Dermatology: Practical and Conceptual Original Article | Dermatol Pract Concept. 2023;13(3):e2023191 1 Clinical Challenges in Primary Erythromelalgia: a Real-Life Experience from a Single Center and a Diagnostic-Therapeutic Flow-Chart Proposal Andrea Michelerio1,2, Carlo Tomasini1,2, Eloisa Arbustini3, Camilla Vassallo2 1 Department of Clinical-Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy 2 Dermatology Clinic, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy 3 Centre for Inherited Cardiovascular Diseases, IRCCS Policlinico San Matteo, Pavia, Italy Key words: erythromelalgia, SCN9A protein, NAV1.7 Voltage-Gated Sodium Channel, mexiletine, treatments Citation: Michelerio A, Tomasini C, Arbustini E, Vassallo C. Clinical Challenges in Primary Erythromelalgia: A Real-Life Experience From A Single Center and a Diagnostic-Therapeutic Flow-Chart Proposal. Dermatol Pract Concept. 2023;13(3):e2023191. DOI: https://doi. org/10.5826/dpc.1303a191 Accepted: February 27, 2023; Published: July 2023 Copyright: ©2023 Michelerio et al. This is an open-access article distributed under the terms of the Creative Commons Attribution- NonCommercial License (BY-NC-4.0), https://creativecommons.org/licenses/by-nc/4.0/, which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original authors and source are credited. Funding: None. Competing Interests: None. Authorship: All authors have contributed significantly to this publication. Corresponding Author: Camilla Vassallo, MD, PhD, Dermatology Clinic, Fondazione IRCCS Policlinico San Matteo, Viale Camillo Golgi, 19, 27100 Pavia, Italy. Phone: + 39 0382-503492 E-mail: c.vassallo@smatteo.pv.it Statement of Informed Consent: Written informed consent was obtained from the patients for their anonymized infor- mation to be published in this article. Introduction: Primary erythromelalgia (EM) is a rare clinical syndrome characterized by recurrent erythema, burning pain and warmth of the extremities. The symptoms greatly compromise the pa- tients’ quality of life leading to severe disability. SCN9A mutations can be the cause of the disease. Dermatologists are often the specialists these patients turn to for assistance. Objectives: To describe the demographic and clinical characteristics of patients with primary EM, to assess the presence and mutation types in the SCN9A gene, to evaluate the effectiveness of several therapeutic approaches, and to propose a diagnostic algorithm with therapeutic implications. ABSTRACT 2 Original Article | Dermatol Pract Concept. 2023;13(3):e2023191 Introduction Erythromelalgia (EM) is a rare clinical syndrome character- ized by the triad of recurrent erythema, burning pain and warmth of the extremities. The burning sensation is the most predominant symptom and is usually triggered and exacer- bated by heat, ambulation, physical activity, emotional stress, fever, sitting, leg dependence, and covering of extremities [1]. The symptoms may occur intermittently or, in rare cases, con- tinuously [2]. Rest, cold temperatures and elevation of the af- fected limbs alleviate symptoms. Indeed, pain is often relieved by putting affected parts in ice cold water, which results in immersion injury of the affected parts, uncovering their feet during sleep or walking barefoot in winter [1-3]. The lower limbs are more commonly affected than the upper limbs, usu- ally with bilateral and symmetrical involvement [2,3]. Occa- sionally, the face, nose, ears, neck, and the genital area may be affected [2,4-6]. Despite not being always considered of dermatologic competence, EM patients are often referred to a dermatologist due to these symptoms. EM may be primary or secondary. As a primary disease, EM can be inherited (familial) or non-inherited (sporadic) [3,4]. As a secondary disease, EM is usually associated with my- eloproliferative disorders such as polycythemia vera and thrombocytopenia, however paraneoplastic, drug-induced, connective-tissue diseases, hypertension, poxviruses and vac- cinations associated cases have also been described [2,7-19]. The primary form has an estimated annual incidence of 1.1 cases per 100,000, with a female predominance [2,5]. The discovery of a gain-of-function missense mutations in SCN9A, a gene encoding the voltage-gated sodium chan- nel alpha subunit Na(v)1.7, in primary familial EM has provided insights into this disorder [20]. Yet, the patho- genesis remains complex, involving both neurological and vascular mechanisms, and resulting in a challenging patient management. As a consequence of the disease, patients’ quality of life is greatly compromised, with patients avoiding school, work- ing and limiting social activities. Disability is not uncommon as a result of intolerable pain, secondary tissue damage, or self-mutilation, leading in some cases to suicide [2,4]. As symptoms and signs of EM are subtle, especially in early stage, and/or mimicking other diseases, diagnosis