Lions mane: extract or powder, what is suggested?

There is no clinical research on the Oriveda brand, either... It's NOT clinically proven. Furthermore, the only in-vivo human clinical research on lion's mane has used the whole fruiting bodies, not the mycelium. I cannot find a single in-vivo human study using the mycelium of lion's mane. Not a single study. Yet somehow the message has become that the mycelium of lion's mane is the only useful part, when all human clinical research is on the fruiting bodies...

Improving Effects of the Mushroom Yamabushitake \(Hericium erinaceus\) on Cognitive Impairment: A Double-blind Placebo-controlled Clinical Trial

The fresh fruit bodies of Yamabusitake were air-dried at 60°C overnight and powdered. The test food was 250 mg tablets containing 96% of Yamabushitake, prepared by adding silicon dioxide and fat to Yamabushitake powder, and tablets of the same shape containing cornstarch and lactose instead of Yamabushitake powder (Table1). The nutrient composition of the test food is shown in Table2. The subjects took four Yamabushitake-containing or placebo tablets three times a day for 16 weeks.

Consequently, Yamabushitake can be regarded as a useful food for the prevention of dementia without any adverse effects. This effect may be attributed to promoting NGF by hericenones, but further studies are needed to clarify the mechanism.

So we have human trials that show the fruiting bodies of Lion's Mane improve cognitive impairment. We do NOT have any human trials showing the same for mycelium products. The study often linked for mycelium only used mouse astroglial cells IN VITRO.

Here is another human clinical trial using the fruiting bodies:

Reduction of depression and anxiety by 4 weeks Hericium erinaceus intake

It showed that whole fruiting body extracts of Lion's Mane significantly improved depression, sleep quality, and anxiety scores. This is valid human clinical research, not in vitro studies using mouse astroglial cells. The mouse studies are certainly interesting. However, the human clinical research behind the effectiveness of Lion's Mane mushroom has used the fruiting bodies. Furthermore, the FDA says that you cannot call a mycelium product a "mushroom" since it is not a mushroom.

http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074627.htm

Any food in which mushroom mycelium is used should be labeled to state that fact. Labeling should not suggest or imply that the food contains mushrooms. For example, a soup in which mushroom mycelium is an ingredient should not be labeled or sold as "mushroom soup" since that name by long consumer understanding and usage is preempted by soup containing real mushrooms.

In addition:

http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM515733.pdf

Page 25-26:

What are examples of processes that chemically alter an article of food present in the food supply?

Below are some examples of processes that FDA would likely consider to involve chemical alteration. These processes would also be likely to affect the safety profile of a dietary ingredient. The examples below are intended only for the purpose of illustration and are not a comprehensive list of processes that result in chemical alteration.

See question IV.B.5 for further discussion on chemical alteration.

Use of a botanical ingredient that is at a different life stage than the life stage of the botanical ingredient used as a conventional food. Examples: making an extract from unripe instead of ripe apples or using the mycelium instead of the fruiting body of a fungus.

So the FDA has stated and clarified their position on the matter: that mycelium is NOT a mushroom, and cannot be sold as such. If mycelium is used, it must be clearly labeled as such, and CANNOT reference clinical research regarding the whole fruiting body of the mushroom, as they are different ingredients. The current human clinical research on Lion's Mane has used fruiting bodies, and has shown them to be effective in a number of different measures. So that is what we sell.

You also have the following study:

Nerve Growth Factor-Inducing Activity of Hericium erinaceus in 1321N1 Human Astrocytoma Cells

Preparation of Mushroom Extracts- Fresh fruiting bodies of H. erinaceus, P. eryngii, G. frondosa, and A. blazei were lyophilized and powdered. The dry powder (5g) of mushrooms was extracted with 150 ml of ethanol for 2h at room temperature, and H. erinaceus ethanol extract (499mg), P. eryngii ethanol extract (386 mg), G. frondosa ethanol extract (328 mg) and A. blazei ethanol extract (426 mg) were obtained. Similarly, H. erinaceus was extracted with H2O and ethyl acetate, and H. erinaceus H2O extract (1734 mg), and H. erinaceus ethyl acetate extract (257 mg) were obtained. The extracts were stored at 30°C before use.

