Table 3.
Summary and risk of bias for botulinum toxin type A studies.
| Study and intervention | HH population and design | Risk of bias | Key results/critical appraisal findings |
|---|---|---|---|
| Lueangarun et al.26 Topical botulinum toxin type A liposomal cream (not commercially available) vs. Vehicle *Newly identified relative to Wade et al.12 |
Axillary W/P, randomized, double-blind, vehicle-controlled 8-week trial in patients ages 18–50 (N = 20) |
Moderate (LRR) | Potential for small short-term benefits of BTX-A cream based on reduced sweat production, expert panel assessments of iodine starch test, HDSS, and patient satisfaction Safety: no AEs (including local skin reactions) were observed in either treatment arm |
| Budamakuntla et al.25 Botulinum toxin A injections vs. subcutaneous curettage (appears also in Table 4 for curettage 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) | Large decrease in sweat rate consistent with HDSS score decrease After BTX-A injections, mean HDSS decreased 1.75 points at month 3 (p<.0001) and by 1.35 points at month 6 (p<.0001) After suction curettage, mean HDSS 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 had bruising which resolved in 3 days; one had a painful bridle (fibrosis) formation in the surgical site persisting for 2–3 months |
| Montaser-Kouhsari et al.27 a Botulinum toxin A injections, 250 MU (per side) vs. botulinum toxin A administered by iontophoresis *New study identified from reference review |
Axillary W/P, randomized trial comparing botulinum toxin A injections to botulinum toxin A administered by iontophoresis over 6 months (N = 11) |
Moderate (LRR) | Iontophoresis of BTX-A reduced sweat production (gravimetry) by 73%, 22%, and 32% after 1 week, 1 month, and 6 months, respectively; injection reduced sweat production by 84%, 76%, and 50%, respectively At month 6, all but one of the injection groups reported being very satisfied; for iontophoresis, no participant reported being very satisfied, 9 reported being satisfied, and 2 reported dissatisfaction Safety: no AEs other than pain were reported. Pain perception (VAS score 0–100) was significantly lower in with iontophoresis vs. injection (15.0 vs. 20.0, p<.05) |
| Yamashita et al.33 Botulinum toxin A 60 U in right palm injections vs. no treatment *Reevaluated based on W/P design |
Palmar W/P, non-randomized, 6-month clinical trial in adults (N = 27) |
Moderate (LRR) | Quantity of sweat on the treated hand decreased to approximately one-fifth at one month after injection. Sweat quantity increased slightly over time but remained less than half at 6 months after injection; significant difference was observed when compared to before injection. Safety data were not presented; authors note “very little effect on grip strength” |
| Schnider et al.32 Botulinum toxin A injections (BTX-A; Dysport) 120 units vs. placebo (saline) *Reevaluated based on W/P design |
Palmar W/P, randomized, double-blind, 13-week comparison in adults with socially handicapping palmar hyperhidrosis (N = 11) |
Moderate (LRR) | Mean sweat reduction of 40% from baseline (digital images) and a 40% improvement using a visual analog scale were reported at 8 weeks (p≤.002) with BTX-A; neither the objective measurement nor the subjective rating showed a statistically significant reduction of sweating in the placebo-treated palms Safety: no serious AEs; 3 patients reported minor handgrip weakness in the BTX-A-treated hand, and 3 reported injections were more painful in BTX-A-treated hands vs. placebo |
| Lowe et al.30 Botulinum toxin A injections (BTX-A) vs. placebo (normal saline) *Reevaluated based on W/P design |
Palmar W/P, randomized, 28-day comparison in adults ages 18–80 (N = 19 each group) |
Moderate (LRR) | Patients experienced a decrease in sweat production of approximately two thirds with BTX-A injections and about one third with placebo at 28 days; 17/17 rated the treatment as successful in the BTX-A-treated palm vs. 2/17 with placebo (p<.0001) Safety: no major AEs reported; 4 patients reported AEs (hand or finger numbness of short duration, pain in hand) |
| Glogau28 Topical botulinum toxin A (200 U) combined with proprietary transport peptide (not commercially available) vs. vehicle *Reevaluated based on W/P design |
Axillary W/P, randomized, vehicle-controlled 4-week trial (N = 12) |
Moderate (LRR) | Week 4 gravimetric sweat reduction was 65.3 ± 21.5% (BTX-A) vs. 25.3 ± 66.2% (vehicle; p<.05); minor’s iodine starch consistent with large response rate in BTX-A group Safety: no systemic AEs were reported. Local AEs (n = 4) occurred in vehicle-treated axillae and included mild folliculitis, tenderness, erythema, and eczema |
| Ibrahim et al.29 Onabotulinumtoxin-A injections vs. suction-curettage (appears also in Table 4 for curettage 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 Toxin injections resulted in a larger decrease in HDSS than suction-curettage by 0.80 points (month 3; p=.0002) and 0.90 points (month 6; p=.0017) 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 |
| Naver et al.31 Botulinum toxin A injection vs. no treatment *Reevaluated based on W/P design |
Axillary; palmar W/P, unblinded study comparing treated vs. non-treated axilla (n = 13), and/or palms (n = 19) (N = 28 total); 1-year follow-up |
Borderline (LRR) | Consistent pattern of improvement in all outcomes Sweating disappeared in 8/13 (axillary) and 5/19 (palmar) or was markedly reduced in another 5/13 (axillary) and 10/19 (palmar) Duration of effect was 2 to 5 months Safety: reduced finger grip in two-thirds of palmar patients; 2 patients with intense pain from injection |
| Heckmann et al.17 Botulinum toxin A injection vs. placebo *Reevaluated based on W/P design |
Axillary W/P, multicenter, randomized, placebo-controlled, 2-week study (26-week follow-up) (N = 145) |
Low (LRR) | Large (approximately 88%) decrease in mean rate of sweat production at week 2 in botulinum toxin A treated group; at week 24, sweat production was reduced by approximately 65% (open label after 2 weeks) Safety: no major AEs reported during first 14 weeks. Temporary adverse effects included headache in 4 patients, muscle soreness of the shoulder girdle in 2, increased facial sweating in 1, and axillary itching in 1 |
Abbreviations. AE, Adverse event; BTX-A, Botulinum toxin A; HDSS, Hyperhidrosis Disease Severity Scale; LRR, Large response rate; W/P, Within patient.
a
SOE considered for botulinum toxin A injection body of evidence only.