中医手法排乳治疗郁滞期乳痈临床试验结局指标的异质性—— 一项系统评价

doi:10.24920/004164

Abstract

Objective To systematically analyze the current status of outcomes reporting in clinical trials on treating stasis acute mastitis with Traditional Chinese Medicine breast massage.

Methods We searched CNKI, Wanfang, VIP, SinoMed, PubMed, Web of Science, Embase, Cochrane library, JBI, CINAHL, PsycINFO, Clinical Trials Registry Platform portal, Clinical Trials Registry, Australian New Zealand Clinical Trials Registry, Center Watch Registry from inception to May 15, 2022 to find randomized controlled trials, non-randomized controlled trials, case series and cohort studies which reported the outcomes of stasis acute mastitis managed with Traditional Chinese Medicine breast massage, with search terms of mastitis, acute mastitis, lactation mastitis, puerperal mastitis, breast problem, breast engorgement, milk stasis, blocked ducked, breast pain, breast massage, and acupoint massage. Outcomes and the measurement schemes (measurement methods, timing of assessing outcome, frequency of assessing outcome, measurers) were extracted from the included studies. We used the Management of Otitis Media with Effusion in Children with Cleft Palate (MOMENT) to assess the quality of each study, then categorized outcomes derived from the included studies into different domains according to the Outcome Measures in Rheumatology Arthritis Clinic Trials (OMERACT) Filter 2.1 framework.

Results We identified 85 clinical trials, in which 54 different outcomes were reported. A total of 81.2% (69/85) of studies were assessed as medium quality with a mean score of 2.6, and 18.8% (16/85) as low quality with a mean score of 0.9. These outcomes were organized in three core areas. Lump size (89.4%, 76/85) was the most frequently reported outcome, followed by breast pain (69.4%, 59/85) and milk excretion (68.2%, 58/85). Five methods were used to assess lump size and four methods to assess breast pain.

Conclusions The outcomes reported in clinical trials regarding stasis acute mastitis treated by Traditional Chinese Medicine breast massage are heterogeneous. Developing a core outcome set to achieve consistent standards for reporting outcomes and modalities for validation of the outcomes is clearly warranted.

Key words: stasis acute mastitis, Traditional Chinese Medicine breast massage, outcome measure, heterogeneity

Yun-Peng Lv,Ting Yuan,Xiao-Ying Mu,Ying-Yi Fan,Ming-Yang An,Fen Zhou. Heterogeneity of Outcomes Reporting in Trials Evaluating Traditional Chinese Medicine Breast Massage for Stasis Acute Mastitis: A Methodological Review[J].Chinese Medical Sciences Journal, 2023, 38(2): 147-158.

Figures/Tables 3

Figure 1.

Table 1.

Table 2.

An inventory of reported outcomes identified from the 85 included studies categorized according to OMERACT Filter 2.1 conceptual framework"

