6

BRIEFRESUMEOFINTENEDWORK:

6.1

NEEDFOR STUDY:

Psoriasis is a chronic autoimmune disorder that significantly affects patients’ quality of life due to its visible symptoms and associated discomfort.⁽¹⁾This studyexplorestheroleofhomeopathyinmanagingpsoriasis,withaparticular focus on assessing the impact on quality of life using the Dermatology Life Quality Index (DLQI). The DLQI is a validated tool used globally to measure the psychological and physical burden of dermatological conditions. It provides insights into the extent to which skin diseases affect patients’ daily lives, thus offering a comprehensive evaluation of treatment outcomes.

The DLQI consists of 10 questions covering symptoms, feelings, daily activities,leisure,workorschool,personal relationships,andtreatment.Itisa simple and practical instrument, making it a valuable tool in both clinical practice and research. This study leverages the DLQI to objectively measure improvements in patients’ quality of life following homeopathic treatment. ⁽²⁾

6.2

REVIEWOFLITERATURE:

Introductionto Psoriasis

Psoriasis is a chronic, non-infectious, immune-mediated inflammatory skin disorder characterized by hyperproliferation of keratinocytes and abnormal differentiation, leading to erythematous, silvery-scaly plaques. The disease significantlyimpactspatients’qualityoflifeduetobothphysical symptomsand psychosocial distress. Despite numerous conventional treatment options, including topical therapies, phototherapy, and systemic agents, there remains a need for alternative approaches that offer holistic benefits withoutsubstantial side effects. ⁽¹⁾

Historyand Epidemiology

Psoriasis has been recognized since ancient times, with varying prevalence acrossdifferentregionsandpopulations.Itsbimodal ageofonsetandfamilial predispositionsuggestageneticcomponent. Psoriasisaffects0.44%to2.8% of the Indian population, with significant variations across regions and demographics.Thechronicnatureofthediseaseoftenleadstopsychological distress, further compounded by visible lesions and associated stigma.⁽³⁾

Etiologyand Pathogenesis

Nooneknowstheexactcauseofpsoriasis. Variouspathogenetichypothesis have been propounded to explain the causation. However, till date, the

etiology is only partially understood. The disease is believed to be multifactorialwithbothgeneticandenvironmentalfactorsplayingaroleinits

development.Something sets off your immune system, causes inflammation thattriggersnewskincellstoformtooquickly,every3-4daysandbuild-upof old cells being replaced by new ones creates the scales.

Psoriasis, a chronic, relapsing disease, is thus characterized on the cellular level by hyperproliferation and abnormal differentiation of epidermal keratinocytes;lymphocyte infiltrationintotheepidermisconsistingmostlyofT- lymphocytes; and various endothelial vascular changes in the dermis, including angiogenesis, dilatation, and high-endothelial venule formation.

Psoriasisisclassifiedinto twotypes.

Type1psoriasis, whichhasapositivefamilyhistory,startsbeforeage40and is associated with HLA-Cw6

Type2psoriasisdoesnotshowafamilyhistory,presentsafterage40,and is

notassociatedwithHLA-Cw6^(1)(3)(4)

Commonpsoriasistriggersinclude:

·         EmotionalStress

·         Skininjury,suchasacut,scrapes,surgeryorbadsunburn

·         Infection,suchasstrep throat

·         Somemedications,includinglithium,prednisone,and hydroxychloroquine

·         Weather,especiallycold,dry weather

·         Tobacco

·         Alcohol(heavydrinking)⁽⁵⁾

AGEOFONSET,SEXRATIO&FAMILIALOCCURENCE

Psoriasis can present at any age yet bimodal age of onset has been recognized - first presentation usually noted at 15 to 20 years of age, while a second peak at 55 to 60 years. A higher prevalence in males has been reported.Theageatonsetofpsoriaticarthritis variesfrom35to50yearswith no sex predilection. ⁽¹⁾

CLINICALPRESENTATION

Most commonly, psoriasis presents as chronic, bilaterally symmetrical, well- defined,erythematous,dry,red,scalypapules,andplaques, commonlyover the scalp, and extensors of extremity, particularly over knees, elbows, and lumbosacral region.

