Successful Treatment of Chronic Viral Hepatitis With High-dilution Medicine
and ABSTRACT
Introduction:
Two
cases of viral hepatitis that had failed conventional therapy are
presented. Both were subsequently treated with protocols using
homeopathic medicines as detailed below. Both patients sustained
remissions for 2 years after taking ultradilute natural medicines after
their conventional treatment had been discontinued.
Methods:
The treatment protocol included Chelidonium majus
6X and Thuja 30C as the main medicines. Other homeopathic medicines
were used as detailed below. Cases were confirmed with standard
hepatitis antibody and viral measurements. Patients were followed for
more than 2 years with measurements of viral counts, liver enzymes, and
other relevant biomarkers of liver disease.
Results:
Both patients are alive and functioning normally in their home environments more than 2 years after treatment initiation.
Discussion:
We
review the literature related to the chief medicines used in these
cases and find that they have known and demonstrated therapeutic effects
suggesting plausible mechanisms of action in these cases.
Conclusions:
Clinical
trials of this homeopathic treatment protocol should be conducted to
explore the therapeutic potential of these medicines for treatment of
viral hepatitis.
Key Words: Viral hepatitis, ultradilute medicines, homeopathy, liver disease, case reports, India
Ultradilute,
serially agitated solutions behave quite differently than normal
solutions; the principles of their behavior are being actively
researched around the world.1
Meanwhile, ultradilute solutions in the form of homeopathic medicines
are widely sought and used clinically throughout the world. In 1999, the
US National Cancer Institute's Office of Cancer Complementary and
Alternative Medicine's rigorous Best Case Series validated the
effectiveness of cancer treatment protocols in 14 cases of different
varieties of the disease using homeopathic medicinal protocols developed
at the Prasanta Banerji Homeopathic Research Foundation (PBHRF) in
Kolkata, India, and identified studies in collaboration with PBHRF as a
funding priority.2
Published research reports also provide credible evidence of the
mechanisms of action and effectiveness of some of the protocols used at
PBHRF to treat cancer.3–7
In
addition to cancer, virtually all diseases are treated at PBHRF with
specific protocols using ultradilute medicines. In this article, we
report on 2 well-documented cases of progressively worsening acute and
chronic viral hepatitis that responded to treatment with these medicines
per the Banerji Protocol.
CASE 1
On
a routine health maintenance visit in 1994, a 37-year-old woman was
found to have elevated liver enzymes. Her first liver biopsy in January
1998 showed grade 1 (of 4) inflammation and stage 1 to 2 (of 4) delicate
bridging fibrosis. Subsequent hepatitis C antibody testing revealed
chronic hepatitis C. Genotyping of the virus in 1998 revealed type 1b
with a viral count of 33 000 000 IU/mL. She enrolled in a clinical trial
of pegylated inter-feron (PEG-INF) subcutaneously 1.5
[.proportional]g/kg once a week for 4 weeks followed by PEG-INF 0.5
[.proportional]g/kg once a week for 44 weeks along with ribavirin 1000
mg orally daily, which was reduced to 600 mg daily due to anemia at
treatment week 30. Serum levels of alanine aminotransferase reflected a
response with relapse. Her virologic response using polymerase chain
reaction (PCR)–based assay for hepatitis C virus RNA showed a temporary
response. Posttreatment liver biopsy performed 6 months after completing
treatment (in July 2000) was scored as grade 3 of 4 inflammation and
stage 1 of 4 fibrosis with piecemeal necrosis consistent with relapse.
Her viral count at that time was 16 000 000 IU/mL. A biopsy conducted in
December 2003 showed inflammation grade 3 and fibrosis stage 3 of 4.
She became increasingly symptomatic with nausea, fatigue, and loss of
appetite. In April 2004, she started a second course of PEG-INF with
ribavirin after undergoing whole-body hyperthermia. After 6 months, she
was found to have no response to the interferon, and the drugs were
discontinued. A biopsy in November 2005 showed stage 3 of 4 fibrosis and
moderate (3 of 4) portal inflammation. Viral count in July 2006 was 14
250 000 IU/mL, and the patient was found to have persistent stage 3 of 4
fibrosis and grade 3 of 4 inflammation with bridging necrosis.
In August 2006, the patient initiated treatment prescribed by the PBHRF. The following protocol was used:
- Chelidonium 6X twice a day,
- Thuja 30C twice a day, and
- Kalium muriaticum 3X and Ferrum phosphoricum 3X twice a day.
