Chinese Herbal Bath Therapy for the Treatment of Knee Osteoarthritis: Meta-Analysis of Randomized Controlled Trials

Table 1

Characteristics of randomized controlled trials of Chinese herbal bath therapy for knee OA.

Source	Diagnostic criteria	Disease duration	(Female, %)	Age (yr)	Chinese herbal bath therapy	Control interventions	Main outcomes
Liang and Lu 2010 [11]	Chinese orthopedic association criteria	2 months–19 yrs	60 (ND)	60	8 herbs: 20–50 g each; Steamed and bathed for 30 min; Once a day, 3 wks/1 course	Salicylic acid glycol patch; Once a day, 3 wks/1 course	() VAS pain; () Lysholm’s score; () Traditional Chinese medicine assessment
Xiong et al. 2010 [12]	ACR OA criteria	0.5–15 yrs	120 (78%)	61	17 herbs: 20 g each; Steamed and bathed; Twice a day, 2 wks/1 course	Diclofenac sodium 75 mg; Twice a day, 2 wks/1 course	Traditional Chinese medicine assessment
Wang and Zhou 2010 [13]	ACR OA criteria	11 patients < 1 yr; 17 patients > 1 yr; 27 patients > 2 yrs	55 (69%)	60	8 herbs: 15 g each; Steamed and bathed for 30 min; Once a day, 3 wks/1 course	Hyaluronate injection; 1 × 2 mL/wk, 3 wks/1 course	Traditional Chinese medicine assessment
He et al. 2011 [14]	Chinese orthopedic association criteria	3 months–5.8 yrs	90 (47%)	59	12 herbs: 6–20 g each; Steamed and bathed for 30 min; Twice a day, 4 wks/1 course	Diclofenac diethylamine gel; Three times a day, 4 wks/1 course	() Lysholm’s score; () Traditional Chinese medicine assessment
Huang 2011 [15]	Traditional Chinese medicine criteria	ND	120 (57%)	58	31 herbs: 9–18 g each; Steamed and bathed for 20 min; Twice a day, 4 wks/1 course	Hyaluronate injection; 1 × 2 mL/wk, 4 wks/1 course; Combined with triamcinolone injection; 1 × 15 mg/wk, 2 wks/1 course.	Japanese orthopedic association assessment
Li 2011 [16]	Chinese orthopedic association criteria	3–9 yrs	204 (60%)	63	14 herbs: 9–30 g each; Steamed and bathed for 30 min; Twice a day, 2 courses, 2 wks/1 course	Loxoprofen, 60 mg; Three times a day, 2 courses treatment, and 2 wks/1 course	VAS pain
Wu and Huang 2011 [17]	Traditional Chinese medicine criteria	0.5–20 yrs	98 (51%)	55	8 herbs: 20 g each; Steamed and bathed for 40 min; Every other day, 10 days/1 course	Meloxicam 7.5 mg; Once a day, 10 days/1 course	Traditional Chinese medicine assessment
Zhang et al. 2011 [18]	ACR OA criteria	38.5 ± 21.3 months	90 (48%)	58	8 herbs: 5–15 g each; Steamed and bathed; Once or twice a day, 2 courses, 1 wk/1 course	Diclofenac sodium 75 mg; Once a day, 2 courses, and 1 wk/1 course	Lysholm’s score
Chen et al. 2012 [19]	Chinese orthopedic association criteria	1 month–10 yrs	120 (53%)	56	12 herbs: 10–30 g each; Steamed and bathed for 30 min; Once a day, 2 courses, 2 wks/1 course	Diclofenac diethylamine gel; Twice a day, 2 courses, and 2 wks/1 course	Traditional Chinese medicine assessment
Wang et al. 2012 [20]	Traditional Chinese medicine criteria	49 patients < 1 yr; 24 patients > 1 yr	73 (49%)	62	12 herbs: 10–30 g each; Steamed and bathed for 30 min; Twice a day, 2 courses, 1 wk/1 course	Nimesulide 100 mg; Twice a day, 15 days/1 course	Japanese orthopedic association assessment
Bai and Chan 2013 [21]	Traditional Chinese medicine criteria	2 months–3 yrs	132 (78%)	53	19 herbs: 10–30 g each; Steamed and bathed for 30 min; Twice a day, 8 wks/1 course	Diclofenac diethylamine gel; Twice a day, 8 wks/1 course	Traditional Chinese medicine assessment
Liao et al. 2013 [22]	ACR OA criteria	3 months–11 yrs	96 (59%)	57	17 herbs: 3–30 g each; Steamed and bathed for 30 min; Once a day, 3 wks/1 course	Diclofenac sodium 25 mg; Three times a day, 3 wks/1 course	(1) VAS pain; (2) Traditional Chinese medicine assessment
Wei et al. 2013 [23]	Chinese orthopedic association criteria	1 month–13 yrs	90 (73%)	62	7 herbs: 10–20 g each; Steamed and bathed for 30 min; Once a day, 2 wks/1 course	Ibuprofen 0.3 g; Twice a day, 2 wks/1 course	Traditional Chinese medicine assessment
Wang et al. 2013 [24]	ACR OA criteria	1 month–22 yrs	100 (84%)	63	16 herbs: 10–30 g each; Steamed and bathed for 40 min in treatment machine (Model: HYZ-IIK); Once a day, 4 wks/1 course	Glucosamine Hydrochloride 480 mg; Three times a day, 4 wks/1 course	VAS pain
Xie 2014 [25]	Chinese orthopedic association criteria	4–71 months	200 (67%)	59	13 herbs: 10–15 g each; Steamed and bathed for 20 min in treatment machine (Model: ND); Once a day, 20 days/1 course	Meloxicam 7.5 mg; Once a day, 20 days/1 course	Lysholm’s score