is often de- layed [21]. Thus, early recognition of the affection is crucial in order to establish an effective treatment. Further, despite the significant clinical impact, no clinical guidelines are cur- rently available for EM management or treatment. Objectives The aims of this study were i) to describe the demographic and clinical characteristics of a series of patients with primary EM in our Center, ii) to assess the presence and mutation types in the SCN9A gene, iii) to evaluate the effectiveness of several therapeutic approaches, and iiii) to propose a diag- nostic algorithm with therapeutic implications. Methods We designed a monocentric retrospective study using the da- tabase of patients with a discharge diagnosis of EM visited between January 2009 and August 2022 at the Dermatology Clinic in collaboration with the Center for Inherited Diseases of our third-level referral Center. Clinical criteria for the diagnosis of EM included: oc- currence of erythema, heat (subjectively and/or objectively observed), and associated discomfort (pain, burning, or tin- gling) in the extremities [22]. When no plausible underlying disease could be identified through anamnesis, examinations, or follow-up, EM was considered primary. Demographic and clinical data of patients were re- viewed. Data as to gender, age at onset of symptoms, age Methods: A monocentric retrospective study using the database of patients with a discharge diagnosis of primary EM of our Center. Demographic, clinical, instrumental and laboratory data of patients were reviewed. Results: Eleven female patients (age range 16 to 57) were selected. All patients were affected in both the lower and upper extremities. Follow-up ranged from 2 to 9 years. Four patients had four different heterozygous variants of the SCN9A gene. Two patients, although genetically negative, had a sugges- tive family history. A variety of medications were tried in all our patients to alleviate symptoms, but their efficacy was variable, partial and/or transitory. The most effective therapies were antihistamines, venlafaxine, and mexiletine. Conclusions: The diagnosis and treatment of EM remain challenging. Patients with this condition display a wide spectrum of clinical manifestations and severity, as well as a paucity of resources and structures to support them. Mutations in the SCN9A gene are not always detected. Original Article | Dermatol Pract Concept. 2023;13(3):e2023191 3 at diagnosis, family history, comorbidities, symptom descrip- tion, triggers and relieving factors, complications, treatment and outcome were obtained for all cases. Laboratory investi- gations, including complete blood count, coagulation panel, autoimmunity panel, basic metabolic panel, hormone panel, and urinalysis, were reviewed as well. In all cases, labora- tory studies such as neurophysiological, neuroimaging, and vascular studies were available. In 3 cases, skin biopsy spec- imens were available and reviewed by one of us (CT). In all patients, genetic consultation with SCN9A gene sequencing and post-test genetic counseling have been provided. Se- quence variants were classified according to the American College of Medical Genetics and Genomics (ACMG) stan- dards [23]. Results A total of 17 patients met the clinical criteria for EM (14 females, 3 males). Fourteen (13 females, 1 male) were clas- sified as primary EM. Three patients were excluded because they had less than 2 accesses in our hospital, resulting in 11 enrolled patients. All the included patients were females, and their average age at the time of the first visit was 36 years (range: 16 to 57). The clinical data are summarized in Table 1. Acral erythrosis, edema, and dysesthesias were experienced by all patients (Figure 1). In 5 cases, the condition developed during infancy, in 2 cases during adolescence and in 4 during adulthood. All patients were affected in both the lower and upper extremities. Five patients developed EM symptoms first in the lower distal limbs (#2, #3, #4, #10, #11), whereas 5 patients developed symptoms in both the upper and lower distal limbs simultaneously (#1, #5, #6, #7, #8). Only patient 9 presented with hand involvement before feet involvement. The EM episodes affected the face in 2 patients (#5, #8), the ears in 2 patients (#6, #8), the knees in 3 patients (#5, #6, #8). Patient 9 complained of a heat sensation throughout her body during EM attacks. Symptoms were persistent in 3 cases (#1, #4, and #11) and intermittent in 8 cases. The frequency of EM attacks in these patients varied from one episode a day to 1 or 2 Figure 1. Erythromelalgia. Red, hot, and painful right (A) and left (B) leg in patient 1. The left leg presents ulceration due to repeated cold-water immersions. (C) Characteristic redness and edema in patient 8 with small bilateral ulcerations. (D) Extreme measures to improve their symptoms, such as going barefoot or cooling affected areas with cold water, are common in patients with erythromelalgia. (E) Persistent erythrosis and pain of the hands in patient 11. 