Herbal Actives Noni 500 mg Extended Release Tablets [Discontinued] by Nature's Plus

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging. Although there has been interest in using oral noni for aging, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Asthma. Although there has been interest in using oral noni for asthma, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Atherosclerosis. Although there has been interest in using oral noni for atherosclerosis, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Athletic performance. It is unclear if oral noni juice is beneficial for athletic performance. Details: Preliminary clinical research shows that drinking 100 mL of a specific juice (Tahitian Noni Juice (TNJ), Tahitian Noni International) containing 89% pureed noni in grapefruit and blackberry juices twice daily for 21 days can increase running time-to-fatigue by approximately 21% in trained distance runners when compared with baseline. Runners taking placebo blackberry juice did not demonstrate improved endurance when compared with baseline (65230).
• Burns. Although there has been interest in using topical noni for burns, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Cancer. It is unclear if oral noni is beneficial in patients with cancer. Details: Preliminary, low-quality clinical research shows that taking noni fruit extract 2-14 grams daily for 28 days does not improve physical function, fatigue, pain, or tumor growth in patients with various forms of advanced cancer when compared with baseline (65173).
• Cardiovascular disease (CVD). Although there has been interest in using oral noni for CVD, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Cataracts. Although there has been interest in using oral noni for cataracts, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Cervical spondylosis. It is unclear if oral noni is beneficial in patients with cervical spondylosis. Details: Preliminary clinical research shows that taking oral noni juice 15 mL twice daily in combination with physiotherapy for 4 weeks can improve neck pain and flexibility scores more than physiotherapy alone in patients with cervical spondylosis. Treatment with noni juice alone was not different than physiotherapy alone. However, the study may have been inadequately powered to detect a difference between these groups (65197).
• Colic. Although there has been interest in using oral noni for colic, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Common cold. Although there has been interest in using oral noni for the common cold, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Cough. Although there has been interest in using oral noni for cough, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Depression. Although there has been interest in using oral noni for depression, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Diabetes. Although there has been interest in using oral noni for diabetes, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Epilepsy. Although there has been interest in using oral noni for epilepsy, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Headache. Although there has been interest in using oral and topical noni for headache, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Hearing loss. It is unclear if oral noni is beneficial for hearing loss. Details: Preliminary clinical research shows that drinking 4 ounces of noni juice daily for 3 months does not improve hearing at most frequencies in hearing-impaired postmenopausal females (65146).
• HIV/AIDS. Although there has been interest in using oral noni for HIV/AIDS, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Hypertension. It is unclear if oral noni is beneficial in patients with hypertension. Details: Preliminary clinical research shows that drinking 4 ounces of a specific noni juice (Tahitian Noni Juice) daily for one month reduces blood pressure by approximately 8% when compared with baseline in individuals with hypertension (65231). The validity of this finding is limited by the lack of a comparator group.
• Insomnia. Although there has been interest in using oral noni for insomnia, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Leishmania lesions. It is unclear if topical noni is beneficial for improving the severity of leishmania lesions. Details: Preliminary clinical research shows that topical application of an ointment containing noni stem extract 1% three times daily for 6 weeks improves leishmania lesion scores when compared with baseline. A good to excellent response was reported in 80% of patients (65174). However, the validity of this finding is limited by the lack of a comparator group.
• Leprosy. Although there has been interest in using topical noni for leprosy, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Liver disease. Although there has been interest in using oral noni for liver disease, there is insufficient reliable information about the clinical effects of noni for this purpose. Additionally, there is some concern that noni might cause hepatotoxicity in some patients.
• Malaria. Although there has been interest in using oral noni for malaria, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Migraine headache. Although there has been interest in using oral noni for migraine headache, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Osteoarthritis. It is unclear if oral noni is beneficial in patients with osteoarthritis. Details: Preliminary clinical research in patients with knee or hip osteoarthritis shows that drinking 3 ounces of a specific noni juice (Tahitian Noni Juice) daily for 90 days can reduce the need for analgesic medications and improve quality of life parameters, including mobility, joint function, social activity, tension level, mood, and the ability to conduct activities of daily living when compared with baseline (65206). However, the validity of this study is limited by the lack of a comparator group.
• Parturition. Although there has been interest in using oral noni for parturition, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Postoperative nausea and vomiting (PONV). It is unclear if oral noni is beneficial in patients with PONV. Details: Preliminary clinical research shows that taking noni fruit extract 600 mg orally one hour prior to surgery reduces postoperative nausea, but not vomiting, in the first 6 hours after surgery by 40% when compared with placebo. However, taking noni fruit extract did not reduce PONV in the first 6-24 hours after the surgery. Taking noni fruit extract 150-300 mg also did not reduce PONV when compared with placebo (17169).
• Premenstrual syndrome (PMS). Although there has been interest in using oral noni for PMS, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Rheumatoid arthritis (RA). Although there has been interest in using oral and topical noni for RA, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Stroke. Although there has been interest in using oral noni for stroke, there is insufficient reliable information about the clinical effects of noni for this purpose.
• Urinary tract infections (UTIs). Oral noni has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Some observational research in females with recurrent UTIs has found that taking antibiotics with a combination of noni fruit extract 200 mg, d-mannose 500 mg, and N-acetylcysteine 100 mg orally twice daily for 2 months, then daily for 4 months, may be associated with a lower incidence of recurrent UTI when compared with antibiotics alone. Of patients without a UTI in the first 2 months, 100% of those taking the combination product remained UTI free at 6 months whereas only 6% of those taking antibiotics alone remained UTI free. This combination also seems to improve symptoms of urgency, frequency, and incontinence (97360). It is not clear if these effects are due to noni, other ingredients, or the combination.
• Wound healing. Although there has been interest in using topical noni for wound healing, there is insufficient reliable information about the clinical effects of noni for this purpose. More evidence is needed to rate noni for these uses.

