Hindawi Publishing Corporation Evidence-Based Complementary and Alternative Medicine Volume 2013, Article ID 241027, 10 pages http://dx.doi.org/10.1155/2013/241027
Review Article Moxibustion for the Correction of Nonvertex Presentation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials Qin-hong Zhang,1 Jin-huan Yue,1,2 Ming Liu,3 Zhong-ren Sun,1,2 Qi Sun,1,2 Chao Han,1,2 and Di Wang1,2 1
Department of Acupuncture and Moxibustion, College of Acupuncture and Moxibustion, Heilongjiang University of Chinese Medicine, Harbin 150040, China 2 The Second Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China 3 College of Basic Medical Sciences, Heilongjiang University of Chinese Medicine, Harbin 150040, China Correspondence should be addressed to Zhong-ren Sun; [emailprotected] Received 29 March 2013; Revised 18 June 2013; Accepted 31 July 2013 Academic Editor: Lixing Lao Copyright © 2013 Qin-hong Zhang et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Objectives. This study aims to assess the effectiveness and safety of moxibustion for the correction of nonvertex presentation. Methods. Records without language restrictions were searched up to February 2013 for randomized controlled trials (RCTs) comparing moxibustion with other therapies in women with a singleton nonvertex presentation. Cochrane risk of bias criteria were used to assess the methodological quality of the trials. Results. Seven of 392 potentially relevant studies met the inclusion criteria. When moxibustion was compared with other interventions, a meta-analysis revealed a significant difference in favor of moxibustion on the correction of nonvertex presentation at delivery (risk ratio (RR) 1.29, 95% confidence interval (CI) 1.12 to 1.49, and 𝐼2 = 0). The same findings applied to the cephalic presentation after cessation of treatment (RR 1.36, 95% CI 1.08 to 1.71, and 𝐼2 = 80%). A subgroup analysis that excluded two trials with a high risk of bias also indicated favorable effects (RR 1.63, 95% CI 1.42 to 1.86, and 𝐼2 = 0%). With respect to safety, moxibustion resulted in decreased use of oxytocin. Conclusion. Our systematic review and meta-analysis suggested that moxibustion may be an effective treatment for the correction of nonvertex presentation. Moreover, moxibustion might reduce the need for oxytocin.
1. Introduction Moxibustion is a traditional Chinese medical intervention that utilizes the heat generated by burning herbal preparations containing Artemisia vulgaris (mugwort) to stimulate acupuncture points [1]. It is also believed to be effective in the treatment of stroke rehabilitation [2], pain [3], cancer care [4], ulcerative colitis [5], hypertension [6], osteoarthritis [7], constipation [8], child chronic cough [9], and breech presentation [10]. In China, moxibustion on the Zhiyin (BL67) point, located on the outer corner of the fifth toenail, has long been used to correct nonvertex presentation in obstetrics [11, 12]. Possible mechanisms of action attributed to moxibustion include stimulation of the production of
placental oestrogens, alterations in prostaglandin levels, and promotion of the uterine contractility, which leads to a stimulation of fetal movements and a higher probability of vertex presentation of the fetus [10, 12–14]. Before moxibustion can be recommended for routine clinical use for the correction of non-vertex presentation, evidence from randomized controlled trials is required. Unfortunately, most studies in which the moxibustion has been evaluated are open clinical trials, blinded to neither the practitioner nor the subjects. In moxibustion trials, sham treatments are conducted by adding insulation below the moxa pillar to prevent the transfer of heat from the pillar to the patient [15]. The sham treatment looks similar to the real moxibustion treatment in appearance and burning
2 procedure, and participants are able to smell the smoke or observe the burning moxa [15]. The efficacy of moxibustion for the correction non-vertex presentation has been evaluated in four clinical reviews [23– 26]. All four studies failed to include all of the relevant articles published [23–26]. For example, none of these reviews included the study of Yang and colleagues [16], which met all of the inclusion criteria for each of the four reviews. Additionally, all of these reviews included interventions other than moxibustion including acupuncture [23–26]. Finally, some reviews included controlled clinical trials [23] and quasirandomised controlled trials [24–26] which were poorly executed and might have affected the conclusion of the reviews. The objective of the current review and meta-analysis was to perform a comprehensive literature search to find and evaluate high-quality RCTs. Also, our study aim was to critically evaluate the clinical efficacy and safety of moxibustion therapy alone for the correction of non-vertex presentation (not combined with acupuncture or acupuncture alone).
