A survey of long-term results with microwave energy device for treating axillary hyperhidrosis

J Cosmet Laser Ther. 2021 Aug 19:1-3. doi: 10.1080/14764172.2021.1957115. Online ahead of print.

ABSTRACT

Microwave energy technology treats axillary hyperhidrosis through thermolysis of the apocrine and eccrine glands. Successful short-term reduction of sweating has been studied, but there is limited information on long-term efficacy and safety. To evaluate patient satisfaction with microwave energy device for axillary hyperhidrosis performed within the last 5 years. From June to August 2019, a standardized telephone survey was conducted of 24 patients who received microwave energy device treatment for bilateral axillary hyperhidrosis between June 2014 and June 2018. Demographic information, previous treatment modalities, sweat reduction scores, and side effects were reported. Eighteen patients completed the survey with a mean follow-up of 38 months (range 12-52). The mean hyperhidrosis disease severity scale (HDSS) was reduced by 1.6 (95% CI 1.2-2.0, p < .01). The mean sweat reduction was 61-70%. Sixty-seven percent of patients experienced a reduction in odor and 54% did not require deodorant after treatment. Adverse effects included bruising (67%), pain (56%), swelling (44%), numbness (28%), and nodules (22%). Sixty-six percent of side effects resolved within 2 weeks and all side effects resolved within 12 weeks. The microwave energy device is an effective, durable therapy for axillary hyperhidrosis associated with minimal downtime and a high degree of long-term patient satisfaction.

PMID:34409892 | DOI:10.1080/14764172.2021.1957115

Measurement properties of patient-reported outcome measures (PROMs) in hyperhidrosis: a systematic review

Qual Life Res. 2021 Jul 30. doi: 10.1007/s11136-021-02958-3. Online ahead of print.

ABSTRACT

PURPOSE: To critically appraise, compare and summarize the quality of all existing PROMs that have been validated in hyperhidrosis to at least some extend by applying the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Thereby, we aim to give a recommendation for the use of PROMs in future clinical trials in hyperhidrosis.

METHODS: We considered studies evaluating, describing or comparing measurement properties of PROMs as eligible. A systematic literature search in three big databases (MEDLINE, EMBASE and Web of Science) was performed. We assessed the methodological quality of each included study using the COSMIN Risk of Bias checklist. Furthermore, we applied predefined quality criteria for good measurement properties and finally, graded the quality of the evidence.

RESULTS: Twenty-four articles reporting on 13 patient-reported outcome measures were included. Three instruments can be further recommended for use. They showed evidence for sufficient content validity and moderate- to high-quality evidence for sufficient internal consistency. The methodological assessment showed existing evidence gaps for eight other PROMs, which therefore require further validation studies to make an adequate decision on their recommendation. The Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) and the short-form health survey with 36 items (SF-36) were the only questionnaires not recommended for use in patients with hyperhidrosis due to moderate- to high-quality evidence for insufficient measurement properties.

CONCLUSION: Three PROMs, the Hyperhidrosis Quality of Life Index (HidroQoL), the Hyperhidrosis Questionnaire (HQ) and the Sweating Cognitions Inventory (SCI), can be recommended for use in future clinical trials in hyperhidrosis. Results obtained with these three instruments can be seen as trustworthy. Nevertheless, further validation of all three PROMs is desirable.

SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020170247.

PMID:34327635 | DOI:10.1007/s11136-021-02958-3

Thoracic sympathectomy for the treatment of primary axillary hyperhidrosis: systematic review and proportional meta-analysis

Ann Med. 2021 Dec;53(1):1216-1226. doi: 10.1080/07853890.2021.1953126.

ABSTRACT

INTRODUCTION: Primary hyperhidrosis is a disorder that involves excessive sweat production, which has a negative impact on the quality of life.

OBJECTIVE: To evaluate the effectiveness and safety of video-assisted thoracoscopic sympathectomy (VATS) for treating primary axillary hyperhidrosis (PAH) and determine which level of ganglion resection offers the best outcome.

METHOD: This was a systematic review and proportional meta-analysis of observational studies. The result was evaluated for satisfaction, control of symptoms, compensatory sweating and complications. A subgroup analysis was performed to compare the sympathetic trunk resection at high and low levels.

RESULTS: Thirteen studies were selected with a total of 1463 patients. The satisfaction rate was 92% (95% CI = 88-95%, I2=47.5%), the symptom control rate was 96% (95% CI = 93-99%, I2=48.2%), and the presence of compensatory sweating could not be assessed because of high heterogeneity among studies. The complications were rare.

