CLINICAL TRIAL OF IN TREATMENT OF HUMAN FASClOLlASlS IN EZBET EL-BAKLY (TAMYIA CENTER) AL-FAYOUM GOVERNORATE

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1 Journal of the Egyptian Society of Parasitology, Vol. 34, No. 3, Decetnber 2004 J. Egypt. Soc. Parasitol., 34 (3), 2004: CLINICAL TRIAL OF IN TREATMENT OF HUMAN FASClOLlASlS IN EZBET EL-BAKLY (TAMYIA CENTER) AL-FAYOUM GOVERNORATE BY AHMED A. ABO-MADYAN', TOSSON A. MORSY* SAAD M. MOTAWEA~ AND AYMAN T.A. MORSY~ Departments of Tropical ~edicine', ~arasitology*, and Community ~edicine~, Faculties of Medicine, Cairo University, ~airo', Ain Shams University, Cairo 11566~, and Mansoura university3, Mansoura, and The Ministry of the Interior ~os~itals~, Egypt. Abstract A field survey was done in Ezbet El-Bakly, Al-Fayoum Governorate, Egypt to assess the efficacy and safety of ~irazid@ in the treatment of human fascioliasis. Among 1019 individuals examined for parasitosis, the prevalence of fascioliasis was 1.7% and the geometric mean egg count (GMEC) was 33.2 eggslgram stools. About 23.5% of the fascioliasis patients were asymptomatic. The most frequent symptoms were abdol-ninal dis\tension and flatulence (76.5%), right hypochondria1 pain (17.6%) and epigastric pain (17.6%). The most prevalent signs were pallor (52.9%,), tender right hypochondrium (23.5%) and tinge of jaundice ( 17.6%). All cases were treated by ~irazid@ as two capsules (600mg) on an empty stomach an hour before breakfast for six consecutive days and followed up clinically and parasitologically. The parasitological cure rate, 'two and three months after treatment was 88.2% and 94.1% with an overt clinical cure without any side-effects. The cases not completely responding to a single course of treatment showed a marked reduction of the egg intensity. It was concluded that ~irazid@ (or Myrrh extract of Conznziphoru molnlol) is safe and effective in the treatment of human fascioliasis under the field conditions.

2 introduction Fascioliasis is an important worldwide zoonolic parasite. It has a worldwide distribution in a large variety of grass-grazing animals as sheep, goats, cattle, buffaloes, camels, horses, donkeys and rabbits (Haridy et ul., 2002). In Egypt, Fcr.rciola eggs have been detected in a mummy, confirming that human fascioliasis has existed since Ancient Egypt time. In 1928 two cases were reported, eleven cases in 1958 and lastly nine cases in The first few confirmed cases were diagnosed in 1 978, by tracing their place of origin, in Abis village (Alexandria G.) which was declared as an endemic area (Farag et al., 1979). Nowadays, fascioliasis proved to be an increasing zoonosis (Haridy el ul., 1999). Different laboratories and clinical service centers have diagnosed human fascioliasis in all governorates of the Nile Delta and in some ones in Upper Egypt. Fascioliasis causes sel-ious hepatic pathological sequences that add to the already known threats to the liver of the Egyptian population (Hasseb et al., 2002). The population at risk in Egypt is considered to be 27 million. Accordingly based on an estimated overall prevalence of 3% the number of infected cases amounts to (WHO, 1995). In Egypt, the presence of diffel-ent animal reservoirs and the snail intermediate host(s) together with dietary habits of eating raw vegetables and salads car]-y the risk of this emerging liver trematode (Farag, 1998). Clinically the disease occurs in acute and chronic phases with complications particularly in children (Haseeb et ul., 2003). Ragab and Farag (1978) reported that the major complications of the disease were bleeding, biliary cirrhosis and ectopic lesions. El-Sefi et al. (1994) reported several hepato-biliary complications of human fascioliasis as re-current attacks of cholecystitis, gall bladder perforation, obstructive jaundice. biliary lithiasis choledochitis and periductal fibrosis, cholangitis segmental bile duct stricture and hepatic granulomas with abscess(~) formation among Egyptian patients. Most of the drug regimens used in fascioliasis tl-eatment were either ineffective or unsafe, toxic, with many side effects and contra-indications. Emetine and Dehydro-emetine cause some degrees of toxic manifestations involving the heart, liver and digestive tract, also