4 Original Article | Dermatol Pract Concept. 2023;13(3):e2023191 Ta b le 1 . C lin ic al d at a of t he p at ie nt s. Pa ti en t A g e at lo w er ex tr em it ie s in vo lv em en t (y ) A g e at u p p er ex tr em it ie s in vo lv em en t (y ) A g e at vi si t (y ) O th er in vo lv ed si te s Pe rs is te n t p ai n Se as o n al it y Tr ig g er in g fa ct o rs SC N A 9 m u ta ti o n Er yt h ro m el al g ia cr is is f re q u en cy D is ea se co n tr o l 1 7 7 18 ye s he at , h um id it y, em ot io na l s tr es s c. 25 72 C >T (e ) (p .L eu 85 8P he ) (p at ho ge ne ti c) ; c. 58 C >T (e ) (p .L eu 20 Ph e) ( V U S) ev er y da y no t su ffi ci en t 2 8 12 43 ye s, s um m er su n ex po su re c. 37 34 A >G (p .A sn 12 45 Se r) (b en ig n) on ce o r tw ic e w ee kl y du ri ng s um m er m on th s go od 3 10 43 43 he at , e ve ni ng , al co ho l c. 19 99 G A (p .A rg 13 56 H is ) (b en ig n) ev er y da y po or V U S = va ri an t of u nc er ta in s ig ni fic an ce . Original Article | Dermatol Pract Concept. 2023;13(3):e2023191 5 paternal aunt. It is likely that both these patients had familial EM harboring an unknown gene mutation. The histopathology examination from skin biopsies performed in 3 patients (#1, #2, #6) showed substantially similar changes consisting of increased numbers of small vessels throughout the dermis, arranged in clusters in the superficial dermis (Figure 2A-B-C) and around the peri- adnexal and neurovascular plexuses in the mid and deep reticular dermis (Figure 2D). The vessel lumen appeared narrowed with wall thickening by PAS positive, hyaline ma- terial (Figure 2E). In one case, endothelial cell hyperplasia was prominent with nuclear atypia and mitoses suggesting a malignant vascular process (Figure 2F). No intraluminal thrombi or inflammatory infiltrate were found. The adnexal structures were preserved, and no quantitative or qualitative changes were observed in the small dermal nerves (Figure 2D). Extravasated erythrocytes were a common finding in all cases (Figure 2F). A variety of medications were tried in all our patients in order to alleviate symptoms, but their efficacy was vari- able, partial and/or transitory (Table 2). Three patients (#2, #3, #4) reported a good reduction in pain intensity and episodes, while four patients (#5, #6, #9, #10) reported a sufficient improvement with the therapy. Four patients (#1, #7, #8, #11) had a poor response to the multiple treat- ments and one of them committed suicide as a result of the disability and depression caused by the disease (#1). As a result of the persistent edema and pain, patient 11 was unable to maintain an upright position and had severe limitations in her walking ability, even for short distances, needing a walker. The association of 2 second-generation non-sedating antihistamines, desloratadine 4 mg/day and rupatadine 10 mg/day, was the most frequently prescribed treatment (10 patients) and was associated with magnesium pidolate sup- plementation in 5 cases. Serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine 75 mg to 150 mg/ day or duloxetine were prescribed in 6 cases. Five cases were treated with mexiletine a sodium channel blocker, at the dosage of 600-1200 mg/day, with good results in 3 of them. Other treatments included caardioaspirin, amlodipine, escitalopram, beta-blockers and pregabalin. An attempt was made to treat patient 1 with a spinal cord stimulator, but it was unsuccessful. Conclusions The dermatologist faces two challenges with EM patients: determining the correct path for a definite diagnosis and engaging other specialists in a multidisciplinary inte- grated approach. To assist clinicians, we propose here a diagnostic-therapeutic flowchart for EM (Figure 3). episodes per week. In patients 6 and 7, erythrosis persisted between attacks. A history of sweating disorders was present in 3 patients before the onset of EM: 2 patients had respectively palmo- plantar and axillary hyperhidrosis (#1, #6), and 1 had hypo- hidrosis (#7). In one case (#1) the sweeting disorder presented in infancy, whilst in 2 cases (#6, #7) in early adulthood. The triggering factors included heat exposure (8 pa- tients), sun exposure (3 patients), humidity (three patients), emotional stress (3 patients), evening time (3 patients), phys- ical activity (1 patient), and alcohol intake (1 patient). In 4 patients (#2, #5, #9, #10), EM crises were more frequent in summer, while 1 patient (#7) reported a winter seasonal- ity. Seven patients reported that cold was a reliving factor (#1, #2, #3, #4, #5, #6, #8), with one of them (#1) walking barefoot in winter in the attempt to alleviate symptoms. Three patients (#2, #8, #10) were misdiagnosed with solar urticaria, rosacea, venous insufficiency, and connec- tive tissue disorders. One