Table 2.
Summary of Clinical Trials Investigating the Effects and Safety of Acupuncture on PMI and PMD
| Author/Year | Study Groups/No. of Participants | Disease (Diagnostic System) | TCM Syndrome Pattern | Acupuncture Interventions | Acupoints | Controls | Outcome Measures | Results (Compared with the Control Group) at Post-Treatment | Follow-Up | Adverse Events |
|---|---|---|---|---|---|---|---|---|---|---|
| Fu et al 201751 | - MA/n=37 - placebo-MA/n=37 |
PMI (ICSD-3) | NR | 20 min/day for 10 sessions | BL18, BL23, GB25, LR14 | Streitberger placebo-needle control | PSQI, ISI, PSG (SOL, TST, WASO, SE, Arl, N1%, N2%, N3%, REM%) | (i) Lower PSQI and ISI in MA group (ii) Shorter SOL and WASO, longer TST, higher SE, lower Arl, lower N1%, and higher REM% in MA group; no differences in N2% and N3% between two groups |
No follow-up | - MA/n=0 - placebo-MA/n=4 (worsening of insomnia) |
| Wang 201552 | - EA/n=30 - placebo-EA/n=30 |
PMI (ICSD-3) | NR | 30 min/day, 3 days/week for 8 weeks | BL15, BL18, BL23, CV3, CV4, CV6, CV12, EX-HN3, GV3, GV4, GV14, GV20, HT7, KI3, LR3, PC6, SP6, ST36 | Streitberger placebo-needle control | PSQI, MRS, Men-QoL | No differences in PSQI, MRS and MEN-QoL between two groups | (1) No difference in PSQI and Men-QoL between two groups at 4-week follow-up (2) Lower MRS in EA group at 4-week follow-up |
No adverse events |
| Lin et al 201753 | - MA/n=33 - waitlist-control/n=32 |
PMI (CCMD-3, CDTE-TCM) | NR | 30 min/day, 3 days/week for 4 weeks | CV4, CV6, CV12, EX-HN3, GV20, GV24, HT7, PC6, SP6, ST36 | Waitlist | PSQI, KI | Lower PSQI and KI in MA group | No follow-up | NR |
| Li et al 2020a54 | - EA/n=42 - placebo-EA/n=42 |
PMI (ICSD-3) | Kidney Yin/Yang deficiency | − 30 min/day for 18 days (3 days/week for 4 weeks + 2 day/week for 2 weeks + 1 day/week for 2 weeks) - continuous wave, 2.5 Hz, 4–5 mA |
BL23, CV4, CV6, EX, EX-HN3, GV4, GV20, GV24, HT7, KI3, KI7, SP6 | Streitberger placebo-needle control | PSQI, MEN-QoL, Actigraphy (TST, WASO, SE, ATs, AA), ISI, SAS, SDS | (i) Lower PSQI, ISI, MEN-QoL, SAS in EA group; no differences in SDS between two groups (ii) Longer TST, higher SE, and less AA in EA group; no differences in ATs and WASO between two groups |
Lower PSQI and Men-QoL in EA group at 4- and 12- week follow-ups | - EA/n=2 [mild bleeding (1); mild pain (1)] - placebo-EA/n=1 (mild pain) |
| Wang et al 201555 | - MA/n=33 - sham-MA/n=33 |
PMD (CCMD-3) | NR | 30 min/day, 3 days/week for 8 weeks | KI6, LU7, PC6, SP4 | Sham-MA [shallow puncture (2.5–5 mm), no De-qi, no retention of the needle] | SDS, Men-QoL | Lower SDS and Men-QoL in MA group | (i) Lower SDS in MA group at 4-week follow-up (ii) no difference in Men-QoL between two groups |
NR |
| Li 2015a56 | - EA/n=30 - sham-EA/n=30 - Escitalopram/n=30 |
PMD (ICD-10) | NR | − 30 min/day, 3 days/week for 12 weeks - dense-sparse wave, 10/50 Hz, 0.5–1 mA |
CV4, EX-CA1, EX-HN3, GV20, LI4, LR3, SP6, ST25 | (i) Sham-MA [shallow puncture (3 mm), no De-qi, no current output] (ii) Escitalopram 10 mg/day for 12 weeks |