CONCLUSION: This review demonstrated that thoracic sympathectomy by VATS is a viable and safe option for the treatment of PAH. There was no difference between high and lower levels of resection. However, the estimation of the effect is quite uncertain because the quality of evidence was extremely low.Key messagePure axillary hyperhidrosis has great potential to compromise quality of life.Surgery should be indicated only when clinical treatment fails.Thoracic sympathectomy by video-assisted thoracoscopy is a viable and safe option for the treatment of primary axillary hyperhidrosis.

PMID:34282698 | DOI:10.1080/07853890.2021.1953126

Hyperhidrosis: treatment, results, problems

Khirurgiia (Mosk). 2021;(7):12-17. doi: 10.17116/hirurgia202107112.

ABSTRACT

OBJECTIVE: To analyze the results of thoracic sympathectomy for hyperhidrosis.

MATERIAL AND METHODS: The study included 166 patients aged from 15-51 years. There were 118 women and 48 men. Isolated palmar hyperhidrosis was observed in 46 patients, axillary – 46 patients, palmar-axillary – 74 cases. Video-assisted thoracic bilateral sympathectomy was performed. In patients with palmar hyperhidrosis, sympathetic chain was transected between the ribs II and III, axillary and palmar-axillary hyperhidrosis – between the ribs III and IV.

RESULTS: Intraoperative injury of intercostal artery occurred in 1 case. Cautery was effective. Postoperative complications occurred in 4 (2.4%) patients (pneumothorax followed by drainage for up to 2-3 days). Symptoms of hyperhidrosis disappeared early after surgery in all cases. Long-term results were followed in 47 patients. Persistent positive effect and patient satisfaction with postoperative outcome were noted in 44 (93.6%) cases. Recurrences occurred in 2 patients with palmar hyperhidrosis and 1 patient with axillary hyperhidrosis for the period from 2 weeks to 6 months. Compensatory sweating developed in 26 (55.3%) patients (within several weeks up to 6 months). Mild compensatory sweating occurred in 17 patients, moderate – 8 patients, severe – 1 patient. Compensatory sweating was more common in patients with axillary and palmar-axillary hyperhidrosis compared to those with isolated palmar hyperhidrosis (p<0.05). We found no significant difference in the incidence of compensatory sweating depending on the level of sympathetic chain intersection (p>0.05).

CONCLUSION: An effectiveness of thoracic sympathectomy for hyperhidrosis is obvious. Compensatory sweating is the main undesirable consequence of this surgery. Prediction and prevention of compensatory sweating are not possible. It is imperative to warn the patient about possible compensatory sweating.

PMID:34270188 | DOI:10.17116/hirurgia202107112

Cost-of-illness study for axillary hyperhidrosis in Japan

J Dermatol. 2021 Jul 9. doi: 10.1111/1346-8138.16050. Online ahead of print.

ABSTRACT

The prevalence of primary axillary hyperhidrosis in Japan is 5.75% (males, 6.60%; females, 4.72%) in the population aged 5-64 years. No study on comprehensively evaluated direct medical costs, hygiene product costs, and productivity loss in axillary hyperhidrosis patients has been published in Japan. The aim of this study was to estimate the cost of illness for axillary hyperhidrosis in Japan by conducting a nationwide insurance claims database analysis and a cross-sectional Web-based survey. Among patients diagnosed with primary axillary hyperhidrosis at least once between November 2012 and October 2019, health insurance receipt data of 1447 patients were analyzed. A cross-sectional Web-based survey was conducted on 321 patients aged 16-59 years with axillary hyperhidrosis to calculate hygiene product costs and productivity loss using a Work Productivity and Activity Impairment questionnaire. Furthermore, nationwide estimation was performed for the hygiene product costs and productivity loss based on the number of patients estimated from the prevalence. The annual direct medical costs per axillary hyperhidrosis patient were ¥91 491 in 2016, ¥93 155 in 2017, and ¥75 036 in 2018. In all of these years, botulinum toxin type A injection accounted for approximately 90% of the total costs. The annual total cost of hygiene products per axillary hyperhidrosis patient was ¥9325. The overall work impairment (%) of working patients with axillary hyperhidrosis was 30.52%, and its monthly productivity loss was ¥120 593/patient. The activity impairment (%) of full-time housewives with axillary hyperhidrosis was 49.05% and its monthly productivity loss was ¥176 368/patient. The annual hygiene product cost based on the nationwide estimation was ¥24.5 billion and the monthly productivity loss was ¥312 billion. The significant cost associated with axillary hyperhidrosis was clarified. If out-of-pocket expenses for treatments not covered by health insurance are included in the estimation, the cost will further increase.

