A preliminary study of painless and effective transdermal botulinum toxin A delivery by jet nebulization for treatment of primary hyperhidrosis.

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A preliminary study of painless and effective transdermal botulinum toxin A delivery by jet nebulization for treatment of primary hyperhidrosis.

Drug Des Devel Ther. 2014;8:931-5

Authors: Iannitti T, Palmieri B, Aspiro A, Di Cerbo A

Abstract
BACKGROUND: Hyperhidrosis is a chronic disease characterized by increased sweat production. Local injections of botulinum toxin A (BTX-A) have been extensively used for treatment of primary hyperhidrosis (idiopathic). The current treatment for this condition involves several intradermal injections, resulting in poor patient compliance due to injection-related pain. Therefore, new protocols, including an improved anesthetic regimen, are required.
AIM: We designed the present study to determine whether JetPeel™-3, a medical device used for transdermal delivery of drugs by jet nebulization, could be used to deliver lidocaine prior to the standard multiple BTX-A injections or deliver lidocaine together with BTX-A in order to determine the protocol giving better results in terms of procedure-related pain, sweating, and patient satisfaction in subjects affected by primary axillary, palmar or plantar hyperhidrosis.
MATERIALS AND METHODS: Twenty patients with a visual analog scale (VAS) sweating score ≥ 8 cm were randomized to receive lidocaine 2% (5 mL) delivered by JetPeel™-3 followed by multiple injections of BTX-A (100 units) or lidocaine 2% (5 mL) and BTX-A (50 units) delivered together by JetPeel™-3. Effect of treatment on sweating was measured by VAS (0= minimum sweating; 10= maximum sweating) at 3-month follow-up. Pain induced by the procedure was assessed by VAS (0= minimum pain; 10= maximum pain) immediately after the procedure. Patient satisfaction was assessed at 3-month follow-up using a 5-point scale (1= not at all satisfied; 2= not satisfied; 3= partially satisfied; 4= satisfied; 5= highly satisfied).
RESULTS: Both treatment modalities reduced sweating at 3-month follow-up, if compared with baseline (all P<0.001). Delivery of lidocaine and BTX-A by JetPeel™-3 resulted in lower procedure-related pain and reduced sweating, if compared with lidocaine delivered by JetPeel™-3 followed by multiple BTX-A injections (all P<0.001). Patient satisfaction with the procedure was higher in the group receiving lidocaine and BTX-A treatment by JetPeel™-3, if compared with lidocaine delivered by JetPeel™-3 followed by multiple BTX-A injections (P<0.001). No side effects were observed in both groups.
CONCLUSION: Lidocaine and BTX-A can be safely delivered together by JetPeel™-3 to treat primary palmar, plantar and axillary hyperhidrosis, resulting in lower procedure-related pain, improved sweating and higher patient satisfaction, if compared with lidocaine delivered by JetPeel™-3 followed by standard BTX-A injection therapy. Our protocol delivering lidocaine and BTX-A together by JetPeel™-3 requires a reduced quantity of BTX-A, further supporting the use of the transdermal drug delivery by jet nebulization over standard injection therapy for treatment of primary hyperhidrosis.

PMID: 25075176 [PubMed – indexed for MEDLINE]

Quality of Life in Patients with Focal Hyperhidrosis before and after Treatment with Botulinum Toxin A.

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Quality of Life in Patients with Focal Hyperhidrosis before and after Treatment with Botulinum Toxin A.