The NGF mRNA level in 1321N1 cells was significantly increased by the calcium ionophore A23187 at a concentration of 1mM (positive control), and by the ethanol extract of H. erinaceus at a concentration of 100mg/ml.

So they used only the fruiting bodies of lion's mane, and found it to significantly increase NGF. This completely goes against the argument that only the mycelium contains the NGF increasing compounds. They even state the following:

These results, therefore, raise the possibility that H. erinaceus has unknown active compounds that promote NGF expression, other than hericenones, which are lipid-soluble (soluble in ethanol and/or ethyl acetate).

Furthermore, the oral administration of H. erinaceus increased NGF mRNA expression in the mouse hippocampus. This result suggests the possibility that the active compound could be absorbed into blood and delivered into the central nervous system through the blood–brain barrier. The hippocampus is postulated to encode working memory. The increase in the level of NGF mRNA in the hippocampus suggests the potential of H. erinaceus to act on the central nervous system in vivo.

Thus, it is necessary to reevaluate whether fruit bodies contain erinacines, and to examine the existence of unknown derivatives with NGF-inducing activity in the fruit bodies of H. erinaceus. In conclusion, H. erinaceus contains active compounds that stimulate NGF synthesis via activation of the JNK pathway; these compounds are not hericenones.

Then you have this recent 2015 study:

Chemical constituents from Hericium erinaceus and their ability to stimulate NGF-mediated neurite outgrowth on PC12 cells

In conclusion, one new compound 11, along with 10 known compounds (1–10) was isolated from the fruiting bodies of H. erinaceum, and their structures were elucidated by spectroscopic analyses. The chiral HPLC was used to separate the (-)- and (+)-antipodes of the two enantiomers, 10 and 11. Compounds (±)-10, (-)-10 and (+)-10 exhibited high neurite outgrowth-promoting activity in NGF-induced PC12 cells, while this activity of compounds 1, 2 and 3 was weak. These data suggested that the aromatic compounds are further neuroactive substances found in H. erinaceum.

So this doesn't only show NGF-promoting effects of compounds in the fruiting bodies, it shows they promoted neurite outgrowth; which is what we are really looking for. So we have two in-vivo human clinical trials using the fruiting bodies of lion's mane, and more recent in-vitro studies showing that the fruiting bodies increase neurite outgrowth and promote NGF expression. The mycelium seems to also have NGF-promoting effects. However, that doesn't invalidate the NGF effects of the fruiting bodies, and it certainly does not invalidate the in-vivo human clinical research on the fruiting bodies of lion's mane.

It's really not hard to do a cultured mycelium extract of lion's mane. We have been wanting to do it for years. However, we have held off till we can get accurate methods for measuring the Erinacine A content in it. We think we have found some now, but need more testing. So we have stuck to using the whole fruiting bodies till this point, which are the only ones with in-vivo human clinical research; which also have been shown to increase NGF. I'm not sure how Oriveda has convinced people their product is clinically proven, because there are no studies that I can find on it. Furthermore, they are not testing for anything other than polysaccharides and beta-glucans, which is what we test for as well. They are not testing for Erinacine A, nor any of the hericenones. So I am unsure how people think they are standardizing to the NGF-promoting compounds. Mixing a cultured mycelium extract with a whole fruiting body extract sounds like a good idea on paper. However, without actual testing methods showing the percentage of actives in the extract, it's really hard to scientifically quantify how effective it is. The only thing Oriveda is standardizing for in their lion's mane product is beta-glucans, which they claim are 234mg in the total 900mg dose. That's 26%. We also standardize to beta-glucans, and our testing showed our current batch at 40.3%. So our extract seems to have more of the standardized ingredient. We can speculate theirs might have more Erinacine A, due to the cultured mycelium extract. However, until they quantify that with actual testing, it's only speculation. On top of that, we have no human clinical research, in-vivo or in-vitro, with Erinacine A. So while the mice and rat studies show it increases NGF, we can only speculate that translates to humans. The fruiting body extracts have both in-vivo and in-vitro human clinical research. So for now that's the one most scientifically proven.