Chinese herbal recipe versus diclofenac in symptomatic treatment of osteoarthritis of the knee: a randomized controlled trial [ISRCTN70292892]

BACKGROUND: Duhuo Jisheng Wan (DJW) is perhaps the best known and most widely used Chinese herbal recipe for arthralgia, but the clinical study to verify its efficacy is lacking. The purpose of this study was to compare the efficacy of DJW versus diclofenac in symptomatic treatment of osteoarthritis (OA) of the knee. METHODS: This study was a randomized, double-blind, double-dummy, controlled trial. The 200 patients suffering from OA of the knee, were randomized into the DJW and diclofenac group. The patients were evaluated after a run-in period of one week (week 0) and then weekly during 4 weeks of treatment. The clinical assessments included visual analog scale (VAS) score that assessed pain and stiffness, Lequesne's functional index, time for climbing up 10 steps, as well as physician's and patients' overall opinions on improvement. RESULTS: Ninety four patients in each group completed the study. In the first few weeks of treatment, the mean changes in some variables (VAS, which assessed walking pain, standing pain and stiffness, as well as Lequesne's functional index) of the DJW group were significantly lower than those of the diclofenac group. Afterwards, these mean changes became no different throughout the study. Most of the physician's and patients' overall opinions on improvement at each time point did not significantly differ between the two groups. Approximately 30% of patients in both groups experienced mild adverse events. CONCLUSION: DJW demonstrates clinically comparable efficacy to diclofenac after 4 weeks of treatment. However, the slow onset of action as well as approximately equal rate of adverse events to diclofenac might limit its alternative role in treatment of OA of the knee

Electroacupuncture versus Diclofenac in symptomatic treatment of Osteoarthritis of the knee: a randomized controlled trial

BACKGROUND: The purpose of this study was to compare the efficacy of electroacupuncture (EA), diclofenac and their combination in symptomatic treatment of osteoarthritis (OA) of the knee. METHODS: This study was a randomized, single-blind, placebo controlled trial. The 193 out-patients with OA of the knee were randomized into four groups: placebo, diclofenac, EA and combined (diclofenac plus EA). Paracetamol tablets were prescribed as a rescue analgesic during the study. The patients were evaluated after a run-in period of one week (week 0) and again at the end of the study (week 4). The clinical assessments included the amount of paracetamol taken/week, visual analog scale (VAS), Western Ontario and McMaster Universities (WOMAC) OA Index, Lequesne's functional index, 50 feet-walk time, and the orthopedist's and patient's opinion of change. RESULTS: One hundred and eighty six patients completed the study. The improvement of symptoms (reduction in mean changes) in most outcome parameters was greatest in the EA group. The proportions of responders and patients with an overall opinion of "much better" were also greatest in the EA group. The improvement in VAS was significantly different between the EA and placebo group as well as the EA and diclofenac group. The improvement in Lequesne's functional index also differed significantly between the EA and placebo group. In addition, there was a significant improvement in WOMAC pain index between the combined and placebo group. CONCLUSION: EA is significantly more effective than placebo and diclofenac in the symptomatic treatment of OA of the knee in some circumstances. However, the combination of EA and diclofenac treatment was no more effective than EA treatment alone

Harpgophytum procumbens for osteoarthritis and low back pain: A systematic review

BACKGROUND: The objective of this review is to determine the effectiveness of Harpagophytum procumbens preparations in the treatment of various forms of musculoskeletal pain. METHODS: Several databases and other sources were searched to identify randomized controlled trials, quasi-randomized controlled trials, and controlled clinical trials testing Harpagophytum preparations in adults suffering from pain due to osteoarthritis or low back pain. RESULTS: Given the clinical heterogeneity and insufficient data for statistical pooling, trials were described in a narrative way, taking into consideration methodological quality scores. Twelve trials were included with six investigating osteoarthritis (two were identical trials), four low back pain, and three mixed-pain conditions. CONCLUSIONS: There is limited evidence for an ethanolic Harpagophytum extract containing less than <30 mg harpagoside per day in the treatment of knee and hip osteoarthritis. There is moderate evidence of effectiveness for (1) the use of a Harpagophytum powder at 60 mg harpagoside in the treatment of osteoarthritis of the spine, hip and knee; (2) the use of an aqueous Harpagophytum extract at a daily dose of 100 mg harpagoside in the treatment of acute exacerbations of chronic non-specific low back pain; and (3) the use of an aqueous extract of Harpagophytum procumbens at 60 mg harpagoside being non-inferior to 12.5 mg rofecoxib per day for chronic non-specific low-back pain (NSLBP) in the short term. Strong evidence exists for the use of an aqueous Harpagophytum extract at a daily dose equivalent of 50 mg harpagoside in the treatment of acute exacerbations of chronic NSLBP