HAMD, Men-QoL, FSH, E2, LH | (i) Lower HAMD and Men-QoL in EA group, compared with sham-EA; no differences in HAMD and Men-QoL between EA and escitalopram groups (ii) No differences in FSH, LH and E2 levels between two groups (vs sham-EA or vs escitalopram) |
(i) Lower HAMD in EA group in 4-week and 12-week follow-ups (vs sham-EA); no difference in HAMD between EA and escitalopram groups in 4-week and 12-week follow-ups (ii) Lower Men-QoL in EA in 4-week follow-up (vs sham-EA or vs escitalopram); Men-QoL from low to high (EA < escitalopram < sham-EA) at 8-week and 12-week follow-ups |
- EA/n=2 (hematoma) - sham-EA/n=0 - Escitalopram/n=25 [fatigue (17); headache (2); sleep disturbance (7); dizziness (7); palpitation (4); sweating (10); dry mouth (14); constipation (8)] |
| Ma 201797 | - EA/n=37 - Progynova + Medroxyprogesterone acetate/n=36 |
PMI (CCMD-2-R) | NR | − 30 min/day, 3 days/week for 12 weeks - sparse-dense wave, 2/15 Hz |
CV4, EX-CA1, EX-HN3, HT7, SP6, ST25 | A total of 3 treatment cycles. Each treatment cycle includes Progynova 1mg daily for 21 consecutive days (with Medroxyprogesterone acetate 10mg daily added from day 14 to day 21) and then stop medication for 7 days | PSQI, KI, Men-QoL, FSH, E2 | (i) Lower PSQI in EA group; no differences in KI and Men-QoL between two groups (ii) No differences in FSH level between two groups; higher E2 level in EA group |
(i) Lower PSQI in EA group at 12-week follow-up (ii) No differences in KI MENQOL, and FSH and E2 levels between two groups |
- EA/n=3 [hematoma (2); mild dizziness (1)] - Progynova + Medroxyprogesterone acetate/n=4 [breast tenderness (2); mild headache (1); colporrhagia (1)] |
| Chen et al 201357 | - EA/n=38 - Alprazolam/n=32 |
PMI (DSM-IV) | NR | − 30 min/day for 20 days (7 days off every 10 days) - continuous wave, 0.7 Hz |
EX, GV20, HT7, KI3, KI7, KI10, LR3, PC6, SP6, SP9, SP10 | Alprazolam 0.4 mg/day for 20 days | AIS | Lower AIS in EA group | No follow-up | - EA/n=0 - Estazolam/n=8 (development of drug dependence after treatment) |
| Luo 202058 | - MA/n=30 - Estazolam/n=30 |
PMI (CCMD-3, CDTE-TCM) | Incoordination between heart and kidney | 30 min/day, 5 days/week for 12 weeks | BL15, BL23, BL62, EX, EX-HN1, GV20, KI3, KI6, PC6, SP6 | Estazolam 1 mg/day, 3 days/week for 12 weeks | PSQI | No differences in PSQI between two groups | No follow-up | - MA/n=0 - Estazolam/n=5 [dizziness (2); nausea and vomiting (2); skin rashes (1)] |
| Du et al 201759 | - EA/n=41 - Estazolam/n=41 |
PMI (CCMD-3) | NR | − 30 min/day, 6 days/week for 4 weeks - continuous wave, >50 Hz |
PC6, SP6, Sishenzhen (1.5 Cun apart from GV20), Dingshenzhen (0.5 Cun up to EX-HN3, and 0.5 Cun up to GB14) | Estazolam 1 mg/day, 7 days/week for 4 weeks | PSQI, KI, WHOQOL-BREF, FSH, E2 | (i) Lower PSQI and KI, and higher WHOQOL-BREF in EA group (ii) Higher E2 levels, and lower FSH levels in EA group |
