Table 1. Basic Characteristics of the Included Studies

First Author (Year), Country Type of Disease Mean Age (Range) Duration of Disease Sample Size (Male/Female) Unilateral/ Bilateral Experimental Intervention (Regimen) Control Intervention (Regimen) Outcome Measure Adverse Effects
Yang (2001), South Korea18) Recurrent otitis media with effusion 6.5yrs(3-12yrs) ≥3 separate episodes of AOM within a 6-month period (A) 40(B) 50 NR (A) HM (Kami-hyunggyeyungyotang) for 3-4 weeks (adjust dosage according to age) (B) Augmentin, cefzil, suprax 1㏄/㎏ each for 1week, total for 3-4 weeks Pneumatoscopy, Tympanogram, Pure tone audiometry, Pneumatization of temporal bone NR
Jeong (2002), South Korea19) Recurrent otitis media with effusion NR(5-11yrs) NR (A) 7(B) 10 (A) 3/4(B) 7/3 (A) HM (Kami-hyunggyeyungyotang) (B) antibiotics The levels of cytokines NR
Wustrow (2005), Germany22) Acute otitis media (A) 4.4±2.3yrs(0-14yrs)(B) 4.3±2.3yrs (1-10yrs) NR (A) 192 (95/96)(B) 193 (105/85) NR (A) Natural medicine Otovowen® (Echinacea purpurea, Sambucus nigra, Sanguinaria canadensis, Chamomilla recutita, Aconitum napellus, Capsicum annuum, Hydrargyrum cyanatum, Hydrastis canadensis, iodinum, sodium tetraboracicum) plus (B) (B) Conventional treatment (antibiotics, analgesics secretolytics, nasal drops) Time to recovery, Pain resolutionAbsence from school or pre-school nursery (days)Assessment of efficacy and tolerability (6-point Likert scale) NR
Wahl (2008), USA17) Recurrent otitis media 1.3yrs(12-60m) ≥3 separate episodes of AOM within a 6-month period, or 4 episodes in one year (A) 44(B) 46 NR (A) Extract of Echinacea purpurea (root and seed) 0.5㎖ 3 times a day for 3 days at the onset of cold symptoms, followed by 0.25㎖ 3 times for 7 more days (B) 50% ethanol, 45% filtered water, 0.5㎖ 3 times a day for 3 days at the onset of cold symptoms and 0.25㎖ 3 times for 7 more days 1) The occurrence of a first episode of AOM during the study period2) The number of episodes of AOM none
Zhang (2017), China23) Acute otitis media 6.21±1.77yrs(4-13yrs)(A) 6.30±1.70yrs(B) 6.20±1.50yrs (A) 2.20±0.70d(B) 2.10±0.50d (A) 70 (34/36)(B) 70 (32/38) (A) 47/23(B) 53/17 (A) HM (Shufeng Jiedu Capsule) 2-4 capsules 3 times a day (adjust dosage according to age) for 7 days (B) Amoxicillin 40㎎/(㎏*d) 3 times a day for 7 days Clinical symptoms evaluation (Earache, Fever, Tympanic membrane erythema and perforation, Hearing loss) (A) Increased stools (4), mild diarrhea (2)(B) Rash (1), diarrhea (1)
Ito (2017), Japan21) Recurrent acute otitis media 17.8m (8-41m) ≥3 separate episodes of AOM within a 6-month period, or 4 episodes in one year (A) 31 (14/17)(B) 39 (25/14) NR (A) HM (Juzen-taiho-to) powder 0.10–0.25 g/㎏/day 2 times a day for 3 months plus (B) (B) Conventional treatment based on the Japanese guidelines for AOM 1) AOM episodes (instances/month)2) Coryza episodes (instances/month),Antibiotic treatment (days/month),Number of tube insertions,Duration until tube insertion NR
Zhang (2020), China20) Secretory otitis media (A) 5.26±1.03yrs(3-10yrs)(B) 5.13±0.95yrs(3-10yrs) (A) 3.61±1.14m (1-8m)(B) 3.52±1.07m (1-7m) (A) 60(B) 60 (A) 46/14(B) 48/12 (A) HM (Wulingsan addition and subtraction) powder plus Nasonex nasal spray, Eucalyptus ∙Lemon∙Pinene Enteric-coated Soft Capsule for 1 month (B) Tympanic membrane positive and negative pressure treatment (80㎐) 20min/time, 1 time/d plus Nasonex nasal spray, Eucalyptus ∙Lemon∙Pinene Enteric-coated Soft Capsule for 1 month Clinical symptoms Pure tone audiometry Level of fibronectin, NO, immune function indicators NR
Wang (2020), China24) Otitis media with effusion NR (6-12yrs) (2w-6m)(A) 7.3±3.24w(B) 8.7±2.69w (A) 60 (28/32)(B) 60 (26/34) (A) 8/52(B) 2/58 (A) HM (CongertangⅠhaofang or CongertangⅡhaofang addition and subtraction) 100㎖ 2 times a day (adjust additives according to symptoms) for 1 week-3 months Plus eustachian tube blow-up therapy 3 times a day Eustachian tube blow-up therapy 3 times a day(B-1) People with acute infections; Clarithromycin 0.25g 2 times a day, dexamethasone 0.75㎎ 3 times a day for 3-6 days(B-2) People without acute infection; Montelukast sodium 5㎎ 1 time a day, Eucalyptus menthol capsule 0.3g 2 times a day, xylostazoline hydrochloride nasal spray 2 times a day for 5 days, 2 days off, continue to use Clinical symptoms evaluation, Condition of tympanic membrane in otoscope, Audiometry, Tympanogram NR
Xu (2022), China25) Secretory Otitis media (A) 6.55±2.37yrs(3-12yrs)(B) 6.36±2.41yrs(3-12yrs) (A) 3.35±1.62m(3d-6m)(B) 3.58±1.69m(3d-6m) (A) 100 (53/47)(B) 100 (55/45) NR (A) HM (Cangerzisan) 2 times a day (adjust dosage according to age) up to 4 weeks (B) Fluticasone propionate nasal spray 1 spray in each nostril 2 times a dayPlus dexamethasone sodium phosphate and chymotrypsin injection for tympanic injection 1 time a day up to 4 weeks Clinical symptoms evaluationThe levels of IL-6, IL-10, inflammatory factors NR
HM : Herbal Medicine, NR : Not reported, d: days, w: weeks, m: months, yrs: years