Clinical Practice Guidelines for Peptic Ulcer Disease

1) Drug Treatment of Gastroduadenal Ulcer associated with Helicobacter Pylori (HP)

a) Seven day regimen: may be taken up to 10-14 days

Options Drug Regimen Eradication Rate

1

- Omeprasol (Losek, Omez) from other

analogues currently recommended is

Lansoprasol (Zoton) 20 mg bid or 30 mg

bid (in the morning and in the evening

before the meal, no later than 8 P.M. with

mandatory 12-hour interval); capsule

should be swallowed, not chewed.

- Klarythromicin (Klacide) 250 mg bid.

- Metronidazole (Trikhopole and other

analogues) 500 mg bid at the end of the

meal. The drug should not be taken with

alcohol; metallic taste and/or dark urine are

possible.

87 – 91%

2

- Omeprasol (Losek, Omez) from other

analogues currently recommended is

Lansoprasol (Zoton) 20 mg bid or 30 mg

bid (in the morning and in the evening

before the meal, no later than 8 P.M. with

mandatory 12-hour interval); capsule

should be swallowed, not chewed.

- Klarythromicin (Klacide) 250 mg bid

- Amoxicillin 1g bid at the end of the meal.

Amoxicillin is recommended in case of

prior Metronidazole failure. Metronidazole

is recommended for use in case of

hypersensitivity to penicillin.

80 – 90%

3

- Omeprasol (Losek and analogues) 20 mg

bid (in the morning and in the evening, no

later than 8 P.M. with mandatory 12-hour

interval)

- Amoxicillin (Flemoksyn Solutab,

Kchikoniil and other analogues) 1 g/bid at

the end of the meal

- Metronidazole (Trikhopole and other

analogues) 500 mg bid at the end of the

meal.

77 – 83%

4

- Pylorid (Ranitidin Bismuth Citrate) 400 mg

bid at the end of the meal

- Klarythromycin (Klacide) 250 mg/bid or

tetracycline 500 mg four times a day or

Amoxicillin 1000 mg/bid

- Metronidazole (Trikhopole and other

analogues) 500 mg bid at the end of the

meal.

78 – 83%

5 - Omeprasol (Losek and analogues) 20 mg

bid (in the morning and in the evening, no

later than 8 P.M. with mandatory 12-hour

interval)

- Colloid Subcitrate of Bysmuth (Ventrisol,

Denol and other analogues) 240 mg/bid 30

minutes before the meal (breakfast or

supper) or 120 mg/q.i.d (first three doses

should be taken 30 minutes before breakfast

or dinner, or supper. The last two – after the

meal before going to bed).With this

medication the tongue and the feces may

develop dark color; half an hour before and

in tetracycline regimen 88 – 90%

in amoxicillin 80 – 86%

after taking the medication it is not

recommended to drink milk; it should be

used with caution in patients hypersensitive

to aspirin; in case of tinnutis the medication

should be discontinued

- Metronidazole 250 mg/qid after the meal

or Tinidazole – 500 mg/bid after the meal

- Tetracyclin or amoxicillin 500 mg/qid after

the meal

b) Two – week regimen

Option Drug Regimen Eradication Rate

1

- Ranitidin (Zantak and other analogies) 150

mg/bid or Famotidin (Gastrosydyn,

- Kvamatel, Ulfamyd) 20 mg/bid in the morning

and in the evening (no later than 8 P.M.)

- with mandatory 12-hour interval;

Potassium salt of bismuth citrate –

gastrostat 120 mg/qid before the

meal

Metronidazole 250 mg/qid after meal

- Tetracyclin hydrochloride 250 mg /qid after

meals. Tetracyclin should not be used with dairy

products, antacids and medications containing

iron; photosensitization in the sun and a rash

may develop

80%

2

- Potassium salt of bismuth citrate – gastrostat

120 mg/qid before the meal

Metronidazole 250 mg/qid after meal

Tetracyclin hydrochloride 250 mg/qid after

meals

75%

Note:

Resistance may develop in regimens with Metronidazole and Klarythromycin

Smoking hinders healing of ulcers and is associated with increased recurrence rate

In absence of symptoms, diagnostic procedures to confirm successful eradication may be

omitted. In case of complicated ulcer, endoscopy is indicated to confirm the success of the

therapy.

