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Results for “Randomised Controlled Trial”

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PubMed2006

Health benefits of antiviral therapy for mild chronic hepatitis C: randomised controlled trial and economic evaluation.

OBJECTIVES: To determine whether combined therapy with interferon-alpha and ribavirin was more effective and cost-effective than no treatment for patients with mild chronic hepatitis C. DESIGN: A multicentre, randomised, controlled, non-blinded trial assessed the efficacy of combination therapy. A Markov model used these efficacy data combined with data on transition probabilities, costs and health-related quality of life (HRQoL) to assess the lifetime cost-effectiveness of the intervention. SETTING: A multicentre NHS setting. PARTICIPANTS: Treatment-naive, adult patients with histologically mild chronic hepatitis C (Ishak necroinflammatory scores <4 and fibrosis scores <3 on liver biopsy). INTERVENTIONS: Patients were randomised to receive interferon-alpha and ribavirin for 48 weeks or no treatment (control). MAIN OUTCOME MEASURES: The primary outcome measure was the proportion of patients having a sustained virological response (SVR), measured at 6 months after cessation of therapy. Secondary outcome measures were: the ability of early phase kinetics to predict the eventual outcome of treating mild disease; HRQoL measured using the Short Form 36 and EuroQol (5 Dimensions) questionnaires, and the cost per quality-adjusted life-year (QALY) of interferon-alpha and ribavirin for mild disease compared with no treatment. RESULTS: In the treatment group, 32 out of 98 patients (33%) achieved an SVR. Patients infected with genotype 1 had a lower SVR than those infected with genotype non-1 (18% versus 49%, p = 0.02). No patients who failed to achieve a 2-log drop in viral load at 12 weeks achieved an SVR. HRQoL fell during treatment and rose with treatment cessation. For patients having an SVR there were modest improvements in HRQoL at 6 months post-treatment. The mean cost per QALY gained was 4535 pounds sterling for 40-year-old patients with genotype non-1 and 25,188 pounds sterling for patients with genotype 1. For patients with genotype 1 aged 65, providing interferon-alpha and ribavirin for mild disease led to fewer QALYs gained, and a mean cost per QALY of 53,017 pounds sterling. The model using efficacy estimates from the literature, showed that the cost per QALY gained from providing pegylated interferon alpha-2b and ribavirin at a mild stage rather than a moderate stage was 7821 pounds sterling for patients with genotype non-1 and 28,409 pounds sterling for patients with genotype 1. CONCLUSIONS: Based on the evidence collected in this study, interferon-alpha and ribavirin treatment for mild chronic hepatitis C patients is in general cost-effective at the 30,000 pounds sterling per QALY threshold previously used by policy-makers in the NHS. For patients with chronic hepatitis C aged 65 or over with genotype 1, antiviral treatment at a mild stage does not appear cost-effective. Further research is required on the cost-effectiveness of pegylated interferon and ribavirin, in particular the intervention's long-term impact on HRQoL and health service costs requires further evaluation. Further research is also needed to develop predictive tests, based on pharmacogenomics, that can identify those cases most likely to respond to antiviral therapy. Liver biopsy before treatment no longer appears justified apart from for older patients (aged 65 or over) with genotype 1. However, further research should monitor the impact this strategy would have on costs and outcomes.

Adult↗

PubMed1999

Oral corticosteroids in patients admitted to hospital with exacerbations of chronic obstructive pulmonary disease: a prospective randomised controlled trial.

BACKGROUND: The role of oral corticosteroids in treating patients with exacerbations of chronic obstructive pulmonary disease (COPD) remains contentious. We assessed in a prospective, randomised, double-blind, placebo-controlled trial the effects of oral corticosteroid therapy in patients with exacerbations of COPD requiring hospital admission. METHODS: We recruited patients with non-acidotic exacerbations of COPD who were randomly assigned oral prednisolone 30 mg once daily (n=29) or identical placebo (n=27) for 14 days, in addition to standard treatment with nebulised bronchodilators, antibiotics, and oxygen. We did spirometry and recorded symptom scores daily in inpatients. Time to discharge and withdrawals were noted in each group. We recalled patients at 6 weeks to repeat spirometry and collect data on subsequent exacerbations and treatment. Hospital stay was analysed by intention to treat and forced expiratory volume in 1 s (FEV1) according to protocol. FINDINGS: FEV1 after bronchodilation increased more rapidly and to a greater extent in the corticosteroid-treated group: percentage predicted FEV1 after bronchodilation rose from 25.7% (95% CI 21.0-30.4) to 32.2% (27.3-27.1) in the placebo group (p<0.0001) compared with 28.2% (23.5-32.9) to 41.5% (35.8-47.2) in the corticosteroid-treated group (p<0.0001). Up to day 5 of hospital stay, FEV1 after bronchodilation increased by 90 mL daily (50.8-129.2) and by 30 mL daily (10.4-49.6) in the placebo group (p=0.039). Hospital stays were shorter in the corticosteroid-treated group. Groups did not differ at 6-week follow-up. INTERPRETATION: These data provide evidence to support the current practice of prescribing low-dose oral corticosteroids to all patients with non-acidotic exacerbations of COPD requiring hospital admission.

