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British Journal of Anaesthesia May 2013Spinal anaesthesia is the primary anaesthetic technique for many types of surgery. Adjuncts to the local anaesthetics (LA) used in spinal anaesthesia can exhibit... (Review)
Review
Spinal anaesthesia is the primary anaesthetic technique for many types of surgery. Adjuncts to the local anaesthetics (LA) used in spinal anaesthesia can exhibit undesirable side-effects, limiting their use, but magnesium may have advantages in this respect. We sought randomized control trials (RCTs) in patients undergoing all types of surgery and in women in labour to compare the effect of intrathecal magnesium sulphate ± LA ± lipophilic opioid (experimental group) with the use of either intrathecal lipophilic opioids ± LA or LA only (control group). The primary outcome was the duration of spinal anaesthesia. Secondary outcomes were: onset and time to maximal sensory blockade, onset of motor block, and duration of sensory and motor blockade. We found 15 RCTs comprising 980 patients. The duration of spinal anaesthesia was significantly increased in the experimental group [standardized mean difference (SMD) -1.05 (-1.70, -0.41) (P = 0.001)], compared with the control group. This increased duration of spinal anaesthesia was seen in non-obstetric studies, SMD -1.38 (-2.11, -0.66) (P = 0.0002), but not in obstetric studies, SMD -0.55 (-1.87, 0.77) (P = 0.41). There was no delay in the onset of sensory or motor blockade. The incidence of hypotension and pruritus was similar in both groups. Heterogeneity was high in all outcome measures. The duration of spinal anaesthesia may be increased by the addition of magnesium to lipophilic opioids ± LA.
Topics: Adjuvants, Anesthesia; Analgesics, Opioid; Anesthesia, Spinal; Anesthetics, Local; Drug Administration Schedule; Humans; Injections, Spinal; Magnesium Sulfate; Randomized Controlled Trials as Topic; Time Factors
PubMed: 23533255
DOI: 10.1093/bja/aet064 -
The Cochrane Database of Systematic... May 2013Magnesium maintenance therapy is one of the types of tocolytic therapy used after an episode of threatened preterm labour (usually treated with an initial dose of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Magnesium maintenance therapy is one of the types of tocolytic therapy used after an episode of threatened preterm labour (usually treated with an initial dose of tocolytic therapy) in an attempt to prevent the onset of further preterm contractions.
OBJECTIVES
To assess whether magnesium maintenance therapy is effective in preventing preterm birth after the initial threatened preterm labour is arrested.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2013).
SELECTION CRITERIA
Randomised controlled trials of magnesium therapy given to women after threatened preterm labour.
DATA COLLECTION AND ANALYSIS
The review authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction. We checked data entry.
MAIN RESULTS
We included four trials involving 422 women. Three trials had high risk of bias and none included any long-term follow-up of infants. No differences in the incidence of preterm birth or perinatal mortality were seen when magnesium maintenance therapy was compared with placebo or no treatment; or alternative therapies (ritodrine or terbutaline). The risk ratio (RR) for preterm birth (less than 37 weeks) for magnesium compared with placebo or no treatment was 1.05, 95% confidence interval (CI) 0.80 to 1.40 (two trials, 99 women); and 0.99, 95% CI 0.57 to 1.72 (two trials, 100 women) for magnesium compared with alternative therapies. The RR for perinatal mortality for magnesium compared with placebo or no treatment was 5.00, 95% CI 0.25 to 99.16 (one trial, 50 infants); and 5.00, 95% CI 0.25 to 99.16 (one trial, 50 infants) for magnesium compared with alternative treatments.Women taking magnesium preparations were less likely to report side effects (RR 0.67, 95% CI 0.47 to 0.96, three trials, 237 women), including palpitations or tachycardia (RR 0.26, 95% CI 0.13 to 0.52, three trials, 237 women) than women receiving alternative therapies. Women receiving magnesium were however, more likely to experience diarrhoea (RR 6.79, 95% CI 1.26 to 36.72, three trials, 237 women).
AUTHORS' CONCLUSIONS
There is not enough evidence to show any difference between magnesium maintenance therapy compared with either placebo or no treatment, or alternative therapies (ritodrine or terbutaline) in preventing preterm birth after an episode of threatened preterm labour.
