Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial.

BACKGROUND: Certolizumab pegol is a PEGylated tumour necrosis factor inhibitor. OBJECTIVE: To evaluate the efficacy and safety of certolizumab pegol versus placebo, plus methotrexate (MTX), in patients with active rheumatoid arthritis (RA). METHODS: An international, multicentre, phase 3, randomised, double-blind, placebo-controlled study in active adult-onset RA. Patients (n = 619) were randomised 2:2:1 to subcutaneous certolizumab pegol (liquid formulation) 400 mg at weeks 0, 2 and 4 followed by 200 mg or 400 mg plus MTX, or placebo plus MTX, every 2 weeks for 24 weeks. The primary end point was ACR20 response at week 24. Secondary end points included ACR50 and ACR70 responses, change from baseline in modified Total Sharp Score, ACR core set variables and physical function. RESULTS: Significantly more patients in the certolizumab pegol 200 mg and 400 mg groups achieved an ACR20 response versus placebo (p< or =0.001); rates were 57.3%, 57.6% and 8.7%, respectively. Certolizumab pegol 200 and 400 mg also significantly inhibited radiographic progression; mean changes from baseline in mTSS at week 24 were 0.2 and -0.4, respectively, versus 1.2 for placebo (rank analysis p< or =0.01). Certolizumab pegol-treated patients reported rapid and significant improvements in physical function versus placebo; mean changes from baseline in HAQ-DI at week 24 were -0.50 and -0.50, respectively, versus -0.14 for placebo (p< or =0.001). Most adverse events were mild or moderate, with low incidence of withdrawals due to adverse events. Five patients developed tuberculosis. CONCLUSION: Certolizumab pegol plus MTX was more efficacious than placebo plus MTX, rapidly and significantly improving signs and symptoms of RA and physical function and inhibiting radiographic progression. TRIAL REGISTRATION NUMBER: NCT00175877.

Would it be ethical or legal for doctors in South Africa to administer testosterone-reducing drugs to Caster Semenya?

The Court of Arbitration for Sport recently confirmed that the decision by the International Association of Athletics Federations to require hyperandrogenic female athletes such as Caster Semenya to reduce their testosterone levels to compete in certain races has been widely condemned. The World Medical Association has warned doctors not to assist in implementing the decision, as it would be unethical. The same would apply in terms of the Health Professions Council of South Africa's rules of professional conduct. Such treatment is 'futile' in medical terms, and does not serve the purpose of providing healthcare. Therefore, doctors may lawfully refuse to prescribe it. The decision is a violation of Semenya's constitutional rights and would be regarded as unethical should doctors comply with it. However, the prescription of such drugs would not be unlawful if Semenya gave informed consent to taking them. Such consent would not be a defence to a disciplinary hearing on unprofessional conduct, but would be a good defence to any legal action arising from unpleasant side-effects - provided they were explained to her.

Labial salivary gland biopsy in Sjögren's disease.

A labial biopsy technique is described and was used to study 40 patients with connective tissue disease and 60 postmortem subjects. More than one focus of lymphocytes per 4 sq mm of minor salivary tissue was found to be a consistent finding in patients with Sjögren's disease. The labial biopsy is shown to be a further valuable investigative procedure in such patients.

Changes in the oral flora in Sjögren's syndrome.

The oral flora of 10 patients with Sjögren's syndrome was compared with that of 10 healthy control subjects. Significantly greater numbers of Candida albicans, Staphylococcus aureus, and coliform bacilli were present in the Sjögren's group. Possible reasons for these changes are discussed.

Oral mycoplasmas in Sjögren's syndrome.

Mycoplasmas were sought in the salivary secretions and minor salivary gland tissue of 26 patients with Sjögren's syndrome or the allied sicca complex. A mycoplasma (M. orale type 1) was recovered from the stimulated parotid saliva of only one case. Possible mechanisms of mycoplasmal cell damage in this and allied disorders are considered and some future lines of investigation are suggested.

