| Literature DB >> 30941191 |
Xin-Xin Ye1,2, Yu-Zhen Gao3, Zhong-Bo Xu4, Qi-Xi Liu1, Chen-Ju Zhan1.
Abstract
Auricular therapy (AT) is a conventional therapy in traditional Chinese medicine. However, the effectiveness of perioperative AT in pain treatment after total hip arthroplasty (THA) is still controversial. Nine randomised controlled trials (RCTs) involving 605 patients who have undergone THA with or without AT from inception to March 2018 were collected and included in this study by searching more than 12 databases (e.g., PubMed, Excerpta Medica Database, and Cochrane Library). A random-effects model that pooled seven articles showed that the visual analogue scale (VAS) in the AT group was lower than that of the control group at each postoperative time point in patients after THA, except at the time points of 6 and 36 h. The intraoperative body mass-adjusted fentanyl amount in the AT group was also lower than that of the control group in two trials. The other outcomes (time to first analgesic request and incidence of postoperative nausea and vomiting, perioperative bradycardia, and transitory hypotension) showed insignificant difference. Then, subgroup analysis showed similar results to those of the total articles with the term "VAS". Regression analysis found that the prolonged time after the operation decreased the difference in VAS between the two groups. Although all the outcomes were assessed as very low to low in the GRADE system, evidence on the effectiveness of perioperative AT in pain treatment after total hip replacement was positive.Entities:
Year: 2019 PMID: 30941191 PMCID: PMC6420993 DOI: 10.1155/2019/2979780
Source DB: PubMed Journal: Evid Based Complement Alternat Med ISSN: 1741-427X Impact factor: 2.629
Figure 1Flowchart of study selection. CENTRAL: Cochrane Central Register of Controlled Trials, CNKI: China National Knowledge Infrastructure, VIP: Chinese Scientific Journal Database, and CBM: Chinese Biomedical Literature Database.
The baseline characteristics of included trials.
| First Author, Year, Setting | Study Design | Participants (n) | Age, Mean(years) | Variety of Disease(n) | Main Outcomes |
|---|---|---|---|---|---|
| Sa1Wetzel, 2011, Germany [ | Prospective randomized patient-,anesthesiologist-, evaluator-,analyst-blinded, sham-controlled study | Randomized =120; | AT=66(10); | Degenerative osteoarthritis(116) | Fentanyl amount, adjusted to body mass (mg/kg); |
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| S2Usichenko, 2005 Germany [ | Prospective randomized patient-, anesthesiologist-, evaluator-,analyst-blinded, sham-controlled study | Randomized= 61; | AT=68(10); | Degenerative osteoarthritis(54) | VAS; |
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| S3Usichenko, 2006, Germany [ | Prospective randomized patient-, anesthesiologist-, evaluator-, analyst- blinded, sham-controlled study | Randomized = 64; | AT=68(9); | Degenerative osteoarthritis(57) | Fentanyl amount, adjusted to body mass (mg/kg); |
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| S4Lv, 2017, China [ | Randomized controlled trial | Randomized = 98; | AT=59.8(8.6); | Unilateral femoral intertrochanteric fracture or femoral neck fracture(98) | VAS |
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| S5Kong, 2010, China [ | Randomized controlled trial | Randomized = 60; Completed = 60 AT+C= 30; | NR | NR | VAS |
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| S6Cui, 2016, China [ | Randomized controlled trial | Randomized = 30; Completed = 30; | AT=71(7.8); | Avascular necrosis of the femoral head(16); Femoral intertrochanteric fracture(5); | VAS |
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| S7Xu, 2014, China [ | Prospective, randomized, sham-controlled trial | Randomized = 38; | AT=60.7(8.8); | Femoral head necrosis(38) | VAS; |
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| S8Shen, 2017, China [ | Randomized controlled trial | Randomized = 80; Completed = 80; | AT=65.8(4.6); | Femoral neck fractures(25); old Femoral neck fractures(5); | VAS; |
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| S9Tian, 2016, China [ | Randomized controlled trial | Randomized = 72;Completed = 72; AT = 36; CON=36 | NR | Ankylosing spondylitis(1); femoral head necrosis(43); | VAS |
Abbreviations: AT=auricular therapy; CON=control group; GA= general anesthesia; AA=auricular acupuncture; APBB=auricular point buried-bean; PCA=patient controlled analgesia; NR=not reported; VAS=visual analogue scale; NR: not reported.
