Randomised clinical trial of manipulative therapy and physiotherapy for persistent back and neck complaints: results of one year follow up.

OBJECTIVE--To compare the effectiveness of manipulative therapy, physiotherapy, treatment by the general practitioner, and placebo therapy in patients with persistent non-specific back and neck complaints. DESIGN--Randomised clinical trial. SETTING--Primary health care in the Netherlands. PATIENTS--256 patients with non-specific back and neck complaints of at least six weeks'' duration who had not received physiotherapy or manipulative therapy in the past two years. INTERVENTIONS--At the discretion of the manipulative therapists, physiotherapists, and general practitioners. Physiotherapy consisted of exercises, massage, and physical therapy (heat, electrotherapy, ultrasound, shortwave diathermy). Manipulative therapy consisted of manipulation and mobilisation of the spine. Treatment by general practitioners consisted of drugs (for example, analgesics), advice about posture, home exercises, and (bed)rest. Placebo treatment consisted of detuned shortwave diathermy (10 minutes) and detuned ultrasound (10 minutes). MAIN OUTCOME MEASURES--Changes in severity of the main complaint and limitation of physical functioning measured on 10 point scales by a blinded research assistant and global perceived effect measured on a 6 point scale by the patients. RESULTS--Many patients in the general practitioner and placebo groups received other treatment during follow up. Improvement in the main complaint was larger with manipulative therapy (4.5) than with physiotherapy (3.8) after 12 months'' follow up (difference 0.9; 95% confidence interval 0.1 to 1.7). Manipulative therapy also gave larger improvements in physical functioning (difference 0.6; -0.1 to 1.3). The global perceived effect after six and 12 months'' follow up was similar for both treatments. CONCLUSIONS--Manipulative therapy and physiotherapy are better than general practitioner and placebo treatment. Furthermore, manipulative therapy is slightly better than physiotherapy after 12 months.     

Early antibiotic treatment of reactive arthritis associated with enteric infections: clinical and serological study.

OBJECTIVE--To find out whether a 10-14 days'' course of antibiotics early in the course of reactive arthritis associated with enteric infections could reduce the severity and duration of the disease and whether the antibody response in patients with reactive arthritis associated with yersinia infection differed between those treated and those not treated with the antibiotics. DESIGN--Prospective multicentre trial in which patients were randomised to treatment or no treatment with antibiotics. Patients were seen at three and six weeks and three, six, nine, 12, and 18 months after their first visit. SETTING--Departments of infectious diseases in three hospitals in Linköping, Malmö, and Stockholm, Sweden. PATIENTS--40 Consecutive patients who had had symptoms of reactive arthritis associated with enteric infection for less than four weeks. INTERVENTIONS--20 Patients were allocated to treatment with antibiotics and 20 patients did not receive antibiotics. All patients received non-steroidal anti-inflammatory drugs, and four also received intra-articular steroid injections after at least six weeks'' observation. MAIN OUTCOME MEASURES--Arthritic symptoms assessed clinically and by using Ritchies'' index; blood measurements reflecting inflammatory activity; serum IgG, IgM, and IgA antibody titres; HLA tissue type. RESULTS--No difference was observed concerning duration of arthritis, grade of inflammation, and number of joints affected between patients treated and those not treated with antibiotics. Furthermore, there was no significant difference between the two groups in erythrocyte sedimentation rate and haptoglobin, IgG, and IgA concentrations. All values had returned to normal within three months. No patient developed chronic arthritis, but sustained slight arthralgia occurred in three patients. The HLA-B27 antigen was found in 23 (58%) of the patients, and its presence did not affect clinical outcome. The IgG, IgM, and IgA antibody responses were similar in patients treated with antibiotics and those not treated. CONCLUSION--Short term antibiotic treatment has no beneficial effect on the clinical outcome of reactive arthritis associated with enteric infection.     

