Modelling the cost effectiveness of interferon beta and glatiramer acetate in the management of multiple sclerosis

ObjectiveTo evaluate the cost effectiveness of four disease modifying treatments (interferon betas and glatiramer acetate) for relapsing remitting and secondary progressive multiple sclerosis in the United Kingdom.DesignModelling cost effectiveness.SettingUK NHS.ParticipantsPatients with relapsing remitting multiple sclerosis and secondary progressive multiple sclerosis.ResultsThe base case cost per quality adjusted life year gained by using any of the four treatments ranged from £42 000 ($66 469; €61 630) to £98 000 based on efficacy information in the public domain. Uncertainty analysis suggests that the probability of any of these treatments having a cost effectiveness better than £20 000 at 20 years is below 20%. The key determinants of cost effectiveness were the time horizon, the progression of patients after stopping treatment, differential discount rates, and the price of the treatments.ConclusionsCost effectiveness varied markedly between the interventions. Uncertainty around point estimates was substantial. This uncertainty could be reduced by conducting research on the true magnitude of the effect of these drugs, the progression of patients after stopping treatment, the costs of care, and the quality of life of the patients. Price was the key modifiable determinant of the cost effectiveness of these treatments.

What is already known on this topic

Interferon beta and glatiramer acetate are the only disease modifying therapies used to treat multiple sclerosisEconomic evaluations of these drugs have had flaws in the specification of the course of the disease, efficacy, duration of treatment, mortality, and the analysis of uncertaintyNone of the existing estimates of cost effectiveness can be viewed as robust

What this study adds

The cost per quality adjusted life year gained is unlikely to be less than £40 000 for interferon beta or glatiramer acetateExperience after stopping treatment is a key determinant of the cost effectiveness of these therapiesKey factors affecting point estimates of cost effectiveness are the cost of interferon beta and glatiramer acetate, the effect of these therapies on disease progression, and the time horizon evaluated     

Concomitant medications and possible side effects of antimuscarinic agents

Antimuscarinic agents are the treatment of choice for overactive bladder syndrome; clinical experience and the literature support their efficacy, tolerability, and safety. The most common side effects experienced include dry mouth and constipation. Many commonly prescribed drugs have anticholinergic effects that could increase the anticholinergic "load" or "burden" in patients with overactive bladder, potentially increasing the frequency and severity of side effects. In addition, the adverse events associated with antimuscarinics may be more pronounced in the elderly, especially those taking multiple medications. Knowledge regarding the potential side effects associated with antimuscarinics is important so that patients can be advised and effectively treated.     

Oral mucolytic drugs for exacerbations of chronic obstructive pulmonary disease: systematic review

ObjectiveTo assess the effects of oral mucolytics in adults with stable chronic bronchitis and chronic obstructive pulmonary disease.DesignSystematic review of randomised controlled trials that compared at least two months of regular oral mucolytic drugs with placebo.StudiesTwenty three randomised controlled trials in outpatients in Europe and United States.ResultsCompared with placebo, the number of exacerbations was significantly reduced in subjects taking oral mucolytics (weighted mean difference −0.07 per month, 95% confidence interval −0.08 to −0.05, P<0.0001). Based on the annualised rate of exacerbations in the control subjects of 2.7 a year, this is a 29% reduction. The number needed to treat for one subject to have no exacerbation in the study period would be 6. Days of illness also fell (weighted mean difference −0.56, −0.77 to −0.35, P<0.0001). The number of subjects who had no exacerbations in the study period was greater in the mucolytic group (odds ratio 2.22, 95% confidence interval 1.93 to 2.54, P<0.0001). There was no difference in lung function or in adverse events reported between treatments.ConclusionsIn chronic bronchitis and chronic obstructive pulmonary disease, treatment with mucolytics is associated with a reduction in acute exacerbations and days of illness. As these drugs have to be taken long term, they could be most useful in patients who have repeated, prolonged, or severe exacerbations of chronic obstructive pulmonary disease.