No follow-up | - EA/n=6 (mild tension before EA) - Estazolam/n=26 [dizziness (26); daytime sleepiness (26)] |
| Kang 201560 | - MA/n=31 - Estazolam/n=33 |
PMI (CCMD-3) | Heart and Gallbladder Qi deficiency | 40 min/day, 6 days/week for 4 weeks | EX, EX-HN1, GB13, GB15, GV16, GV20, GV24, scalp acupoint (1 Cun up to GB15) | Estazolam 1 mg/day, 7 days/week for 4 weeks | PSQI, KI | Lower PSQI and KI in MA group | No follow-up | - MA/n=0 - Estazolam/n=1 (mild nausea) |
| Lai 201661 | - MA/n=34 - Eszopiclone/n=33 |
PMI (CCMD-3) | Incoordination between heart and kidney | 30 min/day, 6 days/week for 3 weeks (acupuncture on specific time) | BL62, KI6, LU7, SI3 | Eszopiclone 3 mg/day, 7 days/week for 3 weeks | PSQI, KI | (i) Lower KI in MA group; no differences in PSQI between two groups | No follow-up | - MA/n=2 (hematoma) - Eszopiclone/n=3 [dizziness (1); dry mouth (2)] |
| Li 201462 | - MA/n=120 - Estazolam/n=120 |
PMI (CCMD-3) | NR | 30 min/day for 30 days | SP6, SP8, Shenguan (Tianhuangfuxue) | Estazolam 2 mg/day for 30 days | PSQI | Lower PSQI in MA group | No follow-up | NR |
| Li et al 2018a63 | - MA/n=60 - Alprazolam/n=62 |
PMI (CDTE-TCM) | NR | 30–40 min/day, 5 days/week for 9 weeks | BL13, BL15, BL17, BL18, BL20, BL23, HT7 | Alprazolam 0.4–0.8 mg/day, 7 days/week for 9 weeks | PSQI, FSH, E2, LH | (i) Lower PSQI in MA group (ii) Higher E2 levels, and lower FSH and LH levels in MA group |
Follow-up 30 days; NR for valid data | NR |
| Lu et al 201449 | - MA/n=52 - Estazolam/n=52 |
PMI (CCMD-3, ICD-10) | NR | 30 min/day for 30 days | CV12, EX-HN1, GB20, GV20, HT7, LR3, LR14, SP6, SP15 | Estazolam 1 mg/day for 30 days | PSQI | Lower PSQI in MA group | No follow-up | NR |
| Ma 201464 | - EA/n=45 - Estazolam/n=45 |
PMI (CCMD-2) | Any TCM syndrome pattern according to CDTE-TCM | − 30 min/day, 3 days/week for 4 weeks - continuous wave, >50 Hz |
PC6, SP6, Sishenzhen (1.5 Cun apart from GV20), Dingshenzhen (0.5 Cun up to EX-HN3, and 0.5 Cun up to GB14) | Estazolam 1 mg/day, 7 days/week for 4 weeks | PSQI, HAMD | Lower PSQI and HAMD in EA group | No follow-up | No adverse events |
| Qin 201865 | - MA/n=34 - Estazolam/n=33 |
PMI (CCMD-3, ICD-10) | Deficiency of kidney and hyperactivity of liver | 30 min/day, 5 days/week for 4 weeks | BL17, BL18, BL23, EX, EX-HN1, GV20, KI3, LR3 | Estazolam 1–2 mg/day, 7 days/week for 4 weeks | PSQI, HAMA MSMSMS (REM%) | (i) Lower PSQI in MA group (ii) Higher REM% in MA group |
No follow-up | - MA/n=3 (hematoma) - Estazolam/n=7 [dizziness (2); daytime sleepiness (2); fatigue (3)] |
| Yang et al 201766 | - MA/n=81 - Estazolam/n=81 |
PMI (CCMD-2) | Liver and kidney Yin deficiency | 30 min/day, 15 days/month (one treatment every other day) for 3 months | CV12, HT7, KI3, PC6, ST36, ST40, four scalp acupoints (middle 1/3 of frontal apical band, posterior 1/3 of frontal apical band, anterior 1/3 of skull base band, middle 1/3 of skull base band) | Estazolam 1 mg/day, 10 days/month for 3 months | PSQI, FSH, E2, LH | (i) Lower PSQI in MA group (ii) Higher FSH levels, and lower E2 and LH levels in MA group |
