Supplementary file 1_Impact of Yuehua Decoction on quality of life and safety in multidrug-resistant tuberculosis: a prospective cohort study using multivariable regression analysis.docx

BackgroundMultidrug-resistant tuberculosis (MDR-TB) remains a major global health challenge, and prolonged chemotherapy often leads to substantial symptom burden and impaired health-related quality of life (HRQoL). Host-directed adjunctive therapies, including Traditional Chinese Medicine, have received growing interest; however, prospective clinical evidence on Yuehua Decoction remains limited. This study evaluated whether adjunctive Yuehua Decoction improves HRQoL and safety among patients receiving standardized MDR-TB treatment.
MethodsWe conducted a prospective, non-randomized cohort study enrolling adults with microbiologically confirmed MDR-TB. Patients received either standard MDR-TB chemotherapy alone (control group) or in combination with Yuehua Decoction (Yuehua group) based on treatment preference. The primary outcome was HRQoL at 6 months, assessed using the St. George’s Respiratory Questionnaire (SGRQ). Between-group differences were analyzed using multivariable linear regression adjusting for baseline SGRQ and other clinically relevant covariates. Secondary outcomes included sputum culture conversion and treatment-related adverse events.
ResultsSeventy-one patients were included (Yuehua group, n = 32; control group, n = 39). Although demographic characteristics were similar, baseline SGRQ scores were significantly higher in the Yuehua group (P = 0.007). After adjustment for this imbalance, adjunctive Yuehua Decoction was associated with greater improvement in SGRQ total score at 6 months (adjusted β = –3.00; 95% CI: –3.87 to –2.12; P < 0.001). The between-group difference was slightly below the conventional minimal clinically important difference (4 points), but the direction and precision of the estimate suggest potential clinical relevance. Rates of sputum culture conversion and overall treatment success were comparable between groups. A significantly lower incidence of skin reactions was observed in the Yuehua group (15.6% vs. 35.9%, P = 0.038), with no increase in serious adverse events.
ConclusionIn this preliminary prospective cohort, adjunctive Yuehua Decoction was associated with improved HRQoL without increasing treatment-related toxicity among patients undergoing MDR-TB chemotherapy. These findings support Yuehua Decoction as a potential host-directed adjunct, but confirmation in larger randomized controlled trials is needed.