This paper presents a protocol for a randomized controlled trial to evaluate the effects of infrared moxibustion on blood lipid levels in patients with mild hyperlipidemia, exploring potential mechanisms through gut microbiota, TMAO metabolites, and brain gray matter volume changes.
The trial will recruit 158 patients with mild hyperlipidemia and randomly assign them to genuine or sham infrared moxibustion groups.
The intervention protocol involves infrared moxibustion administered twice weekly for a total of 8 weeks.
Blood lipid levels will be assessed as the primary outcome at multiple time points before and after treatment.
The trial will assess multiple secondary outcomes including cognitive function, depression, anxiety, and sleep quality.
The trial will investigate gut microbiota composition and the metabolite trimethylamine N-oxide (TMAO) as potential mechanistic mediators of infrared moxibustion effects.
The trial will measure brain gray matter volume changes as a neurological mechanistic outcome.
Hyperlipidemia is identified as a significant risk factor for both cardiovascular diseases and cognitive impairment, justifying early intervention research.
This research describes the design of a clinical trial testing whether infrared moxibustion — a modern form of traditional heat-based therapy — can help lower blood fat (lipid) levels in people with mild high cholesterol or triglycerides. High blood lipid levels are a known risk factor for heart disease and memory problems, but current treatments are not always well-tolerated, which has led researchers to explore complementary therapies. The trial will enroll 158 participants who will receive either real or 'sham' (fake) infrared moxibustion twice a week for 8 weeks, with follow-up assessments continuing for 12 weeks afterward. Beyond measuring blood lipid levels, the study will also track participants' cognitive function, mood, anxiety, and sleep quality at multiple time points. Uniquely, the trial will also investigate two potential biological mechanisms: changes in the gut microbiome and one of its key metabolites (TMAO, a compound linked to cardiovascular risk), as well as changes in brain gray matter volume measured through brain imaging. These additional measures are designed to help explain how — or whether — infrared moxibustion produces its effects. This research matters because it represents a rigorously designed attempt to fill a gap in the evidence base for infrared moxibustion. The inclusion of a sham control group, multiple follow-up time points, and mechanistic biomarker measurements makes this a more rigorous study than much prior work in this area. However, it is important to note that this paper only describes the study protocol — no results are yet available — so the actual effectiveness of infrared moxibustion for high cholesterol remains to be determined.
Xie H, Feng F, Zhu J, Zhu W, Xiong S, Xing B, et al.. (2026). Impact of infrared moxibustion for patients with mild hyperlipidemia: a protocol for a randomized controlled trial.. Annals of medicine. https://doi.org/10.1080/07853890.2026.2665513