No follow-up | NR |
| Zhang et al 201767 | - MA/n=31 - Estazolam/n=30 |
PMI (DTICA, CDTE-TCM) | Six syndrome patterns with liver as the core | 30 min/day, 5 days/week for 4 weeks | BL17, BL18, EX, EX-HN1, GV20, LR3 | Estazolam 1 mg/day, 7 days/week for 4 weeks | PSQI, KI, HAMA, HAMD | Lower PSQI, KI, HAMA and HAMD in MA group | No follow-up | - MA/n=1 (hematoma) - Estazolam/n=4 [dizziness (2); fatigue and daytime sleepiness (2); memory loss (2)] |
| Yan et al 202168 | - MA/n=42 - Estazolam/n=43 |
PMI (CCMD-3) | NR | 30 min/day, 7 days/week for 12 weeks | CV4, CV6, GV20, GV24, HT7, SP6 | Estazolam 1 mg/day, 7 days/week for 12 weeks | PSQI, Men-QoL | Lower PSQI and Men-QoL in MA group | No follow-up | - MA/n=4 [dizziness (3); hematoma (1)] - Estazolam/n=3 [dizziness (1); fatigue and daytime sleepiness (2)] |
| Li et al 2018b69 | - EA/n=116 - Escitalopram/n=105 |
PMD (DSM-V, ICD-10) | NR | − 30 min/day, 3 days/week for 12 weeks - dilatational wave, 50 Hz, 0.5–1 mA |
CV4, EX-CA1, EX-HN3, GV20, LI4, LR3, SP6, ST25 | Escitalopram 10mg/day for 12 weeks | HAMD, Men-QoL, FSH, E2, LH | (i) No differences in HAMD and Men-QoL between two groups (ii) No differences in FSH, E2 and LH levels between two groups |
(i) Lower HAMD in EA group at 4-and 12-week follow-ups (ii) Lower Men-QoL in EA group in 4-, 8-and 12-week follow-ups |
- EA/n=14 (hematoma) - Escitalopram/n=18 (dizziness, palpitation, stomachache) |
| Chi et al 201170 | - MA/n=30 - Fluoxetine/n=30 |
PMD (CCMD-3) | NR | 30 min/day for 4 weeks | EX-HN1, EX-HN3, GV20, KI3, LR3, LR14, SP6, ST36 | Fluoxetine 20 mg/day for 4 weeks | HAMD | Lower HAMD in MA group | No follow-up | - MA/n=0 - Fluoxetine/n=3 [dizziness (1); nausea (2)] |
| Deng 200871 | - MA/n=29 - Deanxit/n=29 |
PMD (ICD-10) | NR | 20–30 min/day, after 3 consecutive days of treatment, once treatment every 3 days for total 4 weeks | CV3, CV4, CV6, CV10, CV12, KI17, Qipang (0.5 Cun beside CV6), Xiafengshidian (1 Cun below and beside ST26) | Deanxit 20mg/day for 4 weeks | HAMD, KI, 5-HT | (i) No differences in HAMD and KI between two groups (ii) No differences in 5-HT levels between two groups |
(i) Lower HAMD in MA at 2-week follow-up (ii) No difference in HAMD between two groups at 4-week follow-up (iii) No difference in KI between two groups at 2-and 4-week follow-ups |
- MA/n=3 [changes of character of stool (2); palpitation (1)] - Deanxit/n=32 [changes of character of stool (6); dry mouth and halitosis (9); dysphoria (6); dreaminess (6); breast distending pain (5)] |
| Dong 201585 | - MA/n=30 - Nilestriol + Fluoxetine/n=30 |
PMD (CCMD-3, CDTE-TCM) | NR | 30 min/day for 30 days | BL13, BL15, BL17, BL18, BL20, BL21, BL23 | Nilestriol 2mg/15days for 30 days + Fluoxetine 20mg/day for 30 days | HAMD | Lower HAMD in MA group | No follow-up | NR |
| Li 2015b72 | - MA/n=32 - Fluoxetine/n=32 |