patient (#1) was diagnosed with restless legs syndrome and dermatitis factitia secondary to obsessive-compulsive disorder. In 2 cases (#1, #8), foot ulcers, intertrigo, and maceration were present as a result of prolonged immersion in cold wa- ter or ice (Figure 1 ABC). In all cases there was no evidence of rheumatological disease. In two patients anti-nuclear anti- bodies (ANA) were positive (1:160). In all cases, extractable nuclear antigen (ENA) panel and other autoimmune serol- ogy tests were negative. Follow-up ranged from 2 to 9 years (median 5 years). In all patients, the coagulation parameters were within the normal range. Neuroimaging and vascular studies were normal in all patients. Despite needle electromyography being normal in all patients, nerve conduction studies and quantitative su- domotor axon reflex revealed small fiber neuropathy in pa- tients 1, 6 and 7. Four patients with primary EM had 4 different heterozy- gous variants of the SCN9A gene (Nav1.7 channel). Accord- ing the American College of Medical Genetics and Genomics (ACMG) criteria [23], Patient 1 was found to have a patho- genic variant, c.2572C>T(e) (p.Leu858Phe), and a variant of uncertain significance (VUS), c.58C>T(e) (p.Leu20Phe). Patient 2 had a benign variant, c.3734A>G (p.Asn1245Ser), patient 3 presented a VUS, c.1999GA (p.Arg1356His). Two patients (#4, #10), although genetically negative, had a family history of EM-like disorder, but their relatives were not examined. The father of patient 4 suffered from of paroxystic pain in the hands and feet and the patient’s grandmother was diagnosed with palmar-plantar erythro- dysesthesia. Patient 10 described EM-like symptoms in her 6 Original Article | Dermatol Pract Concept. 2023;13(3):e2023191 include a complete blood count, peripheral blood smear, and serum tumor markers. Cancer screening exams, based on gender and age, should be performed. Inflammatory markers, serum protein electrophoresis, cryoglobulins, anti-nuclear antibody (ANA), extractable nuclear antigen (ENA) panel, autoantibody panel, complement levels should be assessed to rule out connective tissue diseases, including systemic lu- pus erythematosus, rheumatoid arthritis, and systemic scle- rosis [2,4,12,31]. If a coexisting connective tissue disease or Reynaud’s phenomenon is suspected, nailfold capillaroscopy should also be performed. Other neuropathies, such as those caused by diabetes or other neurological diseases, should be excluded [32]. EM can be confused with complex regional pain syn- drome (CRPS), which also has similar symptoms but is often unilateral, proximal and less commonly triggered by warm- ing [33]. EM should also be distinguished from Fabry dis- ease, a rare genetic disorder that presents with burning pain, acroparesthesias, angiokeratomas, proteinuria, hypohidrosis/ anhidrosis, and cardiac symptoms. Fabry disease can be di- agnosed by testing for a deficiency of alpha-galactosidase activity [34]. Instrumental investigations may provide diagnostic com- plementary information. Infrared thermography, laser Dop- pler flow and transcutaneous oxygenation measurements usually document an increase in skin temperature and blood flow and a paradoxical decrease in oxygenation in affected areas during EM attacks [35]. Anamnesis. The diagnosis of EM depends on clinical history and physical examination. When EM is suspected, a detailed review of patients’ medical history should be col- lected to provide information about possible factors that might lead to secondary EM. A positive or negative family history can further help to confirm familial/sporadic form. Due to the intermittent nature of this disorder, many Authors consider an EM diagnosis even if the typical findings are ab- sent at the time of examination but the history of recurrent episodes of redness, heat and discomfort of the extremities is suggestive for the disease [2–4,24,25]. According to the patients, symptoms have been variably described as “hot”, “burning” or “numbness” feeling, or “tingling”, “prickling”, “throbbing” [2,24,26]. The onset age and the family history can assist in the determination of a primary or secondary form of EM, but this is not always conclusive [3,4,24]. Most cases of primary EM are not inherited [4]. Episode frequency, characteristics, and seasonality, as well as presence of triggering and reliev- ing factors, should be investigated. Asymmetric or unilat- eral involvement should raise the suspicion of a secondary form [27,28]. An accurate drug anamnesis is essential, since erythromelalgia-like symptoms have been reported in associ- ation with a variety of drugs (iodine contrast, calcium chan- nel blockers, bromocriptine, ticlopidine, vaccines) and even intoxicants [2,9,11,28–30]. Diagnostics. To rule out myeloproliferative disorders and paraneoplastic cases, the laboratory examination should Figure 2. (A,B) The biopsy specimen of patient 1 shows an increased number of small vessels in the papillary and mid dermis, mainly clus- tered in small groups. The epidermis with a cornified layer is typical for the region (H&E ×20, H&E ×100). (C) CD34 positivity in endothelial cells (CD34, x100). (D) Neurovascular plexus with increased numbers of capillaries with narrowed lumen and wall thickening. Note the close relation of small vessels with small nerve endings ((H&E ×40). (E) Groups of capillaries with narrowed lumen, endothelial swelling and wall thickening by hyaline material (H&E ×400). (F) Endothelial cell hyperplasia was prominent with nuclear atypia, mitoses and extravasated erythrocytes (H&E ×100). Original Article | Dermatol Pract Concept. 