2. Materials and Methods 2.1. Literature Search. The comprehensive literature search included the following electronic databases: MEDLINE (1950 to February 2013), EMBASE (1980 to February 2013), Cochrane Library (1980 to February 2013), CINAHL (1982 to February 2013), AMED (1985 to February 2013), British Nursing Index (1993 to February 2013), Chinese Biomedical Literature Database (CBM; 1980 to February 2013), China National Knowledge Infrastructure (which includes the database China Academic Journals) (CNKI; 1980 to February 2013), VIP Information (VIP; 1980 to February 2013), Wanfang Data (WAN FANG; 1980 to February 2013), Science paper Online (2006 to February 2013), and 28 major Chinese traditional medicine journals. The following search terms were used: moxibustion OR moxa AND non-vertex presentation or labor presentation or abnormal foetal position or abnormal foetal presentation or podalic presentation or complementary medicine or alternative medicine. We also performed a hand search to identify any other articles. In an attempt to minimize the omission of potentially relevant trials, we also reviewed the reference lists of included articles and relevant reviews for additional eligible studies. Both published and unpublished studies were considered. No language restrictions were imposed. 2.2. Selection of Studies. Potentially relevant studies were independently evaluated by two reviewers (Y. J. H. and Z. Q. H.). Reviewers screened all titles and abstracts when available and they examined the full text if the study met the following inclusion criteria: (a) was a RCT; (b) included a comparison of moxibustion with nonmoxibustion therapy; and (c) included no restriction on the race or gestation of participants with a singleton non-vertex presentation. However, the study with following criteria was excluded: (a) duplication; (b) complex therapy that could not figure out the effect of
Evidence-Based Complementary and Alternative Medicine moxibustion for example, treatment group used moxibustion plus Chinese herbal ointment, while the control group used knee-chest therapy; (c) incomplete data (failed to provide basic characteristics of participants, such as age, gestational week, and duration of intervention); and (d) wrong intervention or comparator that could not evaluate the effect of moxibustion; for example, treatment group used moxibustion plus acupuncture intervention, while control group used moxibustion intervention. Disagreements between the two reviewers were resolved by discussion with a third author (S. Z. R.) to achieve consensus. 2.3. Outcome Measures. In this review, we present the results for the cephalic presentation at birth and after cessation of treatment. In addition, use of oxytocin, Apgar scores less than 7 at 5 minutes, cesarean section, preterm delivery, premature rupture of membranes, intrauterine fetal death, placental abruption, and cord blood pH less than 7.1 were also recorded. 2.4. Data Extraction. Two authors (S. Q. and H. C.) independently extracted data from eligible studies using a predesigned extraction sheet and a third author (W. D.) verified the extracted data. Any discrepancies were settled through discussion. The third review author (W. D.) was consulted if a consensus could not be reached. The extracted data included demographic data, clinical characteristics of the study groups, quality of trial design, inclusion and exclusion criteria, interventions, results, and adverse events. If the required information was not available in the included studies, we contacted the original authors by email. 2.5. Quality of the Studies. The Cochrane risk of bias tool [27] was used to assess methodological quality of the trials. Two authors (Y. J. H. and Z. Q. H.) were independently involved in quality assessment. All discrepancies were resolved by consensus with the other author (L. M.). 2.6. Statistical Analysis. Data were pooled using the randomeffects model. Treatment effect was expressed as a relative risk, and 95% confidence intervals (CIs) were calculated. Heterogeneity was evaluated using Cochrane’s Tau2 , I2 , and Chi2 statistics, and high heterogeneity was assumed if the Tau2 was greater than zero and either the I2 was greater than 30% or 𝑃 value was less than 0.10 in the Chi2 test [27]. Subgroup analysis was conducted to identify and explain heterogeneity. Where possible, a funnel plot was used to assess publication bias. We also performed post hoc sensitivity analysis to test the robustness of the overall effect.
