Natural Ingredients for Managing Premature Ejaculation – Haelf

A Double-Blind, Placebo-Controlled Study - Natural PE Supplement

May 02, 2024By Michael Bartenstein

ABSTRACT

Background: This study aimed to evaluate a dietary supplement in relation to sexual satisfaction, ejaculatory control, and sexually related personal distress among individuals with premature ejaculation.

Methods: In a double-blind, randomized, placebo-controlled trial, 68 premature ejaculation patients aged between 21 and 60 were randomly assigned to either receive the dietary supplement or a placebo for three months. Participants completed questionnaires at the study's outset and again three months later, consisting of the Index of Premature Ejaculation (IPE) and the Premature Ejaculation Diagnostic Tool (PEDT).

Results: Individuals in the treatment group exhibited significant improvements in premature ejaculation symptoms compared to those in the placebo group. The supplement was well-tolerated with minimal adverse effects reported.

Conclusions: This study underscores the efficacy of the dietary supplement in alleviating symptoms associated with premature ejaculation, including enhanced sexual satisfaction and reduced distress during sexual encounters.

1. INTRODUCTION

Premature ejaculation (PE) stands as the most prevalent male sexual dysfunction, affecting both men and their partners, with an incidence of 30% - 40% at various stages of life [1]. Individuals with PE commonly experience three primary symptoms: rapid ejaculation following penetration, limited control over ejaculation timing, and negative emotional repercussions such as anxiety, embarrassment, and diminished sexual fulfillment [2]. Clinically, PE manifests as recurrent ejaculation occurring shortly before or after vaginal penetration, often against the individual's desires [3].

Diagnostic approaches to PE typically involve objective measures like stopwatch assessments of intravaginal ejaculatory latency time (IELT) alongside validated questionnaires [2]. While some studies advocate for IELT alone as a basis for diagnosis, subjective factors like perceived lack of ejaculatory control have been directly linked to heightened personal distress and decreased sexual satisfaction. Consequently, solely relying on IELT may overlook crucial aspects of the condition's impact on individuals' well-being [4]. Moreover, IELT's suitability for clinical management remains debatable due to its potential interference with sexual performance and pleasure. Currently, validated questionnaires like the Index of Premature Ejaculation (IPE) and the Premature Ejaculation Diagnostic Tool (PEDT) are favored for their comprehensive assessment capabilities [5].

Addressing PE effectively is paramount, given its potential to erode confidence and strain relationships. Existing treatments encompass psychological interventions, topical therapies (e.g., Benzocaine wipes), and systemic medications such as adrenergic antagonists and selective serotonin reuptake inhibitors (SSRIs). However, these treatments vary in efficacy and are often accompanied by adverse effects [6] [7]. Despite the widespread prevalence of PE, few therapeutic options offer minimal risks. Traditional Chinese Medicine, including herbal and natural products, emerges as a drug-free alternative with potential benefits and fewer side effects in some cases [8].

The dietary supplement, comprises an herbal aphrodisiac blend featuring key ingredients like L-Tryptophan, L-Citrulline, Cassia (Cinnamon) Bark Powder, Tribulus Fruit Extract, Grape Seed Extract, and essential vitamins. A randomized, double-blind placebo-controlled trial was conducted to assess its efficacy in enhancing sexual satisfaction, ejaculatory control, and reducing distress associated with PE.

2. METHODS

2.1. The Herbal Compound

The dietary supplement investigated in this study comprised a blend of natural herbal concentrates encapsulated in a gel capsule. Each serving included 3 mg Niacin, 2 mg Vitamin B6 (as Pyridoxine HCl), 900 mcg Vitamin B12 (as Cyanocobalamin), 5 mg Pantothenic Acid (as Calcium-D-Pantothenate), 100 mcg Selenium (as L-Selenomethionine), and a 224 mg proprietary blend of L-Tryptophan, L-Citrulline, Cassia (Cinnamon) Bark Powder, Fenugreek Seed Powder, Tribulus Fruit Extract, Grape Seed Extract, and L-Tyrosine.

2.2. Placebo

The placebo utilized in this study consisted of a flavorless starch compound devoid of active ingredients. It was encapsulated in the same capsules as the active herbal compound.

2.3. Study Subjects

Eligible participants were healthy men aged 21 to 60 years diagnosed with primary PE, based on DSM-V criteria. They were also required to be in a stable sexual relationship involving sexual activity at least once per week for the past six months.

Exclusion criteria included prior genital trauma or surgery, erectile dysfunction, severe physical or mental illness, significant relationship problems, inability to engage in sexual intercourse once a week during the study, current alcohol or drug abuse, and various medical conditions such as diabetes mellitus, psychiatric disorders, renal or liver diseases, dyslipidemia, hypertension, hypothyroidism, hyperthyroidism, or cardiac arrhythmias.

Sixty-eight eligible men participated in the study, all providing written informed consent after being briefed on the study's potential risks and benefits. Ethical approval was obtained from the institution's ethics committee.

