A Comparative Study On The Efficacy Of Matbookh e Haleela With Local Application Of Zimad In Comparison With Taliq al Alaq In Stasis Dermatitis

Need of the study:

Stasis Dermatitis, a term synonymous with venous eczema and gravitational eczema, is a common condition secondary to venous hypertension.1 Stasis Dermatitis, characterized by erythema, scaling, pruritis, erosion, oozing, crusting, and occasional vesicles may occur. It typically occurs in the medial supra malleolar region where microangiopathy is most intense. Over time Lesions may lichenify.2   It may arise as an early sign of chronic venous insufficiency but can persist or recur throughout all stages. Stasis Dermatitis is one of the most common causes of secondary dissemination of dermatitis and is therefore a complex and multifactorial condition.3

In the Unani system of medicine, Stasis Dermatitis is not directly mentioned but it can be correlated with *Nār Fārsī*is characterized by dilute fluid-filled blackish vesicles having an erythematous or hyperpigmented base with thickened skin associated with extreme itching and burning. 4-7 The disease is not transmitted through the skin, it does, however, spread locally in its specific area. Severe itching, soreness, and vesicles are three prominent features of Nār Fārsī .8 Studies have estimated an approximately 6-7% prevalence of the condition in patients older than 50 years. A slight female preponderance has been reported in stasis dermatitis.9 In India it commonly affects people of low socioeconomic groups which often forces people to change occupations out of compulsion leading to adversity in the quality of life (QoL) of the individual.1 The main treatment of this disease in modern medicine includes compression of the veins by a firm elastic bandage or appropriate elastic stocking to control venous hypertension, the elevation of the leg, and mild topical corticosteroids to control eczema and itching. In patients with stasis dermatitis, there is poor compliance with compression therapy (Bandage/Stocking).10 Allergic contact dermatitis due to topically applied medicaments is a common complication of venous eczema.11

     In Unani medicine, Nār FārsÄ« is treated successfully with local and oral administration of single and compound drugs possessing properties like MuÊ»addil Ḍam, Mujaffif, Musakkin, Murakki, Muḥallil, and Mubarrid. Accordingly, Matbookh-e-Haleela along withGil-e-Armani, sirka, and water and TaÊ»lÄ«q al-Ê»Alaq  (Leech Therapy) are selected to study their comparative efficacy.

Review of Literature:

Stasis Dermatitis is a common component of the clinical spectrum of chronic venous insufficiency of the lower extremities. It may arise as an early sign of chronic venous insufficiency but can persist or recur throughout all stages and is often most prominent when ulcers are present. 3 Usually, this type of eczema starts around varicosities at the medial ankle, in the region of the Cockett perforating veins in the lower one-third of the leg. The eczema is relatively sharply demarcated and somewhat infiltrated with papules and vesicles, which may also extend beyond the main area of eczematous skin.12 The term “Stasis Dermatitis” was introduced by Pillsbury, and the term “Gravitational Dermatitis” by Belisario.3 The spectrum of Clinical presentation varies from localized mild leg dermatitis to widespread oozing dermatitis with eczematous spread. Stasis Dermatitis develops as an acute eczema or overtime as a subacute eczema or chronic eczema with scaling and itching over the ankle and lower leg. A patient has oedematous pitting on pressure, which is less noticeable in the morning but more easily seen towards the evening. There may be purpuric spots, hemosiderosis (seen as brownish part due to hemosiderin deposits) small atrophic scars (“Atrophic blanche”), and ulcers, all signs of venous hypertension.10 Clinical features depend on the stage of eczema: as in chronic eczema, there may be less exudation, prominent scaling, lichenification (a triad of hyperpigmentation, thickening of the skin, and increased skin markings), and fissuring in flexural lesions.4,13 The signs and symptoms of stasis eczema are assessed on the basis of the TSS visual analog scale (VAS) and EuroQol 5D scale. This is more feasible in obtaining a quick and simple understanding of the severity of the disease and response to medication. A study recommends using VAS, EuroQol 5D scale, and TSS to assess “Objective and subjective” disease severity measurement.14-16

