Category: Treatment

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A novel lotion formulation of 20% oxybutynin hydrochloride for the treatment of primary palmar hyperhidrosis: A randomized, placebo-controlled, double-blind, phase III study in Japan

J Am Acad Dermatol. 2023 Mar 27:S0190-9622(23)00511-X. doi: 10.1016/j.jaad.2023.03.025. Online ahead of print.

ABSTRACT

BACKGROUND: No previous controlled studies have been specifically designed or adequately powered to show the efficacy of topical oxybutynin for palmar hyperhidrosis by using quantitative measures.

OBJECTIVE: To evaluate efficacy of 20% oxybutynin hydrochloride lotion (20% OL) in reducing palmar sweat volume in patients with primary palmar hyperhidrosis (PPHH).

METHODS: In a randomized controlled trial, Japanese patients with PPHH aged 12 years and older received either 20% OL (n = 144) or placebo (n = 140) on both palms once daily for 4 weeks. Palmar sweat volume was measured by the ventilated capsule method. For the primary outcome, response was defined as a reduction of sweat volume of at least 50% from baseline.

RESULTS: At week 4, the responder rate for sweat volume was significantly higher in the 20% OL arm than in the placebo arm (52.8% vs 24.3%, respectively; treatment difference, 28.5% [95% CI, 17.7 to 39.3%]; P < .001). No serious adverse events (AEs) occurred, and no AEs led to treatment discontinuation.

LIMITATIONS: The treatment period was only 4 weeks.

CONCLUSIONS: In patients with PPHH, 20% OL is superior to placebo in reducing palmar sweat volume.

PMID:36990320 | DOI:10.1016/j.jaad.2023.03.025

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A single session of high-energy microwave axillary hyperhidrosis and osmidrosis therapy: Key pretherapeutic assessment and outcome analysis

Lasers Surg Med. 2023 Mar 23. doi: 10.1002/lsm.23656. Online ahead of print.

ABSTRACT

BACKGROUND: Microwave therapy is used to treat axillary hyperhidrosis and osmidrosis. Even while a “danger zone” has been identified and reports of potential complications from nerve injury have been made, there has been little real-world discussion regarding whether there is any pretreatment evaluation key factor that may lower the risk. Furthermore, the efficacy of a single treatment and the safety of high-energy therapies have not been well investigated.

OBJECTIVE: The aim of this study is to demonstrate the key aspects of pre-therapeutic assessment, efficacy, and suitability of a single treatment, as well as the safety of high-energy treatments.

METHODS: Fifteen patients with axillary hyperhidrosis (AH) and axillary osmidrosis (AO) between ages of 20 and 50 had pretherapeutic ultrasonography and clinical assessments performed followed by a single-pass microwave treatment using the miraDry system at energy level 5. The severity of AH and AO was evaluated using the Hyperhidrosis Disease Severity Scale and Odor-10 scale, respectively, at baseline, 1 month, 3 months, and 1 year after treatment. Adverse reactions were recorded at each point of evaluation.

RESULTS: Out of 30 treatment areas, 14 have a danger zone. Female gender, a small mid-upper arm circumference, and a low body mass index (BMI) are all associated risk factors. The average Hyperhidrosis Disease Severity Scale score decreased from 3.1 ± 0.7 to 1.3 ± 0.5 (p < 0.001), while the odor-10 score declined from 7.1 ± 1.6 to 3.0 ± 1.6 (p < 0.001), indicating a significant improvement in AH and AO. Most of the unfavorable treatment effects disappeared within the first month.

LIMITATIONS: This study has no objective quantitative measurement of axillary odor severity and sweat assessment.

CONCLUSION: Female patients, those with a smaller mid-upper arm circumference, and those with a low BMI should be treated with extra caution, and the tumescent anesthetic dose may be increased based on safety. A high-energy microwave treatment procedure performed in a single session is a safe and effective therapeutic option with good recovery.

PMID:36950892 | DOI:10.1002/lsm.23656

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Impact of endoscopic thoracic R4 sympathicotomy combined with R3 ramicotomy for primary palmar hyperhidrosis

Front Surg. 2023 Feb 24;10:1144299. doi: 10.3389/fsurg.2023.1144299. eCollection 2023.

ABSTRACT

BACKGROUND: Endoscopic thoracoscopic sympathectomy (ETS) is the preferred method for treating primary palmar hyperhidrosis (PPH) that bears the risk of compensatory hyperhidrosis (CH) following surgery. The current study aims to evaluate the effectiveness and safety of an innovative surgical procedure of ETS.

METHODS: A survey of the clinical data of 109 patients with PPH who underwent ETS in our department from May 2018 to August 2021 was retrospectively conducted. The patients were organized into two groups. Group A underwent R4 sympathicotomy combined with R3 ramicotomy. Group B underwent R3 sympathicotomy. Patients were followed up to evaluate the safety, effectiveness and the incidence of postoperative CH of the modified surgical approach.

