Skip to main content
. 2020 Dec 24;10(1):35–50. doi: 10.1080/21556660.2020.1857149

Table 4.

Summary and risk of bias for medical devices that alter eccrine glands.

Study and intervention HH population and design Risk of bias Key results/critical appraisal findings
Fatemi Naeini et al.35
Fractionated microneedle radiofrequency (FMR) vs. sham
*Reevaluated based on W/P design
Axillary (severe)
W/P, single-blind,
sham control (N = 25); three sessions of FMR (1 MHz) at 3-week intervals
Moderate HDSS scores (mean ± SD) at week 21 went from 3.46 at baseline to 1.87 ± 0.61 (FMR) and 3.38 ± 0.49 (control) (p<.001)
More than three quarters of patients achieved a 1- or 2-point decrease in HDSS score (week 21)
80% of patients reported >50% satisfaction at the end of the study (week 21)
Safety: most common side effects were erythema (68%) and pinpoint bleeding (56%)
Bechara et al.34
Laser vs. untreated
*Reevaluated based on W/P design
Axillary
W/P, randomized, half-side-controlled trial (N = 21); 5 cycles of an 800-nm diode laser
Moderate Significant reduction in sweat rate was observed on the laser-treated side (median 89 mg/min vs. 48 mg/min; p<.001) and the untreated contralateral side (median 78 mg/min vs. median 65 mg/min; p=.04)
No significant difference was found between the treated and untreated sides (p=.10)
Safety: no serious complications during laser treatment were reported; one instance of axillary skin depigmentation was observed that resolved during the 12-month follow-up
Nestor and Park36
Microfocused ultrasound plus visualization vs. sham
*Reevaluated based on W/P design
Axillary
Two W/P, randomized, double-blind, sham-controlled pilot studies (N = 14 and N = 20)
Moderate Study 1: ≥50% of patients achieved a ≥50% reduction in gravimetric sweat production (day 120)
Study 2: HDSS response (day 60) was 67% (micro-focused ultrasound plus visualization) vs. 0% (sham) (p=.005)
Study 2: HDSS response maintained (month 12)
Safety: AEs were found to be mild; most common (>80%) were axilla tenderness or soreness
Microwave thermolysis      
Suh et al.38
Microwave thermolysis
Included for analysis of Safety only
*New study identified from reference review
Axillary
Case report of a thin, healthy male patient diagnosed with transient median and ulnar neuropathy following microwave treatment for the treatment of axillary hyperhidrosis
Safety only Patient reported numbness and weakness in the first and second fingers and decreased ability to abduct his left arm
Symptoms resolved at six months after intensive physical therapy
Chang et al.39
Microwave thermolysis
Included for analysis of safety only
*Newly identified relative to Wade et al.12
Axillary
Case report of a thin, healthy female patient diagnosed with median and ulnar nerve injury following microwave treatment for the treatment of axillary hyperhidrosis (level 5 microwave for 1.5 s at a size of 140 × 80 mm2)
Safety only Patient experienced severe swelling, numbness and inability to raise her left arm immediately following treatment
Palmar skin was noted to be discolored
Sensory and motor deficits had not resolved at the 6-month follow-up
Liposuction curettage      
Budamakuntla et al.25
Subcutaneous curettage vs. botulinum toxin A injections
(appears also in Table 3 for botulinum toxin results)
*Newly identified relative to Wade et al.12
Axillary
W/P, open-label, 3-month comparative study of efficacy and safety of botulinum toxin A injections and subcutaneous curettage in adults (N = 20)
Moderate (LRR) The mean percent reduction in the resting sweat rate (gravimetry, weighed filter paper) 3 months after BTX-A injections was 80.32% and 3 months after the suction-curettage was 79.79%, p=.2072
After botulinum toxin A injections, mean HDSS score decreased 1.75 points at month 3 (p<.0001) and by 1.35 points at month 6 (p<.0001)
After suction curettage, mean HDSS score decreased 1.70 points at month 3 (p<.0001) and 1.20 points at month 6 (p<.0001)
Safety: after toxin injections no patients reported pain or other AEs; after the suction-curettage procedure, 2 patients had bruising which resolved in 3 days; one patient had a painful bridle (fibrosis) formation in the surgical site which persisted for 2–3 months
Ibrahim et al.29
Suction curettage vs. onabotulinumtoxin-A injections
(appears also in Table 3 for botulinum toxin results)
*Reevaluated based on W/P design
Axillary
W/P, randomized, comparative study (unblinded) in adults 18–65 with 6-month follow-up (N = 20)
Moderate (LRR) At month 3, toxin injections decreased sweat production by 72.1% vs. 60.4% for suction-curettage, p=.29
Duration of effect was ∼6 months
Safety: after toxin injections, none of the 20 patients reported discomfort or adverse reactions; after suction-curettage, patients reported axillary discomfort for about a week; 3 patients in the suction-curettage group reported hyperpigmentation
Tronstad et al.37 a
Tumescent suction curettage vs. curettage only
*Reevaluated based on W/P design
Axillary
W/P, unblinded, half-side comparison randomized, controlled trial in adults (N = 22); 12-month follow-up
Moderate Five patients withdrew or did not meet for any follow-up examination; 17 subjects analyzed
Significant reduction in sweating after both interventions lasting ≥ 12 months was found per skin conductance, gravimetry and visual analogue scale scoring
Significantly better effect of tumescent suction curettage than curettage only; curettage reductions were approximately 40%, 30%, 35%; gravimetric measurements were reported as significantly lower at 6 (p<.05) and 12 months (p<.01) vs. before treatment but effect size estimates not possible from Figure 2. Safety: no infections requiring systemic antibiotics or hematoma after one week; one patient receiving suction with curettage experienced postoperative neuropathic pain, lasting through the observational period; no scarring was observed

Abbreviations. AE, Adverse event; HDSS, Hyperhidrosis Disease Severity Scale; LRR, Large response rate; W/P, Within patient.

a

SOE considered for tumescent suction curettage body of evidence only.