Aged↗

PubMed2006

Cognitive assessment of children at age 2(1/2) years after maternal fish oil supplementation in pregnancy: a randomised controlled trial.

OBJECTIVE: To assess the effects of antenatal omega 3 long-chain polyunsaturated fatty acid (n-3 LC PUFA) on cognitive development in a cohort of children whose mothers received high-dose fish oil in pregnancy. DESIGN: A double-blind randomised placebo-controlled trial. SETTING: Perth, Western Australia, Australia. PATIENTS: 98 pregnant women received the supplementation from 20 weeks' gestation until delivery. Their infants (n = 72) were assessed at age 2(1/2) years. INTERVENTIONS: Fish oil (2.2 g docosahexaenoic acid (DHA) and 1.1 g eicosapentaenoic acid (EPA)/day) or olive oil from 20 weeks' gestation until delivery. OUTCOME MEASURES: Effects on infant growth and developmental quotients (Griffiths Mental Development Scales), receptive language (Peabody Picture Vocabulary Test) and behaviour (Child Behaviour Checklist). RESULTS: Children in the fish oil-supplemented group (n = 33) attained a significantly higher score for eye and hand coordination (mean ((SD) score 114 (10.2)) than those in the placebo group (n = 39, mean score 108 (SD 11.3); p = 0.021, adjusted p = 0.008). Eye and hand coordination scores correlated with n-3 PUFA levels in cord blood erythrocytes (EPA: r = 0.320, p = 0.007; DHA: r = 0.308, p = 0.009) and inversely correlated with n-6 PUFA (arachidonic acid 20:4n-6: r = -0.331, p = 0.005). Growth measurements in the two groups were similar at age 2(1/2) years. CONCLUSION: Maternal fish oil supplementation during pregnancy is safe for the fetus and infant, and may have potentially beneficial effects on the child's eye and hand coordination. Further studies are needed to determine the significance of this finding.

Adult↗

PubMed2005

Randomised-controlled trial of a fibre supplement on the symptoms of irritable bowel syndrome.

The aim of this study was to assess the effect of coarse wheat bran on specific bowel function parameters and symptoms in patients with irritable bowel syndrome (IBS). A longitudinal, prospective, randomised, placebo-controlled trial was undertaken. The duration of treatment was eight to 12 weeks and this consisted of 10-20 g/day of coarse wheat bran or a low fibre placebo taken in addition to the normal diet. Twenty-eight outpatients fulfilling the Rome criteria for constipation-predominant IBS were recruited to the trial (14 in the treatment group; 14 in the placebo group). Twelve people completed the trial in the treatment group and ten in the placebo group. The main outcome measures included changes in symptoms recorded in a diary, changes in objective measurements of bowel function and subjective overall feelings of improvement. The bran group significantly increased their non-starch polysaccharide (NSP) intake over that of the placebo group (p < 0.05). Mean stool wet weight increased significantly more in the bran group than in the placebo group (p < 0.05), but other bowel function measurements and all recorded symptoms were not different. Many patients reported changes in bowel habit that were not reflected in the objective measurements. The addition of coarse wheat bran to the diet increased NSP ingestion and stool wet weight in this group of IBS patients, but no evidence was obtained that such treatment was of benefit to these patients, other than a placebo effect on symptoms.

Abdominal Pain↗

PubMed2005

A randomised controlled trial of oral zinc on the immune response to tuberculosis in HIV-infected patients.

