In 2008, a spike in anaphylactic and allergic adverse drug reations (ADRs) was observed for products including on the ARTG that contained the ingredient Andrographis paniculata.
Nyal cold and flu products were associated with 22 anaphylactic/ allergic-type reactions in 2008. These products also contained Sambucus nigra (Elderberry) and Salix alba (White willow)
No single causative factor was identified but the products were recalled and removed from the ARTG.
However, a subsequent review in 2010 found that only one case could be positively attributed to this ingredient, as all other cases had confounding factors.
The withdrawal of these products was followed by an apparent decline in the number of ADRs reported.
Adverse reports, however, did continue and the TGA undertook a safety review of Andrographis in 2015.
The review considered medical literature and adverse event reporting data relating to the risk of allergic reactions associated with use of andrographis.
Sixteen anaphylactic/ allergic-type cases were located in the WHO Vigibase database between 2008 and 2013 for A.paniculata. Eight of these reports were from Australia, seven from Thailand and one from Canada.
Analysis of the TGA ADR database located 43 reports of anaphylaxis and 78 reports of allergic-type reactions associated with products that contain A.paniculata that were submitted between December 2002 and April 2014.
Since the review in 2015, the TGA has continued to receive adverse event reports concerning anaphylactic/allergic reactions associated with medicines that contain Andrographis paniculata.
Since mid-2019, the TGA has identified a significant increase in the number of adverse event reports involving Andrographis and the development of taste disturbance. Most of these reports have been associated with Armaforce from Bioceuticals.
The onset of taste disturbance frequently occurs after about two weeks of use of Andrographis products, but may also occur in a shorter timeframe. Based on the reports received by the TGA, it can take up to several weeks after you stop using the product for taste to return to normal. In addition, at the time of reporting, not all individuals had regained a normal sense of taste.
That is likely that the causative compound is andrographolide.
The following warning statements are now required on the medicine label for products on the ARTG:
I have used very high daily doses of the MediHerb Andrographis Complex and the Phytomedicine Andrographis Compound (no longer available). Both of these products contained a 10:1 dry extract of Andrographis.
The MediHerb products contains 100 mg of this 10:1 extract equivalent to 10 mg andrographolide.
Armaforce contains 178.58 mg extract according to the ARTG listing. I haven’t got a product to check but online it is listed as being equivalent to 2.5 dry leaf, making that a 14:1 extract.
It is further listed as containing 62.5mg andrographolide per capsule.
The MediHerb product contains 0.1 mg andrographolide per mg extract.
However, Armaforce contains 0.35 mg andrographolide per mg extract. So the extract in Armaforce contains three times more andrographolide per mg than the MediHerb product.
Arguably the best clinically tested Andrographis products is Kan Jang from the Swedish Herbal Institute. The lead researcher is Alexander Panossian, who is also a leading researcher of adaptogens. Panossian is an Armenian researcher now living in Sweden.
Kan jang capsules contain 85 mg of the standardised extract of Andrographis equivalent to 5 mg andrographolide.
The vast majority of the ADRs associated with Andrographis are from highly concentrated extracts.
As we practice galenical medicine, it is my belief that we should use whole herb extract as much as possible as the whole herb is often the active principle. There are exceptions, I am happy to use the new, highly concentrated and bioavailable curcumin extracts or silymarin or ginkgo. However, if concentration also leads to an increase in ADRs, we should go back to a less concentrated extract. A dry extract made from just removing the liquid is typically around a 3:1 or perhaps up to a 5:1. Anything more, and it will no longer be a whole herb or full-spectrum extract.
As mentioned, I have used very high daily doses of the MediHerb Andrographis Complex and the Phytomedicine Andrographis Compoundmyself and for my family and patients without any ADRs. The MediHerb product contains a 10:1 dry extract of Andrographis equivalent to 10 mg andrographolide. Even dosing up to 8 tables daily, we never experienced any ADRs.
I have also use liquid extracts, they taste foul (bitter) so it is unlike patients will consume a high enough dose to cause serious ADRs (apart from feeling a little sick in the stomach from the bitterness).
I can’t really explain why the Armaforce product seem to be the main product having caused these ADRs. The recommend daily dosage of one capsules provides a total of 65 mg andrographolide. I have taken more using the MediHerb product. The extract in Armaforce is however highly concentrated and that may be the problem.
Compare that to the low dose in the Kan jang product which is only 5 mg per capsule.
And the use of Kan Jang in respiratory infections is supported by evidence.
We certainly tend to use heroic dosages in Australia compared to Europe!
Another interesting thing is that Kan Jang is combined with eleuthero while we tend to combine Andrographis with echinacea and other herbs in Australia.
Andrographis can cause ADRs associated with allergic reactions and loss of taste.
The ADRs seems to be dose related with products containing highly concentrated extracts causing more events.
I suggest that that you inform your patients that any product containing Andrographis has the potential to cause these ADRs.
Herbal Tidbits from https://www.facebook.com/phytotherapydeskreference
Fully revised and updated 5th Edition published.
Nigella seed is such an important traditional herbal medicine in the Middle East, and in Europe, yet I don’t think it is highly enough appreciated in Australia.
It is a brilliant herb with so many actions and indications.
Nigella seeds have long been used in folk medicine in the Arabian Gulf region, Far East Asia, and Europe. According to common Islamic and Arabic belief, Habbatul Barakah is a remedy for all ailments (universal healer). Black Seed is also mentioned as the curative “black cumin” in the Bible and is described as Melanthion by Hippocrates and Dioscorides and as Gith by Pliny.