PMD (CCMD-3) | Liver stagnation and kidney deficiency | 30 min/day, 6 days/week for 12 weeks | BL15, BL18, BL23, EX-HN1, EX-HN3, GV20, GV24, PC6 | Fluoxetine 20mg/day for 12 weeks | HAMD, KI | Lower HAMD and KI in MA group | Follow-up for 12 weeks; no data of HAMD and KI global scores for follow-up | - MA/n=0 - Fluoxetine/n=8 [nausea and vomiting (2); dry mouth (1); indigestion (1); diarrhea (1); dizziness (1); headache (1)] |
| Ma et al 200973 | - MA/n=30 - Fluoxetine/n=30 |
PMD (CCMD-3, CDTE-TCM) | NR | 30 min/day, 5 days/week for 8 weeks | EX-HN1, EX-HN3, GV20, HT7, PC6, PC7, SP6, ST36 | Fluoxetine 20mg/day for 8 weeks | HAMD | No differences in HAMD between two groups | No follow-up | - MA/n=0 - Fluoxetine/n=6 [nausea (2); dizziness (2)] |
| Niu et al 201774 | - MA/n=41 - Fluoxetine/n=41 |
PMD (CCMD-3) | Stagnation of liver Qi | 30 min/day, 5 days/week for 6 weeks | BL13, BL15, BL17, BL18, BL20, BL23 | Fluoxetine 20mg/day for 6 weeks | HAMD | Lower PSQI in MA | No follow-up | - MA/n=7 [dizziness (2); palpitation (1); dry mouth (1); nausea (3)] - Fluoxetine/n=6 [dizziness (1); palpitation (2); dry mouth (2); nausea (1)] |
| Qian et al 200775 | - MA/n=33 - Fluoxetine/n=30 |
PMD (CCMD-3) | NR | 25 min/day, 5 days/week for 6 weeks | BL13, BL15, BL17, BL18, BL20, BL23 | Fluoxetine 20mg/day for 6 weeks | HAMD | No differences in HAMD between two groups | No follow-up | - MA/n=2 [dizziness (1); palpitation (1)] - Fluoxetine/n=9 [insomnia (1); akathisia (1); dry mouth (1); nausea (1); palpitation (1); skin symptom (1); excitation and agitation (2)] |
| Qiang 200876 | - MA/n=30 - Fluoxetine/n=30 |
PMD (CCMD-3) | NR | 25 min/day, 5 days/week for 6 weeks | BL15, BL18, BL23, EX-HN1, GB20 | Fluoxetine 20mg/day for 6 weeks | HAMD | No differences in HAMD between two groups | No follow-up | NR |
| Shi et al 201877 | - EA/n=30 - Escitalopram/n=30 |
PMD (DSM-V) | NR | − 30 min/day, 3 days/week for 12 weeks - dense-sparse wave, 10/50Hz, 0.5–1.0mA |
CV4, EX-CA1, EX-HN3, GV20, LI4, LR3, SP6, ST25 | Escitalopram 10mg/day for 12 weeks | HAMD | Lower HAMD in EA group | Lower HAMD in EA at 4- and 12- week follow-ups | NR |
| Sun et al 201578 | - EA/n=21 - Escitalopram/n=21 |
PMD (DSM-V) | NR | − 30 min/day, 3 days/week for 12 weeks - dense-sparse wave, 10/50Hz, 0.5–1.0mA |
CV4, EX-CA1, EX-HN3, GV20, LI4, LR3, SP6, ST25 | Escitalopram 10mg/day for 12 weeks | HAMD | Lower HAMD in EA group | No follow-up | NR |
| Wang et al 201079 | - MA/n=21 - Deanxit/n=21 |
PMD (CCMD-3) | NR | 30 min/day, after 3 consecutive days of treatment, once treatment every 3 days for total 4 weeks | CV3, CV4, CV6, CV10, CV12, KI17 | Deanxit 10 mg/day for 4 weeks | HAMD | No differences in HAMD between two groups | Lower HAMD in MA at 2- and 4- week follow-ups | - MA/n=3 [changes of character of stool (2); palpitation (1)] - Deanxit/n=15 [dry mouth and halitosis (9); dysphoria, dreaminess, or breast distending pain (6)] |
| Zhang 201086 | - EA/n=44 - Nilestriol+ Fluoxetine/n=46 |
