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Neuraxial Anesthesia for the Prevention of Postoperative Mortality and Major Morbidity: An Overview of Cochrane Systematic Reviews

Guay, Joanne MD*; Choi, Peter T. MD; Suresh, Santhanam MD; Albert, Natalie MD§; Kopp, Sandra MD; Pace, Nathan Leon MD

doi: 10.1213/ANE.0000000000000339
Regional Anesthesia: Research Report

BACKGROUND: This analysis summarized Cochrane reviews that assess the effects of neuraxial anesthesia on perioperative rates of death, chest infections, and myocardial infarction.

METHODS: A search was performed in the Cochrane Database of Systematic Reviews on July 13, 2012. We have included all Cochrane systematic reviews that examined subjects of any age undergoing any type of surgical (open or endoscopic) procedure, compared neuraxial anesthesia to general anesthesia alone for the surgical anesthesia, or neuraxial anesthesia plus general anesthesia to general anesthesia alone for the surgical anesthesia, and included death, chest infections, myocardial infarction, and/or serious adverse events as outcomes. Studies included in these reviews were selected on the same criteria.

RESULTS: Nine Cochrane reviews were selected for this overview. Their scores on the Overview Quality Assessment Questionnaire varied from 4 to 6 of a maximal possible score of 7. Compared with general anesthesia, neuraxial anesthesia reduced the 0- to-30-day mortality (risk ratio [RR] 0.71; 95% confidence interval [CI], 0.53–0.94; I2 = 0%) based on 20 studies that included 3006 participants. Neuraxial anesthesia also decreased the risk of pneumonia (RR 0.45; 95% CI, 0.26–0.79; I2 = 0%) based on 5 studies that included 400 participants. No difference was detected in the risk of myocardial infarction between the 2 techniques (RR 1.17; 95% CI, 0.57–2.37; I2 = 0%) based on 6 studies with 849 participants. Compared with general anesthesia alone, adding neuraxial anesthesia to general anesthesia did not affect the 0- to-30-day mortality (RR 1.07; 95% CI, 0.76–1.51; I2 = 0%) based on 18 studies with 3228 participants. No difference was detected in the risk of myocardial infarction between combined neuraxial anesthesia–general anesthesia and general anesthesia alone (RR 0.69; 95% CI, 0.44–1.09; I2 = 0%) based on 8 studies that included 1580 participants. Adding a neuraxial anesthesia to general anesthesia reduced the risk of pneumonia (RR 0.69; 95% CI, 0.49–0.98; I2 = 9%) after adjustment for publication bias and based on 9 studies that included 2433 participants. The quality of the evidence was judged as moderate for all 6 comparisons. The quality of the reporting score of complications related to neuraxial blocks was 9 (4 to 12 [median {range}]) for a possible maximum score of 14.

CONCLUSIONS: Compared with general anesthesia, neuraxial anesthesia may reduce the 0-to-30-day mortality for patients undergoing a surgery with an intermediate-to-high cardiac risk (level of evidence moderate). Large randomized controlled trials on the difference in death and major outcomes between regional and general anesthesia are required.

Published ahead of print June 23, 2014.

From the *Department of Anesthesiology, CSSS Rouyn-Noranda, Rouyn-Noranda, Quebec, Canada; Department of Anesthesiology, Pharmacology and Therapeutics, The University of British Columbia, Vancouver, Canada; Department of Pediatric Anesthesiology and Pediatrics, Northwestern University’s Feinberg School of Medicine, Chicago, Illinois; §Department of Anesthesiology, University Laval, Quebec, Canada; Department of Anesthesiology, Mayo Clinic College of Medicine, Rochester, Minnesota; and Department of Anesthesiology, University of Utah, Salt Lake City, Utah.

Published ahead of print June 23, 2014.

Accepted for publication May 4, 2014.

Funding: The Cochrane Anaesthesia Review Group, Denmark: The search strategy was designed by Mr. Karen Hovhannisyan, Trials Search Coordinator for the Cochrane Anaesthesia Review Group, Rigshospitalet, Dept. 3342, Blegdamsvej 9, 2100 Copenhagen, Denmark. University of Montreal, Canada: Access to electronic databases and to major medical journals was provided by the University of Montreal, Montreal, Quebec, Canada.