2023;13(3):e2023191 7 Ta b le 2 . M ed ic at io ns u se d fo r er yt hr om el al gi a sy m pt om s by t he s tu dy p at ie nt s an d th ei r re po rt ed e ffi ca cy . Pa ti en t D es lo ra ta d in e R u p at ad in e M ag n es iu m su p p le m en t Ca rd io as pi ri n A m lo d ip in e Pr eg ab al in V en la fa xi n e D u lo xe ti n Es ci ta lo p ra m Pr o p ra n o lo l M et op ro lo l M ex ile ti n e C lo n az ep am B ro ti zo la m O p io id s 1 2 3 4 5 A t ne ed 6 7 8 9 10 A t ne ed 11 A t ne ed N ot h el pf ul So m ew ha t he lp fu l H el pf ul 8 Original Article | Dermatol Pract Concept. 2023;13(3):e2023191 whilst neither luminal thrombi or reduction of small nerve fibers were observed. Intermittent skin hypoxia may well be considered a stimulus for capillary proliferation in the af- fected skin, as also previously suggested [37]. Once a primary EM diagnosis is established, the patient should be referred to the center where a SCN9A gene se- quencing can be performed. Unfortunately, even in the pres- ence of a family history, only approximately 10% of families have mutations in SCN9A [38]. In our case series, among the 11 patients, seven presented with a classic early onset pri- mary EM, but only four had SCN9A mutations and only in one of them the mutation was pathogenetic. In Patients 4 and 10 the genetic SCN9A gene mutation analysis was negative, although the family history was highly suggestive for heredi- tary EM. This underlies the limitation of SCN9A sequencing, Nerve conduction studies, needle electromyography, and quantitative sudomotor axon reflex test (QSART, or sweat test) are useful and sensitive tools to demonstrate a small-fiber distal neuropathy, which is most prevalent in EM patients [2,22,35]. Quantitative sudomotor axon re- flex test (QSART, or sweat test) may provide evidence of a sudomotor abnormality, which was clinically evident in three of our patients even before the onset of EM symp- toms [35]. Skin biopsy is considered of little help in EM due to the lack of specific pathologic changes [24]. Davis et al suggested that the presence of thrombi within vessels would distinguish primary from secondary EM [24,36]. In our study, capillary proliferation, narrowing of the lumina, endothelial swelling and hyperplasia were common histopathologic findings, Figure 3. Diagnostic-therapeutic flow-chart proposal or erythromelalgia patients. Original Article | Dermatol Pract Concept. 2023;13(3):e2023191 9 in EM patients harboring V400M and S241T mutations in the Nav1.7 sequence but ineffective in patients with F1449V mutations [53,54]. Finally, a correct and early diagnosis of EM is crucial as it may provide psychological and emotional relief, relieving the burden of a possible malingering or other psychiatric dis- ease diagnosis. Chronic pain may lead to sleeping disorders, school difficulties and poor participation in physical activ- ity in children. Unusual or peculiar behaviors that patients adopt to relieve their pain, such as repeated immersions in water or walking barefoot in the snow can be misinterpreted by the clinician as obsessive-compulsive behaviors or signs of another mental illness. In our case series, Patient 1 had an EM patient typical history: symptoms misinterpretation and misdiagnoses over a period of many years, poor response to many therapies, progressive worsening, social isolation and severe psychiatric complications culminating in suicide. Extreme self-harm and even suicide as in our patient are a rare but well-recognized consequence of EM, with high so- cial costs and great impact on the patients and their fam- ilies [2,4]. Information about online patient communities, which may offer users a valuable educational resource and a source of psychological and social support, should be offered (https://erythromelalgia.org/). To conclude, EM involves several medical fields, and the path from diagnosis to treatment, involving all the necessary specialists, may be frustrating, both for patients and clini- cians. In our experience, patients with this condition display a wide spectrum of clinical manifestations and severity, as well as a paucity of resources and structures to support them. References 1. Tang Z, Chen Z, Tang B, Jiang H. Primary erythromelalgia: a re- view. Orphanet J Rare Dis. 2015;10:127. DOI: 10.1186/s13023- 015-0347-1. PMID: 26419464. PMCID: PMC4589109. 