Post 8: 25th November 2005
Links are given to online full text resources, all other materials can be obtained via the Fade Library, just mail your request to library.services@fade.nhs.uk
Latest Systematic Reviews
RB Haynes, X Yao, A Degani, S Kripalani, A Garg, HP McDonald (2005) Interventions to enhance medication adherence. The Cochrane Database of Systematic Reviews 2005 Issue 4 (Status: Updated)
Many people do not take their medication as prescribed. Our review considered trials of ways to help people follow prescriptions. For short-term drug treatments, counseling, written information and personal phone calls helped. For long-term treatments, no simple intervention, and only some complex ones, led to improvements in health outcomes. They included combinations of more convenient care, information, counseling, reminders, self-monitoring, reinforcement, family therapy, psychological therapy, crisis intervention, manual telephone follow-up, and other forms of additional supervision or attention. Even with the most effective methods for long-term treatments, improvements in drug use or health were not large. Fortunately, several studies showed that telling people about adverse effects of their medications did not affect their use of the medications.
Latest Technology Assessments and Appraisals
The effectiveness and cost-effectiveness of dual-chamber pacemakers compared with single-chamber pacemakers for bradycardia due to atrioventricular block or sick sinus syndrome: systematic review and economic evaluation (Castelnuovo) 262 pages, Volume 9, number 43
A systematic review was carried out of randomised controlled trials (RCTs). The quality of selected studies was appraised using standard frameworks. Meta-analyses, using random effects models, were carried out where appropriate. Limited exploration of heterogeneity was possible. Critical appraisal of economic evaluations was carried out using two frameworks. A decision-analytic model was developed using a Markov approach, to estimate the cost-effectiveness of dual-chamber versus ventricular or atrial pacing over 5 and 10 years as cost per quality-adjusted life-year (QALY). Uncertainty was explored using one-way and probabilistic sensitivity analyses.
Long-term outcome of cognitive behaviour therapy clinical trials in central Scotland (Durham) 174 pages, Volume 9, number 42
Research following up participants in clinical trials of cognitive behaviour therapy found that good outcomes achieved in the short term cannot be guaranteed longer term
Acute coronary syndromes - clopidogrel (No. 80) - Clarification of recommendation 1.3
Review proposal: Diabetes (types 1 and 2) - patient education models (No. 60)
Latest Guidelines
Obsessive-compulsive disorder: NICE guideline
NICE and the National Collaborating Centre for Mental Health have issued a clinical guideline on interventions in the treatment of obsessive-compulsive disorder within the NHS in England and Wales. Listed below are the key documents for this guideline, click on the title to link to the relevant document.
SIGN (2005) Prevention and management of dental decay: a national guideline. Edinburgh: SIGN.
SIGN has issued a guideline on the prevention and management of dental decay in the pre-school child. Areas covered include pathogenesis and diagnosis; epidemiology and impact; predicting caries risk; diet and nutrition; toothbrushing with fluoride toothpaste; community based prevention; practice based prevention; practice based management; implementation and audit; information for parents and carers.
SIGN has issued a guideline on the prevention and management of dental decay in the pre-school child. Areas covered include pathogenesis and diagnosis; epidemiology and impact; predicting caries risk; diet and nutrition; toothbrushing with fluoride toothpaste; community based prevention; practice based prevention; practice based management; implementation and audit; information for parents and carers.
Prosthetic intervertebral disc replacement in the cervical spine - guidance
A number of devices have been developed for the cervical spine. Under general anaesthetic the patient is placed in the supine position. The anterior cervical spine is exposed, and after standard decompression of the neural elements, an artificial disc prosthesis is placed between the vertebrae.
Photodynamic therapy for localised inoperable endobronchial cancer - guidance
Photodynamic therapy is a minimally invasive treatment, involving injection of a photosensitising agent, followed a few days later by photo-radiation to the affected area through a bronchoscope. This is intended to reduce the bulk of the tumour, thus reducing symptoms caused by bronchial obstruction. PDT is performed endobronchially, with debridement of necrotic tumour within a few days of each treatment.
Intramural urethral bulking procedures for stress urinary incontinence in women - guidance
Stress urinary incontinence is the involuntary leakage of urine during exercise or movements such as coughing, sneezing and laughing. It is usually caused by weak or damaged muscles and connective tissues in the pelvic floor, compromising urethral support, or by weakness of the urethral sphincter itself.
