Evaluation of Gabapentin and Baclofen Combination for Inpatient Management of Alcohol Withdrawal Syndrome

The primary outcome of this study was the length of stay (LOS), which was defined as the hours from admission to either discharge or 36 hours with a CIWA score ≤ 8. Secondary outcomes included the occurrence of alcohol withdrawal seizure, the occurrence of DTs, rates of conversions from g/b protocol to lorazepam use, rates of transitions to a higher level of care (eg, an intensive care unit), and readmission for AWS within 30 days.

CPRS was used to collect information including baseline demographics, blood alcohol content, CIWA scores throughout hospitalization, number of admissions for alcohol detoxification in the previous year, AWS readmission within 30 days after discharge, prior treatment with g/b, history of alcohol withdrawal seizures and DTs, hospital LOS, outpatient medications for AUD treatment, rates of conversions from g/b protocol to lorazepam, and rates of transition to a higher level of care.

Statistical Analysis

Study data were stored and analyzed using an Excel spreadsheet and IBM SPSS Statistics software. LOS was compared between the g/b and benzodiazepine groups using inferential statistics. An independent 2-sample t test was used to assess the primary outcome if data were normally distributed. If the collected data were not distributed normally, the Mann-Whitney U test was used. All other continuous variables were assessed by using independent t tests and categorical variables by using χ² tests. A P value < .05 was considered statistically significant. Effect size of d = 0.42 was calculated based on a previous study with a similar research design as our study.⁹ We determined that if using an independent 2-sample t test for the primary outcome analysis, an estimated sample size of 178 subjects would provide the study with an 80% power to detect a difference at a 2-sided significance level with α = 0.05. If using the Mann-Whitney U test, 186 subjects would be required to provide identical power.

Results

We reviewed 196 patient health records, and 39 were initially excluded. The most common reason was that AWS was not the primary diagnosis for hospitalization (n = 28).

After eligibility screening, 102 subjects were excluded with the most common reason for exclusion being the use of gabapentin, baclofen, or benzodiazepines in the outpatient setting before admission (n = 49). Fifty-five patients met the inclusion criteria; 35 patients were in the benzodiazepine group and 20 in the g/b group (Figure 1).

Most patients in both groups were White and male (Table 1). The average admission CIWA score in the benzodiazepine group was higher than the g/b group (6.8 vs 3.9; P = .001). The maximum CIWA score was also higher in the benzodiazepine group compared with the g/b group (12.7 vs 5.5; P < .001).

The Shapiro-Wilk tests showed a significant departure from normality in the benzodiazepine group W(35) = 0.805 (P < .001) and g/b group W(20) = 0.348 (P < .001) for the primary outcome.

The g/b group average LOS was shorter compared with the benzodiazepine group (42.6 vs 82.5 hours, respectively). By using the Mann-Whitney U Test, a statistically significant difference was found in the primary outcome U = 98; z score = 4.41 (P < .001; Figure 2).

Additionally, this study examined multiple secondary outcomes (Table 2).

Length of hospitalization, defined as hours from admission to discharge, was shorter in the g/b group compared with in the benzodiazepine group (76.8 hours vs 115.4 hours; P = .03). There was no significant difference between the benzodiazepine and g/b groups in AWS readmission within 30 days after discharge, adjuvant medications added for AWS management, and the number of patients transitioned to a higher level of care. However, 3 patients had to be transitioned to the intensive care unit in the benzodiazepine group compared with none in the g/b group. Of note, 2 patients (10%) in the g/b group were switched to benzodiazepines. Also, 1 patient experienced a seizure and 1 patient experienced DTs in the benzodiazepine group during admission, with no incidences of seizures or DTs in the g/b group.