What is already know on this topic

Mucolytic drugs have properties that may be beneficial in chronic obstructive pulmonary diseaseThese drugs are not prescribed in the United Kingdom and Australasia, although they are widely used in many other countriesDrugs that reduce exacerbations may reduce the morbidity and healthcare costs associated with progressively severe disease

What this study adds

Regular use of mucolytic drugs for at least two months significantly reduces exacerbations and days of illness compared with placebo in patients with chronic bronchitis and chronic obstructive pulmonary diseaseExacerbations that do occur may not be as severe, and the benefit may be greater in those with more severe diseaseReductions are modest and treatment may not be cost effective     

Efficacy of progesterone and progestogens in management of premenstrual syndrome: systematic review

ObjectiveTo evaluate the efficacy of progesterone and progestogens in the management of premenstrual syndrome.DesignSystematic review of published randomised, placebo controlled trials.ResultsOverall standardised mean difference for all trials that assessed efficacy of progesterone (by both routes of administration) was −0.028 (95% confidence interval −0.017 to −0.040). The odds ratio was 1.05 (1.03 to 1.08) in favour of progesterone, indicating no clinically important difference between progesterone and placebo. For progestogens the overall standardised mean was −0.036 (−0.014 to −0.060), which corresponds to an odds ratio of 1.07 (1.03 to 1.11) showing a statistically, but not clinically, significant improvement for women taking progestogens.ConclusionThe evidence from these meta-analyses does not support the use of progesterone or progestogens in the management of premenstrual syndrome.

What is already known on this topic

The premenstrual syndrome affects about 1.5 million women in the United KingdomThere are numerous treatment options, progesterone being one of the most strongly advocatedProgesterone and progestogens are among the most widely prescribed treatments for premenstrual syndrome in the United Kingdom and the United States

What this study adds

There is no evidence to support the claimed efficacy of progesterone in the management of premenstrual syndromeThere is insufficient evidence to make a definitive statement about progestogens, but current evidence suggests that they are not likely to be effective     

Informing participants of allocation to placebo at trial closure: postal survey

ObjectivesTo assess whether and how investigators of placebo controlled randomised trials inform participants of their treatment allocation at trial closure and to assess barriers to feedback.DesignPostal survey with a semistructured questionnaire.ParticipantsAll investigators who published a placebo controlled randomised trial in 2000 in five leading medical journals, and a random sample of 120 trials listed in the national research register database.Results45% of investigators informed either all or most participants of their treatment allocation, and 55% did not inform any participant or only informed those who asked. The main reasons for not informing participants were that the investigators never considered this option (40%) or to avoid biasing results at study follow up (24%).ConclusionFurther research is required to examine sensitive ways to communicate treatment information to trial participants.

What is already known on this topic

Information is poor on the nature, extent, and effect of informing participants of placebo controlled randomised trials about their treatment allocation at trial closureLess than 50% of participants receiving placebo are informed about their treatment allocation

What this study adds

No standard procedure is available for informing patients of their treatment arm or of study results at the end of a trialEffective and sensitive ways of communicating treatment allocation to participants are required, as is information on the effects on placebo responders     

Vitamin E supplementation and macular degeneration: randomised controlled trial

ObjectiveTo determine whether vitamin E supplementation influences the incidence or rate of progression of age related maculopathy (AMD).DesignProspective randomised placebo controlled clinical trial.SettingAn urban study centre in a residential area supervised by university research staff.Participants1193 healthy volunteers aged between 55 and 80 years; 73% completed the trial on full protocol.InterventionsVitamin E 500 IU or placebo daily for four years.ResultsThe incidence of early age related macular degeneration (early AMD 3) was 8.6% in those receiving vitamin E versus 8.1% in those on placebo (relative risk 1.05, 95% confidence interval 0.69 to 1.61). For late disease the incidence was 0.8% versus 0.6% (1.36, 0.67 to 2.77). Further analysis showed no consistent differences in secondary outcomes.ConclusionDaily supplement with vitamin E supplement does not prevent the development or progression of early or later stages of age related macular degeneration.