Typically, first-line treatment is conservative and includes pelvic floor muscle training, electrical stimulation, and biofeedback. If the condition does not improve, surgical alternatives in women may include colposuspension, tension-free vaginal tape (TVT), transobturator tape, and traditional suburethral slings.
The injection of bulking agents into the wall of the urethra is usually performed under local anaesthesia. A cystoscope is inserted into the urethra to locate the areas where the bulking agent should be introduced. After injection of local anaesthetic, several millilitres of bulking agent are injected into the submucosal tissue at the level of the proximal urethra just distal to the bladder neck. The injections may be administered transurethrally through the cystoscope or paraurethrally via small perineal incisions.
Extracorporeal shockwave therapy for refractory tendinopathies (plantar fasciitis and tennis elbow) - guidance
Tendinopathy is a collective term describing a chronic condition in which the tendon is affected by a series of microscopic tears at its junction with bone. The condition is chronic and heals very slowly. Tendinopathy can affect many different parts of the body and results from either injury or overuse. Symptoms include pain, tenderness, weakness and stiffness. Tendonitis is an inflammatory condition of tendons that is less common than tendinopathy.
Plantar fasciitis is a particular kind of tendinopathy affecting the under surface of the heel. It leads to heel and arch pain and can result in X-ray changes of the heel spur. Another kind of tendinopathy is tennis elbow.
Conservative treatments include rest, ice, orthotic devices, physiotherapy and analgesics. It may take many months for symptoms to resolve. Surgery is an option in refractory cases and consists of release of the tendon from the underlying bone. Surgery is usually followed by a period of programmed rehabilitation.
Extracorporeal shock wave therapy is a non-invasive treatment in which a device is used to pass low- or high-energy shock waves through the skin to the affected area. Ultrasound guidance may be used to assist with positioning of the device. The shock waves are generated and focused using one of three types of energy – electrohydraulic, electromagnetic or piezoelectric. Low-energy shock waves are applied in a series of treatments and do not usually cause any pain. High-energy shock wave treatments are generally given in one session. They are more painful and usually require some kind of anaesthesia.
The mechanism by which this therapy might have an affect on musculoskeletal conditions is not well defined.
Metatarsophalangeal joint replacement of the hallux - guidance
Osteoarthritis is a common condition in which the surface of the joint becomes worn and the adjacent bone thickens and forms osteophytes. If severely affected, the joint becomes painful and stiff.
Rheumatoid arthritis is a chronic inflammatory disease that destroys the joint and will eventually lead to end stage osteoarthritic changes.
Both kinds of arthritis commonly affect the metatarsophalangeal (MTP) joint at the base of the big toe. The joint may become predominantly stiff (hallux rigidus) or deformed (hallux valgus).
Conservative treatments include exercise, physiotherapy, analgesics, non-steroidal anti-inflammatory tablets and cream, and steroid injections into the joint. Severe cases that do not respond to conservative measures may require surgery. If the only problem is an osteophyte on the surface of the joint, this may be trimmed (cheilectomy), but the three main surgical options for treating the whole joint are fusion, simple excision of the arthritic joint (Keller’s procedure) and joint replacement with an artificial implant.
MTP joint replacement is carried out under general or spinal anaesthesia using tourniquet control. An incision is made over the joint and the capsule is exposed by dividing tissue and retracting tendon. The joint surfaces are excised and the medullary canals of the first metatarsal and proximal phalanx are enlarged to accommodate the prosthetic joint implant. A preliminary reduction with a trial implant is done to ensure a snug fit and the implant is then placed in the canal. The joint capsule is closed and a flexible splint is used postoperatively to maintain the correct position.
Automated percutaneous mechanical lumbar discectomy - guidance
Lumbar radicular pain, also known as sciatica, refers to pain that begins in the lower back and radiates down one of the legs. It is commonly caused by a herniated (or prolapsed) lumbar intervertebral disc. The herniation is a result of a protrusion of the nucleus pulposus through a tear in the surrounding annulus fibrosus. The annulus fibrosus may rupture completely resulting in an extruded disc, or may remain intact but stretched resulting in a contained disc prolapse. This may then compress one or more nerve roots, resulting in pain, numbness or weakness in the leg.