Topics: Female; Humans; Magnesium Chloride; Magnesium Compounds; Magnesium Oxide; Magnesium Sulfate; Obstetric Labor, Premature; Pregnancy; Premature Birth; Randomized Controlled Trials as Topic; Ritodrine; Terbutaline; Tocolysis; Tocolytic Agents
PubMed: 23728634
DOI: 10.1002/14651858.CD000940.pub3 -
The Cochrane Database of Systematic... Aug 2014Magnesium sulphate has been used in some settings as a tocolytic agent to inhibit uterine activity in women in preterm labour with the aim of preventing preterm birth. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Magnesium sulphate has been used in some settings as a tocolytic agent to inhibit uterine activity in women in preterm labour with the aim of preventing preterm birth.
OBJECTIVES
To assess the effects of magnesium sulphate therapy given to women in threatened preterm labour with the aim of preventing preterm birth and its sequelae.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (last searched 31 January 2014).
SELECTION CRITERIA
Randomised controlled trials of magnesium sulphate as the only tocolytic, administered by any route, compared with either placebo, no treatment or alternative tocolytic therapy (not magnesium sulphate) to women considered to be in preterm labour.
DATA COLLECTION AND ANALYSIS
At least two review authors assessed trial eligibility and risk of bias and undertook data extraction independently.
MAIN RESULTS
The 37 included trials (total of 3571 women and over 3600 babies) were generally of moderate to high risk of bias. Antenatal magnesium sulphate was compared with either placebo, no treatment, or a range of alternative tocolytic agents.For the primary outcome of giving birth within 48 hours after trial entry, no significant differences were seen between women who received magnesium sulphate and women who did not (whether placebo/no alternative tocolytic drug, betamimetics, calcium channel blockers, cox inhibitors, prostaglandin inhibitors, or human chorionic gonadotropin) (19 trials, 1913 women). Similarly for the primary outcome of serious infant outcome, there were no significant differences between the infants exposed to magnesium sulphate and those not (whether placebo/no alternative tocolytic drug, betamimetics, calcium channel blockers, cox inhibitors, prostaglandin inhibitors, human chorionic gonadotropin or various tocolytic drugs) (18 trials; 2187 babies). No trials reported the outcome of extremely preterm birth. In the seven trials that reported serious maternal outcomes, no events were recorded.In the group treated with magnesium sulphate compared with women receiving antenatal placebo or no alternative tocolytic drug, a borderline increased risk of total death (fetal, neonatal, infant) was seen (risk ratio (RR) 4.56, 95% confidence interval (CI) 1.00 to 20.86; two trials, 257 babies); none of the comparisons between magnesium sulphate and other classes of tocolytic drugs showed differences for this outcome (10 trials, 991 babies). The outcomes of neonatal and/or infant deaths and of fetal deaths did not show differences between magnesium sulphate and no magnesium sulphate, whether compared with placebo/no alternative tocolytic drug, or any specific class of tocolytic drug. For most of the other secondary outcomes, there were no significant differences between magnesium sulphate and the control groups for risk of preterm birth (except for a significantly lower risk with magnesium sulphate when compared with barbiturates in one trial of 65 women), gestational age at birth, interval between trial entry and birth, other neonatal morbidities, or neurodevelopmental outcomes. Duration of neonatal intensive care unit stay was significantly increased in the magnesium sulphate group compared with the calcium channel blocker group, but not when compared with cox inhibitors or prostaglandin inhibitors. No maternal deaths were reported in the four trials reporting this outcome. Significant differences between magnesium sulphate and controls were not seen for maternal adverse events severe enough to stop treatment, except for a significant benefit of magnesium sulphate compared with betamimetics in a single trial.
AUTHORS' CONCLUSIONS
Magnesium sulphate is ineffective at delaying birth or preventing preterm birth, has no apparent advantages for a range of neonatal and maternal outcomes as a tocolytic agent and its use for this indication may be associated with an increased risk of total fetal, neonatal or infant mortality (in contrast to its use in appropriate groups of women for maternal, fetal, neonatal and infant neuroprotection where beneficial effects have been demonstrated).