Conflicts of Interests: See Disclosures at the end of the article.

The protocol of this study has been published: Cochrane Database of Systematic Reviews 2012, Issue 9. Art. No.: CD010108. DOI: 10.1002/14651858.

Reprints will not be available from the authors.

Address correspondence to Joanne Guay, MD, Department of Anesthesiology, CSSS Rouyn-Noranda 4, 9e Rue, Rouyn-Noranda, Québec J9X 2B2, Canada. Address e-mail to joanneguay@bell.net.

Postoperative death may occur after major infectious (superficial, deep, urinary tract, and organ infections or sepsis), hematological (postoperative bleeding requiring transfusion, deep-vein thrombosis, pulmonary embolus), cardiovascular (myocardial infarction, stroke), respiratory (pneumonia, unplanned intubation, prolonged mechanical ventilation), renal (acute kidney injury), and surgical (wound dehiscence, vascular graft loss) complications.

Neuraxial anesthesia with or without general anesthesia may reduce the incidence of some major complications that can lead to death such as pulmonary complications, time to tracheal extubation, cardiac dysrhythmias, venous thromboembolism, blood transfusion, surgical site infection, and acute kidney injury.1–6 Maximal blood concentrations of stress response markers, such as epinephrine, norepinephrine, cortisol, and glucose, are lower in patients to whom epidural anesthesia is added to general anesthesia.2 Several Cochrane reviews have evaluated the effect of neuraxial anesthesia for various types of surgical populations. There is currently no synthesis of those reviews reported in an overview.

Our primary objective was to summarize Cochrane systematic reviews that assess the effects of neuraxial anesthesia on perioperative rates of death, chest infections, and myocardial infarction by integrating the evidence from all Cochrane systematic reviews that have compared neuraxial anesthesia with or without general anesthesia versus general anesthesia alone for different types of surgery on various populations. Our secondary objective was to summarize the evidence about adverse effects (an adverse event for which the causal relation between the intervention and the event is at least a reasonable possibility) of neuraxial anesthesia.

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METHODS

We considered all Cochrane systematic reviews that included randomized controlled trials (RCTs); examined participants of any age undergoing any type of surgical (open or endoscopic) procedure; compared neuraxial anesthesia to general anesthesia alone for the surgical anesthesia or compared neuraxial anesthesia plus general anesthesia to general anesthesia alone for the surgical anesthesia; and included death, chest infections, myocardial infarction, or serious adverse events as outcomes. Neuraxial anesthesia consisted of epidural, caudal, spinal, or combined spinal–epidural techniques administered as a bolus or continuous infusion intraoperatively. We searched the Cochrane Database of Systematic Reviews on July 13, 2012, using the following terms: #1 MeSH descriptor Anesthesia, Epidural explode all trees; #2 MeSH descriptor Nerve Block explode all trees; #3 MeSH descriptor Anesthetics, Local explode all trees; #4 MeSH descriptor Anesthesia, Intravenous explode all trees; #5 MeSH descriptor Analgesia, Epidural explode all trees; #6 MeSH descriptor Anesthesia, Caudal explode all trees; #7 ([epidural or caudal or spinal or spinal?epidural) near (techniq* or administ* or bolus* or infusion*]) or an?esthesia; #8 (an?esthesia or block* or analgesia) near (regional or local or neuraxial or nerve or caudal or spinal or epidural or lumbar or general); #9 (#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8). We analyzed the data with RevMan 5.1 (Review Manager version 5.1) and Comprehensive Meta Analysis version 2.2.044 (http://www.Meta-Analysis.com). One author screened all the abstracts of reviews identified by the search. The full reports of the potential reviews were obtained. Two authors independently reviewed each report for inclusion.

From the included studies of selected reviews, studies were selected independently by 2 authors with the same criteria used for the selection of the reviews without any language restriction. Data of selected studies were reextracted by 1 author and compared with the data included in the corresponding review. Any discrepancy was checked by a second author.