PMID:34245048 | DOI:10.1111/1346-8138.16050

Current treatment options for craniofacial hyperhidrosis

J Vasc Bras. 2020 Nov 16;19:e20190152. doi: 10.1590/1677-5449.200152.

ABSTRACT

Hyperhidrosis (HH) is characterized by sweating exceeding the amount necessary to meet the thermal regulation and physiological needs of the body. Approximately 9.41% of individuals with HH have craniofacial hyperhidrosis (FH). The present study aims to review the most current data in the literature regarding craniofacial hyperhidrosis, including pathophysiology, diagnosis and clinical presentation, treatment options (clinical and surgical), and outcomes. VATS (videothoracoscopy sympathectomy) is considered the gold standard for definitive treatment of axillary or palmar hyperhidrosis. Recently, several studies have shown the usefulness of clinical treatment with oxybutynin hydrochloride, leading to clinical improvement of HH in more than 70% of users. Both clinical and surgical treatment of craniofacial hyperhidrosis have good results. However, surgical treatment of FH is associated with more complications. Clinical treatment with oxybutynin hydrochloride yields good results and can be the first therapeutic option. When the patient is not satisfied with this treatment and has good clinical conditions, surgical treatment can be used safely.

PMID:34211510 | PMC:PMC8218019 | DOI:10.1590/1677-5449.200152

Symptoms of anxiety and depression in patients with primary hyperhidrosis and its association with the result of clinical treatment with oxybutynin

Clinics (Sao Paulo). 2021 Jun 28;76:e2892. doi: 10.6061/clinics/2021/e2892. eCollection 2021.

ABSTRACT

OBJECTIVES: Studies have identified correlations between the psychological characteristics of individuals with primary hyperhidrosis (HH), the degree of sweating, and the quality of life (QoL). This study aimed to evaluate the prevalence of anxiety and depression symptoms in patients with HH before and after oxybutynin treatment.

METHODS: Data were collected from 81 patients. Palmar or axillary HH was the most frequent complaint (84.0%). All patients were evaluated before the medication was prescribed and after five weeks of treatment. The Beck Depression Inventory and Beck Anxiety Inventory were used to evaluate depression and anxiety.

RESULTS: Improvement in HH occurred in 58 patients (71.6%), but there was no improvement in 23 patients (28.4%). The QoL before treatment in all patients was either “poor” or “very poor.” Patients who experienced improvement in sweating rates also experienced a greater improvement in QoL than patients who did not experience improvement in sweating at the main site (87.9% vs. 34.7%) (p<0.001). A total of 19.7% of patients showed an improvement in their level of depression, and a total of 46.9% of patients exhibited improvements in their level of anxiety. A significant correlation was observed between sweating and anxiety (p=0.015).

CONCLUSION: Patients with HH who experienced improvements in sweating immediately after treatment with oxybutynin exhibited small improvements in their levels of depression and significant improvements in their levels of anxiety and QoL.

PMID:34190853 | DOI:10.6061/clinics/2021/e2892

Progress and lack of progress in hyperhidrosis research 2015-2020. A concise systematic review

Int J Dermatol. 2021 May 26. doi: 10.1111/ijd.15654. Online ahead of print.

ABSTRACT

Hyperhidrosis is excessive sweating that is uncontrollable and occurring regardless of temperature. Quality of life is significantly impaired, and psychiatric comorbidity is common. The objective of the study is to undertake a systematic review of research in the last 5 years regarding hyperhidrosis. Five databases were searched from July 2015 to July 2020 for all research on hyperhidrosis. High-quality research articles were sought for progress in diagnosis, etiology and epidemiology, and use of patient reported outcomes (PROs) as well as randomized clinical trials (RCTs) on any treatment intervention. Outcomes of interest were disease severity, sweat rate, quality of life, patient satisfaction, and adverse events. Trial quality was assessed by the Cochrane risk-of-bias tool. A narrative synthesis was presented. Twenty-nine papers were included in the review: 13 investigational articles, 10 RCTs, three cohort studies, and three reviews. The studies varied in terms of quality, population, intervention, and methods of outcome assessment. The majority were very small studies, and most RCTs were at high risk of bias. Few studies on diagnosis, epidemiology, and etiology were of sufficient quality to be presented. The interventions discussed were iontophoresis, botulinum toxin, anticholinergic medication, curettage, and energy-based technologies. Progress in the diagnostics and etiology of hyperhidrosis is limited with the same being true for treatment. In a 5-year-old systematic review, it was concluded that there was moderate-quality evidence to support the use of botulinum toxin for axillary hyperhidrosis. It was advocated to conduct a trial comparing BTX and iontophoresis for palmar hyperhidrosis. Unfortunately, this has not yet been performed. Hyperhidrosis is still as underserved and under-studied as before.