2.4. Study Procedures

In a randomized, double-blind, placebo-controlled study conducted from December 2019 to March 2020, participants were randomly assigned to two groups (Group 1 and Group 2). Group 1 received the dietary supplement, while Group 2 received the placebo. Treatment allocation was undisclosed to both participants and researchers. Participants were instructed to take one capsule of their assigned treatment daily on an empty stomach before their evening meal, at approximately the same time each day. Consumption of medications or alcohol within six hours of sexual activity was prohibited. Couples were instructed not to use condoms or topical anesthetic creams, pause during intercourse, or have interrupted intercourse. Psychosexual counseling was not provided.

Participants completed the Index of Premature Ejaculation (IPE) and the Premature Ejaculation Diagnostic Tool (PEDT) at the beginning and end of the study.

The Cronbach’s alpha coefficient for internal consistency of the IPE scale in our study population was 0.81, indicating high reliability.

2.5. Study Endpoints & Data Analysis

Primary endpoints included increases in IPE scores and decreases in PEDT scores, indicating improvements in PE symptoms (i.e., enhanced ejaculatory control, increased sexual satisfaction, and reduced distress associated with sexual encounters). Safety endpoints included monitoring for adverse events. To compare groups at different time points and assess changes during treatment, the Mann-Whitney test was used. The Wilcoxon signed-rank test was employed to evaluate within-group changes. Additionally, analysis of covariance (ANCOVA) was conducted to compare differences between groups after treatment while adjusting for baseline measurements. Statistical significance was set at 𝑃 ≤ 0.05. IBM SPSS 25.0 was used for statistical analysis.

3. RESULTS

A total of 68 subjects were enrolled in the study, with 62 (91%) completing the trial. Six patients (9%) withdrew from the study and were consequently excluded from the final analysis (Figure 1). The mean age of patients was 31.1 ± 4.7 years (range 24 - 41) in Group 1 and 32.6 ± 4.9 years (range 23 - 44) in Group 2.

The mean frequency of weekly intercourse prior to treatment initiation was 2.05 times per week for the dietary supplement group and 2.03 times per week for the placebo group. At the 12-week mark of treatment, the mean intercourse frequency was 2.14 times per week for Group 1 and 2.12 times per week for Group 2, with no significant difference observed (p = 0.9).

To assess PEDT results, mean PEDT scores at baseline and after 12 weeks were compared. Each answer option in the PEDT questionnaire was assigned a score ranging from 0 to 4, with the total score derived from the sum of individual scores. A score of 11 or higher is indicative of PE.

At the study's outset, the mean baseline PEDT score was 18 and 17 in Groups 1 and 2, respectively. After 12 weeks of treatment, a significant decrease in mean PEDT score was observed in the treatment group (18 to 10) (p < 0.02), whereas the decrease in the placebo group was mild (17 to 15) (p = 0.06) (Table 1).

Baseline and 12-week mean IPE scores were also evaluated. Both groups reported similar IPE scores across sexual satisfaction, control, and distress domains at the study's commencement (p > 0.05). After 12 weeks of treatment, statistically significant improvements were noted in sexual satisfaction and distress domains for both groups, both in unadjusted and adjusted analyses (p < 0.05). However, differences between the groups were not statistically significant in the control domain (p = 0.524). Within-group changes were assessed using the Wilcoxon signed-rank test, indicating significant increases in all domains for both groups, with the treatment group showing significantly higher improvement (Table 2). A higher score signifies enhanced ejaculatory control, increased sexual satisfaction, and reduced distress.

There were slightly more reported instances of adverse effects associated with the dietary supplement compared to the placebo. Four individuals in the treatment group and one in the placebo group reported treatment-related adverse events, including constipation (3 cases in Group 1), nausea (1 case in Group 2), and headache (1 case in Group 1).

4. DISCUSSION

In this study, we evaluated the efficacy of Mate Enduranceas a sexual complementary dietary supplement. To measure results, we used validated questionnaires, including the IPE and PEDT, as opposed to stopwatch measures of IELT. The use of validated questionnaires not only provided a more accurate means of measuring the subjective factors associated with PE, such as lack of ejaculatory

Variable	Time	Group		p-value
Variable	Time	Mate Endurance (n = 32)	Placebo (n = 30)	p-value
PEDT^a	Start of intervention	18.0 ± 1.0	17.0 ± 1.0	<0.001^b
	12 weeks past intervention	10.0 ± 2.0	15.0 ± 1.0	<0.001^b
	Mean differential	8.0 ± 2.0	2.0 ± 1.0	<0.001^b
	p-value	< 0.02^c	0.06^c

Table 1. Comparing PEDT results between two groups of mate endurance and Placebo.

Data presented as Mean ± SD. ^aPEDT, Premature Ejaculation Diagnostic Tool; ^bBased on t-test; ^cBased on paired t-test.

