Treatment Outcome Clinical Studies

A large number of studies on the clinical efficacy of 224RaCl treatment for AS have been published in recent decades. Many of them do not fulfill the strict criteria for scientific studies as demanded today; some are only qualitative descriptions, partly lacking a control group, and others are only retrospective evaluations. However, in a total of 2700 patients described by these historical studies, an overall response was demonstrated in about 75% (15). Table 6 summarizes the 11 most reliably controlled studies, covering a total of 986 patients (27). Therapeutic success lasting at

Table 6 Clinical Studies on the Efficacy of 224RaCl (Radium Chloride) Treatment for Ankylosing Spondylitis

Reference

Number of 224RaCl treatments

Number of control

cases

Improvement

Total

Improvement

Total

Schneller (30)

12

15

9

15

Ruett (31)

17

18

Uibe (32)

219

240

Kutz (33)

86

92

Laschner (34)

75

91

Koch (35)

290

297

44

73

Schmitt (36)

62

78

14

70

Liska (37)

14

16

Redeker et al. (38)

44

53

Biskop et al. (39)

54

60

Mueller (40)

22

26

5

20

Total

895 = 91%

986

72 = 40%

178

Source: From Refs. 15, 27.

least five years was noted in 91% of patients treated with 224RaCl. Forty percent in the control group, treated with conventional anti-inflammatory drugs, experienced significant pain relief. Regarding the effects on spinal ossification, Rudolph et al. (28) reported on a significantly retarded progression following treatment with 224RaCl. Their radiological analysis of the kyphotic angle, number and size of syn-desmophytes, and degree of sacroiliac ankylosis in a total of 181 patients revealed a marked effect of 224RaCl therapy compared with a control group of patients who did not receive the radiopharmaceutical. Interestingly, these effects were still detectable 11 to 15 years after treatment. A dose reduction in anti-inflammatory pharmacotherapy in 65% of patients with AS, following treatment with 224RaCl, was reported by Seyfarth in 1987 (29).

In conclusion, a large number of historical studies demonstrate a good clinical efficacy of treatment with 224RaCl in patients with AS. However, due to the lack of controlled prospective studies, approval by the German Federal Institute for Drugs and Medical Devices is coupled with the charge to conduct a prospective long-term phase IV study. In this clinical trial, all the patients treated with 224RaCl must be followed up for at least 10 years to document any long-term side effects.

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