Subjective effects of a proprietary Eurycoma longifolia and Polygonum minus combination on well-being and sexual performance in patients with mild erectile dysfunction

INTERVENTION: Males aged 40‐65 with mild erectile dysfunction were studied as outpatients in this double‐ blind, randomized, placebo‐controlled, parallel‐group pilot trial. Participants, researchers, and individuals dealing with the data were blinded to the treatment group. Subjects received one of the following two interventions: identical placebo or 300mg of a combination of proprietary freeze‐dried water extracts of Eurycoma longifolia + Polygonum minus daily for twelve weeks. Thirty men were randomized to the study (N=15 per group), and 26 completed the study (N=12 in the treatment group). These 26 subjects were included in the analysis. CONDITION: Erectile dysfunction ; Urological and Genital Diseases ; Impotence of organic origin PRIMARY OUTCOME: 1. Index of Erectile Function (IIEF‐5) is a six‐point scale ranging from 0 to 5. The higher the score, the better the function ; 2. Erectile Dysfunction Inventory for Treatment Satisfaction (EDITS) Questionnaire is a point scale ranging from 0 to 4; 3. Percentage of successful sexual intercourse attempts (SIA) (from patient event logs) 10 questions most of which are yes or no and are coded as 1 or 0, respectively; 4. Erection Hardness Scale (EHS) is a four‐point scale, with scores ranging from 1 to 4; 5. Sexual Health Inventory Questionnaire is a six‐point scale for each question, ranging from 0 to 5; 6. Aging Male Symptom Score is a six‐point Likert scale ranging from 0 to 5. A higher score indicates worse function; ; Measured at screening, baseline, week 6, and week 12 SECONDARY OUTCOME: 1. Self‐Esteem and Relationship Questionnaire (SEAR) uses a six‐point Likert scale ranging from 0 to 5. A higher score indicates better function; 2. Beck Depression Index and Beck Anxiety Index The Beck Depression Inventory and Beck Anxiety Inventory score individual items on a four‐point scale (0‐3). Scores across domains are summed. Total scores =21 indicate concern for depression. ; ; Measured at screening, baseline, week 6, and week 12 INCLUSION CRITERIA: 1. Male subjects between the ages of 40 and 65 at the time of screening, and in a stable heterosexual relationship for at least six months. Both partners had to agree to attempt intercourse at least once a week on average during the study. 2. Subjects with testosterone levels = 450ng/dL 3. Index of erectile dysfunction scores between17‐25