Psoriasis can present with different morphology in the form of plaque, guttate, rupioid, erythrodermic, pustular, inverse and psoriatic arthritis. Variationinasiteisseenwiththeinvolvement ofthescalp,palmoplantar region, genitals, and nails.

CLINICALTYPES

[1]Plaquepsoriasis;Ittypicallypresentsaserythematousplaqueswith silvery scales most commonly over extensors of extremities; i.e. on the

elbows, knees, scalp, and back.It is the most common type of psoriasis which affects 85% to 90% of patients. On successive removal of psoriatic scalespinpointbleedingpointsareseen.ThisiscalledtheAuspitzsignwhich is used to confirm the diagnosis clinically.

[2]  Guttatepsoriasis :Itisalsocallederuptivepsoriasis,commonlyseenin children after an upper respiratory tract infection with the streptococcal organism. It presents with erythematous and scaly raindrop-shaped lesions mainly over the trunk and back. This type of psoriasis has best prognosis.

[3]  Pustular psoriasis : It presents with small non-infectious pus-filled lesions with erythema surrounding it either localized or generalized. Generalizedpustularpsoriasisisassociatedwithhypocalcemiaandpresents with sterile pustules on an erythematous plaque involving the whole body.

[4]  Erythrodermic psoriasis : It presents with widespread inflammation in theformoferythemaandexfoliationoftheskincoveringmorethan90%ofthe body area. It is associated with severe itching, swelling, and pain. It is the result of an exacerbation of unstable plaque psoriasis, mostly following the abrupt withdrawal of systemic steroids.

[5]  Inverse psoriasis : It is also called flexural psoriasis or intertriginous psoriasis. It appears as smooth, erythematous, and sharply demarcated patchesaffectingintertriginousareaslikegroins,armpits,interglutealregion, and inframammary region. The skin may be moist, macerated, and may contain fissures that may be malodorous, pruritic, or both.

[6]  Psoriatic arthritis : 30% of patients with skin and nail psoriasis may develop chronic painful inflammation of joints and connective tissues. It commonlyaffectsfingersandtoesleadingtosausage-shapedswellingknown as dactylitis. Psoriatic arthritis can also affect the knees, elbows, wrists, ankles, neck and spine, particularly the sacroiliac joint.^(1)(3)(4)

DIAGNOSIS

Usually, diagnosis is made by clinical morphology and site of lesions. Histopathologyisrarelynecessarybutmayhelp todifferentiatepsoriasisfrom another dermatosis if the diagnosis is not easy.

Characteristic changes in biopsy show parakeratosis, micro-abscess, the absenceofgranularlesions,regularelongationofridgesintheformofcamel foot appearance, andspongiformpustules ofKogoj with dilated and tortuous capillaries in the dermal papilla. ⁽⁶⁾

LABORATORY STUDIES

·         CBC,renal,andliverfunction tests

·         Rheumatoidfactor

·         ESRmaybeelevatedinerythrodermicandpustular psoriasis

·         Uric acidlevels are highinpsoriasis

·         Ifonlyhandandfeetareinvolved,obtainscrappingsforfungalstudies

·         Hepatitisserology

·         PPD(PurifiedProteinDerivative)⁽⁶⁾

DIFFERENTIALDIAGNOSIS

·         Discoideczema

·         Atopicdermatitis

·         Contactdermatitis

·         Seborrhoeicdermatitis

·         Pityriasisrosea

·         Bowen’sdisease

·         Superficialbasalcellcarcinoma

·         Mycosisfungoides

·         Dermatophytosis⁽⁴⁾

COMPLICATION

·         Secondaryinfections

·         Generalizedpustular psoriasis

·         Risk oflymphoma

·         Increasedrisk ofadversecardiacevents⁽⁶⁾

TREATMENT

Conventionaltreatmentsfocusonsymptomaticrelief,managementofflare ups and extensionof theremissionperiods providing topical &/or systemic treatments.

Topicaltreatmentscomeasointments,creams,solutionsorfoamandinclude:Steroid, salicylic acid, Calcipotriol, Roflumilast, Tapinarof, Tazorac,Immunomodulatoes,dithranol, Coal tar ointment and shampoo, vitamin D analog, retinoids etc. However sometimes they may initiate hypersensitivityreactions.