Two of the authors independently assessed the methodological quality of included reviews using a 10-item index, the Overview Quality Assessment Questionnaire.7 Because the latest version of the risk of bias tool was unavailable when some of the Cochrane reviews were performed, the methodological quality of included RCTs was reassessed using the current Cochrane tool for risk of bias. Studies were classified in to 2 groups: (1) neuraxial anesthesia versus general anesthesia for the surgery; and (2) neuraxial anesthesia added to general anesthesia versus general anesthesia alone for the surgery. Random-effects models were used and the effects were expressed as risk ratio (RR) and its 95% confidence interval (CI). Heterogeneity was quantified by the I2 statistic, with the data entered in the direction (benefit or harm) yielding the lowest value. Although we planned to use a value of >25% as cutoff for exploration, this was not necessary. The I2 value was 0% for 5 of the 6 comparisons and 9% for the outcome pneumonia, comparison neuraxial anesthesia added to general anesthesia versus general anesthesia alone. A priori factors chosen were as follows: ASA physical status (1 or 2 vs 3 or higher); age (<18 years versus 18 to <70 years versus 70 years or higher); type of surgery (high versus intermediate versus low cardiac risk);8 type of neuraxial blockade (spinal versus epidural or caudal; lumbar versus thoracic epidural); type of neuraxial drug (long-acting opioid alone versus local anesthetic alone versus local anesthetic plus long-acting opioid versus other adjuvants [e.g., clonidine, neostigmine, or ketamine]); duration of neuraxial blockade (intraoperative only versus infusion continued for at least 48 hours after surgery); use of thromboprophylaxis (appropriate or not according to current standards); type of thromboprophylaxis (low-molecular weight heparin, ximelagatran, fondaparinux, or rivaroxaban versus regional blockade, pneumatic compression, and aspirin versus warfarin); pregnancy; and mode of analgesia in the control group (IV analgesia versus other routes).

For results where the intervention produced an effect, a number-needed-to-treat (NNT) or number-needed-to-harm was calculated based on the odds ratio (http://www.nntonline.net/visualrx/). Publication bias was assessed with a funnel plot followed by Duval and Tweedie’s trim and fill technique for each outcome or classical fail-safe number (number of studies with no effect required to bring the P value to 0.05; α = 0.05, 2-tails). The quality of the body of evidence for each outcome was judged as high, moderate, or low according to the system developed by the GRADE Working Group.9,10 With a high quality of evidence, further research is unlikely to change our confidence in the estimated effect. When the quality is moderate, further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Three authors independently applied these criteria. Discrepancies were resolved by discussion.

For adverse effects of neuraxial blockade, all selected studies were assessed according to the 7 criteria proposed by Stojadinovic et al.11 method of accrual, duration of data collection, definition of complication, morbidity and mortality rates, grade of complication severity, exclusion criteria, and study follow-up. The following complications related to neuraxial blockade were sought specifically: mortality (anytime up to 5 years), seizure or cardiac arrest related to local anesthetic toxicity (any significant prolonged neurological sequelae related to these events were to be described), prolonged central or peripheral neurological injury lasting >1 month, and infection secondary to neuraxial blockade.

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RESULTS

A total of 1158 titles/abstracts were screened. Of these, 304 were protocols, 844 were not relevant to neuraxial blockade used during surgery, and 1 did not contain a control group with general anesthesia. Therefore, we retrieved and kept 9 systematic reviews.1,4,12–18 The overall quality of included reviews was average (Table 1). These 9 reviews included 117 trials but only 40 studies met our inclusion criteria and were retained (Afolabi, 3; Barbosa, 4; Choi, 1; Craven, 0; Cyna, 0; Jorgensen, 4; Nishimori, 12; Parker, 13; and Werawatganon, 3).1,3,12–58 Altogether we retained 40 studies for the new analysis.19–58 All the retained trials studied adults patients undergoing surgeries with an intermediate, or high cardiac risk, or a mixture of both. These surgeries were performed on the lower limb, in the intra-abdominal cavity or at various parts of the body. Three trials studied pregnant women undergoing cesarean deliveries.19–21 The quality of the 40 studies retained for reanalysis can be found in Figure 1.