2) Refractory ulcer.

The most common causes of refractory and recurrent ulcer include:

ineffective eradication therapy;

unidentified use of NSAID and poor compliance with medications regimens, incomplete

healing of large ulcers, Zollinger-Ellison syndrome and malignant neoplasms.

Should the first stage of therapy fail, a second stage of eradication therapy with other antibiotics

is recommended; term of the therapy: 14 days. Treatment success in the case of gastric and

gastrojejunal ulcers is monitored endoscopically in eight weeks; in the case of complicated

duodenal ulcer; in 4 weeks. Use of serology testing to confirm eradication of HP is not justified,

since antibody titer remains elevated even in the absence of HP.

3) Treatment of Ulcer caused by NSAIDs

NSAID use should be discontinued. Acetaminophen is as effective as NSAID in treatment of

mild/severe arthritis. Routine HP evaluation of patients complaining of dyspepsia for NSAID is

currently not recommended. In those cases when NSAID cannot be discontinued a 20 mg, single

dose for four weeks of Omeprasol (or its analogues) is recommended. Clinical trials have shown

that percentage of healing reaches 75-80% for an eight-week treatment.

If NSAID can be discontinued, ranitidin (or its analogues) is recommended: 150 mg/bid

for 8 weeks. To prevent peptic ulcer development in patients taking NSAID with associated risk

factors (history of peptic ulcer or gastric bleeding, older than 75, history of cardiovascular

problems), a simultaneous prescription of Misoprostole 200 mg/three times a day is

recommended.

3) Drug Treatment of Gastroduadenal Ulcer not associated with Helicobacter Pylori (HP)

To exclude or reduce smoking and alcohol use as well as NSAID use, one of the following drug

combinations and regimens is used:

- Ranitidin (Zantak and other analogues) 300 mg a day, single dose at 7–8 P.M. and

antacid (Maaloks, Remagel, Gastrin gel, etc.) as symptomatic medication

- Famotidin (Gastrosidin, Kvamatel, Ulfamid) 40 mg a day at 7–8 P.M. and antacid

(Maaloks,Remagel, Gastrin gel, etc.) as symptomatic medication

- Sukralfat (Venter, Sukrat gel) 4 g a day; more often 1 g 30 min. before the meal and in

the evening two hours after the meal for four weeks, then 2 g a day for eight weeks.

For the treatment of refractory duodenal ulcers not associated with HP, maximal dose of proton

pump inhibitors is recommended (Omeprasol, etc.). Concurrent use of proton pump inhibitors

(PPI) and 2nd type histamine receptors blockers (HRB) is not recommended due to the potential

decrease in the PPI effectiveness of.

ALGORITHM: MANAGEMENT OF NON-VARICEAL UPPER GASTEROINTESTINAL BLEEDING

Clinical Practice Guidelines for Alcohol Liver Disease (ALD)

1) The most important aspect of treatment in ALD is the immediate and total abstinence from

alcohol. It is also critical that the patient’s nutritional intake is adjusted to maintain a high

caloric, high protein diet.

This does not need to be accomplished within the confines of a hospital, although efforts to

enroll these patients in a detoxification program are clearly justified.

2) Hospitalization may be necessary for those patients who have extrahepatic complications or

those with risks factors associated with acute liver-related mortality. Drugs may be used to

treat the symptoms of withdrawal. Proteins and vitamin dietary supplements are prescribed.

Vitamin B and K are administered. Potassium, magnesium and zinc are administered to those

patients with decompensated liver disease.

3) Corticosteroids are prescribed for severely ill patients. This group of patients, with a high risk

of mortality, have been found to have high levels of circulating proinflammatory cytokines.

These are blocked by steroids, which have an anti-inflammatory effect. Pentoxifylline

prevents worsening of renal function in patients with severe alcoholic hepatitis .

4) Orthotopic liver transplantation improves survival rates in decompensated liver cirrhosis.

Currently, alcoholic liver disease is the single most common indication for transplantation in

adults in the United States. However, considering the scarcity of donors and the financial

expenditure, most transplant centers require a documented period of abstinence from alcohol

(usually 6-12 months).

Clinical Practice Guidelines for Hepatitis A

Guidelines for epidemic measures

1) Determination of mode of transmission, whether person-to-person or by common vector

(vehicle).

