<i>Serenoa repens</i> for benign prostatic hyperplasia

James Tacklind; Roderick MacDonald; Indy Rutks; Judith U Stanke; Timothy J Wilt

doi:10.1002/14651858.CD001423.pub3

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Figure 1

Risk of bias graph: review authors' judgements about each risk of bias item presented as per cents across all included studies.

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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1 SR vs placebo, Outcome 1 AUA total score, mean change from baseline (0 to 35 (35 most severe)).

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Analysis 1.2

Comparison 1 SR vs placebo, Outcome 2 Nocturia (times/evening) at endpoint.

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Analysis 1.3

Comparison 1 SR vs placebo, Outcome 3 Peak urine flow (mL/s), mean change from baseline.

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Analysis 1.4

Comparison 1 SR vs placebo, Outcome 4 Peak urine flow (mL/s) at endpoint.

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Analysis 1.5

Comparison 1 SR vs placebo, Outcome 5 Patient self‐rating for improved symptoms (# events "very good" or "good").

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Analysis 1.6

Comparison 1 SR vs placebo, Outcome 6 Physician‐assessed improvement of symptoms.

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Analysis 1.7

Comparison 1 SR vs placebo, Outcome 7 Prostate size (cc) at endpoint.

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Analysis 1.8

Comparison 1 SR vs placebo, Outcome 8 Prostate size (cc) mean change from baseline.

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Analysis 1.9

Comparison 1 SR vs placebo, Outcome 9 Study withdrawals.

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Analysis 1.10

Comparison 1 SR vs placebo, Outcome 10 Any adverse events.

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Analysis 2.1

Comparison 2 SR + Urtica dioica (PRO 160/120) vs placebo, Outcome 1 Peak urine flow (mL/s) at endpoint.

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Analysis 3.1

Comparison 3 SR vs tamsulosin, Outcome 1 IPSS total score mean change from baseline.

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Analysis 3.2

Comparison 3 SR vs tamsulosin, Outcome 2 Peak urine flow (mL/s) mean change from baseline.

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Analysis 3.3

Comparison 3 SR vs tamsulosin, Outcome 3 Prostate size (cc) mean change from baseline.

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Analysis 3.4

Comparison 3 SR vs tamsulosin, Outcome 4 Study withdrawals.

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Analysis 4.1

Comparison 4 SR (Permixon®) + tamsulosin vs placebo + tamsulosin, Outcome 1 IPSS total score mean change from baseline.

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Analysis 4.2

Comparison 4 SR (Permixon®) + tamsulosin vs placebo + tamsulosin, Outcome 2 Peak urine flow (mL/s) mean change from baseline.

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Analysis 4.3

Comparison 4 SR (Permixon®) + tamsulosin vs placebo + tamsulosin, Outcome 3 Study withdrawals.

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Summary of findings for the main comparison. SR compared to placebo for benign prostatic hyperplasia

Serenoa repens compared to placebo for benign prostatic hyperplasia
Patient or population: men with benign prostatic hyperplasia Settings: clinic Intervention: SR Comparison: placebo
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Placebo	SR
AUA total score, mean change from baseline American Urological Association Symptom Score. Scale from: 0 to 35. Follow‐up: 52 to 72 weeks	The mean AUA total score, mean change from baseline ranged across control groups from ‐0.72 to ‐2.99 points	The mean AUA total score, mean change from baseline in the intervention groups was 0.25 higher (0.58 lower to 1.07 higher)		582 (2 studies)	⊕⊕⊕⊕ high
Peak urine flow, mean change from baseline millilitres/second Follow‐up: 26 to 72 weeks	The mean peak urine flow, mean change from baseline in the control groups was millilitres/second	The mean peak urine flow, mean change from baseline in the intervention groups was 0.40 higher (0.30 lower to 1.09 higher)		667 (3 studies)	⊕⊕⊕⊕ high
Clinical responders ≥ 3 point improvement in AUA Follow‐up: mean 72 weeks	442 per 1000	424 per 1000 (336 to 539)	RR 0.96 (0.76 to 1.22)	357 (1 study)	⊕⊕⊕⊕ high
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.

Summary of findings for the main comparison. SR compared to placebo for benign prostatic hyperplasia

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Table 1. Table of key terms

AUA	The American Urological Association Symptom Score Index, and the same score as the IPSS. These are self‐rated, validated (i.e., symptoms that are confirmed clinically) questionnaires that measure the severity of irritative and obstructive urination symptoms. There are seven questions with each question scaled from 0 to 5. A higher score indicates worse symptoms. There are seven questions with each question scaled from 0 to 5. A higher score indicates worse symptoms.
BPH	Benign prostatic hyperplasia (BPH) is the nonmalignant enlargement of the prostate gland that is caused by an increase in volume of epithelial (top layer of tissue that line cavities and surfaces of the body) and stromal (connective tissue) cells into discrete, fairly large nodules in the periurethral (surrounding the urethra) region. These nodules in turn can restrict the urethral canal causing partial or complete blockage.
Hyperplasia	The proliferation of cells (for BPH, the epithelial and stromal cells) within an organ beyond the ordinary.
IPSS	International Prostate Symptom Score. IPSS is scored precisely like the AUA. See above.
Peak urine flow	The maximum rate of urine as measured by a uroflowmeter. Also known as Qmax.
Phytosterols	Steroidal alcohols that occur naturally in plants.
Phytotherapy	The use of plants, or plant extracts for medicinal purposes.
*Serenoa repens*	A small palm native to the American Southeast, SR is popularly known as Saw palmetto. When used as a phytotherapy, it is often called Sabal serrulatum. It is the extract of its berries, the fatty acids and phytosterols, that is used in the treatment of BPH.
TURP	Transurethral resection of the prostate. A catheter is inserted into the urethra up to the prostate to remove tissue by electrocautery or sharp dissection.

