Clinical Evaluation of Acupuncture as Treatment for Complications of Cerebrovascular Accidents: A Randomized, Sham-Controlled, Subject- and Assessor-Blind Trial

Table 3

Summary and comparison of randomized sham-controlled trials of acupuncture for global functional recovery after stroke (acute to subacute stage).

Study	Study design	Patient population	Experimental treatment	Control treatment	Therapist/session of course	Assessor/ITT or PP/outcome measures	Intergroup differences
Naeser et al. 1992 [19]	Double-blind,; parallel 2-arm	, 1–3 mth after infarction Fresh case?	(A) () Acupuncture + electroacupuncture and scalp acupuncture	(B) (); Sham acupuncture; (penetrating) + sham electrical stimulation (electrical stimulation not conducted)	Therapists?; 20 times; Within 4 wks	3 assessors not belonging to ITT or PP?; (1) Boston Motor Inventory; (2) Boston Motor Inventory with analysis of CT scan of lesion site	Significantly dependent on CT scan lesion site
Gosman-Hedström et al. 1998 [21]	Single-blind,; parallel 3-arm	,; <1 wk after stroke Fresh case?	(A) (); (electrical + manual); Acupuncture + conventional stroke rehabilitation	(B) (); Superficial; acupuncture, no “de chi” +; conventional stroke; rehabilitation; (C) (); Conventional stroke; rehabilitation	4 therapists; 20 times; Within 10 wks	2 assessor intention to treat; (1) Scandinavian Neurological Stroke Scale; (2) Barthel ADL Index; (3) Sunnaas ADL Index; (4) Nottingham Health Profile	Not significant
Johansson et al. 2001 [22]	Single-blind,; parallel; 3-arm	5~10 d after stroke Fresh case?	(A) (); Acupuncture + electroacupuncture + conventional physiotherapy; (B) (); High-intensity, low-frequency TENS + conventional physiotherapy	(C) (); Low-intensity, high-frequency TENS + conventional physiotherapy	Therapists from 7 university and district hospitals; 20 times; Within 10 wks	1 assessor; intention to treat; (1) Barthel Index; (2) Rivermead Mobility Index; (3) Nine-Hole Peg Test; (4) Nottingham Health Profile	Not significant
Park et al. 2005 [20]	Double-blind, parallel 2-arm	,; <4 wk after stroke Fresh case	(A) (); Acupuncture	(B) (); Sham acupuncture; (nonpenetrating on nonacupuncture points)	1 therapist; 9–12 times; Within 2 wks	4 assessors intention to treat; (1) Barthel ADL Index; (2) NIHSS; (3) Motoricity Index; (4) EQ-5D; (5) Nottingham Extended Activities of Daily Living; (6) Modified Ashworth Scale	Not significant; Except a greater improvement in leg function
Schuler et al. 2005 [23]	Single-blind,; parallel; 3-arm	,; 3–35 d after stroke Fresh case?	(A) (); Acupuncture + electrical stimulation	(B) (); Sham electroacupuncture (surface electrodes on acupuncture points with visual stimulation); (C) (); Control (no additional treatment)	3 therapists; 8 times; Within 4 wks	Assessors?; Intention to treat; (1) European Stroke Scale; (2) Barthel Index	No differences
Hopwood et al. 2008 [24]	Single-blind, parallel 2-arm	, 4–10 d after stroke Fresh case	(A) (); Acupuncture + electroacupuncture and scalp acupuncture	(B) (); Sham TENS (with no current flow)	therapists from 5 general hospitals in Hampshire (UK) 12 times Within 4 wks	assessment nurses; intention to treat; (1) Barthel Index; (2) Motoricity Index; (3) Nottingham Health Profile	no significant difference Except improvement in the MI
Shen et al. 2012 [11]	Double-blind, parallel 2-arm	,; 24 hr–14 d after acute ischemic stroke Fresh case	(A) (); Acupuncture + medical treatment	(B) (); Sham acupuncture; (nearby the acupoints) + medical treatment	Therapists of 4 hospitals; 28 times; Within 4 wk	A research nurse; ITT or PP?; (1) Barthel Index; (2) Relapse; (3) Death; (4) NIHSS; (5) Chinese Stroke Scale; (6) Oxford Handicap Scale; (7) Stroke Specific Quality of Life Scale	(1); (2); (3); (4); (5); (6) Intervention < control; (7)
Zhu et al. 2013 [25]	Single-blind,; parallel 2-arm	<30 d after stroke Fresh case	(A) (); Acupuncture (body and scalp) + conventional physiotherapy	(B) (); Conventional physiotherapy	4 acupuncturists and 4 physiatrists? From 4 rehabilitation centers 42.6 times of body acupuncture and 22.5 times of scalp acupuncture within 3 mths	4 physiatrists; Intention to treat; (1) Fugl-Meyer Assessment; (2) Barthel Index	No significant difference
Zhang et al. 2015 [12]	Single-blinded,; parallel; 2-arm	3–10 d after ischemic stroke Fresh case?	(A) (); Acupuncture plus standard care	(B) (); Standard care	Acupuncturists of multicenter (40 hospitals) 20 times; Within 4 wks	Assessors?; Intention to treat; (1) Scandinavian Stroke Scale; (2) Barthel Index	No significant difference
Our study	Double-blind,; parallel; 2-arm	,; 1~2 wk; After stroke Fresh case	(A) (); Acupuncture; (body and scalp) + conventional physiotherapy	(B) (); Sham acupuncture; (superficial, not acupoints and no “de chi”) + conventional physiotherapy	1 therapist, 24 times; Within 8 wks	1 assessor; Intention to treat; (1) NIHSS; (2) Barthel Index; (3) Instrumental Activities of Daily Living; (4) Hamilton Rating Scale for Depression; (5) Visual Analogue Scale for pain	(1); (2); (3) male; female; (4); (5)

TENS: transcutaneous electrical nerve stimulation; NIHSS: National Institutes of Health Stroke Scale; d: day; wk: week; mth: month.
World Health Organization Quality of Life BREF (WHOQOL-BREF); ITT: intention to treat; PP: per-protocol.