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Andrographis

Scientific Name(s): Andrographis paniculata (Burm.f.) Wall. Nees.
Common Name(s): Alui, Bhui-neem, Bhunimba, Chuanxinlian, Kalmegh, Kalmegha, Kalupnath, Kirayat, Mahatita, Sam biloto, Yavatikta

Clinical Overview

Use

Traditionally, andrographis has been used for liver complaints and fever, and as an anti-inflammatory and immunostimulant. In clinical trials, andrographis extract has been studied for use as an immunostimulant in upper respiratory tract infections and HIV infection. The potential for use of andrographolide as an anticancer agent as well as for its immune and anti-inflammatory effects is being investigated. However, limited clinical studies have been published to support any of these uses.

Dosing

The usual daily dose of andrographolides for common cold, sinusitis, and tonsillitis is 60 mg. A clinical trial in children with upper respiratory tract infection reported the use of andrographolide 30 mg daily for 10 days.

Contraindications

Contraindications have not been identified.

Pregnancy/Lactation

Avoid use. Adverse effects, including abortifacient effects, have been documented.

Interactions

None well documented.

Adverse Reactions

In a clinical trial, headache, fatigue, rash, bitter/metallic taste, diarrhea, pruritus, and decreased sex drive were reported with andrographis 10 mg/kg body weight. One HIV-positive participant experienced an anaphylactic reaction.

Toxicology

No data.

Botany

A. paniculata is an erect annual herb native to India, China, and Southeast Asia and widely cultivated in Asia. The plant grows 30 to 110 cm in height. The square stem has wings on the angles of new growth and is enlarged at the nodes. The seeds are yellowish-brown, and small white flowers with rose-purple spots are borne on a spreading panicle. All plant parts have an extremely bitter taste. The aerial portion of the plant is harvested in the fall. The genetic variability of the species has been examined.1, 2, 3

History

A. paniculata has been used for centuries in India, China, Thailand, and other Asian countries and is present in 26 polyherbal formulations in the Ayurvedic traditional health system. A. paniculata is listed in the Pharmacopoeia ofthe People’sRepublicof China(1992 edition) as a cold property herb used to rid the body of fever and dispel toxins. An immunostimulant preparation known as KanJang, which contains A. paniculata and Eleutherococcus, has been used in Scandinavian countries. A. paniculata is also manufactured and marketed in the United States.3, 4, 5, 6

Chemistry

The diterpene lactone andrographolide was first isolated as a major constituent of A. paniculata7 and later characterized as a lactone.8, 9 Its full structure was determined in the 1960s10, 11 and x-ray crystallography later confirmed the structure.12 Several related minor diterpenes and their glycosides have since been identified.6, 13, 14, 15, 16, 17, 18, 19 Methods of analysis, including high-pressure liquid chromatography and nuclear magnetic resonance,20 have been published. A method for rapid isolation of andrographolide is also available.21 When callus cultures of the plant were investigated, andrographolide and the other diterpenes were not produced. Instead, the sesquiterpenes paniculides A-C were found.22 Other constituents of the plant include various flavones.3, 19, 23, 24

Uses and Pharmacology

Anti-inflammatory effects

Animal data

Andrographolide has demonstrated anti-inflammatory effects in several cellular systems, including prevention of phorbol ester–induced reactive oxygen species and N-formyl-methionyl-leucyl-phenylalanine–induced adhesion in rat neutrophils25, 26 inhibition of tumor necrosis factor–induced upregulation of intercellular adhesion molecule expression, monocyte adhesion,27 and activation of protein kinase pathways.28

Clinical data

Limited clinical studies in ulcerative colitis suggest extracts of andrographis may be as effective as mesalazine. A dose of 1,800 mg of an extract daily (in 3 divided doses) was used in the studies.29, 30

In 60 patients with rheumatoid arthritis, andrographolides 30 mg taken 3 times daily over 14 weeks resulted in improved RA symptoms of swelling and tenderness; reductions in rheumatoid factor and other indices were also associated with treatment compared to placebo.31

A clinical study assessing the effects of twice-daily A. paniculata 170 mg on relapse rate and fatigue in 25 patients with multiple sclerosis reported reductions in fatigue.32

