A blinded randomised trial of acupuncture (manual and electroacupuncture) compared with a non-penetrating sham for the symptoms of osteoarthritis of the knee.

OBJECTIVES: To compare the effect of acupuncture (manual and electroacupuncture) with that of a non-penetrating sham ('placebo' needle) in patients with osteoarthritic knee pain and disability who are blind to the treatment allocation. METHODS: Acupuncture naïve patients with symptomatic and radiological evidence of osteoarthritis of the knee were randomly allocated to a course of either acupuncture or non-penetrating sham acupuncture using a sheathed 'placebo' needle system. Acupuncture points for pain and stiffness were selected according to acupuncture theory for treating Bi syndrome. Both manual and electrical stimulation were used. Response was assessed using the WOMAC index for osteoarthritis of the knee, self reported pain scale, the EuroQol score and plasma beta-endorphin. The effectiveness of blinding was assessed. RESULTS: There were 34 patients in each group. The primary end point was the change in WOMAC pain score after the course of treatment. Comparison between the two treatment groups found a significantly greater improvement with acupuncture (mean difference 60, 95% CI 5 to 116, P= 0.035) than with sham. Within the acupuncture group there was a significant improvement in pain (baseline 294, mean change 95, 95% CI 60 to 130, P<0.001) which was not seen by those who had sham acupuncture (baseline 261, mean change 35, 95% CI -10 to 80, P=0.12). Similar effects within group, but not between groups, were seen with the secondary end points of WOMAC stiffness, WOMAC function, and self reported pain. One month after treatment the between group pain difference had been lost (mean difference 46; 95% CI -9 to 100, P=0.10) although the acupuncture group was still benefiting compared to baseline (mean difference 59; 95% CI 16 to 102, P=0.009). The EuroQol score, a generic measure of health related quality of life, was not altered by the treatments. A minority of patients correctly guessed their treatment group (41% in the acupuncture group and 44% in the control group). Plasma beta-endorphin levels were not affected by either treatment. CONCLUSIONS: Acupuncture gives symptomatic improvement for patients with osteoarthritis of the knee, and is significantly superior to non-penetrating sham acupuncture. The study did not confirm earlier reports of release of plasma beta-endorphin during acupuncture.

Hepatotoxicity associated with sulfasalazine in inflammatory arthritis: A case series from a local surveillance of serious adverse events.

BACKGROUND: Spontaneous reporting systems for adverse drug reactions (ADRs) are handicapped by under-reporting and limited detail on individual cases. We report an investigation from a local surveillance for serious adverse drug reactions associated with disease modifying anti-rheumatic drugs that was triggered by the occurrence of liver failure in two of our patients. METHODS: Serious ADR reports have been solicited from local clinicians by regular postcards over the past seven years. Patients', who had hepatotoxicity on sulfasalazine and met a definition of a serious ADR, were identified. Two clinicians reviewed structured case reports and assessed causality by consensus and by using a causality assessment instrument. The likely frequency of hepatotoxicity with sulfasalazine was estimated by making a series of conservative assumptions. RESULTS: Ten cases were identified: eight occurred during surveillance. Eight patients were hospitalised, two in hepatic failure - one died after a liver transplant. All but one event occurred within 6 weeks of treatment. Seven patients had a skin rash, three eosinophilia and one interstitial nephritis. Five patients were of Black British of African or Caribbean descent. Liver enzymes showed a hepatocellular pattern in four cases and a mixed pattern in six. Drug-related hepatotoxicity was judged probable or highly probable in 8 patients. The likely frequency of serious hepatotoxicity with sulfasalazine was estimated at 0.4% of treated patients. CONCLUSION: Serious hepatotoxicity associated with sulfasalazine appears to be under-appreciated and intensive monitoring and vigilance in the first 6 weeks of treatment is especially important.

The effect of acupuncture on the symptoms of knee osteoarthritis--an open randomised controlled study.

BACKGROUND: Using an open randomised controlled study, we examined the effectiveness of manual and electroacupuncture on symptom relief for patients with osteoarthritis of the knee. METHODS: Patients with symptomatic osteoarthritis of the knee were randomised to one of three treatment groups. Group A had acupuncture alone, group B had acupuncture but continued on their symptomatic medication, and group C used their symptomatic medication for the first five weeks and then had a course of acupuncture added. Patients receiving acupuncture were treated twice weekly over five weeks. Needles were inserted (with manual and electrical stimulation) in acupuncture points for pain and stiffness, selected according to traditional acupuncture theory for treating Bi syndrome. Patients were assessed by a blinded observer before treatment, after five weeks' treatment and at one month follow up, using a visual analogue pain scale (VAS) and the Western Ontario McMaster (WOMAC) questionnaire for osteoarthritis of the knee. RESULTS: The 30 patients in our study were well matched for age, body mass index, disease duration, baseline VAS pain score and baseline WOMAC scores. Repeated measure analyses gave a highly significant improvement in pain (VAS) after the courses of acupuncture in groups A (P = 0.012) and B (P=0.001); there was no change in group C until after the course of acupuncture, when the improvement was significant (P = 0.001). Similarly significant changes were seen with the WOMAC pain and stiffness scores. These benefits were maintained during the one month after the course of acupuncture. Patients' rating of global assessment was higher than that of the acupuncturist. CONCLUSION: We conclude that manual and electroacupuncture causes a significant improvement in the symptoms of osteoarthritis of the knee, either on its own or as an adjunct therapy, with no loss of benefit after one month.

Oral and intra-articular remedies: Review of papers published from March 2001 to February 2002.

There have been considerable advances in the drug treatments used to treat osteoarthritis. The development of selective cyclo-oxygenase inhibitors (COX-II) and confirmation of their efficacy and gastrointestinal safety will reduce treatment morbidity in the elderly. Guidelines for safe and appropriate use of COX-II drugs are now available. The role of anti-inflammatory drugs in precipitating cardiorenal events has been highlighted but remains to be fully evaluated. Glucosamine, diacerein, and hyaluronan may all be disease-modifying drugs for osteoarthritis but confirmatory studies are still needed.

A study of parenteral use of methotrexate in rheumatic conditions.

1. This paper reports the findings of a small pragmatic study to compare the safety and efficacy of methotrexate administered by intramuscular and subcutaneous injection, and to teach patients to self-administer methotrexate by the subcutaneous route. 2. Eight patients with rheumatic conditions, already receiving a stable weekly dose of methotrexate by intramuscular injection, were entered into this 13-week study. 3. Serum levels of methotrexate were measured on six consecutive occasions: three whilst patients received intramuscular methotrexate and then three after switching to the subcutaneous route. 4. Patients were taught to self-administer their methotrexate subcutaneously and were then discharged to perform this task at home. 5. Levels of disease activity and psychological scores were measured at the start and end of the study. Satisfaction with self-administration and teaching of injection techniques were assessed at 13 weeks. 6. Serum methotrexate levels were not significantly affected by the route of administration. All patients were able to perform self-injection safely and seven out of eight preferred self-administration at home. 7. This small study demonstrates that there is no difference in the safety and efficacy of methotrexate given by either parenteral route. Patients were able to administer safely methotrexate subcutaneously. Self-administration reduced hospital visits, was more convenient for patients and improved patient satisfaction.