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

摘要/Abstract

摘要：

目的分析中医手法排乳治疗郁滞期乳痈临床试验中结局指标报告的现状。

方法以乳痈、急性乳腺炎、哺乳期乳腺炎、乳房问题、乳房肿胀、乳汁淤积、乳管阻塞、乳房疼痛、手法排乳及穴位按摩等为检索词，检索CNKI、万方、维普、SinoMed、PubMed、WOS、Embase、Cochrane library、JBI、CINAHL、PsycINFO、Clinical Trials Registry Platform portal、Clinical Trials Registry、Australian New Zealand Clinical Trials Registry、Center Watch Registry等数据库，获取关于中医手法排乳治疗郁滞期乳痈的随机对照临床试验、非随机对照临床试验、病例系列和队列研究。提取结局指标及其测量方案，如测量工具、测量时间、测量频率和测量者等指标。采用腭裂儿童中耳炎积液的管理量表（Management of Otitis Media with Effusion in Children with Cleft Palate，MOMENT）评估每项研究的质量。根据风湿病临床试验结局测量（Outcome Measures in Rheumatology Arthritis Clinic Trials，OMERACT）Filter2.1框架，对纳入研究的结局指标进行分类。

结果纳入的85项临床试验共报告了54项结局指标。质量等级评价显示：81.2%（69/85）的研究为中等，MOMENT平均得分为2.6分；18.8%（16/85）的研究为低等，平均得分为0.9分。所有结局指标分属于OMERACT框架的3个核心领域。肿块大小（76/85）是最常用的结局指标，其次是乳房疼痛（59/85）和乳汁排泄（58/85）。5种方法被用于测定肿块大小，4种工具被用于评估乳房疼痛情况。

结论在中医手法排乳干预郁滞期乳痈的临床试验中，结局指标存在异质性的问题。因此，应构建一套核心结局指标，以实现对此类研究结局及测量方案评价的标准化。

关键词: 郁滞期乳痈, 中医手法排乳, 结局测量, 异质性

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.

图/表 3

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)]

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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)

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