ACR: American College of Rheumatology; yr: year; ND: no data; VAS pain: 0–10; lower score: better outcome.
Diagnostic criteria:
(i) Chinese orthopaedic association diagnostic criteria [26]. Main points: () recurrent knee joint pain in the last month; () narrowed joint space, subchondral cyst formation and bone sclerosis, or osteophytosis around joint margin on the radiographs in standing or load position; () evidence of clear, transparent, and viscous joint effusion at least twice; white cell count <2000/mL; () middle-aged and aged patients (40 years old or older); () morning stiffness ≤ 30 min; () palpable bone crepitation (fremitus) on movement of joint. Diagnosis of knee osteoarthritis can be made if the following conditions are satisfied: () + (), () + () + () + () or () + () + () + ().
(ii) Traditional Chinese medicine diagnostic criteria [27]. Main points: () recurrent knee pain recently; () common occurred in the middle-aged and elder people; () bone crepitus is observed when the joint is moved, or joint deformity; () joint space becoming narrow and osteophyte formation in joint edge on the X-ray; () excluded rheumatoid arthritis.
Outcome definition and measurement:
(i) The traditional Chinese medicine assessment comprises three levels: “cured” (pain and swelling of joint disappeared and active function returned to normal); “improved” (pain and swelling of joint alleviated and active function returned improved); and “not cured,” (pain and swelling of joint remained unchanged). Total effectiveness rate (%) is determined as the quotient of number of cured and improved patients divided by the total number of the patients.
(ii) The Japanese orthopedic association assessment is assessed by four facets: pain when walking on flat ground, pain when walking on stairs, angle of flexion, and amount of swelling. All facets are scored from a scale from 0 to 100: “significant improvement” is a difference greater than 6 between the score of after treatment and prior to treatment, “some improvement” is a difference between 3 and 6, and “not effective” is a difference less than 3. Total effectiveness rate (%) is determined as the quotient of number of significant and some improvement patients divided by the total number of the patients.
(iii) Lysholm’s score ranges from 0 to 100: a score of 100 indicates no symptoms, 80 or greater is “excellent”, 70 to 79 is “good,” 60 to 69 is “medium,” and less than 60 is “poor.” Total effectiveness rate (%) is determined as the quotient of number of excellent, good, and medium patients divided by the total number of the patients. Lysholm’s score: 0–100, higher score = better outcome.