A Case Study Of Chronic Hepatitis B & C Presented by: Hk.M.Ahmad Saleemi

1. A Case Study Of Chronic Hepatitis B & C Presented by: Hk.M.Ahmad Saleemi

2. Hepatitis: Hepatitis is an inflammation of the liver characterized by the presence of inflammatorycells in the tissue of the organ. Viral Hepatitis: Viral hepatitis is liver inflammation due to a viral infection. It may present in acute (recent infection, relatively rapid onset) or chronic forms. The most common causes of viral hepatitis are the five unrelated hepatotropic viruses Hepatitis A, Hepatitis B, Hepatitis C, Hepatitis D, and Hepatitis E. In addition to the hepatitis viruses, other viruses that can also cause hepatitis include Herpes simplex, Cytomegalovirus, Epstein-Barr virus, or Yellow fever Virus.

3. Hepatitis-B Chronic hepatitis B is a major global healthcare problem. Affecting an estimated 350 to 400 million people worldwide, 1,Chronic hepatitis B results in approximately one million deaths each year, 2 Making it the world's tenth leading cause of death. In the US,1 to 1.25 million people have chronic hepatitis B,and approximately 4000 to 5000 die each year of its complications. 3 The progression of chronic hepatitis B is variable, ranging from mild asymptomatic infection to severe chronic liver disease. In about 15% to 25% of patients, ongoing viral replication leads to serious complications including hepatic decomposition, cirrhosis, and Hepatocellular carcinoma (HCC). - 4-5 Million people in Pakistan.

4. Hepatitis-C - 170 million people are chronic carrier of Hep-C i.e.3 % of world population. - 2-4Million Persons in USA may be Chronically affected. - 5-10 Million in Europe. - 12 Million in India - 4-6 Million in Pakistan * Source: http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index4.html

5. Modes Of Transmission

6. Difference between Hepatitis Types

7. Signs & Symptoms Malaise(بے چینی ۔ بے قَراری ) Anorexia (Poor appetite)(بھوک کی کمی) Nausea(متلی۔ ابکائیاں ) Abdominal pain(شکمدرد ) Tenderness(نرمی) Muscle & Joint Pain( پٹھاوجوڑدرد)

13. Diagnostic Tests A. Biochemical Indicators • ALT 0 – 20 times. • AST B. ELISA(Enzyme Linked Immune Sorbent assay) C. RIBA(Recombinant Imunoblot assay) D. PCR(Detects RNA of the actual HCV) • Qualitative PCR • Quantitative PCR E. Liver Biopsy. F. Other Biochemical Tests. • Hb • TLC • Alkaline Phosphatase • Bilirubin • ESR etc.

14. TREATMENT A. Mono therapy with alpha interferon. Work in 10 – 20 person out of 100. Side effect profile is high Dosage reduced in 40 out of 100. Treatment withdrawn in 15. Pregnant can not use. B. Combination therapy Interferon + Ribavirin Works in 30 – 40 out of 100 Ribavirin alone does not work. Serious side effects like severe anemia myocardial infarction

15. The challenge of science Paracelsus, the Father of Pharmacology said..“All that mankind needs for good health andhealing is provided in nature..the challenge of science is to find it!”

16. Herbal Treatment Main Ingredients 1. Glycyrrhiza (Mulathi) 2. Silybum marianum(Oont Catara) 3. Withania coagulans (Paneer Doodi) 4. Solanum nigrum Linn (Mako) 5. Piprum nigrum (Mirch sia) 6. Artemisia absinthium(afsanteen) 7.Chichorium intybus(kasni) 8.Aloe Vera (Kanwar Gundal)

17. Silibum marianum(Oont Catara) • - Milk thistle has been used for liver problems for over 2000 years • - It offers Hepato-protective action through a number of mechanisms • Anti-oxidant activity • Toxin blockade at the membrane level • Enhances protein synthesis • Anti fibroitic activity • Anti-inflammatory and • Immune-modulating effects.

18. Silybum marianum (Oont Catara) Silybum marianum has been shown to have clinical applications in the treatment of toxic hepatitis, fatty liver, cirrhosis, ischemic injury, radiation toxicity and viral hepatitis. - Significantly reduces insulin requirements It also significantly reduces insulin requirement in cirrhosis related diabetes mellitus patients.

