Thanks for posting that article. Anybody want to comment on what hes saying here rather then try and criticize or bad mouth his character? Regardless of wether he might be good or bad, doesn't change that article...So, anybody care to confirm what hes written there about what that study shows?
Thanks.
I really want to avoid character disputes, and you are correct in saying that they do nothing to change the contentions of the article. That being said, I suppose the most fair and acute manner of doing this is to simply address the primary points of the article that I disagree with. Those being twofold:
But check out the dose required…the lowest dose examined in the study was 250mgs/kg! On a kg/kg (simple comparative bodyweight) basis you’ll need about 25 grams of the stuff per day for a 100kg (220lb) bodybuilder, going off the absolute lowest dose. The highest dose would require 100g/day based on a 220lb (100kg)human bodyweight. However, this is based on human weight versus rodent weight. Now, if we convert the rodent dose to the human dose equivalent using the accepted body surface area formula bsa We find that we need just over 4 grams per day. And that’s at the lowest dose examined – we’d double that dose for the 500mgs/kg (over 8 grams per day) and double it again for the 1,000mgs/kg dose (over 16 grams per day).
So how much of a boost in serum testosterone did the herb provide? Well, we don’t know, because the study doesn’t tell us. Wait…what? Yeah, you read that correctly, the study doesn’t actually look at serum testosterone levels. So what about free testosterone levels? Well, the study doesn’t look at that either.
a) Because the study features such exorbitant amounts of
Massularia acuminata, any androgenic potential is lost in human cross-over.
b) Because the study does not feature the results of serum or free testosterone, it cannot be considered a reliable source of information.
Now, on face value, these seem to be relatively sound critiques which give USPlabs little in the way of a defensible position. However, they are critiques borne from overlooking minor points of analysis that I feel are easily correctable. And so, on to the first point.
For reference sake, let's examine the dosages again, but with a bit of a keener eye:
Male rats weighing between 220 and 260 gwere completely randomized into four groups: A, B, C and D. Group A, the control received orally 1 ml of distilled water (the vehicle) while groups B, C and D were orally administered with 1ml each corresponding to 250, 500 and 1000 mg/kg body weight of the plant extract, respectively for 21 days.
Take note of the bold portion, and in particular, that special little phrase "corresponding to." What does this mean? Well, it means that, despite what was emphasize in the article, the rats were administered only
1 ml of fluid constituted by a distilled extract of the plant which
corresponds to - or in other words, is equal to - the respective amounts of powdered plant listed. Now, this fact becomes exponentially more important when we examine the materials and methods portion of the full text:
2.5. Animal grouping and extract administration
A total of 60 male rats were used and were completely randomized
into four: A, B, C and D of 15 animals each after being allowed
to acclimatize for 2weeks. The distilledwater and the extractswere
orally administered as follows:
Group A: Control (1 ml of distilled water).
Group B: 1ml of the extract corresponding to 250 mg/kg body
weight.
Group C: 1ml of the extract corresponding to 500mg/kg body
weight.
Group D: 1ml of the extract corresponding to 1000 mg/kg body
weight.
As we can see, while the
corresponding dose is multiplied, the actual amount of fluid ingested remains at 1 ml. Why? Because we are dealing with an aqueous plant extract, and not a simple powdered preparation - and these types of aqueous and methanolic extracts are precisely the type of extracts that are referred to by various companies, USPlabs included, when the phrase "standardized extract" is used. (More on that to come.)
That term means, in other words, "X amount of powder
processed to contain a certain amount of an active constituent." In this case, the researchers prepared a 1 ml aqueous solution which is standardized to correspond to doses of 250, 500 and 1000 mg/kg of raw plant, respectively.
Now, using the body-surface-area equation to normalize the rat dosage, what amount of fluid would a human hypothetically need to achieve the same purported effects. For that, we simply use a standard formula of multiplying the rodent dose by 0.162 to arrive at 0.162 ml. All this considered, statement such as:
And that’s at the lowest dose examined – we’d double that dose for the 500mgs/kg (over 8 grams per day) and double it again for the 1,000mgs/kg dose (over 16 grams per day).
seem somewhat less potent, particularly considering that the abstract itself alludes to the fact that all the rat subjects, even at the highest dosage, took
precisely the same amount of fluid. This is how extracts work and how the supplement industry operates from a practical standpoint - or we would all be eating lbs upon lbs of beef for creatine, half pounds of
Epimedium for our Icariin, and oz of
Mucuna for our L-DOPA. Keep in mind that, at this point, saying "it would only require 0.162 ml" of fluid only means to suggest that, in opposition to the article, noticeable effects could be achieved in a practical way.