Items	Outcomes		Measurement methods [no. of studies (%)]	Timing of assessing outcome [no. of studies (%)]	Frequency of assessing outcome [no. of studies (%)]	Measurers [no. of studies (%)]
Items	Description	No. of studies reporting outcome (%)	Measurement methods [no. of studies (%)]	Timing of assessing outcome [no. of studies (%)]	Frequency of assessing outcome [no. of studies (%)]	Measurers [no. of studies (%)]
Manifestations/Abnormality
Breast symptoms	Lump size^{[4,5,13-25,28-33,35-37,39,42-79,81,83-86,88-95]}	76 (89.4)	TCM criteria-2 [17 (20.0)]	After breast massage [49 (57.6)]	1 time/7 d [2 (2.4)]	H [74 (87.1)]
			TCM criteria-1 [7 (8.2)]	During breast massage [24 (28.2)]	2 times/7 d [1 (1.2)]
			Symptom rating [3 (1.5)]
			B-mode ultrasound [1 (1.2)]
			Clinical disease diagnosis, cure and improvement criteria [1 (1.2)]
	Milk excretion^{[4,5,14-20,24-26,28,30,32,34-37,41, 42,44,45,47-53,56,58-60,62-64,66,68,69,71-73,75,77,78, 80-87,90,91,93,95]}	58 (68.2)	TCM criteria-2 [17 (20.0)]	After breast massage [38 (44.7)]	2 time/d [3 (3.5)]	H [56 (65.9)]
			TCM criteria-1 [7 (8.2)]	During breast massage [17 (20.0)]	1 time/d [1 (1.2)]
			Symptom rating [2 (2.4)]		1-2 times/d [1 (1.2)]
			Number of blocked nipple pores [1 (1.2)]		1 time/7 d [3 (3.5)]
	Engorgement^{[14,17,19,22,24,28,29,31,32,35-37, 41,42,44,54,61,63,64,67,68,75,79,82,84-87,94,95]}	30 (35.3)	TCM criteria-2 [1 (1.2)]	After breast massage [18 (21.2)]	1 time/d [1 (1.2)]	H [30 (35.3)]
			Breast swelling score [1 (1.2)]	During breast massage [12 (14.1)]	2 times/d [1 (1.2)]
					1-2 times/d [1 (1.2)]
	Skin color^{[5,14,17,19,24,26-29,32,33,35,41,42, 44,58,61,64,68,72,73,75,79,82,84,86,88,89,93,95]}	30 (35.3)	TCM criteria-2[1 (1.2)]	After breast massage [18 (21.2)]	-	H [28 (32.9)]
			TCM criteria-1 [2 (2.4)]	During breast massage [10 (11.8)]
			Symptom rating [1 (1.2)]
	Skin temperature^{[14,24,29,33,35,44,62,68,69,71,73,75]}	12 (14.1)	Symptom rating [1 (1.2)]	After breast massage [7 (8.2)]	2 times/d[1 (1.2)]	H [13 (15.3)]
			TCM criteria-1 [1 (1.2)]	During breast massage [5 (5.9)]	1 time/7 d[1 (1.2)]
	Nipple skin^{[20,36,39,43,45]}	5 (5.9)	TCM criteria-2 [2 (2.4)]	After breast massage [4 (4.7)]	1 time/7 d[1 (1.2)]
				During breast massage [2 (2.4)]
	Time of lump disappearance in the breast^{[62,66,68,69,74,85,88]}	7 (8.2)	-	After breast massage [7 (8.2)]	1 time/7 d[1 (1.2)]	P^#[5 (5.9)]
	Nipple inversion^[20,36,39]	3 (3.5)	-	During breast massage [2 (2.4)]	-	H [2 (2.4)]
	Enlarged axillary lymph node^[73]	1 (1.2)	TCM criteria-1[1 (1.2)]	After breast massage [1 (1.2)]	-	H [1 (1.2)]
	Time of engorgement relief^[74]	1 (1.2)	-	After breast massage [1 (1.2)]	-	P [1 (1.2)]
	Range of redness^[72]	1 (1.2)	Symptom rating [1 (1.2)]	After breast massage [1 (1.2)]	-	P [1 (1.2)]
	Time of skin temperature reduction^[69]	1 (1.2)	-	After breast massage [1 (1.2)]	-	P [1 (1.2)]
Systemic symptoms	Temperature^{[4,13,15,18-21,23,24,29,33,36, 39-41,48,42-45,54,56,64,71,73,75,82,85,86,91,93,94]}	32 (37.6)	Thermometer [1 (1.2)]	After breast massage [20 (23.5)]; During breast massage [12 (14.1)]	1 time/7 d [1 (1.2)]	P [31 (36.5)]
	Symptom score^{[5,47,50-53,61,71,72,77,79,80,89]}	13 (15.3)	TCM criteria-2 [12 (14.1)]	After breast massage [13 (15.3)]	-	H [12 (14.1)]
	Time of fever reduction^[4,69,74,89]	4 (4.7)	-	After breast massage [2 (2.4)]; During breast massage [1 (1.2)]	1 time/7 d [1 (1.2)]	P [3 (3.5)]
	Time of symptom relief^[66]	1 (1.2)	TCM criteria-1 [1 (1.2)]	After breast massage [1 (1.2)]	-	P [1 (1.2)]
Laboratory outcomes	WBC^{[20,42,55,57-59,62,64,65,68,69,73,74,77,79,88]}	16 (18.8)	Inspection equipment [15 (17.6)]	After breast massage [16 (18.8)]	1 time/7 d [2 (2.4)]	L [15 (17.6)]
	Peripheral blood cells^{[20,42,43,45,54,55,57,69,93]}	9 (10.6)	Inspection equipment [9 (10.6)]	After breast massage [8 (9.4)]; During breast massage [1 (1.2)]	-	L [9 (10.6)]
	CRP^[60,64,68]	3 (3.5)	Inspection equipment [10 (11.8)]	After breast massage [3 (3.5)]	1 time/7 d [2 (2.4)]	L [9 (10.6)]
