Treatment – Page 24 – Hyperhidrosis Research . org

February 23, 2021

Botulinum Toxin Versus Placebo: A Meta-Analysis of Treatment and Quality-of-life Outcomes for Hyperhidrosis

Aesthetic Plast Surg. 2021 Feb 22. doi: 10.1007/s00266-021-02140-7. Online ahead of print.

ABSTRACT

AIMS: This study aims at assessing the treatment effect, disease severity and quality-of-life outcomes of botulinum toxin (BTX) injections for focal hyperhidrosis.

METHODS: We included randomized controlled trials of BTX injections compared with placebo for patients with primary or secondary focal hyperhidrosis. PubMed, Embase and the Cochrane Library were searched to August 2020. Gravimetric sweat rate reduction, disease severity measured by Hyperhidrosis Disease Severity Scale and quality-of-life assessment measured by Dermatology Life Quality Index were the outcomes of interest. Cochrane risk-of-bias tools were employed for quality assessment of given randomized controlled trials.

RESULTS: Eight studies met our inclusion criteria (n=937). Overall, risk bias was mixed and mostly moderate. BTX injections showed reduced risk in comparison with placebo for the gravimetric quantitative sweat reduction of > 50 % from baseline (risk difference: 0.63, 95% CI 0.51 to 0.74). Additionally, improvements were seen for disease severity and quality-of-life assessments evaluated by Hyperhidrosis Disease Severity Score reduction of ≥ 2 points (risk difference: 0.56, 95% CI 0.42 to 0.69) and mean change in Dermatology Life Quality Index (mean difference: – 5.55, 95% CI – 7.11 to – 3.98). The acquired data were insufficient to assess for long-term outcomes and limited to an eight-week follow-up period.

CONCLUSIONS: In focal axillary hyperhidrosis, BTX significantly reduces sweat production and yields superior outcomes in assessments of disease severity and quality-of-life. However, the quality-of-evidence is overall moderate and included studies account for short-term trial periods only. Further studies assessing BTX in comparison with first-line treatments for hyperhidrosis are warranted.

LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

PMID:33619611 | DOI:10.1007/s00266-021-02140-7

February 21, 2021

Rib-oriented Thoracoscopic Sympathetic Surgery for Hyperhidrosis: Prospective Long-term Results and Quality of Life.

Rib-oriented Thoracoscopic Sympathetic Surgery for Hyperhidrosis: Prospective Long-term Results and Quality of Life.

Surg Laparosc Endosc Percutan Tech. 2021 Feb 16;:

Authors: Nachira D, Meacci E, Congedo MT, Petracca-Ciavarella L, Zanfrini E, Iaffaldano A, Vita ML, Chiappetta M, Griffo R, Lococo F, Margaritora S

Abstract
BACKGROUND: The optimal thoracoscopic sympathetic surgery for primary palmar and/or axillary hyperhidrosis (PPAH) is still unclear because of lack of uniform technique and qualitative/quantitative scales for definition of results. The aims of this study were to compare long-term outcomes based on the surgical technique and the level of sympathetic trunk interruption by clipping and to assess postoperative compensatory sweating (CS), patients’ satisfaction, and quality of life (QoL).
MATERIALS AND METHODS: Between September 2009 and April 2016, 94 patients who underwent 2-stage bilateral thoracoscopic rib-oriented (R) sympathetic clipping were prospectively followed up through the administration of standardized preoperative and postoperative questionnaires.Thirty-four (36.2%) patients underwent single-port transaxillary access instead of the standard two 5-mm incisions. The level of sympathetic clipping for PPAH was R3+4(top and bottom); in patients who complained associated facial or plantar hyperhidrosis R2-bottom and R5-top were clipped, respectively. Seventy-five patients completed bilateral surgery.
RESULTS: There were no significant differences between single-port and biportal video-assisted thoracoscopic surgery in terms of operative times and postoperative results. At a mean follow-up of 72 (SD: 26) months, CS was reported in 42 (56%) patients, severe only in 6 (8%). It was higher in the case of R2-bottom clipping (P=0.03). Thirty-one of 60 (51.6%) patients who had a plantar hyperhidrosis declared an improvement of feet sweating after surgery. Postoperative satisfaction was excellent (86.11% on a 0 to 100 scale) and 95.4% of patients declared an improvement in QoL, which was statistically significant in all evaluated parameters. These results were not related to the level of clipping.
CONCLUSION: Thoracoscopic R3 to R4 clipping appears to be a safe and effective treatment for PPAH. Although postoperative CS was common and higher after R2-bottom clipping, this did not seem to affect patients’ satisfaction and improvement in QoL.

