Randomized controlled trial: Moxibustion and acupuncture for the treatment of Crohn’s disease

Table 1 Acupoints selected for the treatment and control groups

	Treatment group	Control group
Acupuncture points	Zusanli (ST36)	20 mm away from the posterior of ST36
	Shangjuxu (ST37)	20 mm away from the posterior of ST37
	Gongsun (SP4)	On the medial aspect of the 1st cuneiform bone, between LR4 and SP4
	Sanyinjiao (SP6)	15 mm away from the anterior of SP6, on the medial aspect of the tibia
	Taixi (KI3)	15 mm away from the anterior of KI3, on the medial aspect of the tibia
	Taichong (LR3)	On the dorsal aspect of the 1st metatarsal bone between LR3 and SP3
Moxibustion points	Tianshu (ST25), Qihai (CV6), Zhongwan (CV12)

ST: Stomach; CV: Conception vessel; SP: Spleen; LR: Liver; KI: Kidney.

Table 2 Patient characteristics at baseline

Characteristics	Treatment group	Control group	P value1
Age (yr); mean ± SD	36.98 ± 14.46	32.38 ± 11.83	0.113
Gender (male/female)	27/16	25/17	0.757
Height (cm)	167.47 ± 9.20	166.71 ± 6.79	0.670
Weight (kg)	53.69 ± 11.73	53.44 ± 11.73	0.924
Duration of disease (yr)	4.64 ± 3.75	4.67 ± 4.51	0.978
Prior resection (yes/no)	8/35	4/38	0.229
Severity (mild/moderate)	24/19	30/12	0.135
CDAI	210.84 ± 48.03	201.04 ± 57.13	0.394
IBDQ	157.67 ± 30.43	157.36 ± 33.19	0.963
HGB	118.05 ± 17.79	124.79 ± 20.70	0.111
ESR	21.80 ± 16.86	24.64 ± 22.28	0.625
CRP	18.52 ± 24.35	12.32 ± 13.43	0.164
Concomitant medication	27	24	0.398
Aminosalicylates	16	11
Corticosteroids	2	3
Aminosalicylates and corticosteroids	9	10
Montreal classification
Age at diagnosis
A1	2	3	0.373
A2	32	33
A3	9	6
Location
L1	6	8	0.251
L2	8	11
L3	29	23
L4	0	0
Behavior
B1	12	9	0.853
B2	2	2
B3	10	12
B1P	7	10
B2P	3	1
B3P	9	8

¹P values from comparisons between the treatment and control groups. CDAI: Crohn’s disease activity index; IBDQ: Inflammatory bowel disease questionnaire; HGB: Hemoglobin; ESR: Erythrocyte sedimentation rate; CRP: C-reactive protein.

Table 3 Results of the main outcome measurement: Crohn’s disease activity index score (per-protocol and intention-to-treat analysis) (mean ± SD)

Analysis set	Group	n	Baseline	Changes from baseline to post-treatment	P value1	n	Changes from baseline to follow up	P value1
PP analysis	Treatment	43	210.84 ± 48.03	-115.35 ± 55.05b	0.000	40	-128.93 ± 64.46b	0.000
	Control	42	201.04 ± 57.13	-35.68 ± 46.91b		37	-14.32 ± 52.09
ITT analysis	Treatment	46	211.81 ± 50.97	-107.83 ± 60.47b	0.000	46	-117.85 ± 70.10b	0.000
	Control	46	200.20 ± 54.91	-32.58 ± 45.91b		46	-22.19 ± 55.31b

¹P values from comparisons between the treatment and control groups.

^bP < 0.01 vs control group. PP: Per-protocol; ITT: Intention-to-treat.

Table 4 Results of the total efficacy evaluation (per-protocol and intention-to-treat analysis analysis)

Analysis set	Group	n	Clinical remission	Improved	Ineffective	P value
PP analysis	Treatment	43	32	4	7	0.000
	Control	42	15	2	25
ITT analysis	Treatment	46	32	4	10	0.000
	Control	46	15	2	29

P values from comparisons between the treatment and control groups. PP: Per-protocol; ITT: Intention-to-treat.

Table 5 Results of the secondary outcome measures (n = 85) (mean ± SD)

Outcome measures	Group	Baseline	Post-treatment	Changes from baseline to post-treatment	P value
IBDQ	Treatment	157.67 ± 30.43	182.23 ± 33.07b	24.56 ± 34.15	0.017
	Control	157.36 ± 33.19	167.29 ± 29.85b	9.93 ± 19.13
HGB	Treatment	118.05 ± 17.79	123.14 ± 20.87a	5.09 ± 14.45	0.029
(g/L)	Control	124.79 ± 20.70	123.86 ± 21.23	-0.93 ± 10.07
ESR	Treatment	21.80 ± 16.86	17.85 ± 14.14	-3.77 ± 13.00	0.163
(mm/h)	Control	24.64 ± 22.28	24.41 ± 22.10	-0.21 ± 10.12
CRP	Treatment	18.52 ± 24.35	8.71 ± 8.94b	-8.67 ± 20.04	0.008
(mg/L)	Control	12.32 ± 13.43	13.60 ± 14.81	1.16 ± 12.11
CDEIS	Treatment	9.92 ± 8.94	7.64 ± 6.84	-2.28 ± 5.52	0.380
	Control	6.15 ± 3.90	5.54 ± 4.79	-0.60 ± 4.75
HS	Treatment	11.2 ± 1.47	9.00 ± 2.11b	-2.2 ± 2.21	0.029
	Control	11.07 ± 1.44	10.53 ± 2.13	-0.53 ± 1.73

P values from comparisons of changes from baseline to post treatment between the treatment and control groups (^aP < 0.05;

^bP < 0.01 vs control). IBDQ: Inflammatory bowel disease questionnaire; HGB: Hemoglobin; ESR: Erythrocyte sedimentation rate; CRP: C-reactive protein; CDEIS: Crohn’s disease endoscopic index of severity.

Table 6 Changes in Crohn’s disease activity index scores according to subgroup (baseline to post treatment) (n = 85) (mean ± SD)

Subgroup (treatment group/control group)	Treatment group	Control group	P value1
Sex
Male (27/25)	-118.84 ± 47.29	-48.97 ± 51.95	0.001
Female (16/17)	-109.48 ± 67.45	-16.14 ± 30.12	0.001
CDAI at baseline
CDAI ≤ 220 (24/30)	-110.18 ± 49.51	-26.87 ± 43.11	0.001
CDAI > 220 (19/12)	-121.89 ± 62.10	-57.70 ± 50.59	0.005
Treatment with corticosteroids
Yes (11/13)	-131.30 ± 34.25	-28.86 ± 32.35	0.001
No (32/29)	-109.87 ± 60.05	-38.73 ± 52.36	0.001
Location
L1-Ileal (6/8)	-96.77 ± 55.42	-19.70 ± 51.42	0.020
L2-Colonic (8/11)	-114.31 ± 34.93	-50.29 ± 46.47	0.005
L3-Ileocolonic (29/23)	-119.49 ± 60.00	-34.25 ± 45.56	0.001

¹P values from comparisons between treatment and control groups. CDAI: Crohn’s disease activity index.