Efficacy of Ect in Depression a Meta-analytic Review
A clinical reappraisal of electroconvulsive therapy (ECT) was conducted over the terminal decade afterwards the observation that a proportion comprised between xx% and twoscore% of either unipolar or bipolar depressions did non answer satisfactorily to antidepressants (one, 2), despite the availability of more effective competitors for treatment of depression, similar the selective serotonin reuptake inhibitors (SSRIs). An estimate of ECT efficacy can be obtained through the meta-analytic method that combines information from independent studies. Meta-analyses can utilise dichotomous or continuous data, with each type of data presenting advantages and disadvantages (3). Meta-analytic reviews that use continuous data produce reliable standardized weight hateful differences, withal, a decrease in a psychiatric calibration does non necessarily means a clinical remission. A dichotomous measure, such as clinical response or no response, has a considerable advantage over derived statistical parameters because it employs raw data from each individual patients, allowing to know, for example, patients' proportions which achieve response with ECT in comparison other therapeutic tools. The objective of our study was to analyze the efficacy of ECT in depression by means a meta-analytic review of controlled clinical trials published between 1956 and 2003, using dichotomous data.
METHOD
This study reviews, by ways of a MEDLINE search process using the fundamental words electroconvulsive therapy and low, all peer-reviewed publications in English language from Jan 1966 to Feb 2003. Nosotros also manually searched articles published prior to 1966 that might be relevant for our purpose. Among these studies, we selected those comparing ECT with false ECT, or placebo or antidepressants drugs. ECT trials conducted without comparison group were excluded from our analyses. Selected studies were classified and separated in nonrandomized controlled trials and randomized controlled trials.
Like Janicak et al, (4) nosotros used the studies in which it was possible to individualize each patient's response to treatment, using author's ain benchmark of response or no response. Basically, the response benchmark was defined either as a reduction of at to the lowest degree 50% from baseline to end point on the Hamilton Calibration for Depression (HAM-D) or a HAM-D score of ten or less at the end indicate or a clinical judgment of "recovered" or "marked improved" depending on which of these 3 consequence measures were used. The category of "moderately improved" was not considered as a response criterion in this review. The diagnostic categories were major depression, bipolar disorder depressed blazon, schizoaffective disorder depressive type, and other categorizations such every bit neurotic low, reactive depression, endogenous depression, involutional depression, principal depression and secondary depression. Only those studies in which we could directly determine each patient's response to handling were included in the meta-analysis. Therefore, some randomized controlled trials were excluded considering they did not reveal the results of patients individually (v–x).
The software used for the meta-analysis was the EasyMA 2001 of the Section of Clinical Pharmacology, Cardiology Hospital, University of Lyon (France) (eleven). The selected summary statistic and statistical method to our dichotomous finish point, response or not response to the treatments, was respectively the odds ratio and the random consequence model. The odds ratio has statistical advantages relating to its sampling distribution and its suitability for modeling. The random furnishings model assumes a different underlying effect for each study and takes this into consideration as an additional source of variation. In the random model, the test of heterogeneity applied was the Cochran Q-examination with the objective to examine statistically the degree of similarity in the studies' outcomes. If a examination of heterogeneity betwixt trials is statistically significant (P < 0.05) so it may not exist advisable to combine the results.
RESULTS
REAL ECT VERSUS PLACEBO Event (Fake ECT OR PLACEBO)
Initially, nosotros did not distinguish the studies that compared the ECT with the simulated ECT and placebo itself (pill), constituting a comparing grouping denominated placebo effect. As shown in Effigy ane, 11 randomized controlled trials were used in the comparison between real ECT and placebo upshot (simulated ECT/placebo), involving a total number of 523 patients, with a mean number of 48 patients past trial. A discrepancy in sample sizes among studies was found, with the largest trial involving 109 patients and the smallest viii patients.