Antimicrobial effects

Animal and in vitro data

Extracts of andrographis and andrographolide derivatives have shown modest activity in vitro against HIV.19, 33, 34, 35, 36

Antimalarial activity has also been noted during screening of andrographis extracts.37, 38, 39

The extract of A. paniculatablocked Escherichia colienterotoxin–induced secretion in rabbit and guinea pig models of diarrhea.40 Andrographolide and 3 other related diterpenes were responsible for this action.41 Results from other in vitro experiments evaluating the action of andrographolide and A. paniculata leaf extracts on E.coli are conflicting.42, 43

Clinical data

A phase 1 study of andrographolide in HIV-positive patients showed no effect on viral replication after 6 weeks, despite increased CD4+ counts.44 A clinical study evaluated the effect of A. paniculataextract 200 mg/day for 5 days on 9 self-evaluated symptoms (cough, expectoration, nasal discharge, headache, fever, sore throat, earache, malaise/fatigue, and sleep disturbance) in uncomplicated upper respiratory tract infection, with results favoring the study preparation over placebo.45

Cancer

Animal and in vitro data

In animal and in vitro experiments using human cancer cell lines to investigate the potential anticancer effects of A. paniculata, andrographolide was responsible for the observed beneficial effects rather than other diterpenes.6, 46, 47, 48 Various mechanisms of action have been proposed, including enhancement of chemokine activity, inhibition of tumor-specific angiogenesis affecting cell cycle progression, and induction of apoptosis.46, 47, 49, 50 Cancer cell lines investigated included prostate, breast, cervical, colon, hepatoma, melanoma, and lymphocytic leukemia. Researchers are now focusing on synthesizing compounds based on andrographolide to improve selectivity and potency.46, 51

Caution is recommended due to the potential for andrographolide-enhanced SDF-1-chemokine activity, which might induce tumor cell metastasis.50 A. paniculata extract has also induced cell differentiation in mouse myeloid leukemia cells.52

Dengue fever

In vitro data

Cell culture studies of andrographolide have demonstrated effects against serotypes 2 and 4 of the dengue virus.53

Hepatoprotective effects

Animal data

The extract of A.paniculatahas demonstrated hepatoprotective activity in animal studies.54, 55, 56 Hepatic drug-metabolizing enzymes were elevated in one animal experiment.56 However, in one clinical trial, elevated liver enzymes were reported.44

Hypoglycemic effects

Animal data

Extracts of andrographis have demonstrated hypoglycemic action in rats with streptozotocin- and alloxan-induced diabetes, which supports traditional use of the plant in diabetes.19, 57, 58

Hypotensive effects

Clinical data

Two older trials explored the possible hypotensive effects of andrographolide/andrographis, but further investigation is needed.59, 60

Immunostimulant

Animal data and in vitro data

In one study, both antigen-specific and antigen-nonspecific immune responses in mice were stimulated by andrographolide and an ethanolic extract; the extract was more potent than andrographolide, suggesting that other constituents of the extract were also immunostimulants.61 Inhibition of passive cutaneous anaphylaxis and mast cell stabilization was observed in studies of the purified diterpenes in rats.62

Stimulation of the production of key cytokines and immune activation markers has been investigated as a potential mechanism of andrographolide immunomodulation.5, 50, 63

Clinical data

A systematic review of 4 clinical trials found A. paniculata, either alone or in a fixed combination with A. senticosus (Kan Jang), was significantly more effective than placebo (P < 0.0001 and P = 0.0002, respectively) in reducing the severity of upper respiratory tract infections and related symptoms. The review found a lack of outcome consistency in the included studies.64 Other clinical trials have demonstrated similar results for respiratory infections, but methodology in these trials is of poor quality.4, 65, 66

In a small study in patients with familial Mediterranean fever (N=24), a decrease in frequency, duration, and severity of febrile attacks was observed compared with placebo.67

Triglycerides

Clinical data

In a clinical study of patients with modest hypertriglyceridemia (N=60), administration of andrographolide 120 mg/day improved serum triglyceride levels.68

Dosing

In clinical studies, dosages of andrographis as the crude plant have ranged from 3 to 6 g daily.69