3. Results 3.1. Study Description. We identified 392 potentially relevant articles. Seven RCTs, including a total of 1387 participants, met our inclusion criteria [16–22] (Figure 1). The characteristics of the 7 trials are summarized in Tables 1 and 2. Of those 7 RCTs, four studies were from Western countries and
Evidence-Based Complementary and Alternative Medicine
∙ Electronic databases (n = 335)
3
∙ Registry at www.Clinical Trials.gov (n = 3) ∙ Reference lists of relevant studies or previous reviews and a Web of Science search (n = 54)
Articles identified through literature search (n = 392)
∙ Duplicates excluded (n = 14)
Screening of titles and abstracts (n = 378)
Excluded (n = 244) ∙ Reviews (n = 25) ∙ Recommendations or guidelines (n = 3) ∙ Letters, comments (n = 3) ∙ Animal study (n = 1) ∙ Not related to fetal malposition (n = 32) ∙ Not related to efficacy of moxibustion (n = 116) ∙ Not clinical trial (n = 54) ∙ Case report (n = 8) ∙ Retrospective study (n = 2)
Full-text articles reviewed for eligibility (n = 134)
Excluded (n = 127) ∙ Not an RCT (n = 109) ∙ RCT, but excluded because of complex therapy (n = 4) incomplete data (n = 7) wrong intervention or comparator (n = 7)
Articles included in systematic review and meta-analysis (n = 7)
Figure 1: Flowchart of study selection.
published in English [18–21], while the other three trials were from China [16, 17, 22], one published in English [17] and two in Chinese [16, 22]. Four trials compared moxibustion therapy with observation [17, 18] and usual care [19, 20]. Two studies compared moxibustion therapy with postural techniques [16, 21], and one study compared moxibustion plus postural technique therapy with postural measures [22]. 3.2. Study Quality. The Cochrane risk of bias was presented in Figures 2(a) and 2(b) and Table 3. All seven RCTs reported appropriate sequence generation [16–22]. Six studies conducted concealment of allocation by sealed envelopes [16–21], while one trial did report it [22]. In five studies, moxibustion was either applied at home by participants themselves [17–19, 21] or by practitioners in hospital [16, 20], while the remaining one study did not state who applied the
intervention [22]. In that study, it was not feasible to blind the participant or the therapist. Although the outcome assessor was blinded in only one study [18] and the analyst was blinded to groups in three studies [16, 19, 21], the review authors deemed that the outcomes and their measurements were not likely to be influenced by lack of blinding. Thus, all studies had a low risk of bias with the Cochrane risk of bias tool at blinding levels. Four studies reported complete followup of all subjects [17–21]. One study stated that 7 women from treatment group and 10 women from control group withdrew from the trial [16]. One trial reported that 1 woman was lost to followup in the control group, and 14 women discontinued treatment in the intervention group [18]. The other one did not provide any information of followup [22]. When it comes to selective reporting bias, the trial protocol was available for two trials [19, 21]; however, the other five studies failed to provide it [16–18, 20, 22]. Of those five trans, three studies
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Evidence-Based Complementary and Alternative Medicine Table 1: Main characteristics of included RCTs.