Now, to expand on the concept of extracts, allow us to peer further into the full study for a more robust explanation of the researchers' extraction technique:
2.4. Preparation of aqueous extract of Massularia acuminata stem
The plant stem was cut with a sterile knife into pieces and then oven-dried at 40 ◦C until a constant weight was obtained. The pieces were then pulverized with an electric blender (Blender/Miller III, model MS-223, China). The powdered material was stocked in a plastic container from which 200 g each was separately extracted in 500ml of distilled water for 48 h at room temperature with constant shaking. The extract was then filtered with filter paper (Whatman No. 1) and the resulting filtrate was concentrated on a
steam bath to give between 5.48 and 5.60 g of the brownish black slurry (residue) which is equivalent to a % yield of 2.74±0.05 g. The residue was reconstituted in distilled water to give the required dose of 250 mg/kg body weight while higher doses of 500 and 1000 mg/kg body weight were also used. The reconstituted aqueous extract was administered orally to all animals in the various groups using metal oropharyngeal cannula.
So, as we can see from this incredibly basic description, the aqueous extract was little more than pulverized plant distilled and concentrated at corresponding doses. This is important for two reasons. The first, it displays that, as I said previously, the rodents were indeed not ingesting 1000mg/kg of
powder a day, but instead a simple 1 ml
fluid corresponding to that dose.
The second, that the researchers did not attempt to identify nor extract for any particular constituents viz., HPLC, GC/MS or any other such technology, which means the results achieved in the study were the result of a crude, whole plant extract. Suddenly, the dose we must ingest starts to become considerably more practical, and those "meager" results that much more impressive.
Taking this into consideration, let us assume for a moment that supplement producers put the words "standardized extract" on our products for a reason other than to look pretty. Then let's assume the reason is that either ourselves, or independent researchers, have identified one or several principally pharmacologically active compounds that we extract for to ensure a standard dose of active constituent. Assuming this does occur - which it indeed dose - it would occur to avoid precisely the situation that the article describes: that is, consumers ingesting ungodly amounts of raw powders to mimic the effects seen in independent studies. Now, on to more assumptions.
If we take the above as valid, what then is a reasonable amount of "principally pharmacologically active compound" for a whole plant to contain, on average? Well, while each plant is vastly different, a conservative amount to state is the range of 1-10%. An example would be
Mucuna pruriens which, depending on topography, soil conditions, cultivation techniques and so on, contains anywhere from 1-6% native L-DOPA content.
And so, if we assume a similar range for this compound, it means that the rats were receiving a mere 25mg/kg of principally active compound in each 1 ml dosage at maximum, and 2.5mg/kg at minimum. Obviously, had the researchers identified a compound or compounds of interest and extracted it/them at a standardization of 20-50%, the dose becomes even more practical by several degrees of magnitude. As I said before, the "meager" results become that much more impressive when we consider the likely minute amount of active constituent that the rat subjects were actually receiving, and the fact that we can (as supplement producers) and do extract for active compounds.
So, taking all this into consideration, and as we have done with several other of our herbs, USPlabs identified and extracted particular components of Massularia which we feel to be principally active within the plant itself. And while I will obviously not reveal the structures of these compounds, nor the amounts in which they are contained in the whole plant, I will simply say that identifying and extracting these components is a significant contributor to both the delayed time of release since Jacob first commented on them, as well as the "high" cost of the product. Given that we have also received a patent for extracting principally-active components from Cissus quadrangularis, we feel confident that our facilities have indeed identified the correct compounds, have extracted them in adequate amounts, and have given us a product that is both a) a practical dose and b) able to reproduce or exceed the results of the study.
Which brings us to the second portion, the results! I am sick of writing, however, so I will most likely continue this tomorrow if there is still a desire for me to do so.