Effectiveness of physiotherapy exercise after knee arthroplasty for osteoarthritis: systematic review and meta-analysis of randomised controlled trials

Objective To evaluate the effectiveness of physiotherapy exercise after elective primary total knee arthroplasty in patients with osteoarthritis.Design Systematic review.Data sources Database searches: AMED, CINAHL, Embase, King''s Fund, Medline, Cochrane library (Cochrane reviews, Cochrane central register of controlled trials, DARE), PEDro, Department of Health national research register. Hand searches: Physiotherapy, Physical Therapy, Journal of Bone and Joint Surgery (Britain) Conference Proceedings.Review methods Randomised controlled trials were reviewed if they included a physiotherapy exercise intervention compared with usual or standard physiotherapy care, or compared two types of exercise physiotherapy interventions meeting the review criteria, after discharge from hospital after elective primary total knee arthroplasty for osteoarthritis.Outcome measures Functional activities of daily living, walking, quality of life, muscle strength, and range of motion in the knee joint. Trial quality was extensively evaluated. Narrative synthesis plus meta-analyses with fixed effect models, weighted mean differences, standardised effect sizes, and tests for heterogeneity.Results Six trials were identified, five of which were suitable for inclusion in meta-analyses. There was a small to moderate standardised effect size (0.33, 95% confidence interval 0.07 to 0.58) in favour of functional exercise for function three to four months postoperatively. There were also small to moderate weighted mean differences of 2.9 (0.61 to 5.2) for range of joint motion and 1.66 (−1 to 4.3) for quality of life in favour of functional exercise three to four months postoperatively. Benefits of treatment were no longer evident at one year.Conclusions Interventions including physiotherapy functional exercises after discharge result in short term benefit after elective primary total knee arthroplasty. Effect sizes are small to moderate, with no long term benefit.     

Criteria of fitness for anaesthesia in patients with chronic obstructive lung disease.

Twelve patients with severe chronic obstructive lung disease undergoing 15 operations were assessed with preoperative lung function tests and blood gas estimations. Their operative and postoperative course was followed. There were no deaths or serious complications. Patients fell into three groups: those with low respiratory capacity but normal blood gases, who required no special respiratory treatment apart from physiotherapy and antibiotics; those with hypoxaemia but normal arterial carbon dioxide pressure, who needed more prolonged oxygen treatment after operation; and those with hypoxaemia and hypercapnia, who needed postoperative ventilatory support. While forced expiratory volume in one second (FEV) is a good screening test in preoperative assessment it should be supplemented by arterial blood gas estimations in patients with an FEV of less than 1 litre.     

Physiotherapy for patients with soft tissue shoulder disorders: a systematic review of randomised clinical trials.

OBJECTIVE: To assess the effectiveness of physiotherapy for patients with soft tissue shoulder disorders. DESIGN: A systematic computerised literature search of Medline and Embase, supplemented with citation tracking, for relevant trials with random allocation published before 1996. SUBJECTS: Patients treated with physiotherapy for disorders of soft tissue of the shoulder. MAIN OUTCOME MEASURES: Success rates, mobility, pain, functional status. RESULTS: Six of the 20 assessed trials satisfied at least five of eight validity criteria. Assessment of methods was often hampered by insufficient information on various validity criteria, and trials were often flawed by lack of blinding, high proportions of withdrawals from treatment, and high proportions of missing values. Trial sizes were small: only six trials included intervention groups of more than 25 patients. Ultrasound therapy, evaluated in six trials, was not shown to be effective. Four other trials favoured physiotherapy (laser therapy or manipulation), but the validity of their methods was unsatisfactory. CONCLUSIONS: There is evidence that ultrasound therapy is ineffective in the treatment of soft tissue shoulder disorders. Due to small trial sizes and unsatisfactory methods, evidence for the effectiveness of other methods of physiotherapy is inconclusive. For all methods of treatment, trials were too heterogeneous with respect to included patients, index and reference treatments, and follow up to merit valid statistical pooling. Future studies should show whether physiotherapy is superior to treatment with drugs, steroid injections, or a wait and see policy.     

