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

Table 10

Estimated distortion of Issels et al. [23] trial results caused by impact of systematic bias.

Factors	Arm →	TChT		ChT		Distortion (→TChT)
	Pat Nr →	Nr	%	Nr	%	Δ%	Weight	Dist%
	Impact ↓	169	49,6%	172	50,4%
General factors
Tumor size	Reverse	11		11,3		2,7%	100%	2,7%
Grade 3	Reverse	84	49,7%	94	54,7%	10,0%	52%	5,2%
Total						12,7%		7,9%
Chemotherapy
Number of ChT treated	Direct	165	97,6%	167	97,1%	0,6%	97%	0,5%
Median number of cycles	Direct	8		5		60,0%	97%	58,4%
Total						60,0%		59,0%
Surgery
Overall surgery (including previous)	Direct	155	91,7%	154	89,5%	2,4%	91%	2,2%
Definitive surgery	Direct	104	88,9%	102	81,0%	9,8%	60%	5,9%
Measurable disease without surgery	Reverse	13	11,1%	24	19,0%	71,4%	11%	7,8%
R0 surgery + amputation	Direct	60	35,5%	51	29,7%	19,7%	33%	6,4%
R1 surgery	Reverse	35	20,7%	36	20,9%	1,1%	21%	0,2%
R2 surgery	Reverse	9	5,3%	14	8,1%	52,8%	7%	3,6%
Total						154,9%		23,9%
Radiotherapy
Number of radiotherapies	Direct	108	63,9%	106	61,6%	3,7%	63%	2,3%
Radiotherapy average dose	Direct	53,2		52,7		0,9%	63%	0,6%
Total						4,6%		2,9%
TOTAL								93,7%