Domain	Time	Group		Unadjusted p-value	Adjusted p-value
Domain	Time	Mate Endurance (n = 32)	Placebo (n = 30)	Unadjusted p-value	Adjusted p-value
Sexual Satisfaction	Start of intervention	26.6 ± 9.1 25.0 (12.5 - 50.0)	25.2 ± 4.8 25.0 (18.7 - 37.5)	0.547^a	<0.001^b
	12 weeks past intervention	44.7 ± 14.3 50.0 (25.0 - 68.7)	30.0 ± 9.9 25.0 (12.5 - 50.0)	<0.001^a	<0.001^b
	Mean differential	18.2 ± 16.3 15.6 (0.0 - 43.7)	4.8 ± 11.1 0.0 (−12.5 - 31.2)	<0.001^a
	p-value	<0.001^c	0.033^c
	Start of intervention	10.3 ± 9.1 6.2 (0.0 - 25.0)	11.7 ± 6.7 12.5 (0.0 - 25.0)	0.397^a	0.524^b
Control	12 weeks past intervention	17.2 ± 8.2 18.7 (0.0 - 25.0)	16.7 ± 8.3 18.7 (0.0 - 31.2)	0.705^a	0.524^b
	Mean differential	6.8 ± 8.6 3.1 (0.0 - 25.0)	5.0 ± 7.7 0.0 (−6.2 - 18.7)	0.401^a
	p-value	<0.001^c	0.003^c
	Start of intervention	9.8 ± 9.9 12.5 (0.0 - 25.0)	11.7 ± 9.2 12.5 (0.0 - 25.0)	0.403^a	<0.001^b
Distress	12 weeks past intervention	31.6 ± 17.4 25.0 (0.0 - 50.0)	18.3 ± 10.7 25.0 (0.0 - 25.0)	0.005^a	<0.001^b
	Mean differential	21.9 ± 17.7 18.7 (0.0 - 50.0)	6.7 ± 12.2 0.0 (−12.5 - 25.0)	0.001^a
	p-value	<0.001^c	0.007^c

Table 2. Comparing Index of Premature Ejaculation (IPE) results between two groups of Mate Endurance and Placebo.

Data is presented as Mean ± SD, Median (min-max). aBased on Mann-Whitney test; bBased on ANCOVA adjusted for measurements at the beginning of the study; cBased on Wilcoxon signed-rank test.

The utilization of subjective questionnaires not only captured various dimensions of ejaculatory control and personal distress but also circumvented the potential interference with sexual performance and pleasure often associated with stopwatch measurements.

At the outset of the study, there were no significant differences in mean age or mean IPE score between the treatment and placebo groups. Furthermore, both groups reported similar frequencies of weekly intercourse episodes before treatment initiation and during the 12-week treatment period. This suggests that both randomly assigned groups were comparable before treatment, allowing for fair comparison during the treatment phase.

After 12 weeks of treatment, a notable decrease (p < 0.05) in mean PEDT score and a significant increase (p < 0.05) in mean IPE score were observed in subjects receiving the dietary supplement treatment, while a comparatively smaller decrease in PEDT score and increase in IPE score were noted in the placebo group. These changes in the placebo group are likely attributable to the placebo effect. This underscores the superior effectiveness of the dietary supplement over placebo in alleviating symptoms associated with PE, as evidenced by the subjects' responses to the questionnaire. Specifically, the supplement proved effective in enhancing sexual satisfaction and reducing distress related to sexual encounters in individuals afflicted with PE.

Several components of the dietary supplement may have contributed to its overall efficacy across all three domains of the IPE. Tryptophan, for instance, enters the brain where it is converted to 5-Hydroxytryptophan (5-HTP), thereby increasing serotonin synthesis. Given the presence of neurotransmitters and receptors involved in the ejaculatory neuroaxis, including dopamine and serotonin, the heightened serotonin levels resulting from L-Tryptophan intake may play a pivotal role in ejaculatory control.

Additionally, L-citrulline, a component of the supplement, is converted to L-arginine in the body, thereby enhancing blood flow through increased nitric oxide production. This improved blood circulation can lead to enhanced erectile function.

Moreover, the combination of herbal ingredients such as fenugreek and tribulus terrestris in the dietary supplement has been suggested to boost sexual drive and libido in men.

The double-blind, placebo-controlled design, coupled with the statistically significant improvements observed in factors commonly associated with premature ejaculation as measured by the IPE and PEDT, provides compelling evidence of the efficacy of the natural dietary supplement in enhancing sexual satisfaction and reducing distress associated with premature ejaculation.

Limitations

Our study was constrained by its small sample size, limited follow-up duration, and reliance solely on self-reports to assess improvements in symptoms associated with PE.

5. CONCLUSION

Premature ejaculation remains a prevalent male sexual dysfunction, impacting nearly 40% of men at some stage of their lives. While herbal supplements have been proposed as a potential drug-free alternative solution, limited research has explored their efficacy. The findings of this study highlight the effectiveness of the dietary supplement in ameliorating certain subjective symptoms of PE compared to a placebo. Moreover, the dietary supplement was well-tolerated by participants, with minimal reported side effects.

Link to full publication: https://www.scirp.org/journal/paperinformation?paperid=104081

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A Double-Blind, Placebo-Controlled Study - Natural PE Supplement

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