Hepatitis C

The following is a pilot study involving five cases of Hepatitis C. We applied Acupoint Injection Therapy (AIT) in each of these cases to test the potential of this treatment for Hepatitis C.
ABSTRACT:
TITLE: A pilot study of Acupoint Injection Therapy, using Chinese herbs and vitamins for the treatment of chronic Hepatitis C.
INTRODUCTION: There are a number of papers published each month describing Interferon-Ribavirin treatment for chronic Hepatitis C. However, there is a growing concern about certain factors, such as:
1. The long term of treatment (at least 6-12 months).
2. Low positive respondent rate (30-40%).
3. High relapse rate (75-80%).
4. High cost.
5. Side effects, including:
a. Severe flu-like symptoms.
b. A drop in the blood counts - hemoglobin (anemia), white blood cell and platelet.
c. Fatigue.
d. Anxiety.
e. Irritability.
f. Depression and inability to control emotions.
These negative aspects have led to renewed interest in alternative methods of treatment. Acupuncture, certain Chinese herbs and vitamins have been individually used and shown to improve the patients' liver function in different liver diseases, such as acute or chronic Hepatitis. But there is little information regarding the effective combination of these three regimes, especially for chronic Hepatitis C.
In this study we have therefore employed Chinese Acupoint Injection procedures (using specific Chinese herbs and vitamins directly injected into certain acupuncture points) to evaluate whether blood-test changes before and after treatment could provide new clues to the efficacy of this form of combination therapy. Furthermore, we examined whether or not this therapy might help solve other complications without using any western chemical drugs, thereby avoiding further drug-induced liver damage.

OBJECTIVE: The aim of this pilot study was to evaluate the efficacy of Acupoint Injection Therapy for chronic Hepatitis C and its complications.

METHOD: The five patients with chronic Hepatitis C were treated with Acupoint Injection Therapy for one to three months. PCR 's and other liver function indicators were checked before and after treatment.

RESULT: At the end of the treatment period (one to three months), all of the patients had positive clinical responses;
1. Complications such as diabetes, ascites and indigestion were much improved.
2. Overall energy increased
3. Positive biochemical responses (ALT reduced).
4. Positive virological responses (HCV from positive to negative or PCR significantly dropped).
5. No negative side effects were observed.

CONCLUSIONS: The results of this pilot study indicate that Acupoint Injection Treatment is a safe and effective therapy for patients with chronic Hepatitis C. Thus AIT offers itself as a viable curing option for Hepatitis C patients who refuse standard therapy, especially for patients who have no response to or who suffer the negative side effects from Interferon-ribavirin treatment.
However, further research is necessary to prove the effectiveness of this treatment. We therefore suggest that Acupoint Injection Therapy deserves further evaluations in larger and longer clinical trials, and we are prepared to conduct further research to compare AIT with standard therapy.

STATISTICAL ANALYSIS:

DISCUSSION
THE HEPATITIS C DISEASE --
The identification of the Hepatitis C virus in 1989 solved a growing mystery. Over the past ten years, large numbers of Hepatitis victims had begun to appear, apparently with a virally caused disease. But when examined, these patients tested negative for both Hepatitis A and B. The unidentified disease was known as "non-A", "non-B" Hepatitis. When a test was developed in 1990 to identify individuals infected with Hepatitis C, it was found to be responsible for the majority of these cases. It has quickly proved to present a frightening challenge. In contrast to most other types of Hepatitis, more than 80% of Hepatitis C (HCV) infections become chronic and lead to liver disease. Hepatitis C, in combination with Hepatitis B, now account for 75% of all liver disease cases around the world. Liver failure due to Hepatitis C is the leading cause of liver transplants in the United States.
About 3 percent of the world's population - more than 200 million people - carry the virus. Moreover, the number of deaths from HCV may soon surpass the number attributed to AIDS. Hepatitis C can live undetected in the body for years. In fact, up to 90% of those people infected with the HCV may show no symptoms for several decades. We now see that about 85% of people infected with HCV develop chronic Hepatitis. Furthermore, about 30% develop cirrhosis, an incurable liver disease, within 20 years. Up to half of those cases progress to end-stage liver disease or liver cancer.
Since Hepatitis C infection is typically mild in its early stages, it is rarely diagnosed and is often not recognized until its chronic stages, at which time it has caused severe liver disease. Since the typical cycle of the disease, from infection to symptomatic liver disease, takes as long as 20 years, the true impact of this disease on our increasing Hepatitis C population will not be apparent for many years. Therefore, it is often referred to as the "silent epidemic".
At present, it is suspected that there are more than 4.5 million Americans infected with Hepatitis C, and more than 200 million around the world, making it one of the greatest public health threats in this new century. A vaccine against Hepatitis C may not be available for many years to come, and there are already many times more people infected with HCV than have HIV (the virus that causes AIDS). Without prompt intervention to treat infected populations and prevent the spread of this disease, the death rate from Hepatitis C will one day soon surpass that from AIDS -- and it can only get worse.