What is already known on this topic

Age related macular degeneration is the leading cause of loss of vision and blindness in elderly people; for people aged ⩾90 years, two out of every three will be affected and one in four will become blindCurrently, there are no methods of prevention or treatment in most cases, though a third of cases are due to cigarette smokingAntioxidant vitamins have been suggested as a possible prevention

What this study adds

Daily supplementation with 500 mg vitamin E for four years did not alter the incidence or progression of AMD     

臭氧水膀胱腔内灌注治疗女性膀胱过度活动症疗效评价*

目的:评价臭氧水膀胱腔内灌注疗法对膀胱过度活动症的有效性和安全性。方法:2016年1月至2016年12月间共60例患者入组,所有患者均行尿流动力学检查证实膀胱逼尿肌不稳定。患者被随机分入治疗组(n=30)和对照组(n=30),对照组采用行为训练疗法并口服索利那新治疗。治疗组在行为训练疗法于口服索利那新的基础上,同时行臭氧水膀胱腔内灌注治疗。在治疗结束时通过患者病情改善情况评价疗效,主要评价指标包括:治疗前、后的患者24h排尿次数、平均夜尿次数、24h尿失禁次数、OABSS评分、I-QOL评分、治疗前和治疗结束末4周复查尿流动力学检查评估,并评估患者的不良反应。获得的数据采用t检验进行统计学分析。结果:结果证实,在24h排尿次数、平均夜尿次数、OABSS评分和I-QOL评分方面,各组治疗后有改善,而臭氧治疗组改善情况优于对照组(P0.05)。尿流动力学检查证实所有治疗后患者逼尿肌不稳定情况均有改善;初始尿意时膀胱容量、最大膀胱容量、储尿期膀胱逼尿肌最大压力变化情况治疗组改善优于对照组。不良反应由患者自主报告,治疗组主要表现为灌注后尿道内及下腹部不适感,多自主恢复,两组间差异不明显(P0.05)。结论:臭氧水膀胱腔内灌注治疗女性膀胱过度活动症安全、有效,能改善膀胱过度活动症患者排尿次数、夜尿次数和24小时尿失禁次数,能改善OABSS评分,能改善尿流动力学结果,提高患者的生活质量。     

Prescribing new drugs: qualitative study of influences on consultants and general practitioners

ObjectiveTo explore consultants'' and general practitioners'' perceptions of the factors that influence their decisions to introduce new drugs into their clinical practice.DesignQualitative study using semistructured interviews. Monitoring of hospital and general practice prescribing data for eight new drugs.SettingTeaching hospital and nearby general hospital plus general practices in Birmingham.Participants38 consultants and 56 general practitioners who regularly referred to the teaching hospital.ResultsConsultants usually prescribed new drugs only in their specialty, used few new drugs, and used scientific evidence to inform their decisions. General practitioners generally prescribed more new drugs and for a wider range of conditions, but their approach varied considerably both between general practitioners and between drugs for the same general practitioner. Drug company representatives were an important source of information for general practitioners. Prescribing data were consistent with statements made by respondents.ConclusionsThe factors influencing the introduction of new drugs, particularly in primary care, are more multiple and complex than suggested by early theories of drug innovation. Early experience of using a new drug seems to strongly influence future use.