SETTING: The National HIV Unit, Singapore. OBJECTIVE: To test whether zinc supplementation improves the immune response to tuberculosis in HIV-positive patients. DESIGN: A double-blind, randomised, placebo-controlled trial of 28 days of oral zinc sulphate (50 mg of elemental zinc) or placebo in stable adult HIV-positive patients receiving antiretroviral therapy with a CD4 count <200 cells/microl. METHODS: IFN-gamma response to mycobacterial antigen stimulation, CD4/8 cell count, lymphocyte subsets, T-cell receptor excision circle (TREC) levels and viral load were measured at baseline and day 28. RESULTS: Thirty-two patients received zinc and 34 placebo. There was no significant change in the IFN-gamma response to human PPD stimulation in the zinc or placebo groups (placebo baseline: 0.42 +/- 1.03, day 28: 0.84 +/- 1.21 IU/ml, zinc baseline: 1.26 +/- 2.41, day 28: 1.39 +/- 1.88 IU/ml, P = 0.31 between groups), nor any of the other mycobacterial antigens tested. There were no changes in absolute CD4/8 cell levels or other lymphocyte subsets, TREC or viral load. Baseline zinc levels were normal in 62/66 (93.9%) patients. CONCLUSIONS: We found no evidence for recommending pharmacological supplementation with oral zinc in HIV-positive patients without zinc deficiency.

Administration, Oral↗

PubMed2002

Randomised controlled trial of nitrofurantoin versus placebo in the treatment of uncomplicated urinary tract infection in adult women.

BACKGROUND: Urinary tract infections (UTIs) are very common and have been treated with apparent success with antimicrobials for many years. However, there is a paucity of placebo-controlled clinical trials. AIM: To measure the symptomatic and bacteriological short-term effect of nitrofurantoin treatment versus placebo, in the treatment of uncomplicated UTI in adult non-pregnant women. DESIGN OF STUDY: Randomised placebo-controlled trial in general practice. SETTING: Non-pregnant women, aged between 15 and 54 years old, consulting a general practitioner for symtoms suggestive of uncomplicated lower UTI and with pyuria (positive for leucocyte esterase test). METHOD: A dipslide was inoculated in first-void midstream urine and sent for examinion. The patients were randomised to receive nitrofurantoin 100 mg or placebo four times daily for three days. After three, seven, and 14 days a new dipslide was inoculated and symptoms of UTI were checked or improvement of symptoms and bacteriuria. RESULTS: Of 166 women consulting with symptoms suggestive for UTI, 78 had pyuia and agreed to participate in the study (the clinically suspected UTI group); of these, 40 received nitrofurantoin and 38 received placebo. The result for combined symptomatic improvement and cure after three days was 27/35 in the nitrofurantoin group and 19/35 in the placebo group (c2 with Yates' correction P = 0.008; number needed to treat [NNT] = 4.4, 95% confidence interval [CI] = 2.3 to 79). After seven days, combined improvement and cure was observed in 30/34 and 17/33 respectively (P = 0.003, NNT = 2.7, 95% CI = 1.8 to 6.0). At inclusion, 56 women had bacteriuria of > or = 10(5) CFU/ml (the bacteriologically proven UTI group). Of these, 29 received nitrofurantoin and 27 received placebo. After three days the bacteriological cure was 21/26 in the treatment group, compared with 5/25 in the placebo group (P < 0.001; NNT = 1.6, 95% CI= 1.2 to 2.6). After seven days the bacteriological cure rate was 17/23 in the intervention group and 9/22 in the placebo group (P = 0.05, NNT = 3, 95% CI = 1.7 to 17). CONCLUSION: In women with bacteriologically proven UTI, nitrofurantoin was significantly more effective than placebo in achieving bacteriological cure and symptomatic relief in just three days; this was still present after seven days. In patients with clinically suspected UTI the symptomatic effect was statistically significant after

Adolescent↗

PubMed2005

A community-based randomised controlled trial of three different educational resources for men about prostate cancer screening.

Randomised evaluations of resources to facilitate informed decisions about prostate cancer screening are rarely conducted. In this study, 421 men recruited from the community were randomly allocated to receive a leaflet (n = 140) or one of two resources meeting criteria for a decision-aid: a video (n = 141) or an evidence-based booklet, developed by the authors (n = 140). Men in all three groups demonstrated significant increases in knowledge scores from pre to post-test. Scores were significantly higher at post-test amongst those who had received our evidence-based booklet compared with men who received the leaflet or video (P < 0.001). Scores were significantly modified by men's preferences for decisional control (P = 0.002). Decisional conflict was significantly lower amongst men receiving the evidence-based booklet (P = 0.038). Men receiving the evidence-based booklet also were less likely to accept a recommendation by a GP to undergo prostate-specific-antigen (PSA) screening (P = 0.003). Men require detailed information about the pros and cons of PSA screening in order to make an informed decision. Resources are not equivalent in achieving these outcomes.