PMD (CCMD-3) | NR | − 30 min/day, 5 days/week for 12 weeks - dilatational wave, 8–9 mA, 6V |
BL13, BL15, BL17, BL20, BL23, GV20, KI3, LR3, PC6, SP6 | Nilestriol 2mg/14 days for 30 days + Fluoxetine 20mg/day for 12 weeks | HAMD, KI, FSH, E2, LH | (i) No differences in HAMD and KI between two groups (ii) No differences in FSH, LH and E2 levels between two groups |
No follow-up | - EA/n=5 (sweating, dizziness, vomiting) - Nilestriol+ Fluoxetine/n=23 [dry mouth and halitosis (5); nausea (6); dysphoria (2); constipation (6); dreaminess (2); breast distending pain (2)] |
| Zhang 201387 | - MA/n=94 - Premarin + Provera + Fluoxetine/n=94 |
PMD (CCMD-3) | NR | 30 min/day, 7 days/week for 12 weeks | EX-HN1, GB13, GV20, GV24, HT7 | Premarin 0.625mg/day and Provera 6mg/day + Fluoxetine 20mg/day for 12 weeks | HAMD, FSH, E2, LH | (i) Lower HAMD in MA group (ii) No differences in FSH, LH and E2 levels between two groups |
No follow-up | - MA/n=2 (feeling pain when inserting needle) - Premarin + Provera + Fluoxetine/n=12 [dizziness (5); nausea and vomiting (4); hypersomnia (3)] |
| Zheng et al 201088 | - MA/n=60 - Premarin + Provera + Fluoxetine/n=60 |
PMD (CCMD-3) | NR | 30 min/day, 7 days/week for 12 weeks [needle retaining time for 8 hour in three acupoints (BL8, GV19, GV21) per session] |
BL8, BL18, BL23, GV19, GV21, KI3, LR3, SP6 | Premarin 0.625mg/day for 20 days + and Provera 6mg/day + Fluoxetine 20mg/day for 12 weeks | HAMD, KI, FSH, E2, LH | (i) No differences in HAMD and KI between two groups (ii) No differences in FSH and LH levels between two groups; Lower E2 level in MA group |
Lower HAMD and KI in MA at 24-week follow-up | - MA/n=2 (feeling pain when inserting needle) - Premarin + Provera + Fluoxetine/n=18 [loss of appetite (5); dizziness (4); diarrhea (3); breast distending pain (3); leukorrhagia (2); spasmus (1)] |
| Ding et al 200780 | - MA/n=39 - Fluoxetine/n=39 |
PMD (CCMD-2-R) | NR | 30 min/day, 6 days/week for 4 weeks | BL15, BL18, BL20, BL23, GV20, HT7, LR3, SP6 | Fluoxetine 20mg/day for 4 weeks | HAMD, KI | No differences in HAMD between two groups; Lower KI in MA group | No follow-up | NR |
| Li et al 2020b81 | - EA/n=30 - Fluoxetine/n=30 |
PMD (CDTE-TCM) | NR | − 25 min/day, 3 days/week for 6 weeks - dilatational wave, 15 Hz, 1 mA |
EX-HN1, EX-HN3, GV20, HT7, LI4, PC6, SP6, ST36 | Fluoxetine 20mg/day for 6 weeks | HAMD, HAMA | No differences in HAMD between two groups; Lower HAMA in EA group | No follow-up | NR |
| Zhang 201582 | - MA/n=29 - Deanxit/n=29 |
PMD (CCMD-3) | NR | 30 min/day, after 3 consecutive days of treatment, once treatment every 3 days for total 4 weeks | CV3, CV4, CV6, CV10, CV12, KI17 | Deanxit 20 mg/day for 4 weeks | HAMD | No differences in HAMD between two groups | Lower HAMD in MA at 2- and 4- week follow-ups | NR |
| Xing 201183 | - MA/n=120 - Fluoxetine/n=120 |
PMD (CCMD-3) | Stagnation of liver Qi, heart and spleen deficiency; liver depression and phlegm-heat | 20 min/day, 7 days/week for 6 weeks | GV26, PC5 | Fluoxetine 20mg/day for 6 weeks | HAMD | No differences in HAMD between two groups | No follow-up | NR |