Food antibodies in oral disease: a study of serum antibodies to food proteins in aphthous ulceration and other oral diseases.

We have investigated the incidence of antibodies to food antigens in patients with recurrent minor aphthous ulceration and in patients with other oral ulcerative diseases. The incidence of these antibodies was the same in both groups of patients and was significantly greater than the incidence in a control group of normal people. There was no evidence to support the hypothesis that aphthous ulceration is primarily due to hypersensitivity to food antigens. The factors which might contribute to the absorption of antigenic molecules from the mouth and to the increased immune response in patients with oral disease have been considered.

Mycoplasmas and recurrent oral ulceration.

A controlled cultural and serological investigation of mycoplasmas in recurrent oral ulceration was undertaken. No evidence for an aetiological relationship between oral mycoplasmas and this condition was obtained.Mycoplasmas, principally M. orale, were frequently recovered from the oral cavities of individuals with natural teeth, but rarely from edentulous subjects.

Attitudes towards, and utility of, an integrated medical-dental patient-held record in primary care.

BACKGROUND: The need for closer coordination between primary care medical and dental services has been recognized. AIM: To assess the attitudes of general medical practitioners (GMPs), general dental practitioners (GDPs), and patients to an integrated medical-dental patient-held record (integrated medical-dental PHR); to examine patients' use of these records, and the utility of the records for doctors and dentists. METHOD: A three-phase study was carried out: (1) postal survey of GMPs and GDPs; (2) randomized trial of patients, using postal questionnaires before and one year after the issue of integrated medical-dental PHRs to cases; (3) assessment by doctors and dentists of anonymized integrated medical-dental PHRs from this trial. The study was carried out in medical and dental practices in affluent and deprived areas in Greater Glasgow Health Board. Two hundred and thirteen GMPs, 183 GDPs, and 369 patients registered with GMPs and GDPs were surveyed. Eighteen GDPs and GMPs assessed the integrated medical-dental PHRs. RESULTS: Eighty per cent of dentists had contacted a doctor and 16% of doctors had contacted a dentist in the previous three months; 87% of dentists and 68% of doctors thought an integrated medical-dental PHR would be of some use. Twenty-one per cent of dentists and 85% of doctors had practice computers. Most patients wanted to be able to see and read their own records. Twenty-four per cent of patients said there were mistakes and 30% noticed omissions in the integrated medical-dental PHR issued. Experience of having an integrated medical-dental PHR made patients more positive towards the idea of having a patient-held record and being able to check the accuracy of records. Integrated medical-dental PHRs contained important information for half the GDPs and one-third of the GMPs. CONCLUSION: Both professionals and patients have reasonably positive attitudes towards the use of patient-held records. Among patients, the experience of having the integrated medical-dental PHR led to greater enthusiasm towards the idea. Dentists in particular would benefit from the transfer of information from doctors, but better methods are needed to ensure that patients take the integrated medical-dental PHR with them. Given the current lack of ability to easily produce an integrated medical-dental PHR, further examination of the routine issue of a copy of their medical summary, by GMPs, to all patients would be worthwhile.

Lingual nerve damage following lower third molar surgery.

A prospective study was carried out on the effects of surgical, operator, and anatomical variables on the incidence and duration of lingual dysaesthesia after the surgical removal of impacted lower third molars under general anaesthesia. The predictive value of the area of sensory loss in relation to recovery was also studied. 120 instances of dysaesthesia occurred following 1040 operations in 602 patients, an overall incidence of 11.5%. The effects of 22 possible causative factors, analysed initially by the X2 test, are recorded. Since factors may not be independent, the results were then subjected to logit analysis, revealing highly significant effects from depth of impaction, removal of overhanging distal bone, lingual flap elevation, and operating time. Neither individual operators nor operator seniority had significant effects on the incidence. 6 cases of dysaesthesia failed to recover within 6 months. Where the area of sensory loss was incomplete, recovery occurred within 6 months in all cases.

Exercise-induced pulmonary haemorrhage in the horse: results of a detailed clinical, post mortem and imaging study. III. Subgross findings in lungs subjected to latex perfusions of the bronchial and pulmonary arteries.

