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

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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]

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.

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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]

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.

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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]

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

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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]

Efficacy of Photodynamic Therapy for Treatment of Primary Palmar Hyperhidrosis.

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Efficacy of Photodynamic Therapy for Treatment of Primary Palmar Hyperhidrosis.

Dermatol Ther. 2020 Dec 10;:

Authors: Shabaik AH, Shaheen MA, Soltan MY

Abstract
BACKGROUND: Palmar hyperhidrosis represents a condition with a significant cosmetic and psychological burden. Various treatment modalities are available; however, searching for newer options to meet patients’ needs and expectations is encouraged.
AIM: The study aimed to evaluate the efficacy of photodynamic therapy (PDT) for treatment of primary palmar hyperhidrosis. Two different photosensitizers for PDT were evaluated: eosin Y, and methylene blue. The study focused on the clinical efficacy, patient’s satisfaction, and the time & number of sessions needed to achieve a satisfactory response.
METHODS: Twenty patients with primary palmar hyperhidrosis were enrolled in a single-center clinical study. Patients were treated with PDT for a maximum of eight sessions. Two photosensitizers were tested: eosin Y, and methylene blue for the right and left hand, respectively. The Hyperhidrosis disease severity scale (HDSS), and Sweating Intensity Visual Scale of Minor’s test were used for assessment.
RESULTS: Photodynamic therapy effectively reduced the severity scores of hyperhidrosis with comparable results between the two photosensitizers. The treatment effect was maintained up to three months after the last procedure.
CONCLUSION: Photodynamic therapy is a good treatment option for primary palmar hyperhidrosis with results maintainable for three months after the treatment end.

PMID: 33301218 [PubMed – as supplied by publisher]

Craniofacial hyperhidrosis: clinical characteristics and response to treatment in a cohort of 97 patients treated with oral oxybutynin.

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Craniofacial hyperhidrosis: clinical characteristics and response to treatment in a cohort of 97 patients treated with oral oxybutynin.

Dermatol Ther. 2020 Dec 10;:

Authors: García-Souto F, Del Boz J, Colmenero-Sendra M, Polo-Padillo J

Abstract
The term craniofacial hyperhidrosis (HH) refers to HH that affects the face and/or scalp. Few studies have focused on this specific location, and even fewer distinguish between the two areas. Our study aims are to describe the clinical characteristics of patients with craniofacial HH, specifying whether the condition affects the scalp, face or both, and to compare these cases with those recorded at other locations. As secondary objectives, we determine the effectiveness and adverse effects of oral oxybutynin (OOx), and assess patients’ adherence to treatment. This prospective observational study was carried out with respect to the period 2007-2019. All patients diagnosed with HH of the scalp and/or face and who were treated with OOx at our HH unit were included in the study group. Of 292 patients treated with OOx, 97 (33.2%) had craniofacial HH. Of these, four (4.1%) presented HH exclusively on the scalp, 56 (57.7%) exclusively on the face and 37 (38.1%) in both locations. The patients in the latter category (compared to those with exclusively facial HH) were significantly older than the others, had a later onset of HH, a greater frequency of secondary HH, less simultaneous involvement of the classical areas of primary focal HH (the palms, soles and armpits) and greater generalised HH and of the trunk. No significant differences were observed between the three locations (face, scalp or both) regarding the efficacy and side effects of OOx. The patients with exclusively facial HH presented greater adherence to treatment. This article is protected by copyright. All rights reserved.

PMID: 33301207 [PubMed – as supplied by publisher]

Cost-effectiveness of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis.

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Cost-effectiveness of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis.

J Med Econ. 2020 Dec 01;:1

Authors: Bloudek LM, Gillard KK, Nguyen VB, Klein SZ

Abstract
AIMS: Primary axillary hyperhidrosis (PAHH) is a condition characterized by excessive sweating that negatively impacts health-related quality of life, with significant psychological and social impacts. Glycopyrronium tosylate (GT) is a topical anticholinergic approved in the United States for treatment of PAHH in patients 9 years of age and older. Our objective was to assess the cost-effectiveness of GT as first-line topical therapy compared to topical aluminum chloride from a United States commercial perspective.
MATERIALS AND METHODS: A Markov model was developed consisting of four health states based on the Hyperhidrosis Disease Severity Scale (HDSS) over a time horizon of five years with discount rates of 3% for both costs and outcomes. Transitions between health states were driven by HDSS response, defined as an improvement of ≥2 points. Non-responders and those who discontinue could switch to later line treatments or no treatment. Health utility scores were based on HDSS scores, supported by published literature.
RESULTS: Over five years, GT yielded 0.12 greater QALYs and 0.93 greater LYs with response compared to treatment with prescription aluminum chloride at an incremental cost of $10,584. Relative to prescription aluminum chloride, GT resulted in an incremental cost-effectiveness ratio (ICER) of $87,238 per QALY gained, $11,349 per LY with response. The ICER fell below $100,000 for 66% of probabilistic sensitivity analysis simulations and below $150,000 for 82% of simulations.
LIMITATIONS: This analysis represents a simplified scenario of a hypothetical PAHH patient. Due to sparse data, assumptions were required for treatment patterns, efficacy, and persistence.
CONCLUSION: Based on the analysis of incremental cost per QALY gained, GT is may be cost-effective relative to prescription aluminum chloride at commonly accepted willingness to pay thresholds.

PMID: 33256494 [PubMed – as supplied by publisher]

Differences in subjective and objective evaluation of hyperhidrosis. Study among medical students.