The
6X potency is the 6th decimal potency that is achieved by serial
dilution and agitation of the mother tincture, or alcoholic extract, of
the root of the plant Chelidonium majus. Thuja 30C is likewise
the 30th centesimal serial dilution and agitated product; here, the
alcoholic extract is from the fresh leaves and small twigs of the young Thuja occidentalis
plant. The Kali muriaticum 3X and Ferrum phosphoricum 3X are
triturations of the substances to the 3rd decimal potency. The medicine
was procured from reputable homeopathic drug manufacturers and
manufactured as per The Homeopathic Pharmacopoeia of India.
Chelidonium
6X and Thuja 30C are our standard protocol for cases of chronic viral
hepatitis. Chelidonium has a strong body of research supporting its use
for liver disease, and Thuja is effective in treating a wide variety of
viral infections (see Discussion section). The combination of Kali
muriaticum and Ferrum phosphoricum is our standard protocol for
treatment of anemia, which this patient experienced as a side effect of
interferon/ribavirin therapy.
The patient
adhered to this protocol for 2 years and was rebiopsied in the United
States in December 2008. Her inflammation was reduced to stage 1 of 4,
and her fibrosis had regressed to stage 0–1a of 4. She used no other
treatments during this time period. She no longer experiences daily
nausea and has regained her normal body weight. Her viral count in
December 2009 was 7 IU/mL. As of June 2011, she remained in remission
and continued treatment with Chelidonium 6X twice a day. Table 1 provides a summary of the relevant biomarkers.
Case 1: Chronic Active Hepatitis Ca
CASE 2
In
late November 2007, a 28-year-old male was admitted to the premier
Indian medical institution, the All India Institute of Medical Science
(AIIMS) in Delhi, for a case of hepatitis B virus (HBV)–related chronic
liver disease decompensated by acute hepatitis E virus (HEV) infection.
He also had developed spontaneous bacterial peritonitis. His clinical
history included a rapidly progressing jaundice followed by pedal edema,
ascites, fever, and abdominal tenderness. Viral antibody testing
revealed a positive Australia antigen (hepatitis B surface antigen),
negative immunoglobulin M for hepatitis B core antigen, HBV DNA 1300
copies/mL, and positive immunoglobulin M antibody for HEV. At AIIMS, he
was treated with intravenous glycyrrhizin (0.2%) 60 mL daily for 6
weeks, and then the dose was reduced to 3 times a week. Additionally, he
received daily diuretic treatment with spironolactone/furosemide
(Lasilactone, Sanofi-Aventis) 50 to 75 mg per day, 20% albumin 100 mL
intravenously daily for the first 2 months of hospitalization,
cefuroxime axetil (Ceftum, GlaxoSmithKline) 500 mg twice a day for 4
weeks, and lamivudine-HBV 100 mg daily.
After 6 weeks
of hospitalization and treatment at AIIMS, the patient's serum bilirubin
continued to be markedly elevated and alanine transaminase was
continuously 75 times normal, indicating failure of conservative
treatment. Endoscopy revealed esophageal varices. The cancer antigen
19–9 and carcinoembryonic antigen were negative. The patient and his
parents were advised of the need for a liver transplant. They refused to
have him placed on the transplant list, and he was discharged in
January 2008 and returned to Kolkata. After repeated episodes of
spontaneous bacterial peritonitis requiring multiple hospitalizations in
Kolkata, he developed right hepatic hydrothorax.
At
this point, the patient sought treatment at PBHRF. On first presenting
at PBHRF on August 22, 2008, he had severe ascites, dyspnea without
exertion, abdominal pain, and 4+ pitting edema in the lower extremities.
Treatment was initiated with the following protocol:
- Chelidonium 6X 3 drops alternating 3 times a day with
- Carduus marianus (milk thistle) mother tincture 10 drops,
- Thuja 30C 2 pills once every evening,
- Lycopodium clavatum 30C 3 drops 3 times a day, and
- Belladonna 3C alternating with Carduus marianus mother tincture every 10 minutes as needed for pain.
In addition to our first-line agent, Chelidonium, we added Carduus marianus,
as it has a long history of use in traditional herbal medicine for
support of liver problems. Thuja again was prescribed as an antiviral
agent. Lycopodium is our first-line agent for treatment of edema or
fluid retention of any kind. Belladonna is one of our first-line agents
for pain, particularly pain of visceral origin.
When
the patient's condition did not improve, on September 15, 2008, Myrica
(bayberry) mother tincture was added, alternating every 3 hours with
Chelidonium 6X, and Carduus was discontinued. On September 27, acetic
acid 30C, another of our prime medicines for water retention and
effusions, 3 drops 3 times a day replaced the Lycopodium for management
of the ascites. By December 13, 2008, the patient's pleural effusion was
clearing, ascites had decreased substantially, and urine output
improved significantly. Clinic notes from January 7, 2009, reported
worsening of the pleural effusion and ascites, and treatment exclusively
by PBHRF continued with the expectation that improvement was likely to
recur. By March 2009, the patient was reporting a sustained improvement
in symptoms, and the pleural effusion and ascites had almost completely
subsided. On June 3, 2009, the HBV DNA count was 5.82 copies, and the
patient was feeling well. Blood work done on May 9, 2009, revealed liver
function tests generally near the normal range, as indicated in Table 2. Table 2
also shows the continued improvement in liver function tests when
retested in December 2009. As of June 2011, the patient continued to
feel well, having been in remission for 2 years.
