Do Migraine Devices Like Cefaly Actually Work?
REAL TRIALS, REAL SKEPTICISM — BOTH TRUE AT ONCE Cefaly FDA-cleared 2014 Sham-controlled ACME trial CTAF panel: evidence “inadequate” vs.
REAL TRIALS, REAL SKEPTICISM — BOTH TRUE AT ONCE Cefaly FDA-cleared 2014 Sham-controlled ACME trial CTAF panel: evidence “inadequate” vs.
“FDA-CLEARED” AND “CURES THE INFECTION” ARE DIFFERENT CLAIMS Oral Terbinafine 35–76% complete cure Best-evidenced option Requires liver function monitoring Topical
THREE CLAIMS, ONE CONSISTENT VERDICT — AND ONE EXCEPTION Daytime Eye Strain 2023 Cochrane review: “probably no difference” AAO: doesn’t
THREE PRODUCTS, THREE DIFFERENT VERDICTS Passive Braces Real short-term EMG & alignment change Long-term benefit: “remain unknown” Biofeedback Wearables Trains
THREE DEVICES, THREE DIFFERENT REGULATORY CLAIMS Ava Bracelet FDA-cleared, 2021 Prediction AID only Not diagnostic, not contraceptive Natural Cycles FDA-cleared,
TWO $4B+ COMPANIES, ONE MISSING STUDY PHTI (Independent) Non-vendor-funded 2024 evaluation Comparable to in-person PT for many conditions Company Research
WHAT THE RESEARCH ACTUALLY SUPPORTS Stress & Wellbeing Real, replicated effect g=0.45–0.69, p<.001 23-RCT meta-analysis Productivity / ROI “No conclusions
THREE TREATMENTS, REAL FDA RECOGNITION Minoxidil FDA-approved drug Only topical for women ~15 hairs/cm² (5%) vs. placebo Finasteride FDA-approved drug
THREE STEP NUMBERS, THREE VERY DIFFERENT ORIGINS 10,000 Steps 1965 pedometer marketing name No study behind it — still every
THREE TIERS OF CLINICAL OVERSIGHT, NOT ONE CATEGORY Tier 1: MDacne AI analyzes selfie, no clinician in the loop OTC