Objectives To analyse the efficacy of acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee, with respect to pain relief, reduction of stiffness, and increased physical function during treatment; modifications in the consumption of diclofenac during treatment; and changes in the patient's quality of life. Design Randomised, controlled, single blind trial, with blinded evaluation and statistical analysis of results. Setting Pain management unit in a public primary care centre in southern Spain, over a period of two years. Participants 97 outpatients presenting with osteoarthritis of the knee. Interventions Patients were randomly separated into two groups, one receiving acupuncture plus diclofenac (n = 48) and the other placebo acupuncture plus diclofenac (n = 49).
Main outcome measuresThe clinical variables examined included intensity of pain as measured by a visual analogue scale; pain, stiffness, and physical function subscales of the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index; dosage of diclofenac taken during treatment; and the profile of quality of life in the chronically ill (PQLC) instrument, evaluated before and after the treatment programme. Results 88 patients completed the trial. In the intention to treat analysis, the WOMAC index presented a greater reduction in the intervention group than in the control group (mean difference 23.9, 95% confidence interval 15.0 to 32.8) The reduction was greater in the subscale of functional activity. The same result was observed in the pain visual analogue scale, with a reduction of 26.6 (18.5 to 34.8). The PQLC results indicate that acupuncture treatment produces significant changes in physical capability (P = 0.021) and psychological functioning (P = 0.046). Three patients reported bruising after the acupuncture sessions. Conclusions Acupuncture plus diclofenac is more effective than placebo acupuncture plus diclofenac for the symptomatic treatment of osteoarthritis of the knee.
Chronic neck pain is highly prevalent. To determine the efficacy and safety of acupuncture, in comparison with transcutaneous nerve stimulation-placebo (TENS-placebo) in the treatment of chronic uncomplicated neck pain, a single blind prospective study was designed, to be carried out at a Primary Healthcare Centre, with random assignment to two parallel groups and with evaluation and analysis by independent evaluators. A random assignment was made from 123 patients of the 149 initially recruited. These patients had been diagnosed with uncomplicated neck pain and experienced neck motion-related pain intensity equal to or exceeding 30 on a visual analogue scale (VAS) from 0 to 100 mm. The treatment with acupuncture was compared with TENS-placebo, applied over 5 sessions in three weeks. The primary endpoint was the change in maximum pain intensity related to motion of the neck, one week after the final treatment. Sensitivity was analysed per protocol (PP) and variant analyses were by intention to treat (ITT). Adjustment was made for confounders by multiple linear regression, including baseline values and rescue therapy. By ITT analysis, the change in the pain-VAS variable was greater among the experimental group (28.1 (95% CI 21.4-34.7)). The improvements in quality of life (physical aspect), active neck mobility and reduced rescue medication were clinically and statistically significant. In the treatment of the intensity of chronic neck pain, acupuncture is more effective than the placebo treatment and presents a safety profile making it suitable for routine use in clinical practice.
Single-point acupuncture in association with physiotherapy improves shoulder function and alleviates pain, compared with physiotherapy as the sole treatment. This improvement is accompanied by a reduction in the consumption of analgesic medicaments.
BackgroundRifabutin has been found to be effective in multi-resistant patients after various treatment cycles for Helicobacter pylori (HP) infection, but it has not been analysed as a second-line treatment. Therefore, we seek to compare the effectiveness of a treatment regimen including rifabutin versus conventional quadruple therapy (QT).MethodsOpen clinical trial, randomised and multi-centre, of two treatment protocols: A) Conventional regime -QT- (omeprazole 20 mg bid, bismuth citrate 120 mg qid, tetracycline 500 mg qid and metronidazole 500 mg tid); B) Experimental one -OAR- (omeprazole 20 mg bid, amoxicillin 1 gr bid, and rifabutin 150 mg bid), both taken orally for 7 days, in patients with HP infection for whom first-line treatment had failed. Eradication was determined by Urea Breath Test (UBT). Safety was determined by the adverse events.Results99 patients were randomised, QT, n = 54; OAR, n = 45. The two groups were homogeneous. In 8 cases, treatment was suspended (6 in QT and 2 in OAR). The eradication achieved, analysed by ITT, was for QT, 38 cases (70.4%), and for OAR, 20 cases (44.4%); p = 0.009, OR = 1.58. Of the cases analysed PP, QT were 77.1%; OAR, 46.5%; p = 0.002. Adverse effects were described in 64% of the QT patients and in 44% of the OAR patients (p = 0.04).ConclusionA 7-day rifabutin-based triple therapy associated to amoxicillin and omeprazole at standard dose was not found to be effective as a second-line rescue therapy. The problem with quadruple therapy lies in the adverse side effects it provokes. We believe the search should continue for alternatives that are more comfortably administered and that are at least as effective, but with fewer adverse side effects.Trial RegistrationCurrent Controlled Trials ISRCTN81058036
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