Effigy 1. Responsive Rate of ECT, ECT Simulated and Placebo in Randomized Controlled Trials
Data from these studies that compared the efficacy of real ECT and placebo result (Table one), at the finish of the treatment's course, revealed a meaning better response of the real ECT (association χ2 = 19.76, df = 1, P < 0.001). The Q Cochran test of heterogeneity revealed that the null hypothesis of homogeneity betwixt these studies is valid (χii = 12.13, df = 10, P = 0.28). The probability, in terms of odds ratios (OR), of a positive response with ECT is approximately 5 more times greater than with faux ECT or placebo (OR iv.77; 95% CI 2.39, 9.49).
Table 1. Randomized Controlled Trials of ECT Versus Placebo Effect
Table ane. Randomized Controlled Trials of ECT Versus Placebo Result
Enlarge tabular array
Considering the hypothesis that simulated ECT had a greater placebo consequence than placebo (pill), due to a possible larger effect of the grooming process to ECT, we separated the comparisons betwixt, respectively, real ECT versus fake ECT and real ECT versus placebo. Seven randomized controlled trials (Tabular array two) with a total number of 245 subjects were suitable for meta-analysis of ECT versus false ECT and prove a significantly greater effect of ECT equally compared with simulated ECT (association χ2 = 6.87, df = 1, P = 0.0087). The heterogeneity (Q Cochran) between these 7 studies was not statistically significant (χtwo = 7.35, df = 6, P = 0.29). The run a risk of response with ECT when compared with simulated ECT is approximately 3 (OR ii.83; CI 95% 1.30, half-dozen.17) more times greater than with simulated ECT.
Table 2. Randomized Controlled Trials of ECT Versus Simulated ECT
Table 2. Randomized Controlled Trials of ECT Versus Imitation ECT
Enlarge tabular array
But 3 randomized controlled trials (Table 3), involving a full number of 266 patients, made possible a comparison betwixt ECT versus placebo. This comparing revealed a significant more favorable upshot in the ECT grouping (association χ2 = thirteen.68, df = 1, P < 0.001). The Q Cochran exam revealed no significant statistical heterogeneity between these 3 studies (χtwo = 2.71, df = 2, P = 0.26) and the odds ratio suggested a treatment response risk of approximately 11 (OR eleven.083; CI 95% 3.x, 39.65) in favor of ECT when compared with placebo. One trial compared real ECT with imitation ECT plus placebo (pill) (17).
Tabular array three. Randomized Controlled Trials of ECT Versus Placebo
Table 3. Randomized Controlled Trials of ECT Versus Placebo
Overstate table
ECT VERSUS ANTIDEPRESSANTS
In a starting time analysis nosotros compared the ECT with the group of antidepressants in an indistinctive manner, including tricyclic antidepressants (TCA), monoamine oxidase inhibitors (MAOIs), lithium, and SSRIs. This comparison involved 13 randomized controlled trials, with a full number of 892 patients and a mean number of 69 patients for trial; the biggest trial used 242 subjects and the smallest trial involved 8 patients. Of these, 3 studies included 2 comparison groups each of which was analyzed separately (18, 19, 23). Therefore, nosotros had 9 trials comparison ECT versus TCA (531 patients), five trials ECT versus MAOIs (438 patients), 1 trial of ECT versus SSRIs (39 subjects), and 1 trial of ECT versus the combination lithium-TCA (30 patients; Figure 2).
Figure two. Responsive Rate of ECT and Antidepressants in Nonrandomized Controlled Trials.
Overall, the comparing of ECT versus antidepressants in full general demonstrated a significant superior effect of ECT (association χtwo = 51.88, df = 1, P < 0.001). The test of heterogeneity (Q Cochran) demonstrated the homogeneity between these studies (χ2 = 11.45, df = 12, P = 0.49). The chance of response with ECT was well-nigh 4 times greater than with the antidepressant drugs (OR 3.72; CI 95% 2.60, 5.32; Tabular array 4).
