Conference Papers in Science

Conference Paper

Critical Analysis of Electromagnetic Hyperthermia Randomized Trials: Dubious Effect and Multiple Biases

Table 16

Summarized biases of positive randomized clinical trials on hyperthermia.
Author Year Localization Distortions
Inadequate comparator Randomization defects Preselection of patients Incomplete data presentation Incorrect design Systemic distortionInadeqate analysis
Vernon et al. [10]1996 Superficial — — —
Overgaard et al. [11] 1996 Melanoma —? —
Jones et al. [12] 2005 Superficial — ——
van der Zee et al. [21] 2000 Cervix —— —
Harima et al. [24] 2001 Cervix — ————
Issels et al. [23] 2010 STS ————
Notes: 1—data on groups size differ between sources; 2—combination of some trials with different design; 3—negative data were not analyzed; 4—TD 24/27 Gy; 5—overall survival by groups is absent; 6—experimental design (randomization of tumors instead of patients); 7—incorrect survival analysis; 8—median age and TD RT differ >10%; 9—preselection of thermosensitive patients; 10—tumor size analysis missed; 11—inadequate analysis of efficacy, ignorance of bad survival; 12—TD RT 67 Gy, TD to tumor mass <60 Gy; 13—temperature analysis is absent and safety data are hidden; 14—combination of two studies with very different protocols; 15—impact of temperature, tumor volume, and protocol are not analysed; 16—TD to tumor mass 60.6 Gy; 17—preselection of aged patients (+10 years to expected age of first diagnosis); 18—base treatment in the control group is twice weaker compared to the study group; 19—all the parameters affecting the result are distorted in favor of hyperthermia group (+90%); 20—masking of systematic distortion, inadequate toxicity evaluation.