Original Article
Comparison of an Antiinflammatory Dose of Ibuprofen, an Analgesic Dose of Ibuprofen, and Acetaminophen in the Treatment of Patients with Osteoarthritis of the Knee
N Engl J Med 1991; 325:87-91July 11, 1991
- Abstract
- Abstract
Background.
The optimal short-term, symptomatic therapy for osteoarthritis of the knee has not been fully determined. Accordingly, we compared the efficacy of a nonsteroidal antiinflammatory drug, ibuprofen, given in either an antiinflammatory dose (high dose) or an analgesic dose (low dose), with that of acetaminophen, a pure analgesic.
Methods.
In a randomized, double-blind trial, 184 patients with chronic knee pain due to osteoarthritis were given either 2400 or 1200 mg of ibuprofen per day or 4000 mg of acetaminophen per day. They were evaluated after a washout period of three to seven days before the beginning of the study, and again after four weeks of treatment. The major measures of outcome included scores on the pain and disability scales of the Stanford Health Assessment Questionnaire (range of possible scores, 0 to 3), scores on the visual-analogue scales for pain at rest and pain while walking, the time needed to walk 50 ft (15 m), and the physician's global assessment of the patient's arthritis.
Results.
Seventy-eight percent of the patients completed four weeks of therapy. No significant differences were noted among the three treatment groups with respect to failure to complete the trial because of noncompliance or adverse events. All three groups had improvement in all major outcome variables, and the groups did not differ significantly in the magnitude of improvement in most variables. The mean improvement (change) in the scores on the pain scale of the Health Assessment Questionnaire was 0.33 with acetaminophen (95 percent confidence interval, 0.14 to 0.52), 0.30 with the low dose of ibuprofen (95 percent confidence interval, 0.09 to 0.51), and 0.35 with the high dose of ibuprofen (95 percent confidence interval, 0.13 to 0.57). Side effects were minor and similar in all three groups.
Conclusions.
In short-term, symptomatic treatment of osteoarthritis of the knee, the efficacy of acetaminophen was similar to that of ibuprofen, whether the latter was administered in an analgesic or an antiinflammatory dose. (N Engl J Med 1991; 325:87–91.)
Media in This Article
Table 1
Characteristics of the Three Treatment Groups at the Initiation of Treatment of Osteoarthritis of the Knee.*Table 2
Reasons for Failure to Complete Treatment.Article Activity
- Article
OSTEOARTHRITIS is the most common joint disease; as much as 80 percent of the population has radiographic evidence of osteoarthritis by the age of 65.1 Although only about 60 percent of patients with radiographically detectable osteoarthritis have symptoms,2 15 to 30 percent of all visits to general practitioners may be attributed to difficulty with ambulation, largely due to osteoarthritis.
In some patients with idiopathic (primary) osteoarthritis, histologic evidence of synovial inflammation may become apparent early in the course of the disease,3 , 4 but synovitis is most often seen in advanced disease,5 and clinical correlates of synovial inflammation — e.g., joint swelling, effusion, and prolonged morning stiffness — are often only mild or are absent in patients with osteoarthritis. Joint pain, the symptom that most frequently leads patients with osteoarthritis to seek medical attention, may originate not only from synovitis but also from stretching of the joint capsule or ligaments, periosteal irritation due to osteophyte formation, trabecular microfractures, intraosseous hypertension, or muscle spasm.6 7 8 9
Although the contribution of inflammation to both joint pain and the progression of cartilage breakdown in osteoarthritis is unclear, inflammation is commonly treated with nonsteroidal antiinflammatory drugs (NSAIDs), which are often helpful in relieving joint pain and improving mobility in osteoarthritis.10 However, there is little evidence that analgesic agents with no antiinflammatory activity are any less effective than NSAIDs in the treatment of osteoarthritis.
The frequency and potential severity of side effects of NSAIDs,11 such as gastric ulcer,12 13 14 call for an evaluation of the risks and benefits of this therapy in comparison with less toxic therapy for osteoarthritis. In this study we compare a pure analgesic, acetaminophen, with an NSAID, ibuprofen, in short-term, symptomatic treatment of osteoarthritis of the knee.
Methods
Subjects
Two hundred four subjects with idiopathic or post-traumatic osteoarthritis were recruited from the general-medicine, rheumatology, and orthopedic-surgery clinics of the Indiana University School of Medicine and from the surrounding community. All were at least 30 years old and had knee pain and evidence of grade 2 (mild) or grade 3 (moderate) osteoarthritis on standing anteroposterior and lateral radiographs of the knee.15 Patients with fibromyalgia, bursitis, tendinitis, or severe neurologic or vascular disease affecting the lower extremities were excluded. None of the subjects had a history of trauma, surgery, or injection of the knee with corticosteroids in the previous three months, an underlying inflammatory arthropathy (e.g., rheumatoid arthritis, gout, or pseudogout), or a medical condition that would have contraindicated the use of the study medications. All patients were able to walk without assistance or assistive devices (e.g., canes, crutches, or walkers).
