Graviola 4:1 Extract 1800 mg by TerraVita

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Bladder cancer. Oral graviola has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Low-quality, observational research in adults with intermediate to high-risk non-muscular invasive bladder cancer has found that taking graviola 100 mg and ellagic acid 100 mg daily for 6 months is associated with 83% higher recurrence-free survival when compared with no intervention. However, taking graviola and ellagic acid was only associated with higher recurrence-free rates at 6 months, not at 12 months. All subjects included in this study were also unable to receive standard recurrence prevention therapy with Bacillus Calmette-Guerin (BCG) (106054).
• Cancer. Although there has been interest in using oral graviola for cancer, there is insufficient reliable information about the clinical effects of graviola for this purpose.
• Cough. Although there has been interest in using oral graviola for cough, there is insufficient reliable information about the clinical effects of graviola for this purpose.
• Diabetes. Although there has been interest in using oral graviola for diabetes, there is insufficient reliable information about the clinical effects of graviola for this purpose.
• Headache. Although there has been interest in using oral graviola for headache, there is insufficient reliable information about the clinical effects of graviola for this purpose.
• Human papillomavirus (HPV). Oral graviola has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adult females with HPV and low-grade squamous intraepithelial lesions (L-SIL) shows that taking a combination of graviola 100 mg and ellagic acid 16 mg orally twice daily for 6 months increases viral clearance of high-risk HPV by 3-fold when compared with placebo. Graviola treatment also prevented the progression of L-SIL to high-grade squamous intraepithelial lesions (H-SIL) in all patients, whereas 12% of subjects taking placebo progressed to H-SIL (96297). A small observational study in females with HPV suggests that taking graviola 100 mg and ellagic acid 16 mg (Oasit-K, BioSTILOGIT Pharmaceuticals) once daily for 12 months is not associated with improved detection of HPV DNA high-risk genotypes or E6 and E7 oncogene mRNA when compared with nonavalent HPV vaccination, but is linked with reduced cytological abnormalities observed on Pap test when compared to baseline (112855). Additionally, a small observational study in males with HPV and infertility suggests that taking graviola 100 mg and ellagic acid 100 mg daily for 3 months is associated with a reduced percentage of patients with persistent HPV DNA in seminal fluid and improved sperm concentration, motility, and morphology when compared with control (112853). However, for these studies, it is unclear if these effects are from graviola, ellagic acid, or the combination.
• Insect repellent. Although there has been interest in using topical graviola as an insect repellent, there is insufficient reliable information about the clinical effects of graviola for this purpose.
• Interstitial cystitis. Although there has been interest in using oral graviola for interstitial cystitis, there is insufficient reliable information about the clinical effects of graviola for this purpose.
• Leishmania lesions. Although there has been interest in using topical graviola for leishmania lesions, there is insufficient reliable information about the clinical effects of graviola for this purpose.
• Male infertility. Oral graviola has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small observational study in males with human papilloma virus (HPV) and infertility suggests that taking graviola 100 mg and ellagic acid 100 mg daily for 3 months is associated with a reduced percentage of patients with persistent HPV DNA in seminal fluid and improved sperm concentration, motility, and morphology when compared with control (112853). More evidence is needed to rate graviola for these uses.

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POSSIBLY UNSAFE ...when used orally. Some research has found that consumption of large amounts of graviola fruit and/or tea made from graviola leaves (e.g., daily) is associated with an increased odds of having movement disorders that resemble Parkinson disease (7854).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally (7854).

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CARBAMAZEPINE (Tegretol) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, graviola might decrease concentrations of carbamazepine when used concomitantly.  Details A study in rats shows that graviola extract reduces the area under the curve of carbamazepine by 46% and maximum concentration by 35% when compared with carbamazepine alone (112852).

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General ...Orally, regular consumption of graviola may be unsafe.
Most Common Adverse Effects:
Orally: Epigastrium pain, nausea.
Serious Adverse Effects (Rare):
Orally: Movement disorders, myeloneuropathy.

Gastrointestinal ...In one clinical study, some patients reported nausea and burning pain in the epigastrium after taking graviola leaf extract 300 mg daily (95045).

Neurologic/CNS ...Orally, regular consumption of graviola fruit may cause movement disorders and myeloneuropathy. The symptoms of these disorders are similar to Parkinson disease (7854). In addition, a large observational study in patients with Parkinson disease suggests that even low cumulative consumption of graviola fruit, juice, or any amount of herbal tea containing graviola is associated with worsened motor and cognitive symptoms (112854).

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