Declared 25 percent and power categories in scientific reviews

What exactly does the declared 25 percent on the raw material label mean?

The declared 25 percent is a value recorded by the manufacturer for the entire batch, not a measurement of the bag dispensed at the pharmacy. It refers to the sum of tetrahydrocannabinol after heating the raw material and is subject to an allowable deviation of ten percent, meaning it realistically indicates a range from 22.5 to 27.5 percent.

In the fresh flower cluster, the acidic form predominates, which only transforms into the active form under the influence of heat. The number on the label describes the potential of the raw material after heating, not the composition of the plant at the time of harvest. The relationship between what the manufacturer declares and what is shown by the marking made on the sample is the subject of a separate page about declarations. 20 percent. Here, it is enough to remember that the declaration is a commitment to the documentation of the batch, not a reading from the packaging that the patient holds in their hand.

The deviation works both ways, so the ranges defined by neighboring declarations partially overlap. What this means for comparing positions with each other is elaborated on the declaration page. 18 percent. This page does not compare positions available on the market: the current list of strains is maintained by the hub of this cluster, and the store has a separate category dried flower.

How do scientific reviews categorize the potency of dried flower and where does 25 percent stand in this division?

Three reviews from this database categorize potency in three different ways. The first sets one boundary around ten percent, the second creates five ranges corresponding to what is actually on sale, and the third compares only stronger products with weaker ones. The declaration of 25 percent falls into the broadest category in each of them.

The review from Annals of Internal Medicine accepted one boundary: it considered a product with high concentration to be one that provides over 5 mg of tetrahydrocannabinol per serving or exceeds ten percent content, as well as everything described as a concentrate. With this definition, dried flower with a declaration of 25 percent is in the same bag as an extract with double the content. This boundary is supported by a review encompassing 99 studies and over 221 thousand participants, in which 42 percent of the works were randomized.

The review from the American Journal of Psychiatry took a different approach and established five ranges before analysis, tailored to correspond to what actually reaches the market. They are compared in the table below. This is the only division in this database based on something other than the seller's label. The authors sifted through 4545 records, leaving 42 observational and experimental works, and assessed the overall certainty of evidence as very low.

The oldest of these reviews, from The Lancet Psychiatry, does not use numbers at all: it divides the material into stronger and weaker as the studies included in the analysis did. Out of 4171 screened articles, 20 met the criteria, all observational, involving people.

Does the 25 percent division differ from 20 or 30 percent?

No. In the division from the American Journal of Psychiatry, the range from 20 to 30 percent is one category, so declarations of 20, 22, 25, 27, and 30 percent fall into the same field. None of the four studies in this database distinguishes anything within it by a single result.

This single range covers the vast majority of Polish pharmacy dried flower. In this cluster, 85 cultivars carry 112 declarations of content, ranging from 8 to 30 percent. Eighty-one of them fall between 20 and 30 percent, twenty-nine between 10 and 19, and two below ten. Fifty-four cultivars out of 85 have all their declarations within this one range.

No declaration in this set exceeds 30 percent, so the two upper categories from the table above, those intended for kief, resin, and concentrates, remain empty for pharmacy dried flower. All the material available to the doctor here falls within the three lower ranges, and in practice mainly in one of them.

The lack of a common measure of exposure is not a criticism of the editorial team, but a note from the authors themselves. The team from The Lancet Psychiatry stated directly that such a measure is lacking, and the team from the American Journal of Psychiatry admitted that potency has been estimated from participants' declarations and measured differently in each study. Therefore, they had to establish their own ranges before comparing anything.

How is the strength of the raw material matched to the patient?

The attending physician decides, as we are dealing with a raw material issued exclusively by prescription in category Rpw. The number on the label does not directly translate to the dose: with the same declaration, a different mass of raw material and a different route of administration result in completely different exposure to the active substance.

The declared content refers to the proportion, not the dose. The same mass of raw material with a declaration of 25 percent carries more active substance than weaker raw material, but how much of it reaches the body is determined by the method of administration and the size of the dose, which is not described by the number on the label. The gradual approach to dosing, or titration, is elaborated separately on the declaration page. 22 percent.

Tolerance changes the picture even more. The same position in two patients, one of whom has been taking the raw material for months while the other is just starting, is not the same exposure, and this difference is not visible in any number printed on the packaging. Therefore, the choice of potency is not the reader's choice, but a decision made in the office, based on the interview and a complete list of medications taken.

Does the declared 25 percent change the onset of action and its duration?

No. The onset and duration are determined by the route of administration, not the number on the label. The declared content indicates how much active substance the same mass of raw material carries, not how many minutes it takes for the effect to begin or how long it lasts in the body.

The route of administration determines the course more than the variety itself. After vaporization, the substance passes from the lungs to the blood almost immediately, so the first sensations appear after a few minutes, the intensity increases for another ten to thirty minutes, and the whole effect lasts for two to four hours. After ingestion, the raw material first passes through the intestine and liver, so the first sensations are awaited from half an hour to two hours, and the episode can last six, sometimes eight hours. Hence the most common mistake with oral administration: anyone who thinks nothing is happening after thirty minutes and takes another dose will receive both doses at once. The above ranges describe the route of administration, not this variety; pharmacokinetic studies for a single cultivar have not been published.

