A Monocentric Randomized, Double-Blind, Placebo-Controlled Trial on the Effectiveness of Bioarginina® in Oral Administration for the Treatment of Asthenia in Patients without Associated Comorbidities

Abstract

In the last 6 decades a great debate about an idiopathic origin of moderate to severe asthenia was addressed by physicians. Asthenia is defined as a symptom of weakness related to different conditions. It can be associated to disabling symptoms such as sore throat, cervical and axillary lymphadenopathy, myalgia, arthralgia, migraine, concentration, memory and sleep disorders and malaise after physical efforts. Arginine is a conditionally essential amino acid that is involved in protein synthesis, the detoxification of ammonia, and its conversion to glucose as well as being catabolized to produce energy; in addition to these physiological functions, arginine has shown to have ergogenic potential. Arginine-based supplement may be used on an acute basis for delaying the onset of neuromuscular fatigue (i.e., PWCFT) and improving the ventilatory threshold. The present research was conducted according to an experimental double-blind controlled design (vs. placebo), with the aim to evaluate the clinical efficacy and safety of the Bioarginina® (1.66g/20ml vials of L-arginine) in oral administration. The changes in the parameters relevant to physical and/or mental fatigue, monitored for the evaluation of the efficacy of the experimental treatment, showed a clear difference in patients treated with Bioarginina® compared to those treated with placebo, with a statistically better trend in the Bioarginina® group than in the placebo group. The general conditions, especially at the end of the observation period, improved significantly in the Bioarginina® group compared to the placebo group. Overall, asthenia symptoms had a marked improvement in patients in the Bioarginina® group, with a reduction of almost 25% of their intensity after 30 days of therapy and over 70% at the end of the treatment; by contrast, in the placebo group, the symptomatology underwent to an impairment, assessable in the order of 14% after one month and 25% at the end of the therapy. Overall the results of the present study strongly support the effectiveness of oral Bioarginina® for the treatment of symptoms associated to asthenia and highlight the possibility of a clinical application of Bioarginina® in the treatment of asthenia.