	Neutrophils^{[55,57,58,73]}	4 (4.7)	Inspection equipment [4 (4.7)]	After breast massage [4 (4.7)]	-	L [4 (4.7)]
	Procalcitonin^[68,77,79]	3 (3.5)	Inspection equipment [3 (3.5)]	After breast massage [3 (3.5)]	-	L [3 (3.5)]
	Interleukin^[74]	1 (1.2)	Inspection equipment [1 (1.2)]	After breast massage [1 (1.2)]	-	L [1 (1.2)]
	TNF-α^[74]	1 (1.2)	Inspection equipment [1 (1.2)]	After breast massage [1 (1.2)]	-	L [1 (1.2)]
	ESR^[40]	1 (1.2)	Inspection equipment [1 (1.2)]	During breast massage [1 (1.2)]	-	L [1 (1.2)]
TCM featured outcomes	Tongue color^[40]	1 (1.2)	-	After breast massage [1 (1.2)]	-	P [3 (3.5)]
	Tongue coating^[40]	1 (1.2)	-	After breast massage [1 (1.2)]	-	H [1 (1.2)]
Adverse events	Pain caused by breast massage^[45]	1 (1.2)	-	After breast massage [1 (1.2)]	-	P [1 (1.2)]
	Skin redness^[89]	1 (1.2)	-	-	-	-
Life impact
Pain	Breast pain^{[13,14,16-19,20,21-26,28,29,31,33-37,39,42,43-45,47,54-58,61-68,70-73,75,79,82-87,89-91, 93-95]}	59 (69.4)	TCM criteria-2 [6 (7.1)]; VAS [7 (8.2)]; symptom rating [1 (1.2)]; TCM criteria-1 [3 (310.5)]	After breast massage [42 (49.4)]; During breast massage [16 (18.8)]	2 times/d [3 (3.5)]; 1 time/d [1 (1.2)]; 1-2 times/d [1 (1.2)]; 1 time/7 d [2 (2.4)]	P [56 (65.9)]
	Swelling pain^{[5,15,18,23,34,37,41,71,74,85,89,90]}	12 (14.1)	Symptom rating [1 (1.2)]; TCM criteria-1 [2 (2.4)]	After breast massage [11 (12.9)]; During breast massage [1 (1.2)]	1 time/7 d [2 (2.4)]	P [12 (14.1)]
	Tender^{[16,19,22,30,32]}	5 (5.9)	-	After breast massage [2 (2.4)]; During breast massage [3 (3.5)]	-	P [5 (5.9)]
	Pressing pain^{[14,28,42,73]}	4 (4.7)	-	After breast massage [2 (2.4)]; During breast massage [2 (2.4)]	-	P [4 (4.7)]
	Headache^[58,71,73]	3 (3.5)	Symptom rating [1 (1.2)]; TCM criteria-1 [1 (1.2)]; TCM criteria-2 [1 (1.2)]	After breast massage [3 (3.5)]	-	P [3 (2.7)]
	Pain duration^[59,69]	2 (2.4)	-	After breast massage [2 (2.4)]	-	P [5 (5.9)]
	Pain in the axillary region^[94]	1 (1.2)	-	During breast massage [1 (1.2)]	-	P [1 (1.2)]
	Pain in the body^[58,71]	2 (2.4)	Symptom rating [1 (1.2)]	After breast massage [2 (2.4)]	-	P [2 (2.4)]
Infant feeding	Rate of continued breastfeeding^{[4,16,36,41,45,47,61,80,86,88,94]}	11 (12.9)	TCM criteria-2 [1 (1.2)]	During breast massage [5 (5.9)]	1 time/7 d [1 (1.2)]	P [9 (10.6)]
				After breast massage [2 (2.4)]	2 times/7 d [1 (1.2)]
	Milk color^[42,86]	2 (2.4)	-	After breast massage [1 (1.2)]; During breast massage [1 (1.2)]	-	P [2 (2.4)]
	Breast milk volume^[20,33]	2 (2.4)	-	During breast massage [2 (2.4)]	-	P [2 (2.4)]
	Infant status^[35]	1 (1.2)	-	After breast massage [1 (1.2)]	-	P [1 (1.2)]
	Duration of breastfeeding^[4]	1 (1.2)	-	During breast massage [1 (1.2)]	-	P [1 (1.2)]
Satisfaction	Recurrence rate^{[16,22,23,27,31,33,41,45,63]}	9 (10.6)	TCM criteria-2 [2 (2.4)]	After breast massage [6 (7.1)]; During breast massage [3 (3.5)]	-	-
	Patients’ satisfaction^[18,75]	2 (2.4)	-	After breast massage [2 (2.4)]	-	P [2 (2.4)]
Emotion	Irritable^[34,73]	2 (2.4)	-	After breast massage [2 (2.4)]	2 times/7 d [1 (1.2)]	P [3 (3.5)]
	Quality of life^[87]	1 (1.2)	NHP [1 (1.2)]	After breast massage [1 (1.2)]	-	P [1 (1.2)]
Activity and relax	Upper arm lifting range, upper/lower extremity function^[94]	1 (1.2)	-	During breast massage [1 (1.2)]	-	P [1 (1.2)]
	Sleep quality^[35]	1 (1.2)	-	After breast massage [1 (1.2)]	-	P [1 (1.2)]
Social/resource use
Cost	Tendency to form abscesses^{[4,14,26,28, 35,48,50,51,53,57,59-61,63,65,67,69,70,72,73,75,76]}	22 (25.9)	B-mode ultrasound [3 (3.5)]	After breast massage [18 (21.2)]; During breast massage [3 (3.5)]	-	H [21 (24.7)]
	Treatment frequency^{[16,21,30,84]}	4 (4.7)	-	During breast massage [4 (4.7)]	1 time/d [1 (1.2)]	P [4 (4.7)]
	Treatment time^{[17,19,27,88]}	4 (4.7)	-	After breast massage [2 (2.4)]; During breast massage time [2 (2.4)]	1-2 times/d [1 (1.2)]	P [4 (4.7)]
	Incision and drainage^[14,35,62]	3 (3.5)	-	After breast massage [3 (3.5)]	-	H [3 (3.5)]
	Average treatment period^[14]	1 (1.2)	-	After breast massage [1 (1.2)]	-	-
	Transfer^[15]	1 (1.2)	-	After breast massage [1 (1.2)]	2 times/d [1 (1.2)]	H [1 (1.2)]