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Differences in subjective and objective evaluation of hyperhidrosis. Study among medical students.

Postepy Dermatol Alergol. 2020 Oct;37(5):700-704

Authors: Dobosz Ł, Stefaniak T, Halman J, Piekarska A

Abstract
Introduction: Hyperhidrosis is a condition that significantly impairs patients’ quality of life. Qualification for treatment in most cases is based only on subjective evaluation of symptoms without objective confirmation.
Aim: To evaluate the differences between subjective and objective evaluation of sweating among medical students.
Material and methods: There were 179 participants involved in the study. Subjective evaluation of sweating was conducted using the Hyperhidrosis Disease Severity Scale and Numeric Rating Scale in 4 body areas: the face, palms, armpits and abdomino-lumbar area. Objective evaluation of sweating was performed using gravimetry.
Results: The prevalence of hyperhidrosis in gravimetric measures was 1.12%. In subjective evaluation hyperhidrosis (HDSS 3 or 4) was present in 11.17% of cases. There was no significant difference in subjective evaluation of hyperhidrosis between men and women (15% vs. 9.24%; p = 0.32). In gravimetry men showed a higher perspiration rate on the face (5.85 vs. 3.38; p < 0.05) and in the armpits (17.27 vs. 9.12; p < 0.05). Individuals with body mass index ≥ 25 kg/m2 reported hyperhidrosis more often (28% vs. 8.44%; p < 0.05); however, in gravimetric evaluation, beside the facial area, no significant differences in above-mentioned groups were observed.
Conclusions: There is a discrepancy between subjective and objective methods of evaluating sweating.

PMID: 33240009 [PubMed]

Surgical treatment of compensatory hyperhidrosis: Retrospective observational study.

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Surgical treatment of compensatory hyperhidrosis: Retrospective observational study.

Medicine (Baltimore). 2020 Oct 16;99(42):e22466

Authors: Moon MH, Hyun K, Park JK, Lee J

Abstract
Compensatory hyperhidrosis is a debilitating postoperative condition occurring in 30% to 90% of patients with primary hyperhidrosis. The most appropriate treatment for compensatory hyperhidrosis remains controversial.Between January 2018 and December 2019, 44 patients with intractable compensatory hyperhidrosis underwent diffuse sympathicotomy (DS). In the early study periods, DS was performed sparsely (limited DS) to avoid possible adverse effects (right R5/7/9/11, left R5/6/8/10). In the late study periods, levels of surgical interruption were further modified to maximize sympatholytic effects (extended DS; bilateral R5/6/7/8/9/10/11). Patients were followed up for symptom resolution. For objective evidence of improved hyperhidrosis, thermographic images were taken for 7 patients.Immediate resolution of compensatory hyperhidrosis was achieved in 81% of patients, as determined at the 1 to 2 week postoperative visit. With a median follow-up of 22.7 months, compensatory hyperhidrosis continued to be resolved in 46% (n = 20). Logistic regression analysis showed that persistent resolution of compensatory hyperhidrosis was independently predicted by extended DS (odds ratio, 25.67, 95% CI, 1.78-1047.6; P = .036). The presence of gender, BMI, isolated compensatory hyperhidrosis, distribution of sweating, prior operation type, reoperation interval, and same-day lumbar sympathectomy failed to gain statistical significance on maintaining persistent resolution of compensatory hyperhidrosis. No patients experienced surgery-related side effects. Thermographic images obtained before/after surgery in 10 patients showed successful denervation and sweat diminishment.This study shows the safeness and effectiveness of DS for treating compensatory hyperhidrosis, representing a new treatment option. Future research should be directed at confirming a promising result of extended DS with further follow-up.

PMID: 33080682 [PubMed – in process]

Can we predict the compensatory hyperhidrosis following a thoracic sympathectomy?

Can we predict the compensatory hyperhidrosis following a thoracic sympathectomy?

Indian J Thorac Cardiovasc Surg. 2019 Apr;35(2):190-195

Authors: Kara M, Kose S, Cayirci CE, Koksal A

Abstract
Background: Primary hyperhidrosis is a functionally and socially disabling condition resulting in social embarrassment and low quality of life. Thoracic sympathectomy is a definitive choice of treatment with favorable results. However, patients may face another embarrassing condition following surgery as compensatory hyperhidrosis which has no definitive treatment. The predictors of compensatory hyperhidrosis are controversial and remain unclear.
Patients and methods: A total of 74 patients underwent a videothoracoscopic sympathectomy for primary hyperhidrosis. We statistically analyzed our patients with correlations and uni-multivariate logistic regression models to outline the possible predictors of compensatory hyperhidrosis.
Results: A total of 45 (60.8%) patients had compensatory hyperhidrosis. The correlations showed that patients, with age greater than 21 years (P = 0.018), with body mass index (BMI) greater than 22 kg / m2 (P = 0.045), with isolated facial hyperhidrosis (P = 0.044), and with smoking status (P = 0.015), had significantly greater rates of compensatory hyperhidrosis. Similarly, the significant univariate predictors of compensatory hyperhidrosis were age > 21 (P = 0.020), BMI > 22 kg / m2 (P = 0.048), and the presence of smoking status (P = 0.015). Multivariate analysis revealed only smoking as a predictor within the threshold of significance (P = 0.078).
Conclusion: The clinical predictors of compensatory hyperhidrosis following a thoracic sympathectomy appear as older age, greater body mass index, and smoking.

PMID: 33061004 [PubMed]