Description
Noni (Morinda citrifolia), also known as Ba Ji Tian, Cheese Fruit and Indian Mulberry, is a Polynesian plant that has traditionally been used in medicinal remedies. Noni fruit juice has been the main focus of attention in recent years.
A wide range of indications have been proposed for Noni juice and it has been marketed as a general cure-all for conditions including cancer, depression, diabetes, drug addiction, heart disease and obesity. It is also claimed that Noni has general benefits on health.
In vitro and animal studies have shown potential antioxidant action, immune function stimulation, and antitumour activity but there have been few trials in humans for any condition and no randomised controlled trials in cancer patients. Preliminary studies have suggested protective effects in heavy smokers.
Efficacy
Antitumour treatment
Tumour burden: No effect was seen in tumour regression in an uncontrolled Phase 1 study
Prostate specific antigen (PSA) levels: serum PSA levels were not significantly different after 12 months of therapy including noni in 6 low risk prostate cancer patients
Other biomarkers: changes in relevant biomarkers (cancer-related genes) w reported in a preliminary study of 6 low risk prostate cancer patients
Supportive cancer care
Fatigue: a trend to less fatigue was seen in a Phase 1 dose finding study with advanced cancer patients on moderate (as opposed to high or low doses) of noni juice
Cancer prevention
Lung cancer: Two preliminary studies reported possibly beneficial effects on surrogate biomarkers in smokers
Safety
Few adverse effects have been reported although assessment of safety has been limited to date. Several cases of liver toxicity have been reported but these have not been documented to be caused by Noni juice. The potassium content in some noni juice products may cause problems in people with renal insufficiency, on low potassium diets or taking drugs likely to increase potassium levels.
Citation
Karen Pilkington, CAM Cancer Collaboration. Noni [online document], May 31, 2022
Document history
Latest update: May 2022
Next update due: May 2025
Description and background
Noni (Morinda citrifolia) is a small evergreen tree or shrub that grows in Pacific regions including Polynesia, Southeast Asia, India and Australia (NCCIH 2020, NMD 2021). It has also been introduced to the Caribbean (Kew Plants of the World Online 2022). Noni has been used by Polynesians for at least 2000 years and is considered one of the more important traditional Polynesian medicinal plants and is still produced locally (McClatchey 2002). The whole plant (roots, stems, bark, leaves, flowers and fruits) has been used in the preparation of medicinal remedies of which around 40 have been recorded (NMD 2021, McClatchey 2002). Preparations of Noni were applied topically, the roots were also to produce a clothes dye while the fruit was eaten as a food (Wang et al. 2002). These were used to treat a range of common diseases and to maintain overall health (Wang et al. 2002). Various parts of the plant are still used to make remedies but patterns of use have changed (McClatchey 2002). Currently, most interest is in the yellow-green fruits, which produce a pungent odour while ripening (hence ‘Cheese Fruit’) and are used to produce juice. The fruit juice is now manufactured on a large-scale and can be purchased from health food shops, other stores or via numerous websites.
Traditionally used in Polynesia and South East Asia, Noni has been marketed in Australia, Canada, Hong Kong, Japan, Mexico, Norway and the USA (EC 2002). Substantial increases in sales in the USA were reported but it was not possible to substantiate these claims (Potterat and Hamburger 2007, Pawlus and Kinghorn 2007). Use also increased in Western Europe (European Commission 2002).
Other names: Morinda citrifolia L. (a member of Rubiaceae, the coffee family) (Kew Plants of the World Online 2022). Morinda bracteata Roxb., Ba Ji Tian, canary wood, Cheese Fruit, Hai Ba Ji, Hawaiian Noni, hog apple, Indian Mulberry, Noni juice, Tahitian Noni (NCCIH 2020, NMD 2021).
Ingredients and quality issues
A wide range of components have been identified in the Noni plant; over 140 including some novel compounds (Issell 2005). These include alkaloids, anthraquinones, beta-sitosterol, carotene, flavonol glycosides including rutin, iridoids, linoleic acid, ursolic acid and vitamins A and C (Wang 2002). Two fatty acids, caproic (hexanoic) and caprylic (octanoic) acid may be responsible for the pungent odour of the fruit. New anthraquinones and saccharide fatty acid esters have also been isolated (Akihisa 2007). The unfermented juice also contains glucose, fructose, proteins, lipids, calcium, magnesium, potassium and sodium (Potterat 2007, Mueller 2000). Two novel constituents, xeronine and proxeronine, were apparently identified by a researcher in Hawaii and patented but have not been subsequently characterised or reported although one computer-based study has investigated xeronine’s possible structure (McClatchey 2002, Sanni 2017). Five new saccharide fatty acid esters, named nonioside P, nonioside Q, nonioside R, nonioside S, and nonioside T, and one new succinic acid ester were isolated, along with known compounds, from an extract of the fruit (Akihisa 2012).
