Abstract
Background:
Ayurvedic medicines are often considered effective for treating chronic and lifestyle-related diseases only and have not been thoroughly evaluated for treating acute or terminal illnesses. A prospective evaluation of Ayurvedic intervention was proposed for a patient who had metastatic liver disease with abnormal liver functions. The reason given for this was that no other conventional therapies were feasible in this case, and the family and caregivers were not willing to opt for any other intervention.
Materials and methods:
A diagnosed patient with metastatic liver disease that included abnormal liver functions and symptomatic presentation was treated with Ayurvedic therapies and was observed for 10 days for any possible changes.
Results:
A substantial clinical and biochemical improvement was observed in this patient after 10 days of treatment. This improvement was noted to be consistent at a 1-week follow-up after the patient was discharged from the hospital.
Conclusions:
This case offers an opportunity to reconsider whether or not the toxic potentials of heavy metals used in Ayurvedic agents outweigh the possible benefits for treating patients with well-defined, incurable clinical conditions.
Introduction
Liver metastases, in most instances are incurable, and any intervention therein depends on the primary site of the cancer, its spread, and the vitality of the patient. Survival rates are typically between 20 and 24 months in cases of metastatic disease. 2 Systemic chemotherapy, radiotherapy, and surgical resection are common methods used on a case-by-case basis, with a clear understanding that there are no cures for this condition. 3 Patients with liver metastasis eventually die of this disease because complications, such as infections and cholestasis, ultimately lead to complete liver failure. Incidences of tumor shrinkage, symptomatic reversal, and improved life expectancy are, however, also reported, albeit only rarely, in cases of liver metastasis. 4
This article describes the case of a patient with liver metastasis, with the gallbladder being the primary cancer site. This patient was treated with Ayurvedic herbomineral compounds and had significant symptomatic and biochemical improvements. This report is significant and supports the viewpoint expressed in another case of hepatic encephalopathy treated with Ayurvedic herbomineral agents; that case was reported in the literature last year. 5 It is important to understand that, in both of these cases, the interventions involved Ayurvedic herbomineral compounds that are normally used in Ayurvedic practice. These compounds included a few heavy metals, which are otherwise condemned globally because of their toxic potentials. This case, therefore, offers an opportunity to reconsider—in light of the benefits conferred on these patients—the toxic potentials of heavy metals used in Ayurvedic agents to treat patients with well-defined clinical conditions.
Case
Day 1
A 75-year-old, otherwise healthy women presented on September 9, 2011, with a reduced appetite, abdominal distention, diffuse pain abdominal pain, nausea, and vomiting, all of which had developed during the past few days prior to presentation. This patient's history included the fact that she was operated on for an impacted gallbladder stone in December 2009. A histopathologic examination of the resected gallbladder had identified a malignant growth in situ. She resumed her normal life, except for hypertension, for which she was being treated.
A sonogram showed that this patient had mild liver enlargement and a heteroechoic space-occupying lesion (SOL) in the 4b segment of the liver adjacent to the gallbladder fossa. The SOL was 49×42 mm. In addition, the sonography showed that she also had a heteroechoic 30×29 mm SOL in the parietal area of her right hypochondrium. This SOL extended deep into her liver parenchyma. Subsequent biochemical investigations revealed liver-function abnormalities in various dimensions (Table 1). Increased serum bilirubin (5.73), serum glutamic pyruvic transaminase (SGPT; 211), and alkaline phosphatase (800) were the important findings.
S.Bil, serum bilirubin; SGPT, serum glutamic pyruvic transaminase; Alk Ph., alkaline phosphatase.
She was advised not to take anything orally, except as noted below, and was maintained on intravenous fluids. She was given the following: • Yakrita-pleehari lauha (YPL), an Ayurvedic herbomineral preparation (obtained from a Good Manufacturing Practice–certified company)
6
at 250 mg twice per day; the tablets were crushed and mixed in water with buttermilk. • Ursodeoxycholic acid (UDCA), 150 mg twice a day; the tablets crushed and mixed with water. • Symptomatic treatment (conventional Western biomedicine) to address her abdominal pain and her nausea.
On day 1, however, she was not able to retain these oral medications, and she vomited all of them.