Topics: Female; Fetal Death; Humans; Magnesium Sulfate; Obstetric Labor, Premature; Pregnancy; Premature Birth; Randomized Controlled Trials as Topic; Tocolytic Agents; Treatment Outcome
PubMed: 25126773
DOI: 10.1002/14651858.CD001060.pub2 -
Medicine Jun 2019To compare the clinical efficacy and safety of phloroglucinol (PHL) and magnesium sulfate (MS) in the treatment of threatened abortion through systematic review. (Comparative Study)
Comparative Study Meta-Analysis
BACKGROUND
To compare the clinical efficacy and safety of phloroglucinol (PHL) and magnesium sulfate (MS) in the treatment of threatened abortion through systematic review.
METHODS
Foreign databases, such as the Cochrane Library, PubMed and EMBASE, and Chinese databases, including the China Biology Medicine disc (SinoMed), China National Knowledge Infrastructure (CNKI), Chongqing VIP (VIP) and WanFang Data, were searched. Published randomized controlled trials (RCTs) documents obtained from these databases were included if they were associated with the research objective. The search timeframe was from the beginning of the establishment of each database to May 2018. Document selection, data abstraction and document quality evaluation were independently performed by 2 investigators. A combined analysis of the data was performed for those documents that fulfilled the study requirements; Rev Man 5.3 and Stata 12.0 software were used to compare and analyze the 2 drugs in terms of the total effective rate (TER), rate of adverse events, time required to relieve uterine contractions, onset time, time of complete relief of uterine contraction symptoms, medication duration and length of hospital stay.
RESULTS
A total of 21 RCT trials were included in the present research, according to the inclusion criteria. However, the quality of the included studies was low. The meta-analysis suggested that the TER and drug onset time of PHL were higher than those for MS, while the rate of adverse events, the time required to relieve uterine contractions, time to complete relief of uterine contraction symptoms, drug continuous treatment time and length of hospital stay were shorter than those for MS.
CONCLUSION
The clinical efficacy of PHL is better than that of MS, and PHL obviously results in fewer adverse reactions than MS. However, due to poor quality of evidence, high quality, multi-center RCTs with large samples are required for further verification.
Topics: Abortion, Threatened; Female; Humans; Magnesium Sulfate; Phloroglucinol; Pregnancy; Randomized Controlled Trials as Topic; Reproductive Control Agents
PubMed: 31192955
DOI: 10.1097/MD.0000000000016026 -
BMJ Paediatrics Open May 2024To review the efficacy of nebulised magnesium sulfate (MgSO) in acute asthma in children. (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To review the efficacy of nebulised magnesium sulfate (MgSO) in acute asthma in children.
METHODS
The authors searched Medline, Embase, Web of Science and Cochrane Library for randomised controlled trials (RCTs) published until 15 December 2023. RCTs were included if they compared the efficacy and safety of nebulised MgSO as a second-line agent in children presenting with acute asthma exacerbation. A random-effects meta-analysis was performed, and the Risk of Bias V.2 tool was used to assess the biases among them.
RESULTS
10 RCTs enrolling 2301 children with acute asthma were included. All trials were placebo controlled and administered nebulised MgSO/placebo and salbutamol (±ipratropium bromide). There was no significant difference in Composite Asthma Severity Score between the two groups (6 RCTs, 1953 participants; standardised mean difference: -0.09; 95% CI: -0.2 to +0.02, I=21%). Children in the MgSO group have significantly better peak expiratory flow rate (% predicted) than the control group (2 RCTs, 145 participants; mean difference: 19.3; 95% CI: 8.9 to 29.8; I=0%). There was no difference in the need for hospitalisation, intensive care unit admission or duration of hospital stay. Adverse events were minor, infrequent (7.3%) and similar among the two groups.
CONCLUSIONS
There is low-certainty evidence that nebulised MgSO as an add-on second-line therapy for acute asthma in children does not reduce asthma severity or a need for hospitalisation. However, it was associated with slightly better lung functions. The current evidence does not support the routine use of nebulised MgSO in paediatric acute asthma management.
PROSPERO REGISTRATION NUMBER
CRD42022373692.