Aged↗

PubMed2006

Self-reported benefits from successive bilateral cochlear implantation in post-lingually deafened adults: randomised controlled trial.

Adult users of unilateral Nucleus CI24 cochlear implants with the SPEAK processing strategy were randomised either to receive a second identical implant in the contralateral ear immediately, or to wait 12 months while they acted as controls for late-emerging benefits of the first implant. Twenty four subjects, twelve from each group, completed the study. Receipt of a second implant led to improvements in self-reported abilities in spatial hearing, quality of hearing, and hearing for speech, but to generally non-significant changes in measures of quality of life. Multivariate analyses showed that positive changes in quality of life were associated with improvements in hearing, but were offset by negative changes associated with worsening tinnitus. Even in a best-case scenario, in which no worsening of tinnitus was assumed to occur, the gain in quality of life was too small to achieve an acceptable cost-effectiveness ratio. The most promising strategies for improving the cost-effectiveness of bilateral implantation are to increase effectiveness through enhanced signal processing in binaural processors, and to reduce the cost of implant hardware.

Adult↗

PubMed2005

A randomised controlled trial of vitamin E in the treatment of primary dysmenorrhoea.

OBJECTIVE: To study the effect of vitamin E in the treatment of primary dysmenorrhoea. DESIGN: A randomised, double-blind, placebo-controlled trial. SETTING: A secondary school in Tehran, Iran. POPULATION: Two hundred and seventy-eight girls aged 15-17 years who suffered from primary dysmenorrhoea. METHODS: Participants were given 200 units of vitamin E or placebo twice a day, beginning two days before the expected start of menstruation and continued through the first three days of bleeding. Treatment was continued over four consecutive menstrual periods. MAIN OUTCOME MEASURES: The severity and duration of pain, and the amount of menstrual blood loss, at two and four months. A visual analogue scale (VAS) was used to record pain, and a validated Pictorial Blood Loss Assessment Chart (PBLAC) to measure menstrual loss. RESULTS: In the vitamin E group, pain severity was lower with vitamin E at two months (median VAS score 3 vs 5, P > 0.001) and four months (0.5 vs 6, P > 0.001), pain duration was shorter at two months (mean 4.2 [7.1] hours vs 15 [17], P > 0.001) and at four months (1.6 [4.0] hours vs 17 [18] hours, P > 0.0001), and blood loss assessed by PBLAC score was lower at two months (54 [31] vs 70 [40], P > 0.0001) and at four months (46 [28] vs 70 [37], P > 0.0001). CONCLUSION: Vitamin E relieves the pain of primary dysmenorrhoea and reduces blood loss.

Adolescent↗

PubMed2006

Wound healing with honey--a randomised controlled trial.

OBJECTIVES: To compare honey and IntraSite Gel as woundhealing agents, to record side-effects, gauge patient satisfaction and calculate the cost-effectiveness of the honey used. DESIGN AND SETTING: A prospective, randomised, double-blind controlled trial was carried out among goldmine workers. OUTCOME MEASURES: Outcome measures were healing times of shallow wounds and abrasions; side-effects; patient satisfaction with treatment; and amount of honey and IntraSite Gel used. RESULTS: The mean healing times of shallow wounds treated with honey or with IntraSite Gel did not differ significantly (p = 0.75, 95% confidence interval (CI): -5.41; 7.49 days). When adjusted for wound size, the 2.8-day difference in favour of honey was not significant (p = 0.21, 95% CI: -2.41; 8.09). In the case of abrasions there was also no significant difference (p = 0.83, 95% CI: -4.98; 6.19 days). When adjusted for wound size, the difference of 0.22 days in favour of IntraSite Gel was not significant (p = 0.94, 95% CI: -5.72; 6.15.4). Of patients treated with honey, 27% and 10% respectively experienced itching and pain, and 2 experienced burning for a short time after application. Of patients treated with IntraSite Gel, 31% experienced itching. All patients in both treatment groups were either satisfied or extremely satisfied with treatment. The average cost of treatment per patient was R0.49 with honey and R12.03 with with IntraSite Gel. CONCLUSIONS: A distinction should be made between shallow wounds and abrasions when wound healing is being measured. There was no evidence of a real difference between honey and IntraSite Gel as healing agents. Honey is a safe, satisfying and effective healing agent. Natural honey is extremely costeffective.