What is already known on this topic

UK studies show that use of new drugs by general practitioners is influenced by consultants, the nature of the drug, and perceived risk

What this study adds

Consultants generally introduced fewer drugs than general practitioners, usually within their specialtyDecisions were said to be based mainly on the evidence from the scientific literature and meetingsGeneral practitioners prescribed more new drugs and the basis of decisions was more variedDoctors'' interpretations of using a new drug were not consistent     

Relation between insufficient response to antihypertensive treatment and poor compliance with treatment: a prospective case-control study

ObjectivesTo prospectively compare compliance with treatment in patients with hypertension responsive to treatment versus patients with treatment resistant hypertension.DesignProspective case-control study.SettingOutpatient department in a large city hospital in Switzerland, providing primary, secondary, and tertiary care.Participants110 consecutive medical outpatients with hypertension and taking stable treatment with at least two antihypertensive drugs for at least four weeks.ResultsComplete data were available for 103 patients, of whom 86 took ⩾80% of their prescribed doses (“compliant”) and 17 took <80% (“non-compliant”). Of the 49 patients with treatment resistant hypertension, 40 (82%) were compliant, while 46 (85%) of the 54 patients responsive to treatment were compliant.ConclusionNon-compliance with treatment was not more prevalent in patients with treatment resistant hypertension than in treatment responsive patients.

What is already known on this topic

For many patients with arterial hypertension, blood pressure cannot be adequately controlled despite treatment with antihypertensive drugsPatients'' poor compliance with treatment is often suggested as the reason for lack of response to antihypertensive drugs

What this study adds

When treatment compliance was monitored in hypertensive patients following stable treatment regimens, no difference in compliance was found between those with treatment resistant hypertension and those responsive to treatmentFactors other than patients'' compliance with treatment regimens should be examined to explain lack of response to antihypertensive drugs     

Predictors of normotension on withdrawal of antihypertensive drugs in elderly patients: prospective study in second Australian national blood pressure study cohort

ObjectivesTo identify simple long term predictors of maintenance of normotension after withdrawal of antihypertensive drugs in elderly patients in general practice.DesignProspective cohort study.Setting169 general practices in Victoria, Australia.Participants503 patients aged 65-84 with treated hypertension who were withdrawn from all antihypertensive drugs and remained drug free and normotensive for an initial two week period; all were followed for a further 12 months.ResultsThe likelihood of remaining normotensive at 12 months was greater among younger patients (65-74 years), patients with lower “on-treatment” systolic blood pressure, patients on single agent treatment, and patients with a greater waist:hip ratio. The likelihood of return to hypertension was greatest for patients with higher “on-treatment” systolic blood pressure.ConclusionsAge, blood pressure control, and the number of antihypertensive drugs are important factors in the clinical decision to withdraw drug treatment. Because of consistent rates of return to antihypertensive treatment, all patients from whom such treatment is withdrawn should be monitored indefinitely to detect a recurrence of hypertension.

What is already known on this topic

Systematic reviews have identified predictors of success of withdrawal of antihypertensive medicationThe reviewed studies have mainly been in a hospital or specialist clinic setting, and their recommendations may not be practical in general practice

What this paper adds

This study has identified simple predictors of success that are readily available to general practitionersOn-treatment systolic blood pressure, the number of blood pressure lowering drugs, and the age of the patient are reliable indicators of who may successfully stop taking their drugsGeneral practitioner practitioners should not be dissuaded from offering drug withdrawal to patients with greater waist:hip ratios     

Meta-analysis of effects and side effects of low dosage tricyclic antidepressants in depression: systematic review

ObjectiveTo compare the effects and side effects of low dosage tricyclic antidepressants with placebo and with standard dosage tricyclics in acute phase treatment of depression.DesignSystematic review of randomised trials comparing low dosage tricyclics (⩽100 mg/day) with placebo or with standard dosage tricyclics in adults with depression.Results35 studies (2013 participants) compared low dosage tricyclics with placebo, and six studies (551 participants) compared low dosage tricyclics with standard dosage tricyclics. Low dosage tricyclics, mostly between 75 and 100 mg/day, were 1.65 (95% confidence interval 1.36 to 2.0) and 1.47 (1.12 to 1.94) times more likely than placebo to bring about response at 4 weeks and 6-8 weeks, respectively. Standard dosage tricyclics failed, however, to bring about more response but produced more dropouts due to side effects than low dosage tricyclics.ConclusionsTreatment of depression in adults with low dose tricyclics is justified. However, more rigorous studies are needed to definitively establish the relative benefits and harms of various dosages.

