Evaluation of efficacy of Marhame Ahmar in the treatment of haemorrhoids: Randomized placebo controlled double blind study

Transcription

1 International Journal of dvances in Health Sciences (IJHS) ISSN 49-7 Vol, Issue, 6, pp Research rticle Evaluation of efficacy of Marhame hmar in the treatment of haemorrhoids: Randomized placebo controlled double blind study Rashid Qazi, Jaleel hmed, yesha Fatema, Mohammed Yasir 4, Mussarat 5 and Kbar Khan 6.ssociate professor & HoD mraze in, UznnfHalaq, DR MIJ Tibbia Unani Medical College, Versova, Mumbai, India.. ssociate professor& HOD, Department of Kulliyat, Z.V.M. Unani Medical College & Hospital, zam Campus, Camp, Pune.. ssociate professor& HOD, Department of Moalijat, Z.V.M. Unani Medical College & Hospital, zam Campus, Camp, Pune. 4. Research ssociate at Regional Research Institute of Unani Medicine, Mumbai, India (corresponding author)dr.md.yasir@gmail.com 5. Professor Deaprtment of Jarahat, Unani Medical College Gulbarga. 6. Unani Medical officer, NRHM, up Zillah rognalay, Umarga, Dist. Usmanabad. STRCT Introduction: Haemorrhoid is one of the commonestdisease affecting five percent of general population and are vascular and connective tissue cushions that exist in three columns in the anal canal. lthough advanced cases need surgery and outpatient procedures, mild cases having gad I & II got relief with conservative treatments including stool softener, local ointments, sitz bath and diet therapy. Unani system of medicine has treasure of remedies (oral and local) to treat the haemorrhoids.. Our emphasis was to study scientifically the local antihaemorrhoidal efficacy of the compound formulary ointment Marahame hmar mentioned in one of the authentic Unani pharmacopoeia QrabadeenKabeer with reference to Hippocrates. Materials and Methods:This placebo controlled double blind studywas conducted on 6 patients (both sexes) between the ages -5 years of st and early nd degree uncomplicated internal haemorrhoids. Group or test group received Marhamehmar, a Unani formulation for local application, whereas group or placebo group administrated matching placebo locally in the form of ointment. Total duration of study was 45 days. Findings of all patients in each group were recorded on baseline, 5 th day, th day and 45 th day of treatment. The patients were randomly divided into two groups of patients each.the data so obtained were subjected to computerized statistical analysis using Kruskal Wallis test. Results:the test drug is found highly significant (p<.) while the placebo did not produce any change in the parameters. leeding per rectum in test group was reduced significantly, since initial period of study and haemoglobin level also improved. Size of pile masses was decreased remarkably and till the end of the study they disappeared in majority of cases. Conclusion:The present study shows that the test preparation Marhamhmar is very useful in grade I and early grade II haemorrhoids. Keywords: Unani Medicine; Hemorrhoids; Marhamehmar; Hippocrates, INTRODUCTION: Haemorrhoid is one of the oldest and commonest afflictions have been recognized since ancient times. The disease has universal distribution. Perhaps five percent of general