Controlled trial of mobilisation and manipulation for low back pain: hospital patients.

Ninety-four patients with non-specific lumbar pain referred to hospital rheumatology and orthopaedic clinics participated in a double-blind controlled trial comparing mobilisation and manipulation with placebo physiotherapy. Results were assessed immediately after the tratment course, two months later, and at one year. Many patients showed improvement, but in contrast to a study on general-practitioner patients with nonspecific back pain no definite advantage could be associated with mobilisation and manipulation. The benefits of mobilisation and manipulation for low back pain are probably restricted to hastening recovery in patients likely rapidly to improve spontaneously. Hence patients whose severity and duration of symptoms warrant specialist referral are less likely to benefit from the technique.     

Comparison of physiotherapy,manipulation, and corticosteroid injection for treating shoulder complaints in general practice: randomised,single blind study.

OBJECTIVE: To compare the efficacy of physiotherapy, manipulation, and corticosteroid injection for treating patients with shoulder complaints in general practice. DESIGN: Randomised, single blind study. SETTING: Seven general practices in the Netherlands. SUBJECTS: 198 patients with shoulder complaints, of whom 172 were divided, on the basis of physical examination, into two diagnostic groups: a shoulder girdle group (n = 58) and a synovial group (n = 114). INTERVENTIONS: Patients in the shoulder girdle group were randomised to manipulation or physiotherapy, and patients in the synovial group were randomised to corticosteroid injection, manipulation, or physiotherapy. MAIN OUTCOME MEASURES: Duration of shoulder complaints analysed by survival analysis. RESULTS: In the shoulder girdle group duration of complaints was significantly shorter after manipulation compared with physiotherapy (P < 0.001). Also the number of patients reporting treatment failure was less with manipulation. In the synovial group duration of complaints was shortest after corticosteroid injection compared with manipulation and physiotherapy (P < 0.001). Drop out due to treatment failure was low in the injection group (17%) and high in the manipulation group (59%) and physiotherapy group (51%). CONCLUSIONS: For treating shoulder girdle disorders, manipulation seems to be the preferred treatment. For the synovial disorders, corticosteroid injection seems the best treatment.     

General practice orthopaedic outpatient referrals in North Staffordshire.

A study was made of 813 orthopaedic referrals by 134 general practitioners in North Staffordshire. The referral rates showed no relation to practice list size or the doctors'' previous orthopaedic experience. The published waiting times did not accurately reflect clinic vacancies, and no effective priority rating of letters by consultants was shown. Less than 1% of patients had an appointment within four weeks. One quarter of the patients failed to attend and, of those who did, 27% received physiotherapy or a "simple" appliance, or both, while 16% received treatment already available from their general practitioner. Patients from high referring doctors showed the same pattern of distribution in body area affected and treatment outcome as those from low referring doctors, but had a significantly longer time to wait for their appointment. A survey of non-attenders showed that 56% of the patients failed to attend because the condition had resolved.     

Treatment of Acute Herpes Zoster with Amantadine Hydrochloride (Symmetrel)

A double-blind, placebo-controlled trial of amantadine hydrochloride (Symmetrel) in acute herpes zoster (shingles) was carried out in 100 patients in general practice. The cases were serologically proved. There was no difference in duration of pain between the drug and placebo groups when pain disappeared during the 28 days'' observation period. However, pain lasted more than 28 days in a significantly greater proportion of patients receiving placebo than of those on amantadine. Patients with pain after the 28-day observation period were significantly older than those whose pain disappeared during the study. The drug had no effect on rate of healing or appearance of new lesions.     

Psychological impact of adjuvant chemotherapy in the first two years after mastectomy.