Table 1

Table 1

Figure 1

Figure 1

Compared with general anesthesia, neuraxial anesthesia reduced the 0- to 30-day mortality (classical fail safe number = 7; Fig. 2 and Table 2). The NNT calculated on the odds ratio was 44 (95% CI, 27–228) for an incidence of 7.9% for general anesthesia versus 5.2% for neuraxial anesthesia (Fig. 2). Cardiac risk was classified as intermediate for 76.5% (2300/3006) (intraperitoneal or orthopedic surgery) and high for 23.5% (706/3006) (aortic or peripheral vascular surgery) of the participants. With Duval and Tweedie’s trim and fill analysis, the adjusted RR was 0.72 (95% CI, 0.54–0.95) looking for missing studies to the right, and unchanged while looking for missing studies to the left. Egger’s regression intercept did not indicate a small-study effect. Mortality data were available for 896 participants for the 1- to-6-month follow-up (RR 1.52; 95% CI, 0.89–2.62) and for 726 participants at 6- to-12-month follow-up (RR 1.27; 95% CI, 0.74–2.17). Neuraxial anesthesia also decreased the risk of pneumonia (classical fail safe number = 3; Table 2 and Fig. 3). The NNT was 11 (95% CI, 8–27) for incidences of 7.6% and 16.8% for neuraxial anesthesia and general anesthesia, respectively. Egger’s regression intercept did not indicate a small-study effect. The RR adjusted for a possible publication bias was 0.44 (95% CI, 0.26–0.73). There was no difference in the risk of myocardial infarction between neuraxial anesthesia and general anesthesia (Table 2 and Fig. 4). There was no evidence of publication bias for this comparison.

Table 2

Table 2

Figure 2

Figure 2

Figure 3

Figure 3

Figure 4

Figure 4

For the studies where neuraxial anesthesia was added to general anesthesia, a spinal block was used in 1 study and an epidural block was used for 19 studies. The epidural block was used intra and postoperatively for all studies: time unspecified for 2 studies and mean time 59 hours (95% CI, 46–98 hours) for the other studies. Adding neuraxial anesthesia to general anesthesia did not affect the mortality risk (Table 2 and Fig. 2). With Duval and Tweedie’s trim and fill analysis, the effect was almost unchanged (RR 1.13; 95% CI, 0.80–1.59). The risk of myocardial infarction was not different between the 2 anesthetic techniques (Table 2 and Fig. 4). The power to detect a 25% reduction in incidence from 5.7% was only 0.25 (α = 0.05, 2-sided test). With an adjustment for a possible publication bias, the RR would be 0.72 (95% CI, 0.46–1.13). Likewise, the addition of neuraxial anesthesia did not change the risk of a pneumonia when a random model effects was used (Table 2 and Fig. 3) and was marginally suggestive of an effect when a fixed effect model was used (RR 0.74; 95% CI, 0.56–0.98). For the random effects model, the power to detect a 25% reduction is 0.58 (α = 0.05, 2-sided test) from an incidence of 9.5%. For the fixed effect model, the NNT was 40 (95% CI, 24–387). Egger’s regression intercept did not indicate a small-study effect. The funnel plot revealed that 2 studies might be missing on the left side. With Duval and Tweedie’s trim and fill analysis, the adjusted RR was 0.69 (95% CI, 0.49–0.98) with a random effects model. If only studies with an a priori definition for the diagnosis of pneumonia were included, then adding neuraxial anesthesia to general anesthesia reduced the risk of pneumonia (RR 0.70 [95% CI, 0.49–1.00] versus RR 1.28 [95% CI, 0.31–5.19] for the studies where it was not). For the effect of neuraxial anesthesia on the risk of pneumonia by the type of neuraxial block, the RR was 0.90 (95% CI, 0.31–2.62) for spinal anesthesia, RR was 5.5 (95% CI, 0.28–107.78) for lumbar epidural anesthesia, RR was 0.64 (95% CI, 0.17–2.47) for thoracic epidural anesthesia, and RR was 0.69 (95% CI, 0.45–1.06) when either lumbar or thoracic epidural anesthesia could be used. All studies for this comparison included a local anesthetic in the neuraxial block. There was no correlation between the effect size (RR) and the mean age of the patients included in the studies.

No serious adverse events were reported. The quality score of the reporting of complications related to neuraxial blockade was: 9 (4–12) (median [range]) from a possible maximal score of 14. The quality of the evidence was rated as moderate for all 6 comparisons (Table 2). Risk of bias introduced by study design was the reason for downgrading the quality from high to moderate with the absence of blinding of outcome assessors being the most serious potentially avoidable concern (Fig. 1). For the effect on pneumonia of the comparison of neuraxial anesthesia versus general anesthesia, the small fail-safe number (possibility of publication bias) was compensated by the large (<0.5) effect size.