2 population suffers from haemorroidal symptoms but fifty percent of people aged fifty years or older have haemorrhoids to some extent. Male are more commonly afflicted than female.() Peak age ranges from years. The term Haemorrhoids is a Greek word (Haem=lood; Rhoos=Flow) which means flow of blood per rectum one of the main features of the condition. The word Piles comes from Latin (Pila=all) and describes the anal swelling. ()Haemorrhoids are engorgement of the haemorrhoidal venous plexuses with redundancy of their coverings. ccording to the Father of Medicine Hippocrates, Piles are the masses of vascular tissue of the internal mucous membrane of rectum, up to one to two carats, in which these veins becomes dilated and engorged, just like varicose veins of leg. ()bulqasim l-zohravi (96- D) the pioneer of surgery, described this topic in detail in his popular text t Tasreef Liman jizanittaleef. Ibn l Qaf(-86 D) the author of one of the authentic Unani book of surgery KitabulUmdah Fil Jarahat recommended three surgical procedures for treatment of haemorrhoids including Khazm (transfixation), Shuz (ligation), and Qata (excision). Hemorrhoids are vascular and connective tissue cushions that exist in three columns in the anal canal: right anterolateral, right posterolateral, and left lateral. Internal hemorrhoids are located above the dentate line and thus covered with mucosa. These may bleed and prolapse, but they do not cause pain. External hemorrhoids are below the dentate line and covered with anoderm. These do not bleed but may thrombose, which causes pain and itching, and secondary scarring may lead to skin tag formation. Heredity, erect posture, portal hypertension, hard stools, excessive straining, increased abdominal pressure e.g. in pregnancy, and prolonged lack of support to the pelvic floor all contribute to the abnormal enlargement of hemorrhoidal tissue. Vascular cushion in the three typical locations are uniformly present in human anatomy, and it is only when these tissue become abnormally enlarged that the condition of haemorrhoids is said to be present. number of theories had been proposed regarding pathophysiology of haemorrhoids. The most common explanation is abnormalhydro static pressure (pressure from the blood under the force of gravity). natomically the superior haemorrhoidal veins are unsupported in very loose submucous connective tissue of ano rectum. These veins pass through muscular tissue and are liable to be constricted by its contraction during defecation. The anoraetal veins and veins above them in the gastro intestinal tract do not have any valves, which mean the pressure in the vein can raise and possibly push through the walls at weakest point. The same problem occurs with varicose veins in the legs; hence haemorrhoidsare commonly called as varicose veins of the anus. In pregnancy weakness arising from the influence of progesterone on smooth muscle and elastic tissue may be the predisposing factor of haemorrhoids, though an increase in pelvic vascularity may contribute. (4) Clinically the disease is characterized by bleeding, prolapse of mass, pain and discomfort in the anal region.() leeding is common and early complaint in the disease. It is usually bright red, painless and occurring particularly after passing of a non-blood stained hard stool (splash-in-pan).in beginning, protrusion of a mass through the anus is slight, occurs only at defecation and reduction is spontaneous. s the time goes on the haemorrhoids do not reduce requiring digital reduction and later in advance stages of disease it become irreducible. In the permanently prolapsed piles a constant mucous discharge with or without blood staining is seen, causing soiling of underwear, pruritus and sometime perianal excoriation. There may be slight discomfort in permanently prolapsed piles. Real and mind riveting pain can be seen because of complications like strangulation or infection etc. or due to condition that co-exist with piles. lthough advanced cases need surgery and outpatient procedures, mild cases having grade I & II got relief with conservative treatments including stool softener, local ointments, sitz bath and diet therapy. Unani system of medicine has treasure of remedies (oral and local) to treat Mohammed Yasir, et al. 7