HEPATITIS C TREATMENT --

HOW TO DETERMINE WHO NEEDS TREATMENT:
* A positive HCV-RNA test, which indicates circulating virus in the bloodstream.
* A biopsy that indicates significant liver damage.
* Elevated levels in the blood of SGPT (ALT-alanine aminotransferase).
CURRENT THERAPY: Interferon-ribavirin treatment: long term, at least 6 months to a year.
Positive response not very high, only 30% to 40%. More than 60% have no response or cannot bear the side effects. 75% relapse within 2 years.
SIDE EFFECTS:
* Severe flu-like symptoms
* A drop in blood counts, i.e. hemoglobin (anemia), white blood cell and platelet.
* Fatigue,
* Anxiety
* Irritability,
* Depression
* Inability to control emotions.

PILOT STUDY:
We propose to introduce a combination therapy as a pilot study which may give us another option for leading l with this disease -- Acupoint Injection Therapy.
Acupoint injection with Chinese herbs and vitamins combines traditional Chinese acupuncture with non-chemical nutritional substances. We select certain Chinese herbs and suitable dosages of vitamin B1, B12, B6, or even vitamin C, to inject into certain acupuncture points.
BENEFITS:
1. Protects the liver from further damage by the virus.
2. Detoxifies the liver,
3. Promotes nutrition and oxygen to the liver, which is very important for tissue recovery and improves liver function.
4. Strengthens the immune system's ability to defend against and kill the virus and reduces inflammation.
5. Improves the patient's general condition.
6. Solves multiple disorders at the same time without involving chemical drugs.
7. Protects the liver from previous drug damage. One graphic example of this benefit was seen with a patient who suffered from advanced ascites and edema for which he had to take large daily doses of Lasix. With AIT the patient was able to reduce the drug gradually until he could stop it altogether.
REASONS:
1. The special acupoints BL-23, SP-6, SP-9, RN-4, BL-25 are stimulated and thereby reduce ascites.
2. These acupoints are further stimulated with certain herbs and vitamins to further reduce Ascites and edema.
3. The digestive system is enhanced to absorb more nutrition and protein so that albumin levels can be improved. As a long-term consideration, this benefits the cirrhosis patient greatly because, at this advanced stage of disease, chemical drugs will be much more harmful than for a patient with a normal liver.
4. AIT is safe, more effective, and has no side effects - of crucial importance in the treatment of chronic disease.
5. This therapy has potential applications for both the prevention and treatment of chronic Hepatitis, cirrhosis and their complications.

