Emilio Perea-Milla

Acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee: randomised controlled trial

Abstract 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 patients 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 measures The 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.

Efficacy and safety of acupuncture for chronic uncomplicated neck pain: A randomised controlled study☆

&NA; 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.

Correction of nonvertex presentation with moxibustion: a systematic review and metaanalysis

We searched systematically for randomized controlled trials, comparing moxibustion with a nonmoxibustion control group or other methods such as external cephalic version, postural methods, and acupuncture in databases, both Western and Chinese, up to June 2007. Six studies, with 1087 subjects and a high degree of heterogeneity, compared moxibustion vs observation or postural methods and reported a rate of cephalic version among the moxibustion group of 72.5% vs 53.2% in the control group (relative risk, 1.36; 95% confidence interval, 1.17-1.58); the number needed to treat was 5 (95% confidence interval, 4-7). In terms of safety, no significant differences were found in the comparison of moxibustion with other techniques. Moxibustion at acupuncture point BL67 has been shown to produce a positive effect, whether used alone or in combination with acupuncture or postural measures, in comparison with observation or postural methods alone, for the correction of nonvertex presentation, although these results should be viewed with caution, given the considerable heterogeneity found among studies.

Effectiveness of acupuncture, special dressings and simple, low-adherence dressings for healing venous leg ulcers in primary healthcare: study protocol for a cluster-randomized open-labeled trial

BackgroundVenous leg ulcers constitute a chronic recurring complaint that affects 1.0–1.3% of the adult population at some time in life, and which corresponds to approximately 75% of all chronic ulcers of the leg. Multilayer compression bandaging is, at present, the only treatment that has been proved to be effective in treating this type of ulcer. There is no consensus, however, about the dressings that may be applied, beneath the compression, to promote the healing of this type of ulcer, as there does not seem to be any added benefit from using special dressings rather than simple, low-adherence ones. As well as analgesia, acupuncture provokes peripheral vasodilation, in skin and muscles – which has been demonstrated both experimentally and in clinical practice – probably due to the axon reflex, among other mechanisms. The aim of the present study is to measure the effectiveness and cost of compression treatment for venous leg ulcers combined with special dressings, in comparison with low-adherence ones and acupuncture.Methods/designCluster-randomized open-labeled trial, at 15 primary healthcare clinics in the Sevilla-Sur Healthcare District, with a control group treated with compression bandaging and low-adherence dressings; the experiment will consist, on the one hand, of the compression treatment applied in combination with special dressings (Treatment 1), and on the other, the compression treatment applied in association with low-adherence dressings, together with acupuncture (Treatment 2).DiscussionThe results will be measured and recorded in terms of the median time elapsed until complete healing of the ulcer, and the rate of complete healing at 3 months after beginning the treatment. An economic analysis will also be made.This study, carried out in the context of real clinical practice, will provide information for decision-taking concerning the effectiveness of special dressings. Moreover, for the first time a high-quality study will evaluate the effectiveness of acupuncture in the process of healing venous leg ulcers.Trial registrationCurrent Controlled Trials ISRCTN26438275.

Efficacy of rifabutin-based triple therapy as second-line treatment to eradicate helicobacter pylori infection

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

Acupuncture and moxibustion as an adjunctive treatment for osteoarthritis of the knee - a large case series

Background In 1997, the first Pain Management Unit, which was set up as part of primary health care within the Andalusian Public Health System, offered acupuncture among other therapies. This observational study was conducted in preparation for a randomised controlled trial. Methods We conducted a descriptive study of patients who had been diagnosed with osteoarthritis of the knee. The patients received weekly acupuncture treatment, and related techniques, from November 1997 to November 2000. We recorded: socio-demographic data; measures of effectiveness, including intensity and frequency of pain; the daily dose of analgesic and anti-inflammatory medication; the degree of incapacity; and sleep disorders caused by pain in the knee. Results The 563 patients who presented were mainly female (88%) with an average age of 65 years (±10.7); the average age of the male patients was 67 years (±11.8). The condition in most patients (95%) was chronic: 54% had the condition for 5-10 years and a further 23% for more than 10 years. Of the total, 85 (15%) abandoned treatment and were excluded from the evaluation, while 75% of the remainder achieved a reduction in pain of 45% or more. This study is intended to form the basis for a subsequent controlled clinical trial of the effectiveness of acupuncture as a treatment for osteoarthritis of the knee. Conclusion The degree of pain relief experienced by patients from acupuncture justifies a more rigorous study.

Geographic variability of fatal road traffic injuries in Spain during the period 2002-2004: an ecological study

BackgroundThe aim of the present study is to describe the inter-province variability of Road Traffic Injury (RTI) mortality on Spanish roads, adjusted for vehicle-kilometres travelled, and to assess the possible role played by the following explicative variables: sociodemographic, structural, climatic and risk conducts.MethodsAn ecological study design was employed. The mean annual rate of RTI deaths was calculated for the period 2002–2004, adjusted for vehicle-kilometres travelled, in the 50 provinces of Spain. The RTI death rate was related with the independent variables described above, using simple and multiple linear regression analysis with backward step-wise elimination. The level of statistical significance was taken as p < 0.05.ResultsIn the period 2002–2004 there were 12,756 RTI deaths in Spain (an average of 4,242 per year, SD = 356.6). The mean number of deaths due to RTI per 100 million vehicle-kilometres (mvk) travelled was 1.76 (SD = 0.51), with a minimum value of 0.66 (in Santa Cruz de Tenerife) and a maximum of 3.31 (in the province of Lugo). All other variables being equal, a higher proportion of kilometres available on high capacity roads, and a higher cultural and education level were associated with lower death rates due to RTI, while the opposite was true for the rate of alcohol consumers and the road traffic volume of heavy vehicles. The variables included in the model accounted for 55.4% of the variability in RTI mortality.ConclusionAdjusting RTI mortality rates for the number of vehicle-kilometres travelled enables us to identify the high variability of this cause of death, and its relation with risk factors other than those inherent to human behaviour, such as the type of roads and the type of vehicles using them.