Conservative treatments include the use of analgesics, non steroidal anti-inflammatory medicines, physical therapy and hot or cold compresses. Epidural injections of corticosteroid may also be used. Surgery to remove disc material is considered if there is nerve compression or persistent symptoms that are unresponsive to conservative treatment.
Surgical techniques include open repair procedures and minimally invasive alternatives using percutaneous approaches.
Automated percutaneous mechanical lumbar discectomy is performed using local anaesthetic with or without conscious sedation. Under fluoroscopic guidance, a cannula is placed centrally within the disc using a posterolateral approach on the symptomatic side. A probe connected to an automated cutting and aspiration device is then introduced through the cannula. The disc is aspirated until no more nuclear material can be obtained.
There are a number of different devices available that are used to perform this procedure.
Cryotherapy for malignant endobronchial obstruction - guidance
Lung cancer is often at an advanced stage by the time it is diagnosed and survival rates are low. Patients can develop endobronchial lesions that obstruct the major airways, causing symptoms such as dyspnoea, cough, haemoptysis and postobstructive pneumonia. The obstruction may lead to gradual asphyxiation.
The aim of treatment in patients with malignant endobronchial obstruction is mainly palliative. Current treatment options include a variety of endobronchial therapies such as resection, brachytherapy, laser ablation, photodynamic therapy and stenting. External beam radiotherapy and chemotherapy may also be used for palliative treatment.
Cryosurgery uses extreme cold to destroy tissue. General anaesthesia is usually used and a cryoprobe is inserted through a bronchoscope to reach the tumour. The selection of probe diameter depends on the size and position of the tumour. After a period of freezing, the tumour is allowed to thaw until the probe separates from the tissue. The freeze/thaw cycle may be repeated two to three times in the same place. The probe is then moved to an adjacent area and the process repeated until the whole tumour has been treated. Any resulting necrotic tumour material is then removed with forceps or the cryoprobe. Further necrotic-appearing material may be coughed out 24 to 48 hours later. The procedure can be repeated if necessary.
Intraoperative blood cell salvage in obstetrics - guidance
Intraoperative cell salvage is a commonly used technique in cardiac and orthopaedic surgery. However cell salvage has not been routinely adopted in the obstetric field for use in women at risk of postpartum haemorrhage following Caesarean section, where there may be specific safety concerns regarding embolism, or haemolytic disease as a result of re-infusion of foetal cells, or amniotic fluid.
During intra-operative blood cell salvage during Caesarean section, blood that is lost during the operation is aspirated from the surgical field using a catheter. The blood is then suctioned in a reservoir in which a filter removes gross debris. The filtered blood is then washed and re-suspended in saline for transfusion, which may be re-transfused either during or after the operation.
A leukocyte depletion filter may also be used in this process to reduce the number of leukocytes in transfused blood which may reduce adverse reactions to re-infused blood and limit disease transmission.
Cryotherapy as a primary treatment for prostate cancer - guidance
Cancer of the prostate gland may cause it to enlarge, resulting in symptoms such as difficulty in urinating, frequent urination, and blood in the urine. The risk of prostate cancer rises with age and it is rare in men younger than 50.
Treatment options depend on the stage of the cancer. Current treatments for localised prostate cancer include watchful waiting, radiotherapy, and radical prostatectomy.
Cryotherapy may be performed under general or spinal anaesthesia. A warming catheter is inserted into the urethra, to prevent it being damaged by the cold. Cryoneedles or probes are inserted into the prostate, under radiological guidance. Temperature monitor probes may also be placed percutaneously through the perineum. Argon gas or liquid nitrogen is then circulated through the needles or probes generating very low temperatures and causing the formation of ice around the prostate gland, which destroys the tissue. Newer cryotherapy techniques allow for these needles to be removed or repositioned so that the frozen zone conforms to the exact size and shape of the target tissue.
Questions and answers: safety of Long-Acting Beta-Adrenoceptor agonists
(formoterol and salmeterol) in the treatment of asthma.
Following the results of the Salmeterol Multi-Centre Asthma Research Trial (SMART), the MHRA has issued the following recommendations/reminder for prescribers:
Additionally, the MHRA states that the current US FDA warnings are also in line with UK asthma management guidelines. The MHRA also state that healthcare professionals should continue to prescribe salmeterol and formoterol in accordance with UK national guidance, carefully noting advice on safe use.
The advice from the MHRA also highlights and summarises the findings from SMART.
