Benefits
Prostate support: urinary symptoms and nighttime urination in older men
A Cochrane review of 4 controlled trials in 444 men with benign prostate enlargement, lasting 12 to 24 weeks, found that more men on rye pollen extract rated their urinary symptoms as improved than on placebo (risk ratio 2.40) and that nighttime urination improved more. The trials were small and short, and how treatment was allocated was unclear in all of them. The review was later withdrawn because it was not being updated.
Pelvic discomfort and prostate symptom scores in men
In a 12-week placebo-controlled trial in 139 men with chronic pelvic pain and signs of prostate inflammation, the extract improved pain, quality of life and total symptom scores; 70.6% responded versus 50.0% on placebo. A pooled analysis of 4 trials, 2 of them without a placebo group, was positive, but a newer one that mixed pollen with other products found no clear benefit.
Urine flow, residual urine and prostate size
Objective measures are where the evidence is weakest. Pooled across controlled trials, the extract did not improve urine flow rate, urine left in the bladder or prostate size compared with placebo or other products. In one 60-man placebo trial, residual urine and prostate diameter fell on the extract, but flow rate did not differ from placebo.
Longer-term use over months to years
Most controlled trials lasted 6 months or less. In a 4-year Chinese study of 240 men, the higher of two doses gave larger symptom and flow gains and fewer cases of urinary retention and surgery than the lower dose, but there was no placebo group. An uncontrolled Japanese study of 79 men reported better symptoms and flow and no side effects.
Use alongside prescribed prostate medicines
In men whose pelvic pain persisted on an alpha-blocker, adding the extract for 12 weeks lowered pain scores in a trial without a placebo group. In men with urinary symptoms, the alpha-blocker tamsulosin, alone or combined with the extract, worked better than the extract alone. Neither trial supports replacing a prescribed medicine.
Mechanism of action
Prostate tissue and cell growth in lab and animal studies
In older rats with hormone-induced prostate inflammation, the full extract reduced damage to the gland lining and limited overgrowth of the supporting tissue, with each of its two fractions accounting for one of these effects. In prostate cell lines, both fractions slowed cell growth and lowered androgen receptor and PSA protein in stromal cells. These are lab and animal findings, and two of the cell study's authors worked for the maker.
Inflammatory signals in immune and prostate cells
In immune cells and prostate cell lines, the extract raised the anti-inflammatory messenger IL-10, but it also raised the pro-inflammatory messengers IL-6 and IL-8. How these test-tube effects relate to pelvic pain or urinary symptoms in men is not known.
Clinical trials
Cochrane systematic review of randomized or controlled trials comparing Cernilton with placebo or other products in men with benign prostatic hyperplasia; the 2011 reissue was withdrawn because the authors were not going to update it (Wilt et al. 2000, Cochrane Database Syst Rev)
444 men in 2 placebo-controlled and 2 comparative trials lasting 12 to 24 weeks.
More men reported satisfactory or improved urinary symptoms on Cernilton than on placebo (risk ratio 2.40, 95% CI 1.21 to 4.75), and nighttime urination improved (risk ratio 2.05 versus placebo). Urine flow, residual urine and prostate size did not improve. Withdrawal rates were 4.8% on Cernilton and 2.7% on placebo. The authors called the trials short and small with unclear allocation concealment and unknown preparation quality, and the comparison products were not proven treatments.
Double-blind, placebo-controlled trial of a 6-month course of Cernilton in men with outflow obstruction due to benign prostatic hyperplasia (Buck et al. 1990, Br J Urol)
60 men with outflow obstruction due to benign prostatic hyperplasia.
69% of men on Cernilton reported subjective improvement versus 30% on placebo, a significant difference. Residual urine and the front-to-back diameter of the prostate on ultrasound fell significantly with Cernilton, but flow rate and voided volume did not differ significantly from placebo.
Multicentre, randomised, double-blind, placebo-controlled phase 3 trial led by the University of Giessen, Germany; 2 capsules every 8 hours for 12 weeks. The registry entry (NCT00919893) lists Cernelle (Sweden) and Strathmann (Germany) as collaborators (Wagenlehner et al. 2009, Eur Urol)
139 men with inflammatory chronic prostatitis/chronic pelvic pain syndrome (NIH category IIIA); 70 on pollen extract, 69 on placebo.
The primary outcome, the pain domain of the NIH Chronic Prostatitis Symptom Index, improved more than on placebo (p = 0.0086), as did quality of life and the total score. 70.6% of men on the extract responded (a drop of at least 25% or 6 points) versus 50.0% on placebo. Adverse events were minor.
Randomized, double-blind, placebo-controlled trial, published by a single author, of Prostat/Poltit, an extract of pollen from selected grass species, for 6 months (Elist 2006, Urology)
60 men aged 20 to 55 with chronic nonbacterial prostatitis/chronic pelvic pain syndrome who had not responded to earlier treatment for more than 6 months.
More men on the extract were rated cured or improved than on placebo, and no adverse reactions were found. The abstract gives no figures; a later review tabulated response as 73.3% of 30 men versus 64.2% of 28 on placebo. Prostat/Poltit is a different grass pollen product from Cernilton.
Randomized trial in Japan comparing add-on cernitin pollen extract (4 capsules a day) with add-on tadalafil 5 mg/day for 12 weeks in men still in pain on an alpha-blocker (Matsukawa et al. 2020, Neurourol Urodyn)
100 men with chronic prostatitis/chronic pelvic pain syndrome and urinary symptoms despite alpha-blocker therapy; 42 and 45 included in the final analysis.
Both groups improved. Total symptom index scores fell by 6.8 points with cernitin and 4.6 with tadalafil (P = .02), and pain scores by 4.1 and 1.5 (P < .001). Urinary symptom scores improved significantly more with tadalafil. There was no placebo group.
Randomized trial in Japan comparing Cernilton (2 capsules every 8 hours, each with 60 mg cernitin T60 and 3 mg cernitin GBX) with the herbal product Eviprostat for 8 weeks (Iwamura et al. 2015, BMC Urol)
100 men with category III chronic prostatitis/chronic pelvic pain syndrome, 50 per group.
Response, defined as at least a 25% drop in the total symptom index, was 78.1% with the pollen extract and 88.2% with Eviprostat, with no significant difference in total, pain, urinary or quality of life scores. No severe adverse events occurred. With no placebo arm, the trial cannot show how much either product helped beyond placebo, and the authors called the samples very small.
Multicentre randomized trial in Japan, published in Japanese, of tamsulosin, cernitin pollen extract or the combination for 12 weeks (Aoki et al. 2002, Hinyokika Kiyo)
243 men with urinary symptoms associated with benign prostatic hyperplasia.
Prostate symptom scores improved in all three groups, but peak and average urine flow rose significantly only in the groups given tamsulosin. The authors concluded that tamsulosin alone or combined was more effective than cernitin alone. There was no placebo group.