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Ryp4.8
Rye Pollen Extract Research
Mostly mechanism / observational
15 peer-reviewed studies
What the evidence says
Mostly mechanism / observational
Most Rye Pollen Extract studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from medium-quality randomised trials published 1990–2018 with a typical study size of 192 participants.
Based on 15 studies · 5 RCTs · 2,450 total participants
Confidence
High confidence
By outcome
Men's vitalityModest improvement in self-rated urinary symptoms and fewer nighttime voids; no improvement in urine flow rate or prostate size · 4-12 weeks · Better quality of life scores in men whose lower-urinary-tract or pelvic-pain symptoms disrupt sleep and daily function · 6-12 weeks
Mostly mechanism / observational8 studies
BPH & lower urinary tract symptoms
Mostly mechanism / observational8 studies
Safety profile
Mostly mechanism / observational4 studies
Lean body mass & muscle growth
Too few graded studies1 study
InflammationReduced pelvic pain and inflammatory prostatitis symptoms in men with CP/CPPS · 6-12 weeks
Too few graded studies1 study
Pain & analgesia
Too few graded studies1 study
Older research base
Newest study from 2018
199020042018
1ReviewCited 21×2016
In plain English: Twenty years ago, the urologic community was encouraged by trial results that suggested phytotherapy could effectively treat symptomatic benign prostatic hyperplasia.
Keehn A et al. · Current urology reports (2016)
Twenty years ago, the urologic community was encouraged by trial results that suggested phytotherapy could effectively treat symptomatic benign prostatic hyperplasia.
Since that time, several well-constructed studies have consistently demonstrated that these agents are no more efficacious than placebo, despite being largely safe for ingestion.
In plain English: The available evidence suggests Cernilton is well tolerated and modestly improves overall urologic symptoms including nocturia.
Wilt T, Mac Donald R, Ishani A, Rutks I, Stark G · Cochrane Database of Systematic Reviews (2000)
444 men were enrolled in 2 placebo-controlled and 2 comparative trials lasting from 12 to 24 weeks; three used a double-blind method although treatment allocation concealment was unclear in all.
The weighted risk ratio for self-rated urinary symptom improvement versus placebo was 2.40 (95% CI 1.21 to 4.75), and versus Tadenan was 1.42.
Nocturia was reduced versus placebo (weighted RR 2.05, 95% CI 1.41 to 3.00) and versus Paraprost (WMD −0.40 times per evening, 95% CI −0.73 to −0.07).
In plain English: Compared to placebo, the pollen extract significantly improved total symptoms, pain, and QoL in patients with inflammatory CP/CPPS without severe side-effects.
Wagenlehner FM, Schneider H, Ludwig M, Schnitker J, Brähler E, Weidner W · European Urology (2009)
139 men with NIH category IIIA CP/CPPS were randomised to pollen extract (n=70) or placebo (n=69), dosed as two capsules every 8 hours for 12 weeks.
The pain domain (p=0.0086) and quality of life domain (p=0.0250) as well as the total NIH-CPSI score (p=0.0126) were significantly improved versus placebo at 12 weeks.
Response, defined as a decrease in NIH-CPSI total score of at least 25% or at least 6 points, occurred in 70.6% of the pollen-extract group versus 50.0% of placebo (p=0.0141).
In plain English: The available evidence suggests that Cernilton is well tolerated and modestly improves overall urological symptoms, including nocturia.
MacDonald R, Ishani A, Rutks I, Wilt TJ · BJU International (2000)
444 men were enrolled in two placebo-controlled and two comparative trials lasting 12-24 weeks; concealment of treatment allocation was unclear in all.
The weighted risk ratio for self-rated improvement versus placebo was 2.40 (1.21-4.75) and versus Tadenan was 1.42 (1.21-4.75).
Against placebo the weighted RR for nocturia was 2.05 (1.41-3.00); against Paraprost the weighted mean difference was −0.40 times per evening.