| Zhou et al 200784 | - MA/n=30 - Fluoxetine/n=28 |
PMD (CCMD-3) | Liver and kidney Yin deficiency, spleen and kidney Yang deficiency, stagnated Qi transforming into fire, stagnation of phlegm and Qi | 30 min/day, 6 days/week for 6 weeks | BL15, BL18, BL23, EX-HN1, GB13, GV24, SP6, ST36 | Fluoxetine 20mg/day for 6 weeks | HAMD, 5-HIAA, NE, DA | (i) Lower HAMD in MA group (ii) No differences in 5-HIAA and NE levels between two groups; Lower DA level in MA group |
No follow-up | NR |
| Gao et al 201489 | - MA + Estazolam/n=32 - Estazolam/n=32 |
PMI (CCMD-3) | NR | 20 min/day, 6 days/week for 4 weeks | EX-B2 | Estazolam 2 mg/day for 4 weeks | PSQI | Lower PSQI in MA + Estazolam group | No follow-up | NR |
| Xu 202090 | - MA + Alprazolam/n=50 - Alprazolam/n=50 |
PMI (CDTE-TCM) | NR | 30 min/day, 7 days/week for 9 weeks | EX-HN1, GV24, HT7, KI3, LR3, PC6, SP6, ST36 | Alprazolam 0.4–0.8 mg/day, 7 days/week for 9 weeks | PSQI | Lower PSQI in MA + Alprazolam group | No follow-up | NR |
| Ma 201691 | - MA + Estazolam/n=35 - Estazolam/n=35 |
PMI (CCMD-3) | NR | 7 days/week for 4 weeks | EX, HT7, KI3, KI7, KI10, LR3, SP6, SP10, ST36 | Estazolam 2 mg/day, 7 days/week for 4 weeks | PSQI, FSH, E2 | (i) Lower PSQI in MA + Estazolam group (ii) Higher E2 levels, and lower FSH levels in MA + Estazolam group |
No follow-up | NR |
| Zhu et al 201692 | - MA + Estazolam/n=37 - Estazolam/n=37 |
PMI (CCMD-3) | Heart and Spleen deficiency | 20 min/day, 5 days/week for 4 weeks | CV12, EX, EX-HN1, GV20, GV24, HT7, KI3, LR3, SP9, ST25 | Estazolam 1 mg/day, 5 days/week for 4 weeks | PSQI | No differences in PSQI between two groups | No follow-up | NR |
| Ma et al 201195 | - EA + Paroxetine/n=55 - Paroxetine/n=50 |
PMD (CCMD-3) | NR | − 45 min/day, 7 days/week for 6 weeks - dilatational wave, 8–9 mA |
EX-HN3, GV20, LI4, PC6, ST36 | Paroxetine 10mg/day for 6 weeks | HAMD | No differences in HAMD between two groups | No follow-up | - EA + Paroxetine/n=2 [dizziness (1); nausea (1)] - Paroxetine/n=3 [dizziness (1); elevated blood pressure (2)] |
| Liu et al 201993 | - MA + Sertraline/n=40 - Sertraline/n=40 |
PMD (CCMD-3, ICD-10) | NR | 30 min/day, 3 days/week for 12 weeks | BL23, CV4, HT7, KI3, LI4, LR3, SP6 | Sertraline 50mg/day for 6 weeks | HAMD, FSH, E2, 5-HT, GABA | (i) Lower HAMD in MA + Sertraline group (ii) Lower FSH level in MA + Sertraline group; higher E2, 5-HT and GABA levels in MA + Sertraline group |
No follow-up | NR |
| Ning 201594 | - MA + Nilestriol + Fluoxetine/n=45 - Nilestriol + Fluoxetine/n=45 |
PMD (Psychiatry textbook) | NR | 30 min/day, 7 days/week for 12 weeks | BL13, BL15, BL18, BL20, BL23, GV20, HT7, KI3, LI4, LR3 | Nilestriol 2mg/15days + Fluoxetine 20mg/day for 12 weeks | HAMD, TESS | Lower HAMD and TESS in MA + Nilestriol + Fluoxetine group | No follow-up | NR |
