Serenoa Repens (Saw Palmetto) for Lower Urinary Tract Symptoms (LUTS): The Evidence for Efficacy and Safety of Lipidosterolic Extracts. Part II
Abstract
:1. Search Strategy and Selection Criteria Were Pivotal to Perspective on LSESr vs. LUTS
2. LSESr Has a High Safety Profile in Contrast to Counterpart Prescription Drugs
3. An Anti-Inflammatory Effect Appears to Be the Major Mechanism of Action of LSESr
3.1. 5α-Reductase Inhibition
3.2. Anti-Inflammatory Effect
4. The Onset of LUTS Response to LSESr Occurs as Early as 4 Weeks
5. The Response to LSESr vs. LUTS Is Durable
6. The Early Use of LSESr Delays the Progression of LUTS/BPH
- The patient’s subjective evaluation of the aggravation of their condition, as determined by the IPSS, is a relevant sign of BPH progression since it helps a doctor choose the most appropriate treatment.
- When an active supervision method is applied, the medicinal preparations are prescribed as soon as BPH symptoms start impacting the patient’s quality of life. Therefore, the study of long-term pharmacological therapy of patients with minimal subjective manifestations of BPH and the risk of its progression is of utmost relevance.
- Serenoa’s complex pathogenetic effects are aimed at both inhibiting the process of BPH development and eliminating the symptoms of chronic prostatitis.
- Because Serenoa does not decrease the PSA level it does not conceal the development of prostate cancer.
- The presence of the risk of BPH progression was a necessary criterion for admission of patients into the observation group. The reason for this is that the presence of men not subject to the risk of BPH progression would have complicated our ability to prove efficacy using a multi-year continuous administration of the extract of Serenoa repens to prevent BPH progression.
7. Conclusions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Ethical Approval/Patient Consent
References
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First Author | Ref # | Year | Extraction Method | Serenoa Patients (#) a | Study Duration (mos) | IPSS | QoL | Qmax | |||
---|---|---|---|---|---|---|---|---|---|---|---|
Δ | % | Δ | % | Δ | % | ||||||
Cirillo-Marucco ε | [6] | 1983 | Hexane | 47 | 4 | 56 | +4.6 | 50 | |||
Cukierψλ | [7] | 1985 | Hexane | 73 | 2 | 33 | |||||
TostoΩ | [8] | 1985 | Hexane | 20 | 3 | −5.0 | 28 | ||||
Pannunzio | [9] | 1986 | Hexane | 30 | 2 | +5.0 | 74 | ||||
Pescatore | [10] | 1986 | Hexane | 30 | 3 | +2.5 | 27 | ||||
Authieπ | [11] | 1987 | Hexane | 500 | 3 | 78 | |||||
Ollé Carrerasφ | [12] | 1987 | Hexane | 40 | 2 | 68 | |||||
Orfeiχ | [13] | 1988 | Hexane | 30 | 3 | 50 | −2.2 | +0.0 | 0.2 | ||
Matteiψω | [14] | 1990 | CO2 | 20 | 3 | 55 | |||||
Dathe | [15] | 1991 | Hexane | 49 | 6 | +5.9 | 49 | ||||
VahlensieckϷ | [16] | 1993 | CO2 | 1334 | 4 | 47 | |||||
Vahlensieck | [17] | 1993 | CO2 | 312 | 3 | +5.8 | 52 | ||||
Fabriciusδ | [18] | 1993 | CO2 | 176 | 6 | 39;59 | |||||
Derakhshani | [19] | 1997 | Ethanol | 1047 | 3 | −7.4 | 40 | −1.6 | 46 | +3.7 | 31 |
Eickenberg | [20] | 1997 | Ethanol 96% | 6967 | 6 | −8.0 | 44 | −1.8 | 38 | +3.0 | 23 |
Foroutan | [21] | 1997 | Hexane | 592 | 3 | −6.5 | 38 | −1.5 | 45 | +5.9 | 66 |
Redeckerν | [22] | 1998 | Ethanol 90% | 50 | 3 | 48 | +3.4 | 24 | |||
ZieglerΘ | [23] | 1998 | Ethanol 90% | 109 | 3 | 36 | +3.7 | 29 | |||
Bauer γ ψ | [24] | 1999 | CO2 | 101 | 6 | 37 | 16 | ||||
Medeiros † | [25] | 2000 | Hexane | 130 | 3 | −6.5 | 37 | −1.4 | 39 | +2.0 | 22 |
Aliaev | [26] | 2002 | Hexane | 26 | 60 | −8.8 | 76 | −1.3 | 53 | +4.3 | 35 |
Breza | [27] | 2005 | Ethanol | 596 | 12 | −5.9 | 36 | −1.7 | 54 | + 2.3 | 19 |
