We would also ask if it is ethical to permit that such “drugs”, while deceiving consumers, should invade the market, baffling both the Regulatory Agency’s control, as well as common sense. No plausible hypothesis can justify these bizarre “compositions”, and consequently is not surprisingly that so different results have been gathered with nutraceutical supports deprived of any scientific evidence. In several cases, no conclusive insights can be obtained from clinical trials based on unclear rational design, limited number of recruited patients and variable formula composition and dosage(s).įirst, it is improper to compare clinical results from studies in which commercial nutraceutical formulas involve a wide range of concentrations ( Table 1), with the myo-Ins/D-Chiro-Ins ratio varying implausibly from 0.4:1 to 104:1. However, the proper formula-i.e., the respective percentage of myo-Ins and D-Chiro-Ins-is still a matter of debate. Experimental and pilot clinical studies pointed out that a combination of both isomers could provide a reliable rationale for establishing a proper treatment strategy, as first suggested by Beemster’s seminal study ( 10, 11). Myo-inositol, alone or in combination with its isomer D-Chiro-Inositol (D-Chiro-Ins), showed to exert a variable-albeit significant-effect in improving both symptoms and outcome in PCOS patients ( 9). Namely, in the last decade, a growing body of clinical and experimental research provided robust evidence about the efficiency of inositol in reversing a few clinical, metabolic, and endocrine features of the Polycystic Ovary Syndrome (PCOS). Noticeably, inositol is involved in the transduction of several endocrine signals, including insulin ( 3, 4), thyroid hormones ( 5), gonadotropins ( 6), lipids with hormone-like activity (as prostaglandins) ( 7), and many other endocrine systems ( 8). Myo-Inositol (myo-Ins) and its phosphate derivatives-including inositol phosphates (InsPs), inositol pyrophosphates (IPPs) and phosphatidyl-inositol phosphate (PtdIns)-are credited to act as second messengers, which accumulate rapidly and transiently in response to external or endocrine signals, a phenomenon that allows signaling to be discrete and regulated ( 1, 2).
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