SystemicTherapyincludesPhototherapy,Acitretin,MethotrexateandBiologic therapy like Infliximab, ustekinumab, adalimumab, and etanercept.

Buttraditional systemic therapiesmayfailtoachieveanadequateresponseor not tolerated by patients having their own adverse effects, or are unsuitable owing to co-morbidities. Common side effects of Acitrecin includes mucocutaneous dryness, arthralgia, gastrointestinal upset, and photosensitivity whileMethotrexate hashepatotoxic effectresultingin nausea, vomiting, diarrhea, and fatigue Phototherapy is comparatively safe yet its limited availability of phototherapy centres and the need for frequent visits (3 times a week for 3 months initially) renders this option too extremely inconvenient for patients.

Finallychoiceoftherapydependsonclinical needs,benefitsandrisks,patient preferences, convenience and cost effectiveness.

DIET andotherREGIMENalsohavenotmuchspecificpositiveeffecton psoriasis but following measures may helps:

·         Takedaily bath

·         Usemoisturizer,Aloeveragel orfishoil

·         Covertheaffectedareasovernight

·         Exposetheskintosmallamountof sunlight

·         Avoidpsoriasis triggers

·         Eathealthydietandmaintainhealthybodyweight^(3)(6)(7)

HomeopathyinPsoriasis Management

As psoriasis is autoimmune disease of unclear etiology, it is believe that certain stressors will lead to uncertain inflammatory changes ended with excessiveturnoverofcells.Meansinternal disturbanceswillresultinevolution of disease which needs to be corrected to get cure. This is well justify with basic philosophy of Homoeopathy as master has guided us to treat individual (man) and not a disease. Homeopath aims to address that underlying disturbances/ stresses and offersa holistic approach for recovery without any adverse effect justifying superiority and more effectiveness of homoeopathyin the treatment of psoriasis.

HistoricalContextand Principles:

Homeopathy,foundedbyDr.SamuelHahnemann,isbasedontheprinciples of “like cures like” and “minimum dose.” While its mechanisms are often debated, its application in chronic conditions like psoriasis is supported by anecdotal evidence and patient-reported outcomes. Homeopathic remedies aim to stimulate the body’s intrinsic healing processes by addressing both physical symptoms and underlying emotional factors.

EvidenceSupportingHomeopathy:

Several studieshave explored the role of homeopathyin managing psoriasis, with varying degrees of success. A systematic review by Ernst (2011) highlighted mixed results, with some trials showing positive outcomes, while others were inconclusive due to methodological limitations. This underscores theneedforrigorous,well-designedstudiestovalidatehomeopathy’sefficacy in psoriasis management.

Remediescommonlyusedforthehomeopathictreatmentofpsoriasis

1.    Psorinum: Sebopsoriasis; Dirty, dingy skin with foetid discharge and crusts esp. in bends of joints & scalp, wants covering even in summer

2.    Sulphur:Dryhardscalyunhealthywrinkledskin;Itchingburning

worseonnight,scratching,heatandwashingwithaversiontobath

3.    Graphitis: Palmo-planter and nail psoriasis; Fatty, chilly and costive person; dry, rough skin; fissures and cracks; sticky, gelatinous, watery transparent exudation esp. in folds; nails thick, sore, brittle, crumbling and deformed.

4.    Petroleum: Psoriasis of hands: deep cracks at finger tip; thickened skin like parchment; itch violently; scratching ends in suppuration; thick, hard, yellowish, greenish crusts, esp. on occiput and genitals.

5.    Mezereum: Syphilitic psoriasis; intolerable itching with burning, like fire yet chilliness; eruption ulcerate and forms thick leathery crust under which pus exudes and bleeds on removal of scabs.