Study Design
The study was a randomized, double-blind comparison of acetaminophen in a dose of 4000 mg per day, "low-dose" ibuprofen (1200 mg per day), and "high-dose" ibuprofen (2400 mg per day). Tablets of ibuprofen (150 and 300 mg) and acetaminophen (500 mg) were prepared that were identical in appearance. During a washout period of three to seven days, the participants refrained from taking any NSAIDs or analgesics except for "rescue analgesia" (100 mg of propoxyphene napsylate by mouth as needed, up to four times daily). All the subjects had persistent knee pain at the end of the washout period, at which time they were given the treatment medication — two tablets to be taken four times daily after meals or with milk, for four weeks. The use of propoxyphene napsylate was discontinued at the start of the treatment period.
At each of the three study visits (for the base-line evaluation, at the end of the washout period, and after the last dose of drug) each patient completed the Stanford Health Assessment Questionnaire (HAQ) disability and pain scales,16 which were expanded to include horizontal double-anchored visual-analogue scales for pain at rest ("rest pain"), pain on walking ("walking pain"), and walking distance (the distance the patient could walk before having to stop because of knee pain).
At each visit after the first, the patients were asked about their use of analgesics and NSAIDs during the most recent treatment interval, changes (which were discouraged) in their level of physical activity and their use of physical therapy (e.g., exercise, application of heat or cold, or massage), and adverse events, which were defined as any undesired experiences that the patient attributed to the study medication.
At each visit, the tenderness, swelling, and range of motion (the maximal passive flexion and extension, measured with a goniometer) of the knee and the "50-ft—walk time" (the time needed to walk 15 m, with maximal effort) were assessed, and a global assessment was made of the level of disease activity. At the end of the treatment period the physician's assessment of the global change since the end of the washout period was recorded (as much worse, somewhat worse, unchanged, somewhat better, or much better). All assessments were performed by a single physician–nurse team. Compliance with prescribed treatment was assessed by counting the number of tablets of unused medication. Patients taking less than 75 percent of the prescribed doses or using disallowed analgesics or NSAIDs were considered to be noncompliant.
Laboratory Studies
A complete blood count, white-cell differential count, serum chemistry profile, urinalysis, and testing for blood in stool (Hemoccult test) were performed at the initial and final visits.
Data Analysis
The major measures of outcome were the scores on the HAQ disability and pain scales, the visual-analogue scales for rest pain and walking pain, the 50-ft—walk time, and the physician's global assessment. The HAQ disability score is calculated from eight subscale scores, each of which ranges from 0 (no disability) to 3 (severe disability). The walking and arising subscales assess abilities to walk on flat ground, climb steps, rise from a chair, and get into bed and out. Because these subscales specifically evaluate lower-extremity function, they were dissected from the HAQ disability scale and analyzed separately. The visual-analogue scales were all converted to scales on which scores ranged from 0 to 3, with rounding to the nearest 0.1 point. The 50-ft—walk time was recorded to the nearest 0.1 second.
For all major outcome measures except the global assessments, the change from base line was calculated and one-way analysis of variance was performed to determine whether the three treatment groups differed in the magnitude of changes at the end of treatment. Differences among the treatment groups in the physician's global assessment of change and scores on the HAQ subscales for walking and arising were evaluated by chi-square test.
Analyses of covariance were performed in which the outcomes measured at the final visit served as the dependent variables. In these analyses, group differences were examined after adjustment for the following covariates: age, duration of disease, weight, base-line value of the outcome measure, number of anatomical compartments of the index knee (the medial and lateral tibiofemoral compartments and the patellofemoral compartment) showing radiographic evidence of osteoarthritis, and radiographic severity of the arthritis, which was based on the sum of the scores for each compartment of the index knee according to the method of Kellgren and Lawrence.15 Since the results of these analyses did not differ from those of the analyses of variance of the changes in scores, only the results of the latter are presented below.
Finally, to determine whether the condition of subjects improved over the study period, paired t-tests (two-tailed) were performed to compare base-line and post-treatment values for the major outcome measures within each group. The results were expressed as means with 95 percent confidence intervals.
Results
Nine of the 204 subjects who were considered eligible for the study and who had agreed to participate failed to return for the initiation of drug therapy. Of the 195 subjects who were randomly assigned to a treatment group, 11 were lost to follow-up (5 assigned to acetaminophen, 3 assigned to low-dose ibuprofen, and 3 assigned to high-dose ibuprofen). The remaining 184 subjects constituted the study population.
