Table 7.13Adverse events

AEs outcomeReferenceInterventionAssessment timeOutcome/effect size
Paracetamol vs opioids
Number of patients with AEs, nausea and vomiting1 RCT (Bianchi et al. 2003) N=20Paracetamol vs tramadol1 week0% (paracetamol) and 20% (tramadol)
Paracetamol better
Paracetamol vs paracetamol-opioids
GI AEs1 RCT (Boureau et al. 1990) N=234Paracetamol vs codeine-paracetamol3 daysNS
Number of AEs1 RCT (Kjaersgaard et al. 1990) N=161Paracetamol vs codeine- paracetamol4 weeks27.6% (paracetamol) vs 52.3% (codeine- para); p<0.01
Paracetamol-opioids vs NSAIDs
Number of patients with AEs1 RCT (Irani 1980) N=22Dextropropoxyphene- paracetamol (distalgesic) vs indomethacin or sulindac4 weeks22% (distalgesic) and both NSAIDs 0%
NSAIDs better
New cases of dyspepsia or gastritis1 RCT (Irani 1980) N=22Dextropropoxyphene- paracetamol (distalgesic) vs sulindac4 weeksN=8 (distalgesic) and N=1 (sulindac)
NSAIDs better
New cases of dyspepsia or gastritis1 RCT (Irani 1980) N=22Dextropropoxyphene- paracetamol (distalgesic) vs indomethacin4 weeksN=8 (distalgesic) and N=6 (indomethacin)
Both groups similar
Number of study completers with AEs diarrhoea (0.5% vs 38%) and indigestion/epigastric pain (5% vs 11%; p < 0.01)1 RCT (Parr et al. 1989) N=755Dextropropoxyphene- paracetamol vs slow-release diclofenac4 weeks24% (dextro-para) and 13% (diclofenac); <0.01
Favours dextro-para
Number of study completers with diarrhoea1 RCT (Parr et al. 1989) N=755Dextropropoxyphene- paracetamol vs slow-release diclofenac4 weeks0.5% (dextro-para) and 38% (diclofenac); <0.01
Favours dextro-para
Number of study completers with indigestion/epigastric pain1 RCT (Parr et al. 1989) N=755Dextropropoxyphene- paracetamol vs slow-release diclofenac4 weeks5% (dextro-para) and 11% (diclofenac); <0.01
Favours dextro-para
Dizziness/light- headedness1 RCT (Parr et al. 1989) N=755Dextropropoxyphene- paracetamol vs slow-release diclofenac4 weeks8% (dextro-para) and 4% (diclofenac); <0.05
Favours NSAID
Sleep disturbance/ tiredness1 RCT (Parr et al. 1989) N=755Dextropropoxyphene- paracetamol vs slow-release diclofenac4 weeks13% (dextro-para) and 6% (diclofenac); <0.01
Favours NSAID
Gastric AEs; mean overall chronic gastritis index; mean overall acute gastritis grading1 RCT (McIntyre et al. 1981) N=32Dextropropoxyphene- paracetamol vs indomethacin or sulindac4 weeksAll groups similar
Opioids vs NSAIDs
Proportion of patients with major AEs1 MA (Cepeda et al. 2006) 1 RCT, N=108Tramadol vs dclofenac28 days (end of treatment)NS
Proportion of patients with minor AEs1 MA (Cepeda et al. 2006) 1 RCT, N=108Tramadol vs dclofenac28 days (end of treatment)RR 6.0, 95% CI 1.41 to 25.5
NSAIDs better

From: 7, Pharmacological management of osteoarthritis

Cover of Osteoarthritis
Osteoarthritis: National Clinical Guideline for Care and Management in Adults.
NICE Clinical Guidelines, No. 59.
National Collaborating Centre for Chronic Conditions (UK).
Copyright © 2008, Royal College of Physicians of London.

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