Efficacy and safety of acupuncture for the treatment of non-specific acute low back pain: a randomised controlled multicentre trial protocol [ISRCTN65814467]

BackgroundLow back pain and its associated incapacitating effects constitute an important healthcare and socioeconomic problem, as well as being one of the main causes of disability among adults of working age. The prevalence of non-specific low back pain is very high among the general population, and 60–70% of adults are believed to have suffered this problem at some time. Nevertheless, few randomised clinical trials have been made of the efficacy and efficiency of acupuncture with respect to acute low back pain. The present study is intended to assess the efficacy of acupuncture for acute low back pain in terms of the improvement reported on the Roland Morris Questionnaire (RMQ) on low back pain incapacity, to estimate the specific and non-specific effects produced by the technique, and to carry out a cost-effectiveness analysis.Methods/DesignRandomised four-branch controlled multicentre prospective study made to compare semi-standardised real acupuncture, sham acupuncture (acupuncture at non-specific points), placebo acupuncture and conventional treatment. The patients are blinded to the real, sham and placebo acupuncture treatments. Patients in the sample present symptoms of non specific acute low back pain, with a case history of 2 weeks or less, and will be selected from working-age patients, whether in paid employment or not, referred by General Practitioners from Primary Healthcare Clinics to the four clinics participating in this study.In order to assess the primary and secondary result measures, the patients will be requested to fill in a questionnaire before the randomisation and again at 3, 12 and 48 weeks after starting the treatment. The primary result measure will be the clinical relevant improvement (CRI) at 3 weeks after randomisation. We define CRI as a reduction of 35% or more in the RMQ results.DiscussionThis study is intended to obtain further evidence on the effectiveness of acupuncture on acute low back pain and to isolate the specific and non-specific effects of the treatment.

Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial [ISRCTN28687220]

BackgroundAlthough the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to alleviate this problem, has not yet been proven to be effective, because of the small size of sample groups and the lack of methodological rigor in the papers published on the subject. No reviews have been made to assess the effectiveness of acupuncture in treating this complaint, but in recent years controlled randomised studies have been made and these demonstrate an increasing use of acupuncture to treat pathologies of the soft tissues of the shoulder. In this study, we seek to evaluate the effectiveness of physiotherapy applied jointly with acupuncture, compared with physiotherapy applied with a TENS-placebo, in the treatment of painful shoulder caused by subacromial syndrome (rotator cuff tendinitis and subacromial bursitis).Methods/designRandomised controlled multicentre study with blind evaluation by an independent observer and blind, independent analysis. A study will be made of 465 patients referred to the rehabilitation services at participating healthcare centres, belonging to the regional public health systems of Andalusia and Murcia, these patients presenting symptoms of painful shoulder and a diagnosis of subacromial syndrome (rotator cuff tendinitis and subacromial bursitis). The patients will be randomised into two groups: 1) experimental (acupuncture + physiotherapy); 2) control (TENS-placebo + physiotherapy); the administration of rescue medication will also be allowed. The treatment period will have a duration of three weeks. The main result variable will be the change produced on Constants Shoulder Function Assessment (SFA) Scale; as secondary variables, we will record the changes in diurnal pain intensity on a visual analogue scale (VAS), nocturnal pain intensity on the VAS, doses of non-steroid anti-inflammatory drugs (NSAIDs) taken during the study period, credibility scale for the treatment, degree of improvement perceived by the patient and degree of improvement perceived by the evaluator. A follow up examination will be made at 3, 6 and 12 months after the study period has ended. Two types of population will be considered for analysis: per protocol and per intention to treat.DiscussionThe discussion will take into account the limitations of the study, together with considerations such as the choice of a simple, safe method to treat this shoulder complaint, the choice of the control group, and the blinding of the patients, evaluators and those responsible for carrying out the final analysis.

The Andalusian trial on heroin-assisted treatment: a 2 year follow-up.

INTRODUCTION AND AIMS In 2003, a randomised controlled trial comparing injected diacetylmorphine and oral methadone was carried out in Andalusia, Spain. The subsequent follow-up study evaluated the health and drug use status of participants, 2 years after the completion of the trial. DESIGN AND METHODS This follow-up cohort study was carried out between March and August 2006. Data collected included information on socio-demographics, drug use, health and health-related quality of life. We compared data collected before randomisation and at 2 years for the following three groups: those currently on heroin-assisted treatment (C-HAT), those who have discontinued HAT (D-HAT), and those who have never received HAT (N-HAT). RESULTS From the total 62 randomised participants in 2003, 54 (87%) were interviewed for this study. Participants were distributed as follow: C-HAT 44.4% (24), N-HAT 22.2% (12) and D-HAT 33.3% (18). Illicit heroin use had a statistically significant decrease in the three groups from baseline to 2 years post trial. Mean days of heroin use were 2.42 (SD = 3.02); 6.56 (SD = 9.48) and 13.92 (SD = 12.59) for the C-HAT, D-HAT and N-HAT groups, respectively. Those currently on HAT were the only group that sustained at 2 years, their marked improvement in health after 9 months of treatment during the trial period. DISCUSSION AND CONCLUSIONS Patients who received HAT showed better outcomes compared with those not on HAT. The results of this study strengthen the evidence showing that HAT can improve and stabilise the health of long-term heroin users with severe comorbidities and high mortality.