What is already known on this topic

Tricyclics are still prescribed as often as selective serotonin reuptake inhibitors and other newer antidepressants worldwideExperts have often claimed that clinicians prescribe tricyclics at less than adequate dosages

What this study adds

Tricyclics at dosages below the recommended range are more effective than placeboThey may or may not be as effective as standard dosage tricyclics but result in fewer dropouts due to side effectsThe minimum effective dosage and ranges for antidepressants has not been established—a simple set of numbers that every practising doctor and patient would want to know     

The Norwegian naturalistic treatment study of depression in general practice (NORDEP)-I: randomised double blind study

ObjectiveTo evaluate the efficacy of emotional support and counselling combined with placebo or antidepressants with single or dual mechanism of action in the treatment of depression in primary care.DesignRandomised double blind study.SettingSeveral locations in Norway.Subjects372 patients with depression.Results Intention to treat analyses showed 47% remission in patients randomised to placebo compared with 61% remission in patients randomised to sertraline (odds ratio 0.56, 95% confidence interval 0.33 to 0.96) and 54% in patients randomised to mianserin (0.75, 0.44 to 1.27). Women responded better than men (1.86, 1.17 to 2.96). Subgroup analyses showed that subjects with recurrent depression (n=273) responded more frequently to sertraline than to placebo (0.43, 0.23 to 0.82) than those having their first episode of depression (1.18, 0.39 to 3.61). Statistically significant interactions between type of drug treatment and history of depression were not shown by logistic regression.Conclusion The combination of active drug and simple psychological treatment (counselling, emotional support, and close follow up over a 24 week period) was more effective than simple psychological treatment alone, in particular for those with recurrent depression. Overall, women may benefit more than men. If confirmed in future studies, the findings should lead to more differentiated treatment guidelines for depression in primary care.

Key messages

• The effectiveness of simple psychological treatment and active drug provided by general practitioners is comparable to treatment results reported by psychiatrists and clinical psychologists
• Treatment benefits women more than men
• There may be differences in response to treatment depending on the nature of depression
• A 6 month treatment period is necessary to evaluate effectiveness of treatments for depression in general practice
• The development of more differentiated treatment guidelines for depression in primary care is needed

     

Efficacy of cinnamon patch treatment for alleviating symptoms of overactive bladder: A double-blind,randomized, placebo-controlled trial

BackgroundCurrent treatments for overactive bladder (OAB) have limited efficacy, low persistence and a high rate of adverse events commonly leading to treatment cessation in clinical practice. Clinicians in Asia commonly use traditional Chinese medicine as an alternative for OAB treatment despite it having uncertain efficacy and safety. To evaluate the efficacy and safety of cinnamon patch (CP) treatment for alleviating symptoms of OAB, a double-blind randomized, placebo-controlled trial was conducted in the present study.Materials and MethodsIn this 6-week randomized clinical trial conducted in an outpatient setting, 66 subjects diagnosed as having OAB were enrolled and treated with a placebo (n=33) or CP (n=33). The OAB symptom score (OABSS) was selected as the primary end point, and a patient perception of bladder condition (PPBC), an urgency severity scale (USS), and post-voiding residual urine (PVR) volume were selected as secondary end points. Statistical analyses were performed with IBM SPSS Statistics 20. Groups were compared using an independent sample t-test, Fisher exact test, and Chi-squared test.ResultsIn total, 66 participants (40 women and 26 men), 60.35 ± 12.77 years of age, were included in the intention-to-treat analyses. Baseline characteristics were comparable between the CP (n ==33) and placebo (n ==33) groups. Treatment with a CP showed statistically significant differences in reductions in OABSS scores (9.70 ± 2.20 to 6.33 ± 2.42), PPBC scores (3.36 ± 0.60 to 2.15 ± 0.83), and USS scores (2.67 ± 0.54 to 1.64 ± 0.60).ConclusionsCompared to a placebo, treatment with CP might be considered an effective and safe complementary therapy for OAB. Further studies employing a positive control, different dosage forms, larger sample sizes, and longer treatment periods are warranted.     

