Article type
Abstract
Background Chinese patent medicines (CPMs) are popular for treating primary osteoporosis (POP) due to their convenience, stability, and low adverse effects. Clinical guidelines recommend using syndrome differentiation to determine the appropriate CPMs for specific syndromes. For treatment duration, a minimum of six months is recommended for delaying bone loss and increasing bone mass, while one to three years is recommended to reduce fracture risks and improve quality of life (QoL). Nevertheless, original studies on CPMs for POP, particularly randomized controlled trials (RCTs), have some quality and design problems. Objectives: To raise awareness about current RCTs' methodological and study design limitations for CPMs in POP treatment. Methods We searched Pubmed and CNKI databases for recent systematic reviews (SRs) and overviews of SRs of published RCTs on POP treated with CPMs within the last three years to identify methodology features. Results 96 of 167 RCTs did not clearly report randomized methods, while only 4 reported allocation concealment. Six RCTs claimed blinding, but only one used a placebo control group. Five SRs assessed 156 RCTs as having a low bias risk for incomplete outcome data, but some trials lacked information on sample size calculation, dropouts, or follow-up loss. From the study design perspective, few RCTs required TCM diagnostic criteria and specific TCM syndromes in participants. Studies on POP treatment often overlooked active ingredients, mechanisms of action, and potential drug interactions. The treatment duration ranged from one month to two years. Most studies lasted around six months, with few lasting over a year. Out of the 27 RCTs investigating Gushukang for POP, only five trials reported liver and kidney dysfunction as safety outcomes. Most studies assessed symptoms using total effective rate or TCM syndrome indexes. Few studies have looked at fracture risks and QoL. Conclusion Our review highlights the need for methodological improvements in RCTs with CPMs for POP, including clarification and verification of the relationship between tested CPM and TCM syndrome, the rationality of interventions and medication regimens, and missing or conflicting information in CPM instructions. It is crucial to determine the drug's clinical positioning and use appropriate outcomes and treatment duration.