PMID: 33605681 [PubMed – as supplied by publisher]

January 27, 2021

Transareolar single-port endoscopic thoracic sympathectomy with a flexible endoscope for primary palmar hyperhidrosis: a prospective randomized controlled trial.

Transareolar single-port endoscopic thoracic sympathectomy with a flexible endoscope for primary palmar hyperhidrosis: a prospective randomized controlled trial.

Ann Transl Med. 2020 Dec;8(24):1659

Authors: Lin JB, Kang MQ, Chen JF, Du Q, Li X, Lai FC, Tu YR

Abstract
Background: Transareolar single-port endoscopic thoracic sympathectomy (ETS) with a flexible endoscope has rarely been reported. This study assessed the performance of this novel minimally invasive technique for primary palmar hyperhidrosis (PPH).
Methods: From January 2019 to September 2019, 118 males with severe PPH requiring single-port and bilateral ETS were randomly allocated to undergo transareolar ETS using a flexible endoscope (group A, n=58) or transaxillary ETS using a 5 mm thoracoscope (group B, n=60).
Results: Both groups had similar patient characteristics. All procedures were performed successfully, with no mortality or conversion to open surgery. All patients had dry and warm palms immediately after surgery. Compared with group B, group A had a significantly shorter median incision length [5.1 (5.0-5.2) vs. 10.9 (10.8-11.9) mm; P<0.001], and significantly lower median postoperative pain score [1 (1.0-2.0) vs. 3 (3.0-4.0); P<0.001]. There were no differences between the two groups in operative time, palmar temperature increase, and transient postoperative sweating. After complete follow-up, group A had a significantly higher median cosmetic score than group B [4.0 (3.0-4.0) vs. 3.0 (3.0-3.0); P<0.001]. There were no differences between the two groups regarding symptom resolution, compensatory hyperhidrosis, and satisfaction score. No patient reported residual pain or symptom recurrence.
Conclusions: Transareolar single-port ETS with a flexible endoscope is safe, effective, and minimally invasive with a small incision, minimal pain, and excellent cosmetic results. This novel procedure is suitable for routine treatment of PPH in males.

PMID: 33490171 [PubMed]

January 27, 2021

A systematic evidence-based review of treatments for primary hyperhidrosis.

A systematic evidence-based review of treatments for primary hyperhidrosis.

J Drug Assess. 2020 Dec 24;10(1):35-50

Authors: Stuart ME, Strite SA, Gillard KK

Abstract
Objective: Hyperhidrosis (excessive sweating) is associated with significant quality-of-life burden yet is often undertreated. With limited FDA-approved treatments, health care providers must determine optimal treatment among approved and off-label options. Key objectives of this review were to reassess, update, and expand a previous systematic review of commonly used treatment options for primary hyperhidrosis, including consideration of aluminum and zirconium compounds.
Methods: We performed a qualitative systematic review of efficacy, health-related quality of life, satisfaction, and safety of interventions, replicating and expanding the strategy outlined in a previous systematic review, with the addition of studies utilizing a within-patient design. We performed a critical appraisal of identified studies to determine risk of bias (RoB) and strength of evidence (SOE).
Results: A total of 32 studies were eligible for critical appraisal. Only three studies – two clinical trials of glycopyrronium cloth (2.4%) and one trial of botulinum toxin A injections in axillary hyperhidrosis were rated as “low” RoB; both had SOE ratings of “moderate” for use in axillary hyperhidrosis – the highest rating included in this review.
Conclusions: Optimal treatment choice depends on several factors, including understanding the quality of evidence regarding each treatment’s efficacy and safety (considerations of convenience and cost are beyond the scope of this review). In hyperhidrosis, as in other clinical conditions, treatment decisions should be patient centered. At this time, because of the quality of evidence, only imprecise estimates of effect are possible for hyperhidrosis treatments included in this review, and statements about comparative effectiveness are not possible.