2. Davis MD, O’Fallon WM, Rogers RS 3rd, Rooke TW. Natural history of erythromelalgia: presentation and outcome in 168 patients. Arch Dermatol. 2000;136(3):330-336. DOI: 10.1001 /archderm.136.3.330. PMID: 10724194. 3. Kalgaard OM, Seem E, Kvernebo K. Erythromelalgia: a clinical study of 87 cases. J Intern Med. 1997;242(3):191-197. DOI: 10.1046/j.1365-2796.1997.00185.x. PMID: 9350163. 4. Cook-Norris RH, Tollefson MM, Cruz-Inigo AE, Sandroni P, Davis MD, Davis DM. Pediatric erythromelalgia: a retrospective review of 32 cases evaluated at Mayo Clinic over a 37-year pe- riod. J Am Acad Dermatol. 2012;66(3):416-423. DOI: 10.1016/j .jaad.2011.01.010. PMID: 21798623 5. Mantyh WG, Dyck PJB, Dyck PJ, et al. Epidermal Nerve Fi- ber Quantification in Patients With Erythromelalgia. JAMA Dermatol. 2017;153(2):162-167. DOI: 10.1001/jamaderma- tol.2016.4404. PMID: 27926760. 6. Prevost N, English JC 3rd. Case reports: red scrotal syndrome: a localized phenotypical expression of erythromelalgia. J Drugs Dermatol. 2007;6(9):935-936. PMID: 17941366. as the same mutation can result in phenotypic variability [39] and patients may also display protein-modifying mutations in other genes [39,40]. Consequently, if the sequencing result is negative for mutations, the primary EM diagnosis should not be questioned. On the other side, if any mutation is found, the Literature should be reviewed to determine if the genotype is associated with sensitivity to specific treatments. Treatment. As a matter of fact, EM is resistant to many treatments and our findings confirm its refractory nature [1,2,4,15]. Various pharmacologic trials have been con- ducted with varied results, and no single medication or drug combination has been found to be universally helpful in re- lieving patients symptoms. In our study, the most effective therapies were antihis- tamines, venlafaxine, and mexiletine. With regard to anti- histamines, therapeutic efficacy in our EM patients might be attributed to their action against neurogenic inflamma- tion [41]. Although these drugs are safe, their use in EM is off-label. Five patients were given magnesium pidolate in combination with antihistamines, which would act as a cal- cium antagonist, a sympatholytic and a muscle-relaxant [42]. In 3 patients, venlafaxine has provided some relief from symptoms of by acting both on sympathetic fibers by inhib- iting the reuptake of noradrenaline, as well as on hormonal vascular control by inhibiting the reuptake of serotonin [43-45]. As this medication is approved to treat major de- pression, which is a common comorbidity among these pa- tients, it is likely to prove useful for both diseases. Mexiletine is a class IB orally active sodium channel blocker structurally similar to lidocaine, which appears to be particularly effective in neuropathic pain by shortening the action potential duration [46]. This drug was very effective in 3 patients and moderately effective in one, whilst in an- other was totally ineffective. Pharmacodynamic factors and genetic polymorphisms of the SCN9A gene, encoding the so- dium channel Nav1.7, may for the variable efficacy of mex- iletine in EM. Based on the available literature, a therapeutic attempt with mexiletine may be recommended for patients with V872G, L858F, and I848T mutant Nav1.7 channels, while the same treatment may not be appropriate for patients with I136V and V1316A mutations [47-49]. Furthermore, a clinically favorable response to intravenous lidocaine may predict a favorable response to oral mexiletine [50]. Patients should undergo periodic cardiological examinations, espe- cially during drug titration, and be informed about common side effects involving the gastrointestinal and central nervous systems [51,52]. The use of mexiletine for EM is off-label. A literature review may assist in providing other treat- ment options for EM. These include use of tricyclic an- tidepressants, gabapentin, anticonvulsants, and others. Carbamazepine, for instance, has been shown to be effective 10 Original Article | Dermatol Pract Concept. 2023;13(3):e2023191 22. Davis MD, Sandroni P, Rooke TW, Low PA. Erythromelal- gia: vasculopathy, neuropathy, or both? A prospective study of vascular and neurophysiologic studies in erythromelalgia. Arch Dermatol. 2003;139(10):1337-1343. DOI: 10.1001/arch- derm.139.10.1337. PMID: 14568838. 23. Richards S, Aziz N, Bale S, et al. Standards and guidelines for the interpretation of sequence variants: a joint consensus rec- ommendation of the American College of Medical Genetics and Genomics and the Association for Molecular Pathology. Genet Med. 2015;17(5):405-424. DOI: 10.1038/gim.2015.30. PMID: 25741868. PMCID: PMC4544753. 