Topics: Humans; Magnesium Sulfate; Asthma; Child; Nebulizers and Vaporizers; Acute Disease; Administration, Inhalation; Bronchodilator Agents; Randomized Controlled Trials as Topic; Anti-Asthmatic Agents
PubMed: 38782483
DOI: 10.1136/bmjpo-2024-002638 -
The Cochrane Database of Systematic... May 2014A number of tocolytics have been advocated for the treatment of threatened preterm labour in order to delay birth. The rationale is that a delay in birth may be... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
A number of tocolytics have been advocated for the treatment of threatened preterm labour in order to delay birth. The rationale is that a delay in birth may be associated with improved neonatal morbidity or mortality. Nitric oxide donors, such as nitroglycerin, have been used to relax the uterus. This review addresses their efficacy, adverse effects and influence on neonatal outcome.
OBJECTIVES
To determine whether nitric oxide donors administered in threatened preterm labour are associated with a delay in birth, adverse effects or improved neonatal outcome.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 December 2013).
SELECTION CRITERIA
Randomised controlled trials of nitric oxide donors administered for tocolysis.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial quality and extracted data.
MAIN RESULTS
Twelve trials, including a total of 1227 women at risk of preterm labour, contributed data to this updated review. The methodological quality of trials was mixed; trials comparing nitric oxide donors with other types of tocolytics were not blinded and this may have had an impact on findings.Three studies compared nitric oxide donors (glyceryl trinitrate (GTN)) with placebo. There was no significant evidence that nitric oxide donors prolonged pregnancy beyond 48 hours (average risk ratio (RR) 1.19, 95% confidence interval (CI) 0.74 to 1.90, two studies, 186 women), and although for most adverse effects there was no significant difference between groups, women in the active treatment group in one study were at higher risk of experiencing a headache. For infant outcomes there was no significant evidence that nitric oxide donors reduced the risk of neonatal death or serious morbidity (stillbirth RR 0.36, 95% CI 0.01 to 8.59, one study, 153 infants; neonatal death RR 0.43, 95% CI 0.06 to 2.89, two studies, 186 infants). One study, using a composite outcome, reported a reduced risk of serious adverse outcomes for infants in the GTN group which approached statistical significance (RR 0.29, 95% CI 0.08 to 1.00, 153 infants). Overall, these studies were underpowered to identify differences between groups for most outcomes.When nitric oxide donors were compared with other tocolytic drugs there was no significant evidence that nitric oxide donors performed better than other tocolytics (betamimetics, magnesium sulphate, a calcium channel blocker or a combination of tocolytics) in terms of pregnancy prolongation, although nitric oxide donors appeared to be associated with a reduction in most adverse effects, apart from headache. There was no significant difference between groups for infant morbidity or mortality outcomes.
AUTHORS' CONCLUSIONS
There is currently insufficient evidence to support the routine administration of nitric oxide donors in the treatment of threatened preterm labour.
Topics: Female; Humans; Nitric Oxide Donors; Nitroglycerin; Obstetric Labor, Premature; Pregnancy; Randomized Controlled Trials as Topic; Tocolysis; Tocolytic Agents
PubMed: 24809331
DOI: 10.1002/14651858.CD002860.pub2 -
Journal of Caring Sciences Mar 2020Primary dysmenorrhea is considered as one of the main problems in women. This review study aimed to characterize the effect of micronutrients on primary dysmenorrhea.... (Review)
Review
Primary dysmenorrhea is considered as one of the main problems in women. This review study aimed to characterize the effect of micronutrients on primary dysmenorrhea. In this systematic and meta-analysis study, the articles were searched at Cochrane library, PubMed, Scopus, Web of Science databases. The searching process was conducted with the key terms related to dysmenorrhea and micronutrients. Risk of bias assessment was performed, using Rev Man 5.3 software. In view of the heterogeneity of some of the studies, they were analyzed, using a qualitative method (n=10), and only 6 studies were included in Meta analyze. STATA statistical software version 11 was used for the analysis. In this study, finally 16 clinical trials were investigated. Most micronutrients studied in the relevant articles had anti-inflammatory and analgesic properties with a desirable effect on dysmenorrhea pain relief. Vitamins (K, D, B1, and E) and calcium, magnesium, zinc sulfate and boron contributed effectively to dysmenorrhea pain management. Two months after the intervention, there was a significant mean decrease in the pain score for the vitamin D intervention group (SMD: -1.02, 95% CI: -1.9 to - 0.14, P =0.024) , as well as in the vitamin E intervention group compared to placebo group (SMD: -0.47,95% CI:-0.74 to - 0.2, P = 0.001). Despite the paucity of related research, the studies indicated the potential effects of micronutrients on reducing the pain severity in primary dysmenorrhea. But more studies are needed to confirm the safety and effectiveness of various types of micronutrients on primary dysmenorrhea.
