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TABLE B Summary of Adverse Effects in Clinical Trials Using Saw Palmetto in Blended Preparations

Study Design

Subjects

Parameters Monitored

Supplement / Placebo / Reference

Adverse Effects and Related Findings

Clinical Trial Using Blended Preparations with Female Subjects

1 trial, 20 subjects ingested blended saw palmetto-containing preparations, 10 subjects in placebo group

Timmermans and Timmermans, 1990

Randomized?

Double-blind?

Placebo-control

Condition: Hypotonic bladder [incontinence (18 subjects) and other conditions]

Age: 25-76 y

All subjects were female.

Parameters monitored: Unknown

Saw palmetto group:

Number of subjects: 20 (25–68 y, mean age of 45y)

Type: Extract of saw palmetto fruit plus extract of Echinacea purpurea in dropsa

Amount: 78-104 mg/day (90-120 drops/day)

Route: Oral

Frequency: ~3 times/day (20–25 drops/dose) Duration: ~ 77 days (mean)

Saw palmetto group:

Adverse effects: Unknown

 

 

 

Placebo group:

Number of subjects: 10 (29–76 y, mean age of 52 y) Form: Drops Duration: ~52 days (mean)

Placebo group:

Adverse effects: Unknown

a Urgenin® (Madaus GmbH, Wien, Austria) contained an extract/tincture of saw palmetto fruit (78-104 mg/day) and an extract of rhizomes/roots of purple coneflower (Echinacea purpurea) (84-112 mg/day). This product was a liquid intended for use as drops (~25 drops) to be ingested in water before meals (or after meals in subjects with gastric disturbances). Urgenin was used in the one clinical trial with female subjects summarized in this table.



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