Psychological symptoms were assessed over two years in a randomised trial of three forms of treatment given to women after mastectomy for stage II breast cancer. The treatments were: three weeks'' radiotherapy; one year''s adjuvant chemotherapy with cyclophosphamide, methotrexate, and 5-fluorouracil; and radiotherapy followed by chemotherapy. Analysis of the results on an intention to treat basis showed no substantial differences in depression or anxiety among groups at one, three, or six months after the operation. At 13 months, however, patients who had been allocated chemotherapy had significantly more symptoms, especially depression, than control patients treated with radiotherapy alone. Conditioned reflex nausea and vomiting increased considerably during the second six months of chemotherapy and persisted for up to a year afterwards. The psychological morbidity of adjuvant chemotherapy could be substantially reduced if courses of treatment were restricted to about six months.     

Physiotherapy intervention late after stroke and mobility.

OBJECTIVE--To determine whether the intervention of a physiotherapist improved mobility in patients seen more than one year after stroke. DESIGN--Randomised crossover trial comparing two groups offered intervention by a physiotherapist, one immediately after entry into the trial and the other after a delay of three months. The intervention consisted of identifying problems and offering advice and help to solve the problems. SETTING--Patients'' homes in Oxfordshire. SUBJECTS--Patients who had reduced mobility due to a stroke more than one year before entry; 60 were recruited from a community stroke register and 34 in other ways. MAIN OUTCOME MEASURES--Standard measures of mobility including gait speed, functional ambulation categories, the Nottingham extended activities of daily living index, and individual items from the Barthel activities of daily living index and the Frenchay activities index. Measures of manual dexterity, depression, and anxiety were used as controls. RESULTS--94 patients entered the trial and 49 were randomised to immediate and 45 to delayed physiotherapy; 89 were compared at the crossover point. At randomisation the two groups were comparable. At three months the group given early therapy showed an improvement in gait speed whereas the untreated group had declined (differences of -3.9 v 6.4 s to walk 10 m; p less than 0.01); between three and six months the group given delayed therapy showed improvement and the previously treated group declined (differences of 6.5 v -3.9 s to walk 10 m; p less than 0.01). A 9% (95% confidence interval 0% to 18%) decrease in time taken to walk 10 m was associated with treatment and a 12% (2% to 19%) increase when patients were untreated. Other measures did not change significantly. CONCLUSION--Intervention of an experienced physiotherapist late after stroke specifically improves mobility, albeit by a small amount, but the effects do not seem to be maintained, perhaps because there is an underlying decline in mobility in these patients. Gait speed offers a simple and sensitive measure of outcome.     

Treatment of Cushing's disease with low dose radiation therapy.

Nineteen patients with Cushing''s disease were treated with low dose external pituitary irradiation (20 Gy (2000 rad) in eight fractions over 10 days). While awaiting the effects of pituitary irradiation all patients were treated with metyrapone. Seven patients had a complete remission of their disease within six to 12 months of irradiation. They did not require any further treatment and were followed up for a mean of three and a half (range one to eight) years. Another patient had a complete remission after a second course of pituitary irradiation. A further two patients showed a significant biochemical improvement after irradiation, although they were not rendered eucorticoid. There were no complications after this dose of irradiation. These results compare favourably with those reported after pituitary irradiation at conventional doses (40-50 Gy (4000-5000 rad) over four or five weeks) but were not associated with any complications. It is therefore recommended that low dose external pituitary irradiation be used as definitive first line treatment for Cushing''s disease.     

Spinal manipulation and mobilisation for back and neck pain: a blinded review.