PMID: 33489435 [PubMed]

January 23, 2021

CHRNA1 promotes the pathogenesis of primary focal hyperhidrosis.

CHRNA1 promotes the pathogenesis of primary focal hyperhidrosis.

Mol Cell Neurosci. 2021 Jan 18;:103598

Authors: Lin JB, Kang MQ, Huang LP, Zhuo Y, Li X, Lai FC

Abstract
The aim of the study was to elucidate the involvement of cholinergic receptor nicotinic alpha 1 subunit (CHRNA1) in the pathogenesis of primary focal hyperhidrosis (PFH). The hyperhidrosis mouse model was constructed using pilocarpine injection. The expression levels of CHRNA1 in sweat gland tissues of PFH patients and hyperhidrosis mice were compared using Western blots and quantitative real-time PCR (qRT-PCR) analyses. Sweat secretion in hyperhidrosis mice treated with small-interfering RNA (siRNA) targeting CHRNA1 (si-CHRNA1) or non-specific siRNA were compared. Sweat secretory granules in the sweat gland cells of hyperhidrosis mice were examined using transmission electron microscopy. The serum level of acetylcholine was measured using enzyme-linked immunosorbent assay, while markers associated with PFH, including Aquaporin 5 (AQP5) and Calcium Voltage-Gated Channel Subunit Alpha1 C (CACNA1C), were assessed using immunohistochemical assay and Western blots. Brain-derived neurotrophic factor (BDNF) and Neuregulin 1 (NRG-1) in sympathetic ganglia axons of hyperhidrosis mice were quantified using Western blots. CHRNA1 up-regulation is a characteristic of the sweat glands of PFH patients and Hyperhidrosis mice. Silencing CHRNA1 decreased sweat secretion and the number of sweat secretory granules of hyperhidrosis mice. Serum acetylcholine, as well as AQP5 and CACNA1C expression in the sweat glands, was reduced by siCHRNA1. BDNF1 and NRG-1 levels in the sympathetic ganglia axons were also attenuated by siCHRNA1 treatment. CHRNA1 up-regulation is a potential biomarker of PFH and downregulating CHRNA1 could alleviate the symptoms of PFH through inactivating the sympathetic system.

PMID: 33476802 [PubMed – as supplied by publisher]

January 16, 2021

A 1% glycopyrronium bromide cream for the topical treatment of primary axillary hyperhidrosis: Efficacy and Safety Results from a Phase 3a Randomised Controlled Study.

A 1% glycopyrronium bromide cream for the topical treatment of primary axillary hyperhidrosis: Efficacy and Safety Results from a Phase 3a Randomised Controlled Study.

Br J Dermatol. 2021 Jan 14;:

Authors: Abels C, Soeberdt M, Kilic A, Reich H, Knie U, Jourdan C, Schramm K, Heimstaedt-Muskett S, Masur C, Szeimies RM