In plain English: The administration of only tamsulosin hydrochloride and the combination of tamsulosin hydrochloride and cernitin pollen extract seemed more effective then the administration of only cernitin pollen extract in the treatment of urinary disturbance associated with benign prostatic hyperplasia.
Aoki A, Naito K, Hashimoto O, Yamaguchi M, Hara Y, Baba Y, et al. · Hinyokika Kiyo (2002)
243 patients with urinary disturbance associated with BPH were randomly assigned to tamsulosin, cernitin pollen extract, or their combination for 12 weeks.
The International Prostate Symptom Score improved in each group.
Maximum flow rate and average flow rate increased significantly only in the tamsulosin-administered groups.
6RCTn=240 · medium study2008
In plain English: Long-term administration of cernilton at the dose of 750 mg may achieve faster and more obvious efficacy than at 375 mg in improving symptomatic BPH and preventing the clinical progression of BPH, with no adverse events.
Xu J, Qian WQ, Song JD · Zhonghua Nan Ke Xue (National Journal of Andrology) (2008)
240 BPH patients with IPSS >7 were equally allocated to oral cernilton 750 mg or 375 mg twice daily for 4 years.
After treatment the 750 mg group reached IPSS 10.5 ± 5.6 and Qmax 16.2 ± 4.5 ml/s versus 14.9 ± 4.3 and 13.5 ± 4.1 ml/s in the 375 mg group (P < 0.0001).
The incidence of urinary retention was lower on the higher dose (5 vs 16 person-times, P = 0.0147), as was the rate of surgery (2 vs 8 person-times, P = 0.0462).
7RCTn=192 · medium study1990
In plain English: By committee judgement, the rate of more than moderate effectiveness was 49.1% in the CN group compared to 41.2% in the PP group, but there was no significant difference between the two groups.
Maekawa M, Kishimoto T, Yasumoto R, Wada S, Harada T, Ohara T, et al. · Hinyokika Kiyo (1990)
A multicentre double-blind study of 192 patients compared Cernilton with Paraprost; overall effect was assessed in 159 patients and safety in 178.
Patient impression and overall committee/physician-judged effect were slightly higher with Cernilton than Paraprost, but the difference was not statistically significant.
Analysis of objective symptoms showed significant improvement in residual urinary volume, average flow rate, maximum flow rate and prostatic weight in the Cernilton group.
8RCTn=60 · small study1990
In plain English: There was a statistically significant subjective improvement with Cernilton (69% of the patients) compared with placebo (30%).
Buck AC, Cox R, Rees RW, Ebeling L, John A · British Journal of Urology (1990)
60 patients with outflow obstruction due to BPH entered a double-blind, placebo-controlled study of a 6-month course of Cernilton.
Subjective improvement occurred in 69% of Cernilton patients versus 30% on placebo.
There was a significant decrease in residual urine and in the antero-posterior diameter of the prostate on ultrasound with Cernilton.
In plain English: WITHDRAWN — this 2011 update of the Cochrane review of Cernilton for BPH was withdrawn, so no maintained Cochrane assessment of Cernilton currently exists.
Wilt TJ, Macdonald R, Ishani A, Rutks I, Stark G · Cochrane Database of Systematic Reviews (2011)
PubMed titles this record 'WITHDRAWN: Cernilton for benign prostatic hyperplasia' — it is the withdrawn 2011 update of CD001042.
Its unchanged results repeat the 2000 review: 444 men in two placebo-controlled and two comparative trials lasting 12 to 24 weeks.
Cernilton was not more effective than placebo or the comparative study agents in improving urinary flow rates, residual volume or prostate size.
In plain English: In the group without complicating factors, 56 (78%) had a favorable response; 26 (36%) were cured of their symptoms and signs and 30 (42%) improved significantly.
Rugendorff EW, Weidner W, Ebeling L, Buck AC · British Journal of Urology (1993)
90 patients with chronic prostatitis syndrome received Cernilton N one tablet three times daily for 6 months in a prospective, uncontrolled study.