6.    Silicea: Psoriasis inveterate; Dry, cracked finger tip; itching only in daytime and evening; crippled nail

7.    Nat Mur: Greasy skin yet dry crusty eruptions in bend of limbs, margin of scalp, behind ears; worse at sea shore, eating salt

8.    Staphysagria: Psoriasis in children; after grief or suppressed emotion. Thick, dry scabs; itch violently as from vermin; scratches changing location of itching;

9.    Phytolacca: Psoriatic arthritis; Syphilitic psoriasis; painful and deformed joints; part become dry, shrunken, pale

10. Arsenic Album: Skin looks seared, dry like parchment, rough, scaly,dirty,shrivelied;itchingwithintenseburning;worsecoldand better warmth. ⁽⁸⁾

DermatologyLifeQualityIndex(DLQI) Development and Validation:

TheDermatologyLifeQualityIndex(DLQI)wasdevelopedbetween1990and

1994 by Andrew Y. Finlay and Gul Karim Khan at the University of Wales, College of Medicine, now known as Cardiff University. It was developed to provide a simple, yet comprehensive tool for assessing the impact of skin diseasesonqualityoflife.Itencompassesphysical symptoms,emotional well- being, anddaily functioning, makingitparticularlysuited for chronic conditions like psoriasis.

The DLQI has been widely adopted in dermatology research and clinical practiceduetoitsrobustvalidationacrossdiversepopulationsanditsabilityto capture both objective and subjective disease impacts. Studies have consistently shown that higher DLQI scores correlate with greater disease severity and lower quality of life. This tool’s sensitivity to changes over time makes it invaluable for monitoring treatment outcomes in longitudinal studies.

CritiqueoftheDLQI:

WhiletheDLQIiswidelyused,itisnotwithoutlimitations.Somecriticsargue that its generic nature may not fully capture disease-specific nuances, particularly in conditions like psoriasis that have complex psychosocial dimensions. Additionally, its reliance on patient self-reporting can introduce bias, particularly in populations with varying levels of health literacy.

Existing Gaps in Research IntegrationofHomeopathyandDLQI:

DespitetheDLQI’sextensiveuse,fewstudieshavespecificallyexaminedits

application in evaluating homeopathic treatments for psoriasis. This represents a significant gap in the literature, as understanding the impact of homeopathyonbothclinical symptomsandqualityoflifecanprovideamore holistic view of its efficacy.

NeedforRigorousMethodology:

Previous research on homeopathy often suffers from methodological weaknesses, such as small sample sizes, lack of control groups, and inconsistent follow-up periods. To address these gaps, future studies must adopt rigorousdesigns, including well-defined inclusion and exclusion criteria, standardizedoutcome measures,andlongerfollow-upperiodstocaptureboth immediate and sustained effects.

Conclusion

The current literature supports the potential role of homeopathy in psoriasis management, particularly when evaluated through comprehensive tools like theDLQI.However,theevidenceremainsinconclusiveduetomethodological limitationsandtheneedformorerobust,well-designedstudies.Thisproposal aims to bridge these gaps by systematically evaluating the utility of homeopathyinimprovingbothclinicaloutcomesandqualityoflifeinpsoriasis patients, using the DLQI as a primary assessment tool. This research will contribute to a more nuanced understanding of homeopathy’s role in chronic disease management and its potential integration into holistic patient care strategies. ^(10)(2)

6.3

OBJECTIVEOFTHESTUDY:

AIM

Toevaluatetheeffectivenessofhomoeopathictreatmentinpatientsof psoriasis as measured by the Dermatology Life Quality Index scale.

OBJECTIVE

·         TomeasureimprovementinqualityoflifeusingtheDLQIscale.

·         To assess the physical and psychological impact of psoriasis improvement through objective parameters like symptom severity and dailyactivities,andsubjectiveparameterssuchasemotionalwell-being and social interactions, using the DLQI scale.

·         Toanalyzetheimpactofhomeopathyonsymptomremissionand frequency of exacerbations.

7

MATERIAL&METHOD:

7.1

SOURCEOF DATA:

-Projectsite:C.D.PachchigarCollegeofHomoeopathicMedicineand Hospital, Surat – OPD

-PeripheralOPD

7.2

MATERIAL:

1.   StandardCaseFormatofC.D.PachchigarCollegeofHomoeopathic Medicine and Hospital, Surat – OPD

2.   Computerizedhomoeopathicsoftware.

3.   Consentformofpatient

4.   Books:variousbooksrelatedtoPracticeofmedicine,dermatology, HomoeopathicMateriamedica,Organonofmedicineandphilosophy.