Alleged indications
Traditional use is based on claims of beneficial effects in wound healing and treating inflammation and infection (McClatchey 2002). Manufacturers of Noni juice have claimed a wide range of therapeutic effects (Wang 2002) and it has been marketed as a general cure-all for various chronic conditions (Pawlus 2007). Among the indications for which Noni is promoted are cancer, diabetes, hypertension, immunostimulation and pain (MSKCC 2020). An application for approval of a Noni juice product in Europe did not specify any indications other than general health benefits similar to those of other fruit juices (EMA 2002).
Women in the USA reported utilizing noni for the prevention and treatment of breast cancer and as a secondary course of treatment following conventional chemotherapy (Boon 2007). More recently, it has been reported to be used by liver cancer patients in Latin America to control symptoms (Rojas 2018).
Application and dosage
Many parts of the plant, including the bark, flowers, fruit, leaves, stem and roots are used medicinally (NMD 2020). Noni is administered both orally and topically. The fruit and juice are taken orally for a range of health reasons such as arthritis, angina and diabetes (West 2018). The leaves are used in preparations for topical use for skin conditions and wound-healing (Palu 2010). Various dose regimens for the fruit juice are recommended by suppliers but, in research studies, doses used most frequently are 90-120ml once or twice daily for 1-3 months (Natural Medicines 2020). One ounce (approximately 30ml) every 12 hours has been suggested for ‘overall health maintenance’ (Wang 2002). An application to the European Scientific Committee on Food for approval of ‘Tahitian Noni juice’ described the product as a mixture of 89% Noni fruit, 11% common grape and blueberry juice concentrates and natural flavours (EMA 2002). The suggested consumption was 30 ml/day.
A phase 1 dose finding trial was carried out in 29 cancer patients (Issell 2009). Patients with advanced cancer were treated with commercially manufactured capsules containing 500mg of ripe Noni fruit extract. A dose of 2g was used initially then doses were increased by 2g to a maximum of 10g (20 capsules) daily. A minimum of 5 patients were observed at each dose level for 28 days. Quality of life, symptom status, response, toxicity and pharmacokinetics were measured. Effects on several quality of life measures were reported although these did not reach statistical significance, except for decrease in pain. No adverse effects or tumour response attributable to Noni were observed.
Mechanisms of action
Studies of the pharmacology of Noni and its constituents have focused on three main areas: cancer, inflammation and metabolic diseases although research is preliminary (Potterat 2007) An early study found that a polysaccharide fraction obtained from the fruit juice inhibited tumour activity and stimulated cytokine release (Hirazumi 1999). Two constituents, a fatty acid glycoside and an iridoid, were reported to inhibit neoplastic cell transformation in mouse cells (Potterat 2007). Prevention of the initiation of carcinogenesis, antimutagenic activity, and inhibition of angiogenesis with capillary vessel degeneration and apoptosis have all been reported (Potterat 2007). Inhibition of the growth of several cancer cell types has also been recorded in vitro including breast cancer (Sharma 2016), lung cancer (Ma 2021) and melanoma (Masuda 2012). An anthraquinone isolated from Noni appeared to be a potent inducer of an enzyme, quinone reductase, known to be protective against cancer due to its involvement in metabolism and elimination of carcinogens (Pawlus 2005). Subsequently, various such inducing compounds have been isolated (e.g. Youn 2016). Several fatty acid esters showed inhibitory activities against melanogenesis in B16 melanoma cells induced with α-melanocyte-stimulating hormone (α-MSH) (Akihisa 2012). The anthraquinones, particularly damnacanthal, has also shown anti-cancer activity in vitro and been under investigation by various research groups (Li 2022).