Among the 72 patients without complicating factors, 78% responded favourably — 36% cured and 42% significantly improved, with increased flow rate and reduced leukocyturia in post-prostatic-massage urine.
Among the 18 patients with complicating factors (urethral stricture, prostatic calculi, bladder neck sclerosis) only 1 responded.
In plain English: The mean change in serum prostate-specific antigen and rate of change after administration of cernitin pollen extract in all patients were -0.6 ± 1.4 ng/mL and -7.6 ± 16.1%, respectively, which were significantly different from the baseline values.
Togo Y, Ichioka D, Miyazaki J, Maeda Y, Kameyama K, Yasuda M, et al. · International Journal of Urology (2018)
61 prostate biopsy candidates took cernitin pollen extract two tablets three times daily for 30 days before biopsy.
Mean serum PSA fell by 0.6 ± 1.4 ng/mL (−7.6 ± 16.1%), significantly different from baseline (P = 0.0003 and P = 0.0005).
PSA change values and rates differed significantly between patients whose biopsy was negative versus positive for cancer (P = 0.04 and P = 0.03).
In plain English: It is evident that cernilton is effective in monotherapy of prostatic adenoma and combined treatment of chronic bacterial prostatitis.
93 men were studied: 31 with prostatic adenoma received cernilton for 3 months, 32 with chronic bacterial prostatitis received antibacterial treatment plus cernilton, and 30 received standard antibiotic treatment alone.
In the adenoma group IPSS showed significant regression of lower urinary tract symptoms and improved quality of life (p < 0.001), Qmax increased significantly (p < 0.001), and serum PSA fell by 21.2%.
On NIH-CPSI, relief of pain and dysuria and improvement in quality of life were greater with antibiotics plus cernilton than with antibiotics alone (p < 0.05).
13In Vitro1991
In plain English: The radio-TLC separation of the reaction metabolites showed a dose dependent inhibition of the cyclo-oxygenase and the 5-lipoxygenase activity by the fat soluble pollen extract fraction.
Loschen G, Ebeling L · Arzneimittelforschung (1991)
A standardized extract mainly from rye pollen (Cernilton N) was tested in vitro for inhibition of prostaglandin and leukotriene synthesis in ram seminal vesicle microsomes and rat basophilic leukemia (RBL-1) cells.
The fat-soluble fraction dose-dependently inhibited cyclo-oxygenase and 5-lipoxygenase with IC50 values of 0.005 mg/ml and 0.08 mg/ml, similar to diclofenac tested in the same system.
The water-soluble fractions showed no effect in this test system.
14In Vitro1990
In plain English: Of the 9 continuous cell lines tested, only those derived from the human prostate were growth inhibited by the pollen extract, whereas the non-prostate derived cells exhibited variable degrees of resistance to the T-60.
Habib FK, Ross M, Buck AC, Ebeling L, Lewenstein A · British Journal of Urology (1990)
Nine human-derived cancer and non-cancer continuous cell lines were used to evaluate the in vitro activity of the pollen extract Cernitin T-60, assessed by growth and cell survival.
Only prostate-derived cell lines were growth-inhibited; non-prostate lines showed variable resistance.
Selectivity for prostate cell lines was even more pronounced in the hormone-independent models.
In plain English: These results indicate that CN has an anti-inflammatory action, and that the inhibitory effect of CN on the prostatic inflammatory cytokine is an important factor in its action.
Asakawa K, Nandachi N, Satoh S, Honma M, Namikata S, Ishii M, et al. · Hinyokika Kiyo (2001)
Aged Wistar rats were castrated and injected with 17β-estradiol for 30 days to induce nonbacterial prostatitis; cernitin pollen extract (630 and 1,260 mg/kg orally) was given for the last 14 days.
In control rats prostatic IL-6 and TNF-α rose approximately 2-3 fold with acinar glandular inflammation and stromal proliferation on histopathology.
Cernitin pollen extract decreased the increased cytokine contents in a dose-dependent manner.