Latest Reports
The Future of Primary Care: Meeting the challenges of the new NHS market
Primary care has been the subject of a quiet revolution in recent years, with the ending of the monopoly of provision by independently contracted GPs and the introduction of a range of new targets and new forms of first contact care. Now it is poised for further radical change with reforms to the structure and roles of primary care trusts and the introduction of practice-based commissioning and competition between primary care providers. This paper examines the potential impact of these changes and the role of primary care in the new NHS market, outlining some of the main challenges and suggesting possible ways forward.
Delivering quality and value: A briefing for NHS Chairs and Non-Executive Directors
Delivering Quality and Value is the first in a series of briefings aimed to guide NHS Chairs and Non-Executive directors towards the important issues affecting NHS organisations and the best practice that can help manage them. This briefing aims to:
Choosing better oral health: An oral health plan for England
Oral Health Plan sets out to inform and provide support for dental practices as they focus more on preventative care under new contractual arrangements which will be in place from 1 April 2006. Designed to improve oral health both nationally and locally, this plan also sets out to assist and support Primary Care Trusts in meeting their new responsibilities for dental services under the Health and Social Care (Community Health and Standards) Act 2003. This legislation extends their remit to assessing local oral health needs and commissioning the appropriate services to tackle long standing oral health inequalities.
Older people's mental health is Everybody's Business
Everybody Business was launched on 14 November 2005 to improve health and social care practice at the front line. Our message is clear. Older people’s mental health cuts across health and social care, physical and mental health and mainstream and specialist services.
The new service development guide is committed to:
Major review of healthcare programmes
The Department of Health, in partnership with the Nursing and Midwifery Council, the Health Professions Council and the Strategic Health Authorities have contracted with the Quality Assurance Agency for Higher Education (QAA) to carry out reviews of all NHS-funded healthcare programmes in England during the period 2003-06.
Alcohol Misuse Interventions: Guidance on developing a local programme of improvement
This document provides guidance on developing and implementing programmes that can improve the care of hazardous, harmful and dependent drinkers. Whilst this document focuses on guidance for the development of screening and brief interventions, it is also part of a wider programme that will develop over time.
Action on health care associated infections in England: Summary of responses to the consultation
This document provides a summary of responses to the consultation document 'Action on health care associated infections in England', which had set out a range of measures designed to give a firm statutory footing to accepted best practice to monitor and reduce levels of health care associated infection in England.
Evidence from Journals
MENTAL HEALTH
Clinical and Social Outcomes five years after closing a mental hospital: a trial of cognitive behavioural interventions. Antonino Mastroeni, Carla Bellotti, Esterina Pellegrini, Francesco Galletti, Elena Lai and Ian RH Falloon. Clinical Practice and Epidemiology in Mental Health 2005, 1:25
Background To investigate the outcome of patients transferred from hospital to community care in Como, Italy after 6 months intensive psychosocial rehabilitation prior to discharge.
Method All 149 residents with a primary psychiatric diagnosis were assigned to receive either a 6-month pre-discharge course of goal-oriented rehabilitation, IT, or routine management, RT. BPRS and GAF ratings were made by blind, independent assessors before and at 12, 24, 36, 48, and 60 months after discharge and the results examined with repeated measures analysis of variance. Results Overall change in residence was achieved without any major detriment to the health and welfare of most patients. The cohort of patients who received intensive rehabilitation, IT, prior to discharge showed significantly lower impairment and disability throughout the five years compared to the cohort receiving routine management, RT, prior to discharge. Total BPRS scores remained significant when initial differences in the cohorts were covaried, whereas GAF failed to remain significant (p = 0.051). Conclusions
The treatment provided prior to transfer from long-stay hospital to community residence may have long-term clinical benefits for chronically disabled patients.
DIABETES
Yamaoka K, et al. Efficacy of lifestyle education to prevent type 2 diabetes: a meta-analysis of randomized controlled trials. Diabetes Care 2005 Nov;28(11):2780-6.