RESULTS: A total of 102 patients completed follow-up, and seven of the total enrolled patients were lost to follow-up, with a loss rate of 6% (7/109). Among these, Group A constitutes 54 cases, group B constitutes 48 cases, and the mean follow-up was 14 months (interquartile range 12-23 months). There was no statistically difference in surgical safety, postoperative efficacy, and postoperative quality of life (QoL) score between group A and group B (p > 0.05). The score of the psychological assessment was higher (p = 0.004) in group A (14.15 ± 2.06) compared to group B (13.30 ± 1.86). The incidence of CH in group A was lower than in group B (p = 0.019).

CONCLUSION: R4 sympathicotomy combined with R3 ramicotomy is safe and effective for PPH treatment, along with a reduced incidence of postoperative CH rate and improved postoperative psychological satisfaction.

PMID:36911618 | PMC:PMC9998541 | DOI:10.3389/fsurg.2023.1144299

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Effectiveness of Iontophoresis in Treating Plantar Hyperhidrosis

J Am Podiatr Med Assoc. 2023 Jan-Feb;113(1):21-003. doi: 10.7547/21-003.

ABSTRACT

BACKGROUND: The purpose of this study was to evaluate the effectiveness of tap water iontophoresis as a treatment for plantar hyperhidrosis.

METHODS: Thirty participants living with idiopathic plantar hyperhidrosis and consented to undergo treatment using iontophoresis were recruited. The Hyperhidrosis Disease Severity Score was used to evaluate the severity of the condition before and after treatment.

RESULTS: Tap water iontophoresis was found to be effective in the treatment of plantar hyperhidrosis in the study group (P = .005).

CONCLUSIONS: Treatment with iontophoresis led to the reduction of disease severity and improvement of quality of life, and it is a safe, easy-to-use method with minimal side effects. This technique should be considered before the use of systemic or aggressive surgical interventions, which could have potentially more severe side effects.

PMID:36905622 | DOI:10.7547/21-003

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Safety and efficacy of oxybutynin in patients with hyperhidrosis: systematic review and meta-analysis of randomized controlled trials

Arch Dermatol Res. 2023 Mar 4. doi: 10.1007/s00403-023-02587-5. Online ahead of print.

ABSTRACT

BACKGROUND: Sweating is a physiologic mechanism of human thermoregulation. Hyperhidrosis is defined as a somatic disorder where the sweating is exaggerated in an exact area because the sweat glands are hyperfunctioning. It negatively affects the quality of life of the patients. We aim to investigate patient satisfaction and the effectiveness of oxybutynin in treating hyperhidrosis.

METHODS: We prospectively registered the protocol of this systematic review and meta-analysis on PROSPERO (CRD 42022342667). This systematic review and meta-analysis were reported according to the PRISMA statement guidelines. We searched three electronic databases (PubMed, Scopus, Web of Science) from inception until June 2, 2022, using MeSH terms. We include studies comparing patients with hyperhidrosis who received oxybutynin or a placebo. We assessed the risk of bias using the Cochrane risk of bias assessment tool (ROB2) for randomized controlled trials. The risk ratio was calculated for categorical variables, and the mean difference was calculated for continuous variables using the random effect model with 95% confidence intervals (CI).

RESULTS: Six studies were included in the meta-analysis, with a total of 293 patients. In all studies, patients were assigned to receive either Oxybutynin or Placebo. Oxybutynin represented an HDSS improvement (RR = 1.68 95% CI [1.21, 2.33], p = 0.002). It also can improve the quality of life. There is no difference between oxybutynin and placebo regarding dry mouth (RR = 1.68 95% CI [1.21, 2.33], p = 0.002).

CONCLUSION: Our study suggests that using oxybutynin as a treatment for hyperhidrosis is significant and needs to be highlighted for clinicians. However, more clinical trials are needed to grasp the optimum benefit.

PMID:36869926 | DOI:10.1007/s00403-023-02587-5

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Pharmacovigilance-based drug repurposing: searching for putative drugs with hypohidrosis or anhidrosis adverse events for use against hyperhidrosis

Eur J Med Res. 2023 Feb 24;28(1):95. doi: 10.1186/s40001-023-01048-z.

ABSTRACT

BACKGROUND: Drug repurposing refers to the application of existing drugs to new therapeutic indications. As phenotypic indicators of human drug response, drug side effects may provide direct signals and unique opportunities for drug repurposing.

OBJECTIVES: We aimed to identify drugs frequently associated with hypohidrosis or anhidrosis adverse reactions (that is, the opposite condition of hyperhidrosis) from the pharmacovigilance database, which could be potential candidates as anti-hyperhidrosis treatment agents.

METHODS: In this observational, retrospective, pharmacovigilance study, adverse event reports of hypohidrosis or anhidrosis in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) were assessed between January 2004 and December 2021 using reporting odds ratio (ROR) estimates and categorized by the World Health Organization Anatomical Therapeutic Chemical (ATC) classification code. The onset time of drug-associated hypohidrosis or anhidrosis was also examined.