ISRN Dermatol. 2014;2014:308650

Authors: Kouris A, Armyra K, Christodoulou C, Karimali P, Karypidis D, Kontochristopoulos G

Abstract
The aim of this study is to assess the effectiveness of treatment with BTX-A in quality of life of patients suffering from primary focal hyperhidrosis. Materials and Methods. A total of 119 patients (62 females and 57 males) between 18 and 65 years suffering from moderate to severe focal hyperhidrosis were treated with BTX-A. Thirty-nine patients suffered from axillary hyperhidrosis, 47 patients from palmar hyperhidrosis, 12 patients from plantar hyperhidrosis, and 21 patients from palmar and plantar hyperhidrosis. A baseline and posttreated examination of patients 6 months after BTX-A is included. The Hyperhidrosis Disease Severity Scale (HDSS) was chosen to assess the disease severity and the modified Dermatology Life Quality Index was used (DLQI) to assess the quality of life. Results. Quality of life showed a significant improvement after treatment with BTX-A. The total DLQI score resulted significantly lower than the basal value (P < 0.0001). The seriousness of hyperhidrosis significantly decreased after the treatment (P < 0.0001). In addition, there was notable difference between the posttreatment DLQI scores and pretreatment severity of hyperhidrosis by sex. Conclusions. Treatment with BTX-A led to the reduction of disease severity and improvement of quality of life, while it is a safe, easy to use method with minimal side effects.

PMID: 24891956 [PubMed]

Evaluation of anxiety and depression prevalence in patients with primary severe hyperhidrosis.

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Evaluation of anxiety and depression prevalence in patients with primary severe hyperhidrosis.

An Bras Dermatol. 2014 Mar-Apr;89(2):230-5

Authors: Bragança GM, Lima SO, Pinto Neto AF, Marques LM, Melo EV, Reis FP

Abstract
BACKGROUND: Primary hyperhidrosis (PH) can lead to mood changes due to the inconveniences it causes.
OBJECTIVE: This study aimed to examine the existence of anxiety and depression in patients with severe primary hyperhidrosis who sought treatment at a medical office.
METHODS: The questionnaire “Hospital Anxiety and Depression Scale” was used for 197 individuals, in addition to the chi square test and Fisher exact test, p <0.05.
RESULTS: There was an increased prevalence of anxiety (49.6%) but not of depression (11.2%) among patients with PH, with no link to gender, age or amount of affected areas. Palmar and plantar primary hyperhidrosis were the most frequent but when associated with the presence of anxiety, the most frequent were the axillary (p = 0.02) and craniofacial (p = 0.02) forms. There was an association between patients with depression and anxiety (p = 0.001).
CONCLUSIONS: the involvement of Primary hyperhidrosis was responsible for a higher prevalence of anxiety than that described among the general population and patients with other chronic diseases. Depression had a low prevalence rate, while mild and moderate forms were the most common and frequently associated with anxiety. The degree of anxiety was higher in mild and moderate types than in the severe form.

PMID: 24770497 [PubMed – indexed for MEDLINE]

Impact of transthoracic endoscopic sympathectomy on plantar hyperhidrosis.

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Impact of transthoracic endoscopic sympathectomy on plantar hyperhidrosis.

Ann Ital Chir. 2014 Mar-Apr;85(2):114-9

Authors: Paliogiannis P, Scognamillo F, Attene F, Pala C, Marrosu A, Pulighe F, Trignano M

Abstract
INTRODUCTION: The aim of this study is to evaluate the impact of transthoracic endoscopic sympathectomy on plantar hyperhidrosis in patients operated on for upper limb hyperhidrosis.
MATERIALS AND METHODS: From 2003 to 2011, 41 consecutive patients underwent videothoracoscopic T3-T4 sympathicotomy or T3-T4 ganglion block at our Unit for upper limb hyperhidrosis. Twenty-one (51%) were affected by palmar hyperhidrosis and 20 (49%) by palmar and axillary hyperhidrosis combined. The patients affected by the plantar form were 26 (63%). Clinical follow-up was performed at 3, 6 and 12 months after surgery. Phone interviews and/or clinical assessment were made after a variable period of time (range 6 months to 8 years) to asses long term results.
RESULTS: Plantar hyperhidrosis improved in 14 patients, which represents the 54% of the sufferers and the 34% of all patients. It was partially regressed in 11 patients (79%) and resolved in 3 cases (21%). There were not significant differences between patients treated with sympathicotomy and those treated with ganglion block.
CONCLUSIONS: Transthoracic endoscopic sympathectomy performed through T3-T4 sympathicotomy or ganglion block improves plantar hyperhidrosis in approximately 54% of the affected patients, with a partial and complete resolution rate of 79% and 21% respectively.