To evaluate the efficacy of lifestyle education for preventing type 2 diabetes in individuals at high risk by meta-analysis of randomized controlled trials, as assessed by incidence and a reduced level of plasma glucose 2 h after a 75-g oral glucose load (2-h plasma glucose). Through an electronic search, 123 studies were identified. A literature search identified eight studies that met strict inclusion criterion of meta-analysis for 2-h plasma glucose and five studies for the incidence of diabetes. All were randomized controlled trials of ≥6 months with lifestyle education that included a dietary intervention. Subjects were adults diagnosed as being at high risk for type 2 diabetes. The difference in mean reduction of 2-h plasma glucose from baseline to the 1-year follow-up and relative risk (RR) of the incidence of diabetes in the lifestyle education group versus the control group were assessed. Overall estimates were calculated using a random-effects model. Those estimates were confirmed by several models, and the possibility of selection bias was examined using a funnel plot. Lifestyle education intervention reduced 2-h plasma glucose by 0.84 mmol/l (95% CI 0.39-1.29) compared with the control group. The 1-year incidence of diabetes was reduced by ~50% (RR 0.55,95% CI 0.44-0.69) compared with the control group. Results were stable and little changed if data were analyzed by subgroups or other statistical models. Funnel plots revealed no selection bias. Lifestyle education was effective for reducing both 2-h plasma glucose and RR in high-risk individuals and may be a useful tool in preventing diabetes.
HEART DISEASE
Imazio M , et al. Colchicine in addition to conventional therapy for acute pericarditis: results of the COlchicine for acute PEricarditis (COPE) trial. Circulation 2005 Sep 27;112(13):2012-6.
Latest Questions to the Primary Care Question Answering Service
CAUSES, RISKS AND PREVENTION
Should a patient with multiple sclerosis be given the influenza vaccination?
Should all patients with coeliac disease or dermatitis herpetiformis be offered annual influenza vaccination?
Is there any evidence for adverse outcomes in the use of over the counter stretch mark cream ("Skin Doctors Stretch Away" topically daily from approx 16 weeks to 35 weeks pregnancy.
What is the evidence for antioxidants and zinc in preventing and delaying progression of age related macular degeneration ?
What is the effect of delayed operation in upper femoral fractures (Transcervical) and what is the optimum time for intervention?
Treatment of Tinea unguis: When should at treatment with Lamisil (Terbinafine) the LFT s taken and how long should a course of oral antifungal treatment last (minimum and maximum)
Is there any evidence of a link between the use of the combined oral contraceptive pill and the development of Polycystic Ovarian Syndrome? Is there any evidence/guideline on the 'best choice' of contraception in patients with PCOS?
Is a patient with inactive Toxoplasma retinitis (but who has had 2 flares in the last 10 years) at risk of intrauterine infection if she now becomes pregnant, and has a further flare.
ASSESSMENT AND DIAGNOSIS
How should we follow up otherwise asymptomatic, non-diabetic patients with reasonable control of BP, found to have 1+ proteinuria at their routine CHD annual check up?
How sensitive and specific is troponin t testing as a marker of MI?
What is the definition of sleep paralysis and what is considered to be the aetiology, prognosis and treatment options?
What is the cause in a well asymptomatic patient of a TSH <0.02>
How should I clean the ear pieces on my auroscope?. Is wiping with an alcohol swab enough?
After the last dose of buprenorphine (SUBUTEX), how long can it be detected in the urine?
Can any patient be diagnosed as having COPD and asthma at the same time? How do you label and treat such patients? - I used to use the term partly reversible COPD.
What are the important diseases to consider in a patient complaining of haematospermia?
DIABETES
What is the evidence that retinal screening improves outcome in diabetic retinopathy?
Is any evidence surrounding the use of insulin pens for patients who are being managed by District Nurses and are not self-administering their insulin?
CARDIOVASCULAR DISEASE
1). How important is the control of blood pressure in the secondary prevention of stroke and 2) How effective is perindopril in the secondary prevention of CVA events also what is the recommended dose?
How do I calculate CHD risk for patients who are hypertensive on treatment to assess need for primary prevention of CHD/CVD?
Should an 89yr old lady with ischaemic heart disease, found to have cholesterol of 8.8 on first time of testing, be treated with a statin?
What is the recommended time interval for U&Es blood tests following initiation and titration of ACE antihypertension medication as there seems to be a variation on opinion
CANCER
For patients with Ca prostate being treated with Zoladex is there any indication whether it is better to continue giving regular injections once the PSA has fallen to a minimum, or just monitor PSA and restart therapy if/when the PSA rises again?
CHILD HEALTH
For infants, is there any proven benefit of cranial osteopathy for any conditions?
Do babies with plagiocephaly need to wear corrective helmets?