RESULTS: There were 540 reports of 192 drugs with suspected drug-associated hypohidrosis or anhidrosis in the FAERS database, of which 39 drugs were found to have statistically significant signals. Nervous system drugs were most frequently reported (187 cases, 55.82%), followed by alimentary tract and metabolism drugs (35 cases, 10.45%), genitourinary system and sex hormones (28 cases, 8.36%), and dermatologicals (22 cases, 6.57%). The top 3 drug subclasses were antiepileptics, drugs for urinary frequency and incontinence, and antidepressants. Taking disproportionality signals, pharmacological characteristics of drugs and appropriate onset time into consideration, the main putative drugs for hyperhidrosis were glycopyrronium, solifenacin, oxybutynin, and botulinum toxin type A. Other drugs, such as topiramate, zonisamide, agalsidase beta, finasteride, metformin, lamotrigine, citalopram, ciprofloxacin, bupropion, duloxetine, aripiprazole, prednisolone, and risperidone need more investigation.

CONCLUSIONS: Several candidate agents among hypohidrosis or anhidrosis-related drugs were identified that may be redirected for diminishing sweat production. There are affirmative data for some candidate drugs, and the remaining proposed candidate drugs without already known sweat reduction mechanisms of action should be further explored.

PMID:36829251 | DOI:10.1186/s40001-023-01048-z

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Efficacy and Safety of Botulinum Toxin B in Focal Hyperhidrosis: A Narrative Review

Toxins (Basel). 2023 Feb 11;15(2):147. doi: 10.3390/toxins15020147.

ABSTRACT

Botulinum toxin type B (BoNT-B), known as Myobloc® in the United States and as Neurobloc® in Europe, is a new therapeutically available serotype among the botulinum toxin family. During the last years several data have been reported in literature investigating its efficacy and safety, as well as defining the dosing and application regiments of BoNT-B in the treatment of hyperhidrosis. Moreover, recent studies have been examining its safety profile, which may be different from those known about BoNT-A. The aim of this review is to provide information about what is currently known about BoNT-B in regards to the treatment of focal hyperhidrosis.

PMID:36828461 | DOI:10.3390/toxins15020147

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Botulinum toxin in the treatment of residual limb hyperhidrosis: A systematic review

Rehabilitacion (Madr). 2023 Feb 13;57(3):100754. doi: 10.1016/j.rh.2022.07.003. Online ahead of print.

ABSTRACT

The aim of the study was to analyze the current evidence regarding the effect of intradermal injections of botulinum toxin on residual limb hyperhidrosis. A comprehensive search of the MEDLINE and Scopus databases from inception until December 2021 was performed according to the PRISMA guidelines. The search terms used were “botulinum toxins”, “botulinum toxins, Type A”, “rimabotulinumtoxinB”, “amputees”, “amputation stumps”, “amputation” and “residual limbs”. The specific controlled vocabulary of each database was also used (e.g., MeSH). One hundred and thirty-one different studies met this search criteria and were reviewed. Two independent reviewers assessed the quality of the manuscripts. Eight studies met the inclusion criteria for this review. The results demonstrated an improvement in residual limb hyperhidrosis in all studies. Botulinum toxin A or B can be regarded as safe and effective for the treatment of residual limb hyperhidrosis, as well as improving prosthesis use and quality of life.

PMID:36791670 | DOI:10.1016/j.rh.2022.07.003

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Use of thoracoscopy for thoracic sympathetic nerve block in primary hyperhidrosis

Sci Rep. 2023 Jan 25;13(1):1402. doi: 10.1038/s41598-023-28727-5.

ABSTRACT

Thoracic sympathetic nerve block (TSNB) has been widely used in the treatment of neuropathic pain. To reduce block failure rates, TSNB is assisted with several modalities including fluoroscopy, computed tomography, and ultrasonography. The present study describes our experience assessing the usefulness of thoracoscopy in TSNB for predicting compensatory hyperhidrosis before sympathectomy in primary hyperhidrosis. From September 2013 to October 2021, TSNB was performed under local anesthesia using a 2-mm thoracoscope in 302 patients with severe primary hyperhidrosis. Among the 302 patients, 294 were included for analysis. The target level of TSNB was T3 in almost all patients. The mean procedure time was 21 min. Following TSNB, the mean temperature of the left and right palms significantly changed from 31.5 to 35.3 °C and from 31.5 to 34.8 °C, respectively. With TSNB, primary hyperhidrosis was relieved in all patients. Pneumothorax occurred in six patients, in which no chest tube insertion was required. One patient developed hemothorax and was discharged the next day after small-bore catheter drainage. Transient ptosis developed in 10 patients and improved within a day in all patients. Our experiences showed that thoracoscopic TSNB is accurate, safe, and feasible to block the thoracic sympathetic nerve in patients with severe primary hyperhidrosis.

PMID:36697462 | DOI:10.1038/s41598-023-28727-5