Chronic venous insufficiency (CVI) of the lower extremities is the cause of stasis syndrome. The venous flow up from the feet against gravity is made possible physiologically by the action of calf muscles and the competence of valves in the veins, this mechanism is defective in chronic venous insufficiency because of damage to the veins by thrombophlebitis or due to structural weakness of veins in the form of an incompetent valvular system. Because of incompetent valves, there blood reflux from the deep to the superficial veins, causing venous hypertension. Recent theories of CVI are related to the abnormal microcirculation leading to an inflammatory response.10 This commonly occurs in those who have to work in a stationary position for hours. Another explanation for cutaneous inflammation is the release of proteolytic enzymes and free radicals from sequestrated white blood cells in venules (due to venous hypertension), which produces tissue damage.10 Both microangiopathy and chronic inflammation are likely to be responsible for stasis dermatitis.3 Risk factors for chronic venous disease include heredity, age, female sex, obesity, pregnancy, prolonged standing, and greater height.2

In the Unani system of medicine stasis eczema is not mentioned directly but its clinical features resemble with Nār FārsÄ«. Unani physicians have given detailed descriptions of Nār FārsÄ« including various modes of treatment.  Nar -e-Farsi is characterized by dilute fluid-filled blackish vesicles having erythematous or hyperpigmented base with thickened skin associated with extreme itching and burning.4-7 The disease is not transmitted through the skin, it does, however, spread locally in its specific area. Severe itching, soreness, and vesicles are three prominent features of Nār FārsÄ«.8 The etiology of Nār FārsÄ« is considered as khilá¹­ haad raqiq which is á¹¢afrāʼwÄ«in nature, sometimes khilt sawdāʼ may present with it,5,17 excess in quality and quantity of khilá¹­ Dam is a causative factor as well.7,18 Madda causing Nār FārsÄ«  is thought to be Akkāl (corrosive), munafiq(vesiculant), Raá¹­b, and less infective 5

The major aim of therapy in the management of venous hypertension, basic measures include the regular use of adequate compression bandages or stockings to improve venous return, lifestyle changes, and exercise of the calf muscles3 The legs should be elevated when the patient is resting, lying down or sleeping mild topical corticosteroids may be used to control eczema and itching for a short period.10 Despite all available therapies, recurrence, relapse, and chronicity of the disease is still a major problem in the management of eczema. On the other hand, long-term use of these medications has been linked to multiple local and systemic side effects. Therefore, it is essential to provide an alternative therapy that can provide not only effective, safe, and economical treatment but also can act for a longer duration, prevent recurrence, and should be free from adverse drug reactions. Unani medicine is a bounty of effective and safe drugs for several skin dermatoses and these drugs are time-tested. Since this disease is chronic, relapsing, and recurrent, Unani scholars incorporated a multidirectional approach where they recommended various treatment modalities like Ê»Ilāj biʼl Taghdhiya (dietotherapy), Ê»Ilāj biʼl TadbÄ«r (regimental therapy), and Ê»Ilāj biʼl Dawāʼ(pharmacotherapy) with several preventive measures.4

Management of Nār Fārsī includes the elimination of predisposing and aggravating factors, correction of environment and diet, systemic therapy, and local medication. The most important part is to reassure the patient that this disease is not contagious and is curable too. The procedure of Istifrāghis used to remove khilṭ fasid (morbid materials). This khilṭ fasid should be removed from the body as they are detrimental 4,18 Before Istifrāgh, nudj must be provided by giving adwiyae mundij Ṣafrā or Sawdā as per the need. Any of the following procedures for Istifrāgh can be utilized after the manifestation of nudj according to the corresponding khilṭ like Taʻrīq (diaphoresis*), Ishāl* (purgation), Idrār (diuration) Qayʼ (purging), fasd (phlebotomy) hijama (cupping), irsal e alaq (leeching), tabreed wa tadeel (cooling and normalization) 19. First thing to do Istefrāgh Safrā by fasd, and then Islah-e-hazam to avoid constipation i.e describe treatment in unani literature Oral medication may include Advia Muʻaddil Ḍam like shahitra, gul-e-surkh,Ushba,unnab,mundi,chobchini,chiraita,sarphooka,neem etc.17,20,21,22

Local application of Advia Mujaffif, Musakkin,murakkhi, Muhallil, Mubarrid is useful in acute eczema while Advia Muhallil,Mubarrid, and Muskkin in chronic eczema.6 A formulation of Matbookh-e-haleela ingredients for oral administration from Tibb e Akber and Gil-e-Armani and sirka with water for local application from classical unani text 20,23,24 and  TaÊ»lÄ«q al-Ê»Alaq for local application 19is selected for stasis eczema to evaluate their efficacy

Objectives of the study:

To evaluate the comparative efficacy of Matbookh-e-Haleela with local application of Gil-e-Armani with sirka and water versusLeech therapy in Stasis Dermatitis