NUTRITION AND METABOLIC DISEASES
In a patient on thyroxine, following a total thyroidectomy for carcinoma of the thyroid, what level of TSH should be aimed for to decide the dose of replacement thyroxine?
RESPIRATORY
For the treatment of acute asthma, have there been any studies done comparing the efficacy/equivalence of using multiple doses of a reliever from an MDI (e.g.salbutamol aerosol inhaler) in a Volumatic spacer with the same in an Aerochamber Plus spacer?
PALLIATIVE CARE
For patients in the end stages of terminal care (not taking oral fluids) is there are evidence that subcutaneous fluids improve quality of life?
Hitting the Headlines - Evidence Behind the Press Stories
Infliximab for psoriasis
An anti-inflammatory drug has proved effective for the treatment of moderate-to-severe psoriasis, reported two newspapers (14 October 2005). The reasonably accurate reports were based on the results of a well-conducted trial which found significant improvements in the psoriasis symptoms in patients receiving the drug infliximab compared to placebo.
Two newspaper articles (1,2) reported on the results of a trial assessing the effectiveness of the anti-inflammatory drug infliximab (marketed as Remicade) for the skin condition psoriasis. Both articles stated that treatment with infliximab had excellent results in improving the symptoms of the patients in the trial.
The newspaper articles were based on the results of a randomised controlled trial which was published in The Lancet (3). The trial compared the improvement in psoriasis symptoms of people receiving infliximab or a placebo (dummy drug). All of the participants included in the trial had moderate-to-severe plaque psoriasis, for the duration of at least six months. The participants receiving infliximab experienced significant improvements compared to those receiving placebo after 10 weeks of the trial. These improvements were maintained throughout the trial which lasted a year.
The newspaper articles were generally accurate summaries of the results of this well designed and conducted trial. However, it is not clear how applicable the results would be to patients with less severe forms for psoriasis. One newspaper stated that the drug has just been licensed for the treatment of psoriasis and now awaits assessment by the National Institute for Health and Clinical Excellence (NICE).
Evaluation of the evidence base for infliximab induction and maintenance therapy for moderate-to-severe psoriasis
Where does the evidence come from?
This multi-centre trial was led by Professor Christopher Griffiths from the Dermatology Centre, Hope Hospital, Salford, UK on behalf of the EXPRESS study investigators. The study was funded by Centocor (the manufacturer of infliximab) and Schering-Plough (responsible for marketing infliximab in Europe). For the study, Centocor staff collected the data, conducted the statistical analysis and participated in the preparation of the paper.
What were the authors' objectives?
The aim of the trial was to investigate the efficacy and safety of infliximab in the treatment of individuals with moderate-to-severe plaque psoriasis.
What was the nature of the evidence?
This was a multi-centre, double-blind, randomised controlled trial (RCT). A total of 378 patients were randomised to receive either infliximab (n=301) or a placebo (n=77). Patients included in the trial had had a diagnosis of moderate-to-severe psoriasis for at least six months, with at least 10% of their total body surface area affected by psoriasis. All other treatments for psoriasis were stopped before starting study treatment and were not allowed until the end of the study (except hydrocortisone applied topically to the face and/or groin after week 10).
The main objective of the trial was to assess the proportion of patients experiencing at least a 75% improvement in psoriasis symptoms (as measured with the PASI system) from baseline to week 10. Other outcomes included: patients achieving at least 75% improvements at week 24; patients achieving 50% and 90% improvement from baseline to week 10 and 24 (again using the PASI system); percentage improvement in NAPSI at weeks 10 (nail psoriasis severity index), and the proportion of patients with either cleared or minimal psoriasis at week 10. Patients were assessed at each study visit until week 50 by clinicians who did not know what treatment the patients were receiving.
What interventions were examined in the research?
Patients were randomised to either infliximab (5mg/kg as intravenous infusions at weeks 0, two and six and then every eight weeks until week 46) or a placebo. Patients receiving the placebo infusions were crossed over to receive infliximab from weeks 24 onwards.
What were the findings?
After 10 weeks, 80% of the patients receiving infliximab experienced improvements of at least 75% in their psoriasis compared to 3% of the patients receiving placebo. This finding remained statistically significant at week 24, with 82% of patients receiving infliximab experiencing improvements of at least 75% compared to 4% of patients in the placebo group. The patients receiving infliximab also experienced statistically significant improvements of at least 50% and 90% compared to those receiving placebo at weeks 10 and 24. Complete clearing of the skin was experienced by 26% of patients receiving infliximab compared to no patients receiving placebo. The numbers of adverse events were similar in both treatment groups.