2) Identification of the population exposed to increased risk of infection. Elimination of

common sources of infection.

3) Improvement of sanitary and hygienic practices to eliminate faecal contamination of food

and water.

4) Hepatitis A vaccination has been shown to be effective in controlling outbreaks of infection

in communities that have high or intermediate rates of infection, provided a sufficient percent

of the target population is reached.30, 45

5) Passive immunization provides temporary protection, but it is not effective in controlling

HAV on a community level.

Treatment

1) As no specific treatment exists for hepatitis A, prevention is the most effective approach

against the disease.

2) Therapy should be supportive and aimed at maintaining adequate nutritional balance (1

g/kg protein, 30-35 cal/kg). There is no good evidence that restriction of fats has any

beneficial effect on the course of the disease. Eggs, milk and butter may actually help

provide a correct caloric intake. Alcoholic beverages should not be consumed during

acute hepatitis because of the direct hepatotoxic effect of alcohol. On the other hand, a

modest consumption of alcohol during convalescence does not seem to be harmful.

Hospitalization is usually not required.

3) Patients who are taking oral contraceptives do not need to discontinue their use during the

course of the disease.

4) Referral to a liver transplant centre is appropriate for patients with fulminant hepatitis A,

although the identification of patients requiring liver transplantation is difficult. A good

proportion of patients (60%) with grade 4 encephalopathy will still survive without

transplantation. Temporary auxiliary liver transplantation for subacute liver failure may

be a way to promote native liver regeneration.

Clinical Practice Guidelines for Hepatitis B

Currently there are no treatments available for acute hepatitis B. Symptomatic treatment

of nausea, anorexia, vomiting and other symptoms may be indicated. There are 2 main classes of

treatment:

- Antiviral: aimed at suppressing or destroying HBV by interfering with viral replication

- Immune modulators: aimed at helping the human immune system to mount a defense

against the virus

Currently, chronic hepatitis B is treated with interferons. The only approved ones are interferons-

α-2a and interferon-α-2b.

Guidelines for Epidemic measures

1) When two or more cases occur in association with some common exposure, a search for additional cases should be conducted.

2) Introduction of strict aseptic techniques. If a plasma derivative like antihaemophilic factor, fibrinogen, pooled plasma or thrombin is implicated.

3) Tracing of all recipients of the same lot in search for additional cases.

4) Relaxation of sterilization precaution and emergency use of unscreened blood for transfusion may result in increased number of cases.

Clinical Practice Guidelines for Hepatitis C

- The rationales for treatment of chronic hepatitis C are to reduce inflammation, to prevent

progression to fibrosis, cirrhosis and HCC through the eradication of the virus in chronically

infected patients and to decrease infectivity and control the spread of the disease.

- Interferon has been shown to normalize liver tests, improve hepatic inflammation and reduce

viral replication in chronic hepatitis C and is considered the standard therapy for chronic

hepatitis C.

- Combination therapy with pegylated interferon and ribavirin for 24 or 48 weeks should be

the treatment of choice for patients who relapse after interferon treatment. A relapse rate of

less than 20% occurs in relapse patients treated with combination therapy for a year.

Clinical Practice Guidelines for Hepatitis D

- Currently there is no effective antiviral therapy available for acute or chronic type D

hepatitis.

- For infected patients, massive doses of α-interferon (9 million units, 3 times a week for 12

months or 5 million units for up to 12 months) have yielded remissions but most patients

remained positive for HDV RNA despite the improved disease conditions.

- The effect of interferon is considered to be most likely an indirect one, possibly via an effect

on the helper hepa DNA virus and/or the immune response to the infections.

Clinical Practice Guidelines for Hepatitis E

- As no specific therapy is capable of altering the course of acute hepatitis E infection,

prevention is the most effective approach against the disease.

- As with hepatitis A, hepatitis E patients generally do not require hospitalization.

- Admission is required for fulminant hepatitis and should be considered for infected pregnant

women

Guidelines for epidemic measures

1) Determination of mode of transmission.

2) Identification of the population exposed to increased risk of infection.

3) Elimination of common source of infection.

4) Improvement of sanitary and hygienic practices to eliminate faecal contamination of food

and water.