3 the haemorrhoids. Local medications have advantages like self administration, no need of medical supervision, feasibility in pregnancy and suitable in those unfit for surgery. Topical therapies for the treatment of haemorrhoids are; bzan (sitz bath), Marham (ointment), Hamool (Suppository, pessary), Zimad andlatookh (Paste, andage), Zaroor (Dusting Powder), and ukhoor (fumigation) etc. Marham (Local ointment) can easily be introduced into the rectum using a collapsible tube fitted with a nozzle. There are combinations of topical Unani anesthetics and analgesics mixed with astringents, anti-inflammatory agents and vasoconstrictors. Our emphasis was to study scientifically the local anti-haemorrhoidal efficacy of the compound formulary ointment Marahamehmar mentioned in one of the authentic Unani pharmacopoeia QarabadeenKabeer with reference to Hippocrates. MTERILS ND METHODS: This placebo controlled double blind study was conducted on 6 patients (both sexes) between the ages -5 years of st and early nd degree uncomplicated internal haemorrhoids fromthe outpatient Dept. of Surgery (Jaharat) Haji.R. Table no.(ingredients of Marhamehmar) KalsekarTibbia Hospital Yari, Versova, ndheri (w) Mumbai. written informed consent was obtained from all patients. Patients of rd and 4th degree haemorrhoids, complicated cases of haemorrhoids, patients receiving concurrent drug therapy or having systemic diseases were excluded from this study.the patients were randomly divided into two groups of patients each. The research drug Marhamehmar is a compound formulation (ingredients are given in Table No.)mentioned in one of the authentic Unani pharmacopeia QarabadeenKabeer.(5) The author described that this Marhamehmar was formulated by father of medicine Hippocrates and is very much effective for awaseer (haemorrhoid), as it controls bleeding, decreases discomforts, givessoothing effects to the patient and on continuous long term application shrinks the pile masses and gradually removes them out. Due to unavailability of Zift-e-Roomi it is replaced by equal quantity of Mom Safed.(6) ll the ingredients were purchased from local market and ointment was prepared as per standard guideline in pharmacy of Dr. M.I. JamkhanawalaTibbia Unani Medical College under supervision of expert Unani pharmacist. Sr. No. Drugs Scientific Name Form Used Quantity. SafedaKashghari Zinc oxide Powder 5gm.. nzaroot stragalus Sarcocolla Powder 4gm.. Damulkhwain Dracaena Cinnabari Powder 7.5gm. 4. Murdarsang Lead oxide Powder 5gm. 5. Sindur Read lead Powder 7.5gm. 6. Zaitoon Olea europaea Fixed Oil 48gm. 7. Mom Safed White wax Wax gm. Group or test group received Marhamehmar, a Unani formulation for local application, whereas group or placebo group administrated matching placebo locally in the form of ointment.total duration of study was 45 days. Findings of all patients in each group were recorded on the same pattern on baseline, 5 th day, th day and 45 th day of treatment. The parameters of study were bleeding per rectum, number of pile masses, size of pile masses and haemoglobin percentage. For statistical analysis they were given scores as shown in Table no.. Table no. Findings leeding per rectum Score No bleeding (bleeding absent) Mild bleeding (few drops: 5- drops) Mohammed Yasir, et al. 74

4 Moderate bleeding (- drops) Sever bleeding (- drops) Massive bleeding 4 No pile mass (pile mass absent) One pile mass Number of Pile Masses Two pile masses Three pile masses More than three pile masses 4 Pile mass absent Size of Pile Masses Small pile mass Medium pile mass ig pile mass bove gm % >- gm % Haemoglobin Percentage (Hb %) >8- gm % 6-8 gm % Hb less than 6 gm% 4 Findings of all patients in each follow up were recorded as per above mentioned scoring of parameters. The data so obtained were subjected to computerized statistical analysis using Kruskal Wallis non parametric test through website The details are given in the result section. OSERVTIONS ND RESULTS: Patients in both groups were comparable in respect to age, sex, weight and the type of clinical symptoms. Maximum number of patients was in the age range -4 years. There were Male and 8 female patients, randomly divided in and groups. The mean age of patients of group was 8.6, and group was 8.. The mean weight in kg of group was 6.6 and group was 6.9. The number of non-vegetarian patients was and 4 times more than vegetarians in groups and respectively. We observed 46% and 5% of total patients having positive family history of haemorrhoids in group and respectively. Figure No. Graph: of leeding P/ R.5.5 Figure No. Grap: - No. of Pile Masses.5.5 Mohammed Yasir, et al. 75

5 Figure No. Graph: - Size of Pile Masses.5.5 Figure No. 4 Graph: - Hb%.5.5 Figure No. 5 Graph: - Total leeding per rectum in test group was reduced significantly, since initial period of study and haemoglobin level also improved.size of pile masses was decreased remarkably and till the end of the study they disappeared in majority of cases. No adverse effect was noted to any patient during complete trial. The data are subjected to Kruskal Wallis test and the test drug is found highly significant (p<.) while the placebo did not produce any change in the parameters. The result is shown in Table No.. Table No. Effect of drug on hemorrhoid (N=) leeding Per Parameters Rectum No. of pile masses Size of pile masses Hb % Total Score Test Placebo Test Placebo Test Placebo Test Placebo Test Placebo P value < <..955 <..955 <..954 <..744 H DISCUSSION: There were no significant differences in both (test and placebo) groups before starting treatment but right from first up till completion of study the data showed significant difference in test group, as marked clinical improvement Mohammed Yasir, et al. 76

