Chatterjee A, Biswas J, Chatterjee AK, Bhattacharya S, Mukhopadhyay B, and Mandal S. Psorinum therapy in treating stomach, gall bladder, pancreatic, and liver cancers: a prospective clinical study. Evid Based Complement Alternat Med. 2011;2011:724743.
Non-randomized, observational, single-arm trial considering Psorinum therapy in treatment of advanced pancreatic adenocarcinoma, gastric adenocarcinoma, gallbladder adenocarcinoma, and hepatocellular carcinoma
158 total subjects (44 with pancreatic adenocarcinoma, 42 with gastric adenocarcinoma, 40 with gallbladder adenocarcinoma, and 32 with hepatocellular carcinoma); 25% were diagnosed with stage III and 71% with stage IV disease.
- histopathology/cytopathologic confirmation of malignancy,
- inoperable tumors, and
- no prior chemotherapy or radiation treatment.
Psorinum 6X was administered, up to 0.02 ml/Kg body weight orally (as liquid drops under the tongue) once daily for all participants. Conventional (eg, infection and pain control, electrolyte balancing, abdominal/pleural paracentesis) and homeopathic (ie, administration of homeopathic medicines on pathological indications) supportive measures were also administered.
Results of this study, which demonstrate a 19-38-fold improvement compared to conventional treatment in five-year survival of non-resectable pancreatic cancer are, to put it mildly, intriguing.
Primary outcome measures were radiological tumor response and survival at 1, 2, 3, 4 and 5 years. Secondary outcome measure was assessment of side effects of Psorinum 6X.
Complete tumor response occurred in 33.33% of those diagnosed with stage III disease and 10.71% of those with stage IV. Partial response occurred in 41.03% and 33.93% respectively.
Five-year survival rates were 38.64% (pancreatic), 38.1% (gastric), 37.5% (gallbladder), and 43.75% (liver).
No adverse effects of Psorinum were observed, though a few participants had mild oral irritation and skin itching.
The cancer types considered in this study are among the most intractable and deadly malignancies. Conventional treatment of these conditions, though improving, is still of very limited effectiveness. For instance, in the last decade with the use of the standard first-line therapy gemcitabine, median overall survival for advanced pancreatic adenocarcinoma has increased from 3–4 months to 5–8 months,1 while 5-year survival of the non-resectable form is nearly unchanged at a dismal 1–2%.2,3 Roughly 80% of all pancreatic malignancies are inoperable at diagnosis.4 Therefore, results of this study, which demonstrate a 19–38-fold improvement compared to conventional treatment in five-year survival of non-resectable pancreatic cancer are, to put it mildly, intriguing.
Similar improvements in survival rates with Psorinum therapy were demonstrated in the other cancer types studied.
Caution should be taken, however, in interpreting these findings. Promising phase II trials are notorious for disappointing in the phase III setting. Independent verification in a controlled context is needed before an unqualified recommendation can be made.
Nevertheless, considering 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 oncologic experience might offer this therapy to their patients on an individual basis.
Common homeopathic medicines such as Lycopodium 200C and Baryta carbonicum 200C were used supportively and prescribed on a pathologic (as opposed to individualized) basis. This is an important feature, as the complexity of individualized homeopathic prescribing is an obstacle both to its reproducibility in independent trials and its broad clinical adoption.
The author is currently working on a manuscript detailing the guidelines of the supportive homeopathic measures. Additionally, he will be publishing 3 detailed case reports involving Psorinum therapy, which will give further insight into the homeopathic supportive approach. Execution of this protocol is therefore likely to be feasible for practitioners in the near future.
The primary limiting factor of this study is the lack of a control for the effects of the supportive homeopathic measures. Since supportive homeopathic medicines were extensively used, it is quite possible the outcomes were due in part (or in chief) to their influence.
A phase III trial comparing Psorinum 6X plus conventional and homeopathic supportive care to 1) conventional treatment and 2) Psorinum 6X plus conventional (but not homeopathic) supportive care in treatment of advanced pancreatic cancer is currently underway.
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- Heinmann V, Boeck S, Hinke A, Labianca R, Louvet C. Meta-analysis of randomized trials—evaluation of benefit from gemcitabine-based combination therapy applied in advanced pancreatic cancer. BMC Cancer. 2008;8:82
- Cancer Facts and Figures 2009. American Cancer Society. Available at http://www.cancer.org/downloads/STT/500809web.pdf. Accessed February 5, 2010.
- Erickson A, Larson C, Shabahang M. Pancreatic Cancer. Available at http://emedicine.medscape.com/article/280605-overview. Accessed February 21, 2010.
- Surveillance Epidemiology and End Results (SEER). U.S. Cancer Statistics: 1999-2007 Incidence and Mortality Report. Available at http://www.seer.cancer.gov/publications/uscs.html. Accessed January 31, 2011.