Trial Waste in Hyaluronic Acid-Related Randomised Controlled Trials

A notable obstacle in applying the findings of hyaluronic acid (HA)-related randomised controlled trials (RCTs) to real-world patient treatment is trial waste (TW). To date, the extent of TW in RCTs for HA is not clear.

To analyse the extents of TW within HA-RCTs and identify protective factors against TW.

In July 2024, we searched the ClinicalTrials database using the 'hyaluronic acid' as keyword. We documented the data available and then explored PubMed and Scopus for the publication status. Reporting adequacy was evaluated using the CONSORT checklist. Design limitations were analysed based on bias risk and whether the article referenced a relevant systematic review. Subsequently, we evaluated extent of TW (unpublished studies, insufficient reporting and design flaws).

One hundred and eighty-four RCTs met the inclusion criteria. The analysis of TW excluded 53 RCTs completed after June 2020 that remained unpublished. Among the remaining 131 RCTs, 72 were published, 47 had adequate reporting and 19 had design limitations. Taken together, 96 RCTs (73.3%) exhibited at least one characteristic of TW. Characteristics of these RCTs included early registration (p < 0.001) and the absence of a multi-blind approach (p = 0.007). Registration prior to 2014 (p < 0.001) and the open-label or single-blinding design (p = 0.003) emerged as independent risk factor for TW.

We delineated the features of 184 HA-related RCTs. 73.3% of the RCTs included in TW analysis exhibited TW. The diverse traits of the different TW indicators identified could serve as valuable insights for conducting future HA-RCTs more rationally and efficiently.