HERBS COMMONLY USED IN ACUPOINT INJECTION TO TREAT HEPATITIS C:
According to each patient's individual situation, suitable herbs and vitamins are selected to perform a stimulating role at the acupoints;
1. Ban Lan Ge-Baphicacanthi radix-Radix isatidis --
Antiviral, antipyretic (reduces fever, clears heat), anti-infectant, detoxifies the liver, eliminates heat and toxins in the blood.
2. Chai Hu-Bupleurum-Radix bupleui --
Antipyretic, anticirrhotic, liver detoxifier, anti-inflammatory, hepatoprotector, effects liver, gallbladder, pericardium, removes stagnancy of liver Qi.
3. Yu Xin Cao-Herba Houttuyniae --
Clears heat, anti-infectant, detoxifier.
4. Dan Shen-Radix salviae miltiorrhizae --
Anti-fibrosis, eliminates blood heat, removes stagnancy, promotes cell tissue and organ recovery.
5. Da Huang Teng--Caulis Fibraureae --
Anti-infectant, anticancer, increases white blood cell counts, strengthens
immune system, clears heat.
6. Huang Qin-Radix Scutellariae --
Anti-inflammatory, antiviral, anticancer; clears heat.
7. Dang Gui-Radix angelicae Sinensis --
Strengthens liver function, improves blood circulation, increases red blood cell
counts.

VITAMINS COMMONLY USED IN ACUPOINT INJECTION TO TREAT HEPATITIS C:
Liver disease patients usually suffer from multiple vitamin deficiency, especially of vitamins B and C.
Vitamin B1:
For brain and nervous system, liver and spleen, gastrointestinal system.
Vitamin B12:
For pernicious anemia, the immune system, brain and nervous system, gastrointestinal system, heart disease. Necessary for production of nucleic acids and make up of DNA - the genetic material of cell-tissue recovery.
Vitamin B6:
Improves appetite, digestion and the immune system.
Vitamin C:
Involved in hundreds of vital biological processes in the body. Helps support and protect blood vessels, bones, joints, organs and muscle. Is necessary in sizeable quantities for healthy skin, tendons, the cornea of the eye, ligaments, cartilage, teeth and bone. Boosts the immune system. Involved in antibody production, white blood cell function and activity. A powerful antioxidant and plays a vital role in protecting against oxidative damage. Anti-cancer, anti-aging, antiviral.

PATIENT DETAILS:
CASE 1
Sex : Male
Nationality: USA
Age: 58 years.
Patient's statement:
I was first tested positive for Hepatitis-C in 1996. Unusual fatigue was my only obvious symptom, but the chronic nature of the disease indicated that I had probably contracted it some 25 to 30 years before from intravenous drug use in the late '60s.
Several sonagrams and an MRI have been performed, all showing a heavily scarred liver and slightly enlarged spleen. Two liver biopsies have been done. The first, on 15/01/99 reported: "cirrhosis cannot be ruled out." A second biopsy on 04/03/2000 reported: "Histology is that of micronodular cirrhosis with mild activity. The grade of iron deposits is not enough to warrant a diagnosis of Hemachromatosis." Other than gradually cutting down and then stopping intake of alcohol, and adding vitamins, antioxidants and other supplements to my diet, until 1999 I attempted no treatment for the disease. In February-March 1999 I undertook treatment with "Infergen," an interferon-based antiviral medication; I injected myself with a few cc's of this drug three times a week. The side-effects were appalling. I felt like I had a constant case of influenza: nausea, fever, dizziness, sore joints and muscles, severe depression. After one month I discontinued the treatment, due to side-effects and the fact that I was traveling abroad and could not maintain the routine safely.
In December 1999 I began to take, on a daily basis, three prescribed homeopathic medications: "Hepar," "Engystol" and "Hepeel." Blood tests after 3 months indicated that these medicines had no noticeable positive effect.
In mid-March 2000 I underwent a phlebotomy to remove 500 cc of blood from my system. This did not significantly reduce blood ferritin levels.
On March 28, 2000, I began the acupoint-injection therapy administered slightly more than seven weeks of daily treatments my hep-C condition had improved very noticeably. Not only did the LFT blood-test results demonstrate this improvement, but for the first time in many years I felt a great increase in physical energy and mental well-being.
Following is a synopsis of LFT Blood-test results:
LABORATORIES/UNITED STATES (Oregon):
TEST 3/1/96 26/7/96 1/3/99 2/9/99 5/10/99 NORMAL
---------------------------------------------------------------
ALKP 106 103 103 117 95 30--120

