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document
Codeine/acetaminophen and hydrocodone/acetaminophen combination tablets for the management of chronic cancer pain in adults : a 23-day , prospective , double-blind , randomized , parallel-group study . BACKGROUND Analgesics are an essential component of the treatment of cancer-associated pain . Pharmacologic treatment is usually begun with nonopioid analgesics , most frequently acetaminophen . If pain relief is not achieved , the so-called " weak " opioids , such as codeine and hydrocodone , may be used in combination with acetaminophen . Adverse effects ( AEs ) of the opioids include constipation , somnolence , nausea , and vomiting . Based on the results of a literature search , data comparing the effects of the opioids are lacking . OBJECTIVE The purpose of this study was to compare the analgesic efficacy and tolerability of codeine phosphate versus hydrocodone bitartrate in combination with acetaminophen in the relief of cancer-related pain . METHODS This 23-day , prospective , double-blind , randomized , parallel-group study was conducted at 3 Colombian centers : University Libre , Social Security Institute , and General Hospital of Medellín , Cali , Colombia . Outpatients with cancer were eligible for the study if they were aged > -18 years and had chronic ( duration , > /= 3 months ) moderate to severe cancer-related pain ( score on 10-cm visual analog scale [ VAS ] , > 3 cm [ moderate ] ; score on a 4-point verbal pain-intensity scale , > 1 [ moderate ] ) . Eligible patients were randomly assigned to receive 1 tablet of codeine/acetaminophen ( C/A ) 30/500 mg or hydrocodone/acetaminophen ( H/A ) 5/500 mg PO q4h ( total daily doses , 150/2500 and 25/2500 mg , respectively ) for 23 days . In both groups , if pain intensity was rated as > 3 on the VAS at week 1 or 2 , the dosage was doubled . The primary end point was the proportion of patients who achieved pain relief ( defined as a score of > 1 on a 5-point verbal rating scale [ VRS ] ( 0 = none ; 1 = a little ; 2 = some ; 3 = a lot ; and 4 = complete ) on study days 1 and 2 and weeks 1 , 2 , and 3 . The secondary end point was the proportion of patients in whom pain was decreased ( VAS score , < - 3 cm ) . AEs were self-reported on a 4-point VRS ( 0 = absent ; 1 = mild ; 2 = moderate ; and 3 = severe ) . RESULTS Of the 121 patients who participated , 59 received C/A and 62 received H/A . Of the total number of cases , 59 % were aged 60 to 89 years , and 55 % were men . At baseline , 88 % of the patients described their pain intensity as moderate ; 12 % , severe . Of the patients who received C/A , 58 % responded to the initial dosage of 150/2500 mg/d , and 8 % of the patients responded to the double dosage ; 34 % did not experience pain relief . In patients with H/A , pain was reported as absent or mild in 56 % of patients at the starting dosage of 25/2500 mg/d ; an additional 15 % of the patients responded to the double dosage ; the remaining 29 % of patients did not experience any pain relief . None of the between-group differences in response rates were significant . The most common AEs in the C/A and H/A groups were constipation ( 36 % and 29 % , respectively ) , dizziness ( 24 % and 19 % ) , vomiting ( 24 % and 16 % ) , and dry mouth ( 15 % and 18 % ) , with no significant differences between groups . CONCLUSION In this study , efficacy and tolerability were comparable between C/A and H/A over 23 days of treatment in these patients with moderate or severe , chronic , cancer-related pain .
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Intervention_Pharmacological
Codeine/acetaminophen
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Intervention_Pharmacological
hydrocodone/acetaminophen combination
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Intervention_Pharmacological
acetaminophen
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Intervention_Pharmacological
codeine and hydrocodone
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Intervention_Pharmacological
combination with acetaminophen
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Intervention_Pharmacological
codeine phosphate
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Intervention_Pharmacological
hydrocodone bitartrate
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Intervention_Pharmacological
acetaminophen
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Outcome_Pain
pain relief
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Outcome_Other
analgesic efficacy and tolerability
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Participant_Condition
chronic cancer pain
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Participant_Age
adults
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Participant_Age
> -18 years
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Participant_Sample-size
121
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Participant_Age
aged 60 to 89 years
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Participant_Sex
men