Day 2
A Ryle's tube was used to evacuate the patient's stomach, and the therapy from day 1 was continued. Her vomiting stopped after the stomach evacuation; however, recurrent nausea was still noted. She was not able to take anything orally. Medicines given to her with water induced the vomiting to recur.
Day 3
The patient was the same therapy once again but she was also injected with vitamin K intramuscularly. She was advised to take some sips of water, which she could tolerate; however, it was noted that whatever quantity of fluid was given to her came out again through the Ryle's tube.
Day 4
The patient was able to tolerate a larger quantity of water; however, the Ryle's tube was connected to an evacuation tube, thus, a substantial quantity of fluid was still being regurgitated into the tube. The patient's abdominal pain was substantially reduced, and she was no longer vomiting. She was tested for liver functions, and small reductions in her levels of serum bilirubin and liver enzymes were found (Table 1).
Day 5
This patient was continued on the same therapy. A larger quantity of fluid was given to her orally. She was also given oral electrolyte solutions and glucose water. The medicines given orally were tolerated. She had no nausea or vomiting.
Day 6
The patient was continued on the same therapy. Her oral tolerance was much better. She was given a larger quantity of oral fluids. She had no abdominal pain, no nausea, and no vomiting.
Day 7
Because of this patient's improved tolerance for oral liquids, the Ryle's tube was locked so that the fluid could be retained within the patient. She reported feeling much better and started to experience hunger. A liver-function test was repeated and substantial improvements were noted in the values, compared to the values observed on day 4 (Table 1).
Day 8
The patient was continued on the same therapy. The Ryle's tube was remained blocked. She was able to tolerate the oral liquids, and she was allowed to have vegetable soups and fruit juice along with water, oral electrolytes, and glucose. She had no specific complaints. She started feeling hungry. She passed loose stools 3 or 4 times.
Day 9
Because of the patient's improved general condition and better tolerance of oral intake, the Ryle's tube was removed. She was advised to continue being cautious regarding any oral intakes.
Day 10
A repeat liver-function test was performed only to identify the continued improvements in liver functions (Table 1). A repeat sonographic examination however revealed that the heteroechoic SOL in the 4b segment of her liver adjacent to the gallbladder fossa increased to the dimension of 55×54 mm. A heteroechoic SOL in the parieties of her right hypochondrium was also found increased to the size of 35×30 mm.
The patient was found to be clinically much improved and was able to consume a liquid diet consisting of vegetable soup, buttermilk, fruit juices, and rice porridge. Her vitals were functioning well, with improved appetite and bowel movements. She had no specific symptoms or complaints except for a concern regarding prospective abdominal discomfort after starting on solid food. She was advised to continue with same therapy and with same dietary schedule for the next week and, with this advice, she was discharged from the hospital.
Results
A subsequent 7-day follow up found her much better in terms of her vitals and symptoms reported earlier.
Discussion
YPL is a classical Ayurvedic drug, and has been referenced in the Bhaishjya Ratnavali. The indications for YPL use are yakrit roga (chronic liver disease), pleeha roga (spleen disease), udar roga (abdominal swelling), jwara (fever), pandu (anemia), kamala (jaundice ), shotha (edema), agnimandya (indigestion), and aruchi (loss of appetite). This agent is especially indicated for liver diseases. 6 Lauha bhasma, one principal component of the compound has a special affinity toward correcting pitta-induced disease. YPL was the only Ayurvedic drug administered in this case. YPL has been used regularly for patients with various liver diseases in standard Ayurvedic practice. No specific adverse effects or toxicity were found by the authors in the available literature. Given that YPL is composed of a few strong virechaka (purgatives) such as Croton tiglium, Baliospermum montanum, and Operculina turpethum, users are cautioned that they should not exceed the recommended dose of 150–250 mg, twice in per day (see Appendix). Incidentally, according to Ayurvedic principles, virechana happened to be the first-line therapy for any pitta disorder, of which liver disease is the best example. Pharmaco-epidemiologic references regarding actual use of YPL in Ayurvedic practice, however, is not available.