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POSSIBLY SAFE ...when used orally and appropriately. Noni juice has been used in doses of up to 200 mL daily with apparent safely in small clinical studies for up to 3 months (11944,17169,65173). However, there have been several case reports of increased liver enzymes and hepatotoxicity in people taking some noni products (13107,14341,14468,17170,17171,17172). In three reports, hepatotoxicity was linked to a specific brand of noni juice (Tahitian Noni Juice, Tahitian Noni International) (14341,17171). It is unclear if potential contaminants or hypersensitivity reactions may be the cause of these events. More evidence is needed to determine if noni increases the risk for hepatotoxicity. There is insufficient reliable information available about the safety of noni fruit extract when used orally or the safety of noni when used topically.

PREGNANCY AND LACTATION:
While animal research is conflicting on the teratogenic effects of noni (65205,65206), there is insufficient reliable information available about the safety of noni in humans; avoid using.

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ACE INHIBITORS (ACEIs) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, combining noni and ACE inhibitors might increase the risk of hyperkalemia.  Details Noni juice contains significant amounts of potassium, about 6 mEq/100 mL juice (1298). This may increase the risk for hyperkalemia when used in conjunction with ACE inhibitors, which can also increase potassium levels.

ANGIOTENSIN RECEPTOR BLOCKERS (ARBs) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, combining noni and ARBs might increase the risk of hyperkalemia.  Details Noni juice contains significant amounts of potassium, about 6 mEq/100 mL juice (1298). This may increase the risk for hyperkalemia when used in conjunction with ARBs, which can also increase potassium levels.

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, noni may increase the risk of hypotension when used in combination with antihypertensive drugs.  Details Preliminary clinical research suggests that drinking noni juice can reduce blood pressure in individuals with hypertension (65231).

HEPATOTOXIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking noni with hepatotoxic drugs might increase the risk of liver damage.  Details There is concern that noni might cause hepatotoxicity in some patients (13107,14341,14468). Advise patients against combining noni with potentially hepatotoxic drugs.