6 was noted. The first parameter of study was bleeding per rectum. The mean of bleeding per rectum in group (test group), before starting treatment was.6; on first F.U. it was dropped to.; on second F.U to.5 and by the time of completion of trial it became.6. This descending graph of bleeding per rectum in test group shows that Marhame hmar has significant property to control bleeding. This may be because of its ingredients: Dammul- khwain(dracaena cinnabari) is a potent haemostatic agent. Safedakashghari (Zincioxidum) and Sindur (Red oxide) having good haemostatic and astringent properties and Murdarsang(Lead oxide) is a powerful astringent and cooling agent. ll the above ingredients are strongly recommended by many eminent Unani physicians for local treatment of haemorrhoids. In group (placebo group) the pretreatment mean of bleeding per rectum was.7; on st F.U. was.5; on nd F.U. was.4 and at the end of the treatment (on rd FU) it was.6. It reveals the non effectiveness of placebo in respect to bleeding per rectum. The second parameter of study wasnumber of pile masses.pre treatment mean of number of pile masses in group was.46. On first F.U. it was reduced to.4; on II F.U. it was.86 and by the end of treatment it came on.7. This gradual but significant reduction in the number of pile masses indicates the effectiveness of our test drug, as reported by author of Qarabadeen Kabeer, Hakim HadiHusain Khan, on its (Marhamehmar s) continuous use pile masses shrinks and gradually disappears.(5) In group pre treatment mean of number of pile masses was.4 till the end of first F.U. there was no significant change in the same but on rd F.U. it became.5. This data reveals that there were no significant variations in group before and after treatment in respect to number of pile masses. The third parameter was size of pile masses. The mean of size of pile masses before starting treatment in group was.5. On st F.U. it was decreased by.46 on nd F.U. by. and on rd F.U. means at the end of treatment it became.5 only. The sharply descending graphs of size of pile masses indicate that test drug decreases the size of pile masses and shrinks them. This may be because of its ingredients having potent astringent and desiccant properties including Dammul-khawain, Murdarsang and Safedakashghari. In group pre treatment mean of size and pile masses was.5. On st F.U. was.6, on nd FU was.5 and at the end of the trial it was again.6. It shows that there is no significant change in above reading in placebo group. The fourth parameter was Hb%. Chronic blood loss results in marked iron deficiency anaemia in haemorrhoids patients and in chronic cases even it may lead to high output cardiac failure.() Improvement in Hb% by controlling blood loss was our important target. The data shows encouraging results. In group mean of Hb% before treatment was.6. On st F.U. it was.6, on nd F.U. and at the end of treatment it became O.46.This data reveals marked improvement in haemoglobin level.in group pretreatment mean of Hb% was.56. On st FU.6, on nd FU.5 and on rd FU it was.66. These readings indicate there is no improvement in Hb% placebo group. CONCLUSION: The present study significantly corroborates Unani claim, that the test preparation Marhame hmar is very useful and safe in grade I and grade II haemorrhoids. It is suggested that further large scale standard controlled trials must be undertaken to establish our findings. CKNOWLEDGEMENT: Dr. Rashid Qazi was involved in whole research process, patients enrollment, intervention and data recording. Dr. M. Yasir was involved in data analysis and manuscript writing. njuman- I-Islam s Kalsekar Hospital has sponsored the medicines. ILIOGRPHY:. Schrock TR. enign and Malignant Disease of the norectum in Gastrointestinal Surgery Fromm D, editor. New York: Churchill Livingstone; Williams NS. ailey and Love s Short Practice of Surgery. In Russell RCG, Mohammed Yasir, et al. 77

7 Williams NS, Christoph JK, editors. The nus and nal canal. London;. p Tabri M. l Mualijatuluqratiya. st ed. New Delhi: Central Council for Research in Unani Medicine; Thomson WH. Haemorrhoids or Piles in Oxford Text ook of Surgery. In Wood, Morris PJ, C. W, editors. Oxford Text ook of Surgery. New York: Oxford University Press;. p Khan MH. QarabadeenKabeer Lucknow: Munshi Naval Kishore; Rampuri NG. Khazainuldvia New Delhi: IdaraKitabushShifa. Mohammed Yasir, et al. 78