PMID: 24557360 [PubMed – indexed for MEDLINE]

Gravimetry in sweating assessment in primary hyperhidrosis and healthy individuals.

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Gravimetry in sweating assessment in primary hyperhidrosis and healthy individuals.

Clin Auton Res. 2013 Aug;23(4):197-200

Authors: Stefaniak TJ, Proczko M

Abstract
OBJECTIVE: Though hyperhidrosis is generally considered a subjectively perceived disease, it seems more and more doubtful that merely subjective evaluation is sufficient to qualify the patient to surgery. The aim of this study was to develop further gravimetry as a method of evaluation of sweating intensity and determination of the applicability of it in post-operative follow-up of primary hyperhidrosis (PHH) patients.
METHODS: Total of 1,485 gravimetry assays has been performed in 343 patients treated for hyperhidrosis and in 220 healthy volunteers. In all of the subjects the measurements were taken from four localizations (face, hands, armpits and trunk) and normalized by body surface of the participant. The measurements were taken twice for every participant to obtain test-retest correlations. Mean values and standard deviations (SD) have been evaluated and on that basis reference values were quantified. Thresholds for diagnosis of hyperhidrosis were quantified on the basis of normal distribution theory as healthy population mean +2 SD.
RESULTS: In healthy volunteers, mean value of gravimetrically evaluated intensity of sweating were: facial: 19.15 ± 14.97 mg/min/m(2), palmar: 18.49 ± 14.06 mg/min/m(2), axillary: 42.39 ± 47.08 mg/min/m(2) and plantar: 15.77 ± 16.87 mg/min/m(2). Thresholds for diagnosis of hyperhidrosis were quantified, respectively as: 49, 46, 136 and 50 mg/min/m(2). The overall test-retest correlation was 0.71.
INTERPRETATION: Gravimetry is easy, reproducible and fast method of evaluation of sweating. The reference values are stable and can serve as a qualifying and follow-up tool for evaluation of the patients with PHH in any localization.

PMID: 23761115 [PubMed – indexed for MEDLINE]

Thoracoscopic sympathectomy for palmar hyperhidrosis in children: 21 years of experience at a tertiary care center.

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Thoracoscopic sympathectomy for palmar hyperhidrosis in children: 21 years of experience at a tertiary care center.