Table 2.

References 99

1	Amir LH, Forster DA, Lumley J, et al. A descriptive study of mastitis in Australian breastfeeding women: incidence and determinants. BMC Public Health 2007 ; 7(1):1-10. doi: 10.1186/1471-2458-7-62. doi: 10.1186/1471-2458-7-62
2	State Administration of Traditional Chinese Medicine. Criteria for the diagnosis and therapeutic effect of TCM diseases and syndromes (ZY/T001.1-001.9-94). Nanjing: Nanjing University Press 1994. p.128-9. Chinese.
3	Lu P, Ye ZQ, Qiu J, et al. Acupoint-tuina therapy promotes lactation in postpartum women with insufficient milk production who underwent caesarean sections. Medicine (Baltimore) 2019 ; 98(35):e16456. doi: 10.1097/MD.0000000000016456. doi: 10.1097/MD.0000000000016456
4	Wang ZY, Gan YX, Song FR, et al. Observation of the effect of massage therapy on patients with lactation mastitis. Contemp Med Forum 2019 ; 17(4):220-2. Chinese. doi: 10.3969/j.issn.2095-7629.2019.04.159. doi: 10.3969/j.issn.2095-7629.2019.04.159
5	Du R, Li YL, Zhao XL, et al. The influence of Chinese medicine’s idea of “treating the untreated” in lactation mastitis nursing. Chin Health Care Nutrition 2019 ; 29(4):161. Chinese. doi: 10.3969/j.issn.1004-7484.2019.04.200. doi: 10.3969/j.issn.1004-7484.2019.04.200
6	Qiu RJ, Zhang XY, Li M, et al. The significance and methods of standardized research on naming of TCM syndrome in the development of core outcome sets. Chin J Tradit Chin Med Pharm 2018 ; 33(6):2240-3. Chinese.
7	Zhang YY, Shen C, Zhang Y, et al. Misunderstanding in using “total effective rate” as an outcome for evaluating the therapeutic effect of Traditional Chinese Medicine. Chin J Drug Evaluat 2020 ; 37(5):337-40. Chinese. doi: 10.3969/j.issn.2095-3593.2020.05.005. doi: 10.3969/j.issn.2095-3593.2020.05.005
8	Williamson PR, Altman DG, Bagley H, et al. The COMET Handbook: version 1.0. Trials 2017 ; 18(Suppl 3):1-50. doi: 10.1186/s13063-017-1978-4. doi: 10.1186/s13063-017-1978-4
9	Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021; 372:n71. doi: 10.1136/bmj.n71. doi: 10.1136/bmj.n71
10	Lv YP, Wang X, Zhou F. Outcome report of breast massage for lactational mastitis patients in early stage: a protocol for systematic review. TMR Int Nurs 2021 ; 4(5):133-9. doi: 10.53388/TMRIN2021082503. doi: 10.53388/TMRIN2021082503
11	Harman NL, Bruce IA, Callery P, et al. MOMENT-management of otitis media with effusion in cleft palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. Trials 2013 ; 14(1):1-8. doi: 10.1186/1745-6215-14-70. doi: 10.1186/1745-6215-14-70
12	Beaton DE, Maxwell LJ, Shea BJ, et al. Instrument selection using the OMERACT filter 2.1: the OMERACT methodology. J Rheumatol 2019 ; 46(8):1028-35. doi: 10.3899/jrheum.181218. doi: 10.3899/jrheum.181218
13	Shengli Oilfield Drilling 57th Brigade Health Center. Tuina and massage therapy for acute mastitis. Baref Doct Magaz 1976(5): 23. Chinese.
14	Xiao CN. Massage for acute mastitis. J Guangxi Med Univ 1984 ; 1(2):35-6. Chinese. doi: 10.16190/j.cnki.45-1211/r.1984.02.009. doi: 10.16190/j.cnki.45-1211/r.1984.02.009
15	Li JT, Liu JS. 50 cases of acute mastitis treated with Tuina. J Zhongyuan Med 1984(4):33. Chinese.
16	Quan Y. Tuina treatment of 47 patients in the early stage of lactation mastitis. Chin Manipulat Qi Gong Therap 1989(1): 21. Chinese. doi: 10.19787/j.issn.1008-1879.1989.01.012. doi: 10.19787/j.issn.1008-1879.1989.01.012
17	Liu FL, Li HM. 86 cases of acute mastitis treated by breast massage. Henan J Tradit Chin Med 1996(3):61. Chinese. doi: 10.16368/j.issn.1674-8999.1996.03.035. doi: 10.16368/j.issn.1674-8999.1996.03.035
18	Yu LX. Experience in the treatment of stasis acute mastitis by breast massage. Chin J Rural Med Pharm 1996(5): 28. Chinese.
19	Hou YH. Massage treatment of acute mastitis 64 cases: efficacy summary. Jiangsu J Tradit Chin Med 1996(11):31. Chinese.
20	Huai SF, Yu QC. Report of 36 cases of acute mastitis treated with Tuina. Chin Manipulat Qi Gong Therap 1997(2):20-1. Chinese. doi: 10.19787/j.issn.1008-1879.1997.02.015. doi: 10.19787/j.issn.1008-1879.1997.02.015
21	Liu GL, Chen YL. Treatment of 140 cases of acute mastitis by massage. J Clin Acup Mox 1997 ; 13(10):37. Chinese. doi: 10.19917/j.cnki.1005-0779.1997.10.035.Chinese. doi: 10.19917/j.cnki.1005-0779.1997.10.035.Chinese
22	Zhang YH. Summary of 15 cases of early acute mastitis treated by patting and kneading method. Chin Manipulat Qi Gong Therap 1998 ; 14(6):31. Chinese. doi: 10.19787/j.issn.1008-1879.1998.06.027. doi: 10.19787/j.issn.1008-1879.1998.06.027
23	Chen YF. Breast massage treatment of 108 cases of lactation mastitis. Nei Mongol J Tradit Chin Med 1998(4):29. Chinese. doi: 10.1604/jcnki.cn15-1101.1998.04.030. doi: 10.1604/jcnki.cn15-1101.1998.04.030
24	Zhang LP, Zhang ZP. Breast massage for lactation mastitis. J Ext Therap Tradit Chin Med 1998 ; 7(2): 9. Chinese.
25	Wang L. 67 cases of acute mastitis treated with Tuina. Shandong J Tradit Chin Med 2000 ; 19(8):479. Chinese.
26	Wang W, Tang CE, Huang YQ. 30 cases of acute mastitis treated with massage. J Hebei Tradit Chin Med Pharmacol 2001 ; 16(2):38. Chinese. doi: 10.16370/j.cnki.13-1214/r.2001.02.024. doi: 10.16370/j.cnki.13-1214/r.2001.02.024
