This multicenter randomized controlled trial enrolled 1,480 patients with skeletal fluorosis to evaluate three traditional Chinese medicine (TCM) combinations—Ginkgo biloba with Epimedium, Xianling Gubao with Eucommia ulmoides, and Gusongbao with Rosa roxburghii—in conjunction with lifestyle modifications. The comparator was not reported, and follow-up duration was not specified. The primary outcome focused on cardiovascular metabolic outcomes, with secondary measures including diastolic blood pressure, systolic blood pressure, sleep quality, healthy dietary habits, and LDL-C levels.
Key results showed that smoking and alcohol consumption were independent risk factors for reduced therapeutic efficacy, with an odds ratio of 2.755 (95% CI: 1.400–5.421). For specific TCM combinations, Drug 2 (Xianling Gubao with Eucommia ulmoides) significantly counteracted adverse risk factors for treatment failure (OR = 0.461) and showed synergistic benefits for sleep quality (β = 1.596, P = 0.002), healthy dietary habits (β = -1.180, P = 0.001), and LDL-C reduction (P < 0.05). Drug 3 (Gusongbao with Rosa roxburghii) also reduced treatment failure risk (OR = 0.430) and demonstrated superior efficacy for diastolic blood pressure reduction (β = -2.263, P = 0.010), though its systolic blood pressure effect diminished with increasing age.
Safety and tolerability data were not reported. Limitations include unspecified follow-up, lack of comparator details, and potential confounding from lifestyle factors. The practice relevance highlights the clinical necessity of integrating behavioral interventions with pharmacotherapy to optimize cardiovascular metabolic safety, but clinicians should interpret these findings conservatively due to the mixed results and incomplete safety profile.
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IntroductionSkeletal fluorosis patients face a markedly elevated risk of cardiovascular metabolic abnormalities, including endothelial dysfunction, excessive oxidative stress, and impaired calcium-phosphate metabolism. Current clinical interventions for this condition are limited to symptomatic analgesia and conventional anti-osteoporotic treatments, and lack targeted therapeutic strategies for the “kidney deficiency and blood stasis” pathogenesis of skeletal fluorosis that can synergistically protect both the skeletal and cardiovascular systems.MethodsThis multicenter randomized controlled trial was conducted on 1,480 skeletal fluorosis patients from the China Fluorosis Cohort (CFC), to investigate the synergistic therapeutic effects of three traditional Chinese medicine (TCM) combinations—Ginkgo biloba combined with Epimedium (Drug 1), Xianling Gubao combined with Eucommia ulmoides (Drug 2), and Gusongbao combined with Rosa roxburghii (Drug 3)—in conjunction with lifestyle modifications on cardiovascular metabolic outcomes.ResultsSmoking and alcohol consumption were identified as independent risk factors for reduced therapeutic efficacy in skeletal fluorosis patients with comorbid cardiovascular metabolic abnormalities (OR = 2.755, 95% CI: 1.400 –5.421). Among the three TCM combinations, Drug 2 and Drug 3 significantly counteracted these adverse risk factors, reducing the risk of treatment failure by 53.9% (OR = 0.461) and 57.0% (OR = 0.430), respectively. Drug 3 exhibited superior efficacy in reducing diastolic blood pressure (β = −2.263, P = 0.010), while its systolic blood pressure-lowering effect diminished with increasing age. Drug 2 showed synergistic benefits with improved sleep quality (β = 1.596, P = 0.002) and healthy dietary habits (β = −1.180, P = 0.001), which enhanced its antihypertensive effects and led to a significant reduction in low-density lipoprotein cholesterol (LDL-C) levels (P < 0.05). Additionally, the interaction models outperformed the main-effect models, confirming the dynamic synergistic effect between lifestyle interventions and TCM pharmacotherapy.DiscussionThese findings highlight the clinical necessity of integrating behavioral interventions with pharmacotherapy to optimize cardiovascular metabolic safety in the clinical management of skeletal fluorosis. Based on these results, we propose a novel theoretical framework—Personalized Behavioral-Integrated Therapy (PBIT)—which guides the incorporation of patient-specific behavioral and demographic factors into tailored treatment strategies, thereby improving the precision and clinical outcomes of skeletal fluorosis treatment.
