Authors and Disclosures

Robert Tan, M.D., Department of Internal Medicine,United Doctors Medical Center

August 2002 – July 2003

ABSTRACT

OBJECTIVE

Acute Viral Hepatitis is a systematic infection affecting the liver predominantly. Virtually all previously healthy patients with hepatitis A recover completely from their illness with no clinical sequelae. There are, however, certain clinical and laboratory features that suggest a more complicated and protracted course. With the advent of different hepatic protectors which some of them offer benefit to patients with liver disorder such as the Carnitine Orotate (GODEX). The aim of this study, was to evaluate the efficacy of Carnitine Orotate + Liver extract Anti toxic fraction + Vit. B2, B6, B12 (Godex) in patients with Viral Hepatitis A or B. a) to evaluate its effectiveness in terms of the following:

• Liver profile – SCOT, SGPT, protime, albumin and globulin, total bilirubin
• Clinical improvement b) to evaluate its adverse effects.

METHODS

This is a single blind experimental study done from August 2002 up to July 2003 at United Doctors Medical Center. All 18 years or above, presenting with clinical picture of acute viral hepatitis admitted at UDMC or seen at the OPD clinic. Those that were admitted were treated as follows: 2 vials Godex + 250 ml of D5W, 4 hours, once daily for the first 5 days then 2 capsules every 8 hours for the next 9 days of treatment.

Administration
Dissolve 2 vials of Carnitine Orotate freeze dried cake with 4 ml water for injection, shake and incorporate solution to IV slowly for 4-8 hours once daily N.B. Incorporation of Godex should be with non-electrolyte fluids. If with electrolyte solution (e.g. Ringers solution) will be used, Carnitine Orotate will precipitate.

The OPD patients were treated as follows: 2 capsules of Godex every 8 hours for 14 days for the treatment group.

Arm B: The Placebo group
All patients in placebo groups whether admitted or managed at the Outpatient were given one capsule of multivitamin every 8 hours for 14 days.

PARAMETERS EVALUATED

• A. Clinical signs and symptoms
  • All patients whether in the treatment arm or in the placebo arm were assess for the presence of:
    • 1. jaundice
    • 2. bowel flatulence
    • 3. nausea, vomiting
    • 4. abdominal discomfort
    • 5. liver span
• B. Biochemical markers:
  • The following laboratory examinations were done before and after treatment for both arms:
    • Prothrombin Time (NV 1-3 secs) ,SGPT (NV 5-40 u/I), SGOT (NV 5-40 u/I),Total Protein (NV 60-80 gm/I)
    • Albumin (NV 35-55 gm/I) ,Globulin (NV 13-35 gm/I) ,Total Bilirubin (NV 5-25 umol)

RESULTS

22 out of 25 qualified patients were included in the treatment arm. The 3 other patients were lost to followup. Of the 22 patients who completed clinical study. 5 patients were managed as out patient basis, while 17 patients managed as in patients.

A. Clinical Signs and Symptoms
On examining the patients in the treatment arm prior to drug administration, 21 patients (95%) presented with jaundice, 8 patients (36%) had bowel flatulence, 6 patients, (27%) had nausea and vomiting, 4 patients (18%) had abdominal discomfort and 2 of them (9%) had hepatomegaly

After 14 days of drug administration, the patients in the treatment arm has shown significant improvement in theseclinical parameters. Of the initial 21 patients with jaundice, after treatment only 2 patients (9%) had persistent jaundice , those who presented with bowel flatulence no longer had the symptom after treatment. Likewise nausea or vomiting completely resolved. Among those with abdominal discomfort prior to treatment only 1 patient (4%) was still complaining. And of those with hepatomegaly on physical examination only 1 (4%) still had palpable liver edge.

On examining the patients in the placebo arm prior to drug administration, 22 patients (88%) presented with jaundice, ‘7 patients (28%) had nausea and vomiting, 5 patients (20%) had abdominal discomfort and 2 of them (8%) had hepatomegaly. After 14 days of drug administration, the patients in the placebo arm did showed much improvement in these clinical parameters. Of the initial 22 patients with jaundice, after placebo administration 20 patients (80%) still had persistent jaundice, those who presented with bowel flatulence still had the same symptom. While those with nausea or vomiting 6 of the 7 patients (24%) still have the symptoms. Among those with abdominal discomfort 4 patients (16%) was still complaining. And hepatomegaly did not resolved on physical examination.

B. Biochemical Markers
The liver function test was done as the biochemical markers to quantitatively assess the patients clinical response. In the treatment arms it was shown that there was a statistically significant decreased from the pre treatment values to the post treatment values, is all of the measured parameters (table 3). While the placebo arm, there were statistically significant improvement in the Protime, total protein and bilirubin, while there are no significant change in the SGPT, SGOT, ALBUMIN, GLOBULIN. Comparing the liver function test in the treatment and placebo arm, those patients who received Godex showed marked improvement in these parameters compared to those given placebo, the difference noted to be statistically significant.

CONCLUSIONS

Carnitine Orotate has presented outstanding therapeutic effects on 22 subjects out of 25, with diffused liver hepatitis.

According to laboratory finding, the improvement data of SGPT, SGOT, Albumin, Globulin, Prothrombin time, serum bilirubin and only few who developed epigastric pain and pain on the injection site, it represents that Carnitine Orotate is effectively applicable to diffused viral hepatitis.

Single blinded experimental study of Carnitine Orotate on 25 patients with Acute Viral Hepatitis as the treatment, was performed for the period of 2 weeks to compare the effects in the improvement of biochemical liver function tests, and clinical status. With the clear reduction in serum transaminase, disappearance of symptoms, we conclude that “Carnitine Orotate + Liver Extract Antitoxic Fraction”, has favorable effects in patients with Viral Hepatitis.