Study
Study design
Patient population
Treatment group
Control group
Outcome measures
Yang et al. [16]
Parallel 2-arm
296 participants
Moxibustion at bilateral BL67; twice daily, 30 min each time, 15 min each side; 7 d course (𝑛 = 147)
Knee-chest therapy; twice daily, 15 min each time (𝑛 = 149)
NCPCT
260 participants
Moxibustion at bilateral BL67; first 87 subjects once daily for 1 week, next 43 women twice daily for 7 d; 30 min each time, 15 min each side (𝑛 = 130)
Observation; once or twice daily for 30 min each time, 15 min each side (𝑛 = 130)
Parallel 2-arm
123 participants
Moxibustion at bilateral BL67; twice daily, 30 min each time, 15 min each side for 1 or 2 wk (𝑛 = 65)
Observation (𝑛 = 58)
Do et al. [19]
Parallel 2-arm
20 participants
Moxibustion at bilateral BL67; twice daily, 20 min each time, 10 min each side for 10 d (𝑛 = 10)
Usual antenatal care for 10 d (𝑛 = 10)
Guittier et al. [20]
Parallel 2-arm
212 participants
Moxibustion at bilateral BL67; three times weekly; 20 min each time, 10 min each side for 2 wk (𝑛 = 106)
Expectant management care (𝑛 = 106)
Vas et al. [21]
Parallel 3-arm
270 participants
Moxibustion at BL67; 20 min each time, 2 wk (𝑛 = 136)
Yang [22]
Parallel 2-arm
206 participants
Moxibustion at bilateral BL67 + knee-chest therapy; 15–20 min, twice daily, 7 d course for 1 wk (𝑛 = 103)
Cardini and Weixin [17]
Parallel 2-arm
Cardini et al. [18]
Knee-chest therapy; 20 min each time, 2 wk (𝑛 = 134) Knee-chest therapy, 15–20 min each time, twice daily, 7 d course for 1 wk (𝑛 = 103)
(i) NCPDE (ii) NCPCT (iii) CS (iv) UO (v) AS (vi) PD (vii) PRM (viii) IFD (i) NCPCT (ii) PRM (iii) PA (i) NCPDE (ii) CS (iii) AS (iv) PD (v) PRM (i) NCPDE (ii) CS (iii) AS (iv) CBPH (i) NCPDE (ii) CS (iii) PD NCPCT
d: day, wk: week, NCPDE: number of cephalic presentations at delivery (excluding external cephalic version), NCPCT: number of cephalic presentations after cessation of treatment, CS: cesarean section, UO: use of oxytocin, AS: Apgar scores 8 cm, before placenta attach to uterine wall Pelvic anomalies, previous uterine Normal fetal surgery, pregnancy-related illness, fetal biometry (biparietal malformation, twin pregnancy, and abdominal fibroma > 4 cm, uterine malformation, 33 wk circumference risk of premature delivery between percentiles (hypercontractility, Bishop 4 or 10 and 90) greater), and tocolysis during pregnancy Nonacceptance of randomization, pelvic anomalies, previous uterine surgery, fetal malformation, uterine 32-33 wk plus Normal fetal malformation, fibroma > 4 cm, twin 3d biometry pregnancy, previous or current tocolysis, and other pregnancy-related complications Twin pregnancy, risk of premature birth, heart or kidney diseases affecting Women were aged the mother, placenta previa, history of greater than 18 years, antepartum haemorrhage, intrauterine at 34–36.5 wk of growth restriction, hypertensive gestation with a disease, isoimmunisation, previous 34–36.5 wk singleton breech uterine operations, uterine anomaly, presentation prelabour rupture of the membranes, (confirmed by multiple pregnancy, fetal congenital ultrasound), and abnormality, contraindication to normal fetal biometry vaginal delivery, and fetal death in utero Single fetus in breech T: 35 ± 0.8 wk presentation between Uterine malformation, placenta C: 34.8 ± 0.7 wk 34 and 36 wk of praevia, and transverse lie gestation Diagnosed by physical examination Multiple pregnancy, bone pelvic and ultrasound; at defects, previous uterine surgery, fetal least 18 years; malformation or chromosomal 33–35 wk of gestation disorder, uterine malformations, risk (confirmed by of preterm birth (preterm uterine 33–35 wk ultrasound); normal contractions and/or initial dilatation fetal biometry and no or shortening of the cervix with a score prior treatment with of 4 on the Bishop scale), uterine moxibustion to fibroids >4 cm, tocolytic therapy, and achieve version of the maternal heart or kidney disease fetus Meet the diagnostic criteria, 30 to 34 wk, informed consent, and voluntary acceptance of the experiment
28–32 wk
T: treatment group, C: control group, S: sham group, y: year, wk: week, d: day.
Not stated
Not stated
6
Evidence-Based Complementary and Alternative Medicine Random sequence generation (selection bias) Allocation concealment (selection bias) Blinding of participants and personnel (performance bias) Blinding of outcome assessment (detection bias) Incomplete outcome data (attrition bias) Selective reporting (reporting bias) Other bias 0
25
50 (%)
75
100
Low risk of bias Unclear risk of bias High risk of bias
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel (performance bias)
Blinding of outcome assessment (detection bias)
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other bias
(a)
Cardini and Weixin, 1998
+
+
+
+
+
+
+
Cardini et al., 2005
+
+
+
+
−
+
−
Do et al., 2011
+
+
+
+
+
+
+
Guittier et al., 2009
+
+
+
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Vas et al., 2013
+
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Yang, 2006
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?
