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Chatterjee A, Biswas J, Chatterjee AK, Bhattacharya S, Mukhopadhyay B and Mandal S. Psorinum therapy in the treatment of gastric, gallbladder, pancreatic and liver cancers: a prospective clinical trial.Evid Based Complement Alternate Med.2011;2011:724743.
design
Non-randomized, single-arm, observational study of Psorinum therapy for the treatment of advanced pancreatic adenocarcinoma, gastric adenocarcinoma, gallbladder adenocarcinoma, and hepatocellular carcinoma
Participant
A total of 158 subjects (44 with pancreatic adenocarcinoma, 42 with gastric adenocarcinoma, 40 with gallbladder adenocarcinoma, and 32 with hepatocellular carcinoma); 25% were diagnosed with stage III disease and 71% with stage IV disease.
Inclusion criteria:
- histopathologische/zytopathologische Bestätigung der Malignität,
- inoperable Tumoren und
- keine vorherige Chemotherapie oder Bestrahlung.
Treatment
Psorinum D6 was administered orally (as a liquid drop under the tongue) to all participants up to 0.02 ml/kg body weight once daily. Conventional (e.g., infection and pain control, electrolyte balancing, abdominal/pleural paracentesis) and homeopathic (i.e., administration of homeopathic medicines for pathologic indications) supportive measures were also administered.
The results of this study, showing a 19- to 38-fold improvement in five-year survival rates for unresectable pancreatic cancer compared to conventional treatment, are intriguing, to say the least.
Target parameters
Primary endpoints were radiographic tumor response and survival at 1, 2, 3, 4, and 5 years. The secondary endpoint was the assessment of the side effects of Psorinum 6X.
Key findings
Complete tumor response occurred in 33.33% of patients diagnosed with stage III disease and 10.71% of patients with stage IV disease. Partial response occurred in 41.03% and 33.93%, respectively.
The five-year survival rates were 38.64% (pancreas), 38.1% (stomach), 37.5% (gallbladder), and 43.75% (liver).
No adverse effects were observed from Psorinum, although some participants experienced mild mouth irritation and skin itching.
Clinical implications
The cancers considered in this study are among the most persistent and deadly malignancies. Conventional treatment for these diseases is better, but still only very effective to a limited extent. For example, over the last decade, with the use of the standard first-line therapy gemcitabine, the median overall survival time for advanced pancreatic adenocarcinoma has increased from 3–4 months to 5–8 months.1while the 5-year survival rate of the unresectable form remains almost unchanged at a dismal 1-2%.2.3Approximately 80% of all pancreatic malignancies are inoperable at the time of diagnosis.4Therefore, the results of this study showing a 19- to 38-fold improvement in five-year survival rates for unresectable pancreatic cancer compared to conventional treatment are intriguing to say the least.
Similar improvements in survival rates with Psorinum therapy have been demonstrated in the other cancer types studied.
However, caution should be exercised when interpreting these results. Promising Phase II trials are notorious for disappointing Phase III trials. Before an unqualified recommendation can be made, independent verification in a controlled context is required.
However, given the very poor response of these cancers to conventional treatment and the apparent lack of toxicity and potential benefit of Psorinum therapy, it seems reasonable that clinicians with oncology experience could offer this therapy to their patients on an individual basis.
Common homeopathic medicines such as Lycopodium C 200 and Baryta carbonicum C 200 were used as supportive measures and prescribed on a pathological (not individualized) basis. This is an important feature because the complexity of individualized homeopathic prescription represents a barrier both to its reproducibility in independent studies and to its widespread clinical acceptance.
The author is currently working on a manuscript that describes the guidelines for supportive homeopathic measures in detail. In addition, he will publish three detailed case reports on Psorinum therapy, providing further insight into the homeopathic supportive approach. Therefore, implementation of this protocol should be feasible for practitioners in the near future.
The primary limiting factor of this study is the lack of control for the effect of supportive homeopathic measures. Since adjuvant homeopathic medicines have been used extensively, it is quite possible that the results are partly (or mainly) due to their influence.
A Phase III trial is currently underway comparing Psorinum 6X plus conventional and homeopathic supportive care with 1) conventional treatment and 2) Psorinum 6X plus conventional (but not homeopathic) supportive care in the treatment of advanced pancreatic cancer.
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