27	Yu XH, Zhang XQ, Guo WQ. Tuina treatment of 22 cases of stasis acute mastitis. Chin Manipulat Qi Gong Therap 2011 ; 17(2):52. Chinese.
28	Hu MX, Hu YJ. 78 cases of stasis acute mastitis treated with acupressure points. China’s Naturop 2002 ; 10(7):20. Chinese. doi: 10.19621/j.cnki.11-3555/r.2002.07.026. doi: 10.19621/j.cnki.11-3555/r.2002.07.026
29	Xi YX, Li LY. 25 cases of acute mastitis treated with Tuina. Heilongjiang J Tradit Chin Med 2002(5):46-7. Chinese.
30	Xie XJ. 54 cases of stasis acute mastitis treated with Tuina. Chin Manipulat Qi Gong Therap 2002 ; 18(2):55-7. Chinese.
31	Xu H, Jia XG. Experience of 28 cases of acute mastitis treated with Tuina. Chin Manipulat Qi Gong Therap 2003 ; 19(3):48-9. Chinese.
32	Wang CL, Zhou LL. Tuina treatment for acute mastitis. J Ext Therap Tradit Chin Med 2005 ; 14(2):44-5. Chinese.
33	Wang GH, Wang XK, Han QG. 18 cases of acute mastitis treated with Tuina plus dredging. Beijing: China Academic Journal Electronic Publishing House 2006. p.127-8. Chinese.
34	Cui RF. Curative effect observation of massage treatment of acute mastitis 47 cases. Chin Manipulat Qi Gong Therap 2007 ; 23(9):42. Chinese.
35	Qin L. Clinical observation of 38 cases of acute mastitis treated by breast massage. Beijing: Chinese Acupuncture and Moxibustion Society 2008. p. 204-6. Chinese.
36	Zhang CL. Application of Tuina methods in acute mastitis. Henan J Surg 2008 ; 15(2):97-8. Chinese.
37	Qi W, Wu LS. 105 cases of acute mastitis treated with point acupressure. J Emerg Tradit Chin Med 2009 ; 18(11):1890-1. Chinese.
38	Qu X, Qu F, Shi YL, et al. Acupressure treatment and nurse of lactation mastitis. Shandong Med J 2010 ; 50(13): 15. Chinese.
39	Zhang DX, Zhao LN, Zhu DS, et al. Efficacy of breast massage in 101 cases of postpartum lactation breast diseases. Beijing J Tradit Chin Med 2010 ; 29(7):550-1. Chinese. doi: 10.16025/j.1674-1307.2010.07.035. doi: 10.16025/j.1674-1307.2010.07.035
40	Qu F, Sun AH, Wang LL. Clinical care of 158 cases of acute mastitis with high fever treated with massage. J Qilu Nurs 2011 ; 17(3): 17. Chinese.
41	Wang DM, Xiu WM, Zheng Q. The efficacy of breast massage in treating 156 cases of acute mastitis. Chin Commun Doct 2011 ; 13(23):207. Chinese. doi: 10.3969/j.issn.1007-614x.2011.23.201. doi: 10.3969/j.issn.1007-614x.2011.23.201
42	Niu B, Zhang JY, Zhang TJ. 50 cases of acute mastitis treated by breast massage. World Chin Med 2012 ; 7(4):341. Chinese.
43	Ling WJ, Qiu P. 120 cases of stasis acute mastitis treated by kneading and pushing breast drainage technique. Acta Med Sinic 2013 ; 26(2):356-8. Chinese.
44	Song RZ, Guo WX, Bao YC. A brief discussion of lactation mastitis treated with breast massage. Contemp Med Symp 2013 ; 11(5): 301. Chinese.
45	Ling WJ. 286 cases of stasis acute mastitis treated by kneading and pushing breast drainage technique. Beijing: China Academic Journal Electronic Publishing House 2013. p.2. Chinese.
46	Yang ST. Experience of 300 cases of acute mastitis treated by TCM massage therapy. Chin J Clin Ration Drug Use 2013 ; 6(29):127. Chinese. doi: 10.15887/j.cnki.13-1389/r.2013.29.014. doi: 10.15887/j.cnki.13-1389/r.2013.29.014
47	Zheng JJ, Qu XY, Shen XY, et al. Clinical observation on acupoint-tuina treatment for beginning of acute mastitis. Liaoning J Tradit Chin Med 2014 ; 41(3):543-4. Chinese. doi: 10.13192/j.issn.1000-1719.2014.03.068. doi: 10.13192/j.issn.1000-1719.2014.03.068
48	Han LL. Clinical experience of breast massage for stasis acute mastitis. World Latest Med Inform 2016 ; 16(60):155-63. Chinese. doi: 10.3696/j.issn.1671-3141.2016.60.117. doi: 10.3696/j.issn.1671-3141.2016.60.117
49	Liang YY, Chang X, Chen YX. A brief discussion on the characteristic painless technique of breast drainage in the treatment of acute mastitis. Med Forum 2020 ; 24(24):3531-2. Chinese. doi: 10.19435/j.1672-1721.2020.24.078. doi: 10.19435/j.1672-1721.2020.24.078
50	Zhou M, Zhao Y, Chen ZW, et al. Clinical observation on the treatment of stasis acute mastitis by kneading and dispersing method. Beijing: China Academic Journal Electronic Publishing House 2013. p.127. Chinese.
51	Zhou M, Zhao ZM, Zhang M, et al. Clinical observation of 32 cases of stasis acute mastitis treated by Tuina rubbing and dispersing method. Jiangsu J Tradit Chin Med 2007 ; 39(4):42-3. Chinese.
52	Liu Y, Sun YT, Yang JC, et al. Clinical study on the treatment of stasis acute mastitis with Tuina and TCM. J Emerg Tradit Chin Med 2008 ; 125(9):1228-9. Chinese.
53	Zhou M, Li X, Cheng YQ, et al. A randomized controlled clinical study on the treatment of stasis acute mastitis by kneading and dispersing method. J Int Med 2009 ; 7(12):1130-3. Chinese. doi: 10.3736/jcim20091207. doi: 10.3736/jcim20091207
54	Ling WJ, Qiu P. The efficacy of kneading and pushing breast drainage technique in the treatment of stasis acute mastitis. J Int Med 2011 ; 34(1):35-6. Chinese. doi: 10.3969/j.issn.1003-0719.2011.01.018. doi: 10.3969/j.issn.1003-0719.2011.01.018
55	Wang H, Guo QY, Liao T. 60 cases of stasis acute mastitis treated with peripheral prick and Tuina. J Ext Therapy Tradit Chin Med 2012 ; 21(5):40-1. Chinese.
