The Role of Acupuncture in Treating Perimenopausal Insomnia: An Overview and Quality Assessment of Systematic Reviews and Meta-Analyses

Figures & data

Figure 1 Flow diagram of the literature search and study selection process.

Table 1 Characteristics of Included Nine SRs/MAs

Authors, Year	Country	Databases Searched	Study Design (n); Participants (n)	Treatment Group	Control Group	Quality Assessment	Outcomes	Major Results
He et al 2021^Citation25	China	①②③	RCTs (n = 27); PMI women (n = 2349)	Acupuncture	(i) hypnotics (or + oryzanol) (ii) HRT	Cochrane Collaboration’s risk of bias tool	(i) PSQI (ii) total clinical effectiveness rate	(i) acupuncture is better than Western medication in improving PMI (ii) incidence of AEs in acupuncture group (3.5%) is lower than that in Western medication group (12.5%)
Li et al 2020^Citation26	China	①②③④⑤⑦⑧⑫	RCTs (n = 10); PMI women (n = 708)	(i) acupuncture (ii) acupuncture + hypnotics (iii) acupuncture + CHM	(i) waitlist control (ii) placebo-acupuncture (iii) hypnotics (iv) CHM	Cochrane Collaboration’s risk of bias tool	(i) PSQI (ii) KI (iii) serum FSH and E2 levels (iv) ISI	(i) acupuncture is effective in improving PMI and other perimenopausal symptoms (ii) acupuncture combined with CHM or Western medication is more effective than CHM or Western medication alone in decreasing FSH level; no significant difference in regulating E2 level between these two groups (iii) no AEs is reported in acupuncture group, while worsening of insomnia is reported in placebo-acupuncture group (10.8%)
Ma et al 2020^Citation27	China	①②③④⑤⑦⑧	RCTs (n = 6); PMI women (n = 453)	(i) acupuncture (ii) acupuncture + CHM	(i) waitlist-control (i) hypnotics (iii) CHM	Cochrane Collaboration’s risk of bias tool	(i) PSQI (ii) AIS (iii) SRSS (iv) KI (v) total clinical effectiveness rate	(i) acupuncture combined with CHM is better than CHM in improving PMI (ii) no significant difference in improving PMI between acupuncture and Western medication
Wang 2021^Citation28	China	①②③	RCTs (n = 12); PMI women (n = 1054)	Acupuncture + CHM	(i) hypnotics (ii) oryzanol	Cochrane Collaboration’s risk of bias tool	Total clinical effectiveness rate	(i) acupuncture combined with CHM is better than Western medication in improving PMI (ii) mild dizziness is reported in acupuncture group, while more AEs such as dry mouth, dizziness, fatigue, rash, etc. is reported in hypnotics; AEs also affected the patients’ treatment compliance
Zhang et al 2016^Citation29	China	①②③④⑤⑦⑧⑬⑭⑯⑰	RCTs (n = 8); PMI women (n = 539)	Acupuncture	(i) hypnotics (or + oryzanol) (ii) CHM (or + oryzanol)	(i) Cochrane Collaboration’s risk of bias tool (ii) GRADE	(i) PSQI (ii) total clinical effectiveness rate	(i) acupuncture is better than either CHM or Western medication in improving PMI (ii) incidence of AEs in acupuncture group (0%) is lower than that in Western medication group (4.2%)
Zhang et al 2012^Citation30	China	①②③④⑤⑦⑧	RCTs (n = 11); PMI women (n = 858)	Acupuncture	(i) hypnotics (or + oryzanol) (ii) CHM (or + oryzanol)	Cochrane Collaboration’s risk of bias tool	(i) PSQI (ii) serum E2 level (iii) total clinical effectiveness rate	(i) acupuncture is better than Western medication in improving PMI (ii) no significant difference in improving PMI between acupuncture and CHM
Zhao et al 2021^Citation11	Australia; China	①②③④⑤⑥⑦⑧⑨⑩⑪⑬⑮	RCTs (n = 15); PMI women (n= 1410)	(i) acupuncture (ii) acupuncture + hypnotics	(i) hypnotics (ii) HRT	(i) Cochrane Collaboration’s risk of bias tool (ii) STRICTA	(i) PSQI (ii) KI (iii) serum FSH, LH and E2 levels (iv) total clinical effectiveness rate	(i) acupuncture alone or acupuncture combined with Western medication is better than Western medication alone in improving PMI and other perimenopausal symptoms (ii) no significant differences were identified between acupuncture and Western medication in regulating either FSH or E2 levels (iii) incidence of AEs in acupuncture group is lower than that in Western medication group
Zhou et al 2020^Citation31	China	①②③⑤⑦⑧	RCTs (n = 12); PMI women (n= 1192)	Acupuncture	(i) placebo-acupuncture (ii) hypnotics (or + oryzanol)	Cochrane Collaboration’s risk of bias tool	(i) PSQI (ii) total clinical effectiveness rate	(i) acupuncture is better than either Western medication or placebo-acupuncture in improving PMI
Jiang et al 2021^Citation32	China	①②③④⑤⑦⑧⑫	RCTs (n = 10); PMI women (n= 879)	Acupuncture	(i) hypnotics (or + oryzanol)	(i) Cochrane Collaboration’s risk of bias tool (ii) GRADE	(i) PSQI (ii) AIS (iii) serum E2 level (iv) HAMD (v) HAMA (vi) total clinical effectiveness rate	(i) acupuncture is better than Western medication in improving PMI (ii) no significant differences were identified between acupuncture and Western medication in regulating E2 level (iii) acupuncture is better than Western medication in improving depression and anxiety due to PMI