PubMed: 32296659
DOI: 10.34172/jcs.2020.008 -
The Cochrane Database of Systematic... May 2024Magnesium sulphate is a common therapy in perinatal care. Its benefits when given to women at risk of preterm birth for fetal neuroprotection (prevention of cerebral... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Magnesium sulphate is a common therapy in perinatal care. Its benefits when given to women at risk of preterm birth for fetal neuroprotection (prevention of cerebral palsy for children) were shown in a 2009 Cochrane review. Internationally, use of magnesium sulphate for preterm cerebral palsy prevention is now recommended practice. As new randomised controlled trials (RCTs) and longer-term follow-up of prior RCTs have since been conducted, this review updates the previously published version.
OBJECTIVES
To assess the effectiveness and safety of magnesium sulphate as a fetal neuroprotective agent when given to women considered to be at risk of preterm birth.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) on 17 March 2023, as well as reference lists of retrieved studies.
SELECTION CRITERIA
We included RCTs and cluster-RCTs of women at risk of preterm birth that assessed prenatal magnesium sulphate for fetal neuroprotection compared with placebo or no treatment. All methods of administration (intravenous, intramuscular, and oral) were eligible. We did not include studies where magnesium sulphate was used with the primary aim of preterm labour tocolysis, or the prevention and/or treatment of eclampsia.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed RCTs for inclusion, extracted data, and assessed risk of bias and trustworthiness. Dichotomous data were presented as summary risk ratios (RR) with 95% confidence intervals (CI), and continuous data were presented as mean differences with 95% CI. We assessed the certainty of the evidence using the GRADE approach.
MAIN RESULTS
We included six RCTs (5917 women and their 6759 fetuses alive at randomisation). All RCTs were conducted in high-income countries. The RCTs compared magnesium sulphate with placebo in women at risk of preterm birth at less than 34 weeks' gestation; however, treatment regimens and inclusion/exclusion criteria varied. Though the RCTs were at an overall low risk of bias, the certainty of evidence ranged from high to very low, due to concerns regarding study limitations, imprecision, and inconsistency. Primary outcomes for infants/children: Up to two years' corrected age, magnesium sulphate compared with placebo reduced cerebral palsy (RR 0.71, 95% CI 0.57 to 0.89; 6 RCTs, 6107 children; number needed to treat for additional beneficial outcome (NNTB) 60, 95% CI 41 to 158) and death or cerebral palsy (RR 0.87, 95% CI 0.77 to 0.98; 6 RCTs, 6481 children; NNTB 56, 95% CI 32 to 363) (both high-certainty evidence). Magnesium sulphate probably resulted in little to no difference in death (fetal, neonatal, or later) (RR 0.96, 95% CI 0.82 to 1.13; 6 RCTs, 6759 children); major neurodevelopmental disability (RR 1.09, 95% CI 0.83 to 1.44; 1 RCT, 987 children); or death or major neurodevelopmental disability (RR 0.95, 95% CI 0.85 to 1.07; 3 RCTs, 4279 children) (all moderate-certainty evidence). At early school age, magnesium sulphate may have resulted in little to no difference in death (fetal, neonatal, or later) (RR 0.82, 95% CI 0.66 to 1.02; 2 RCTs, 1758 children); cerebral palsy (RR 0.99, 95% CI 0.69 to 1.41; 2 RCTs, 1038 children); death or cerebral palsy (RR 0.90, 95% CI 0.67 to 1.20; 1 RCT, 503 children); and death or major neurodevelopmental disability (RR 0.81, 95% CI 0.59 to 1.12; 1 RCT, 503 children) (all low-certainty evidence). Magnesium sulphate may also have resulted in little to no difference in major neurodevelopmental disability, but the evidence is very uncertain (average RR 0.92, 95% CI 0.53 to 1.62; 2 RCTs, 940 children; very low-certainty evidence). Secondary outcomes for infants/children: Magnesium sulphate probably reduced severe intraventricular haemorrhage (grade 3 or 4) (RR 0.76, 95% CI 0.60 to 0.98; 5 RCTs, 5885 infants; NNTB 92, 95% CI 55 to 1102; moderate-certainty evidence) and may have resulted in little to no difference in chronic lung disease/bronchopulmonary dysplasia (average RR 0.92, 95% CI 0.77 to 1.10; 5 RCTs, 6689 infants; low-certainty evidence). Primary outcomes for women: Magnesium sulphate may have resulted in little or no difference in severe maternal outcomes potentially related to treatment (death, cardiac arrest, respiratory arrest) (RR 0.32, 95% CI 0.01 to 7.92; 4 RCTs, 5300 women; low-certainty evidence). However, magnesium sulphate probably increased maternal adverse effects severe enough to stop treatment (average RR 3.21, 95% CI 1.88 to 5.48; 3 RCTs, 4736 women; moderate-certainty evidence). Secondary outcomes for women: Magnesium sulphate probably resulted in little to no difference in caesarean section (RR 0.96, 95% CI 0.91 to 1.02; 5 RCTs, 5861 women) and postpartum haemorrhage (RR 0.94, 95% CI 0.80 to 1.09; 2 RCTs, 2495 women) (both moderate-certainty evidence). Breastfeeding at hospital discharge and women's views of treatment were not reported.