7.3

METHODOFCOLLECTIONOFDATA:

Thestudywill beperformedinfollowing ways:

1.  Studydesign:experimentalstudy

2.  Studytype:Prospective study

3.  Studypopulation:PatientsdiagnosedwithPsoriasisandtreatedwith homoeopathic medicines at C.D.Pachchigar college of Homoeopathic Medicine and Hospital, Surat.

4.  Samplingtechniques:Simplerandomsampling

5.  SampleSize:30cases

6.  Selectioncriteria Inclusion Criteria:

·         Patientsofallgendersaged16yearsandabove,diagnosedwith psoriasis clinically or by a dermatologist.

·         Patientsirrespectiveofsocioeconomicconditionandreligionare included.

·         Patientswithnopriorsystemictreatmentforpsoriasiswithinthelast6 months.

·         Participantswhocanattendregularfollow-upvisitsevery4weeksfor9 months.

ExclusionCriteria:

·         Patientswithcriticalconditionssuchaserythrodermicpsoriasisor generalized pustular psoriasis (GPP).

·         Individualswithsevereuncontrolledsystemicillnesseslikediabetesor hypertension.

·         Patientsonimmunosuppressivetherapyorthosewithahistoryof malignancies.

Individualswhoareunableorunwillingtoadheretothestudyprotocol and follow-up schedule.

7.  StudyDurationand Follow-up:

Thestudywill beconductedoverdurationof9months,withfollow-upvisits scheduled every 4 weeks. Each follow-up will assess clinical symptoms, patient-reported outcomes via the DLQI scale, and any adverse events or changes in treatment protocols.

Regularfollow-upsareat4,8,12,16,20,24,28,32and36weeksoras required.

Thechosenfollow-upintervalsofevery4weeksovera9-monthperiodare optimal for several reasons:

1.    Psoriasis Disease Progression: Psoriasis is a chronic condition with periods of remission and exacerbation. Changes in symptoms often occurgraduallyoverweekstomonths.A4-weekintervalallowsenough time for noticeable changes in skin lesions, symptom severity, and patient adaptation to treatment to emerge, providing a clear picture of the treatment’s impact.

2.    Monitoring Treatment Efficacy: Homeopathic treatments, like many othertherapies,typicallytakeseveralweekstoshownoticeableeffects. Monthly follow-ups strike a balance between giving the treatment adequate time to work and ensuring that patient progress. This interval allows for timely adjustments to the treatment plan if necessary.

3.    Patient Compliance and Practicality: Monthly visits are convenient forpatients,reducingtheburdenoffrequentclinicvisitswhileensuring consistentmonitoring.Thisintervalhelpsmaintainpatientengagement and adherence to the study protocol, which is critical for obtaining reliable data.

4.    QualityofLifeAssessment: Changesinqualityoflife,asmeasured by the DLQI scale, often reflect both immediate and longer-term adaptations to treatment. A 4-week interval allows for capturing both short-term symptom relief and longer-term improvements in daily functioning and emotional well-being, providing a comprehensive assessment of the treatment’s impact.

5.    ConsistencywithClinicalPractice:Monthlyfollow-upvisitsare

consistent with standard clinical practices in dermatology and homeopathy.Thisfrequencyalignswithroutinecare,ensuringthatthe study’s findings are applicable and relevant to real-world clinical settings.

Theseintervalsaredesignedtobalancetheneedforthoroughdatacollection with the practicalities of patient care, ensuring that meaningful changes in psoriasis symptoms and qualityof life are effectively captured throughout the study duration.

8.  ASSESSMENTCRITERIA

The DLQI scale will be utilized to measure both objective parameters (e.g., symptomseverity,dailyactivityinterference)andsubjectiveparameters(e.g., emotional well-being, social engagement). Each patient’s responses will be recorded at baseline and during follow-up visits to monitor progress

BasedontheDLQIscale,thefollowingobjectiveandsubjectiveparameters will be used to assess improvement in psoriasis:

ObjectiveParameters:

1.     SymptomSeverity:

•   Reductioninitching,soreness,pain,orstingingoftheskin(Q1).

2.     DailyActivities:

•   Improvedabilitytoengageindailyactivitieslikeshoppingorhomecare without interference from skin condition (Q3).

3.     PhysicalActivity:

•   Enhancedcapacitytoparticipateinsportsorphysicalactivities (Q6).