OBJECTIVE--To assess the efficacy of spinal manipulation for patients with back or neck pain. DESIGN--Computer aided search for published papers and blinded assessment of the methods of the studies. SUBJECTS--35 randomised clinical trials comparing spinal manipulation with other treatments. MAIN OUTCOME MEASURES--Score for quality of methods (based on four main categories: study population, interventions, measurement of effect, and data presentation and analysis) and main conclusion of author(s) with regard to spinal manipulation. RESULTS--No trial scored 60 or more points (maximum score 100) suggesting that most were of poor quality. Eighteen studies (51%) showed favourable results for manipulation. In addition, five studies (14%) reported positive results in one or more subgroups. Of the four studies with 50-60 points, one reported that manipulation was better, two reported that manipulation was better in only a subgroup, and one reported that manipulation was no better or worse than reference treatment. Eight trials attempted to compare manipulation with some placebo, with inconsistent results. CONCLUSIONS--Although some results are promising, the efficacy of manipulation has not been convincingly shown. Further trials are needed, but much more attention should be paid to the methods of study.     

Double blind placebo controlled trial of pulse treatment with methylprednisolone combined with disease modifying drugs in rheumatoid arthritis.

OBJECTIVE--To assess whether monthly treatment with intravenous methylprednisolone enhances or accelerates the effect of disease modifying drugs in patients with rheumatoid arthritis. DESIGN--A 12 month double blind, placebo controlled, multicentre trial in which patients with active rheumatoid arthritis were randomly allocated to receive pulses of either methylprednisolone or saline every four weeks for six months. At the start of the pulse treatment all patients were started on penicillamine or azathioprine. SETTING--Four rheumatology departments in Denmark. PATIENTS--97 Patients (71 women, 26 men) aged 23-84 (mean 60) who had active rheumatoid arthritis of at least four weeks'' duration despite treatment with non-steroidal anti-inflammatory drugs. MAIN OUTCOME MEASURES--Monthly clinical recording of morning stiffness, number of tender and swollen joints, blinded observers'' evaluation of therapeutic effect, and patients'' self assessed condition. Concomitant laboratory measurements of erythrocyte sedimentation rate and concentrations of C reactive protein and haemoglobin. Radiography to determine the number of erosions at the start of treatment and after 12 months. RESULTS--57 Patients completed the trial, taking the same disease modifying drug throughout. Evaluation four weeks after each pulse treatment and at 12 month follow up showed no significant differences between the methylprednisolone and placebo groups in any of the clinical or laboratory variables. Radiography showed the same degree of progression of erosions in both groups. Evaluation of the total data on 97 patients and on the 57 who completed the trial showed the same lack of significance between the treatment groups. CONCLUSIONS--Intravenous pulse treatment with steroids can be recommended only for rapid temporary relief of flares of disease in patients with rheumatoid arthritis. The response is short lived. Repeated pulses of methylprednisolone at four week intervals do not improve the results of treatment with drugs that induce remission such as penicillamine and azathioprine.     

How much physical therapy for patients with stroke?

The use of physiotherapy, occupational therapy, and speech therapy for patients with stroke was investigated, and the three treatments were compared. Out of 135 patients with stroke surviving at two weeks, 107 received physiotherapy, but only 35 received occupational therapy and 19 speech therapy. Those who received most physiotherapy were the most severely disabled and had the worst prognosis, and, although almost no recovery occurred after six months, 30 patients continued with treatment beyond this time. Stiff and painful shoulders were present in 21 of the patients by two weeks and had developed in a further 37 by one year. Physiotherapy did not prevent this. The objectives of physiotherapy for patients with stroke need careful definition, with emphasis on treatment in the early months. Alternative treatment, possibly carried out by volunteers or more simply trained personnel, merits further consideration.     

Controlled Trial Comparing Effect of Two and Six Weeks' Treatment in Recurrent Urinary Tract Infection

Patients with recurrent urinary tract infection were allocated at random to two weeks'' or six weeks'' treatment with an appropriate antibacterial drug. There was no difference in the results achieved by the two different periods of treatment as judged by the presence of infection in the urine one week and six weeks after treatment was stopped.The urine was clear of infection in a higher percentage of patients following a course of nitrofurantoin than following a course of ampicillin, but the difference was not significant.     

Treating heartburn in pregnancy: comparison of acid and alkali mixtures.