3 hexachloropara-xylol (Hetol) induces the gastrointestinal Lrpset and dizziness (Chen and Mott, 1990). Metronidazole and Albendazole are not effective in different doses (Nik-Akhtar and ~a'bubi, 1977). Niclofolan is not recommended because of its toxicity as being teratogenic and embryogenic in small animals as rats (Echardt and Hekers, 1981). Triclabendazole, besides being a veterinary drug, resistance of Fascioln helmticr~ was reported by several authors (Overend and Bowen, 1995; Mitchell er nl., 1998; Thomas et al., 2000; Coles et nl., 2000; Moll et nl., 2000; Robinson et ril., Mirazid (combination from oleo-resin extract from Coninli- phor~l imolnzol, Family: Burseraceae, Kunth) is one of the oldest known medicinal plants and was widely used by the Ancient Egyptians (Chevallier, 1996) and Arabia (Migahid, 1996). The wild medicinal plant or C. nzoln~ol is a shrub or small tree having its leaves crowded at end of short lateral branches. Leaves small fasciculate, simple or 3-5 foliate. Flowers polygamous and clustered. Calyx 4 toothed, persistent; petals 4 or sometimes 3 erect; stamens 8. Fruit a glabrous pointed drupe, splitting irregularly at maturity into 2-6 valves, exposing mesocarpic pulp surrounding endocarpic pulp one seeded nut (Migahid, 1996). It has probed to possess high therapeutic efficacy in treatment of schistosomiasis nzansoni and haenzatohi~an infection (Massoud et al., 1989; 1996; 1998; 1999,: 199gb: 1999,; El Baz et crl., 2003, Soliman et al., 2004). In the previous study by Abo-Madyan et (11. (2004) in Ezbet El Bakly (Tamyia Center), Al-Fayoum Governorate, they reported the safe and successful use of ~irazid@ in treatment of human schistosomiasis (I~crenlutobiiiiiz and i7zaizsorzi). Consecluently, this field work aimed at the evaluation of the efficacy of ~irazid@ (Myrrh or in Arabic "Mecca Mur") in the treatment of proven fascioliasis patients on the parasitological and clinical bases. Subjects, Materials and Methodology This study was conducted at a small village, Ezbet El-Bakly (Markaz Tamiya), Al-Fayoum Governorate, about 100 Km south of Cairo and about 10 Km from the traffic center of Kom-

4 Aushim at the main road of Cairo-Fayoum. It is located eastward and after Ezbet Binwah. All the cases agreed to participate in this field trial. The attendants (1019) of the treating campaign were screened by stool analysis using sedimentation and Kato-Katz techniques (Katz et al., 1972). Besides, thorough clinical examination, full history taking and a Medical sheet was filled-out on all the fascioliasis patients, who were treated by ~irazid~ as two capsules (600mg) an hour before breakfast for six consecutive days. Follow up study (two and three 1nontl.1~ after treatment) was done clinically as well as parasitologically by Kato-Katz method, where at least three slides from each patient were peer examined for quality assurance). Any new sign or symptom was considered as a side effect. Data entry, processing and statistical analysis was carried out using Epi info Chi squared and Fisher exact tests of' significance were used to compare between different groups p values less than 0.05 (5%) were considered to be statistically significant. Results The results are shown in tables (I to 8) and figures ( I). Table 1 : Fascioliasis among attendants ( 101 9). Parasite Fusciola giganticu No 17 Prevalence O/c 1.7 Table 2: Infection intensity by Kato-Katz (eggsfgram) of fascioliasis cases before treatment by range, mean, standard deviation (SD), standard error of mean (SEM) and geometric mean (GM). Hcl~ninthes Fusciolrr Cases No I Range I Mean I SD I SEM I G.M / 72.6

5 Table 3: Clinical presentation of fascioliasis before treatment. I Clinical presentation I No. J 1 Symptoms: Asy~nptornatic Right hypocliondrial pain Epigastric pain Abdo~i~inal distension & flatulence Signs: Pallor Tingc of jaundice Tender right hypochondriunl Hcpato~i~egaly Table 4: Fascioliasis according to socio-demographic characters. I Variable No. Percent I Age: <I Sex: Male Female Education: Illiterate 1 9 I 52.9 Read & write I Basic formal High school Occupation: Housewife Farmer 35.2 Student Table 5: Fascioliasis according to intensity of infection by Kato-Katz rcchnique before treatment. I I Intensity of infection (EggIlOnil) / No. Percent 1 Light (1-100) Modera~e ( I l I -400) Heavy (>400)

6 Table 6: Clinic;ll presentations of 17 fascioliasis before alli! three months after treatment (TTT). Clinical presentation Right hypochondrial pain Epigastric pain Abdolninal distension & llatulcnce Pallor Tinge of jaundice Tender right hypochondrium O.S= Obvious significance Before TTT Post 'TTT No % No 5% Significance 'Test 0.S ;c2 = 1.2. P>O.Os ~2 = P< S ;c2 = I.I, P>O.OS O.S Fig. I : Children at risk of parasitic infection in Ezbet El-Bakly. 812