56	Zhang FX, Xu LL, Zhu LP. Clinical efficacy of acute mastitis patients after breast massage. Ningxia Med J 2013 ; 35(9):887-8. doi: 10.13621/j.1001-5949.2013.09.015. doi: 10.13621/j.1001-5949.2013.09.015
57	Xu L, Liu J. Clinical observation on the treatment of stasis acute mastitis by combining the method of kneading and dispersing with the method of external application of Chinese medicine. Special Health 2013(12): 93. Chinese.
58	Chu YJ, An R, Sun SQ, et al. Clinical observation of 60 cases of stasis acute mastitis treated by Tuina. Matern Child Health Care Chin 2013; 28(35):5812-3. Chinese.
59	Li YM, Jia KP, Wang YX, Clinical efficacy of modified breast massage in the treatment of stomach heat congestion type acute mastitis. World Chin Med 2015(s1):459-60. Chinese.
60	Wang YY, Lv G, Min J, et al. Clinical observation of Lv’s triple therapy for early acute mastitis. J Emerg Tradit Chin Med 2015 ; 24(4):693-5. Chinese. doi: 10.3969/j.issn.1004-745X.2015.04.046. doi: 10.3969/j.issn.1004-745X.2015.04.046
61	Jiang YC. An overview of the effectiveness of Tuina in the care of stasis acute mastitis in Chinese medicine. New Mom New Born 2017 ; 7(14):55-9. Chinese. doi: 10.3969/j.issn.1671-2242.2017.14.050. doi: 10.3969/j.issn.1671-2242.2017.14.050
62	Wang S, Zhang YY, Li YZ, et al. The efficacy of breast dredging and massage combined with external application of traditional Chinese medicine in the treatment of acute mastitis. Matern Child Health Care Chin 2018; 33(6):1216-8. Chinese. doi: 10.7620/zgfybj.j.issn.1001-4411.2018.06.06. doi: 10.7620/zgfybj.j.issn.1001-4411.2018.06.06
63	Gu XD, Han M, Chen XJ, et al. The efficacy of breast massage combined with Chinese medicine in the treatment of stasis acute mastitis. J Liaoning Univ Tradit Chin Med 2018 ; 20(9):124-6. Chinese. doi: 10.13194/j.issn.1673-842x.2018.09.035. doi: 10.13194/j.issn.1673-842x.2018.09.035
64	Qiu P. Observation on the effect of external application of Chinese medicine combined with breast dredging and massage in the treatment of acute mastitis. Chin J Clin Ration Drug Use 2019 ; 12(19):89-90. Chinese. doi: 10.15887/j.cnki.13-1389/r.2019.19.047. doi: 10.15887/j.cnki.13-1389/r.2019.19.047
65	Huang Y. Clinical observation of 39 cases of stasis acute mastitis treated with kneading and squeezing techniques. Zhejiang J Tradit Chin Med 2019 ; 54(2):126. Chinese. doi: 10.13633/j.cnki.zjtcm.2019.02.030. doi: 10.13633/j.cnki.zjtcm.2019.02.030
66	Guo J. Analysis of the efficacy of extracorporeal shock wave acupoint stimulation in the treatment of acute mastitis. Chin J Urban Rural Ent Hygien 2019 ; 34(8):28-30. Chinese. doi: 10.16286/j.1003-5052.2019.08.011. doi: 10.16286/j.1003-5052.2019.08.011
67	Wen LP, Xie W, Sha Y. Clinical observation of 100 cases of postpartum acute mastitis caused by Qi Zhi Re Yong treated with the combination of knot-unblocking acupuncture and Tuina. Hunan J Tradit Chin Med 2019 ; 35(6):71-2. Chinese. doi: 10.16808/j.cnki.issn1003-7705.2019.06.032. doi: 10.16808/j.cnki.issn1003-7705.2019.06.032
68	Rao T. Application of acupressure combined with drug topical application in acute mastitis. Modern Nurse 2019 ; 26(6):165-6. Chinese.
69	Liu S, Zhao HM, Gao Y. Clinical study on the treatment of acute mastitis by combining breast dredging and massage with external application of traditional Chinese medicine. Chin Med Modern Dist Educ Chin 2019; 17(21):50-2. Chinese. doi: 10.3969/j.issn.1672-2779.2019.21.021. doi: 10.3969/j.issn.1672-2779.2019.21.021
70	Wen LP, Sha Y, Liu YF. Clinical observation of moxibustion combined with Tuina in the treatment of Qi Zhi Re Yong acute mastitis. J Pract Tradit Chin Med 2020 ; 36(8):1085-6. Chinese.
71	Qu X, He PZ, Huang M, et al. Summary of the efficacy and nursing care of acupuncture stone massage lactation therapy with music therapy for patients with stasis acute mastitis. Diet Health 2020 ; 7(1):125-6. Chinese.
72	Li TH, Zhu DS, Zhong X, et al. The efficacy of external application of Ru Tong San plus breast massage in the treatment of patients with stasis acute mastitis. World J Int Tradit West Med 2020 ; 15(12):2173-5. Chinese. doi: 10.13935/j.cnki.sjzx.201204. doi: 10.13935/j.cnki.sjzx.201204
73	Li XC, Zhou FH, Li LL. A study of breast massage with semiconductors for the treatment of acute mastitis. Chin J Urban Rural Ent Hygien 2020 ; 35(5):154-6. Chinese. doi: 10.16286/j.1003-5052.2020.05.061. doi: 10.16286/j.1003-5052.2020.05.061
74	Wang YM. Effectiveness of Chinese medicine external application combined with breast sparing massage in the treatment of acute mastitis. Women’s Health Research 2020(2):106-7. Chinese. doi: 10.16040/j.cnki.cn15-1101.2020.07.065
75	Zhang L. Early acupressure duct sparing combined with breast warming care in first-time mothers with acute mastitis. Henan Med Research 2020 ; 29(18):3419-20. Chinese. doi: 10.3969/j.issn.1004-437X.2020.18.080. doi: 10.3969/j.issn.1004-437X.2020.18.080
76	Chen XL, Lu SY, Wang JZ, et al. Clinical effects of warm acupuncture in the treatment of Gan Yu Qi Zhi acute mastitis. Inner Mong J Tradit Chin Med 2020 ; 39(8):139-40. Chinese. doi: 10.16040/j.cnki.cn15-1101.2020.08.087. doi: 10.16040/j.cnki.cn15-1101.2020.08.087