Table 4. Nonrandomized Controlled Trials of ECT Versus Antidepressants
Table 4. Nonrandomized Controlled Trials of ECT Versus Antidepressants
Enlarge table
Separated comparisons betwixt, respectively, ECT and TCA and between ECT and MAOIs were also performed. The analysis of ECT trials versus TCA trials revealed a pregnant greater efficacy of ECT than TCAs (association χ2 = 22.81, df = i, P < 0.001). The Q Cochran examination of heterogeneity between the trials was not significant (χ2 = half-dozen.04, df = viii, P = 0.64). Patients receiving real ECT had nearly 3 more hazard of a positive response than a patient that used TCA (OR 2.99; 95% CI 1.91, 4.71; Tabular array 5).
Table v. Randomized Controlled Trials of ECT Versus TCA
Table 5. Randomized Controlled Trials of ECT Versus TCA
Overstate table
As compared with MAOIs, the ECT showed a significant greater efficacy (clan χ2 = 56.55, df = 1, P < 0.001) and the likelihood of a positive response with ECT was approximately 6 greater than with MAOIs (OR half-dozen.13; 95% CI 3.82, 9.83; Table 6). A statistical homogeneity was present between the studies of this subgroup [heterogeneity χii (Q Cochran) = 1.47, df = 4, P = 0.83].
Tabular array half dozen. Randomized Controlled Trials of ECT Versus MAOI
Tabular array vi. Randomized Controlled Trials of ECT Versus MAOI
Enlarge table
ECT VERSUS ANTIDEPRESSANTS IN NONRANDOMIZED CONTROLLED TRIALS
We also made a systematic review of the nonrandomized controlled trials that compared ECT versus antidepressants. Seven nonrandomized controlled trials were used in this meta-analysis, revealing a big total number of patients (north = 2275) and a large mean number of patients past trial (north = 325; Figure 3).
Figure three. Responsive Charge per unit of ECT and Antidepressants in Randomized Controlled Trials.
Two nonrandomized controlled trials compared ECT with imipramine (30, 31) and the other 5 studies compared ECT with diverse antidepressants (TCA and MAOIs) in adequate doses. These studies confirmed the superiority of ECT in comparison with antidepressants even in clinical settings (association χtwo = 26.77, df = 1, P < 0.001), with a similar common odds ratio (OR 2.84) and statistical homogeneity betwixt the trials [heterogeneity χii (Q Cochran) = 7.77, df = half dozen, P = 0.26; Table 7]. The nonrandomized controlled trials results barbarous inside the confidence interval of the randomized controlled trials (95% CI 1.91, 4.21).
Table 7. Randomized Controlled Trials of ECT Versus Antidepressants
Tabular array 7. Randomized Controlled Trials of ECT Versus Antidepressants
Enlarge table
Word
In the nowadays meta-analysis, equally compared with the recent review of The Britain ECT Review Grouping, (37) we used a different statistical strategy identifying each patient's response to treatment. Depressive symptoms were assessed by a dichotomous end point. Furthermore, we adopted more stringent criteria than those used by Janicak et al. (4). In fact, nosotros considered as responsive only those patients who presented "marked comeback" or "recovery," whereas we excluded from the analyses those who were reported to have "moderate improvement." Additionally, we conducted a large meta-assay of observational studies that compared ECT versus antidepressants, which included 2272 patients.
RANDOMIZED AND NONRANDOMIZED CONTROLLED TRIALS
The results of our meta-analytic review of the randomized controlled trials revealed a significant superiority of the ECT in all comparisons: ECT versus placebo effect, ECT versus simulated ECT, ECT versus placebo, ECT versus antidepressants, ECT versus TCA and ECT versus MAOIs. Additionally, the meta-analysis of the observational studies that compared ECT versus antidepressants presented similar results, reinforcing the assumption that systematic reviews of observational studies and randomized controlled trials usually produce similar conclusions (38). The fundamental criticism toward observational studies is that they have inherent biases. On the other hand, the arroyo that includes only randomized controlled trials not always ensures relevancy in the reviews even though it minimizes biases (39).
Inside the group of randomized controlled trials nosotros increased the relevancy of the meta-analysis combining all anti-depressants in a single group and the simulated ECT and the placebo itself (pill) in another group.
