Abstract
In Thalassemia repeated transfusions and chelating agents besides certain other drug trials aimed to alleviate the agony of repeated transfusions and bone marrow transplant did show some credible results in a group of patients but eventually it goes a long way to achieve some convincing results. The role of Fagonia cretica in treatment of Thalassemia was a chance occurrence, when a patient suffering from Thalassemia Major, who was receiving weekly transfusions and chelation therapy, got seriously ill. She had huge spleen, fairly enlarged liver and ascites. Out of curiosity this herbal preparation was given to the dying patient, who had otherwise no chance of survival. Surprisingly, she showed miraculous results and was no longer transfusion dependent after about six months and after nine months her reports for Thalassemia were negative. It was expedient to have drug trial of this herbal plant that could possibly help patients suffering hemolytic anemia like Thalassemia. Our earlier trials of Fagonia cretica had shown convincing results in a number of patients suffering from Thalssemia; it not only reduced the transfusion needs but also improved the quality of life in a large number of patients. For this study, a total of 180 Thalssemia suffering patients, mean age 7 years (1 to 17 years), were selected randomly. Of the 180, 100 patents were allocated to the treatment group and 80 to the control group, who were put on placebo. Among the treatment group, 25 patients were suffering from Thalassemia Intermedia, 10 from Sickle cell and the rest 65 from Thalassemia Major. Of all these patients, only 19 Thalassemia Intermedia patients, six Sickle cell patients, 54 Thalassemia Major category patients and 50 control group patients completed the study. The patients belonging to Thalassemia Major treatment category were further divided into three sub-groups according to their response to the treatment of Fagonia cretica. The patients in the treatment group were given 120 mg/kg body weight Fagonia cretica over a period of 10 to 18 months. The patients of the control group were put on placebo. The primary and the clinical end points were: reduced transfusion needs with decrease in the HbF, HbA2 and HbS in Sickle Cell Thalassemia and increase in the total Hb and HbA. The secondary end points included the improvement of all the clinico-pathological events resulting from anemia, repeated transfusions, iron overload, i.e., frontal bossing, maxillary hyperplasia, swelling of joints with arthralgia and myalgia, frequent chest infections and fever, sleep disturbances, shortness of breath, bleeding of gums and epistaxis, etc. Data were analyzed by the intention to treat. The total hemoglobin and size of the spleen and liver palpable below costal margins in cm were recorded at the time of admission to the study and then at the end of study, whereas the HbA, HbA2, HbF DQG+E6ZHUHUHFRUGHGZKHQWKHSDWLHQWVZHUH¿UVWGLDJQRVHGDQG¿QDOO\DWWKHHQGRIVWXG\ :HREVHUYHG WKDWWKHUHZDVVLJQL¿FDQW
3
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3
LQDOOFDWHJRULHVRISDWLHQWV 7KHUHVXOWVRI WKLVVWXG\FOHDUO\GH¿QHGWZRJURXSVRISDWLHQWVDFFRUGLQJWRWKHLUUHVSRQVHWRWKHWUHDWPHQW 7KHSDWLHQWVRI Group-1 initially had HbA on electrophoresis present (it included all the 25 patients belonging to Thalassemia Intermedia, six patients belonging to Sickle Cell Thalassemia and nine patients of Thalassemia Major. The Thalassemia Major patients in this group presented with all the features of iron overload with enlarged liver and spleen, frontal bossing, maxillary hyperplasia, etc. This group of patients never needed transfusion after they started Fagonia cretica Treatment. The patients in Group-2 included 45 Thalassemia Major patients, who did not have HbA on electrophoresis at the initial stage of diagnosis. They were further divided into two categories: 33 patients belonging to Category-A showed evidence of iron overload with enlarged liver DQGVSOHHQ IURQWDOERVVLQJDQGPD[LOODU\K\SHUSODVLD HWF 7KHUHZDVVLJQL¿FDQWUHGXFWLRQLQWKHWUDQVIXVLRQ needs in this group of patients. The 12 patients of Category-B were suffering with Thalassemia major. These patients looked quite normal. They had no evidence of iron overload. There was no enlargement of liver and VSOHHQRURWKHUERQ\DEQRUPDOLWLHV 7KLVJURXSRISDWLHQWVGLGQRWVKRZVLJQL¿FDQWUHVSRQVHWRWKHWUHDWPHQW by Fagonia cretica. Fagonia cretica was given in doses of 120 mg/kg body wt to all these patients.