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Yang et al., 2007
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(b)
Figure 2: (a) Risk of bias graph: review authors’ judgments about each risk of bias item presented as percentages across all included studies. (b) Risk of bias summary: review authors’ judgements about each risk of bias item for each included study.
CI 0.13 to 0.60) (Figure 4). No other statistically significant differences were found in the comparison between moxibustion treatment group and nomoxibustion group on Apgar scores less than 7 at 5 minutes, cesarean section, preterm delivery, premature rupture of membranes, intrauterine fetal
death, placental abruption, and cord blood pH less than 7.1 (Figure 4). 3.4. Adverse Events. Three trials reported the adverse events in the moxibustion group [17–19]: two reported two and four
Evidence-Based Complementary and Alternative Medicine Study or subgroup
7
Moxibustion Control Weight Risk ratio M-H, random, 95% CI Events Total Events Total
1.1.1 Cephalic presentation at delivery 62 106 57.7% 98 129 Cardini and Weixin, 1998 Do et al., 2011 0 10 0.2% 10 2 17 106 5.7% 19 106 Guittier et al., 2009 60 134 36.4% 79 136 Vas et al., 2013 356 100.0% 381 Subtotal (95% CI) 139 198 Total events Heterogeneity: 𝜏2 = 0.00; 𝜒2 = 1.06, df = 3 (P = 0.79); I2 = 0% Test for overall effect: Z = 3.52 (P = 0.0004) 1.1.2 Cephalic presentation after treatment 62 130 26.9% 98 130 Cardini and Weixin, 1998 21 58 13.8% 65 22 Cardini et al., 2005 77 103 30.6% 90 103 Yang, 2006 75 149 28.6% Yang et al., 2007 123 147 440 100.0% 445 Subtotal (95% CI) 235 333 Total events Heterogeneity: 𝜏2 = 0.04; 𝜒2 = 14.94, df = 3 (P = 0.002); I2 = 0% Test for overall effect: Z = 2.59 (P = 0.009) 1.1.3 Subanalysis for cephalic presentation after treatment 62 130 42.1% 98 130 Cardini and Weixin, 1998 75 149 57.9% 123 147 Yang et al., 2007 279 100.0% 277 Subtotal (95% CI) 137 221 Total events Heterogeneity: 𝜏2 = 0.00; 𝜒2 = 0.13, df = 1 (P = 0.71); I2 = 0% Test for overall effect: Z = 7.18 (P < 0.00001)
Test for subgroup differences: 𝜒2 = 5.73, df = 2 (P = 0.06), I2 = 65.1%
Risk ratio M-H, random, 95% CI
1.30 [1.08, 1.57] 5.00 [0.27, 92.62] 1.12 [0.62, 2.03] 1.30 [1.02, 1.64] 1.29 [1.12, 1.49]
1.58 [1.29, 1.94] 0.93 [0.58, 1.51] 1.17 [1.02, 1.34] 1.66 [1.40, 1.98] 1.36 [1.08, 1.71]
1.58 [1.29, 1.94] 1.66 [1.40, 1.98] 1.63 [1.42, 1.86]
0.01 0.1 1 10 100 Favours control Favours moxibustion
Figure 3: Effectiveness of moxibustion for the correction of non-vertex presentation.
cases of premature deliveries at 37 weeks, respectively. Four cases of premature rupture of the membranes after treatment were also reported [17]. Another trial noted two cases of premature deliveries and one case of bleeding at week 37 after ECV due to excessive pressure on the rear of the placenta [18]. The third trial recorded two cases of premature deliveries and three cases of prelabour rupture of the membranes [19].