AST 112 148 120 134 101 5--40

ALT 195 248 160 177 167 0--45

GGT 273 284 * * 283 0--60

AFP * * * * * 0--15
FERRITIN * * * * 1681 20-380

LABORATORIES/INDIA (New Delhi):
TEST 7/2/00 25/2/00 22/3/00 NORMAL
---------------------------------------------------------------
ALKP 140 153 131 38--117

AST 174 151 164 5--40

ALT 198 165 193 5--40

GGT 257 244 239 10--50

AFP * * * 0--15

FERRITIN 1724 1615 * 30--400

LABORATORIES/hospital:
TEST 21/10/97 23/12/97 28/3/00 5/5/00 21/5/00 NORMAL
------------------------------ --before treatment--after treatment-------------------------------
ALKP 144 133 125 108 89 38--126
AST 131 99 164 123 108 14--50
ALT 180 140 188 149 129 21--72
GGT 386 * 260 209 210 8--78
AFP 12.8 * 27.4 21.8 24 0-15
FERRITIN 2295 * 1738 1193 875.5 30--400

PCR 3.5 > 30 < 0.2 Meq/ml An analysis of the above LFT results reveals that from 1996, except for minor occasional lower readings, the trend was stable to, in most cases, higher. By March 28 2000 all readings were about the same or somewhat higher than those from March 1 1996. On May 21, 2000, seven weeks after start of acupoint-injection therapy, we see a consistent and dramatic downward trend in all readings.
August, 2000 to end January, 2001:
I went back to USA for 3 months without any treatment; when I returned to AIT, blood tests (17/8/2000) were again elevated slightly, but ferritin went up more significantly. I got 2 weeks acupoint injection treatment, then left for the month of September to India, returning 4 October, 2000. After one month acupoint treatment (4/10/00 till 4 /11/00), the blood tests moved downward again. Then I requested to get intensive treatment, which means twice a day for 6 weeks (exclude two weeks holiday ) till the end of Jan. 2001. Reductions in ferritin level and PCR-RNA were dramatic.
Test* 28/3/00 5/5/00 21/5/00 17/8/00 7/11/00 31/01/001 Normal
Before Tr. After Tr. Further Tr. Quit Tr. Tr. Again further Tr.
1. AFP 27.4 21.8 24.1 19.8 21.7 20 0 --- 15
2. AST 164.0 123.0 108.0 126 112 103 14 --- 50
3. ALT 188.0 149.0 129.0 153 145 146 21 --- 72
4. GGT 260.0 209.0 210.0 212 193 197 8 --- 78
5. ALK 125.0 108.0 89.0 * * * 38 --- 126
6. FERRIIN 1738.0 1193.0 875.5 1280 1147 835.1 30 --- 400
7. PCR > 1M copies/ml 8.436 4.099 < 0.2 Meq/ml
*All tests done by hospital /USA-equivalent facility.

