Table 5.
Adverse event data (narrative report)
| Trial | Adverse event data¹ | Summary of reported results | |
| Carbamazepine (CBZ) | Phenobarbitone (PB) | ||
| Banu 2007² | Reported list of 'problems' at the last visit (provided as IPD) | CBZ (n = 54): speech/learning delay (n = 6), headaches (n = 3), restlessness/hyperactivity/poor attention/irritability (n = 6), psychomotor deterioration/delay (n = 2), sleep disturbances (n = 2), fatigue (n = 1), hydrocephalus (build up of fluid on the brain) (n = 1), CBZ hypersensitivity (n = 1), aggression (n = 1), temper tantrums (n = 1), other behavioural problems (n = 5), poor cognition (n = 1), mild stroke (n = 1), mild right‐sided weakness (n = 1), intolerable behavioural problems (n = 6) | PB (n = 54): speech/learning delay (n = 7), restlessness/hyperactivity/poor attention/irritability (n = 8), sleep disturbances (n = 1), fatigue (n = 1), poor cognition (n = 2), aggression (n = 1), temper tantrums (n = 3), breath‐holding attacks (n = 1), other behavioural problems (n = 3), facial twitching (n = 1), left‐sided weakness (n = 1), leg pain (n = 1), vomiting (n = 1), intolerable behavioural problems (n = 4) |
| Bidabadi 2009³ | Rate of drug side‐effects | No statistical significant difference was seen after treatment between 2 groups in the rate of drug side‐effects | No statistical significant difference was seen after treatment between 2 groups in the rate of drug side‐effects |
| Cereghino 1974²,⁴ | Most frequently observed side‐effects | Gastrointestinal side‐effects and "impaired function" (general malaise). Frequency not clearly stated | Gastrointestinal side‐effects and "impaired function" (general malaise). Frequency not clearly stated |
| Chen 1996 | Withdrawal from the study due to 'allergic reactions' | CBZ (n = 24): 1 participant withdrew due to an allergic reaction | PB (n = 23): 2 participants withdrew due to allergic reactions |
| Cossu 1984 | No adverse events reported | Not reported | Not reported |
| Czapinski 1997³ | "Exclusions due to adverse events or no efficacy" | Proportion "excluded": 30% (out of 30 randomised to CBZ) | Proportion "excluded": 33.3% (out of 30 randomised to PB) |
| de Silva 1996⁵,⁶ | "Unacceptable" adverse events leading to drug withdrawal | CBZ (n = 54): drowsiness (n = 1), blood dyscrasia (n = 1) | PB (n = 10): drowsiness (n = 1), behavioural (n = 5) |
| Feksi 1991 | Reports of minor adverse events and side‐effects leading to drug withdrawal | CBZ (n = 150): withdrawals due to side‐effects: skin rash (n = 4), psychosis (n = 1), aggressive behaviour (n = 1). Minor adverse events: CBZ: 46 participants reported 68 adverse events |
PB (n = 152): withdrawals due to side‐effects: skin rash (n = 1), psychosis (n = 1), hyperactivity (n = 3). Minor adverse events: 58 participants reported 86 adverse events |
| Heller 1995⁵ | "Unacceptable" adverse events leading to drug withdrawal |
CBZ (n = 61): drowsiness (n = 3), rash (n = 2), headache (n = 1), depression (n = 1) | PB (n = 58): drowsiness (n = 4), lethargy (n = 4), rash (n = 1), dizziness (n = 2), headaches (n = 1), nausea and vomiting (n = 1) |
| Mattson 1985² | Narrative report of 'adverse effects' and 'serious side‐effects' | CBZ (n = 155): motor disturbance (ataxia, incoordination, nystagmus, tremor ‐ 33%), dysmorphic and idiosyncratic side‐effects (gum hypertrophy, hirsutism, acne, and rash ‐ 14%), gastrointestinal problems (27%), decreased libido or impotence (13%). No serious side‐effects | PB (n = 155): motor disturbance (ataxia, incoordination, nystagmus, tremor ‐ 24%), dysmorphic and idiosyncratic side‐effects (gum hypertrophy, hirsutism, acne, and rash ‐11 %), gastrointestinal problems (13%), decreased libido or impotence (16%). No serious side‐effects |
| Mitchell 1987 | Systemic side‐effects and side‐effects leading to drug change | CBZ (n = 15): 4 participants switched from CBZ to PB; 3 due to systemic side‐effects (1 with persistent rashes and 1 with marked granulocytopenia (decrease of granulocytes (white blood cells)) and 1 due to behavioural changes | PB (n = 18): 1 participant switched from PB to CBZ due to substantial behavioural side‐effects |
| Ogunrin 2005² | Participant‐reported symptomatic complaints (provided as IPD) | CBZ (n = 19), memory impairment (n = 9), psychomotor retardation (n = 1), inattention (n = 1), transient rash (n = 1), CBZ‐induced cough (n = 1) | PB (n = 18), memory impairment (n = 13), psychomotor retardation (n = 8), inattention (n = 9) |
| Placencia 1993 | Number of participants reporting side‐effects | CBZ (n = 95): 53 participants reported at least 1 side‐effect | PB (n = 97): 50 participants reported at least 1 side‐effect |
CBZ: carbamazepine; PB: phenobarbitone ¹We recorded adverse event data as reported narratively in the publications; therefore, exact definition of a symptom may vary. Adverse event data were supplied as IPD for Banu 2007 and Ogunrin 2005. Adverse event data were not requested in original IPD requests (de Silva 1996; Heller 1995; Mattson 1985; Placencia 1993), but will be for all future IPD requests. For numbers of withdrawals due to adverse events in studies for which we received IPD (Banu 2007; de Silva 1996; Heller 1995; Mattson 1985; Placencia 1993), see Table 6. ²Bidabadi 2009 and Czapinski 1997 are abstracts only so very little information was reported. ³Participants may report more than one adverse event. ⁴Note that the recruited participants in this study were institutionalised; therefore, the "precise nature of side‐effects was not always determinable". The two most frequently occurring side‐effects were reported as the frequency of participants reporting the side‐effect on each day of the treatment period; however, overall totals of participants reporting each side‐effect were not reported. ⁵Participants may have withdrawn due to adverse event alone or a combination of adverse events and poor efficacy (seizures). ⁶The phenobarbitone arm of de Silva 1996 was stopped prematurely after 10 children were randomised to this arm because of concerns over behavioural adverse events (see the 'Characteristics of included studies' tables).