Eur J Pediatr Surg. 2013 Dec;23(6):486-9

Authors: Sinha CK, Kiely E

Abstract
PURPOSE: The aim of this study was to find out the outcome of “thoracoscopic sympathectomy” (TS) for palmar hyperhidrosis (PH) in children. To our knowledge, this is the largest experience of TS from the United Kingdom.
METHOD: All patients who underwent TS for PH during the past 21 years were studied retrospectively.
RESULTS: A total of 85 procedures were done in 44 children. Ratio of female to male was 4:1. Median age at operation was 12.8 years. Types of operations performed were as follows: bilateral T2-T3 sympathectomy in 87% (38/44), bilateral T2-T5 sympathectomy in 9% (4/44), and right-sided thoracoscopic (left-sided done open) in 1% (0.5/44); operation was not possible in 3% (1.5/44) of cases. No chest drains were used. Median postoperative stay was 2 days (range 1 to 5). Median follow-up time was 1.3 years (range 0.2 to 4.7 years). Only problematic patients were followed up for longer. During follow-up, 21% (9/44) developed severe hyperhidrosis of other parts of body. Seven percent (3/44) of patients developed severe axillary hyperhidrosis (AH) and required T4-T5 sympathectomy later on at a median age of 14.4 years (range 11 to 16 years). Another 9% (4/44) patients developed severe plantar hyperhidrosis. Severe hyperhidrosis of the whole body was seen in 5% (2/44) of the patients. Postoperative complications were seen in 47% (21/44) of the patients. They were as follows: postoperative pain (needing > 48 hours hospital stay) in 18% (8/44); transient Horner syndrome in 18% (8/44-right 5, left 3); and recurrence of PH in 11% (5/44) of cases. In the recurrence group, 7% (3/44) were unilateral (right 2, left 1) and 5% (2/44) were bilateral. Redo operations were performed in 11% (5/44) of cases. Median time to redo was 2.6 years (range 8 months to 4.2 years). All three unilateral recurrent patients underwent respective sided redo. In the bilateral recurrence group (2/44), one patient had bilateral redo (remained dry), whereas the other patient underwent only right-sided operation (remained dry), as that sided operation was difficult and so the other side was not tried. FINAL OUTCOMES: The final outcomes were recurrence 3.5% (3/85-right 2, left 1) and technically failed operation 3.5% (3/85-both sides 1, one side 1). Success rate for thoracoscopic sympathetectomy was 93% (79/85) overall.
CONCLUSION: TS for PH is a safe and feasible operation in children. It is successful in the majority; however, the procedure is not trouble free.

PMID: 23460464 [PubMed – indexed for MEDLINE]

Botulinum toxin therapy: its use for neurological disorders of the autonomic nervous system.

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Botulinum toxin therapy: its use for neurological disorders of the autonomic nervous system.

J Neurol. 2013 Mar;260(3):701-13

Authors: Dressler D

Abstract
Botulinum toxin (BoNT) has gained widespread use for the treatment of overactive muscles, overactive exocrine glands and, most recently, non-muscular pain conditions. Autonomic conditions treated with BoNT include achalasia, gastroparesis, sphincter of Oddi spasms, and unspecific esophageal spasms in gastroenterology and prostate disorders in urology. BoNT’s use for autonomic conditions related to neurology includes various forms of bladder dysfunction (detrusor sphincter dyssynergia, idiopathic detrusor overactivity, neurogenic detrusor overactivity, urinary retention and bladder pain syndrome), pelvic floor disorders (pelvic floor spasms and anal fissures), hyperhidrosis (axillary, palmar, and plantar hyperhidrosis, diffuse sweating, Frey’s syndrome) and hypersalivation (hypersalivation in Parkinsonian syndromes, motor neuron disease, neuroleptic use, and cerebral palsy). Hyperhidrosis, hypersalivation, some forms of bladder dysfunction and pelvic floor disorders can easily be treated by neurologists. Most bladder dysfunctions require cooperation with urology departments.

PMID: 22878428 [PubMed – indexed for MEDLINE]

A randomized placebo-controlled trial of oxybutynin for the initial treatment of palmar and axillary hyperhidrosis.

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A randomized placebo-controlled trial of oxybutynin for the initial treatment of palmar and axillary hyperhidrosis.

