Efficacy of prosultiamine treatment in patients with human T lymphotropic virus type I-associated myelopathy/tropical spastic paraparesis: results from an open-label clinical trial

Table 1 Profile of HAM/TSP patients enrolled and improvement of motor function in the lower extremities 12 weeks after treatment

	Age (years)	Sex	Duration of illuness (years)	Concomitant therapy			Intermittent self-catheterization	OMDS^a		Spasticity of the lower extremities
Case no.				Immunomodulator	Drug for neurogenic bladder
					Anticholinergic	α1 blocker		Before treatment	After treatment	Before treatment	Improvement^b
1	80	Female	23	No	Yes		Yes	6	6	Yes	Yes
2	64	Female	16	No	Yes		Yes	6	6	Yes	Yes
3	57	Male	51	PSL/ IFN-α	Yes		Yes	6	6	Yes	Yes
4	51	Female	36	No	Yes		Yes	9	9	Yes	Yes
5	67	Female	3	No			Yes	3	3	No
6	61	Female	30	No			Yes	5	5	Yes	Yes
7	68	Female	12	No		Yes	No	4	4	Yes	Yes
8	64	Male	11	PSL		Yes	No	5	5	Yes	No
9	66	Male	23	PSL	Yes		Yes	9	9	Yes	Yes
10	76	Male	23	No			No	6	6	Yes	Yes
11	53	Female	7	No			Yes	6	6	Yes	No
12	62	Female	12	PSL		Yes	Yes	4	4	No
13	44	Female	22	No			Yes	6	6	Yes	No
14	56	Male	10	No	Yes		Yes	5	5	Yes	Yes
15	71	Female	45	No	Yes		Yes	9	9	No
16	78	Female	18	No	Yes		Yes	5	5	Yes	Yes
17	50	Female	19	No			No	5	5	Yes	Yes
18	63	Female	29	No	Yes		Yes	8	8	Yes	Yes
19	62	Female	9	PSL	Yes		Yes	8	8	Yes	No
20	60	Female	34	No	Yes		Yes	2	1	No
21	46	Female	26	PSL		Yes	No	2	1	Yes	Yes
22	31	Female	7	No		Yes	No	4	3	Yes	Yes
23	56	Male	18	No			Yes	10	10	No
24	56	Male	16	IFN-α			No	2	2	Yes	Yes
Remarks	mean ± SD;		mean ± SD;								% improvement:
	60.1 ± 11.2		20.9 ± 12.1								78.9 (P = 0.0003)^c

^aOsame’s motor function score (OMDS) was rated from 0 to 13 according to the disability grade [13].
^bImprovement in spasticity of more than 1 grade according to the modifiedAshworth scale [14].
^cStatistical significance was determined by the McNemar test.
IFNα interferon α, PSL prednisolone.