The declaration thus changes the scale, not the clock. It is a separate matter that the raw material tested twenty years ago was weaker than today's: a review from the journal Addiction showed through a meta-analysis of subsequent years that concentrations have increased, so older studies describe material that is no longer available on the market today. This thread is developed on the declaration page. 30 percent.

What is known, and what is not known about the relationship between the potency of the raw material and the effect?

It is known that higher concentrations are more often associated with the diagnosis of psychosis and cannabis use disorder. It is not known whether a higher declaration provides a better therapeutic effect: there are few studies on medical use, their results are mixed, and the certainty of evidence has been assessed by the authors of two reviews as very low.

The largest collection comes from Annals of Internal Medicine: a systematic review of 99 studies involving 221,097 people, of which 42 percent were randomized studies. In studies outside the therapeutic context, an unfavorable association with psychosis or schizophrenia was shown in 70 percent of studies, and with cannabis addiction in 75 percent. For anxiety, this percentage was 53 percent, and for depression 41, mainly concerning individuals without a diagnosis. Moderate or high risk of systematic error burdened over 95 percent of the included studies.

The therapeutic side of the same review looks different: benefit for anxiety was found in 47 percent of studies, for depression 48, but at the same time 24 and 30 percent of these areas showed unfavorable associations. The review from The Lancet Psychiatry, based solely on observational studies, observed an increased risk of psychosis and cannabis addiction with stronger products, while for depression and anxiety, it considered the evidence to be inconsistent. The review from the American Journal of Psychiatry found a signal in the area of problematic use, while in other areas the results were less consistent, although they tended to be rather unfavorable for stronger products.

The fourth study, from the journal Addiction, does not measure the effect on the patient at all. A meta-analysis of subsequent years showed that concentrations in the raw material have increased, and the conclusion from this is methodological: a study from a decade ago describes material that is weaker than today's, so transferring its results directly to today's dried flower underestimates exposure.

What adverse effects are associated with higher potency raw material?

For the range covering a declaration of 25 percent, there are no Polish data on frequency. National reports on adverse events concern dried flower as a group of raw materials, and reviews focused on potency primarily describe non-medical use and psychological effects, so their percentages do not directly transfer to a patient with a prescription.

Reports of adverse effects are collected for medicinal products with a batch number, not for the strain name, so the following pertains to hemp dried flower as a group of raw materials. The most frequently reported symptoms are dry mouth, red eyes, and increased heart rate. Dizziness upon rapid standing, daytime drowsiness, and temporary worsening of short-term memory are less frequently described, as well as anxiety that increases with dosage. A separate issue is medications taken concurrently, especially sedatives and those affecting coagulation: their assessment requires knowledge of the entire list of preparations, not just the description of the plant. We do not provide the frequency of these symptoms numerically, as public compilations for hemp dried flower in Poland do not separate them by individual products.

The reviews referenced on this page discuss something different than the above list: they address diagnoses made after years of use, not symptoms after a single dose. The relationship with psychosis and addiction is described there for stronger products as groups, without separating declarations within it. Symptoms reported at higher concentrations are elaborated on the declaration page. 27 percent.

Frequently asked questions about the declared 25 percent

Does a higher percentage on the label mean stronger therapeutic effects?

It has not been shown that a higher declared percentage on the label indicates stronger or better therapeutic effects. The evidence regarding the potency of the raw material pertains almost exclusively to adverse effects and non-medical use, not efficacy, and studies on therapeutic applications are few and yield mixed results. The authors of both of the latest reviews assessed the certainty of evidence as very low. There is also no study that compared two pharmaceutical dried flowers differing only in declared content.

How much tetrahydrocannabinol can dried flower with a declaration of 25 percent realistically contain?

With an allowable deviation of ten percent from the declared value, the range is from 22.5 to 27.5 percent. The result of the analysis performed on a sample from the batch can fall anywhere within this range and still remain compliant with the label.

Is 25 percent a lot compared to Polish pharmaceutical dried flower?

This is the upper part of the declaration range. In this cluster, there are 112 declarations for 85 cultivars, the lowest being 8 percent and the highest 30. There are none above 30 percent, so categories reserved in the literature for kief, resin, and concentrates remain empty for pharmaceutical dried flower.

What is the difference between a declaration and the result of analysis in a specific batch?

The declaration is a value assigned to the batch in the manufacturer's documentation, while the analysis pertains to a sample taken from that batch. Compliance is assessed against the tolerance range, not against a single number.

Do the reviews differentiate dried flower with a declaration of 25 percent from concentrates?

Only one of them does. The review from the American Journal of Psychiatry keeps concentrates in a separate category above 60 percent. The review from the Annals of Internal Medicine sets one boundary at ten percent, and once exceeded, it no longer separates dried flower from extract.

Who decides on the potency of raw material in treatment?

The attending physician. The raw material is dispensed by prescription in the Rpw category, so the selection of the item, its potency, and method of administration is up to them, not the patient reading the description online.

Dried flower is a pharmaceutical raw material dispensed by prescription in the Rpw category, and the material is informational in nature and does not replace medical advice.

The editorial text was prepared by redakcja ubucha.pl.