Abbreviations: NR, no report; MA, manual acupuncture; EA, electroacupuncture; PMI, perimenopausal insomnia; PMD, perimenopausal depression; DSM-IV, Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition); ICSD-3, International classification of sleep disorders (Third Edition); CCMD-2-R, revised Chinese Classification of Mental Disorders (Second Edition); CCMD-3, Chinese Classification of Mental Disorders (Third Edition); ICD-10, International Classification of Diseases (10th edition); DTICA, Guidelines for Diagnosis and Treatment of Insomnia in Chinese Adults (2012 Edition); CDTE-TCM, Criteria of Diagnosis and Therapeutic Effect of Diseases and Syndromes in TCM; PSQI, Pittsburgh Sleep Quality Index; ISI, Insomnia Severity Index; AIS, Athens Insomnia Scale; KI, Kupperman Index; MRS, Menopause Rating Scale; Men-QoL, Menopause-Specific Quality of Life; HAMA, Hamilton Anxiety Scale; HAMD, Hamilton Depression Scale; SAS, Self-Rating Anxiety Scale; SDS, Self-Rating Depression Scale; WHOQOL-BREF, World Health Organization’s quality of life scale-brief form questionnaire; TESS, Treatment Emergent Symptom Scale; PSG, polysomnography; MSMSMS, micromovement sensitive mattress sleep monitoring system; SOL, sleep onset latency; WASO, wake after sleep onset; TST, total sleep time; SE, sleep efficiency; ATs, awakening times; AA, average awakening; ArI, arousal index; REM, rapid eye movement; N1(2, 3, 4), 1st(2nd, 3rd, 4th) period of non-rapid eye movement sleep (NREM); FSH, follicle-stimulating hormone; LH, luteinizing hormone; E2, estradiol; 5-HT, 5-hydroxy tryptamine; NE, norepinephrine; DA, dopamine; GABA, gamma-aminobutyric acid; six syndrome patterns with liver as the core [liver stagnation (stasis); excessive liver fire due to emotional suppression; Disturbance of liver Yang; deficiency of kidney and hyperactivity of liver; liver depression invading the stomach; liver depression invading the heart]; five TCM syndrome patterns according to CDTE-TCM [excessive liver fire due to emotional suppression; disturbance of Heart due to phlegm heat; Yin deficiency leading to excessive fire; Heart and Spleen deficiency; Heart and Gallbladder Qi deficiency]; BL8, Luoque; BL13, Feishu; BL15, Xinshu; BL17, Geshu; BL18, Ganshu; BL20, Pishu; BL21, Weishu; BL23, Shenshu; BL62, Shenmai; CV3, Zhongji; CV3, Zhongji; CV4, Guanyuan; CV6, Qihai; CV10, Xiawan; CV12, Zhongwan; EX, Anmian; EX-B2, Jiaji; EX-CA1, Zigong; EX-HN1, Sishencong; EX-HN3, Yintang; GB13, Benshen; GB14, Yangbai; GB15, Toulinqi; GB20, Fengchi; GB25, Jingmen; GV3, Yaoyangguan; GV4, Mingmen; GV14, Dazhui; GV16, Fengfu; GV19, Houding; GV20, Baihui; GV21, Qianding; GV24, Shenting; GV26, Shuigou; HT7, Shenmen; KI3, Taixi; KI6, Zhaohai; KI7, Fuliu; KI10, Yingu; KI13, Qixue; KI17, Shangqu; LI4, Hegu; LR3, Taichong; LR14, Qimen; LU7, Lieque; PC5, Jianshi; PC6, Neiguan; PC7, Daling; SI3, Houxi; SP4, Gongsun; SP6, Sanyinjiao; SP8, Diji; SP9, Yinlingquan; SP10, Xuehai; SP15, Daheng; ST25, Tianshu; ST26, Wailing; ST36, Zusanli; ST40, Fenglong.