74	Li J. Effect of Tongru dispersing cream combined with breast massage on WBC, CRP and calcitoninogen in patients with acute mastitis. Inner Mong J Tradit Chin Med 2020 ; 39(7):106-8. Chinese. doi: 10.16040/j.cnki.cn15-1101.2020.07.065.
78	Zhang JH. Clinical study of breast massage combined with reverse compression for the treatment of initial lactation mastitis and puerperal milk stasis. Health Friend 2019(12): 40. Chinese.
79	Bai LH, Zhang YL. Clinical observation on the treatment of acute mastitis by combination of manual lactation and topical application of Mongolian medicine Habudren-9 flavor powder. J Med Pharm Chin Minor 2020 ; 26(2):23-4. doi: 10.16041/j.cnki.cn15-1175.2020.02.013. doi: 10.16041/j.cnki.cn15-1175.2020.02.013
80	Ye YP, Jin AH, Bi DJ, et al. Application of breast massage combined with Chinese medicine oral administration and external fumigation in the treatment of acute mastitis during early lactation. Zhejiang Medical Educ 2021 ; 20(1):42-4. Chinese. doi: 10.3969/j.issn.1672-0024.2021.01.015. doi: 10.3969/j.issn.1672-0024.2021.01.015
81	Chen QL, Bei JH. Analysis on the efficacy of massage combined with pricking collaterals and cupping at back-shuacupoints in the early stage of acute mastitis during lactation. Chin Med Pharm 2021 ; 11(11):76-9. Chinese. doi: 10.3969/j.issn.2095-0616.2021.11.020. doi: 10.3969/j.issn.2095-0616.2021.11.020
82	Chen XJ, Wang YJ, Hu PP. 34 cases of breast discharge by thunder-fire moxibustion in combination with position pushing and kneading techniques for the treatment of stiff lumps in the depressed stage of canker sores. Zhejiang Tradit Chin Med 2021 ; 56(8):606. Chinese. doi: 10.13633/j.cnki.zjtcm.2021.08.037. doi: 10.13633/j.cnki.zjtcm.2021.08.037
83	Hong LQ, Xu JL, Chen MG, et al. A clinical study on the analgesic effect of wrist and ankle acupuncture in acute mastitis based on the “painless concept”. Zhejiang Tradit Chin Med 2022 ; 57(1):42-3. Chinese. doi: 10.13633/j.cnki.zjtcm.2022.01.025. doi: 10.13633/j.cnki.zjtcm.2022.01.025
84	Li J, Han H. Clinical observation on the treatment of acute mastitis mainly by patting method. Chin Manipulat Qi Gong Therap 2001 ; 17(5):15-6. Chinese.
85	Su Y, Fu HP, Zhao J, et al. Clinical observation on treatment of early mastitis by massage of shoulder and neck point. J Nurs Train 2003; 18(2):122-3. Chinese. doi: 10.16821/j.cnki.hsjx.2003.02.014. doi: 10.16821/j.cnki.hsjx.2003.02.014
86	Zhang RQ, Zhang FM, Liu ZT. A study of TCM therapy on treating and preventing acute mastitis. Clin J Chin Med 2014 ; 6(16):92-3. Chinese.
87	Zhang XP. Analysis of the effect of breast massage combined with milk duct lavage in the treatment of stasis acute mastitis. Bao Jian Wen Hui 2022 ; 23(9):110-1. Chinese.
88	Ma MJ. Clinical study on the treatment of acute mastitis by combining breast dredging and massage with external application of traditional Chinese medicine. Jian Kang Zhong Gao 2021(16):143-4. Chinese.
89	Zhang N, Li H. Application of fire-acupuncture and bloodletting therapy in patients with Qi Zhi Re Yong acute mastitis. J Med Forum 2021 ; 42(15):137-9. Chinese.
90	Pu W. The application of breast massage in acute mastitis. Pan Zhi Hua Med 1992 ; 14(1): 64. Chinese.
91	Xu JM. Tuina for acute mastitis. Jiangsu J Tradit Chin Med 1994 ; 15(3): 26. Chinese.
92	Zhang H. Tuina for mastitis. Chin Manipulat Qi Gong Therap 1995 ; 4(3):19. Chinese. doi: 10.19787/j.issn.1008-1879.1995.03.013. doi: 10.19787/j.issn.1008-1879.1995.03.013
93	Zhang LL, Zhang XL, Gao ZY. A sample of professor Zhang Xiaolin’s experience in the treatment of acute mastitis by breast draining massage. Acta Chin Med Pharm 2011 ; 39(6):92-3. Chinese. doi: 10.19664/j.cnki.1002-2392.2011.06.036. doi: 10.19664/j.cnki.1002-2392.2011.06.036
94	Feng YY, Guo YH, Wu J, et al. Professor Yu Juan’s experience in the treatment of acute mastitis with tuina. Chin Manipulat Rehabilitat Med 2017 ; 8(16):29-30. Chinese. doi: 10.19787/j.issn.1008-1879.2017.16.014. doi: 10.19787/j.issn.1008-1879.2017.16.014
95	Feng YH. Treatment of acute mastitis with Tuina. Acup Mass Med 2004 ; 2(3):34-6.
96	Wuytack F, O’Donovan M. Outcomes and outcomes measurements used in intervention studies of pelvic girdle pain and lumbopelvic pain: a systematic review. Chiropr Man Therap 2019; 27(2019):62-74. doi: 10.1186/s12998-019-0279-2. doi: 10.1186/s12998-019-0279-2
97	Heemskerk SCM, Rotteveel AH, Melenhorst J, et al. Heterogeneous outcome reporting in adult slow-transit constipation studies: systematic review towards a core outcome set. J Gastroenterol Hepatol 2020 ; 35(2):192-203. doi: 10.1111/jgh.14818. doi: 10.1111/jgh.14818
98	Zhang Q, Chen YY, Ying XH. Learning from the development of health technology assessment in France, Germany and Netherlands. Chin Health Qual Manage 2011 ; 18(1):4-7. Chinese. doi: 10.13912/j.cnki.chqm.2011.01.006. doi: 10.13912/j.cnki.chqm.2011.01.006
99	Tang M, Geng JS, Liu WB, et al. History and experience of the development of health technology assessment in the world. Chin Hosp Manage 2014 ; 34(4):6-9. Chinese.