Pre-clinical studies have shown a range of actions potentially beneficial in cancer. Preventative effects based on anti-carcinogenic activity via inhibition of TPA (Akihisa 2007), tumour cell-selective anti-proliferative effects (Arpornsuwan 2006), anti-angiogenic activity (Beh 2012), and stimulation of the immune system (Palu 2008) have all been reported. One report describes that Noni Juice was useful in suppressing tumour growth in a mice model for HER2/neu breast cancer in amounts equivalent to human dosages below 90 ml/day (Clafshenkel 20112).
Legal issues
Food or drink products derived from Noni require authorisation in Europe. Several Noni products have been approved as novel food products in Europe. These include Noni juice in various forms: fresh, puree, concentrated, frozen, dried and mixed with other juices (FSA 2006, EFSA 2006, eFSA 2009). The dried and roasted leaves have also been approved as a new novel food ingredient for the preparation of infusions (EFSA 2008).
No systematic reviews or randomized controlled trials of Noni to assess the effects of Noni in cancer patients have been published. Two reviews described as systematic reviews simply provide an overview of a wide range of research on anticancer and other health-related effects (Saminathan 2013, Kaur 2018). A narrative review concluded that some research suggested ‘broad potential health benefits’ and promising results had been reported for several constituents but increased use of Noni was probably due to effective marketing (Pawlus 2007). A second review of the literature reached similar conclusions, highlighting the fact that knowledge about the chemistry of Noni had increased but there was still a lack of clinical research (Potterat 2007). A review of anticancer activity concluded that, other than two case studies, only two human clinical studies existed (Brown 2012). One of these studies involved cancer patients and one recruited smokers. Both studies are described below. Subsequent reviews have also only referred to these two studies (Torres 2017, Almeida 2019)
Description of studies
Antitumour treatment
No controlled trials of noni for anticancer treatment have been conducted.
A phase 1 dose finding trial in 51 advanced cancer patients reported that no tumour regression was measured using RECIST criteria after treatment with doses of between 2 to 14g daily for at least 28 days (Issell 2005).No dose toxicity was observed and the main adverse effects was queasiness associated with ingesting noni capsules.
Six patients, one with very low and 5 with low risk prostate cancer, were treated with 6200 mg/day of noni in capsule form for 1 year (Hirasawa 2021). Median serum PSA slightly increased from 7.1 ng/mL (4.4-9.7 ng/ mL) to 7.9 ng/mL (5.7-10.2 ng/mL) from baseline over the treatment period. Change in the expression of 12 genes was tested during biopsy at 12 months. Changes were observed in several genes, including FAM13C, KLK2 (associated with the androgen pathway), and GSTM2 (associated with cellular organization). Noni was well tolerated except for grade 2 diarrhoea reported by one participant.
Supportive care
The phase I study of noni in patients with advanced cancer described above also assessed quality of life (Issell 2005). Fifty-one patients were enrolled at seven dose levels study with doses ranging from the usual suggested daily dose of 1–2 grams to seven capsules four times daily (14 grams). No dose limiting toxicity was found but seven of eight patients on the highest dose withdrew due to difficulty in ingesting so many capsules. Patients on doses of 8g per day appeared to experience less fatigue than those on higher or lower doses with a trend to improved 60 day maintenance in physical function, pain control and fatigue control (by both CLQ C30 and BFI) in those taking 6–8 grams daily compared with other doses. The lack of a control group prevents any firm conclusions on the effects of noni on quality of life.
Prevention
Two trials assessed the effects of Noni on levels of substances thought to increase the risk of developing cancer. A double-blind, placebo-controlled trial was conducted to assess antioxidant activity of Noni in smokers (Wang 2009a). A total of 285 heavy smokers were randomly allocated to placebo, 29.5ml (1 fluid ounce) Noni juice or 118ml (4 ounces) Noni juice per day for 30 days. Levels of plasma superoxide anion radicals and lipid hydroperoxide were reported to have decreased in the Noni groups. A second related study assessed levels of aromatic DNA adducts, a surrogate biomarker for risk of lung cancer, again in smokers who drank Noni juice for a month (Wang 2009b). Of 283 smokers recruited for the trial, 203 completed the study. The results indicated that Noni juice daily may reduce cancer risk in heavy cigarette smokers by blocking carcinogen-DNA binding or removing DNA adducts from genomic DNA. Both were preliminary studies. Over 25% of participants did not complete the trial although all patients were included in the analysis. Noni juice and the placebo seemed well matched but contained a mixture of grape and blueberry juice which could have contributed to some of the beneficial effects reported.
