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. 2022 Jul;40(3):456-464.
doi: 10.5534/wjmh.210048. Epub 2022 Jan 25.

Efficacy and Safety of 5-Aminolevulinic Acid for Patients with Symptoms of Late-Onset Hypogonadism: A Preliminary Study

Hiroki Koyasu  1 , Shigeo Horie  2 , Kazuhito Matsushita  1 , Takeshi Ashizawa  1 , Satoru Muto  1 , Shuji Isotani  1 , Tohru Tanaka  3 , Motowo Nakajima  3 , Akira Tsujimura  4
Affiliations

Efficacy and Safety of 5-Aminolevulinic Acid for Patients with Symptoms of Late-Onset Hypogonadism: A Preliminary Study

Hiroki Koyasu et al. World J Mens Health. 2022 Jul.

Abstract

Purpose: As the concept of late-onset hypogonadism (LOH) has gained increased attention, the treatment of eugonadal patients with LOH symptom has become a clinical problem. Previous studies have shown the possible benefits of 5-aminolevulinic acid (5-ALA) on the somatic, psychological and sexual functions. We therefore conducted this randomized, double-blind, placebo-controlled study to confirm the efficacy and safety of 5-ALA for LOH symptoms.

Materials and methods: Thirty-two eugonadal subjects with LOH symptoms were randomly divided into a 5-ALA group (n=15) and a placebo group (n=17). Treatment was continued for 8 weeks. The change of the Aging Males' Symptoms (AMS) scale score and several biochemical and endocrinological variables during treatment were compared between the groups.

Results: After treatment, the change in the total AMS in the 5-ALA group was significantly greater than that in the placebo group (-7.4±4.7 vs. -4.9±4.9, p=0.029). However, the differences between the groups in the change of the somatic, psychological, and sexual sub-scores of the AMS did not reach the statistical significance, although these changes in the 5-ALA group were greater than those in the placebo group. Furthermore, the change in the biochemical and endocrinological variables in the two groups did not differ to a statistically significant extent. During the 8-week treatment period, no patients discontinued 5-ALA due to treatment-emergent adverse events (TEAEs).

Conclusions: The intake of 5-ALA for 8 weeks was beneficial for eugonadal patients with symptoms of LOH and no severe TEAEs was experienced. 5-ALA should be considered as an option for those patients.

Keywords: Aminolevulinic acid; Efficacy; Hypogonadism; Safety; Testosterone.

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Conflict of interest statement

The authors have nothing to disclose.

Figures

Fig. 1
Fig. 1. The comparison of the change in the total AMS score between the 5-ALA group and the placebo group during treatment. The change in the 5-ALA group was significantly greater than that in the placebo group after 8 weeks of treatment (-7.4±4.7 vs. -4.9±4.9, p=0.029). AMS: Aging Males’ Symptoms, 5-ALA: 5-aminolevulinic acid.
Fig. 2
Fig. 2. Comparison of the change in the (A) somatic, (B) psychological, and (C) sexual sub-scores of the AMS (Δ somatic AMS, Δ psychological AMS and Δ sexual AMS) between the groups during treatment. Although each respective change in the 5-ALA group was greater than that in the placebo group after 8 weeks of treatment, none of the differences reached statistical significance. AMS: Aging Males’ Symptoms, 5-ALA: 5-aminolevulinic acid, NS: not significant.
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