Notes: Databases include [①China National Knowledge Infrastructure (CNKI), ②Chongqing VIP database (CQVIP), ③Wanfang database, ④China biomedical literature service system (SinoMed), ⑤Cochrane Central Register of Controlled Trials (CENTRAL), ⑥Sciverse ScienceDirect, ⑦PubMed, ⑧EMBASE, ⑨Springer, ⑩Allied and Complementary Medicine Database (AMED), ⑪PsycINFO (ProQuest), ⑫Web of Science, ⑬ClinicalTrials.gov, ⑭Chinese Clinical Trial Registry (ChiCTR), ⑮World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal, ⑯www.controlled-trials.com (CCT), ⑰Google scholar].

Abbreviations: RCTs, randomized controlled trials; CHM, Chinese herbal medicine; PMI, perimenopausal insomnia; HRT, hormone replacement therapy; AEs, adverse events; PSQI, Pittsburgh Sleep Quality Index; AIS, Athens Insomnia Scale; ISI, Insomnia Severity Index; SRSS, Self-Rating Scale of Sleep; KI, Kupperman Index; HAMA, Hamilton Anxiety Scale; HAMD, Hamilton depression scale; FSH, follicle-stimulating hormone; E2, Estradiol; LH, luteinizing hormone; STRICTA, revised Standards for Reporting Interventions in Clinical Trials of Acupuncture.

Table 2 Critical Appraisal for Methodological Quality of SRs/MAs Based on AMSTAR-2 Checklist

Authors, Year	AMSTAR-2																Quality Assessment
	Q1	Q2	Q3	Q4	Q5	Q6	Q7	Q8	Q9	Q10	Q11	Q12	Q13	Q14	Q15	Q16
He et al 2021^Citation25	Y	N	Y	PY	Y	Y	N	Y	Y	N	Y	Y	Y	Y	Y	Y	CL
Li et al 2020^Citation26	Y	N	Y	PY	Y	Y	N	PY	Y	N	Y	N	Y	Y	N	Y	CL
Ma et al 2020^Citation27	Y	N	Y	PY	Y	Y	N	PY	Y	N	Y	Y	Y	Y	N	Y	CL
Wang 2021^Citation28	Y	N	Y	PY	Y	Y	N	PY	Y	N	Y	Y	Y	Y	Y	N	CL
Zhang et al 2016^Citation29	Y	N	Y	Y	Y	Y	N	PY	Y	N	Y	N	Y	Y	Y	Y	CL
Zhang et al 2012^Citation30	Y	N	Y	PY	Y	Y	N	PY	Y	N	Y	N	Y	Y	N	N	CL
Zhao et al 2021^Citation11	Y	Y	Y	Y	Y	Y	N	Y	Y	Y	Y	Y	Y	Y	Y	Y	L
Zhou et al 2020^Citation31	Y	N	Y	PY	Y	Y	N	PY	Y	N	Y	N	Y	Y	N	Y	CL
Jiang et al 2021^Citation32	Y	N	Y	PY	Y	Y	N	PY	Y	N	Y	Y	Y	Y	Y	N	CL

Abbreviations: Y, yes; PY, partial yes; N, no; CL, critically low; L, low; M, moderate; H, high.