Adverse events
Limited assessment of safety has been carried out and there is a lack of high-quality studies but there have been few adverse effects reported after using Noni and the fruit has been consumed as food for many years (NCCIH 2020, NMD 2021, ECSC 2002). In 2002, a review of safety of one Noni juice product by the European Scientific Committee on Food concluded that there were no indications of adverse effects from animal studies on subacute and subchronic toxicity, genotoxicity and allergenicity (ECSC 2002). A double-blind safety study of Noni fruit juice sponsored by a manufacturer carried out in 96 healthy volunteers did not reveal any significant adverse effects with up to 750ml noni juice daily for 28 days (West 2009). A phase 1 dose increase study in 51 cancer patients reported that the main adverse effect was queasiness associated with ingesting noni capsules (Issell 2005). Noni was also well-tolerated in 5 of 6 prostate cancer patients with one patient experiencing grade 2 diarrhoea requiring withdrawal of noni for a short period (Hirasawa 2021).
Between 2005 and 2011, 7 cases of hepatotoxicity in previously healthy people were reported, 2 involving a tea or other herbal product, 4 involving a Noni juice and 1 involving an energy drink2. It is unclear whether Noni juice was the cause of liver toxicity. Liver function tests improved once the Noni product was stopped but other ingredients or treatments may have been responsible. The possibility of product contamination during production was also raised as the root and bark contain anthraquinones. Subsequent analyses by the researchers at the manufacturer did not detect anthraquinones in the juice or reveal toxicity (West 2006, West 2009a, West 2009b). A review of the first 4 cases by the European Food Safety Authority (EFSA) concluded that there was ‘no convincing evidence for a causal relationship between the acute hepatitis observed in the case studies reported and the consumption of noni juice’(EFSA 2006). LiverTox rated the likelihood of noni juice as a cause of liver injury as C (probable rare cause of clinically apparent liver injury) with the cases having had all of the characteristics of idiosyncratic liver injury rather than direct toxicity (LiverTox 2020). Latency was between 2 to 8 weeks and resembled acute hepatitis with a hepatocellular pattern of serum enzyme elevations. An EFSA Panel concluded that, on the basis of data provided, the use of dried Noni leaves for preparation of infusions was safe (EFSA 2008)
Noni contains relatively high levels of potassium (similar to levels in orange and tomato juice) and a case of hyperkalaemia was reported in a patient with chronic renal insufficiency (Mueller 2000). Mineral content of commercial noni juices has been shown to vary widely (West 2006).
Contraindications
Several cases of liver toxicity have been linked to Noni although it is not clear whether Noni caused these problems. Because of this, some authorities recommend that Noni is avoided in people with liver dysfunction. Caution is also recommended in people with hyperkalaemia, kidney dysfunction, taking potassium-sparing diuretics or other drugs that increase potassium levels such as ACE inhibitors (NCCIH 2020). Toxicity tests in animals has found conflicting evidence of toxicity from Noni juice to developing embryos and foetuses (NMD 2021). In addition, large amounts of the fruit have been reported to cause an abortion and historically Noni root bark has been used as an abortifacient indicating it may be unsafe in pregnancy. It is recommended that it is avoided in pregnancy and lactation (NMD 2021).
Interactions
Due to the potassium content of some Noni juice products, there is a potential for interaction with drugs causing increased potassium levels (Mueller 2000, West 2006).
One case has been reported of resistance to the anticoagulant, coumadin, due to the vitamin K content of the particular Noni product being used by the patient (Carr 2004). There is a theoretical risk of reduced warfarin effects (NMD 2021).
A single-dose, randomized, open-label and 2-period crossover study in 20 healthy volunteers showed that the aqueous fruit extract influenced the motor activity of the gastrointestinal tract. The fruit extract enhanced the rate and the extent of ranitidine absorption, partly due the ability of its active component scopoletin to stimulate the 5-HT4 receptor (Nima 2012).
There is a theoretical risk of hypotension in those treated with antihypertensives (NMD 2021).
Other problems or complications
Commercial preparations of Noni occasionally contain Morinda officinalis as well as Morinda citrifolia which has been reported to stimulate the kidneys and can exacerbate urinary difficulties.
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