A randomised crossover trial was performed in 55 pregnant women who complained of heartburn to see whether alkali or acid treatment alleviated it. Each woman was given a week''s treatment with an acid mixture, an alkali mixture, and a placebo in randomised order. Both acid and alkali mixtures were better than placebo, but there was no significant difference between the acid and alkali treatments. Together with the inconsistent reports of some patients, these findings suggest that both acid reflux and bile regurgitation may cause heartburn in pregnant women and that other factors may also play a part. Because the cause of heartburn may be difficult to determine, treatment should be empirical. If the patient does not respond to seven days'' acid treatment an alkali mixture should be prescribed; there is a 98% chance that one of these treatments will relieve symptoms.     

Albendazole chemotherapy for treatment of diarrhoea in patients with AIDS in Zambia: a randomised double blind controlled trial.

OBJECTIVE--To determine the value of short course, high dose albendazole chemotherapy in the treatment of persistent diarrhoea related to HIV in unselected patients in urban Zambia. DESIGN--A randomised double blind placebo controlled trial of albendazole 800 mg twice daily for two weeks. Patients were monitored intensively for one month and followed for up to six months. SETTING--Home care. AIDS services in Lusaka and Ndola. PATIENTS--174 HIV seropositive patients with persistent diarrhoea (defined as loose but not bloody stools three or more times a day for three weeks or longer). No investigations were undertaken except HIV testing after counselling. MAIN OUTCOME MEASURES--Proportion of time periods during which diarrhoea was experienced after completion of treatment; proportion of patients with full remission after completion of treatment; mortality. RESULTS--The patients taking albendazole had diarrhoea on 29% fewer days than those taking placebo (P < 0.0001) in the two weeks after treatment. The benefit of albendazole was maintained over six months. In patients with a Karnofsky score of 50 to 70 (needing help with activities of daily living and unable to work, but not needing admission to hospital) diarrhoea was reduced by 50%. Remission was obtained in 26% of all patients who received albendazole (P = 0.004 against 9% receiving placebo), and this difference was maintained over six months (log rank test, P = 0.003). Albendazole had no effect on mortality. Minimal adverse effects were noted. CONCLUSIONS--For HIV infected Zambians with diarrhoea of more than three weeks'' duration albendazole offers substantial relief from symptoms and may be used empirically, without prior investigation.     

Ischaemic Heart Disease: A Secondary Prevention Trial Using Clofibrate

A trial is reported of the effects of giving clofibrate to prevent progression of pre-existing ischaemic heart disease. There were two groups randomly distributed between clofibrate (350 patients) and placebo (367 patients) regimens. The trial lasted about six years and was conducted in 19 hospitals in Scotland. The criteria of acceptance into the trial were precise and were monitored by one observer. The standards of diagnosis of events were defined and all protocols and electrocardiograms were read blind by one observer.Three categories of patients were admissible to the trial: (1) patients with one myocardial infarction (W.H.O. E.C.G. criteria) between 8 and 16 weeks before the start of the trial; (2) patients with angina of a duration of 3 to 24 months, provided their E.C.G. showed signs of myocardial ischaemia at rest or after exercise; and (3) patients with one recent myocardial infarction and pre-existing angina as defined above.There were fewer deaths in patients with angina (categories 2 and 3 above) treated with clofibrate than in those on placebo. The mortality in the former group was reduced by 62%, and this is a statistically significant difference. Clofibrate did not have any statistically significant effect in reducing the rate of non-fatal infarction in patients with angina or in those with myocardial infarction and pre-existing angina, though a beneficial trend was evident when both subgroups were combined (a 44% reduction compared with the placebo group). There was a significant reduction in all events (fatal and non-fatal) in patients with angina (“all anginas”) in the clofibrate-treated group; the rate was reduced by 53%.Clofibrate did not alter the overall mortality or morbidity rates in patients admitted to the trial with recent myocardial infarction without preceding angina of more than three months'' duration. In one subgroup there was a statistically significant adverse effect in the clofibrate-treated group. The lack of any overall effect in patients with myocardial infarction might be related to the unexpectedly low mortality rate (2·97%) in the placebo group; it is usually in the region of 4-9% per annum after first myocardial infarction.In patients categorized as “all anginas” there was significant reduction in events whether the initial serum cholesterol level was high (greater than 260 mg/100 ml) or normal. Clofibrate seemed to have a small but not significant beneficial effect in patients with myocardial infarction with initially high serum cholesterol levels, but was of no value in those with initially normal serum cholesterol levels. There was no significant relationship between the response or lack of response of serum cholesterol to clofibrate and the incidence of events either in patients with angina or in those with infarction.The main conclusion of this trial is that clofibrate had a beneficial effect in reducing mortality and, to a lesser extent, morbidity in patients who presented with angina (“all anginas”). This effect was independent of initial serum cholesterol levels or the extent to which serum cholesterol was lowered. The drug had no significant overall effect on prognosis in patients with myocardial infarction alone.     