The usual daily dose of andrographolides for common cold, sinusitis, and tonsillitis is 60 mg70, 71 but doses up to 1,200 mg have been reported.69, 71

Familial Mediterranean fever

Andrographolide 48 mg daily.67

HIV

Doses of andrographolide 5 to 10 mg/kg were used in a trial in HIV patients, but adverse reactions at this dosage led to discontinuation of the trial.44

Ulcerative colitis

A. paniculata extract 1,200 or 1,800 mg daily (in 3 divided doses).29, 30

Upper respiratory tract infection in children

A clinical trial in children with upper respiratory tract infection reported use of andrographolide 30 mg daily for 10 days.66

Pregnancy / Lactation

Avoid use. Adverse effects, including abortifacient effects, have been documented.72

Interactions

None well documented in humans. When andrographis and andrographolide were administered in conjunction with nabumetone in rats, decreases in nabumetone area under the curve and peak serum concentration were noted, which contradicts earlier findings of cytochrome P450 1A2 inhibition.73 Animal studies evaluating andrographolide in combination with glyburide have noted CYP3A4 inhibition.74

Adverse Reactions

Research reveals few adverse reactions reported with use of A. paniculata. However, adverse reactions (eg, headache, fatigue, rash, bitter/metallic taste, diarrhea, pruritus, decreased sex drive) during a phase 1 study of andrographolide in HIV-positive patients and healthy volunteers required interruption of the trial. One HIV-positive participant experienced an anaphylactic reaction. Adverse reactions became apparent at an andrographolide dose of 10 mg/kg body weight.44 In the same trial, elevated liver enzymes were experienced by many subjects. Two cases of urticaria were reported in other trials.64

Research reveals few adverse reactions reported with the use of A. paniculata. However, adverse reactions (eg, headache, fatigue, rash, bitter/metallic taste, diarrhea, pruritus, decreased sex drive) during a phase 1 study of andrographolide in HIV required interruption of the trial. One HIV-positive participant experienced an anaphylactic reaction. Doses of andrographolide 10 mg/kg body weight were used when the adverse reactions became apparent.44 In the same trial, elevated liver enzymes were experienced by many of the participants. Two cases of urticaria have been reported in other trials.64

Toxicology

Toxicology studies are limited, but andrographis does not appear to be acutely toxic. Acute lethal doses (median lethal dose) in mice are reported to be more than 40 g/kg for andrographolide.44

Ames, chromosome aberration, and micronucleus in vitro tests on a standardized extract of A. paniculata demonstrated no evidence of mutations or clastogenicity, and no evidence of acute toxicity was observed in the female rats studied.75

Male reproductive toxicity studies have been conducted with andrographis. A subchronic 60-day study in male rats showed no changes in testicular weight, histology, or testosterone levels.76 However, studies in rats given purified andrographolide for 48 days showed decreases in sperm counts and motility that were linked to disruption of spermatogenesis.3, 77

In a small, short-duration, phase 1 clinical trial in healthy men, no adverse effects were observed with Kan Jang at doses 3 times the usual daily dose. Instead, there was a positive trend in the number of spermatozoids, percentage of active forms, and fertility indexes. Study limitations included the small number of participants (N=14), short duration (10 days), and the low dose tested (3 times the normal dose versus 10-fold in animal studies).70

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This information relates to an herbal, vitamin, mineral or other dietary supplement. This product has not been reviewed by the FDA to determine whether it is safe or effective and is not subject to the quality standards and safety information collection standards that are applicable to most prescription drugs. This information should not be used to decide whether or not to take this product. This information does not endorse this product as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this product. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this product. This information is not specific medical advice and does not replace information you receive from your health care provider. You should talk with your health care provider for complete information about the risks and benefits of using this product.

This product may adversely interact with certain health and medical conditions, other prescription and over-the-counter drugs, foods, or other dietary supplements. This product may be unsafe when used before surgery or other medical procedures. It is important to fully inform your doctor about the herbal, vitamins, mineral or any other supplements you are taking before any kind of surgery or medical procedure. With the exception of certain products that are generally recognized as safe in normal quantities, including use of folic acid and prenatal vitamins during pregnancy, this product has not been sufficiently studied to determine whether it is safe to use during pregnancy or nursing or by persons younger than 2 years of age.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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