Abstract
BACKGROUND: Effective topical treatment options for patients with primary axillary hyperhidrosis are limited. Recent phase 1 trial showed promising results regarding efficacy and safety for topical cream containing glycopyrronium bromide (GPB).
OBJECTIVE: To assess efficacy, safety and tolerability of a 4-week topical treatment with 1% GPB cream in subjects with primary axillary hyperhidrosis compared to placebo.
METHODS: 171 patients (84 placebo; 87 1% GPB) with primary axillary hyperhidrosis were included in this 4 week, multicenter, randomised, double-blind, placebo-controlled Phase 3a part of the pivotal study. Sweat production was measured by gravimetry. Patients rated disease impact using the Hyperhidrosis Disease Severity Scale (HDSS) and Hyperhidrosis Quality of Life Index (HidroQoL© ).
RESULTS: Absolute change in sweat production from baseline to day 29 in logarithmic values was significantly larger in the 1% GPB group than in the placebo group (p=0.0038). The improvement in HidroQoL© exceeded minimal clinically important difference of 4. The proportion of responders was two-fold higher than for placebo for sweat reduction, HDSS and HidroQoL© (-197.08 mg GPB vs. -83.49 mg placebo; 23% GPB vs 11.9% placebo and 59.8% GPB vs. 26.2% placebo respectively). Treatment was safe, most TEAEs were mild or moderate and transient. Local tolerability was very good with 9.2% of patients having only mild or moderate application site reactions. The most reported ADR was dry mouth (16.1%), an expected anticholinergic effect of the treatment.
CONCLUSION: 1% GPB cream may provide an effective new treatment option exhibiting a good safety profile for patients with primary axillary hyperhidrosis. The long-term open-label part (Phase 3b) is ongoing.

PMID: 33445205 [PubMed – as supplied by publisher]

January 14, 2021

Lumbar Sympathetic Nerve Modulation Using Absolute Ethanol for the Treatment of Primary Lower-Extremity Hyperhidrosis: A Dose-Effect Pilot Study.

Lumbar Sympathetic Nerve Modulation Using Absolute Ethanol for the Treatment of Primary Lower-Extremity Hyperhidrosis: A Dose-Effect Pilot Study.

Med Sci Monit. 2021 Jan 12;27:e928209

Authors: Liu M, Ni H, Tao J, Xie K

Abstract
BACKGROUND Primary lower-extremity hyperhidrosis (PLEH) can be treated by CT-guided lumbar sympathetic nerve modulation using absolute ethanol. However, doses of ethanol that are too high can cause nerve injury, and doses that are too low have suboptimal results. The present study aimed to investigate the dose-effect relationship of CT-guided lumbar sympathetic nerve modulation with absolute ethanol for PLEH. MATERIAL AND METHODS The study was conducted at the First Affiliated Hospital of Jiaxing University between 07/2014 and 02/2017. Twenty participants were enrolled in each group. The doses of absolute ethanol were 2.0 ml in the R₁ group, 2.5 ml in the R₂ group, 3.0 ml in the R₃ group, 3.5 ml in the R₄ group, and 4.0 ml in the R₅ group. Treatment effectiveness was assessed according to the time to complete hyperhidrosis relief: <10 min, effective; ≥10 min, non-effective. RESULTS The patient characteristics among the 5 groups were not statistically different (P>0.05). The onset time and time to complete hyperhidrosis relief decreased significantly with increasing dose of absolute ethanol (P<0.05). The effective rates in the 5 groups were 15.0%, 35.0%, 60.0%, 90.0%, and 100.0%, respectively. The ED₅₀ and ED₉₅ were 2.306 ml (95% CI: 2.003-2.512 ml) and 3.343 ml (95% CI: 3.051-3.962 ml), respectively. CONCLUSIONS This was the first dose-effect pilot study of consecutive PLEH patients treated by CT-guided lumbar sympathetic nerve modulation. CT-guided lumbar sympathetic nerve modulation with 2.306 ml (ED₅₀) and 3.343 ml (ED₉₅) of absolute ethanol showed treatment efficacy for PLEH. No complications were seen.

PMID: 33434188 [PubMed – in process]

January 9, 2021

A phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis.

A phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis.