PMID:34080686 | DOI:10.1111/ijd.15654

A phase III, 52-week, open-label study to evaluate the safety and efficacy of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis

J Dermatol. 2021 May 26. doi: 10.1111/1346-8138.15927. Online ahead of print.

ABSTRACT

A long-term study was conducted in Japanese patients with primary axillary hyperhidrosis who completed the preceding 6-week phase III, confirmatory study of 5% sofpironium bromide gel (hereinafter referred to as sofpironium) to evaluate the safety and efficacy of 52-week treatment with sofpironium. In the long-term study, 185 patients who completed the confirmatory study (94 and 91 patients in the vehicle and sofpironium groups, respectively) started to receive sofpironium (switching and extension groups, respectively), and all these patients were included in both the full analysis set (FAS) and the safety analysis set (SAF). In the FAS, there were more females than males (73.0% vs. 27.0%), and median age was 38.0 years. A total of 161 patients (86 and 75 patients in the switching and extension groups, respectively) completed the study at week 52. The proportions of patients with hyperhidrosis disease severity score of 1 or 2 and a 50% or more reduction in total gravimetric weight of sweat were 57.4% in the switching group and 58.2% in the extension group at week 52. The proportions of patients who achieved this efficacy end-point in the long-term study were similar to that (53.9%) in the sofpironium group in the confirmatory study. In the SAF, the incidences of adverse events (AEs) were 80.9% in the switching group and 83.5% in the extension group, and the incidences of adverse drug reactions were 39.4% and 45.1%, respectively. AEs that occurred in at least 20% of patients in both treatment groups were application site dermatitis (25.5% and 33.0%, respectively) and nasopharyngitis (31.9% and 23.1%, respectively). Reported AEs were generally mild, and there were no deaths. Serious AEs occurred in three patients, but none were considered related to the study drug. In this study, the efficacy of sofpironium was maintained during 52-week treatment, and no new safety risk was observed.

PMID:34041788 | DOI:10.1111/1346-8138.15927

Pathological Changes in Axillary Hyperhidrosis and Axillary Osmidrosis Induced by Microwave Treatment: Comparison of Single- and Double-Pass Irradiation

Lasers Surg Med. 2021 May 26. doi: 10.1002/lsm.23412. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: To analyze histopathological changes and degree of damage to the axillary tissue due to single- and double-pass irradiation therapy using a microwave energy-based device. STUDY DESIGN/MATERIALS AND METHODS: We included 15 axillary hyperhidrosis and axillary osmidrosis patients who received microwave irradiation therapy between March 2017 and March 2019. Ten patients underwent single-pass irradiation and five underwent double-pass irradiation, after which skin samples were collected from the right and left axillae for pathological analysis. Samples were taken in a consistent manner from Patient 6 onwards and a comparative study of five single-pass and five double-pass patients was conducted (n = 10).

RESULTS: Histopathological analysis showed destruction and fibrosis in addition to necrosis and damage to the adipose tissue in apocrine and eccrine sweat glands. In the superficial microvasculature, blood vessel wall damage and thrombus formation were observed as well as damage in the hair follicles and hair bulbs. No obvious damage was observed in the epidermis and nerves. The amount of damage to sweat glands was higher in patients undergoing double-pass instead of single-pass irradiation.

CONCLUSION: From a histopathological point of view, microwave energy-based irradiation therapy can be considered efficient, as there was no damage to epidermis and nerves and favorable destruction of apocrine and eccrine glands. As the amount of damaged sweat glands was higher after double-pass irradiation, it can be considered more effective than single-pass irradiation. Lasers Surg. Med. © 2021 Wiley Periodicals LLC.

PMID:34036606 | DOI:10.1002/lsm.23412