Bezafibrate in men with lower extremity arterial disease: randomised controlled trial

ObjectiveTo assess the effect of bezafibrate on the risk of coronary heart disease and stroke in men with lower extremity arterial disease.DesignDouble blind placebo controlled randomised trial.Setting85 general practices and nine hospital vascular clinics.Participants1568 men, mean age 68.2 years (range 35 to 92) at recruitment.InterventionsBezafibrate 400 mg daily (783 men) or placebo (785 men).ResultsBezafibrate did not reduce the incidence of coronary heart disease and stroke. There were 150 and 160 events in the active and placebo groups respectively (relative risk 0.96, 95% confidence interval 0.76 to 1.21). There were 90 and 111 major coronary events in the active and placebo groups respectively (0.81, 0.60 to 1.08), of which 64 and 65 were fatal (0.95, 0.66 to 1.37) and 26 and 46 non-fatal (0.60, 0.36 to 0.99). Beneficial effects on non-fatal events were greatest in men aged <65 years at entry, in whom benefit was also seen for all coronary events (0.38, 0.20 to 0.72). There were no significant effects in older men. There were 60 strokes in those on active treatment and 49 in those on placebo (1.34, 0.80 to 2.01). There were 204 and 195 deaths from all causes in the two groups respectively (1.03, 0.83 to 1.26). Bezafibrate reduced the severity of intermittent claudication for up to three years.ConclusionsBezafibrate has no effect on the incidence of coronary heart disease and of stroke combined but may reduce the incidence of non-fatal coronary events, particularly in those aged <65 years at entry, in whom all coronary events may also be reduced.

What is already known on this topic

The beneficial effects of bezafibrate on blood lipids and fibrinogen concentrations should reduce the incidence of heart attacks and strokesSo far, however, there is only limited evidence on clinical outcomes from randomised controlled trials

What this study adds

Treatment with bezafibrate was not associated with a reduction in the combined incidence of heart attacks and strokes, though there were substantially fewer non-fatal heart attacks in those taking bezafibrateBezafibrate was associated with a reduction in the incidence of all heart attacks, especially non-fatal, in men aged <65 yearsBezafibrate seems to reduce the severity of intermittent claudication for two or three years     

Cross sectional survey of effectiveness of lipid lowering drugs in reducing serum cholesterol concentration in patients in 17 general practices

ObjectiveTo compare the effectiveness of lipid lowering drugs in lowering serum cholesterol concentrations.DesignCross sectional study.Setting17 practices within 17 primary care groups in Trent region, United Kingdom.ParticipantsPatients aged 35 years or over taking lipid lowering drugs and with at least two serum cholesterol concentrations recorded on computer.Results1353 of 2469 (54.8%) patients receiving lipid lowering treatment had a last recorded serum cholesterol concentration of ⩽5 mmol/l. Significantly more patients taking statins achieved the target value for serum cholesterol (5 mmol/l) than those taking fibrates (1307 (57%) v 46 (26%); P<0.0001). Atorvastatin and simvastatin were the most effective drugs in achieving the target. Significant differences were found between lipid lowering drugs for the pretreatment serum cholesterol concentration, the most recent cholesterol concentration, and the associated percentage reduction. Atorvastatin and simvastatin achieved the greatest percentage reduction in serum cholesterol concentrations (30.1%, 95% confidence interval 28.8% to 31.4%, and 28.0%, 26.7% to 29.3%, respectively). Although the mean serum cholesterol concentrations in this unselected population tended to be higher than those in clinical trials, the percentage reduction was consistent with the trials.ConclusionThe ability of individual statins to lower serum cholesterol concentration varied, with atorvastatin and simvastatin being the most effective. The percentage reductions agreed with those of randomised controlled trials indicating likely benefits in unselected patients in primary care. As the initial serum cholesterol concentrations were higher than those in randomised controlled trials, target serum cholesterol values of ⩽5 mmol/l may be unrealistic even for patients taking the most efficacious drugs. Also, the higher initial levels could mean that the absolute reduction in cardiovascular risk in primary care patients is greater than thought.