AUTHORS' CONCLUSIONS
The currently available evidence indicates that magnesium sulphate for women at risk of preterm birth for neuroprotection of the fetus, compared with placebo, reduces cerebral palsy, and death or cerebral palsy, in children up to two years' corrected age, and probably reduces severe intraventricular haemorrhage for infants. Magnesium sulphate may result in little to no difference in outcomes in children at school age. While magnesium sulphate may result in little to no difference in severe maternal outcomes (death, cardiac arrest, respiratory arrest), it probably increases maternal adverse effects severe enough to stop treatment. Further research is needed on the longer-term benefits and harms for children, into adolescence and adulthood. Additional studies to determine variation in effects by characteristics of women treated and magnesium sulphate regimens used, along with the generalisability of findings to low- and middle-income countries, should be considered.
Topics: Female; Humans; Infant, Newborn; Pregnancy; Bias; Cerebral Palsy; Magnesium Sulfate; Neuroprotective Agents; Premature Birth; Randomized Controlled Trials as Topic; Tocolytic Agents
PubMed: 38726883
DOI: 10.1002/14651858.CD004661.pub4 -
The Cochrane Database of Systematic... Jan 2016Recurrent miscarriage affects 1% to 3% of women of reproductive age and mostly occurs before the 10th week of gestation (and around the same gestational week in... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Recurrent miscarriage affects 1% to 3% of women of reproductive age and mostly occurs before the 10th week of gestation (and around the same gestational week in subsequent miscarriages). Although most pregnant women may not recognise a miscarriage until uterine bleeding and cramping occur, a repeat miscarriage after one or more pregnancy loss and the chance of having a successful pregnancy varies. To date, there is no universally accepted treatment for unexplained recurrent miscarriage. Chinese herbal medicines have been widely used in Asian societies for millennia and have become a popular alternative to Western medicines in recent years. Many clinical studies have reported that Chinese herbal medicines can improve pregnancy outcomes for pregnant women who had previously suffered recurrent miscarriage. This systematic review evaluated the efficacy of Chinese herbal medicines for recurrent miscarriage.
OBJECTIVES
To assess the effectiveness and safety of Chinese herbal medicines for the treatment of unexplained recurrent miscarriage.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (01 June 2015), Embase (1980 to 01 June 2015); Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to 01 June 2015); Chinese Biomedical Database (CBM) (1978 to 01 June 2015); China Journal Net (CJN) (1915 to 01 June 2015); China Journals Full-text Database (1915 to 01 June 2015); and WanFang Database (Chinese Ministry of Science & Technology) (1980 to 01 June 2015). We also searched reference lists of relevant trials and reviews. We identified and contacted organisations, individual experts working in the field, and medicinal herb manufacturers.
SELECTION CRITERIA
Randomised or quasi-randomised controlled trials, including cluster-randomised trials, with or without full text, comparing Chinese herbal medicines (alone or combined with other intervention or other pharmaceuticals) with placebo, no treatment, other intervention (including bed rest and psychological support), or other pharmaceuticals as treatments for unexplained recurrent miscarriage. Cross-over studies were not eligible for inclusion in this review.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed all the studies for inclusion in the review, assessed risk of bias and extracted the data. Data were checked for accuracy.