Adult↗

PubMed2005

Oral zinc supplementation in pregnant women and its effect on birth weight: a randomised controlled trial.

Pakistan lies in a zinc deficient area where oral zinc supplementation has been advocated for various reasons. A double blind, randomised case-control study was carried out on pregnant women to evaluate the effects of oral zinc supplementation on the weights of newborns. No significant difference was found in the birth weights between the cases supplemented with 20 mg elemental zinc and controls receiving oral placebos (p=0.57).

Administration, Oral↗

PubMed2002

A randomised controlled trial of intravenous immunoglobulin in IgM paraprotein associated demyelinating neuropathy.

This multicentre randomised double blind crossover trial tested the short term efficacy of intravenous immunoglobulin (IVIg) 2.0 g/kg given over 24 or 48 hours in patients with paraproteinaemic demyelinating neuropathy (PDN). Twenty-two patients were randomised and completed the trial. After 2 weeks, the overall disability grade decreased during both IVIg treatment and placebo but neither change was significant nor was the mean difference between the treatment effects. After 4 weeks the overall disability decreased by a mean of 0.55 [0.67] grades during the IVIg period (p = 0.001) while it was substantially unmodified during the placebo period. The mean difference between the treatment effects was significant (p = 0.05). Overall during the IVIg period 10 patients improved and 11 were stable and one got worse. During the placebo period 4 patients improved, 4 deteriorated and 14 were stable. Many secondary outcome measures, including Rankin scale, time to walk 10 metres, grip strength, sensory symptoms score were significantly better during IVIg treatment. Two serious adverse events occurred during the trial, both during placebo treatment. In conclusion the trial showed some short-term benefit of IVIg in about half of the patients confirming previous observation.

Aged↗

PubMed1999

Prevention of postmenopausal bone loss at lumbar spine and upper femur with tibolone: a two-year randomised controlled trial.

OBJECTIVE: To examine the effects of tibolone on bone mineral density and its concurrent safety and subject acceptability. DESIGN: Prospective randomised controlled study. SETTING: Centre for Metabolic Bone Disease, Hull. POPULATION: Forty-seven healthy post-menopausal women aged 50-57 years with normal bone mineral density at lumbar spine. METHODS: Bone mineral density was assessed every 24 weeks at lumbar spine and proximal femur using dual energy X-ray absorptiometry. RESULTS: The bone mineral density of the tibolone treated subjects tended to increase while those of the controls tended to fall. The higher densities in the tibolone group were significant at lumbar spine from week 24 (P = 0.002) and at the trochanter from week 72 (P = 0.014). The lower bone densities in the controls were significant at Ward's Triangle and femoral neck at week 96 (P < 0.0001), and at lumbar spine from week 24 onwards (P < 0.05). Between-treatment analysis indicated that, by the 96th week, the bone densities at all sites in the tibolone group were significantly different from those in the control group. At the lumbar spine the differences were highly significant throughout the study (P < 0.0004). Four women receiving tibolone withdrew from the study due to unacceptable adverse events. Two women withdrew from the control group. There was no significant difference between the groups in the number of subjects suffering adverse experiences. Vaginal bleeding occurred in seven women, all from the tibolone treated group, resulting in one withdrawal from the study. CONCLUSION: Tibolone is thus an effective and well-tolerated alternative to oestrogen in the prevention of osteoporosis with its beneficial effects being most apparent at the lumbar spine.

Absorptiometry, Photon↗

PubMed2001

Randomised controlled trial of infantile colic treated with chiropractic spinal manipulation.

AIMS: To investigate the efficacy of chiropractic spinal manipulation in the management of infantile colic. METHODS: One hundred infants with typical colicky pain were recruited to a randomised, blinded, placebo controlled clinical trial. RESULTS: Nine infants were excluded because inclusion criteria were not met, and five dropped out, leaving 86 who completed the study. There was no significant effect of chiropractic spinal manipulation. Thirty two of 46 infants in the treatment group (69.9%), and 24 of 40 in the control group (60.0%), showed some degree of improvement. CONCLUSION: Chiropractic spinal manipulation is no more effective than placebo in the treatment of infantile colic. This study emphasises the need for placebo controlled and blinded studies when investigating alternative methods to treat unpredictable conditions such as infantile colic.

Colic↗

PubMed2006

Randomised controlled trial of topical ciclosporin A in steroid dependent allergic conjunctivitis.