Table 3 Critical Appraisal for Evidence Quality of SRs/MAs Based on GRADE System

Authors, Year	Interventions	Outcomes	Numbers of Studies (Numbers of Participants)	MD/SMD/RR, 95% CI	I^2% (p)	Limitations	Inconsistency	Indirectness	Imprecision	Publication Bias	Quality of Evidence
He et al 2021^Citation25	Acupuncture vs hypnotics (or + oryzanol)/HRT	PSQI	13 (1115)	−0.63 [−0.75, −0.51]	96 (<0.001)	−1^①	−1^②	0	0	−1^⑤	Very low
		Effectiveness rate	20 (1737)	1.85 [1.57, 2.18]	17 (<0.001)	−1^①	0	0	0	−1^⑤	Low
Li et al 2020^Citation26	Acupuncture vs placebo-acupuncture	PSQI	3 (185)	−3.98 [−6.35, −1.61]	92 (0.001)	−1^①	−1^②	0	−1^③	0	Very low
		ISI	2 (149)	−6.05 [−9.44, −2.65]	84 (<0.001)	−1^①	−1^②	0	−1^③	0	Very low
	Acupuncture + hypnotics/CHM vs hypnotics/CHM	Serum FSH level	4 (312)	−11.26 [−12.71, −9.82]	31 (<0.001)	−1^①	0	0	−1^③	0	Low
		Serum E2 level	4 (312)	8.48 [−7.58, 24.54]	97 (0.30)	−1^①	−1^②	0	−1^③	0	Very low
	Acupuncture (or + hypnotics/CHM) vs waitlist control/hypnotics/CHM	PSQI	7 (509)	−3.66 [−4.50, −2.22]	89 (<0.001)	−1^①	−1^②	0	0	0	Low
Ma et al 2020^Citation27	Acupuncture + CHM vs CHM	Effectiveness rate	4 (300)	1.19 [1.08, 1.31]	0 (<0.001)	−1^①	0	0	0	0	Moderate
Wang 2021^Citation28	Acupuncture + CHM vs hypnotics (or oryzanol)	Effectiveness rate	12 (939)	1.10 [1.05, 1.15]	38 (<0.001)	−1^①	0	0	0	0	Moderate
Zhang et al 2016^Citation29	Acupuncture vs hypnotics	PSQI	2 (162)	−4.43 [−5.20, −3.66]	0 (<0.001)	−1^①	0	0	−1^③	−1^④	Very low
	Acupuncture vs hypnotics (or + oryzanol)	Effectiveness rate	4 (292)	4.09 [2.02, 8.28]	0 (<0.001)	−1^①	0	0	−1^③	−1^④	Very low
Zhang et al 2012^Citation30	Acupuncture vs hypnotics/CHM	PSQI	2 (120)	−0.62 [−2.75, 1.51]	81 (0.57)	−1^①	−1^②	0	−1^③	−1^⑤	Very low
		Serum E2 level	2 (180)	33.69 [29.87, 37.50]	0 (<0.001)	−1^①	0	0	−1^③	−1^⑤	Very low
	Acupuncture vs hypnotics/CHM (or + oryzanol)	Effectiveness rate	11 (858)	5.99 [2.32, 15.49]	76 (<0.001)	−1^①	−1^②	0	0	−1^⑤	Very low
Zhao et al 2021^Citation11	Acupuncture vs hypnotics	PSQI	10 (1059)	−2.38 [−3.38, −1.37]	93 (<0.001)	−1^①	−1^②	0	0	0	Low
		KI	4 (274)	−5.95 [−10.68, −1.21]	96 (0.01)	−1^①	−1^②	0	−1^③	0	Very low
		Serum FSH level	3 (366)	−0.53 [−1.45, 0.39]	94 (0.26)	−1^①	−1^②	0	−1^③	0	Very low
		Serum E2 level	3 (366)	0.63 [−0.51, 1.77]	96 (0.28)	−1^①	−1^②	0	−1^③	0	Very low
		Effectiveness rate	10 (1047)	1.10 [1.05, 1.16]	20 (<0.001)	−1^①	0	0	0	0	Moderate
	Acupuncture + hypnotics vs hypnotics	PSQI	3 (208)	−3.13 [−5.43, −0.83]	84 (0.008)	−1^①	−1^②	0	−1^③	0	Very low
Zhou et al 2020^Citation31	Acupuncture vs hypnotics (or + oryzanol)	Effectiveness rate	11 (1102)	2.85 [2.02, 4.04]	37 (<0.001)	−1^①	0	0	0	−1^④	Low
		PSQI	8 (720)	−3.80 [−5.46,-2.14]	97 (<0.001)	−1^①	−1^②	0	0	−1^④	Very low
Jiang et al 2020^Citation32	Acupuncture vs hypnotics (or + oryzanol)	PSQI	8 (737)	−3.46 [−4.95, −1.96]	97 (<0.001)	−1^①	−1^②	0	0	−1^④	Very low
		Effectiveness rate	10 (879)	4.14 [2.66, 6.46]	0 (<0.001)	−1^①	0	0	0	−1^④	Low
		Serum E2 level	3 (374)	1.70 [−7.52, 10.92]	93 (0.72)	−1^①	−1^②	0	−1^③	−1^④	Very low