Table 1. Table of key terms

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Table 2. Summary table of adverse effects (SR versus placebo)

	*Serenoa repens*	Placebo	(Significance, P ≤ 0.05)
5 trials	n/N (%)
Diarrhea, n = 3	2/191 (1.0)	3/194 (1.5)	P = 0.67
Dizziness, n = 1	0/38 (0)	1/37 (2.7)	P = 0.49
GI distress, n = 5	9/315 (2.9)	3/312 (1.0)	P = 0.10
Headache, n = 2	0/115 (0)	2/114 (1.8)	P = 0.29
Denominator is number in arm. Per cents are rounded to the nearest tenth.

Table 2. Summary table of adverse effects (SR versus placebo)

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Table 3. Summary table of adverse effects (SR versus tamsulosin)

	Permixon®	Tamsulosin	(Significance, P ≤ 0.05)
1 trial	n/N (%)
Asthenia	0/20 (0)	2/20 (10)	P = 0.29
Decrease in libido	0/20 (0)	4/20 (20)	P = 0.13
Dizziness	0/20 (0)	2/20 (10)	P = 0.29
Ejaculation disorders	0/20 (0)	7/20 (35)	P = 0.06
Postural hypotension	0/20 (0)	1/20 (0.5)	P = 0.49
Denominator is number in arm. Per cents are rounded to the nearest tenth.

Table 3. Summary table of adverse effects (SR versus tamsulosin)

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Table 4. Summary table of adverse effects (SR versus finasteride)

	Permixon®	Finasteride	(Significance, P ≤ 0.05)
1 trial	n/N (%)
Decrease in libido	12/551 (2.2)	16/542 (3.0)	P = 0.42
Diarrhea	5/551 (1)	6/542 (1)	P = 0.74
Gastrointestinal distress	10/551 (1.8)	15/542 (2.8)	P = 0.30
Headache	7/551 (1.3)	2/542 (0.4)	P = 0.12
Denominator is number in arm. Per cents are rounded to the nearest tenth.

Table 4. Summary table of adverse effects (SR versus finasteride)

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Comparison 1. SR vs placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 AUA total score, mean change from baseline (0 to 35 (35 most severe)) Show forest plot	2	582	Mean Difference (IV, Random, 95% CI)	0.25 [‐0.58, 1.07]

2 Nocturia (times/evening) at endpoint Show forest plot	9	581	Mean Difference (IV, Random, 95% CI)	‐0.79 [‐1.28, ‐0.29]

3 Peak urine flow (mL/s), mean change from baseline Show forest plot	3	667	Mean Difference (IV, Random, 95% CI)	0.40 [‐0.30, 1.09]

4 Peak urine flow (mL/s) at endpoint Show forest plot	6	741	Mean Difference (IV, Random, 95% CI)	0.35 [‐1.05, 1.76]

5 Patient self‐rating for improved symptoms (# events "very good" or "good") Show forest plot	4	381	Risk Ratio (M‐H, Random, 95% CI)	1.83 [1.09, 3.08]

6 Physician‐assessed improvement of symptoms Show forest plot	2	286	Risk Ratio (M‐H, Random, 95% CI)	1.81 [0.78, 4.21]

7 Prostate size (cc) at endpoint Show forest plot	2	276	Mean Difference (IV, Random, 95% CI)	‐2.20 [‐8.98, 4.58]

8 Prostate size (cc) mean change from baseline Show forest plot	2	300	Mean Difference (IV, Random, 95% CI)	‐0.28 [‐2.51, 1.95]

9 Study withdrawals Show forest plot	11	1453	Risk Ratio (M‐H, Random, 95% CI)	0.95 [0.69, 1.30]

10 Any adverse events Show forest plot	4	425	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.27, 3.19]

Comparison 1. SR vs placebo

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Comparison 2. SR + Urtica dioica (PRO 160/120) vs placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Peak urine flow (mL/s) at endpoint Show forest plot	2	69	Mean Difference (IV, Random, 95% CI)	2.48 [‐0.05, 5.02]

Comparison 2. SR + Urtica dioica (PRO 160/120) vs placebo

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Comparison 3. SR vs tamsulosin

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 IPSS total score mean change from baseline Show forest plot	2	582	Mean Difference (IV, Random, 95% CI)	‐0.52 [‐1.91, 0.88]

2 Peak urine flow (mL/s) mean change from baseline Show forest plot	2	645	Mean Difference (IV, Random, 95% CI)	0.14 [‐0.54, 0.83]

3 Prostate size (cc) mean change from baseline Show forest plot	2	579	Mean Difference (IV, Random, 95% CI)	‐0.15 [‐1.44, 1.13]

4 Study withdrawals Show forest plot	2	744	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.69, 1.37]

Comparison 3. SR vs tamsulosin

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Comparison 4. SR (Permixon®) + tamsulosin vs placebo + tamsulosin

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 IPSS total score mean change from baseline Show forest plot	2	356	Mean Difference (IV, Random, 95% CI)	‐0.61 [‐1.69, 0.47]

2 Peak urine flow (mL/s) mean change from baseline Show forest plot	2	357	Mean Difference (IV, Random, 95% CI)	0.09 [‐0.80, 0.98]

3 Study withdrawals Show forest plot	2	369	Risk Ratio (M‐H, Random, 95% CI)	0.90 [0.58, 1.40]

Comparison 4. SR (Permixon®) + tamsulosin vs placebo + tamsulosin

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