What is already known on this topic

Statins in patients with coronary heart disease help reduce further cardiovascular events and improve survivalThis seems to be a class effect of statins, although there may be important differences in effectiveness between themLess than half of patients in the community who take lipid lowering drugs achieve target serum cholesterol values

What this study adds

Statins vary in their ability to lower serum cholesterol concentration, with atorvastatin and simvastatin achieving the best resultsThe percentage reductions agreed with those found in randomised controlled trialsSince the initial serum cholesterol concentrations were higher than in trials, absolute risk reductions in primary care patients may be greater than thoughtTarget values of ⩽5 mmol/l may be unrealistic even for patients on the most efficacious drugs, because the initial mean cholesterol values of primary care patients are higher than those of patients in trials     

Is voice therapy an effective treatment for dysphonia? A randomised controlled trial

ObjectivesTo assess the overall efficacy of voice therapy for dysphonia.Design Single blind randomised controlled trial.Setting Outpatient clinic in a teaching hospital.Participants204 outpatients aged 17-87 with a primary symptom of persistent hoarseness for at least two months.Interventions After baseline assessments, patients were randomised to six weeks of either voice therapy or no treatment. Assessments were repeated at six weeks on the 145 (71%) patients who continued to this stage and at 12-14 weeks on the 133 (65%) patients who completed the study. The assessments at the three time points for the 70 patients who completed treatment and the 63 patients in the group given no treatment were compared.ResultsVoice therapy improved voice quality as assessed by rating by patients (P=0.001) and rating by observer (P<0.001). The treatment effects for these two outcomes were 4.1 (95% confidence interval 1.7 to 6.6) points and 0.82 (0.50 to 1.13) points. Amplitude perturbation showed improvement at six weeks (P=0.005) but not on completion of the study. Patients with dysphonia had appreciable psychological distress and lower quality of life than controls, but voice therapy had no significant impact on either of these variables.ConclusionVoice therapy is effective in improving voice quality as assessed by self rated and observer rated methods.

What is already known on this topic

Many patients with dysphonia are treated by voice therapyThe effectiveness of voice therapy in a diverse group of patients is unknown

What this study adds

Voice therapy is an effective treatment for dysphonia in terms of report by patients and perceptual ratings by an expertPsychological distress and reduction in general health status are common in patients with dysphonia but are not significantly affected by a course of voice therapy     

Randomised study of long term outcome after epidural versus non-epidural analgesia during labour

ObjectiveTo determine whether epidural analgesia during labour is associated with long term backache.DesignFollow up after randomised controlled trial. Analysis by intention to treat.SettingDepartment of obstetrics and gynaecology at one NHS trust.Participants369 women: 184 randomised to epidural group (treatment as allocated received by 123) and 185 randomised to non-epidural group (treatment as allocated received by 133). In the follow up study 151 women were from the epidural group and 155 from the non-epidural group.ResultsThere were no significant differences between groups in demographic details or other key characteristics. The mean time interval from delivery to interview was 26 months. There were no significant differences in the onset or duration of low back pain, with nearly a third of women in each group reporting pain in the week before interview. There were no differences in self reported measures of disability in activities of daily living and no significant differences in measurements of spinal mobility.ConclusionsAfter childbirth there are no differences in the incidence of long term low back pain, disability, or movement restriction between women who receive epidural pain relief and women who receive other forms of pain relief.

What is already known on this topic

Previous research has suggested an association between epidural analgesia during labour and low back painIt is not known whether this association is causal

What this study adds

This long term follow up study found no evidence of a causal link between epidural analgesia during labour and low back pain