J Vasc Surg. 2012 Jun;55(6):1696-700

Authors: Wolosker N, de Campos JR, Kauffman P, Puech-Leão P

Abstract
INTRODUCTION: Video-assisted thoracic sympathectomy provides excellent resolution of palmar and axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low doses of oxybutynin, an anticholinergic medication that competitively antagonizes the muscarinic acetylcholine receptor, can be used to treat palmar hyperhidrosis with fewer side effects.
OBJECTIVE: This study evaluated the effectiveness and patient satisfaction of oral oxybutynin at low doses (5 mg twice daily) compared with placebo for treating palmar hyperhidrosis.
METHODS: This was prospective, randomized, and controlled study. From December 2010 to February 2011, 50 consecutive patients with palmar hyperhidrosis were treated with oxybutynin or placebo. Data were collected from 50 patients, but 5 (10.0%) were lost to follow-up. During the first week, patients received 2.5 mg of oxybutynin once daily in the evening. From days 8 to 21, they received 2.5 mg twice daily, and from day 22 to the end of week 6, they received 5 mg twice daily. All patients underwent two evaluations, before and after (6 weeks) the oxybutynin treatment, using a clinical questionnaire and a clinical protocol for quality of life.
RESULTS: Palmar and axillary hyperhidrosis improved in >70% of the patients, and 47.8% of those presented great improvement. Plantar hyperhidrosis improved in >90% of the patients. Most patients (65.2%) showed improvements in their quality of life. The side effects were minor, with dry mouth being the most frequent (47.8%).
CONCLUSIONS: Treatment of palmar and axillary hyperhidrosis with oxybutynin is a good initial alternative for treatment given that it presents good results and improves quality of life.

PMID: 22341836 [PubMed – indexed for MEDLINE]

Treatment of hyperhidrosis with botulinum toxin.

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Treatment of hyperhidrosis with botulinum toxin.

Aesthet Surg J. 2012 Feb;32(2):238-44

Authors: Doft MA, Hardy KL, Ascherman JA

Abstract
Botulinum toxin type A is a safe and effective method for treating focal hyperhidrosis, providing longer-lasting results than topical treatments without the necessity of invasive surgical procedures. Although more useful for axillary hyperhidrosis, botulinum toxin injections can also be effective in treating palmar and plantar disease. The effects of botulinum toxin last for six to nine months on average, and treatment is associated with a high satisfaction rate among patients. In this article, the authors discuss their preferred methods for treating axillary, palmar, and plantar hyperhidrosis. This article serves as guide for pretreatment evaluation, injection techniques, and posttreatment care.

PMID: 22328694 [PubMed – indexed for MEDLINE]

Evaluation of trace elements, calcium, and magnesium levels in the plasma and erythrocytes of patients with essential hyperhidrosis.

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Evaluation of trace elements, calcium, and magnesium levels in the plasma and erythrocytes of patients with essential hyperhidrosis.

Int J Dermatol. 2011 Sep;50(9):1071-4

Authors: Güder H, Karaca S, Cemek M, Kulaç M, Güder S

Abstract
BACKGROUND: Essential hyperhidrosis is a disease that expresses itself with excessive sweating in palmar, plantar, axillary, and craniofacial regions. The etiopathogenesis of the disease, which has particular importance because of leading to psychosocial morbidity, could have not been completely elucidated. In previous studies, it has been shown that oxidative stress might play a role in the pathogenesis.
AIMS: Assessing the levels of trace elements such as Se, Zn, Cu, Fe, and Mg that have an important role in oxidative stress, as well as Ca and Mg that have an important role in membrane physiology, in patients with essential hyperhidrosis.
MATERIALS AND METHODS: Blood samples taken from the patient group with essential hyperhidrosis (42) and the control group (37) were separated into plasma and erythrocytes, and the levels of the bioelements were measured by use of ICP-OES device.
RESULTS: Erythrocyte levels of Se, Fe, Cu, Zn, Ca, and Mg were detected significantly higher in patients with essential hyperhidrosis. Furthermore, plasma levels of Cu, Ca, and Mg were significantly lower in patients with essential hyperhidrosis. Plasma levels of Se, Fe, and Zn showed no statistical difference between two groups.
DISCUSSION: It was thought that the high levels of Cu and Fe in erythrocytes may play a role in increased intracellular oxidative stress, whereas the increase in Se and Zn levels may be secondary to increased oxidative stress. Low extracellular concentrations of Ca and Mg raise the thought that they play a role either enhancing the membrane excitability of eccrine sweat glands or influencing the autonomic nerve system.
CONCLUSION: The levels of trace elements, which were determined to be different from the control group, may play a role in the pathogenesis of essential hyperhidrosis either in direct relation with or without oxidative mechanisms.

PMID: 22126867 [PubMed – indexed for MEDLINE]