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Psychological and Emotional Effects of the Use of Oral Baclofen: a Preliminary Study

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Psychological and Emotional Effects of the Use of Oral Baclofen: a Preliminary Study Paraplegia 32 (1994) 349-353 © 1994 International Medical Society of Paraplegia Psychological and emotional effects of the use of oral baclofen: a preliminary study A Jamous MD MSc (Oxon), P Kennedy MSc C Psychol AFBPsS, N Grey BA (Cantab) National Spinal Injuries Centre, Stoke Mandeville Hospital, Aylesbury, Bucks HP21 8AL, UK. Spasticity is a common problem following spinal cord injury. The drug of choice to control spasms is baclofen. There would appear to be no reported studies which have evaluated the psychological and emotional effect of this drug. This preliminary study investigated a number of such effects, including depression, anxiety and general mood state. First, we examined 10 subjects before and during the administration of baclofen. They were then compared to a control group of 12 subjects. A second cohort of 12 subjects taking baclofen were compared to a control group of nine subjects at a specific time after injury. Results indicated that whilst some significant differences were found, suggesting an increase in fatigue with use of baclofen, no major adverse psychological effects were noted. The implications of these results were discussed and suggestions for further research were highlighted. Keywords: spinal cord injury; spasms; baclofen; psychology; adverse side effects. Introduction ways. First, by within-subject comparison of ratings taken before and during the use For years, oral baclofen has been one of the of oral baclofen. Secondly, by a between­ main drugs for the treatment of spasticity subject comparison of ratings at a fixed after spinal cord injury. It is usually well point in time after injury of a group of tolerated, but with common adverse side subjects taking baclofen at that time and a effects such as sedation, confusion and control group who used no antispasticity fatigue. There have also been case reports medication at any time in their rehabilita­ of temporary side effects induced by baclo­ tion. Finally, the study investigates whether fen, such as frontal lobe syndrome, I psy­ there is any correlation between dosage of chotic depression,2 and pseudopsychosis.3 baclofen and disturbance in psychological The reported incidence of side effects has and emotional measures. ranged from 30% 4 to 75%.5 Gradual with­ drawal is usually recommended as rapid withdrawal may induce adverse effects such Method as visual hallucinations.6 Despite baclofen being one of the most Subjects widely used drugs controlling spasticity, the Comparison 1: repeated measure and authors can find no reference in the control group literature concerning the evaluation of emo­ The experimental group consisted of 10 tional and psychological side effects of its male inpatients, whose average age was 24 user. Previously, these effects have merely years, SD = 5 (range 18-34), and included been clinically reported. This initial pilot two incomplete tetraplegic patients, four study investigates the relationship between complete tetraplegics and four complete the use of baclofen and the disturbance in paraplegics. Patients were assessed before emotional and psychological measures. (mean of 17 weeks post injury, range 17-24 The study attempts to do this in three weeks) and after (mean of 28 weeks post 350 famous et al Paraplegia 32 (1994) 349-353 lllJury, range 24-30 weeks) baclofen over the past week, matches that of each of therapy. They had been on baclofen for an the 20 statements in the scale. average of 8 weeks, within a mean daily Anxiety was measured using the State y).9 dose of 51 mg, SD = 27 (range 10-100). Anxiety Inventory (Form This consists They were then compared to a control of 20 statements concerning both anxiety, group who received no antispasticity medi­ present states (eg 'I am worried'), and cation at any time during rehabilitation. The anxiety absent states (eg 'I feel calm'). The 12 inpatient controls were matched for age subjects indicate their agreement with each at injury (27 years, SD = 5, range 19-36), item at that moment. Each item is scored and level (three incomplete tetraplegics, 1-4, higher scores indicating higher anxiety. four complete tetraplegics, five para­ The Psychosocial Adjustment to Illness plegics), and were 18 weeks post injury Scale Seven: Psychological DistresslO was when the measures were taken. used to measure dysphoric thoughts and feelings that are associated with the sub­ ject's disorder, or are a direct result of the Comparison 2: 30 weeks post injury illness and its sequelae. Its seven items cross-sectional comparison investigate anxiety, depression, hostility, Two groups of inpatients were compared at reduced self esteem, body image problems 30 weeks post injury; one taking baclofen at and inappropriate guilt and refer to the that time, the other known not to have preceding month. Each item is