There are two principal arguments that can be posited with respect to the clinical and biochemical improvements observed in the current case of metastatic liver disease. Interestingly, these arguments are important from the perspective of Ayurveda and the controversy surrounding the presence of heavy metals in Ayurvedic preparations, and also because of the potential for providing qualitative improvement in patients who have conditions for which there are no known cures.
The first argument is that the Ayurvedic herbomineral compound (YPL) used in this case is composed of many heavy metals such as mercury, copper, iron, and arsenic together with many herbs processed together to create the final product (Appendix). There is a great deal of discussion about the controversy surrounding the use of heavy metals in Ayurvedic preparations and the potential toxicity of these metals. 7 –9 The possibility of toxicity affecting liver and renal functions are of particular importance. The current case report in which compromised liver functions were substantially improved after intake of this Ayurvedic herbomineral preparation—which was indeed composed of many of controversial metal components—brings into question just how much of a problem the “heavy metal toxicity” of Ayurvedic medicine is. Incidentally, previously reported observations of similar improvements in a case of hepatic encephalopathy emphasize further the need of a reappraisal before Ayurvedic drugs are discriminated against because of their heavy metal contents. 5 It has been repeatedly argued that adverse effects may occur because of Ayurvedic drug consumption if such agents are not properly processed or consumed. 10 As there are still many deficits found in aspects of Ayurvedic drug manufacturing and prescription, an adverse event caused by an Ayurvedic drug, therefore, should always be viewed in light of drug quality and its consumption methods in accordance to the classical descriptions available in Ayurvedic texts. In this case, the observations regarding YPL use were limited to a small period of use and, therefore, the potential for toxicity with long-term use cannot be ruled out.
The second argument involves an opportunity to consider Ayurvedic medicines as viable options for treating many conditions for which there are no definitive cures. Despite a continuous progression of the current patient's tumor size, which was an expected prognosis, she had improved liver functions and subsequent clinical improvements following Ayurvedic therapy. This occurrence makes a clear argument for considering use of these drugs for patients who have terminal and/or incurable illnesses or for patients for whom other options are not feasible because of various patient- or disease-centered limitations. There are a few more case reports that justify the use of Ayurvedic herbomineral therapy for patients with malignant conditions; these are cases for which conventional therapy was either refused or failed to provide quantifiable relief. 11 It is necessary to note that there are also rare incidences of spontaneous remissions in metastatic liver disease. To rule out any such possibility in the present case, a further study with the same drug protocol in a sufficient number of similar patients would be warranted.
Conclusions
In the above case, the smiling face of the patient and her family members at the time of her discharge from the hospital was the biggest reward a physician could achieve. “We had lost hopes of taking her back alive. This is just beyond our imaginations,” were the expressions of her relatives when she was getting discharged. An improved quality of life with reduction of symptom intensity as was observed in this case pleads strongly for Ayurveda to be given a fair chance to prove its worth in such cases and beyond.
Footnotes
Disclosure Statement
No competing financial conflicts exist.
Appendix
| Components | Ratio |
|---|---|
| Hingulotha parada (mercury extracted from Hingula) | 1 part |
| Gandhaka (Sulfur) | 1 part |
| Lauha bhasma (iron ash) | 1 part |
| Abhraka bhsama (mica ash) | 1 part |
| Tamra bhasma (copper ash) | 2 part |
| Suddh manahshila (purified arsenic compound) | 1 part |
| Haldi churna (Curcuma powder) | 1 part |
| Suddha jamalgota (purified Croton tiglium) | 1 part |
| Suhaga kheel (roasted sodium pyroborate) | 1 part |
| Suddha shilajeet | 1 part |
Combine ingredients all together. Process the total raw material with extracts of the following herbs, Danti mula (Baliospermum montanum root), Nishoth (Operculina turpethum), Chitraka (Plumbago zelanica), Nirgundi (Vitex nigundo), Trikatu (three bitters, namely, Zingiber officinale, Piper nigrum, and Piper longum), Bhringaraj (Eclipta elba) by soaking the raw material in each extract, drying, and soaking again in another in a one-to-one order.
Dosage and method of intake: 150–250 mg twice a day with buttermilk or with cow's urine.
From Joshi RD, Vaidya RN (ed), Nagpur, Maharashtra, Ayurveda Saara Samgraha, Baidyanaath prakashana, 2004:503.