7 Table 7: Parasitological cure rate of fascioliasis two and three 0. months after Mirazid tleatment. I Cases Cure rate before Af'ter 2 months After 3 months TTT + ve cases / % of cure + ve cases % of cure 17 'I,. 88.2% I 94.1% Table (8): Reduction in intensity of fascioliasis infection still positive two and three months after treatment. Follow-up after 'ITT 2 months 3 rnonllis Positive No. 3 1 Jl~lensity (egglgra~n) (X+SD) Prc-TIT Post-ITT 21 6k33.9 l2? k22.9 (,+I2 I-lcst. p-value 1=8.3,p<0.05 1=1 l.x,p<o.os Discussion In the present work, the overall prevalence of Fci.vciolti sp. atnong attendants of the treating campaign in thc village was 1.7% with a mean intensity ol' 91.8k63.1 egglgt-am siooi. However, this was not a true prevalence in the study region that can not be compared with other prevalence studies in Egypi where higher prevalence rates were reported by other authors in other localities. Most of the fascioliasis cases were <Isyears (47.1%), females (52.9%), housewives (41.2%) and illitcrates (-52.9%). This is in agreement with El-Sahn et nl. (1995); Farag (1998) and Esteban et 111. (2003) who reported that fascioliasis affects particularly inhabitants of rural areas and that the ik~nales are Inore infected than males. In the present work, about 23.5% of fascioliasis patients wcre asymptomatic in agreement with Motawea et (11. (2001). Merino et (11. (1998) reported that most of the human infections arc asylnpto~natic or with unspecific self limited abdominal symptoms making the diagnosis difficult. The clinical diagnosis is often difficult hecause the presentations are not markectly different from the hepatobiliary diseases of other causes. Fever, hepatoniegaly and high eosinophilia are very suggestive of

8 fascioliasis particularly if accompanied by urticaria. In more chronic cases, painful hepatomegaly, obstructive jaundice, anaemia, neutrophilia and eosinophilia to 60% (Plourde and Keystone, 1994; Haseeb et ul., 2003). The commonest symptoms, in this work were abdominal distension and flatulence (76.5%), right hypochondrial pain (17.6%) and epigastric pain (17.6%). The comnionest signs were pallor, tender right hypochontlrium and tinge of jaundice among 52.9%, 23.5% and 17.6% respectively. Clinical well-being is the criteria of drug efficacy (El-Karaksy et nl., 1999). In the present work, after MirazidB treatment, there was a complete clinical improvement as regards right hypochondrial pain andlor tenderness and pallor, as well as significant clinical improvement of abdominal distension and flatulence, epigastric pain and tinge of jaundice. Parasitological cure rate was 88.2% & 94.1%, two and three months after treatment. Similar results of high cure rate of ~irazid" on human fascioliasis were reported by El-Gohary er czl. ('1999): Motawea et al. (2001); Massoud et al. (2001); Hegab and Hassan (2003); Hassan et crl. (2004) and Soliman et al. (2004). Besides, Haridy et al. (2003) reported 100% cure rate in fascioliasis infected sheep. Apart from Misazido in fascioliasis in man & animals and human schistosomiasis (hnenzertol~iiim and mcrn.soni), ~ irazid~ has been successfully used in treatment of Dicrocoelicinz clendriticunz in man and animals in Egypt (Massoud et nl., 2003) and in Saudi Arabia (Al Mathal and Fouad, 2004). ~irazid@ proved safe and successful in treatment of sheep infected with Morziezia exparzsa (Hasidy et ul., 2004). In the present study, there was marked reduction in intensity of Fasciolei infection with a statistical significant difference. This is of utmost public health importance as it decreases the transmission of the disease in the community. In conclusion, ~irazid@ proved to be a safe and effective human fasciolicidal drug under field conditions. References Abo-Madyan, A.A.; Morsy, T.A. and Motawea, S.M. (2004): Efficacy of Mirazid in the treatment of schistosomiasis (haemat-