What were the authors' conclusions?
The authors concluded that infliximab is an effective treatment for moderate-to-severe psoriasis. The benefits of infliximab were generally well-maintained throughout the one year trial.
How reliable are the conclusions?
This was a well-designed and conducted RCT. The study design and methods used to randomise patients to treatment and to analyse the results were appropriate. The investigators, study site personnel and patients were not aware which treatment was being received. The results presented and the authors' conclusions are therefore likely to be reliable.
Systematic reviews
Information staff at CRD searched for systematic reviews relevant to this topic. Systematic reviews are valuable sources of evidence as they locate, appraise and synthesize all available evidence on a particular topic.
There were no related systematic reviews identified on the Cochrane Database of Systematic Reviews (CDSR) or on the Database of Abstracts of Reviews of Effects (DARE).
References and resources
1. Is relief on the way for 1m victims of psoriasis? Daily Mail, 14 October 2005, p31.
2. Skin healing hope. The Times, 14 October 2005, p4.
3. Reich K, Nestle FO, Papp K, et al. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet 2005;366:1367-74.
Consumer information
The Psoriasis Association
NHS Direct – Psoriasis
Psoriatic Arthropathy Alliance
Homeopathic remedies for chronic disease
Homeopathic remedies improve the health of 70% of patients, reported the Daily Mail (22 November 2005). The research was accurately presented, but limitations in study design and methods used to assess changes in health status mean that the study cannot provide a reliable evaluation of the effectiveness of homeopathy.
On the 22 November 2005 the Daily Mail (1) reported that homeopathic remedies can improve the health of 70% of patients. The article also refers to a study (2) that found that homeopathy is no more effective than placebo, which has previously been covered by Hitting the Headlines (http://www.nelh.nhs.uk/hth/homeopathy.asp)
The newspaper article was based on research published in the Journal of Alternative and Complementary Medicine (3). This was an observational study of 6,544 people with chronic diseases who were referred to a homeopathic hospital out-patient department. The study assessed perceived changes in health following initial consultation and treatment. The research found that 70.7% of people reported a positive improvement in health at follow-up.
The newspaper accurately reports a summary of the research, and considers the limitations of the research presented. Despite the large number of people studied, the lack of a comparison group means that the study cannot provide a reliable evaluation of the effectiveness of homeopathy.
Evaluation of the evidence base for the homeopathic treatment of chronic disease
Where does the evidence come from?
The research was performed by Dr David Spence and colleagues at the Bristol Homeopathic Hospital, NHS Teaching Trust, UK.
What were the authors' objectives?
The objective was to assess the health changes observed following routine homeopathic care in patients with a range of chronic medical conditions.
What was the nature of the evidence?
The research was an observational study of 6,544 consecutive people referred by a GP or hospital specialist to a homeopathic hospital outpatient department. All participants had a diagnosis of chronic disease, and many had already received treatment by one or more hospital specialists. The conditions treated included eczema, asthma, depression and menopausal problems. Participants were both adults and children, with the majority being less than 48 years of age.
What interventions were examined in the research?
Participants received an initial 45-minute consultation and attended 15-minute follow-up appointments to determine any health change. No details were given on the homeopathic treatments administered.
What were the factors of interest?
At each follow-up appointment participants were asked to rate their current state of health using a scale ranging from 'much better' (+3 on the scale) to 'much worse' ( 3 on the scale). The overall outcomes were compared to baseline assessment, and the proportion of participants reporting each category of health change was calculated overall and separately for the most commonly referred diagnosis, and for children (less than 16 years), adult women and men.
What were the findings?
Overall, 70.7% of participants reported a positive health change, with 50.7% rating the health change as 'better' or 'much better'. A further 23.1% of participants reported no change following treatment, and 3.1% reported deterioration. 69.2% of adult women and 65.3% of men reported a positive health change. The biggest improvements were found in those aged less than 16 years, with 80.5% reporting a positive health change. In this group, 82% of those with eczema and 89% of those with asthma reported an improvement.
What were the authors' conclusions?