19. Glycyrrhiza glabra (Mulathi) • OUTSTANDING EFFICACY IN LIVER DISORDERS • Glycyrrhiza Glabra offers out standing surveillance rate in liver patients. • Reduces The Risk Of Liver Carcinoma • Glycyrrhiza Glabra has reduced half the rate of hepatocellular carcinoma as compared to other supportive therapy. • Restores Liver Functions • Hepatitis treatment with Glycyrrhiza Glabra restores AST & ALT plasma concentrations.

20. Withania coagulans (Paneer Doda) • IMPROVES LIVER FUNCTIONS • Increases thyroxine (T4), hepatic glucose and decreases liver lipid peroxidation. • Anti Inflammatory Action • Anti-inflammatory action is comparable to hydrocortisone. • Reduces Hepatotoxicity • Hepatotoxicity is reduced by withania comparable to hydrocortisone.

21. Piper nigrum(Kali mirch or Black pepper ) Black pepper has stimulant, expectorant, carminative, antipyretic, anthelmintic, antiperiodic action when used internally and externally it acts as rubefacient, stimulant, resolvent. Pepper has long been known for stimulating the appetite and relieving nausea. In India it had been used as a medicine for variety of ailments from paralysis to toothache. According to Ayurveda it is useful in treatment of asthma, chronic indigestion, colon toxins, obesity, sinus congestion, fever, intermittent fever, cold extremities, colic pain, cholera, gastric ailments, diarrhea, piles, worms and sore throat. Externally it can be applied to boils and other skin diseases in form of paste. DETOXIFYING AGENT - Hepatotoxicity is decreased reducing lipid peroxidation, enzymatic leakage of GPT, AP and preventing depletion of GSH.

22. Chichorium intybus (Chicory) (Kasni) Chicory (especially the flower) was used as a treatment in Germany, and is recorded in many books as an ancient German treatment for everyday ailments. It is variously used as a tonic and as a treatment for gallstones, gastro-enteritis, sinus problems and cuts and bruises. (Howard M. 1987). Inulin, the dietary fiber found in Chicory finds application in diabetes and constipation. Chicory has demonstrated antihepatotoxic potential in animal studies.,[

23. Artemisia absinthium(Afsanteen) Its active substances include silica, two bitter substances (absinthin and anabsinthine), thujone, tannic and resinous substances, malic acid, and succinic acid. It is used medicinally as a tonic, stomachic, antiseptic, antispasmodic, carminative, cholagogue, febrifuge and anthelmintic. It has also been used to remedy indigestion.

24. Compound medicine Majoon Dabeed ul ward Jawarish Amla Dawa ul Qurkum kabir Dawa ul Misk Sharbat Deenar Sharbat Kasni Sharbat Bazoori Hepta Care Akseer e Jiger Syrup & Tab Aloe Care Cap & Syrup Jigreen Actirn Tab Berisal Syrupetc

25. Frequency Tests Hb 3 Week Interval ALT “ AST “ Platelets “ ESR At start and end of therapy Urea “ Biliribin “ Anti HCV. “ PCR Quantitative “ Condition Chronic Hepatitis B & C Investigational drugs. A combination of herbal ingredients mainly Glycrrhiza, Silybum marianum. Investigational Tests & frequency. Data collection procedure On a specific designed format through patient interview & lab reports. Location of trial Private clinic R&D Qarshi Industries Qarshi Health Shop Time frame One year.

26. Clinical Trials of Herbal medicine on Hepatitis C Patients

27. Hepatitis C Study PATIENTS & METHODS All patients who were Hepatitis B surface antigen negative, and had impaired liver functions were tested for Hepatitis C virus antibodies. PCR was done in those who tested positive for HCV antibodies. Patients who had detected virus on PCR and abdominal ultra sound showed no stigmata of portal hypertension were included in the study. Hemoglobin SGPT (ALT), AST, White cell count. Platelets were done at the interval of every three weeks. Liver function test, Renal function test, PCR was done Pre and Post treatment. The study comprised of 18 patients (12 males, 6 females) The mean age was (40  15) Mean AST 105  30 (N < 40 L/ml) Mean ALT 115  42 (N < 41 L/ml)