Randomization produced three treatment groups with similar base-line characteristics (e.g., age, weight, and duration of arthritis symptoms) (Table 1Table 1
Characteristics of the Three Treatment Groups at the Initiation of Treatment of Osteoarthritis of the Knee.*). The proportion of patients with grade 3 radiographic changes was somewhat greater in the high-dose ibuprofen group than in the other two groups. However, the sum of the radiographic scores for the three knee compartments and the number of compartments affected in the index knee did not differ among the three groups (Table 1). Base-line scores for the major outcome measures (Table 1), findings on base-line examination of the knee, and base-line laboratory assessments (data not shown) in the three groups also were comparable.Of the 184 study subjects, 144 (78.3 percent) completed the four weeks of treatment. The reasons for failure to complete the trial included noncompliance (12.5 percent), adverse events (8.2 percent), and uncontrolled joint pain (1.1 percent), with no significant differences among the groups (Table 2Table 2
Reasons for Failure to Complete Treatment.).The study findings were not substantially affected whether analysis included all patients in whom treatment was initiated and compliance was verified or only the patients who completed treatment. The data presented below therefore reflect the findings in all 184 subjects — i.e., they represent an intention-to-treat analysis.
Overall pain scores (HAQ), which have a range of 0 to 3, improved by an average of 0.33 point in the acetaminophen group, 0.30 in the low-dose ibuprofen group, and 0.35 in the high-dose ibuprofen group. This change represented a mean overall reduction of the scores by 10 to 12 percent. Rest pain decreased significantly in the high-dose ibuprofen group (mean change, 0.40) and the low-dose ibuprofen group (mean change, 0.33), as did walking pain (mean changes, 0.45 and 0.31), reflecting reductions of 10 to 15 percent for each dose and each type of pain. Small but significant improvements in the HAQ disability score (mean change, 0.08) and the 50-ft—walk time (mean change, 0.5 second) were observed in the acetaminophen group (Table 3Table 3
Changes in Outcome Measures after Treatment.).Scores on the walking subscale of the HAQ disability scale improved in 20 to 25 percent of patients in each treatment group and worsened in about 8 percent. Scores on the arising subscale improved in approximately 25 percent of each group and worsened in approximately 15 percent.
Minor gains in the range of knee motion were noted in all three treatment groups; however, changes of more than 10 degrees were rare. Mild knee swelling was present at the start of treatment in a minority of patients and lessened in 10 to 16 percent. Knee swelling developed or worsened during the treatment period in 2 to 5 percent. Knee tenderness was common; it diminished in 22 to 26 percent of patients and increased in 11 to 23 percent. The incidence of these changes did not differ significantly among the treatment groups.
At the end of the treatment period, no significant differences were observed between the three treatment groups in any of the major outcome variables except rest pain, which decreased to a greater extent in both ibuprofen groups than in the acetaminophen group (Table 3).
The rates of compliance with medication in the treatment groups were similar: approximately 88 percent of the prescribed dose was taken in each group. The numbers of reported adverse events also were similar in the three groups. The organ system most often affected was the gastrointestinal tract (Table 4Table 4
Adverse Events Reported during the Treatment Period.). There was a trend toward an increase in the incidence of nausea and dyspepsia in the high-dose ibuprofen group. Two patients in this group became positive for occult blood in stool during treatment. Proteinuria (protein >0.3 g per liter [30 mg per deciliter]) developed in four patients in association with pyuria due to urinary or vulvovaginal infection.Significant differences in some laboratory-test values were found among the groups at the end of the treatment period (Table 5Table 5
Changes in Laboratory Variables after Treatment.). The serum creatinine concentration increased slightly in the high-dose ibuprofen group (P = 0.04), and the aspartate aminotransferase concentration increased in the acetaminophen group (P = 0.01). The creatinine level increased by more than 17 μmol per liter (0.2 mg per deciliter) in one subject receiving acetaminophen, four receiving low-dose ibuprofen, and six receiving high-dose ibuprofen. The aspartate aminotransferase level rose more than 0.17 μkat per liter (10 U per liter) in 11 subjects receiving acetaminophen, 4 receiving low-dose ibuprofen, and 5 receiving high-dose ibuprofen. The hematocrit declined slightly in all three groups, decreasing by more than 2 percent in 25 percent of each group. The mean serum alkaline phosphatase level decreased in all groups.Discussion
Over the past decade the dosages of NSAIDs recommended for the treatment of arthritis have risen.17 Associated with this shift are increases in prescription costs and the risks of adverse drug effects, particularly gastrointestinal blood loss and gastric erosions.12 13 14 As the population ages, the prevalence of osteoarthritis, and hence the proportion of the population at risk for adverse effects of NSAID treatment, will continue to rise. Careful assessment of the comparative advantages and disadvantages of analgesic agents and NSAIDs in the treatment of osteoarthritis is therefore needed.