All the same, more than specific comparisons betwixt ECT versus other treatments taken singly (TCA, MAOIs, imitation ECT, placebo itself), even with small relevancy, revealed significantly greater risk of treatment response with ECT as compared with MAOIs, placebo and, to a less extent, TCA. The larger effect of false ECT as compared with placebo (pill) suggested that the procedure of ECT preparation might have a greater impact on patient'due south upshot than placebo itself; however, definitive conclusions cannot be obtained because only 3 studies comprised a group of patients treated with placebo (pill).
Since 1985, few controlled trials compared the ECT with others treatments or placebo. The simply report that compared ECT versus SSRIs in patients with treatment resistant depression showed a significant higher response charge per unit of ECT (28). Nevertheless, more studies with larger samples are needed to ostend the superiority of ECT over SSRIs in general for the handling of resistant depression. No studies, to our knowledge, compared ECT with other classes of antidepressants (SNRI, NASSA, NRI).
LIMITATIONS
Some limitations inherent the meta-analytic method must be acknowledged: issues in the randomization processes used in controlled trials, publication biases, variation of standard treatments over time and heterogeneity of studies (39, 40). Second, ECT studies were in general heterogeneous for multiple aspects. For instance, we did not take into business relationship possible variations in the ECT techniques and procedures adopted in the various studies. In fact, most studies did non specify electrical parameters and type of equipment adopted. Furthermore, we did non discriminate between studies using unilateral ECT from those using bilateral ECT.
The reason why nosotros did not distinguish between unilateral and bilateral ECT stays in some controversies regarding which of the 2 techniques is most efficient method of electrical consecration of the ECT (41–43). Some studies pointed out that the efficacy of unilateral ECT is simply a question of adequate dosage levels; with high-dose unilateral ECT and bilateral ECT present equivalents response rate, with the reward that unilateral ECT produces less anterograde and retrograde memory deficits (44–49).
Another consideration regarding the variation of standard treatments is the apply of traditional ECT (constant-voltage modified sine-wave stimuli) or modernistic ECT (abiding electric current brief-pulse). The physiological efficiency of the brief-pulse device is more optimal than the sine wave, merely comparisons between the traditional sine-wave ECT and the bilateral suprathreshold modern ECT revealed that the clinical improvement were virtually identical for the 2 methods (50–52).
Another caveat for interpreting information on ECT, regards the diagnostic heterogeneity of samples used in the various studies, which included diagnoses such as neurotic depression (22, 31, 53), depression with psychotic symptoms (20, 22), melancholic depression (29), treatment-resistant major depression (28), and schizoaffective disorders, depressed type (33–36). There are contradictions in the analysis of the association of specific symptom profiles with ECT issue. Early observational studies found that endogenous or melancholic depression were predictive of greater response to ECT than "neurotic low"; nevertheless, subsequent trials did not reveal a difference in ECT response betwixt patients with versus without melancholia (54). A combined analysis of randomized controlled trials of ECT versus fake ECT showed that real ECT had a therapeutic reward, specifically among patients with delusions and/or retardation (55). Nevertheless, in 2 randomized controlled trials, involving 143 patients, Sobin et al (56) investigated the utility of depression subtypes in predicting ECT response and concluded that ECT is a treatment option for patients with major low regardless of the presence of psychotic features, retardation and/or agitation. More responsible of the variation of results among studies on ECT can exist, respectively, the dissimilar instruments used to measure the reduction of the depressive symptoms, the difficulties to maintain some inquiry team bullheaded to this therapeutic method, the number of ECT sessions applied and the methodological weakness of some studies that did not specify the electrical parameters of the bilateral ECT and/or unilateral ECT. Moreover, the proportion of patients who previously failed adequate antidepressant medication trials could impact on rates of response to ECT (57–59).
Determination
In conclusion, past this meta-analysis we tried to analyze systematically available scientific information on ECT trials to provide a reliable estimate of ECT efficacy for depression. Data analyzed suggest that ECT is a valid therapeutic tool in the armamentarium for low, including severe and resistant forms. Futurity studies are needed to clarify whether and when such an intervention can be a first choice treatment of some patients.
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Source: https://focus.psychiatryonline.org/doi/abs/10.1176/foc.6.1.foc155
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