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December 16, 2016
Authors: Dr Ravi Doctor
Various complementary systems of medicine are used for palliation during IVstage Carcinomas. Numerous medicinal products used individually or in combination with palliative Radiotherapy/Chemotherapy to help improve quality of life in palliative Cancer and one of them is Mistletoe (Viscum Album Extracts).
Mistletoe (Viscum Album Extracts) are one of the most researched pharmaceutical preparation used in cancer for the past 75 years. With its growing awareness in European patients and its application in recognised palliative care centres in Europe the author conducted an observational study with its effects on Indian cancer patients.
A clinical observational study was conducted on protocols of good clinical practice using Mistletoe (Viscum Album extracts) adjuvant with/post radiotherapy and chemotherapy protocols in IVstage Cancer.
Mistletoe (Viscum Album extracts) is a parasite plant growing on different host trees. Its extracts from the Mistletoe berries are available in injectable preparations. These preparations are being used in various cancerous conditions from the beginning of the 20th century. Various extract preparations made from different host tress are available all over Europe.90 clinical trials have been conducted with Iscador (systematic reviews in 3/5).The studies have been published in peer review publications. These studies have been carried out with protocols of good clinical and epidemiology protocols. Viscum Album extracts have major compositions of Mistletoe Lectins1, 2, Viscotoxins, Oligo -Polysachrides.These compounds have been studied in vitro to have properties of immunomodulation, promoting cell apoptotic activities and DNA stabilization. Considering the properties and taking it into account clinically the author has applied its application in 4th stage of cancer post conventional medicine protocols with the only objective of improving quality of life.
Clinical observation considered for the study:
1)Pain 2)Appetite 3)Psychological comfort 4)General well being
Study conducted at Saifee Hospital, Mumbai
Number of patients: 30
Stage of Cancer:IV
Duration of follow up: 3 Months – 2years
Assessment based on: WHO Performance Status Score.
Site of Cancer:
Adenocarcinoma:Stomach3/30(10%),Oesophagus2/30(6.66),Pancreas2/30(6.66), Gallbladder1/30(3.33),Ovary2/30(6.66),Lung 5/30(16.66),Bladder2/30(6.66),Parotid 1/30(3.33)
Squamous Cell carcinoma:Larynx2/30(6.66),Nasopharyx1/30(3.33),
Breast-Ductal Carcinoma1/30(3.33),Cervix1/30(3.33), Alveoulus1/30(3.33),Retroperitoneal Liposarcoma1/30(3.33), EwingSarcoma1/30(3.33), Glioblastoma2/30(6.66),Hepatocellular2/30(6.66)
Lung Metastasis6/30(20%), Skeletal Metastasis7/30(23.33)
Adjuvant with palliative Radiotherapy/Chemotherapy protocols: 15/30(50%)
Post palliative Radiotherapy /Chemotherapy protocols: 15/30(50%)
Consent: Informed consent and all the details of the drug has been provided to all the patients. The case records and all the details is maintained with the patient and the clinical observer.
Viscum Album extract Iscador was administered to patients.
Preparations used: Iscador series M,P,Qu according to series of 0,1,2.
Mode of administration/frequency-Subcutaneous, thrice a week
Dosage-0.01mg to 20mg followed by maintenance dosage
Duration of follow up– Min-3months, Max-4 years.
Patient’s clinical evaluation in 4th stage carcinoma post radiotherapy and chemotherapy protocols before starting Mistletoe (Viscum Album extracts)
Pain: 10/30 Patients complained of pains due to metastasis, 20/30 patients complained of somatic pains. Both the group of patients were being administered opiate derivatives and NSAID’S. Patients of bone metastasis were undergoing palliative radiotherapy for pain relief.
The intensity of pain was graded by a ratio of 6/10 along with conventional medicine protocols. Here 0 is no pain and 10 maximum level pain.
Appetite; 30/30 patients were considered for appetite related complaints. These patients did not feel like eating regular stipulated meals neither they relished the food which they would enjoy before.15/30 showing fall in appetite nor disturbed bowel functions were also those patients who had undergone limited doses of palliative chemotherapy. On an average the patient graded the appetite to 4/10 ratio.0 is anorexia and 10, excellent appetite with patient enjoying all three meals in the day.
Psychological comfort: 30/30
Patient considered in the observational study suffered from a mild form of depression. The will to live and enjoy life seemed fading. At times the choice of not living but dying was prevalent among some of these patients.
Patient rated on an average 5/10.0 complete depressive state and 10 enjoying life to the fullest.
General well being
All 30 patients were considered for the clinical evaluation study. Patient on an average rated general well being to 3/10.General well being included their inner personal state, enjoying the daily chores of life, looking forward for each day as it comes. It also included the daily routine if the patient could do by oneself and the energy levels during the day.
General condition analysis by(WHO Performance Score):
Patients presented at WHO Score3-19/30(63.33%),Score4-11/30(36.66%)
The results were evaluated on a patient evaluation based system.The experience of the patient was recorded during the course of the treatment.
Patients clinical evaluation in 4th stage carcinoma post radiotherapy and chemotherapy protocols during Mistletoe(Viscum Album extracts) administration.
The intensity of pain was reduced. Patient graded the improvement to 7/10 instead of 6/10 grading in 20/30 patients. There was a reduction of opiate pain killer intake in 8/30 patients, reduction of routine pain killers was seen in 10/30 patients.
20/30 patients showed a good improvement of appetite, patients rated their improvement on an average of 6/10 scoring. With reduction of pain killers there was a reduction of gastric irritation patient could relish the food better.
18/30 patients showed a good behavioural improvement in terms of socializing and a desire to live,5/30 patients did continue to show signs of depression,7/30 patients did feel some psychological improvement but not significant enough for comparison.
General well being:
With reduction of pain, improving appetite and improvement of psychological affections there was a considerable change in quality of life in these patients. Patients rated the general well being post VAE to 6/10.
General condition (WHO score):Score4to3in5/30patients (16.66%), 4to2in2/30(6.66%), 4to1in2/30(6.66%), 3to2in5/30(16.66%)
Survival>2 years: 14/30(46.66%)
The study shows European Mistletoe(Viscum Album extracts) given post Palliative Radiotherapy/Chemotherapy can certainly improve quality of life in terms of physical & psychological aspects in IV stage of Cancer. The ECOG/WHO score in these patients too had a dramatic fall when it came to quality of life assessment. Reduction of pain to some extent, improving appetite and thereby improving psychological aspects of the patient not only did it make a difference to their lives but a difference in the lives of their care takers and their family. It gave a chance to live the end stage of life with dignity.
The patients undergoing the clinical observational study were registered at Saifee hospital OPD and were taking treatment for their aliments. Patients were informed about the observational study and documented in their case records for the same. As Iscador the Mistletoe preparation used for the study is legally allowed by the Indian Government to be imported all details of the said drug, its effects and the side-effects were explained to the patients. The case records have been maintained in the case record file of the patient as well as with the clinical observer. There was no commercial involvement of either the company manufacturing it or the clinical observer.
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