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DISCUSSION

Compared with general anesthesia, neuraxial anesthesia reduced the mortality rate by approximately 2.5% (Fig. 2) and the risk of perioperative pneumonia (Fig. 3). Adding neuraxial anesthesia to general anesthesia may reduce the incidence of pneumonia; however, this is less conclusive because the results varied depending on whether the effect size was adjusted or not for a possible publication bias. We decided to use only random effects models regardless of the amount of heterogeneity because we wanted to reduce the possibility of finding an effect where there was none. When heterogeneity is present, a random effects model will usually widen the confidence interval. The only comparison where we saw statistical heterogeneity was the effect on the risk of pneumonia when neuraxial anesthesia was added to general anesthesia compared with general anesthesia alone (I2 = 9%). If data were pooled with a fixed effect model, then adding neuraxial anesthesia to general anesthesia reduced the incidence of pneumonia, whereas no effect was detected if data were pooled with a random effects model. However, when we included only the studies where an a priori definition for the diagnosis of pneumonia was reported, addition of neuraxial anesthesia to general anesthesia reduced the risk of pneumonia regardless of the model used. None of the interventions (neuraxial anesthesia compared with general anesthesia or neuraxial anesthesia added to general anesthesia versus general anesthesia alone) reduced the risk of myocardial infarction (Fig. 4), but the power to detect a 25% risk reduction from the addition of neuraxial anesthesia to general anesthesia was only 0.25 (α = 0.05, 2-sided test).

When deciding which intervention to choose for a patient, one has to balance the benefits versus the risks. Although many studies gave an appropriate description of the techniques used, a clear mention of the presence or absence of complications related to the techniques, with an adequate duration of follow-up, was lacking in many of the reports.20,22,23,25,29,31,32,34–36,41–43,45,48,49,51–54,57,58 There is no doubt for the authors of this overview that complications will need to be evaluated in future trials. Currently, we have to rely on the data provided by the most recent large prospective studies to estimate the incidence of complications related to neuraxial blockade.

The 40 studies retained for analysis are of good quality except for 2 criteria. First, blinding was usually not used in these studies. Considering the potentially serious (although rare) side effects that can be associated with the insertion of an epidural catheter, many clinicians would consider insertion of an epidural catheter to be unethical if it is not used to provide neuraxial blockade. Second, many of our studies suffered from the absence of reporting of side effects of neuraxial blocks, which resulted in lower scores of quality.20,22,23,25,29,31,32,34–36,41–43,45,48,49,51–54,57,58

Using systematic reviews to find relevant studies to answer a question could be considered an unusual technique, but we do not think that this led us to “biased” results. First, all the included systematic reviews used very comprehensive search strategies. Second, by using Duval and Tweedie’s trim and fill analysis, we were able to quantify the effects sizes while considering any potential publication bias. Publication bias occurs when medical journals publish more studies favoring one intervention than studies favoring another one or a placebo. No matter the search technique used, it is never possible to be certain that all studies will be included. One simple reason for this is that authors themselves may simply not submit a study with absence of effect. When performing a study, we do not measure all the population to whom the treatment may apply, instead we choose a fair sample of participants and then assume that the treatment will be equally effective or ineffective to other patients with characteristics similar to those included in our study. Likewise, we chose a sample of studies while clearly defining in advance our criteria for inclusion. As in the example above, results of our overview apply to patients with characteristics similar to those included in our overview.

In a metaanalysis published in 2000, Rodgers et al.6 concluded that neuraxial blockade reduced the overall 30-day mortality by approximately one-third and that this would apply to trials in which neuraxial blockade was combined with general anesthesia as well as to trials in which neuraxial blockade was used alone. The metaanalysis of Rodgers et al.6 included studies published up to 1996, while we were able to include 13 studies published after 1996. We demonstrated that these 2 interventions (neuraxial anesthesia compared with general anesthesia versus adding neuraxial anesthesia to general anesthesia) are not equivalent (I2 for heterogeneity between the 2 interventions is 69%) (Fig. 2). Using neuraxial anesthesia as the sole anesthetic technique reduced the 30-day mortality rate, while adding neuraxial anesthesia to general anesthesia did not. Our overview does not allow us to determine whether this difference between the 2 interventions is due to a diminishing of the beneficial effects of neuraxial anesthesia by general anesthesia, to adverse effects of general anesthesia itself, or a combination of both. Our results apply to patients undergoing an intermediate-to-high cardiac risk procedure (peripheral vascular, intraperitoneal, orthopedic, and prostate surgery). The magnitude of this effect requires further exploration because the overall quality of the included trials was moderate. Large high-quality trials will be required to confirm or refute our results on the effects of using neuraxial anesthesia as opposed to general anesthesia on the mortality rate. A larger sample size is required before drawing any conclusions on the effects of adding neuraxial anesthesia to general anesthesia on the risk of myocardial infarction. These trials should include appropriate follow-up and description of side effects of each technique to allow the reader to balance the risks and benefits of each technique.