24. Davis MD, Weenig RH, Genebriera J, Wendelschafer-Crabb G, Kennedy WR, Sandroni P. Histopathologic findings in primary erythromelalgia are nonspecific: special studies show a decrease in small nerve fiber density. J Am Acad Dermatol. 2006;55(3):519- 522. DOI: 10.1016/j.jaad.2006.04.067. PMID: 16908366. 25. Reed KB, Davis MD. Incidence of erythromelalgia: a population-based study in Olmsted County, Minnesota. J Eur Acad Dermatol Venereol. 2009;23(1):13-15. DOI: 10.1111/j.1468-3083.2008.02938.x. PMID: 18713229. PM- CID: PMC2771547. 26. Kurzrock R, Cohen PR. Erythromelalgia: review of clinical char- acteristics and pathophysiology. Am J Med. 1991;91(4):416-422. DOI: 10.1016/0002-9343(91)90160-y. PMID: 1951386. 27. Michiels JJ, Abels J, Steketee J, van Vliet HH, Vuzevski VD. Erythromelalgia caused by platelet-mediated arteriolar inflam- mation and thrombosis in thrombocythemia. Ann Intern Med. 1985;102(4):466-471. DOI: 10.7326/0003-4819-102-4-466. PMID: 3977194. 28. Cohen JS. Erythromelalgia: new theories and new therapies. J Am Acad Dermatol. 2000;43(5 Pt 1):841-847. DOI 10.1067 /mjd.2000.109301. PMID: 11050591. 29. Bibb LA, Winter RP, Leicht SS. Cyclosporine-induced Erythrome- lalgia. Cureus. 2018;10(10):e3506. DOI: 10.7759/cureus.3506. PMID: 30648046. PMCID: PMC6318136. 30. Nakajima N, Ueda M, Higashi N, Katayama Y. Erythro- melalgia associated with Clitocybe acromelalga intoxi- cation. Clin Toxicol (Phila). 2013;51(5):451-454. DOI: 10.3109/15563650.2013.792933. PMID: 23641936. 31. Grinnell M, Keyes E, Wat M, et al. Erythromelalgia associ- ated with dermatomyositis: A case series. JAAD Case Rep. 2021;16:37-40. DOI 10.1016/j.jdcr.2021.07.035. PMID: 34522744. PMCID: PMC8426183. 32. Reach P, Lazareth I, Coudore F, et al. A reappraisal of the pres- ence of small or large fiber neuropathy in patients with eryth- romelalgia. Neurophysiol Clin. 2021;51(4):349-355. DOI: 10.1016/j.neucli.2021.03.008. PMID: 33888389. 33. Shim H, Rose J, Halle S, Shekane P. Complex regional pain syn- drome: a narrative review for the practising clinician. Br J An- aesth. 2019;123(2):e424-e433. DOI: 10.1016/j.bja.2019.03.030. PMID: 31056241. PMCID: PMC6676230. 34. Germain DP. Fabry disease. Orphanet J Rare Dis. 2010;5:30. DOI: 10.1186/1750-1172-5-30. PMID: 21092187. 35. Sandroni P, Davis MD, Harper CM, et al. Neurophysiologic and vascular studies in erythromelalgia: a retrospective analysis. J Clin Neuromuscul Dis. 1999;1(2):57-63. DOI: 10.1097/00131402- 199912000-00001. PMID: 19078553. 36. Michiels JJ, ten Kate FW, Vuzevski VD, Abels J. Histopathol- ogy of erythromelalgia in thrombocythaemia. Histopathology. 7. Mørk C, Kalgaard OM, Kvernebo K. Erythromelalgia as a paraneoplastic syndrome in a patient with abdom- inal cancer. Acta Derm Venereol. 1999;79(5):394. DOI: 10.1080/000155599750010409. PMID: 10494725. 8. Han JH, Lee JB, Kim SJ, Lee SC, Won YH, Yun SJ. Parane- oplastic erythromelalgia associated with breast carcinoma. Int J Dermatol. 2012;51(7):878-880. DOI: 10.1111/j.1365- 4632.2010.04643.x. PMID: 22715841. 9. Eisler T, Hall RP, Kalavar KA, Calne DB. Erythromelalgia-like eruption in parkinsonian patients treated with bromocrip- tine. Neurology. 1981;31(10):1368-1370. DOI: 10.1212 /wnl.31.10.1368. PMID: 6213882. 10. Thami GP, Bhalla M. Erythromelalgia induced by possible calcium channel blockade by ciclosporin. BMJ. 2003;326(7395):910. DOI: 10.1136/bmj.326.7395.910. PMID: 12714471. PMCID: PMC153834. 11. Michelerio A, Derlino F, Brazzelli V, Vassallo C. Secondary erythromelalgia: a tryptophan dietary supplement-induced case associated with elevated 5-hydroxyindoleacetic acid (5HIAA) urinary levels. Int J Dermatol. 2018;57(1):83-85. DOI: 10.1111 /ijd.13760. PMID: 29152720. 12. Parker LK, Ponte C, Howell KJ, Ong VH, Denton CP, Sch- reiber BE. Clinical features and management of erythrome- lalgia: long term follow-up of 46 cases. Clin Exp Rheumatol. 2017;35(1):80-84. PMID: 27494156. 13. Grinnell M, Keyes E, Wat M, et al. Erythromelalgia associ- ated with dermatomyositis: A case series. JAAD Case Rep. 2021;16:37-40. DOI: 10.1016/j.jdcr.2021.07.035. PMID: 34522744. PMCID: PMC8426183. 14. Drenth JP, Michiels JJ, Ozsoylu S. Acute secondary erythermalgia and hypertension in children. Erythermalgia Multidisciplinary Study Group. Eur J Pediatr. 1995;154(11):882-885. DOI: 10.1007/BF01957497. PMID: 8582398. 15. Mann N, King T, Murphy R. Review of primary and secondary erythromelalgia. Clin Exp Dermatol. 2019;44(5):477-482. DOI: 10.1111/ced.13891. PMID: 30609105. 16. Zheng ZM, Zhang JH, Hu JM, Liu SF, Zhu WP. Poxviruses isolated from epidemic erythromelalgia in China. Lancet. 1988;1(8580):296. DOI: 10.1016/s0140-6736(88)90372-8. PMID: 2893103. 17. Confino I, Passwell JH, Padeh S. Erythromelalgia following influ- enza vaccine in a child. Clin Exp Rheumatol. 1997;15(1):111-3. PMID: 9093785. 18. Rabaud C, Barbaud A, Trechot P. First case of eryther- malgia related to hepatitis B vaccination. J Rheumatol. 1999;26(1):233-234. PMID: 9918272. 