Psychological outcomes of different treatment policies in women with early breast cancer outside a clinical trial.

OBJECTIVES--To assess outside a clinical trial the psychological outcome of different treatment policies in women with early breast cancer who underwent either mastectomy or breast conservation surgery depending on the surgeon''s opinion or the patient''s choice. To determine whether the extent of psychiatric morbidity reported in women who underwent breast conservation surgery was associated with their participation in a randomised clinical trial. DESIGN--Prospective, multicentre study capitalising on individual and motivational differences among patients and the different management policies among surgeons for treating patients with early breast cancer. SETTING--12 District general hospitals, three London teaching hospitals, and four private hospitals. PATIENTS--269 Women under 75 with a probable diagnosis of stage I or II breast cancer who were referred to 22 different surgeons. INTERVENTIONS--Surgery and radiotherapy or adjuvant chemotherapy, or both, depending on the individual surgeon''s stated preferences for managing early breast cancer. MAIN OUTCOME MEASURES--Anxiety and depression as assessed by standard methods two weeks, three months, and 12 months after surgery. RESULTS--Of the 269 women, 31 were treated by surgeons who favoured mastectomy, 120 by surgeons who favoured breast conservation, and 118 by surgeons who offered a choice of treatment. Sixty two of the women treated by surgeons who offered a choice were eligible to choose their surgery, and 43 of these chose breast conserving surgery. The incidences of anxiety, depression, and sexual dysfunction were high in all treatment groups. There were no significant differences in the incidences of anxiety and depression between women who underwent mastectomy and those who underwent lumpectomy. A significant effect of surgeon type on the incidence of depression was observed, with patients treated by surgeons who offered a choice showing less depression than those treated by other surgeons (p = 0.06). There was no significant difference in psychiatric morbidity between women treated by surgeons who offered a choice who were eligible to choose their treatment and those in the same group who were not able to choose. Most of the women (159/244) gave fear of cancer as their primary fear rather than fear of losing a breast. The overall incidences of psychiatric morbidity in women who underwent mastectomy and those who underwent lumpectomy were similar to those found in the Cancer Research Campaign breast conservation study. At 12 months 28% of women who underwent mastectomy in the present study were anxious compared with 26% in the earlier study, and 27% of women in the present study who underwent lumpectomy were anxious compared with 31% in the earlier study. In both the present and earlier study 21% of women who underwent mastectomy were depressed, and 19% of women who underwent lumpectomy in the present study were depressed compared with 27% in the earlier study.) CONCLUSIONS--There is still no evidence that women with early breast cancer who undergo breast conservation surgery have less psychiatric morbidity after treatment than those who undergo mastectomy. Women who surrender autonomy for decision making by agreeing to participate in randomised clinical trials do not experience any different psychological, sexual, or social problems from those women who are treated for breast cancer outside a clinical trial.