MAIN RESULTS
We included nine randomised clinical trials (involving 861 women). The trials compared Chinese herbal medicines (various formulations) either alone (one trial), or in combination with other pharmaceuticals (seven trials) versus other pharmaceuticals alone. One study compared Chinese herbal medicines and other pharmaceuticals versus psychotherapy. We did not identify any trials comparing Chinese herbal medicines with placebo or no treatment, including bed rest.Various Chinese herbal medicines were used in the different trials (and some of the classical the formulations were modified in the trials). The Western pharmaceutical medicines included tocolytic drugs such as salbutamol and magnesium sulphate; hormonal supplementation with human chorionic gonadotrophin (HCG), progesterone or dydrogesterone; and supportive supplements such as vitamin E, vitamin K and folic acid.Overall, the methodological quality of the included studies was poor with unclear risk of bias for nearly all the 'Risk of bias' domains assessed.Chinese herbal medicines alone versus other pharmaceuticals alone - the live birth rate was no different between the two groups (risk ratio (RR) 1.05; 95% confidence interval (CI) 0.67 to 1.65; one trial, 80 women). No data were available for the outcome of pregnancy rate (continuation of pregnancy after 20 weeks of gestation).In contrast, the continuing pregnancy rate (RR 1.27 95% CI 1.10 to 1.48, two trials, 189 women) and live birth rate (average RR 1.55; 95% CI 1.14 to 2.10; six trials, 601 women, Tau² = 0.10; I² = 73%) were higher among the group of women who received a combination of Chinese herbal medicines and other pharmaceuticals when compared with women who received other pharmaceuticals alone.For Chinese herbal medicines and psychotherapy versus psychotherapy alone (one study) - there was a higher live birth rate (RR 1.32; 95% CI 1.07 to 1.64; one trial, 90 women) in the group of women who received a combination of Chinese herbal medicines and psychotherapy compared to those women who received psychotherapy alone. No data were available on the continuing pregnancy rate for this comparison.Other primary outcomes (maternal adverse effect and toxicity rate and the perinatal adverse effect and toxicity rate) were not reported in most of the included studies. Two trials (341 women) reported that no maternal adverse effects were found (one trial compared (combined) medicines with other pharmaceuticals, and one trial compared combined Chinese herbal medicine alone versus other pharmaceuticals). One trial (Chinese herbal medicine alone versus other pharmaceuticals alone) reported that there were no abnormal fetuses (ultrasound) or after delivery.There were no data reported for any of this review's secondary outcomes.
AUTHORS' CONCLUSIONS
We found limited evidence (from nine studies with small sample sizes and unclear risk of bias) to assess the effectiveness of Chinese herbal medicines for treating unexplained recurrent miscarriage; no data were available to assess the safety of the intervention for the mother or her baby. There were no data relating to any of this review's secondary outcomes. From the limited data we found, a combination of Chinese herbal medicines and other pharmaceuticals (mainly Western medicines) may be more effective than Western medicines alone in terms of the rate of continuing pregnancy and the rate of live births. However, the methodological quality of the included studies was generally poor.A comparison of Chinese herbal medicines alone versus placebo or no treatment (including bed rest) was not possible as no relevant trials were identified.More high-quality studies are needed to further evaluate the effectiveness and safety of Chinese herbal medicines for unexplained recurrent miscarriage. In addition to assessing the effect of Chinese herbal medicines on pregnancy rate and the rate of live births, future studies should also consider safety issues (adverse effects and toxicity for the mother and her baby) as well as the secondary outcomes listed in this review. This review would provide more valuable information if the included studies could overcome the problems in their designs, such as lacking of qualified placebo-controlled trials, applying adequate randomisation methods and avoiding potential bias.
Topics: Abortion, Habitual; Adult; Birth Rate; Drugs, Chinese Herbal; Female; Hormones; Humans; Live Birth; Pregnancy; Pregnancy Rate; Psychotherapy; Randomized Controlled Trials as Topic; Tocolytic Agents
PubMed: 26760986
DOI: 10.1002/14651858.CD010568.pub2