14013). Further, some animal research suggests that the antioxidant effects of rose hip might attenuate cyclophosphamide-induced testicular toxicity (111413). More evidence is needed to determine what effect, if any, antioxidants found in rose hip, such as vitamin C, have on the effectiveness and adverse effects of chemotherapy.

ALUMINUM Interaction Rating = Moderate Be cautious with this combination. Severity = Mild •  Occurrence = Probable •  Level of Evidence = D Theoretically, rose hip might increase the amount of aluminum absorbed from aluminum compounds.  Details Rose hip contains vitamin C. Theoretically, vitamin C increases the absorption of aluminum. Concomitant use might increase aluminum absorption, but the clinical significance of this is unknown (3046). Administer rose hip two hours before or four hours after antacids.

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, rose hip might reduce the effectiveness of anticoagulant or antiplatelet drugs.  Details In vitro and animal research suggests that a constituent of rose hip, rugosin E, can induce platelet aggregation (71653). This has not been shown in humans. Theoretically, concomitant use of rose hip might reduce the effectiveness of antiplatelet or anticoagulant drugs.

ANTITUMOR ANTIBIOTICS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, the antioxidant effects of rose hip might reduce the effectiveness of antitumor antibiotics.  Details Rose hip contains the antioxidant vitamin C. There is concern that antioxidants might reduce the activity of chemotherapy drugs that generate free radicals, such as antitumor antibiotics (391). In contrast, other researchers theorize that antioxidants might make antitumor antibiotic chemotherapy more effective by reducing oxidative stress that could interfere with apoptosis (cell death) of cancer cells (14012,14013). More evidence is needed to determine what effects, if any, antioxidants such as vitamin C have on antitumor antibiotic chemotherapy.

ASPIRIN Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Unlikely •  Level of Evidence = B Theoretically, rose hip might reduce the clearance of aspirin; however, its vitamin C content is likely too low to produce clinically significant effects.  Details Rose hip contains vitamin C. It has been suggested that acidification of the urine by vitamin C can decrease the urinary excretion of salicylates, increasing plasma salicylate levels (3046). However, short-term use of up to 6 grams daily of vitamin C does not seem to affect urinary pH or salicylate excretion (10588,10589). The vitamin C content of rose hip is typically about 500 mg per 100 grams. Thus, a clinically significant interaction between rose hip and aspirin is unlikely.

ESTROGENS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, rose hip might increase blood levels of estrogens.  Details Rose hip contains vitamin C. Increases in plasma estrogen levels of up to 55% have occured under some circumstances when vitamin C is taken concurrently with oral contraceptives or hormone replacement therapy, including topical products (129,130,11161). It is suggested that vitamin C prevents oxidation of estrogen in the tissues, regenerates oxidized estrogen, and reduces sulfate conjugation of estrogen in the gut wall (129,11161). When tissue levels of vitamin C are high, these processes are already maximized and supplemental vitamin C does not have any effect on estrogen levels. However, increases in plasma estrogen levels may occur when women who are deficient in vitamin C take supplements (11161).

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, rose hip might increase blood levels of lithium.  Details Rose hip is thought to have diuretic properties (5,18). Theoretically, due to these potential diuretic effects, rose hip might reduce excretion and increase levels of lithium. The dose of lithium might need to be decreased.

WARFARIN (Coumadin) Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, rose hip might reduce the effectiveness of warfarin; however, its vitamin C content is likely too low to produce clinically significant effects.  Details Rose hip contains vitamin C. High doses of vitamin C may reduce the response to warfarin, possibly by causing diarrhea and reducing warfarin absorption (11566). This occurred in two people who took up to 16 grams daily of vitamin C, and resulted in decreased prothrombin time (9804,9806). Lower doses of 5-10 grams daily of vitamin C can also reduce warfarin absorption, but this does not seem to be clinically significant (9805,9806,11566,11567). The vitamin C content of rose hip is typically about 500 mg per 100 grams. Thus, a clinically significant interaction between rose hip and warfarin is unlikely.

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General ...No adverse effects have been reported in adults. However, a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Gastrointestinal adverse effects, such as necrotizing enterocolitis, when recombinant human bile salt-stimulated lipase is used in premature infants.

Gastrointestinal ...Orally, when added to the formula or pasteurized breast milk consumed by premature infants, recombinant human bile salt-stimulated lipase (rhBSSL) can cause gastrointestinal adverse effects, including abdominal distension, flatulence, constipation, colic, abdominal pain, gastroenteritis, vomiting, regurgitation, and rectal bleeding (101940). Premature infants receiving rhBSSL also had a slightly higher rate of necrotizing enterocolitis (NEC) when compared with those receiving placebo. After review by a panel of experts, it was determined that the rate of confirmed or suspected NEC in infants consuming rhBSSL was 3.3%, compared with 0.5% in those receiving placebo. Although this rate of NEC is lower than the historical rate of occurrence in premature infants (11%), a possible increased risk for NEC cannot be ruled out (101940).

(Read more about LIPASE)

General ...Orally and topically, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.

(Read more about MARSHMALLOW)

General ...Orally, proteolytic enzymes are generally well tolerated. See specific monographs for detailed safety information related to individual proteolytic enzymes.
Most Common Adverse Effects:
Orally: Gastrointestinal upset.
Serious Adverse Effects (Rare):
Topically: Allergic reactions.

Gastrointestinal ...Orally, some patients taking proteolytic enzymes may have gastrointestinal complaints (101517).

Immunologic ...Proteolytic enzymes are commonly found in laundry detergents and pre-spotter products. Rarely, protease specific IgE positive tests possibly related to these products have occurred. Exposure may be airborne or topical (102705). In addition, in case reports, occupational exposure to the airborne proteolytic enzyme pepsin has resulted in allergic rhinoconjunctivitis or asthma (102706,102707).

(Read more about PROTEOLYTIC ENZYMES (PROTEASES))

General ...Orally, rose hip from Rosa canina is well tolerated. Rose hip from Rosa damascena also seems to be well tolerated. A thorough evaluation of safety outcomes has not been conducted for rose hip derived from other species.
Most Common Adverse Effects:
Orally: Flatulence, loose stools.

Dermatologic ...Orally, one case of mild urticaria has been reported in a clinical trial for a patient taking a specific rose hip powder product (LitoZin/i-flex, Hyben Vital) 2. 5 grams twice daily (71646).

Gastrointestinal ...Orally, gastrointestinal reactions have been reported. These include abdominal cramps, acid reflux, constipation, diarrhea, flatulence, nausea, vomiting, gastrointestinal obstruction, esophagitis, heartburn, acid reflux, and water brash. However, in most cases, these adverse effects occurred at the same frequency in patients taking placebo (15,18104,71641,71646,97938).
Rose hip powder is a source of vitamin C. Osmotic diarrhea and gastrointestinal upset have been reported with doses of vitamin C greater than the tolerable upper intake level (UL) of 2000 mg daily (4844). However, most rose hip products contain only 500 mg of vitamin C per 100 grams.

Genitourinary ...Orally, a few mild cases of frequent voiding have been reported in clinical trials. However, the frequency of occurrence does not seem to differ from those taking placebo (71641,71646).

Immunologic ...When inhaled in the workplace, rose hip dust has caused mild to moderate anaphylaxis (6).

Neurologic/CNS ...Orally, vertigo and headache have been reported rarely (97938).

Ocular/Otic ...A case of keratoconjunctivitis secondary to contact with rose hip has been reported. The adverse effect was attributed to irritant hairs found on the fruit of rose hip. Symptoms resolved after treatment with topical prednisolone 1% eye drops (71642).

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