Case 2: Hepatitis B Virus and Hepatitis E Virusa
DISCUSSION
The
protocols used in these cases were developed based on the extensive
experience of the physicians at PBHRF, which spans several generations,
as well as the known actions of its specific component medicines. We
will briefly review the research literature that is available on these
medicinal substances.
Chelidonium majus (greater celandine) is an herb with documented hepatotoxic properties in its undiluted tincture or herbal form,8–10 but it has also been shown to have hepatoprotective, antitumor, and immunostimulatory actions.11
Thuja occidentalis has been reported to have similar hepatoprotective and antitumor effects.4,12–17 Thuja and its related species also have been reported to have antiviral13,18 and antimetastatic4
properties. Myrica, or bayberry, is a common herb that is high in
tannins; there is virtually no research documenting its effectiveness in
treatment of liver disease, but standard homeopathic references all
list jaundice as one of its principle indications.19
Carduus marianus (milk thistle) was reviewed recently in the Cochrane database. The conclusion of this rigorous review was that
milk thistle could potentially affect alcoholic and/or hepatitis B or C virus liver diseases. Therefore, large-scale randomized clinical trials on milk thistle for alcoholic and/or hepatitis B or C liver diseases versus placebo are needed. 20
The
larger issue is how ultradilute, serially agitated preparations of
these biologically active substances are able to exert therapeutic
effects even when the dilutions exceed Avogadro's number, which is the
case for the dilutions of 30C used in the Banerji Protocol for
hepatitis. The preparations of Chelidonium are diluted to a factor of
1/1 000 000; this explains the lack of toxicity observed in the normally
hepatotoxic Chelidonium when in its crude form but does not explain its
effectiveness as a hepatoprotectant. The emerging disciplines of
complexity, nanoscience, and materials science offer some hypotheses on
how these ultradilute medicines may still maintain biological activity.21
One research team advocated the hypothesis based on available
scientific evidence and logic that one major pathway of ultra-dilute
homeopathic drugs could possibly be through regulation of expression of
relevant genes.1 A recent study by Frenkel et al provided solid support for this hypothesis.3
The medicines used by PBHRF for treatment of breast cancer were tested
in vitro at the University of Texas MD Anderson Cancer Center, Houston.
The remedies exerted preferential cytotoxic effects against 2 breast
cancer cell lines, causing cell cycle delay/arrest and apoptosis. The
researchers demonstrated a clear biological activity of the tested
natural products (Phytolacca, Carcinosin, Conium, and Thuja) when
present at ultradiluted doses.
Despite the lack of a
proven explanation for how these ultradilute medicines exert their
effects, there is significant laboratory evidence that highly dilute
toxins can paradoxically protect the very tissues they harm in
macrodoses. There are several reports of liver damage reversal in mice
with ultradilutions of arsenic trioxide after exposure to toxic doses of
the same substance.5,22
One randomized double-blind placebo-controlled human study documented
favorable improvements in multiple markers of arsenic toxicity after 2
months of treatment with a serially agitated dilution (1:100 dilution 30
times) of arsenic,23
or the 30th centesimal potency. A recent review of the in vitro
research on serially diluted and agitated solutions concluded that even
the studies with high methodological standards demonstrated an effect of
these solutions.24
A
number of articles have been published in medical journals denouncing
categorically the use of homeopathic medicine, claiming that there is no
evidence to support any further research into their therapeutic
effects. Clearly, even in this very brief research review and in these
case reports, there is enough to suggest that this is an area that
should be further explored. The era of nanomedicine is upon us and
requires a fresh look at medicines that are ultradiluted. A major
advantage of treating disease with ultradilute solutions is that adverse
effects are virtually eliminated. The case reports in this article
will, hopefully, inspire a fresh interest and further research in this
fascinating and controversial area of therapeutics.
Contributor Information
Barbara Sarter, Barbara Sarter, PhD, APRN, FNP-C, DiHom, is an associate professor at Hahn School of Nursing and Health Sciences, University of San Diego, California.Prasanta Banerji, Prasanta Banerji, FMIH, is managing trustee at PBH Research Foundation, Kolkata, India.
Pratip Banerji, Pratip Banerji, MD(Hom), is deputy managing trustee at PBH Research Foundation, Kolkata, India.
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