AIM: To evaluate the efficacy, safety, and therapeutic effect of topical ciclosporin A 0.05% as a steroid sparing agent in steroid dependent allergic conjunctivitis. METHODS: Prospective, randomised, double masked, placebo controlled trial comparing signs, symptoms, and the ability to reduce or stop concurrent steroid in steroid dependent atopic keratoconjunctivitis and vernal keratoconjunctivitis using 0.05% topical ciclosporin A compared to placebo. Steroid drop usage per week (drug score), symptoms, and clinical signs scores were the main outcome measures. RESULTS: The study included an enrolment of 40 patients, 18 with atopic keratoconjunctivitis and 22 with vernal keratoconjunctivitis. There was no statistical significant difference in drug score, symptoms, or clinical signs scores between the placebo and ciclosporin group at the end of the treatment period. No adverse reactions to any of the study formulations were encountered. CONCLUSIONS: Topical ciclosporin A 0.05% was not shown to be of any benefit over placebo as a steroid sparing agent in steroid dependent allergic eye disease.

Adult↗

PubMed2003

One year effectiveness of an individualised smoking cessation intervention at the workplace: a randomised controlled trial.

AIMS: To assess the effectiveness of a smoking cessation intervention at the workplace. The intervention was adapted to smokers' tobacco dependence, and included minimal structured counselling at the first visit (5-8 minutes), nicotine patches for three months, and three sessions of counselling for reinforcement of abstinence (2-3 minutes) over a three month period. METHODS: Open randomised trial with two groups: the intervention group, and the control group which was subjected to standard clinical practice, consisting of short (30 seconds to one minute) sporadic sessions of unstructured medical antismoking advice. The trial was carried out among 217 smokers of both sexes, aged 20-63 years, motivated to quit smoking and without contraindications for nicotine patches, who were employees at a public transport company and at two worksites of an electric company. The main outcome measure was self reported tobacco abstinence confirmed by carbon monoxide in expired air </=10 ppm. Analysis was performed according to intention-to-treat. RESULTS: The rate of continuous abstinence at 12 months was 20.2% for the intervention versus 8.7% for the control group (OR: 2.58; 95% CI: 1.13 to 5.90; p = 0.025). In subgroup analyses, effectiveness of the intervention did not vary substantially with age, tobacco dependence, number of cigarettes smoked per day, number of years of tobacco consumption, degree of desire to quit smoking, time spent with smokers, subjective health, and presence of tobacco related symptoms. Weight gain at 12 months was similar for both groups (1.69 kg in the intervention v 2.01 kg in the control group; p = 0.21). CONCLUSIONS: A simple and easily generalisable intervention at the workplace is effective to achieve long term smoking cessation. In a setting similar to ours, nine subjects would have to be treated for three months for one to achieve continuous abstinence for 12 months.

Adolescent↗

PubMedDate not supplied

Buteyko breathing techniques in asthma: a blinded randomised controlled trial.

OBJECTIVE: To evaluate the effect of Buteyko breathing techniques (BBT) in the management of asthma. DESIGN: Prospective, blinded, randomised study comparing the effect of BBT with control classes in 39 subjects with asthma. The study was conducted from January 1995 to April 1995. PARTICIPANTS AND SETTING: Subjects recruited from the community, aged 12 to 70 years, with asthma and substantial medication use. MAIN OUTCOME MEASURES: Medication use; morning peak expiratory flow (PEF); forced expiratory volume in one second (FEV1); end-tidal (ET) CO2; resting minute volume (MV); and quality of life (QOL) score, measured at three months. RESULTS: No change in daily PEF or FEV1 was noted in either group. At three months, the BBT group had a median reduction in daily beta 2-agonist dose of 904 micrograms (range, 29 micrograms to 3129 micrograms), whereas the control group had a median reduction of 57 micrograms (range, -2343 micrograms to 1143 micrograms) (P = 0.002). Daily inhaled steroid dose fell 49% (range, -100% to 150%) for the BBT group and 0 (range, -82% to +100%) for the control group (P = 0.06). A trend towards greater improvement in QOL score was noted for BBT subjects (P = 0.09). Initial MV was high and similar in both groups; by three months, MV was lower in the BBT group than in the control group (P = 0.004). ET CO2 was low in both groups and did not change with treatment. CONCLUSION: Those practising BBT reduced hyperventilation and their use of beta 2-agonists. A trend toward reduced inhaled steroid use and better quality of life was observed in these patients without objective changes in measures of airway calibre.

Adolescent↗

PubMed2004

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

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 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.

Acupuncture Therapy↗