Little evidence ADHD drugs improve lives
A COCHRANE review of 185 randomised controlled trials comparing methylphenidate with placebo or no intervention for children and adolescents with attention deficit hyperactivity disorder (ADHD) has found that the quality of the available evidence does not clearly show that taking the drug improves lives. The researchers found that methylphenidate might reduce teacher-reported ADHD symptoms, improve teacher-reported general behaviour, and improve parent-reported quality of life among children and adolescents diagnosed with ADHD, but “the low quality of the underpinning evidence means that we cannot be certain of the magnitude of the effects”. They also found a high risk of bias for all trials. The review included 12 245 participants, mostly aged 3‒18 years who were treated for an average of 75 days. Most trials had a follow-up period of less than 6 months. The review authors found some evidence that methylphenidate was associated with an increased risk of non-serious adverse events, such as sleep problems and decreased appetite, but no evidence of an increase in the risk of serious adverse events. They called for better designed trials to assess the benefits of methylphenidate, saying large, 'nocebo tablet' controlled trials would be best because of the low risk of serious adverse events. These use a placebo-like substance that causes adverse events in the control arm comparable to those associated with methylphenidate. “However, for ethical reasons, such trials should first be conducted with adults, who can give their informed consent”, they wrote. The findings “highlight the urgent need for large RCTs of non-pharmacological treatments”. A meta-analysis published last week in Pediatrics found that children taking stimulants for ADHD had worse sleep than those not taking medications.
Atlas shows extent of health care variation
The Australian Atlas of Healthcare Variation, which details the substantial variation in the provision of health care across Australia, was released last week. In a foreword to the report, Professor Villis Marshall, chair of the Australian Commission on Safety and Quality in Health Care, wrote that the atlas was “a powerful resource to inform efforts to identify and reduce unwarranted variation in health care, while also highlighting some population health concerns that warrant further investigation”. The commission collaborated with the Australian, state and territory governments, specialist medical colleges, clinicians and consumer representatives to develop the atlas, which examines six clinical areas covering prescribing, diagnostic, medical and surgical interventions. The atlas found the key priorities for investigation and action included the use of antimicrobials and psychotropic medicines; variation in rates of fibre optic colonoscopy, knee arthroscopy, hysterectomy and endometrial ablation; and inequitable access to cataract surgery. “Healthcare variation is important because it reflects the care patients receive – or do not receive”, the report said. “The suggested actions and recommendations are designed to improve equity and efficiency, as well as the safety and quality of health care.”
Safety, efficacy misperceptions undermine generics
ALL doctors should prescribe generic medications whenever possible, according to best practice advice from the Clinical Guidelines Committee of the American College of Physicians. The guidelines, published in the Annals of Internal Medicine, said research showed that patient and provider perceptions of safety and efficacy were the major obstacle to the use of generic medicines. The authors wrote that clinicians often prescribed more expensive brand-name drugs, even when equally effective, well proven generic therapies were available. The committee had conducted a literature review into how often brand-name drugs were used when generic versions were available, how the use of generics influenced adherence, whether brand-name drugs and generics had similar clinical effects, the barriers to increasing the use of generics, and strategies that could promote greater use of generics. They found that while there had been an increase in the use of generic drugs in the past decade, for patients with diabetes, 23%‒45% of prescriptions were brand-name drugs, depending on the class, even though identical generics were available. The authors found that combining generic substitution and therapeutic interchange for diabetes patients alone could save Medicare US$1.4 billion. They found that 25% of physicians preferred not to use generic drugs personally or prescribe them for family. “This may stem in part from a lack of awareness of the regulatory standards for approval of generic drugs, especially in the context of media reports of problems with the manufacturing of generics …”, the authors wrote. “Despite a long-established regulatory approval process for generic drugs, increasing their use will require the development of more robust data about their comparative safety and effectiveness relative to their brand-name counterparts.” The authors said greater use of generic drugs could improve long-term adherence to prescription medication, offering significant long-term savings.
Severe PMS linked to hypertension
WOMEN with moderate to severe premenstrual syndrome (PMS) have a 40% higher risk of developing hypertension over the following 20 years compared with women who experience few menstrual symptoms, according to a prospective observational study published in the American Journal of Epidemiology. The research, based on a substudy of the Nurses’ Health Study II, included 1257 women with clinically significant PMS and 2463 age-matched women with few menstrual symptoms who were all followed for incident hypertension over 6‒20 years. The observed higher risk of hypertension persisted in women with significant PMS even after adjustment for established risk factors such as body mass index, cigarette smoking, physical activity, alcohol consumption, postmenopausal hormone use, oral contraceptive use and a family history of hypertension. In women who had hypertension before 40 years of age, those with PMS had a threefold higher risk of developing hypertension than those without PMS symptoms. The researchers wrote that previous studies supported the existence of underlying differences in vascular physiology in women with PMS compared with symptom-free women. Another explanation was that the association between PMS and hypertension could be due to adverse effects of PMS medication on blood pressure. The researchers acknowledged limitations in their study, but said the observation warranted confirmation in future research.
No evidence progesterone therapy prevents miscarriage
PROGESTERONE therapy in the first trimester of pregnancy does not affect the rate of live births among women with a history of unexplained recurrent miscarriages, according to research published in the New England Journal of Medicine. The double-blind, randomised, placebo-controlled trial included 836 women aged 18‒39 years who had lost three or more pregnancies and were trying to conceive naturally. Women were randomly assigned to receive twice daily vaginal suppositories, with 404 women receiving 400mg of progesterone and 432 receiving placebo. Treatment started no later than at 6 weeks of gestation and finished at 12 weeks. There were no significant differences found in the rates of pregnancy at 6, 8 or 12 weeks, ectopic pregnancy, miscarriage, stillbirth, live birth or neonatal outcomes between the two groups. The researchers found no increase in the risk of congenital anomalies among offspring of women treated with progesterone, but said the study was not powered for such rare outcomes. “Nonetheless, this finding is reassuring because progesterone therapy is commonly used as part of assisted-conception treatment”, they wrote.
Dermatologic drug costs soar in US
PRICES of brand-name and generic dermatologic prescription drugs in the US have increased significantly in recent years, according to researchers who found the greatest increases were in the antineoplastic sector. The research, published in JAMA Dermatology, found the increases for multiple, frequently prescribed medications “greatly outpaced” inflation, national health expenditure growth and increases in reimbursements for physician services. They surveyed four national chain pharmacies requesting price data on commonly prescribed dermatologic drugs in 2009, 2011, 2014 and 2015. The final analysis was based on 19 brand-name drugs with data available in all four surveys, owing to the frequency of prescription, diseases treated or unusual price increases. The 19 drugs were grouped into treatment indication groups for acne and rosacea, psoriasis, topical corticosteroids, anti-infectives and antineoplastics. Between 2009 and 2015, prices of all surveyed classes of brand-name drugs increased, with a mean increase of 401%. Prices of topical antineoplastic drugs had the greatest mean absolute and percentage increase (1240%), while drugs in the anti-infective class had the smallest mean absolute increase, and psoriasis medications the smallest mean percentage increase (180%). The researchers noted that prescription drugs generally cost more in the US than anywhere else in the world. “Medicare legally cannot negotiate drug prices for beneficiaries, unlike government health programs in other countries such as France and Australia”, they wrote.