Latex was injected under pressure into bronchial and pulmonary arteries of the inflated lungs of Thoroughbreds and transverse sections taken to calculate the area of lesions resulting from exercise-induced pulmonary haemorrhage. Extensive areas of dense brown haemosiderin varying from 0 to 45 per cent of total lung volume were identified, predominantly in the dorsocaudal lungfields. Bronchial arterial proliferation appeared to have replaced the pulmonary supply in affected areas of the lung. Closely associated with the staining and bronchial arterialisation, there was widespread small airway disease. The most severely affected bronchioles contained thick gelatinous or mucous exudate or mucoid plugs and had grossly thickened walls. These lesions suggest that the source of haemorrhage in exercise-induced pulmonary haemorrhage is from alveolar capillaries anomalously supplied by the bronchial arterial circulation through the development of pathological shunts. Small airway disease is suggested as being of major importance in the pathogenesis of the disease and may have led to the initial proliferation of the bronchial circulation.

Mike Grace talks to the President of the General Dental Council, Sir David Mason.

Dentistry, as with all things, moves in the direction of the thinking of those people within it, whether they are members of the dental team working within their surgeries, various colleagues in practice and on the many dental committees, teachers involved with undergraduates, people in the dental industry and trade, technicians in laboratories or leaders of the many organisations. This column will explore the thoughts and attitudes of many of these people--both those in the public limelight and those as yet unknown. To celebrate the launch of 'Interview with the Editor' who better to feature than the President of the General Dental Council, Sir David Mason. In this interview he shares his own thoughts and hopes for the future, thoughts that will influence the lives of most of the profession.

General dental practice--challenges and opportunities: a personal view.

This second paper in the Future of Dentistry series considers the implications for general dental practice of trends in health care nationally and internationally. Its main objective is to increase awareness of the major changes occurring in primary care which provide the dental profession with new challenges and opportunities. It is important that the dental profession is given its proper place in the changing scene and that general dental practice is not isolated from new developments in primary health care.

The changing role of the dentist.

This paper considers some of the specific factors which have changed the role of the dentist in a historical context. The impact of post-war developments on postgraduate education, the Nuffield Inquiry of 1980 and the Dental Strategy Review Group are examined. The broader scope of the dentist and dental auxiliaries in general dental practice in the light of changes in disease patterns is described. The benefits to patient care of involving the general dental practitioner and the dental team in primary care services are emphasised. There is a need to educate and train all health care professionals together to promote multidisciplinary teamwork in clinical practice. Change is inevitable but is to be welcomed more than feared.

William and John Hunter.

This article describes some of the contributions which the brothers William and John Hunter made to medical and dental science. John is revered in London and William in Glasgow. Both had an important influence on dentistry and its development as an academic subject.

Contributions of William Hunter (1718-1783) to dental science.

This article briefly describes some of the many and varied contributions which William Hunter made to medical and dental science in the eighteenth century. His work provided the foundations from which anatomy became one of the cornerstones of modern medicine. Hunter's teaching methods are still influential today and his specimen collection is one of the most comprehensive in existence.

Integration of primary care dental and medical services: a pilot investigation.

During the past decade the development of primary care medical services has been based on the medico-social model of health care delivery and this has resulted in the creation of the primary care team. These changes have so far not involved the general dental services. It was therefore decided to test the potential for coordination and integration of general dental practice in the primary care services. This started by examining a general medical and a general dental practice, occupying the same site, but functioning separately. Around 24% of patients were common to both practices. The initial data collected from a pilot study have been analysed and assessed in relation to patient attendance, record systems, staff cooperation, screening programmes, health promotion, patient referrals and staff education. The potential of this model for improving patient care and targeting the pre-school, middle-aged and elderly is described. It is concluded that coordinated primary care dental and medical services is an important area for further health services and educational research.

Integration of primary care dental and medical services: a three-year study.

