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Is there any evidence that α-lactalbumin enhances the actions of myo-inositol?

The short answer: none that we are aware of at this time. Our guiding principles for product formulation are built upon robust and reproducible studies; our myo-inositol products include only myo-inositol as we appreciate that most of us only wish to have treatments where there is a discernible benefit. You will not find folic acid or α-lactalbumin in Replenitol because we can not find any evidence that their addition would improve outcomes. We understand that the inclusion of folic acid is unlikely to cause adverse reactions and the word "folic" is a useful device to suggest the product concerns women's reproductive health. However, folic acid is used as the placebo for the control group in most of the published studies and does not affect myo-inositol metabolism so we choose not to include it.

Why do some providers include α-lactalbumin?

α-lactalbumin is included in most baby formula as it is part of bovine whey which is difficult to remove from milk during production and is generally regarded as safe. Hundreds of millions of babies have relied on baby formula in their early years but we are not aware of any evidence of the benefit of its inclusion with respect to myo-inositol. In most jurisdictions, there is a legal requirement for baby formula to include myo-inositol so it is not an uncommon combination and is highly unlikely to cause harm.

The only studies that we can find have been published in the very recent past and seem to consist of 3 micro studies involving 34, 18 and 14 subjects only. None had a recognised control arm so there is an absence of value in further consideration of them. They have very little to offer in support of its inclusion so it is not a route that we intend to explore further but we are happy to forward the citations should you wish to make your own judgement.

Most clinicians recommend that women with PCOS should be treated for a minimum of 6 months with myo-inositol as they respond to differing degrees and at different times. The 14-subject study, for example, involved adding α-lactalbumin at 3 months to the regular myo-inositol dose taken for the preceding 3 months and assigning any benefit in the second 3-month period to its addition - not the ongoing normal protocol. The inclusion of a control arm may have allowed them to draw clinically useful conclusions.

There is a recurring misunderstanding about the pharmacokinetics of myo-inositol within many studies that may have contributed to the idea that some women are inositol-resistant. Many authors quote the plasma half-life of myo-inositol as 26 hours based upon transplacental studies, the actual period is 22 minutes in an individual. Women who drink the dissolved contents of sachets can expect to have absorbed and cleared the myo-inositol within 180 minutes. We believe the most effective way of augmenting the effectiveness of treatment is to prolong the dose delivery window. Replenitol 1g tablets can be taken throughout the day or 2 twice daily, allowing the patient and clinician to adopt a more flexible approach to meet specific needs. And they are much preferred by almost all women as well as they are much more convenient compared with sachets.

The EMmy pilot study demonstrated that just over half of the participants adhered to the treatment regime because they could not tolerate the sachets. Many of the women and researchers observed that a solid form of the product would be much preferred and this has led the authors to conclude that the large-scale trial should be based on a tablet in order to maximise compliance.

Non-adherence to treatment with sachets was an astonishing 48%! "Sandy sachets" were associated by women with their nausea and vomiting and led to many leaving the trial.