Nigella seeds contain volatile oils including thymoquinone (major compound), carvone, thymol, nigellone, nigellicine, and nigellimine.
For the new edition of the Phytotherapy Desk Reference I highlighted its three primary actions as Anticancer, Antidiabetic, and Hepatoprotective.
It actually has so many other extremely useful actions: Everything you can think of for the digestive and respiratory systems.
It is even a galactogogue and a uterine tonic. It also has anti-inflammatory and sedative properties.
Nigella seed is used for all disorders of the digestive and respiratory systems. It is also indicated for dyslipidaemia, metabolic syndrome, dysmenorrhoea and PCOS.
Now, I just found another indication: kidney stones!
Preclinical (animal) studies have found that nigella is beneficial in the prevention and treatment of kidney stones.
Recently a randomised, controlled clinical trial (n=60) conducted by Iranian researchers found that nigella seed powder significantly resolved or reduced kidney stones in participants taking nigella capsules containing 500 mg powdered seeds twice daily for ten weeks.
Patients were assessed in terms of size of renal stones by using sonography before and after the intervention. They were only included in the study if they had stones large than 5 mm.
The difference in the mean size of renal stones after the study was significant between the two groups (p < 0.05).
This study was a well-designed study. The methods are clearly described in the article and it included a sample size power analysis, something you don’t often see in herbal medicine trials although it is critical.
A power analysis is basically an analysis to find out how many participants to include in a study based on the estimated effect size which is deemed significant. Note also that they used sonography to measure the response.
The results of this study suggest that nigella seed powder is effective in the early stages of kidney stones when the stones are smaller, but once the stones increase in size, the efficacy is reduced.
Participants who took nigella seed were nearly 3 times as likely to excrete the kidney stones compared to placebo.
Larger stones may need longer time to treat or perhaps an extract of nigella seed would be more effective. The typical liquid extract dosage is 30-80 ml per week.
Nigella should certainly be considered for the prevention and treatment of urinary and kidney stones.
Drinking green tea has been described as being beneficial for reducing the risk of diabetes type 2.
A retrospective cohort study performed in Japan, found a 33% risk reduction of developing type 2 diabetes was found in subjects consuming six or more cups of green tea daily compared to those consuming less than 1 cup per week https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3689013/
However, green tea supplementation does not seem to be efficacious in the treatment of diabetes. The results of a systematic review and meta-analysis suggest that the supplementary intake of green tea had no significant effect on FPG, fasting insulin, HbA1c and HOMA-IR in patients with T2DM. https://pubmed.ncbi.nlm.nih.gov/33285391/
Akdogan, M., M. N. Tamer, E. Cure, M. C. Cure, B. K. Koroglu, and N. Delibas. 2007. 'Effect of spearmint (Mentha spicata Labiatae) teas on androgen levels in women with hirsutism', Phytother Res, 21: 444-7.
M. spicata contains about 0.21–2.1% volatile oil, 29–74% carvone, 4–24% limonene and 3–18% cireole. Carvone is the most important constituents of M. spicata.(Akdogan et al. 2007) Carvone has some endocrine function but it is not well studied.https://pubmed.ncbi.nlm.nih.gov/17310494/
Clinicians have investigated whether the men who live in Yeniarbademli town have been admitted to the hospitals with the complaints of diminished libido. They thought that daily consumption of four cups of tea steeped with M. spicata or M. piperita caused diminished libido.(Akdogan et al. 2007)https://pubmed.ncbi.nlm.nih.gov/17310494/
A single-blind randomised clinical trial found that a herbal mixture of Mentha spicata, Zingiber officinale, Cinnamomum zeylanicum, and Citrus sinensis along with clomiphene citrate was found to improve free testosterone, HOMA-IR, lipid profile, and clinical features of 60 women with PCOS.Free full article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7667414/
Spearmint (Mentha spicata) has no significant toxic effect on the reproductive system, fertility and number of offspring in adult male rats (dose: 40 mg/kg spearmint extract orally for 45 days).
Reference (full, free article): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4224956/
A randomised controlled trial has found that spearmint herbal tea has significant anti-androgen effects in 42 women with polycystic ovarian syndrome.
The women drank spearmint tea twice daily.
Free and total testosterone levels were significantly reduced over the 30 day period in the spearmint tea group (p < 0.05). LH and FSH also increased (p < 0.05).
Patient's subjective assessments of their degree of hirsutism scored by the Dermatology Quality of Life Index were significantly reduced in the spearmint tea group (p < 0.05).
While these hormonal changes were associated clinically with a reduction in the self-reported degree of hirsutism there was no significant reduction in the objective Ferriman-Galwey ratings of hirsutism between the two trial groups over the trial duration (p = 0.12). It is very likely that the study period of just 30 days is too short.
The authors conclude that the time taken for hirsutism to resolve is significant and a much longer future study is proposed as the preliminary findings are encouraging that spearmint has the potential for use as a helpful and natural treatment for hirsutism in PCOS.Reference: https://pubmed.ncbi.nlm.nih.gov/19585478/
Case studies provided by Dr Greg Schwarz in Hobart showing the benefit of integrative oncology with IVC, injectable herbal extracts, other supplements, diet and exercise and moderate whole body hyperthermia to detoxify, heal and support recovery following conventional treatment.
Note that hyperthermia can be used during chemotherapy and radiotherapy as well as afterwards.