Efficacy and safety of injectable deoxycholic acid for submental fat reduction: a systematic review and meta-analysis of randomized controlled trials

ABSTRACT

Objective: To investigate the efficacy and safety of deoxycholic acid (DOC) for SMF reduction.

Methods: We conducted a systematic review and meta-analysis of randomized controlled trials. We searched PubMed/MEDLINE, EMBASE, and Cochrane databases until June 2020. Efficacy outcomes: Clinician-Reported Submental Fat Rating Scale; Patient-Reported Submental Fat Rating Scale; Subject Self-Rating Scale; SMF reduction measured using caliper and resonance magnetic imaging; Early therapeutic success. Safety outcomes: Withdrawals due to adverse events (AEs), Rates of AEs, Skin laxity.

Results: Five studies were included, comprising 1,838 participants. DOC (1 or 2 mg/cm²) had greater improvement in all efficacy measures compared to placebo. No differences were seen between both doses of DOC. Withdrawals due to AEs were low with 1 and 2 mg/cm² of DOC (6.8% vs. 9.9%, respectively), and there was no difference between the two doses (p = 0.22). AEs were usually associated with the injection site, were predominantly transient, and commonly resolved within the treatment session interval. Injection site pain, hematoma, anesthesia/numbness, erythema, and swelling/edema were the most common AEs. There was no difference in their prevalence between both doses of DOC.

Conclusions: DOC is effective and safe for SMF reduction with no differences between doses of 1 and 2 mg/cm².

KEYWORDS:

• ATX-101
• deoxycholic acid
• deoxycholate
• submental fat
• safety
• efficacy

Reviewer disclosures

Peer reviewers in this manuscript have no relevant financial or other relationships to disclose.

Authors’ contributions

K.S.C. and R.M.C. conceived and designed the study. K.S.C. and F.L. selected the studies and extracted the data. K.S.C performed the statistical analyses and interpretations. K.S.C. wrote the paper. F.L. and R.M.C. revised the paper critically for important intellectual content. All authors provided final approval for the version to be submitted.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties

Additional information

Funding

This paper was not funded