Liposuction versus conservative therapy for patients with lipoedema in Germany: a multicentre, randomised controlled clinical trial.

BACKGROUND: Lipoedema is a painful, chronic disease of the subcutaneous adipose tissue, predominantly affecting women. Conservative complex decongestive therapy is the standard of care but offers limited symptom relief. Liposuction appears to be a promising approach but lacks evidence of effectiveness and safety. The aim of this trial was to show superiority of liposuction compared with conservative therapy regarding relevant pain reduction with reasonable safety. METHODS: In this multicentre, randomised controlled trial at 11 German centres, eligible women with stage I, II, or III lipoedema and leg pain of at least 4 points on a 0-10 numeric rating scale received conservative therapy for up to 7 months and then were randomly assigned to liposuction or conservative therapy (2:1) stratified by lipoedema stage and study site. For all visits involving an assessment, patches were applied to the legs of all patients, and patients were instructed not to reveal the treatment they had received, in order to mask the assessor. The primary endpoint was reduction of patient-reported leg pain by at least 2 points after 12 months, and missing assessment was considered non-successful.The primary outcome was analysed in the intention-to-treat population which included all randomly assigned patients, and safety analysis included all enrolled patients. A long-term follow-up of 36 months is ongoing. This study is registered at ClinicalTrials.gov, NCT04272827. FINDINGS: Of 1973 patients screened between Jan 19, 2021, and June 7, 2022, 453 were enrolled, and 410 were randomly assigned to the liposuction group (n=278) or to the conservative therapy group (n=132). All 410 patients were included in the intention-to-treat analysis (mean age 42·9 [ SD 10·6]; ethnicity data were not collected). After 12 months, 190 (68%) of 278 randomisly assigned patients undergoing liposuction achieved the primary endpoint of pain reduction versus ten (8%) of 132 randomly assigned to conservative therapy (odds ratio 26·2 [95% CI 13·1-52·5]; p<0·0001). Adverse events occurred in 124 (47%) of 265 patients undergoing liposuction, and 20 (8%) of 265 were rated as serious. In the conservative therapy group, 30 (21%) of 145 patients reported adverse events, and five (3%) 145 were rated as serious. Secondary endpoints regarding quality of life showed greater improvement in the liposuction group. INTERPRETATION: Liposuction was superior to conservative therapy in reducing leg pain and improving quality of life in patients with lipoedema, but was associated with a higher rate of serious adverse events. Liposuction has the potential to be a promising treatment option for patients with lipoedema. FUNDING: The Federal Joint Committee, Germany.