A randomized, double-blinded, superiority clinical trial to compare two dimensions of traditional medical precision medicine for allergic rhinitis: syndrome differentiation-based treatment or staging treatment?

Background: Traditional Chinese medicine (TCM) is widely used for allergic rhinitis (AR) treatment. The precision medicine of TCM treatment included 1) syndrome differentiation-based treatment (SDT) and 2) staging-based prescription modifying treatment (ST). This study conducted a randomized, controlled, double-blinded, superiority, non-inferiority, and equivalence clinical trial to compare their therapeutic effect on AR. Methods: Participants were diagnosed with TCM syndrome differentiation. Participants in the SDT group received a 6-week regular SDT with different prescriptions. Participants in the ST group received a 6-week ST in which every two weeks were defined as a stage (early, mid, and late) with different prescriptions. The prescriptions were all recommended by the Chinese National Administration of TCM and their therapeutic effects were supported by both classics of TCM literature and modern reference. The symptoms and constitutions related to AR patients were assessed at week 0 and week 6 and followed up after 1 year. SDT and ST in different gender, ages, and syndrome differentiation groups were compared. All the prescriptions in this study were analyzed using TCM components and property analysis and bioinformatic analysis. Results: 158 SDT and 159 ST patients were included in the analysis. Both SDT and ST significantly improved symptoms and constitution of AR. ST had a better therapeutic effect than SDT except for “Lung meridian heat” patients. Although gender might not affect the difference between SDT and ST, age might be an impact factor. The TCM components and property analysis and bioinformatic analysis provide information to better understand these classical prescriptions. Conclusion: For most AR patients, the syndrome differentiation based on disease alteration course over the treatment time was more therapy-critical than the syndrome differentiation based on patients’ constitution (or disease subtypes) and syndrome differentiation type and age are affecting factors.