Effectiveness and safety of acupoint catgut embedding for patients with mild psoriasis and overweight: study protocol of a multicenter double-blind randomized controlled trial

TL;DR

This study will test if a type of acupuncture called acupoint catgut embedding can safely and effectively treat mild psoriasis and overweight in a controlled trial.

Contribution

This is the first multicenter, double-blind RCT to evaluate the dual effects of ACE on psoriasis and metabolic dysfunction.

Findings

ACE may modulate both immune and metabolic responses in patients with mild psoriasis and overweight.

The trial will assess the long-term durability of ACE effects through 32 weeks of follow-up.

Abstract

Psoriasis is a systemic inflammatory disease frequently comorbid with obesity, as both conditions share common pathogenic pathways. Acupoint catgut embedding (ACE), a sustained-release form of acupuncture, has demonstrated potential in modulating both immune and metabolic responses. This trial aims to evaluate the efficacy, safety, and underlying mechanisms of ACE in patients with mild psoriasis and concurrent overweight/obesity.

This is a multicenter, randomized, double-blind, sham-controlled trial. Participants aged ≥ 18 years with mild plaque psoriasis (PASI< 3, BSA < 3%) and overweight (BMI ≥ 24 kg/m2) will be randomized (1:1) to receive either verum ACE at 14 specific acupoints or a sham procedure. Interventions will be administered every 2 weeks for 8 weeks. The primary endpoints are the changes in PASI score and BMI from baseline to week 8. Secondary outcomes include the Dermatology Life Quality Index (DLQI), waist circumference (WC), lipid profiles, and systemic inflammatory markers. The safety of the procedure will be monitored through the recording of adverse events and conducting laboratory tests. Participants will be followed through week 32 to evaluate long-term therapeutic durability.

This trial will provide high-quality evidence regarding the “dual-action” potential of ACE in simultaneously improving psoriatic lesions and metabolic dysfunction, establishing its role as an integrative therapy for this specific patient phenotype.

https://itmctr.ccebtcm.org.cn/, identifier ITMCTR2025002460.

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