The detailed treatments in both groups of included trials.
| First Author, Year, Setting | Intraoperative Anesthesia | Starting Time of AT | AT Group | Control Group | Details of Sham Acupuncture | Preoperative or | Details of Conventional Treatments | |
|---|---|---|---|---|---|---|---|---|
| NSAIDs | Narcotics | |||||||
| Sa1Wetzel, 2011, Germany [ | GA | Preoperative |
| SA+CT | Three nonacupuncture points | Yes, but no name | NR | Preoperative medication such as NSAIDs, Anticonvulsants, Beta-blocking agents and Antihypertensive agents |
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| S2Usichenko, 2005 Germany [ | GA | Preoperative | AA+CT | SA + CT | Four nonacupuncture points | Ibuprofen | PCA pump | PCA pump with piritramide in 48h; |
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| S3Usichenko, 2006, Germany [ | GA | Preoperative |
| SA+CT | Four nonacupuncture points | NR | NR | NR |
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| S4Lv, 2017, China [ | NR | Preoperative | APBB+ CT | CT | NR | NR | Opioid analgesics | Postoperative per two hours for the assessment; Opioid analgesics for those sever pain patients; Ice bag cold compress in pain area; other rehabilitation exercise |
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| S6Cui, 2016, China [ | NR | Postoperative | APBB+ CT | CT | NR | NR | PCA pump | PCA pump in 48 hours; Rehabilitation exercise begin 6 hours after operation |
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| S5Kong, 2010, China [ | NR | Postoperative | APBB+ CT | CT | NR | NR | PCA pump | PCA pump with fentanyl and Lappaconitine in 48 hours; Rehabilitation exercise: Isometric contraction training of quadriceps femoris after 6 hours and Isometric contraction training of gluteus maximus and gluteus medius after 24 hours; Active motion of knee joint after 2 or 3 days |
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| S7Xu, 2014, China [ | GA | Preoperative | APBB+ CT | SA + CT | Nonacupuncture points | Celecoxib | PCA pump | PCA pump with Fentanyl, Tramadol, Tropisetron in 48 hours; |
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| S8Shen,2017, China [ | GA | Preoperative | APBB+ CT | CT | NR | NR | PCA pump | PCA pump with sufentanil and tropisetron in 24 hours; health education |
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| S9Tian, 2016,China [ | GA | Postoperative | APBB+ CT | CT | NR | NR | PCA pump | PCA pump and rehabilitation guidance for every patients |
Abbreviations: AT=auricular therapy; PCA=patient-controlled analgesia; GA= general anesthesia AA=auricular acupuncture; APBB=auricular point buried-bean; SA=sham acupuncture; CT= conventional treatments; RCT=randomized controlled trial; NSAIDs = nonsteroidal anti-inflammatory drugs; NR= not reported. ∗information from the authors' email.
Figure 2Risk of bias graph and summary of the included 9 RCTs.
Figure 3Pooled VAS pain score results in patients after auricular therapy and total hip arthroplasty.
Figure 4Pooled body mass-adjusted Fentanyl amount and time to first analgesic request results in the patients after auricular therapy and total hip arthroplasty.
Figure 5Postoperative nausea and vomiting, perioperative transitory hypotension, and bradycardia results in the patients after auricular therapy and total hip arthroplasty.
Subgroup analysis for the VAS in the patients after THA by Random-Effect Model.
