In short
Serenoa repens (bartram) small., also known as saw palmetto, is a herbal substance prepared from the fruit of the Serenoa repens plant. It is being studied in a phase 3 clinical trial for benign prostatic hypertrophy (BPH), a non-cancerous enlargement of the prostate gland. The trial, which is authorised and plans to enrol 410 participants, is testing whether a 320 mg daily oral dose of the extract can reduce chronic prostate inflammation.
Key points
- Serenoa repens (bartram) small. is a herbal preparation from saw palmetto fruit, used in solid oral dosage forms.
- A phase 3 trial is testing Permixon® 320 mg daily in benign prostatic hypertrophy.
- The trial plans to enrol 410 participants and is currently authorised.
- The main measure is the proportion of patients needing a repeat prostate biopsy within 12 months.
- The herbal substance has well-established use status in the EU for certain preparations.
- Researchers have proposed a mechanism involving inhibition of the enzyme 5α-reductase.
What is Serenoa repens (bartram) small.?
Serenoa repens (bartram) small. is a herbal substance prepared from the ripe fruit of the saw palmetto plant, a small palm native to the southeastern United States. The European Medicines Agency (EMA) has issued a herbal monograph for this substance, recognising both well-established use and traditional use preparations. The well-established use preparation is a soft extract with a drug-to-extract ratio (DER) of 7–11:1, obtained using hexane as the extraction solvent, while the traditional use preparation is a soft extract with a DER of 7.5–14.3:1, extracted with ethanol 90% to 96% m/m.
How does Serenoa repens (bartram) small. work?
The mechanism of action of Serenoa repens (bartram) small. is not fully established. A 2016 research article proposed that components of the extract may inhibit the enzyme 5α-reductase, which converts testosterone to dihydrotestosterone (DHT), a hormone involved in prostate growth. This hypothesis was developed using an in silico approach, meaning a computer-based modelling study, based on the X-ray structure of a related enzyme called 5β-reductase. The authors suggested that inhibition of 5α-reductase could reduce the production of DHT in the prostate.
Which conditions is it used or studied for?
- Benign prostatic hypertrophy (BPH) — a non-cancerous enlargement of the prostate gland that can cause urinary symptoms. The phase 3 trial is studying whether Serenoa repens extract can reduce chronic prostate inflammation in this condition.
- Lower urinary tract symptoms — the EMA herbal monograph recognises traditional use of certain preparations for the relief of lower urinary tract symptoms related to BPH.
How is Serenoa repens (bartram) small. given?
Serenoa repens (bartram) small. is given by mouth in solid dosage forms, such as capsules or tablets. In the phase 3 trial, the product Permixon® is administered as a hard capsule containing 160 mg of the extract, with a total daily dose of 320 mg (two capsules) taken orally. The comparison arm in the trial receives a placebo capsule containing only Macrogol 6000, an inactive substance.
What do the clinical trials show?
The SERENDIPITY trial is a phase 3, multicentric, randomised study comparing Permixon® 160 mg capsules (320 mg daily) with placebo in 410 participants with benign prostatic hypertrophy. The trial is authorised but results are not yet available. The primary outcome is the proportion of patients undergoing a repeat prostate biopsy within 12 months. The study will also evaluate changes on MRI using the PIRADS scoring system and potential reductions in prostate-specific antigen (PSA) values. Participants are adults with chronic prostate inflammation associated with benign prostatic hypertrophy.
What side effects are known?
The sources provided do not include a specific list of side effects for Serenoa repens (bartram) small. The EMA assessment report is a regulatory document that would contain safety information, but the excerpt provided does not detail adverse reactions. No side effect data were provided in the trial record or the supplementary sources.