ABSTRACT
Malnutrition is a common complication of cancer and cancer treatment in children. This occurs in 50% of these patients. Dietary supplements may have a significant effect on the response to treatment, survival, recurrence, mortality, and complications induced by chemotherapy in these children. The effects of Pediasure and Carnitine intake on anthropometric indices in children with acute lymphoblastic leukemia [ALL] have been investigated in this study. This clinical trial was conducted in 34 new cases of childhood ALL under chemotherapy, in Afzalipour Hospital, Kerman, Iran. The patients were divided by randomized design into two groups; 17 cases and 17 controls with mean age of 5.79 +/- 3.97 and 7.17 +/- 3.66 years, respectively. 100-150 cc Pediasure every other day for one month and 50 mg/kg per day Carnitine were given to case group. Anthropometric indices including skin fold thickness [SFT], weight, height, and arm circumference were measured at the beginning of the study and 6 months later. Anthropometric indices were compared in these two periods. Data were analyzed using paired t-test. Mean of SFT [mm], weight [Kg], height, and arm circumference [cm] at the beginning of the study in case group were 7.20 +/- 3.29, 18.05 +/- 9.67, 107.35 +/- 24.47, and 15.88 +/- 4.17 and in control group were 10.57 +/- 6.23, 22.38 +/- 11.1, 115.82 +/- 22.29, and 16.05 +/- 4.02, respectively. After 6 months of study these indices in case group were 7.29 +/- 0.80, 18.35 +/- 2.31, 108.11 +/- 5.88, and 15.98 +/- 1 and in control group were 10.61 +/- 1.52, 22.88 +/- 2.67, 116.34 +/- 5.37, and 16.16 +/- 0.97, respectively. No statistically significant differences were observed between the two groups in the two time periods. Although the differences of SFT were not statistically significant, this finding was clinically important [P = 0.05]. In spite of observed acute malnutrition in both groups, effects of dietary supplements on anthropometric indices did not show significant differences between groups. This may be related to many factors such as number of subjects under study, duration of intervention, and that the case group consumed only 100-150 Kcal/day energy more than the control group [we are not free in prescribing dietary supplement to these patients because of relapse risk and other unknown adverse effects of supplements]. Therefore, further studies are recommended
ABSTRACT
Human behavior is influenced by what we know or believe. In research projects, when the researcher expected a particular finding then explaining the results would be biased. Thus, blinding is a fundamental aspect of all research projects. A retrospective descriptive study was performed. During a 4-year period [2001- 2004] all approved research projects in deputy of research affaires of Kerman University of Medical Sciences that had been referred to pathology laboratories were evaluated. The mechanism used for blinding is questioned by interview with researchers or reviewing the proposals. Only 31% of research proposals had observed blinding policies correctly. Mistakes occurred most often in blinding process were as follow: single pathologist who was aware of research design, inappropriate group labeling by alphabetic abbreviations rather than case labeling by randomized numbers, remaining of interventions such as orthopedic devices in the test group, step by step remittance of specimens to pathology laboratory in multiphase studies, etc. Our results revealed that the pathologist should be blinded to group assignment. The blinding process and evaluating techniques should be supervised by statisticians and the monitoring committee [research center]