OBJECTIVE: To develop and evaluate a model of integrated primary dental and medical care. DESIGN: 3-year prospective study. SETTING: A general dental practice and a general medical practice occupying the same building in Glasgow. INTERVENTION: Regular staff meetings, joint use of patient records systems and information derived from patient questionnaires. Dentistry was included in established screening programmes such as child health surveillance and care of elderly. Staff were encouraged to participate in joint work practices and joint consultations were carried out. MAIN OUTCOME MEASURES: Patient registration, avoidance of discrepancies in information, reduction of secondary referrals, joint work practices. RESULTS: The number of registered joint patients attending both medical and dental practices increased by 90%. The joint use of patient record systems avoided discrepancies in patient information which would have affected the quality of patient care. Including dentistry in child health surveillance and care of elderly screening programmes resulted in an increase in 0-5 year olds registering with dentists from 36% to 68% (P < 0.001) and with > 75 year olds from 47% to 71% (P < 0.001). Joint consultations reduced the need for secondary referrals. CONCLUSIONS: This model of health care demonstrated the potential for coordination and integration of functions between the dental team and the primary care team. Integrated primary dental and medical care requires attitudinal change in health care professionals and requires greater emphasis in education and training of health care professionals in the future.

Temporal headaches and associated symptoms relating to the styloid process and its attachments.

The styloid process is a slender spike-like bony process that is attached to the base of the skull that has been of interest to physicians for centuries. From this process is the attachment for five structures--three muscles and two ligaments are attached to it. Any of these soft tissues of the styloid process are prone to be torn due to trauma by way of detachment of the periosteum from the bone. These lesions may occur from auto accidents, falls, sports injuries, to prolonged medical or dental procedures requiring excessive mouth opening. The detachment of Sharpey's fibres results in the release of noxious chemicals such as kinins, histamines, prostaglandins, etc, which can produce a withdrawal reflex, causing muscle tension, ischaemia, spasm and pain. Pain transmission via C fibres may induce a host of autonomic responses as well. We have observed 11 common pains and symptoms that are associated with soft tissue lesions of the styloid process and stylomandibular ligament. They are (1) headaches localised in the anterior temporal fossa, (2) sore throat and difficulty swallowing in the absence of inflammation, (3) pain radiating to the temporomandibular joint and ear, (4) voice alteration, (5) dry, non-productive cough, (6) pain in the masseter muscle, (7) restricted mandibular opening or the "closed lock", (8) development of the "open lock", (9) sinusitis, congested stuffy nose or post nasal drip, (10) tinnitus, and (11) excessive lacrimation and bloodshot eyes. A few drops of local anesthetic into the styloid process and stylomandibular ligament attachment can temporarily relieve the pain and symptoms.(ABSTRACT TRUNCATED AT 250 WORDS)

Symptoms from impacted wisdom teeth.

A study of patients referred for wisdom teeth removal was carried out, to investigate symptoms prior to consultation and during the period on the waiting list for surgery. The reasons for treatment of asymptomatic wisdom teeth were investigated. Pain was the main indication for surgery in 73.7% of patients waiting for consultation. 168 patients waiting for consultation consumed a total of 271 courses of antibiotics, averaging 1.6 courses of antibiotics per patient. The antibiotic consumption increased to an average of 2.5 courses per patient in 94 patients waiting for operation. 67 out of 423 patients had an average of three lost working days due to symptoms from wisdom teeth. The long waiting list for consultation and treatment added further to the discomfort. The extent of symptoms from wisdom teeth may be underestimated.

Dental and facial injuries following sports accidents: a study of 130 patients.

Details of injuries to the face and teeth have been collected over a five-year period. One hundred and thirty patients were seen with injuries resulting from 21 different sports. Estimates of the numbers of people playing various team sports in the Bradford area suggest that the incidence of facial injuries is most common in rugby, followed by soccer and cricket. Miniature motor cycling and horse-riding are the most dangerous individual sports. The ages of injured patients varied widely in different sports, but the severity of injuries sustained is less than those due to other causes.