In the present study, all three treatment groups had significant improvement over the four-week treatment period. Although the sizes of our groups were sufficient to permit us to detect with more than 90 percent statistical power between-group differences in changes of less than 20 percent in visual-analogue pain scores and of less than 10 percent in disability as assessed by questionnaire, the groups differed significantly only in the relief of rest pain (Table 3). Thus, the higher dose of ibuprofen (2400 mg per day) was not superior to either the dose of acetaminophen (4000 mg per day) or the lower dose of ibuprofen (1200 mg per day) for pain relief or improvement of function. Nor were any significant differences among the treatment groups revealed when the final scores for the major outcome variables were adjusted for demographic or radiographic characteristics or for scores for the outcome measures at base line.
According to the physician's global assessment, approximately 40 percent of our patients improved. Although the degree of improvement was small (a mean reduction of 2 to 15 percent in overall pain, rest pain, and walking pain), changes of this magnitude are consistent with outcomes in other trials of drug treatment for osteoarthritis.18 19 20
In the present trial, the dosages of the study medications were chosen to reflect current clinical practice and to match the treatments for analgesic efficacy as closely as possible. Ibuprofen in a dose of 1200 mg per day has only weak antiinflammatory effects,21 but in a dose of 2400 mg per day its antiinflammatory effects compare favorably with those achieved with antiinflammatory doses of fenoprofen, tolmetin, and naproxen.22 As is consistent with the results of the present study, ibuprofen in a dose of only 1200 mg per day was equivalent to several other NSAIDs in relieving joint pain due to osteoarthritis23 24 25 26 even when the other NSAIDs were given in antiinflammatory doses.24 , 26 Since our aim was to detect differences among our treatment groups, and not to document the previously proved efficacy of each regimen as symptomatic therapy for osteoarthritis,19 , 20 , 23 24 25 26 27 we did not include a placebo group in the present study.
Before our study began, a comparison of an NSAID (ketoprofen) with a non-NSAID analgesic (propoxyphene—acetaminophen) in the treatment of osteoarthritis was reported.28 There were no differences in pain relief between these two regimens. Two subsequent reports compared the efficacy of an NSAID and an analgesic drug in the symptomatic treatment of osteoarthritis; one study showed diclofenac to be superior to propoxyphene—acetaminophen,29 and the other found no significant difference between nefopam (an analgesic) and flurbiprofen.30
A third study showed few differences between patients with osteoarthritis of the knee treated with diclofenac for two years and patients treated with matching placebo.31 The proportion of patients in each group who completed the study and reported that their condition was the same or better than at entry was comparable (approximately 70 percent).
Acetaminophen, when administered over the long term, causes a small but significant decrease in renal function.32 When given in the doses commonly used to treat osteoarthritis, however, it is generally well tolerated and safe. It is superior to placebo in the treatment of osteoarthritis, and because of its efficacy, safety, and low cost, several investigators have recommended its use as first-line treatment for osteoarthritis.33 34 35
Although NSAIDs are effective in reducing the symptoms of osteoarthritis, their inhibition of prostaglandin biosynthesis is directly related to many common and occasionally severe side effects, including gastrointestinal bleeding, hypertension, congestive heart failure, hyperkalemia, and renal insufficiency.11 12 13 14 , 36 Many of our patients were receiving NSAIDs when the base-line blood samples were collected, which may explain the decline in the serum creatinine concentration in the acetaminophen-treated group.
The present results call into question the routine use of a high (i.e., antiinflammatory) dose of ibuprofen for osteoarthritis of the knee. It should be emphasized that our study evaluated only short-term treatment of this condition. Possibly, the long-term outcome of treatment of the knee, the outcome of treatment of other joints, or the outcome in patients with osteoarthritis characterized by greater inflammation37 than in our patients would differ from the outcome reported here. However, the knee is one of the joints most commonly affected by osteoarthritis and the chief source of disability in this disease,38 and the importance of successful treatment of such osteoarthritis cannot be argued.
Supported by a grant (AR-39250) from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
We are indebted to Donna White, Roberta Fehrman, and Lisa Braun for excellent assistance in the preparation of the manuscript, and to William Tierney, M.D., and the Department of Orthopaedic Surgery, Indiana University School of Medicine, for their help in recruiting patients.
Source Information
From the Rheumatology Division (J.D.B., K.D.B., S.I.R.) and the Regenstrief Institute for Health Care (B.P.K., L.A.K.), Department of Medicine, Indiana University School of Medicine, Indianapolis. Address reprint requests to Dr. Brandt at the Rheumatology Division, Indiana University School of Medicine, 541 Clinical Dr., Rm. 492, Indianapolis, IN 46202–5103.
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