| Variables | Number of points# | Pooled SMD | 95%CI | P-value | I-squared | Tau-squared |
|---|---|---|---|---|---|---|
| Total | 27 | -0.82 | (-1.012,-0.642) | <0.001 | 92.30% | 0.2100 |
| the threshold of Observation Time | ||||||
| 24 hours | ||||||
| <24 hours | 14 | -1.076 | (-1.426,-0.726) | <0.001 | 82.30% | 0.3582 |
| >=24 hours | 13 | -1.375 | (-1.813,-0.938) | <0.001 | 86.40% | 0.5446 |
| 48 hours | ||||||
| <=48 hours | 22 | -1.174 | ( -1.496, -0.853) | <0.001 | 86.10% | 0.4969 |
| >48 hours | 5 | -1.394 | (-1.832,-0.955) | 0.021 | 65.30% | 0.1593 |
| the Grade of quality | ||||||
| A | 1 | 0.000 | (-0.535,0.535 ) | - | - | - |
| B | 4 | -1.000 | (-1.339,-0.660 ) | 0.591 | 0% | 0.0000 |
| C | 22 | -1.311 | (-1.62,-1.001) | <0.001 | 85.70% | 0.4583 |
| the type of Intraoperative anesthesia | ||||||
| GA | 18 | -1.111 | (-1.479,-0.743) | <0.001 | 86.7% | 0.5421 |
| Not reported | 9 | -1.436 | (-1.492,-0.941) | 0.002 | 66.7% | 0.1567 |
| the type of control treatment | ||||||
| SA +CT | 5 | -1.311 | (-1.620,-1.001) | <0.001 | 85.70% | 0.4583 |
| Just CT | 22 | -0.780 | (-1.270,-0.290) | 0.022 | 65.10% | 0.2022 |
| General Analgesics (NASIDs) | ||||||
| Yes | 5 | -0.772 | (-0.172,-0.292) | 0.001 | 65.8% | 0.2045 |
| No | 22 | -1.217 | (-1.492,-0.941) | 0.002 | 85.2% | 0.4583 |
| the starting time of AT | ||||||
| Preoperative | 14 | -1.241 | (-1.071,-1.207 ) | <0.001 | 86.2% | 0.2922 |
| Postoperative | 13 | -1.114 | (-1.221,-1.008) | <0.001 | 83.5% | 0.5877 |
#: The number of points was including the different observation time for the patients after THA. SA=sham acupuncture; CT= conventional treatments; GA= general anesthesia; SMD= standardised mean difference; CI= confidence interval.
Figure 6Metaregression for the VAS pain score in the patients after auricular therapy and total hip arthroplasty (P=0.108).
The GRADE tool for the pooled results of different period in the patients after total hip arthroplasty.
| Outcomes | No. of studies | Quality assessment | Summary of results | Importance | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Risk of Bias | Inconsistency | Indirectness | Imprecision | Publication Bias | No. of patients | 95%CI | Quality | ||||
| Auricular therapy | Control | ||||||||||
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| Pain intensity (VAS-10) | |||||||||||
| At 6h | 2 | Serious(1) | Serious(2) | no | very serious(4)(5) | no | 55 | 55 | SMD -0.74 (-1.80,0.32) | VERY LOW | CRITICAL |
| At 12h | 6 | serious(1) | serious(2) | no | serious(4) | no | 189 | 189 | SMD -1.03 (-1.51,-0.55) | VERY LOW | CRITICAL |
| At 24h | 6 | serious(1) | serious(2) | no | Serious(4) | no | 189 | 189 | SMD -0.95 (-1.53,-0.37) | VERY LOW | CRITICAL |
| At 36h | 3 | serious(1) | serious(2) | no | very serious(4)(5) | no | 93 | 89 | SMD -0.39 (-0.83,0.05) | VERY LOW | CRITICAL |
| At 48h | 5 | serious(1) | serious(2) | no | serious(4) | no | 149 | 149 | SMD -0.89 (-1.48,-0.30) | VERY LOW | CRITICAL |
| At 72h | 3 | serious(1) | no | no | serious(4) | no | 94 | 94 | SMD -0.79 (-0.92,-0.66) | LOW | CRITICAL |
| At 5d | 1 | serious(1) | no | no | serious(4) | no | 30 | 30 | SMD -0.60 (-0.94,-0.26) | LOW | CRITICAL |
| At 7d | 1 | serious(1) | no | no | serious(4) | no | 30 | 30 | SMD -0.68 (-1.01,-0.35) | LOW | CRITICAL |
| Time to first analgesic request (min) | 3 | no | serious(2) | serious(3) | very serious(4)(5) | no | 126 | 124 | SMD20.95. (-11.01,52.9) | VERY LOW | IMPORTANT |
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| Fentanyl amount, adjusted to body mass ( | 2 | no | no | serious(3) | serious(4) | no | 87 | 86 | SMD -0.73 (-1.09,-0.36) | LOW | IMPORTANT |
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| Nausea and vomiting | 3 | no | no | serious(3) | very serious(4)(5) | no | 19/105 | 23/103 | OR 0.72 (0.36,1.46) | VERY LOW | IMPORTANT |
| Bradycardia | 2 | no | no | serious(3) | very serious(4)(5) | no | 14/87 | 12/86 | OR 1.18 (0.51,2.72) | VERY LOW | IMPORTANT |
| Transitory hypotension | 2 | no | no | serious(3) | very serious(4)(5) | no | 36/90 | 35/90 | OR 1.06 (0.58,1.92) | VERY LOW | IMPORTANT |
Note: (1) allocation sequence concealment and blinding are missing, (2) I2>50%, P<0.1, (3) indirectness, (4) insufficient sample size, (5) confidence interval spanning invalid lines.