Measuring the ICF components of impairment, activity limitation and participation restriction: an item analysis using classical test theory and item response theory

The International Classification of Functioning, Disability and Health (ICF) proposes three main health outcomes, Impairment (I), Activity Limitation (A) and Participation Restriction (P), but good measures of these constructs are needed The aim of this study was to use both Classical Test Theory (CTT) and Item Response Theory (IRT) methods to carry out an item analysis to improve measurement of these three components in patients having joint replacement surgery mainly for osteoarthritis (OA). A geographical cohort of patients about to undergo lower limb joint replacement was invited to participate. Five hundred and twenty four patients completed ICF items that had been previously identified as measuring only a single ICF construct in patients with osteoarthritis. There were 13 I, 26 A and 20 P items. The SF-36 was used to explore the construct validity of the resultant I, A and P measures. The CTT and IRT analyses were run separately to identify items for inclusion or exclusion in the measurement of each construct. The results from both analyses were compared and contrasted. Overall, the item analysis resulted in the removal of 4 I items, 9 A items and 11 P items. CTT and IRT identified the same 14 items for removal, with CTT additionally excluding 3 items, and IRT a further 7 items. In a preliminary exploration of reliability and validity, the new measures appeared acceptable. New measures were developed that reflect the ICF components of Impairment, Activity Limitation and Participation Restriction for patients with advanced arthritis. The resulting Aberdeen IAP measures (Ab-IAP) comprising I (Ab-I, 9 items), A (Ab-A, 17 items), and P (Ab-P, 9 items) met the criteria of conventional psychometric (CTT) analyses and the additional criteria (information and discrimination) of IRT. The use of both methods was more informative than the use of only one of these methods. Thus combining CTT and IRT appears to be a valuable tool in the development of measures

Theoretical framework and methodological development of common subjective health outcome measures in osteoarthritis: a critical review

Subjective measures involving clinician ratings or patient self-assessments have become recognised as an important tool for the assessment of health outcome. The value of a health outcome measure is usually assessed by a psychometric evaluation of its reliability, validity and responsiveness. However, psychometric testing involves an accumulation of evidence and has recognised limitations. It has been suggested that an evaluation of how well a measure has been developed would be a useful additional criteria in assessing the value of a measure. This paper explored the theoretical background and methodological development of subjective health status measures commonly used in osteoarthritis research. Fourteen subjective health outcome measures commonly used in osteoarthritis research were examined. Each measure was explored on the basis of their i) theoretical framework (was there a definition of what was being assessed and was it part of a theoretical model?) and ii) methodological development (what was the scaling strategy, how were the items generated and reduced, what was the response format and what was the scoring method?). Only the AIMS, SF-36 and WHOQOL defined what they were assessing (i.e. the construct of interest) and no measure assessed was part of a theoretical model. None of the clinician report measures appeared to have implemented a scaling procedure or described the rationale for the items selected or scoring system. Of the patient self-report measures, the AIMS, MPQ, OXFORD, SF-36, WHOQOL and WOMAC appeared to follow a standard psychometric scaling method. The DRP and EuroQol used alternative scaling methods. The review highlighted the general lack of theoretical framework for both clinician report and patient self-report measures. This review also drew attention to the wide variation in the methodological development of commonly used measures in OA. While, in general the patient self-report measures had good methodological development, the clinician report measures appeared less well developed. It would be of value if new measures defined the construct of interest and, that the construct, be part of theoretical model. By ensuring measures are both theoretically and empirically valid then improvements in subjective health outcome measures should be possible