Acupuncture in diabetic peripheral neuropathy-neurological outcomes of the randomized acupuncture in diabetic peripheral neuropathy trial

Table 1 Baseline characteristics, n (%)

Characteristics	Acupuncture group (n = 31)	Control group (n = 31)
Age mean (SD)	66.7 (7.6)	69.5 (7.2)
Age group > 60 yr	24 (77.4)	27 (87.1)
Male	25 (80.6)	24 (77.4)
BMI > 25 kg/m²	27 (87.1)	27 (87.1)
Duration of neuropathy symptoms > 5 yr	14 (45.2)	19 (61.3)
Types of neuropathy
Painful neuropathy	4 (12.9)	7 (22.6)
Mixed neuropathy	27 (87.1)	24 (77.4)
Severe neuropathy	3 (10.0)	7 (24.1)
Palpable pedal pulse right	29 (93.6)	25 (80.7)
Palpable pedal pulse left	25 (83.3)	26 (86.7)
Relevant comorbidities (cardiovascular, hyperlipidemia, arthrosis)	27 (87.1)	27 (87.1)
Previous treatment with medication	12 (38.1)	13 (41.9)
NPSI total intensity score
Mean (SD)	28.1 ± 15.8	28.8 ± 20.5
Median (range)	30 (4-63)	23 (0-72)
11-NRS scale for numbness
Mean (SD)	5.8 ± 1.8	5.8 ± 2.0
Median (range)	6 (0-9)	6 (1-8)
NDS
Mean (SD)	8.1 ± 2.6	8.1 ± 1.9
Median (range)	9 (2-10)	8 (4-10)
NSS
Mean (SD)	7.2 ± 1.8	7.6 ± 1.5
Median (range)	7 (4-10)	7 (5-10)
TNSc Total
Mean (SD)	10.2 ± 4.1	11.3 ± 3.9
Median (range)	11 (2-17)	11 (6-19)
NSS Sub-groups
Mild	3 (9.7)	0 (0.0)
Moderate	8 (25.8)	6 (19.3)
Severe	20 (64.5)	25 (80.7)
Sural nerve conduct velocity of both legs (m/s)
Mean (SD)	40.9 ± 13.6	33.6 ± 19.9
Median (range)	44 (0-59)	44 (0-55)
Sural nerve Amplitude of the sensory nerve action potential of both legs (µV)
Mean (SD)	4.0 ± 1.9	3.7 ± 2.1
Median (range)	4 (0-7)	4 (0-7)

TENS: Transcutaneous electrical nerve stimulation; NPSI: Neuropathy symptom pain inventory; NRS: Numeric rating scale; NDS: Neuropathy deficit score; NSS: Neuropathy symptom score; TNSc: Total clinical ceuropathy score; BMI: Body mass index.

Table 2 Overview of the outcome parameters

Outcome	Week	Acupuncture group adj. mean (95%CI)	Control group adj. mean(95%CI)	Difference adj. mean (95%CI)	P value
NRS 11 numbness	8	4.2 (3.1; 5.2)	6.5 (5.4; 7.6)	2.3 (1.3; 3.4)	< 0.001
	16	4.6 (3.7; 5.6)	6.8 (5.8; 7.9)	2.2 (1.3; 3.1)	< 0.001
NPSI	8	17.4 (13.5; 21.4)	30.0 (26.0; 34.0)	12.6 (7.1; 18.0)	< 0.001
	16	20.9 (16.2; 25.6)	32.6 (27.8; 37.4)	11.7 (5.0; 18.4)	< 0.001
NDS	8	7.0 (6.1; 8.0)	8.1 (7.1; 9.1)	1.0 (0.2; 1.9)	0.021
	16	7.3 (5.7; 9.0)	8.2 (6.5; 9.9)	0.9 (0.1; 1.7)	0.035
NSS	8	6.3 (5.8; 6.8)	7.6 (7.1; 8.1)	1.3 (0.6; 2.0)	< 0.001
	16	6.0 (4.1; 7.9)	7.4 (5.4; 9.3)	1.4 (0.4; 2.3)	0.005
TNSc	8	7.8 (5.7; 9.8)	9.8 (7.7; 11.9)	2.0 (0.9; 3.1)	< 0.001
	16	8.3 (6.8; 9.8)	10.1 (8.5; 11.7)	1.8 (0.5; 3.1)	0.010
N. suralis CV (m/s)	8	38.2 (36.1; 40.4)	38.6 (36.4; 40.7)	0.4 (-2.7; 3.5)	0.818
	16	38.8 (33.5; 44.1)	38.8 (33.6; 44.1)	0.0 (-6.2; 6.3)	0.988
N. suralis ampl. (µV)	8	3.8 (3.3; 4.4)	4.4 (3.8; 4.9)	0.6 (-0.2; 1.3)	0.156
	16	4.2 (3.5; 5.0)	4.6 (4.0; 5.3)	0.4 (-0.6; 1.4)	0.428

NRS-11: 11 point numeric ratings scale; NPSI: Neuropathic pain symptom inventory; NDS: Neuropathy deficit score; NSS: Neuropathy symptom score; TNSc: Total clinical ceuropathy score; CV: Conduction velocity.

Table 3 Pre and post comparison of outcomes in the acupuncture group at last follow-up in week 24. Intervention had ended in week 8

Variable unadjusted means (SD)	Pre (baseline)	Post (week 24)
NRS_11	5.8 ± 1.8	4.5 ± 2.3
NPSI	28.1 ± 15.8	22.6 ± 16.8
NDS	8.1 ± 2.0	7.2 ± 2.9
NSS	7.2 ± 1.8	6.2 ± 2.4
TNSc	10.2 ± 4.1	7.9 ± 3.5
Nervus suralis CV (ms)	40.9 ± 13.6	41.1 ± 11.8
Nervus suralis amplitude (µV)	4.0 ± 1.9	4.6 ± 2.0

NRS-11: 11 point numeric ratings scale; NPSI: Neuropathic pain symptom inventory; NDS: Neuropathy deficit score; NSS: Neuropathy symptom score; TNSc: Total clinical ceuropathy score; CV: Conduction velocity.