Notes: GRADE [^①The design of the trial has a large bias in randomization, allocation concealment, blinding or other factors; ^②the confidence interval overlaps less, the heterogeneity test p is very small, the I² is larger, and the heterogeneity could not be completely explained by conducting subgroup analysis, sensitivity analysis, or meta-regression; ^③the confidence interval is not narrow enough;^④funnel graph asymmetry;^⑤fewer studies are included due to incomplete retrieval and there may be a greater risk of publication bias].

Abbreviations: Effectiveness rate, total clinical effectiveness rate; PSQI, Pittsburgh Sleep Quality Index; ISI, Insomnia Severity Index; KI, Kupperman Index; FSH, follicle-stimulating hormone; E2, Estradiol; CHM, Chinese herbal medicine.

Table 4 Critical Appraisal for Reporting Quality of SRs/MAs Based on PRISMA-2009 Statement

Checklist Item	He et al 2021^Citation25	Li et al 2020^Citation26	Ma et al 2020^Citation27	Wang 2021^Citation28	Zhang et al 2016^Citation29	Zhang et al 2012^Citation30	Zhao et al 2021^Citation11	Zhou et al 2020^Citation31	Jiang et al 2020^Citation32
Title
Title	CR	CR	CR	CR	CR	CR	CR	CR	CR
Abstract
Structured summary	CR	CR	CR	CR	CR	CR	CR	CR	CR
Introduction
Rationale	CR	CR	CR	CR	CR	CR	CR	CR	CR
Objectives	CR	CR	CR	CR	CR	CR	CR	CR	CR
Methods
Protocol and registration	UR	UR	UR	UR	UR	UR	CR	UR	UR
Eligibility criteria	CR	CR	CR	CR	CR	CR	CR	CR	CR
Information sources	CR	CR	CR	CR	CR	CR	CR	CR	CR
Search	UR	UR	UR	CR	CR	CR	CR	UR	CR
Study selection	CR	CR	CR	CR	CR	CR	CR	CR	CR
Data collection process	CR	CR	CR	CR	CR	CR	CR	CR	CR
Data items	CR	CR	CR	CR	CR	CR	CR	CR	CR
Risk of bias in individual studies	CR	CR	CR	CR	CR	CR	CR	CR	CR
Summary measures	CR	CR	CR	CR	CR	CR	CR	CR	CR
Synthesis of results	CR	CR	CR	CR	CR	CR	CR	CR	CR
Risk of bias across studies	CR	UR	CR	CR	CR	UR	CR	UR	CR
Additional analyses	CR	UR	CR	CR	PR	CR	CR	UR	CR
Results
Study selection	CR	CR	PR	CR	CR	PR	CR	PR	PR
Study characteristics	PR	PR	PR	PR	PR	PR	CR	PR	PR
Risk of bias within studies	CR	CR	CR	CR	UR	CR	CR	CR	CR
Results of individual studies	CR	CR	CR	CR	CR	CR	CR	CR	CR
Synthesis of results	CR	CR	CR	CR	CR	CR	CR	CR	CR
Risk of bias across studies	CR	UR	PR	CR	CR	UR	CR	PR	CR
Additional analysis	CR	UR	CR	CR	UR	CR	CR	UR	CR
Discussion
Summary of evidence	CR	CR	CR	CR	CR	CR	CR	CR	CR
Limitations	CR	CR	CR	CR	CR	CR	CR	CR	CR
Conclusions	CR	CR	CR	CR	CR	CR	CR	CR	CR
Funding
Funding	CR	CR	CR	UR	CR	UR	CR	CR	UR

Abbreviations: CR, complete report; PR, partial report; UR, unreported.

Figure 2 Veritas plots for the included SRs/MAs. Dashed line shows Veritas score of each SR/MA; solid line shows rank score in each quality dimension of each SR/MA.

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