4. Discussion In this systematic review and meta-analysis, moxibustion at point Zhiyin (BL67) is found to be an effective intervention for correcting non-vertex presentation. With respect to safety, there was no significant difference between moxibustion and control group with outcomes of the use of oxytocin, Apgar scores less than 7 at 5 minutes, cesarean section, preterm delivery, premature rupture of membranes, intrauterine fetal death, placental abruption, and cord blood pH less than 7.1. In case of the use of oxytocin, moxibustion resulted in decreased use of it. Previous reviews did not include all relevant trials [23– 26]. For example, all four reviews failed to include the study of Yang and colleagues [16]. Although the newest Cochrane
review (from Coyle and colleagues in January 2012, updated to August 2011) was published within the last two years [26], two high-quality RCTs from Do and colleagues in 2011 and Vas and colleagues in 2013 were not included [19, 21]. Moreover, all these reviews included interventions other than moxibustion. For instance, all four studies included trials, which combined with acupuncture therapy [23–26] or even laser intervention [23]. As we know, moxibustion, acupuncture, and lasers are different interventions. Thus, it is difficult to determine what kind of intervention really works for the correction of non-vertex presentation. We made an effort to identify all relevant trials and included high-quality RCTs. Although one study included in this analysis was of lower quality and resulted in high heterogeneity [22], the subgroup analysis that excluded it still showed a favorable effect of moxibustion for the correction of non-vertex presentation. Our study aims to evaluate the clinical efficacy and safety of moxibustion intervention for the correction of non-vertex presentation, so we only included trials comparing moxibustion with non-moxibustion therapy in participants with non-vertex presentation. Our review has several limitations. Although great efforts were made to retrieve all trials on the subject, there may
8
Evidence-Based Complementary and Alternative Medicine Control Moxibustion Events Total Events Total
Study or subgroup 1.2.1 Use of oxytocin Cardini and Weixin, 1998 Subtotal (95% CI) Total events Heterogeneity: not applicable Test for overall effect: Z = 3.23 (P = 0.001)
7 7
81 81
1.2.2 Apgar scores less than 7 at 5 minutes Cardini and Weixin, 1998 0 130 0 10 Do et al., 2011 Guittier et al., 2009 1 106 Subtotal (95% CI) 246 Total events 1 2 2 Heterogeneity: 𝜏 = 1.98; 𝜒 = 1.97, df = 1 (P = 0.16); I2 = 49% Test for overall effect: Z = 0.94 (P= 0.35) 1.2.3 Cesarean section Cardini and Weixin, 1998 46 130 Do et al., 2011 6 10 68 106 Guittier et al., 2009 69 136 Vas et al., 2013 Subtotal (95% CI) 382 Total events 189 2 2 Heterogeneity: 𝜏 = 0.01; 𝜒 = 3.95, df = 3 (P = 0.27); I = 24% Test for overall effect: Z = 0.63 (P= 0.53) 2 1.2.4 Preterm delivery 2 130 Cardini and Weixin, 1998 Do et al., 2011 2 10 4 136 Vas et al., 2013 Subtotal (95% CI) 276 Total events 8 2 2 Heterogeneity: 𝜏 = 0.00; 𝜒 = 1.49, df = 2 (P = 0.47); I = 0% Test for overall effect: Z = 0.16 (P = 0.87)
25 25
7 0 1 8
47 9 62 78 196
3 0 5 8
1.2.5 Premature rupture of membranes Cardini and Weixin, 1998 12 4 130 Cardini et al., 2005 2 65 0 Do et al., 2011 3 10 0 Subtotal (95% CI) 205 Total events 12 9 Heterogeneity: 𝜏2 = 2.52; 𝜒2 = 5.77, df = 2 (P = 0.06); I = 65% Test for overall effect: Z = 0.38 (P = 0.70) 1.2.6 Intrauterine fetal death Cardini and Weixin, 1998 Subtotal (95% CI) Total events Heterogeneity: not applicable Test for overall effect: Z = 0.67 (P = 0.50) 1.2.7 Placental abruption Cardini et al., 2005 Subtotal (95% CI) Total events Heterogeneity: not applicable Test for overall effect: Z = 0.76 (P = 0.45) 1.2.8 Cord blood pH less than 7.1 Guittier et al., 2009 Subtotal (95% CI) Total events Heterogeneity: not applicable Test for overall effect: Z = 0.96 (P = 0.34)
0 0
0 0
3 3
130 130
1
65 65
1
106 106
1
