Sir,
Zolpidem has been used in baclofen group for sleep purpose only. Since zolpidem has quick onset of action and short half-life, it is unlikely to affect the pervasive alcohol withdrawal syndrome.[1]
Patients with a history of complicated withdrawal was one of the exclusion criteria for the study, and hence, patients with confusion/disorientation were not enrolled for the study; however, two patients, one from each group, developed complicated withdrawal during detoxification and hence excluded from the study.[2]
Since caffeine and nicotine dependence is so common with or without alcohol dependence, we did not exclude them. However, patients with nicotine dependence did receive nicotine replacement therapy in the current study.
The index study was conducted in 2011–2013 and most of the studies[3,4] had used this dose only although we did mention about using higher doses to find any dose–response relationship in the discussion part.[2]
Certainly, for comparison of results, time × treatment interaction effects could have been more informative and this is the limitation of the study.
Patients were first screened in the outpatient department and then admitted in the ward only after taking consent from them, and their relative and patients under intoxication were not admitted till the intoxication was subsided. Moreover, the severity of alcohol withdrawal was not so severe which could lead to confusion and inability to understand the implication of indoor treatment.
Patients with serious physical illness including renal dysfunction were excluded from the study thorough physical examination, history, and routine laboratory screening. The baseline investigations were carried out in all 64 patients (33 in baclofen and 31 in lorazepam groups, and it was typing error in Table 1 where it is written as 22 and 23 in baclofen and lorazepam group, respectively).
Table 1.
Routine investigations, including markers of alcohol consumption, at baseline (values in mean± standard deviation)
| Baclofen (n=33) | Lorazepam (n=31) | P value | |
|---|---|---|---|
| Haemoglobin | 12.42±0.663 | 11.94 ±0.727 | 0.368 |
| Platelet | 2.12±0.6 | 2.16±0.523 | 0.626 |
| Total serum bilirubin | 1.12±0.409 | 1.32±0.388 | 0.549 |
| Conjugated bilirubin | 0.24±0.25 | 0.22±0.203 | 0.12 |
| Alkaline phosphatase | 146.76±42.126 | 165.13±43.059 | 0.783 |
| SGOT | 153.39±54.569 | 140.1±46.242 | 0.614 |
| SGPT | 142.76±36.491 | 134.23±36.796 | 0.924 |
| Total serum protein | 7±0.176 | 6.96±0.156 | 0.458 |
| Albumin | 3.95±0.112 | 3.87±0.202 | 0.065 |
| GGT | 207.15±126.966 | 178.42±97.16 | 0.063 |
SGOT – Serum glutamic oxaloacetic transaminase; SGPT – Serum glutamic pyruvic transaminase; GGT – Gamma glutamyl transpeptidase
It was explained to patients about the cost of baclofen versus cost of lorazepam, and once the patients agreed to buy baclofen, only after that they were included in the study, and for those who could not buy any medicine, they were provided free samples by the investigator.
The study protocol was approved by the institutional ethics committee and also registered with the CTRI/2016/01/006525.
The current study was conducted in 2011–2013, whereas recent reviews of randomized controlled trials of baclofen suggest caution in view of poor-quality evidence came in 2017–2018.[5,6]
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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