Items	Results
Year of publication
1976-1980	1 (1.1)
1981-1990	3 (3.5)
1991-2000	12 (14.1)
2001-2010	21 (24.7)
2011-2020	40 (47.1)
2021-2022	8 (9.4)
Study type
Case series	37 (43.5)
RCT	37 (43.5)
Non-RCT	6 (7.0)
Case report	5 (5.9)
Control
Herbal patching	13 (15.3)
Antibiotic	11 (12.9)
Oral Chinese medicine	4 (4.7)
Physical therapy	4 (4.7)
Acupuncture	4 (4.7)
Others	6 (7.1)
Setting
Western medicine dominated hospital	36 (42.4)
TCM dominated hospital	35 (41.1)
Massage organization	4 (4.7)
Integrative medicine hospitals	3 (3.5)
Community hospital	2 (2.3)
Unclear	5 (5.9)
Department
TCM department^*	15 (17.6)
Non-TCM outpatient clinics	12 (14.1)
Outpatient clinic and breast department/ outpatient clinic	6 (7.1)
Other departments^**	7 (8.2)
Unclear	45 (53.0)

Early edition

Current issue

Archive

Specialties & Topics

Author center

Reviewer center

Heterogeneity of Outcomes Reporting in Trials Evaluating Traditional Chinese Medicine Breast Massage for Stasis Acute Mastitis: A Methodological Review

RichHTML

PDF (PC)

Supplement

Knowledge

Abstract

Cite this article

share this article

Figures/Tables 3

References 99

Related Articles 0

Metrics

Recommended 10