1
Weight
Risk ratio M-H, random, 95% CI
80 80
100.0% 100.0%
0.28 [0.13, 0.60] 0.28 [0.13, 0.60]
130 10 106 246
49.2% 50.8% 100.0%
0.07 [0.00, 1.16] Not estimable 1.00 [0.06, 15.78] 0.26 [0.02, 4.27]
130 10 106 134 380
19.9% 8.1% 36.5% 35.5% 100.0%
0.98 [0.71, 1.36] 0.67 [0.39, 1.15] 1.10 [0.89, 1.36] 0.87 [0.70, 1.09] 0.95 [0.81,1.12]
130 10 134 274
30.8% 11.4% 57.9% 100.0%
0.67 [0.11,3.92] 5.00 [0.27, 92.62] 0.79 [0.22, 2.87] 0.92 [0.35, 2.47]
130 57 10 197
45.6% 26.5% 28.0% 100.0%
0.33 [0.11, 1.01] 4.39 [0.22, 89.66] 7.00 [0.41, 120.16] 1.55 [0.17, 14.35]
130 130
100.0% 100.0%
0.33 [0.01, 8.11] 0.33 [0.01, 8.11]
57 57
100.0% 100.0%
0.29 [0.01, 7.05] 0.29 [0.01, 7.05]
100.0% 100.0%
3.00 [0.32, 28.38] 3.00 [0.32, 28.38]
1 106 106 1
Test for subgroup differences: 𝜒2 = 12.16, df = 7 (P = 0.10), I2 = 42.4%
0.01
Risk ratio M-H, random, 95% CI
0.1
1
10
100
Favours control Favours moxibustion
Figure 4: Safety of moxibustion for the correction of non-vertex presentation.
be still the possibility of missing studies. In addition, some incomplete information may affect the quality and validity of the results. Finally, a large degree of variability of frequency and duration from three times weekly to once or twice daily might be the possible source of bias.
5. Conclusion The results of our systematic review and meta-analysis showed a positive effect of moxibustion on the correction of non-vertex presentation. In addition, moxibustion might
Evidence-Based Complementary and Alternative Medicine
9
Table 3: Risk of bias of included RCTs. Study
Random sequence generation
Yang et al. [16]
Computer generated
Sealed envelopes
Not stated
Cardini and Weixin [17]
Computer generated
Sealed envelopes
Neither participants nor practitioner was blinded
Cardini et al. [18]
Computer generated
Sealed envelopes
Neither participants nor practitioner was blinded
Do et al. [19]
Computer generated
Sealed envelopes
Not stated
Guittier et al. [20]
Computer generated
Sealed envelopes
Not stated
Vas et al. [21]
Computer generated
Sealed envelopes
Participants in true and sham moxibustion groups were blinded
Table of random numbers
Not stated
Not stated
Yang [22]
Allocation Blinding of participants concealment and personnel
Blinding of outcome assessment
Incomplete outcome data
Selective Other reporting bias
7 subjects from treatment group and 10 subjects from SPUU control group withdrew from the trial Complete followup of all Not stated SPUP subjects 1 subject in control group was lost to followup; 14 Assessor was subjects in intervention SPUP blinded group discontinued treatment 1 subject in control group Study Analyst was was lost to followup, but protocol blinded less than 10% available Complete followup of all Not stated SPUP subjects Study Analyst was Complete followup of all protocol blinded subjects available Followup of all subjects was Not stated SPUU not reported Analyst was blinded
IID NIR; SAF
TIIA
NIR; SAF NIR; SAF NIR; SAF IID
SPUU: study protocol unavailable; unable to determine whether all outcomes were prespecified, SPUP: study protocol unavailable, but published report includes all expected outcomes, IID: insufficient information to determine whether the other bias is present, NIR: no imbalances at randomization, SAF: study appears free of other sources of bias, TIIA: trial was interrupted when interim analysis revealed poor compliance and a high number of treatment interruptions.
reduce the need for oxytocin. More rigorous high-quality RCTs are still needed to evaluate the efficacy as well as safety of moxibustion for the correction of non-vertex presentation in the future.
Conflict of Interests The authors declare that they have no conflict of interests.
Authors’ Contribution Qin-hong Zhang and Jin-huan Yue contributed equally to this paper.
Acknowledgment The study was supported by the Foundation of Heilongjiang University of Traditional Chinese Medicine (nos. 2012RCQ64 and 2012RCL01).
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