Although neuraxial analgesia was used for the vast majority of the studies in the group neuraxial anesthesia added to general anesthesia (19 of 20), the effects of postoperative neuraxial analgesia cannot be determined from our overview because we retained studies where neuraxial anesthesia was used for the intraoperative period regardless of their use or not for the postoperative period.

In conclusion, compared with general anesthesia, neuraxial anesthesia may reduce the 0- to-30-day mortality for patients undergoing a surgery with an intermediate-to-high cardiac risk (level of evidence moderate). Large RCTs on the difference in death and major outcomes between regional and general anesthesia are required.

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DISCLOSURES

Name: Joanne Guay, MD.

Contribution: This author helped design the study, conduct the study, analyze the data, and write the manuscript.

Attestation: Joanne Guay has seen the original study data (data contained in the published reports), reviewed the analysis of the data, approved the final manuscript, and is the author responsible for archiving the study files.

Conflicts of Interest: The author has no conflicts of interest to declare.

Name: Peter T. Choi, MD.

Contribution: This author helped design the study, conduct the study, and write the manuscript.

Attestation: Peter T. Choi has seen the original study data, reviewed the analysis of the data, and approved the final manuscript.

Conflicts of Interest: Peter T. Choi has published a prior systematic review included in this Cochrane overview. He had no participation in judging the quality of his own review or in selecting studies or extracting data from studies pertaining to his review. The author has no other conflicts of interest.

Name: Santhanam Suresh, MD.

Contribution: This author helped design the study, conduct the study, and write the manuscript.

Attestation: Santhanam Suresh has seen the original study data (data contained in the published reports), reviewed the analysis of the data, and approved the final manuscript.

Conflicts of Interest: The author has no conflicts of interest to declare.

Name: Natalie Albert, MD.

Contribution: This author helped design the study, conduct the study, and write the manuscript.

Attestation: Natalie Albert has seen the original study data (data contained in the published reports), reviewed the analysis of the data, and approved the final manuscript.

Conflicts of Interest: The author has no conflicts of interest to declare.

Name: Sandra Kopp, MD.

Contribution: This author helped design the study, conduct the study, and write the manuscript.

Attestation: Sandra Kopp has seen the original study data (data contained in the published reports), reviewed the analysis of the data, and approved the final manuscript.

Conflicts of Interest: The author has no conflicts of interest to declare.

Name: Nathan Leon Pace, MD.

Contribution: This author helped design the study, conduct the study, analyze the data, and write the manuscript.

Attestation: Nathan Leon Pace has seen the original study data (data contained in the published reports), reviewed the analysis of the data, and approved the final manuscript.

Conflicts of Interest: The author has no conflicts of interest to declare.

This manuscript was handled by: Terese T. Horlocker, MD.

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ACKNOWLEDGMENTS

The authors thank Karen Hovhannisyan, Trials Search Coordinator for the Cochrane Anesthesia Review Group (CARG) for designing the search and the University of Montreal for access to electronic databases and major medical journals. We also thank Dr. Stephan Schwarz for the translation of the 2 German articles in our systematic overview, Dr. Helen Handoll for providing translations of some Japanese and Italian articles, and Dr. Mina Nishimori for granting us access to her data extraction sheets. Finally, we are also indebted to Drs. Mark Neuman (content editor), Marialena Trivella (statistical editor), Lorne Becker, Denise Thompson, Jørn Wetterselv, and Mina Nishimori (peer reviewers) for their help and editorial advice during the preparation of this for overview.

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