J Dermatol. 2021 Jan 07;:

Authors: Yokozeki H, Fujimoto T, Abe Y, Igarashi M, Ishikoh A, Omi T, Kanda H, Kitahara H, Kinoshita M, Nakasu I, Hattori N, Horiuchi Y, Maruyama R, Mizutani H, Murakami Y, Watanabe C, Kume A, Hanafusa T, Hamaguchi M, Yoshioka A, Egami Y, Matsuo K, Matsuda T, Akamatsu M, Yorozuya T, Takayama S

Abstract
A phase 3 study was conducted to verify the efficacy and safety of 5% sofpironium bromide (BBI-4000) gel (hereinafter referred to as sofpironium) administrated for 6 weeks in Japanese patients with primary axillary hyperhidrosis. The primary efficacy end-point was the proportion of patients who satisfied both criteria of a Hyperhidrosis Disease Severity Score (HDSS) of 1 or 2 at the end of 6-week treatment and a 50% or more reduction in total gravimetric weight of sweat at the end of treatment relative to baseline. A total of 281 patients were randomized to receive 5% sofpironium (141 patients) or vehicle (140 patients), and all patients were included in the full analysis set (FAS). In the FAS, 70.1% of patients were female, and the median age was 35.0 years. The proportion of patients who achieved the primary efficacy end-point was 53.9% in the sofpironium group and 36.4% in the vehicle group, with a statistically significant difference of 17.5% (95% confidence interval, 6.02-28.93) between these two groups (P = 0.003). The incidence of adverse events was 44.0% in the sofpironium group and 30.7% in the vehicle group, and the incidence of adverse drug reactions was 16.3% in the sofpironium group and 5.0% in the vehicle group. Reported adverse events were generally mild or moderate in severity. In the sofpironium group, common events (incidence, ≥5%) were nasopharyngitis (14.2%) and dermatitis/erythema at the application site (8.5%/5.7%), with no serious adverse events reported. This study demonstrated the efficacy and safety of 5% sofpironium.

PMID: 33410265 [PubMed – as supplied by publisher]

December 23, 2020

CT-assisted thoracic sympathicolysis for therapy of primary hyperhidrosis palmaris-retrospective analysis of the influence of the amount and position of the sympathetic agent on the therapeutic outcome and side effects.

CT-assisted thoracic sympathicolysis for therapy of primary hyperhidrosis palmaris-retrospective analysis of the influence of the amount and position of the sympathetic agent on the therapeutic outcome and side effects.

Rofo. 2020 Dec 21;:

Authors: Andresen JR, Scheer F, Schlöricke E, Andresen R

Abstract
PURPOSE: The objective of the present study was to evaluate the benefit of a thoracic, computed tomography-guided sympathicolysis (CTSy) in patients with primary, focal hyperhidrosis of the hands. In addition, the influence of the amount and distribution of the administered sympathicolytic agent was to be assessed.
PATIENTS AND METHODS: Retrospectively, 78 patients [13 (16.7 %) men, mean age 31.2 ± 9 years and 65 (83.3 %) women, mean age 34.2 ± 12 years], who had been treated using CTSy, were included in the study. The indication for treatment was primary focal palmar hyperhidrosis grade II and grade III after exhaustion of all conservative treatment options and a continued high level of suffering. CTSy was performed after establishing the entry plane at the level of the intervertebral space T2 / T3 via a dorsolateral approach using a 22-G coaxial needle. On average 5 (2-10) ml of a sympathicolytic mixture (10 ml consisting of 8 ml 96 % alcohol, 1.6 ml 0.5 % Carbostesin and 0.4 ml 0.9 % NaCl solution, with added amounts of contrast medium) were instilled. The volume of distribution of the sympathicolytic agent was determined in craniocaudal direction using CT images. The patients evaluated their sense of discomfort preinterventionally, 2 days postinterventionally, and 6 and 12 months after the intervention, on the basis of a Dermatology life Quality Index (DLQI) as well as the side effects that occurred.
RESULTS: The technical success rate of CTSy was 100 %. No major complications occurred. The interventions performed led to a significant reduction (p < 0.001) in the preinterventional sense of discomfort 2 days, 6 and 12 months after CTSy. As the most common side effect, compensatory sweating was reported by 16/78 (20.5 %) of the patients over the further course. In all of these patients, the volume of sympathicolytic agent administered was below 5 ml. In no case did the sympathicolytic agent extend caudally beyond the base plate of Th 3. No compensatory sweating of the back was observed in 5/78 (6.4 %) patients; here the sympathicolytic volume was above 5 ml and extended significantly caudally below the baseplate of T3.Transient miosis and ptosis was found in 8/78 (10.3 %) patients. In all of these patients, the volume of sympathicolytic agent administered was above 5 ml and it extended markedly cranially beyond the upper plate of T2. A mild to moderate recurrent sweating developed in 35/78 (44.9 %) patients, which was more marked if the volume of sympathicolytic administered was below 5 ml and slightly more pronounced on the left than on the right. Given a high level of satisfaction overall, 71/78 (91.0 %) patients said that they would undergo the intervention again.
CONCLUSION: For patients with primary, focal palmar hyperhidrosis CTSy represents a therapeutic option that offers good benefit and has few side effects. The amount and spatial distribution of the sympathicolytic agent has an influence on the therapeutic outcome and the side effects.
KEY POINTS: · CT-assisted thoracic sympathicolysis is a minimally invasive, low-complication therapy for treatment of severe forms of primary hyperhidrosis palmaris.. · CT-assisted thoracic sympathicolysis can usually be performed on an outpatient basis.. · The quantity and local distribution of the sympathicolytic agent has an influence on the therapeutic outcome and the side effects..
CITATION FORMAT: · Andresen J, Scheer F, Schlöricke E et al. CT-assisted thoracic sympathicolysis for therapy of primary hyperhidrosis palmaris-retrospective analysis of the influence of the amount and position of the sympathetic agent on the therapeutic outcome and side effects. Fortschr Röntgenstr 2020; DOI: 10.1055/a-1299-2098.

PMID: 33348382 [PubMed – as supplied by publisher]

December 20, 2020

Fractional CO2 Laser for Transcutaneous Drug Delivery of Onabotulinum Toxin in Palmar Hyperhidrosis.

Fractional CO2 Laser for Transcutaneous Drug Delivery of Onabotulinum Toxin in Palmar Hyperhidrosis.

Dermatol Surg. 2020 Dec 15;Publish Ahead of Print:

Authors: Agamia NF, Sobhy N, Abd-Elraouf A, Tawfik A

Abstract
BACKGROUND: Palmar hyperhidrosis is a common disorder of excessive sweating due to over-stimulation of cholinergic receptors on eccrine glands.
OBJECTIVE: To compare the efficacy of laser-assisted drug delivery of onabotulinum toxin A (BoNTA) and intradermal BoNTA injections in the management of palmar hyperhidrosis.
PATIENTS AND METHODS: This intrapatient comparative study was conducted on 30 adult patients with idiopathic palmar hyperhidrosis. The palms of the patients were divided into 2 groups. Group 1 was treated with intradermal injections of 50 units of BoNTA, whereas Group 2 was subjected to laser-assisted transcutaneous BoNTA delivery using fractional CO2 laser at different doses (25, 50, and 75 units). Each treatment modality was evaluated using the iodine starch test, hyperhidrosis disease severity scale, and gravimetric scoring.
RESULTS: Delivery of 75 units of BoNTA to the dermis on the right-sided palms assisted by fractional CO2 laser was clinically equivalent to 50 units of injection on the left side. Pain intensity was significantly higher on the injected side than on the other side.
CONCLUSION: Laser-assisted drug delivery of botulinum toxin can be considered an effective and safe alternative for treatment of palmar hyperhidrosis with minimal side effects and complications.

PMID: 33337732 [PubMed – as supplied by publisher]