4.     TreatmentBurden:

•   Decreasedimpactoftreatment-relatedinconveniences,suchastime consumption or messiness (Q10).

SubjectiveParameters:

1.     EmotionalWell-being:

•   Reducedembarrassmentorself-consciousnessrelatedtoskin condition (Q2).

2.    ClothingChoices:

•   Lessinfluenceofskinconditiononclothingdecisions(Q4).

3.     SocialandLeisure Activities:

•   Increasedparticipationinsocial andleisureactivitieswithoutrestriction (Q5).

4.     WorkorStudyInterference:

•   Fewerdisruptionstoworkorstudiescausedbytheskincondition(Q7).

5.     PersonalRelationships:

•   Improvedrelationshipswithpartners,friends,orrelatives,with less impact from the skin condition (Q8).

6.     SexualHealth:

•   Fewersexualdifficultiesassociatedwithskincondition (Q9).

Theseparameterswillcollectivelyofferacomprehensiveassessmentofboth the physical and psychological impact of psoriasis, helping to gauge overall improvement in the patient’s quality of life. ⁽²⁾

SignificantImprovement:

Low DLQI scores. A significant improvement in psoriasis management is indicated by a substantial decrease in the DLQI score from baseline. This reflectsamarkedreductioninthenegativeimpactofpsoriasisonthepatient’s quality of life. Specifically:

·         DLQI Score Reduction: A decrease of 5 points or more fromthe baselinescoreisgenerallyconsideredameaningfulimprovement, indicating that the patient experiences fewer symptoms, less interferenceindailyactivities, andimproved emotional well-being.

Non-Improvement:

High DLQI scores. Non-improvement is indicated by minimal or no change in theDLQIscoresoverthecourseofthestudy.Thissuggeststhatthepsoriasis condition continues to significantly affect the patient’s quality of life.

Specifically:

·         DLQI Score Stability or Increase: A change of fewer than 2 points or anincreaseintheDLQI scoreindicatesthatthetreatmenthashadlittle to no positive impact or the patient’s condition may have worsened.

Thesethresholdshelptoobjectivelyassesstheeffectivenessofhomeopathic treatment in improving the overall quality of life for psoriasis patients.⁽²⁾

7.4

DOES THE STUDY REQUIRING ANY INVESTIGATION TO BE CONDUCTEDONPATIENTSOR OTHERHUMANSORANIMALS:

Aspertherequirementofacase

7.5

HAS ETHICAL CLEARANCE BEENOBTAINEDFROMYOUR INSTITUTE?

 Yes

8

REFERANCES:

Bibliography

9

APPENDIX

Theappendixwill providethecompleteDLQIscale,illustratingthespecific parameters assessed, including symptom severity, emotional impact, and daily activity interference.

DermatologyLifeQualityIndex (DLQI)

TheDLQIconsistsof10questions,eachscoredonascaleof0to3:

•          0=Notatall/Notrelevant

•          1= Alittle

•          2= Alot

•          3=Verymuch

Questions:

1.  Overthelastweek,howitchy,sore,painful,orstinginghasyour skin been?

2.  Overthelastweek,howembarrassedorself-conscioushaveyoubeen because of your skin?

3.  Overthelastweek,howmuchhasyourskininterferedwithyougoing shopping or looking after your home/garden?

4.  Overthelastweek,howmuch hasyourskininfluencedtheclothesyou wear?

5.  Overthelastweek,howmuchhasyourskinaffectedanysocial or leisure activities?

6.  Overthelastweek,howmuchhasyourskinmadeitdifficultforyouto do any sport?

7.  Overthelastweek,hasyourskinpreventedyoufromworkingor studying?

8.  Overthelastweek,howmuchhasyourskincreatedproblemswith your partner or any of your close friends or relatives?

9.  Overthelastweek,howmuchhasyourskincausedsexual difficulties?

10.  Overthelastweek,howmuchofaproblemhasthetreatmentforyour skin been (e.g., by making your home messy, or by taking up time)?

Scoring:

•          0–1:Noeffectatallonpatient’slife

•          2–5:Smalleffectonpatient’slife

•          6–10:Moderateeffectonpatient’slife

•          11–20:Verylargeeffectonpatient’slife

•          21–30:Extremelylargeeffectonpatient’slife⁽²⁾