CASE 2.
Sex: female

Age: 51 years
I was diagnosed with Hepatitis C cirrhosis 3 months ago. I was in very bad condition:
1. Severe lung infection for months, very bad cough, antibiotics didn't work for me.
2. Heart disease, heart enlarged, doctor was waiting for chance to operate on me.
3. Diabetes, blood sugar level always goes up for long time( more than 200). Drugs didn't reduce my sugar at all.
4. Hypertension, blood pressure 180-190 /100-110 mmHg, no response to drugs.
5. Spleen 3rd Degree enlarged.
6. Others: very poor digestion, always diarrhea, both legs swollen, headache and dizziness all the time, no energy, no appetite , difficult to sleep.
7. Blood test: SGPT 52, SGOT 49 , sugar 263 , BUN 31. HCV-positive, no PCR test
I have taken many drugs for a long time, but my situation was getting worse all the way, so I turn to AIT. Dr. treats me with acupoint injection therapy, which is using Chinese herb plus vitamin directly injected into acupuncture points. At the same time, she helps me reduce my medicine gradually. I stopped all the medication within 2 weeks. Everything improved within one month, cough significantly reduced, and finally no more cough and more energy. I can walk upstairs for 4 floors, where I could not walk up even 2nd floor before. The happiest thing that I can see is that my blood pressure is stable normal every day after 2 weeks treatment, 140-150/80-90mmHg. I can feel my spleen is getting smaller. I can eat more, no more diarrhea and my legs no more swollen. No more headache, no dizziness and sleep very well. My face looks healthier. I'm totally new. Not just I feel better but, after 3 months treatment, Dr. asked me go back to hospital check up again. More surprise as follows:
1. Chest X-ray shows : normal lung and heart, my enlarged heart became normal now - incredible.
2. Blood pressure : 142/84mmHg
3. Blood test: Sugar 126, SGPT 35, SGOT 35 , BUN 10.9, HCV (-)
Thanks very much Dr. with wonderful treatment.

CASE 3
Sex: Male, Age: 52 years
Nationality: U.S.A.
History: CA. on LB spine, post-operation + radiation, blood transfusion after operation.
Diagnosis: Hepatitis C, 5 years ago.
The patient came to request acupoint injection treatment with the following symptoms:
fatigue, digestive problems, stomach-ache and frequent diarrhea. After 2 weeks treatment, the symptoms were much improved. He had more energy, digested food better and very little diarrhea. His PCR-RNA dropped 50% from 28.66 to 14.33 MEq/ml after two and a half months' treatment. Then the patient stopped treatment for one month's rest. He then requested treatment again for about one month . The blood test showed PCR was further reduced from 14.33 to 9.033 Meq / ml.
TEST RESULTS:
1. PCR : before Treatment = 28.66 MEq /ml
After 2.5 months AIT treatment dropped to 14.33 MEq /ml
After 4 months AIT treatment further dropped to 9.033 MEq / ml .

CASE 4:
Sex: Male
Age: 52 years
Nationality: Canadian
History: Intravenous drug abuse about 30 years ago (1969). He was diagnosed HCV positive with PCR of HCV 260,000 copies/ ml two years ago, late the situation was getting worse. The diagnosis was chronic Hepatitis C with cirrhosis and a history of hepatic encephalopathy (two times , and frequent acute ascites and edema which was controlled only by large doses of Lasix.
The patient came to request acupoint injection treatment with the following symptoms:
both legs swollen, big belly, fatigue, poor digestion and constipation. The patient was taking Lasix - 40mg, two tablets per day and other drugs for constipation. When the patient started with acupoint injection treatment, we reduced his drugs and Lasix slowly. Within three weeks the patient quit Lasix completely. The edema was much reduced and other symptoms were much improved -- he could digest much better and his energy was substantially increased.
Blood-test results:
1. PCR: before AIT treatment = 560,000 copies/ml
After 3 months AIT treatment dropped to 37,000 copies/ml
2. AST: from 87 dropped to 81
3. ALT : from 80 dropped to 75
4. GGT: from 58 dropped to 32
5. AFP : from 16 dropped to 5.3
6. Albumin : from 1.7 up to 2.5
7. A/G : from 0.4 up to 0.6
8. RBC : from 3.6 up to 4.47

CASE 5
Sex: Male
Age: 44
Nationality: Poland
History: Hepatitis B & C for 25 years. Extreme fatigue.
After 25 days of acupoint injection treatment, the blood tests showed a vast improvement.
Test results:
1. PCR : before treatment > 5, 000,000 copies/ml
After 25 days ( 50 treatments) dropped to 1,640,000 copies/ml.
2. AST : from 105 dropped to 75 . After stopping treatment, still continuously dropped to 69 .
3. ALT : from 129 dropped to 115 , and further dropped to 73 after stopping the AIT.