Aliaev | [28] | 2007 | Ethanol | 50 | 6 | −2.9 | 26 | −1.8 | 43 | + 1.7 | 14 |
Razumov | [29] | 2007 | Ethanol | 30 | 6 | −6.9 | 43 | -2.7 | 68 | +2.8 | 23 |
Aliaev∞ | [30] | 2009 | Ethanol | 50 | 24 | −4.2 | 37 | −2.2 | 52 | + 2.7 | 21 |
Vinarov | [31] | 2010 | Ethanol | 50 | 36 | −6.0 | 50 | −2.0 | 50 | + 4.5 | 39 |
Aliaev | [32] | 2013 | Ethanol | 38 | 120 | −1.3 | 12 | −1.1 | 35 | + 3.3 | 26 |
Mean Across All 27 Studies | 463 | 12 | −5.8 | 40–41 b | −1.8 | 47 | +3.5 | 31 | |||
Hexane extraction n = 12 Ethanol extraction n = 10 Carbon dioxide extraction n = 5 |
Senior Author | Ref. (#) | Year | Extraction | Serenoa Patients (#) a | Study Duration (mos) | IPSS * | QoL | Qmax | |||
---|---|---|---|---|---|---|---|---|---|---|---|
Δ | % | Δ | % | Δ | % | ||||||
Bent | [114] | 2006 | CO2 | 102 | 12 | −0.7 | 4 | +0.4 | 4 | ||
Braeckman π | [115] | 1997 | CO2 | 67 | 12 | −10.2 | 60 | −1.5 | 42 | +2.6 | 24 |
Aliaev Ω | [30] | 2009 | Ethanol | 50 | 24 | −4.2 | 37 | −2.2 | 52 | +2.7 | 21 |
Aliaev | [32] | 2013 | Ethanol | 38 | 120 | −1.3 | 12 | −1.1 | 35 | +3.3 | 26 |
Bach | [34] | 1996 | Ethanol | 315 | 36 | 73 | +6.1 | 46 | |||
Barry π | [110] | 2011 | Ethanol | 151 | 18 | −2.2 | 15 | ||||
Breza | [27] | 2005 | Ethanol | 596 | 12 | −5.9 | 36 | −1.7 | 54 | +2.3 | 19 |
Romics | [117] | 1993 | Ethanol | 31 | 12 | +4.3 | 39 | ||||
Saidi | [118] | 2019 | Ethanol | 40 | 12 | −2.1 | 18 | +0.8 | 6 | ||
Sinescu | [37] | 2011 | Ethanol | 120 | 24 | −5.5 | 40 | −1.8 | 50 | +5.6 | 54 |
Vinarov | [31] | 2010 | Ethanol | 50 | 36 | −6.0 | 50 | −2.0 | 50 | +4.5 | 39 |
Vinarov | [38] | 2019 | Ethanol | 30 | 180 | −6.0 | 50 | −3.0 | 60 | +5.0 | 45 |
Aliaev | [26] | 2002 | Hexane | 26 | 60 | −8.8 | 76 | −1.3 | 53 | +4.1 | 35 |
Debruyne | [109] | 2002 | Hexane | 350 | 12 | −4.4 | 28 | +1.9 | 17 | ||
Debruyne | [116] | 2004 | Hexane | 124 | 12 | −7.8 | 35 | −1.2 | 29 | +1.2 | 11 |
Djavan δ | [35] | 2005 | Hexane | 88 | 24 | −1.0 | 17 | −0.4 | 19 | +1.8 | 15 |
Pytel | [36] | 2002 | Hexane | 116 | 24 | −5.3 | 42 | −1.3 | 40 | +1.2 | 10 |
Averages of 17 Studies 15 positive studies 2 negative studies | Ethanol (10) Hexane (5) CO2 (2) | 135 | 37 | −4.8 | 37 | −1.6 | 44 | + 3.0 | 26 |
Study Group | Cumulative Progression | Changes * in IPSS, QoL, Qmax at 2-Years (%) | p Value | Changes ** in IPSS, QoL, Qmax at 3-Years | p Value |
---|---|---|---|---|---|
Watchful Waiting | IPSS: −0.3 (+5%) QoL: −0.2 (−9%) Qmax: 0.10 (−8%) | p = 0.03 at 2-years | IPSS: +5% QoL: −10% Qmax: −9% | p = 0.001 at 3-years | |
At 6 months | 6% | ||||
At 12 months | 13% | ||||
At 18 months | 15% | ||||
At 24 months | 24% | ||||
At 36 months | 31% | ||||
Permixon | IPSS: −1.0 (−17%) QoL: −0.4 (−19%) Qmax: +1.8 (+15%) | IPSS: −22% QoL: −24% Qmax: +14% | |||
At 6 months | 1% | ||||
At 12 months | 7% | ||||
At 18 months | 9% | ||||
At 24 months | 16% | ||||
At 36 months | 19% |
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Strum, S.B. Serenoa Repens (Saw Palmetto) for Lower Urinary Tract Symptoms (LUTS): The Evidence for Efficacy and Safety of Lipidosterolic Extracts. Part II. Uro 2021, 1, 139-154. https://doi.org/10.3390/uro1030016
Strum SB. Serenoa Repens (Saw Palmetto) for Lower Urinary Tract Symptoms (LUTS): The Evidence for Efficacy and Safety of Lipidosterolic Extracts. Part II. Uro. 2021; 1(3):139-154. https://doi.org/10.3390/uro1030016
Chicago/Turabian StyleStrum, Stephen B. 2021. "Serenoa Repens (Saw Palmetto) for Lower Urinary Tract Symptoms (LUTS): The Evidence for Efficacy and Safety of Lipidosterolic Extracts. Part II" Uro 1, no. 3: 139-154. https://doi.org/10.3390/uro1030016