28. Hepatitis C Study These patients were treated with a combination of herbal ingredients mainly glycyrrhizinate, silybum marianum, zinc compound, withinia coagulant, ginseng, Rheum emodi given in divided doses daily for one year. With serial monitoring of AST, ALT, hemoglobin and platelets. Of initial 18 patients 5 patients lost follow up. Of the 13 patients who completed this study for 6 months, a subjective improvement was seen in 12 patients (93 %). Out of 13 only 8 patients completed the study for 11 months ( Recommended duration of treatment is one year). The response to therapy with Herbal medicine depending on biochemical and molecular biological test (PCR) were as follows. Improvement in ALT & AST levels 12 (93%) Results PCR – Non Detected 5 out of 8 (62.5 %) (in patients taken the medicine for recommended duration i.e. 11 months) The Mean level of ALT, for the 13 patients who completed the study successfully, fell from (115  42) to 40  24 UL/ml and that of AST fell from (105  30) to 43  21 UL/ml. There was no major side effect. Two patients complaint of colic pain in abdomen.

29. Clinical Trials of Herbal medicine on Hepatitis B Patients

30. Hepatitis B Study All patients were confirmed Hepatitis ‘B’ surface antigen positive, and had increased SGPT & SGOT levels. PCR was done and willing patients (child bearing female exempted) were included in the study. Pregnant ladies and patients with diabetes and leumpensated cirrhosis were included. Hemoglobin, SGPT (ALT), AST, Blood chemistry were done at the interval of every three weeks , pcr was done pre & post treatment. The study comprised of 10 patients (6 male, 4 female)  The Mean age was 40 MEAN AST 1300 (N < 40µl/ml) MEAN ALT 1950 (N < 42 µl/ml)

31. These patients were treated with a combination of herbal ingredients mainly glycyrrhizinate, silybum marianum, zinc compound, withinia coagulant, ginseng, Rheum emodi given in divided doses daily maximum 180 days with periodic monitoring of AST, ALT & CBC. At the initial stage 10 patients completed the study and showed 100% results within 180 days response was as follows. Improvement in ALT & AST 10 (100%) PCR Non Detected 10 (100%) (Mean period in which PCR became –ve in 155 days) Mean improvement in ALT & AST Before 1950 1300 After 22 20 (Mean period 60 days) No major side effect was reported.

32. Herbal Treatment Feedback of Hepatitis B Patients No. of patients registered for Treatment: - 100 patients Regular Patients: - 92 patients Defaulters: - 8 patients

33. PCR Test Reports From Aga Khan University Hospital Karachi

34. PCR Test Reports From Aga Khan University Hospital Karachi Through Collection Unit Dhairki

35. PCR Test Reports From Aga Khan University Hospital Karachi Through Collection Unit Dhairki

36. PCR Test Reports From Aga Khan University Hospital Karachi Through Collection Unit Dhairki

37. PCR Test Reports From Aga Khan University Hospital Karachi Through Collection Unit Dhairki

38. PCR Test Reports From Aga Khan University Hospital Karachi Through Collection Unit Dhairki

39. PCR Test Reports From Aga Khan University Hospital Karachi Through Collection Unit Dhairki

40. PCR Test Reports From Aga Khan University Hospital Karachi Through Collection Unit Dhairki

41. Herbal Treatment Feedback of Hepatitis B Patients • Observations: • Medication • 1. 8 patients out of 100 didn't complete the course of medicine (7 patients left the course and 1 was Cirrhotic patient). • 2. 82 patients out of 92 were healthy and feeling better than before taking the medicine. • 3. 10 patients out of 92 patients had one of these problems like constipation, flatulence, weakness & insomnia.

42. Herbal Treatment Feedback of Hepatitis B Patients Observations: PCR Test Results: 1. PCR test of 90 patients was conducted to find out the Hepatitis - B virus in patients after treatment. 2. As per PCR Tests Report from Aga Khan University Hospital Karachi, in 66% patients (59 patients) Hepatitis – B virus was not detected. 3. Whereas in 34% patients (31 patients), Hepatitis B + virus was detected.

43. Herbal Treatment Feedback of Hepatitis C Patients No. of Patients Registered for Treatment: - 40 patients Results: - Treatment of Hepatitis C Patients under process - Treatment process will be completed till April 2011

44. Thanks