PHENYTOIN (Dilantin) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking noni fruit juice concomitantly with phenytoin may lower phenytoin levels and increase the risk of seizures.  Details In one case report, an adult taking phenytoin for partial seizures experienced low serum phenytoin levels while taking noni juice 90-200 mL daily. Serum phenytoin levels increased after decreasing noni juice consumption; similarly, serum phenytoin levels decreased after increasing noni juice consumption. Some researchers believe noni juice may induce cytochrome P450 2C9 enzymes, which would decrease phenytoin levels, but this has not been well studied. Patients may need additional monitoring when starting or stopping noni juice supplementation (106057).

POTASSIUM-SPARING DIURETICS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, combing noni and a potassium-sparing diuretic might increase the risk of hyperkalemia.  Details Noni juice contains significant amounts of potassium, about 6 mEq/100 mL juice (1298). This may increase the risk for hyperkalemia when used in conjunction with potassium-sparing diuretics, which can also increase potassium levels.

RANITIDINE (Zantac) Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = B Taking noni fruit with ranitidine might increase the levels and clinical effects of ranitidine.  Details Clinical evidence shows that taking an aqueous extract of noni fruit 30 minutes prior to taking a single oral dose of ranitidine can increase the rate of absorption and plasma concentration of ranitidine (23387).

WARFARIN (Coumadin) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking noni juice concomitantly with warfarin might decrease the effectiveness of warfarin.  Details In one case, a 41-year-old patient stabilized on warfarin had a decreased international normalized ratio (INR) following consumption of a specific commercial noni juice product (Noni juice 4 Everything). While the patient was still taking noni juice, an increase in warfarin dose did not produce an increase in INR (14434). However, it should be noted that this particular product contained extracts and derivatives from more than 115 components, many of which contained vitamin K. Furthermore, vitamin K was listed as a separate ingredient of the product, suggesting that the product was possibly fortified with vitamin K. It has not been verified that noni fruit alone contains a significant amount of vitamin K or interacts with warfarin.

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General ...Orally and topically, noni seems to be generally well tolerated; however, high quality studies of adverse effects have not been conducted.
Most Common Adverse Effects:
Orally: Abdominal discomfort, nausea.
Serious Adverse Effects (Rare)::
Orally: Hepatotoxicity, including liver failure. However, studies have not conclusively identified whether noni, or contaminants in noni products, were responsible for this toxicity.

Gastrointestinal ...Orally, dehydrated noni fruit has been reported to cause nausea and abdominal discomfort (65173).

Hepatic ...Noni has been associated with several cases of hepatotoxicity in previously healthy patients ranging in age from 14 to 62 years (13107,14341,14468,17170,17171,17172). In two cases, the patients had used a tea or other herbal products containing noni (13107,17172); five had consumed noni juice, specifically Tahitian Noni Juice (Tahitian Noni International) (14341,16648,17171); and two cases involved energy drinks containing several herbal ingredients including noni (17170,90125). Symptoms of liver dysfunction and elevated liver function tests (LFTs) were seen between 2 weeks and 4 months after starting noni. The LFTs started to improve within 2 days of stopping noni and generally normalized within 1 month (13107,14468,17171). Biopsy findings included acute hepatitis, inflammation, hepatocyte necrosis, and hepatocellular cholestasis (14341,17170). One patient, who had a history of prior mild acetaminophen toxicity, had rapidly progressive liver failure after noni ingestion and required transplantation (14341).
Potential product contamination was not ruled out in these case reports. Some researchers theorize that anthraquinones contained in noni could potentially cause hepatotoxicity. Other products containing anthraquinones, such as senna, have been linked to cases of hepatotoxicity. However, analyses of a noni juice product associated with reports of liver damage (Tahitian Noni Juice, Tahitian Noni International) have not detected anthraquinone content (14444). Another analysis of noni fruit puree from which the seeds and skin had been removed had no detectable anthraquinones (92201). However, products containing seed or leaf material had detectable amounts of anthraquinones (92201). The part of the noni plant used might affect hepatotoxicity risk. More evidence is needed to determine if noni causes hepatotoxicity.

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