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10 with schistnsomiasis in villages in the Nile Delta of Egypt. Am. J. Trop. Med. Hyg., 69(4): Migahid, A.M. (1996): Flora of Saudi Arabia. Vol. 1, 4''' Ed. University Libraries, King Saud University Press. Farag, H.F. (1998): Human Fascioliasis in some countries 01. the Eastern Mediterranean Region. East. Mediterranean HI th. J.. 4 ( I): Farag H.F.; Barakat, R.M.: Kagab, PI. and Omar, E. (1979): A focus on human fascioliasis in the Nile Delta, Egypt..I. Trop. Med. Hyg., 82: Gaballah, M.; El-Gilany, Motawea, S. and El,-Shazly, A.M. (2001): Control of schistosomiasis a rural using a new safe effecttive Herbal treatment. J. Environ. Sci., 2 l(5): Hall, R.L. and Oser, B.L. (1965): Recent progress in the consideration of flavouring in-gradients under food additives arnendment. 3. GRASS substances. Food Technol., 19 (2): 15 I Haridy, F.M.; Ibrahim, B.B.; Morsy, T.A.; El Sharkawy, I. M.A. (1999): Fascioliasis an increasing zoonotic disease in Egypt. J. Egypt. Soc. Parasitol., 29(1): Haridy, F.M.; Morsy, T.A.; Gawish, N.I.; Antonios, S.N. and Abd-el Gawad, A.E. (2002): The potential role of donkeys and horses in zoonotic fascioliasis in Gharbia Governorate. Egypt..T. Egypt. Soc. Parasitol., 32(2): Haridy, F.M.; El Garhy, M.F. and Morsy, T.A. (2003): Efficacy of mirazid (Coiiziiziplzo~+~~ i~zolnzol) against fasciol iasis in Egyptian sheep. J. Egypt. Soc. Parasitol., 33(3): Haridy, F.M.; Dawoud, H.A. and Morsy, T.A. (2004): Efficacy of Cowtrniplznrn n~olmol (~irazid') against sheep naturally infected with lnonieziasis expulwa in AI-Santa Center. Gharbia governorate, Egypt. J. Egypt. Soc. Parasitol., 34(3): Haseeb, A.N.; El-Shazly, A.M.; Arafa, M.A. and Morsy, A.T.A. (2002): A review on fascioliasis in Egypt. J. Egypt. Soc. Parasitol., 32(1): Haseeb, A.N.; El-Shazly, A.M.; Arafa, M.A. and Morsy, A. T.A. (2003): Clinical, laboratory and ultl-asonography fee '1 t uses of proven human fascioliasis. J. Egypt. Soc. Parasitol., 33(2): Hassan, M.M.; Abbaza, B.E.; El Karamany, I.; Dyab, A.K.; El Sharkawy, I.M.A.; Ismail, F. and Asal, Kh.H. (2004):

11 Detection of anti-fasciolu isotypes among patients with i'ascioliasis before and after treatment with J. Egypt. Soc. Parasitol., 34(3): Hegab, M.H. and Hassan, R.M. (2003): Role of Circulating Fusciolu antigens and 1GG4 isotype in assessment of cure froin fascioliasis. J. Egypt. Soc. Parasitol., 33(2): Katz, N.; Chaves, A. and Pellegrino, J. (1972): A simple device for quantitative stool thick-smear technique in schistoserniasis mansoni. Rev. Inst. Mecl. Trop. Siio Paulo, 14: Massoud, A.M. (1999a): Efficacy of Myrrh as a ncw schistosomicide: An experimental study. Ain Shams Med. J., SO( 10. I I, Massoud, A.M. (1999b): Myrrh: A schistosomicide for human schistosomiasis mnn,~oni. Ain Shams Metl. J., 50(10,11,12): Massoud, A.M. (1999~): Myrrh; A schistosomicide for human schistosomiasis h~lenzatohiunz. Ain Shams Med. J., 50( 10,l 1,12) : Massoud, A,; Salama, 0. and Bennett, J.L. (1989): The therapeutic efficacy of a new schistosomicidal drug, derived fronl Myrrh in active intestinal schistosomiasis complicated with hepatosplenomegaly. 9'" Intern. Cong. Parasitol. (ICOPA IX) Ma kuhari Messe, Chiba, Japan. Massoud, A.M.; Galal, M.M. and Bennet, J.L. (1996): Experimental studies demonstrating the anti-schistosomal activity of Myrrh (Commil~hot-[I n~nlnzol). Am. J. Trop. Med. Hyg., 57 (3,Suppl.): 244. Massoud, A.; Salama, 0. and Bennett, J.L. (1998): The therapeutic efficacy of a new schistoson~icial drug derivetl from Myrrh. Am. J. Trop. Med. Hyg., 57(3): 244. Massoud, A.; El Sisi, S.; Salama, 0. and Massoud, A. (2001): Preliminary study of therapeutic efficacy of a new fasciolicidal drug derived from Conznziphora nzol~nol (myrrh). Am J 'I'rop Med Hyg., 65(2): Merino, J.; Amerigo, M.J.; Alvarez, R.L. and Erdozain, R.I. (1998): Human fascioliasis with atypical sever presentation. Treatment with triclabendazole. Enfer. Infec. Microbiol., l6( 1 ):

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HUMAN FASCIOLIASIS AMONG IMMIGRANT WORKERS IN SAUDI ARABIA. Abstract

Journal of the Egyptian Society of Parasitology, Vol. 35(3), December 2005 - J. Egypt. Soc. Parasitol., 35 (Supplement, 3): 1 199-1207 HUMAN FASCIOLIASIS AMONG IMMIGRANT WORKERS IN SAUDI ARABIA BY EBTESAM