The authors conclude that homeopathic interventions improve health in a substantial proportion of patients with a wide range of chronic diseases. Further research, using a range of study designs, is needed in the field of homeopathy.
How reliable are the conclusions?
The study was based on a large cohort of 6,544 consecutive people attending a referral homeopathic hospital outpatient department, with more than 95% attending one or more follow-up appointment. Despite the large number of people studied, the lack of a comparison group means that the study cannot provide a reliable evaluation of the effectivness of homeopathy. The method used to determine health change relied entirely on the participants' self-reported assessment using a subjective scale. This is a very weak form of assessment (for example, it is unclear how meaningful was the improvement in the 20% of participants who reported being 'slightly better' after homeopathic treatment); the lack of an objective measurement of improvement severely limits the validity of the findings. No details were given on the homeopathic remedies given, the severity of condition or any other potential factors that may lead to an improvement in condition. Consequently, the results of additional studies should be drawn on to determine the effectiveness of homeopathic remedies in people with chronic disease.
Overall, the study tells us that many people do feel they receive some benefit from being referred to and treated by homeopathic medicine, however, it does not demonstrate the effectiveness of homeopathic medicine. In addition, as acknowledged by the newspaper report, the results of this study contradict the findings of a systematic review of 110 trials of homeopathy and 110 trials of conventional medicine, which found that homeopathic remedies are no better than placebo (2).
Systematic reviews
Information staff at CRD searched for systematic reviews relevant to this topic. Systematic reviews are valuable sources of evidence as they locate, appraise and synthesize all available evidence on a particular topic.
There was one related systematic review identified on the Cochrane Database of Systematic Reviews (CDSR) (4) and one review which is currently being completed and will be available in the future (5). Four related systematic reviews were identified on the Database of Abstracts of Reviews of Effects (DARE) (6-9).
References and resources
1. Homeopathic remedies that work for 70pc of patients. Daily Mail, 22 November 2005, p22.
2. Shang AS, Huwiler-Müntener K, Nartey L, Jüni P, Dörig S, Sterne JAC, Pewsner D, Egger M. Are the clinical effects of homeopathy placebo effects? Comparative study of placebo-controlled trials of homeopathy and allopathy. Lancet 2005;336:726-732.
3. Spence DS, Thompson EA, Barron SJ. Homeopathic treatment for chronic disease: a 6-year, university-hospital outpatient observational study. Journal of Alternative and Complementary Medicine 2005;11(5):793–798.
4. McCarney RW, Linde K, Lasserson TJ. Homeopathy for chronic asthma. The Cochrane Database of Systematic Reviews 2004, Issue 1. Art. No.: CD000353. DOI: 10.1002/14651858.CD000353.pub2.
5. Kassab S, van Haselen R, Fisher P, McCarney R. Homeopathy for adverse effects of cancer management. [Cochrane Protocol] The Cochrane Database of Systematic Reviews 2004, Issue 3. Art. No.: CD004845. DOI: 10.1002/14651858.CD004845.
6. Ernst E. Homeopathic prophylaxis of headaches and migraine: a systematic review. Journal of Pain and Symptom Management 1999;18(5):353-357. [DARE Abstract]
7. Long L, Ernst E. Homeopathic remedies for the treatment of osteoarthritis: a systematic review. British Homoeopathic Journal 2001;90(1):37-43. [DARE Abstract]
8. Mulrow C D, Ramirez G, Cornell J E, Allsup K. Defining and managing chronic fatigue syndrome. Rockville, MD, USA: Agency for Healthcare Research and Quality 2001:199. [DARE Abstract]
9. Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges L V, Jonas W B. Are the clinical effects of homoeopathy placebo effects: a meta-analysis of placebo-controlled trials. Lancet 1997;350:834-843. [DARE Abstract]
10. NHS Centre for Reviews and Dissemination. Homeopathy. Effective Health Care , 7(3), 2002.
11. Hoare C, Li Wan Po A, Williams H. Systematic review of treatments for atopic eczema. Health Technology Assessment 2000;4(37):1-191.
Consumer information
British Homeopathic Association
NHS Direct - Homeopathy
The Prince of Wales's Foundation for Integrated Health
Previous Hitting the Headlines summaries on this topic
'Is this the end for homeopathy? Hitting the Headlines archive, 26 August 2005.
Homeopathy for the treatment of asthma. Hitting the Headlines archive, 1 April 2003.
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