19. McMahon DE, Amerson E, Rosenbach M, et al. Cutaneous re- actions reported after Moderna and Pfizer COVID-19 vaccina- tion: A registry-based study of 414 cases. J Am Acad Dermatol. 2021;85(1):46-55. DOI: 10.1016/j.jaad.2021.03.092. PMID: 33838206. PMCID: PMC8024548. 20. Yang Y, Wang Y, Li S, et al. Mutations in SCN9A, encoding a sodium channel alpha subunit, in patients with primary ery- thermalgia. J Med Genet. 2004;41(3):171-417. DOI: 10.1136 /jmg.2003.012153. PMID: 14985375. PMCID: PMC1735695. 21. Alhadad A, Wollmer P, Svensson A, Eriksson KF. Erythrome- lalgia: Incidence and clinical experience in a single centre in Sweden. Vasa. 2012;41(1):43-48. DOI: 10.1024/0301-1526 /a000162. PMID: 22247059. Original Article | Dermatol Pract Concept. 2023;13(3):e2023191 11 Anesth Analg. 2005;101(6):1738-1749. DOI: 10.1213/01 .ANE.0000186348.86792.38. PMID: 16301253. 47. Choi JS, Zhang L, Dib-Hajj SD, et al. Mexiletine-responsive erythromelalgia due to a new Na(v)1.7 mutation showing use-dependent current fall-off. Exp Neurol. 2009;216(2):383-389. DOI: 10.1016/j.expneurol.2008.12.012. PMID: 19162012. 48. Cregg R, Cox JJ, Bennett DL, Wood JN, Werdehausen R. Mexile- tine as a treatment for primary erythromelalgia: normalization of biophysical properties of mutant L858F NaV 1.7 sodium chan- nels. Br J Pharmacol. 2014;171(19):4455-4463. DOI: 10.1111 /bph.12788. PMID: 24866741. PMCID: PMC4209151. 49. Wu MT, Huang PY, Yen CT, Chen CC, Lee MJ. A novel SCN9A mutation responsible for primary erythromelalgia and is resis- tant to the treatment of sodium channel blockers. PLoS One. 2013;8(1):e55212. DOI: 10.1371/journal.pone.0055212. PMID: 23383113. PMCID: PMC3561374. 50. Jang HS, Jung D, Kim S, et al. A case of primary erythromelalgia improved by mexiletine. Br J Dermatol. 2004;151(3):708-710. doi: 10.1111/j.1365-2133.2004.06167.x. PMID: 15377366. 51. Johansson BW, Stavenow L, Hanson A. Long-term clinical expe- rience with mexiletine. Am Heart J. 1984;107(5 Pt 2):1099-1102. DOI: 10.1016/0002-8703(84)90181-9. PMID: 6720535. 52. Kerin NZ, Aragon E, Marinescu G, Faitel K, Frumin H, Ruben- fire M. Mexiletine. Long-term efficacy and side effects in patients with chronic drug-resistant potentially lethal ventricular arrhyth- mias. Arch Intern Med. 1990;150(2):381-384. DOI: 10.1001 /archinte.150.2.381. PMID: 2302013. 53. Fischer TZ, Gilmore ES, Estacion M, Eastman E, Taylor S, Melanson M, Dib-Hajj SD, Waxman SG. A novel Nav1.7 muta- tion producing carbamazepine-responsive erythromelalgia. Ann Neurol. 2009;65(6):733-741. DOI: 10.1002/ana.21678. PMID: 19557861. PMCID: PMC4103031. 54. Yang Y, Dib-Hajj SD, Zhang J, et al. Structural modelling and mutant cycle analysis predict pharmacoresponsiveness of a Na(V)1.7 mutant channel. Nat Commun. 2012;3:1186. doi: 10.1038/ncomms2184. PMID: 23149731. PMC3530897. 1984;8(4):669-678. DOI: 10.1111/j.1365-2559.1984. tb02379.x. PMID: 6384014. 37. Kalgaard OM, Clausen OP, Mellbye OJ, Hovig T, Kvernebo K. Nonspecific capillary proliferation and vasculopathy in- dicate skin hypoxia in erythromelalgia. Arch Dermatol. 2011;147(3):309-314. DOI: 10.1001/archdermatol.2010.337. PMID: 21079053. 38. Goldberg YP, Pimstone SN, Namdari R, et al. Human Mendelian pain disorders: a key to discovery and validation of novel anal- gesics. Clin Genet. 2012;82(4):367-373. DOI: 10.1111/j.1399- 0004.2012.01942.x. PMID: 22845492. 39. McDonnell A, Schulman B, Ali Z, et al. Inherited erythromelalgia due to mutations in SCN9A: natural history, clinical phenotype and somatosensory profile. Brain. 2016;139(Pt 4):1052-1065. DOI: 10.1093/brain/aww007. PMID: 26920677. 40. Zhang Z, Schmelz M, Segerdahl M, et al. Exonic mutations in SCN9A (NaV1.7) are found in a minority of patients with eryth- romelalgia. Scand J Pain. 2014;5(4):217-225. DOI: 10.1016/j. sjpain.2014.09.002. PMID: 29911575. 41. Rosa AC, Fantozzi R. The role of histamine in neurogenic in- flammation. Br J Pharmacol. 2013;170(1):38-45. DOI: 10.1111 /bph.12266. PMID: 23734637. PMCID: PMC3764847. 42. Cohen JS. High-dose oral magnesium treatment of chronic, intrac- table erythromelalgia. Ann Pharmacother. 2002;36(2):255-260. DOI: 10.1345/aph.1A186. PMID: 11847944. 43. Moiin A, Yashar SS, Sanchez JE, Yashar B. Treatment of eryth- romelalgia with a serotonin/noradrenaline reuptake inhibitor. Br J Dermatol. 2002;146(2):336-337. DOI: 10.1046/j.1365- 2133.2002.4653_6.x. PMID: 11903257. 44. Firmin D, Roguedas AM, Greco M, et al. Treatment of familial erythromelalgia with venlafaxine. J Eur Acad Dermatol Venereol. 2007;21(6):836-837. DOI: 10.1111/j.1468-3083.2006.02039.x. PMID: 17567325. 45. DiCaudo DJ, Kelley LA. Alleviation of erythromelalgia with ven- lafaxine. Arch Dermatol. 2004;140(5):621-623. DOI: 10.1001 /archderm.140.5.621. PMID: 15148116. 46. Tremont-Lukats IW, Challapalli V, McNicol ED, Lau J, Carr DB. Systemic administration of local anesthetics to relieve neuropathic pain: a systematic review and meta-analysis.