scored 0-3, taken any antispasticity medication at any higher scores indicating higher distress. time during rehabilitation. The group taking The Intrusion Scale of the Impact of baclofen at 30 weeks post injury consisted of Events Scalell was used to measure the the 10 patients in the experimental group frequency of intrusive thoughts and images, described above, plus two further patients, troubled dreams, strong pangs or waves of one tetraplegic and one paraplegic (these feelings, and repetitive behaviour in the had not been included in the original experi­ preceding week. Each of the seven items is mental group because the data for before scored 0-5, higher scores indicating higher taking baclofen is not available for them). distress. The comparison 2 control group was The Profile of Mood States12 measured chosen so as to match for age and comprised affect by subjects indicating the extent to five males and four females, average age 29 which they felt their mood corresponded to years, (SD = 8), range 19-45. It included the list of adjectives presented. The scales of one incomplete tetraplegic, two complete anger, vigour, fatigue and confusion were tetraplegic patients and six complete para­ measured by 12 and these were not elev­ plegics. ated, eight, seven and seven items respect­ ively. Each item is scored 0-4, higher score indicating higher level of that emotion. Measures Depression was measured using the Beck Procedure Depression Inventory, 7 in which subjects The subjects of this study form a subset of a have to choose for each item the most larger longitudinal study currently in pro­ appropriate of four concerning their well­ gress. The patients are rated every 6 weeks being for the previous week. The 21 ques­ from admission to discharge on each of the tions measure both somatic symptoms (eg psychological impact measures with a re­ appetite, insomnia, fatigue) and nonsomatic search psychologist. This assessment takes symptoms (eg guilt, dissatisfaction, sadness) approximately 30 minutes. The available of depression. Each item is scored 0-3, medical records of these patients were higher scores indicating more depressive investigated to study whether they had at symptoms. any time been taking baclofen or any other Hopelessness was measured with the antispasticity medication. This was done Beck Hopelessness Scale.s Subjects indicate after all the impact measure had been taken. whether their attitude toward the future, Hence, the rating had been taken 'blind'. Paraplegia 32 (1994) 349-353 Psychological and emotional effects of baciofen 351 Comparison 1: The within-subject data Table I Mean score and standard deviations of were provided by comparing the last set of emotional and psychological measures at 30 results, before taking baclofen, with results weeks post injury for group taking baclofen and obtained after baclofen had been taken for group taking no antispasticity medication at any time during rehabilitation at least 2 weeks. The pre-baclofen group was compared also to the matched control. Measure No drug Taking p Com arison 2: Between-subject data p group baclofen com ared those taking baclofen and those p (n = 9) (n = 12) not taking any antispasticity medication at 30 weeks, post injury. BDI 10.22 13.67 NS (8.33) (12.4) BHS 4.56 5.33 NS (4.80) (5.71) Results SAl 29.89 39.75 NS t (7.99) (14.8) Comparison 1: Using independent tests, PAIS-7 5.22 6.75 NS no significant differences were found in any (4.87) ( 4.16) of the measures between the baclofen group RIES-1 8.00 9.67 NS before they started using the drug and the (10.2) (8.61) control group, or between the pre-baclofen Anger 5.78 5.33 NS scores and during baclofen scores in the (4.81) (6.53) Vigour 17.00 9.58 0.028 baclofen group. Pearson product-moment .20) (6.11) correlations were calculated with the dos­ (8 Fatigue 5.33 10.92 0.019 ages of baclofen being taken at the time of (3.28) (5.85) testing and the emotional and sychological p Confusion 0.78 3.50 NS measures. None of the correlations were (2.22) (4.87) significant. t Comparison 2: Independent tests were BDI = Beck Depression Inventory, BHS = carried out to compare the scores at 30 Beck Hopelessness Scale, SAl = State Anxiety weeks post injury for those taking baclofen Inventory, PAIS-7 = Pain Adjustment to Ill­ at that time and those who had not taken ness Scale Seven, RIES-1 = Revised Impact of Events Scale One any antispasticity at any time in their rehabi­ Standard deviations in parentheses. litation. Significant differences were found in two measures. Those not taking any antispasticity medication were significantly more vigorous than those on baclofen, as Discussion measured on the POMS (t = 2.38, p < 0.05). Correspondingly, those patients Significant differences were found on taking baclofen were significantly more measures of vigour and fatigue between fatigued than those not on any antispasticity those taking baclofen and those who took medication as measured on the POMS no antispasticity medication at any time in (t = 2.57, P < 0.05).
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