Table 2.
Author Publication Year | Evidence | Study Design (Sample Size) | Condition | Intervention | Number of Treatments/Intervals | Outcome Measures | Clinical Outcomes | Patient Reported Outcomes | Adverse events |
---|---|---|---|---|---|---|---|---|---|
Fatemi Naeini et al. 2015 (13) | 3 | Single blind sham control (n = 25) | Primary axillary hyperhidrosis | FMR w/ topical anesthesia | 1 session q3 weeks x3 | HDSS Sweating visual analogue scale (VAS) Pre and post histology |
HDSS:
Baseline: treated 3.46; control 3.46 5 months: treated 1.87; control 3.38 (p=<0.001) VAS: Baseline: treated 9; control 9 5 months: treated 3.92; control 8.44 Histology changes: Sweat gland necrosis Mild inflammatory cell infiltrate |
Patient satisfaction: 80% of pts reported more than 50% satisfaction |
Erythema 68% Pinpoint bleeding 56% Hyperpigmentation 44% Tingling 1 pt |
Fatemi Naeini et al. 2015 (15) | 5 | Case report (n = 1) | Primary axillary hyperhidrosis | FMR | 1 session q2 weeks x4 | Starch-iodine test |
Starch-iodine: Pretreatment positive Post treatment negative |
No hyperhidrosis at 6-months | Skin irritation, erythema, and pin-point bleeding |
Kim et al. 2013 (12) | 4 | Case series (n = 20) | Primary axillary hyperhidrosis | FMR w/tumescent anesthesia | 1 session q4 weeks x2 | Hyperhidrosis Disease Severity Scale (HDSS): 4-point scale (1–4) Starch-iodine test Histologic analysis |
HDSS: Baseline: 3.3 4 weeks after 1st treatment: 1.5 8 weeks after 2nd treatment: 2.3 (p<0.001) Starch-iodine test: Decreased area in 95% of subjects Histology: Decreased density and size of sweat glands |
Patient satisfaction: (0 “no improvement”- 4 “>75% improvement”): 4 weeks after 1st treatment: 3.3 4 weeks after 2nd treatment: 3.0 8 weeks after 2nd treatment: 2.5 |
Temporary tingling, swelling and erythema in all pts Compensatory hyperhidrosis in 2 pts and transient numbness in 1pt |
Schick et al. 2016 (14) | 4 | Case series (n = 30) | Grade III axillary hyperhidrosis | FMR w/ local anesthesia | 1 session q6 weeks x3 | HDSS Dermatology Life Quality Index (DLQI) |
HDSS: Baseline: 3.5 5 months 2.1 (p<0.05) DLQI: Baseline: 16 5 months: 7 (p<0.05) |
Patient satisfaction: Satisfied 53% Very satisfied 37% Average reduction 72% |
Petechial bleeding 50% Arm twitching during treatment 27% Erythema 100% Ulceration 7% Post anesthesia pain 70% |