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Interventions for leg cramps in pregnancy.

BACKGROUND: Many women experience leg cramps in the second half of pregnancy. OBJECTIVES: The objective of this review was to assess the effects of treatments for leg cramps in pregnancy. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register. SELECTION CRITERIA: Randomised trials of treatments for leg cramps, persisting for at least two weeks, in pregnancy. DATA COLLECTION AND ANALYSIS: Trial quality was assessed and data were extracted independently by two reviewers. MAIN RESULTS: Three trials involving 217 women were included. The trials were of moderate quality. Compared with placebo, calcium reduced leg cramps (odds ratio 0.29, 95% confidence interval 0.15 to 0.56). However there was significant heterogeneity between these results. One trial comparing sodium chloride with placebo showed a reduction in leg cramps (odds ratio 0.08, 95% confidence interval 0.03 to 0.24). Based on one trial, there appeared to be no difference between calcium and sodium chloride. REVIEWER'S CONCLUSIONS: Both calcium and sodium chloride appear to help reduce leg cramps in pregnancy. However the results of the sodium chloride trial may no longer be relevant because of dietary changes.

Female↗

Interventions for psoriatic arthritis.

OBJECTIVES: To assess the effects of salazopyrin, auranofin, etretinate, fumaric acid, IMI gold, azathioprine, and methotrexate, in psoriatic arthritis. SEARCH STRATEGY: We searched Medline up to 1995, and Excerpta Medica (June 1974-95). Search terms were psoriasis, arthritis, therapy and/or controlled trial. This was supplemented by manually searching bibliographies of previously published reviews, conference proceedings and contacting drug companies. All languages were included in the initial search. SELECTION CRITERIA: All randomized trials comparing salazopyrin, auranofin, etretinate, fumaric acid, IMI gold, azathioprine, and methotrexate, in psoriatic arthritis. The main outcome measures included individual component variables derived from Outcome Measures in Rheumatology Clinical Trials (OMERACT). These include Acute Phase Reactants, Disability, Pain, Patient Global Assessment, Physician Global Assessment, Swollen joint count, Tender joint count and radiographic changes of joints in any trial of 1 year or longer [Tugwell 1993], and the change in pooled disease index. Only English trials were included in the review. DATA COLLECTION AND ANALYSIS: Data were independently extracted from the published reports by two of the reviewers. An independent blinded quality assessment was also performed. MAIN RESULTS: Nineteen randomized trials were identified of which eleven were included in the quantitative analysis with data from 777 subjects. Although all agents were better than placebo, parenteral high dose methotrexate (not included), salazopyrin, azathioprine and etretinate were the agents that achieved statistical significance in a global index of disease activity (although it should be noted that only one component variable was available for azathioprine and only one trial was available for etretinate suggesting some caution is necessary in interpreting these results). Analysis of response in individual disease activity markers was more variable with considerable differences between different medications and responses. In all trials the placebo group improved over baseline (pooled improvement 0.43 DI units, 95% CI 0. 28-0.59). There was insufficient data to examine toxicity. REVIEWER'S CONCLUSIONS: Parenteral high dose methotrexate and salazopyrin are the only two agents with well demonstrated published efficacy in psoriatic arthritis. The magnitude of the effect seen with azathioprine, etretinate, oral low dose methotrexate and perhaps colchicine suggests that they may be effective but that further multicentre clinical trials are required to establish their efficacy. Furthermore, the magnitude of the improvement observed in the placebo group strongly suggests that uncontrolled trials should not be used to guide management decisions in this condition.

Antirheumatic Agents↗

Interventions for trichomoniasis in pregnancy.

BACKGROUND: Vaginitis due to Trichomonas vaginalis is one of the most common of sexually transmitted diseases. Trichomoniasis affects women during pregnancy as well but it is not clearly established whether it causes preterm birth and other pregnancy complications. OBJECTIVES: The objective of this review was to assess the effects of various treatments for trichomoniasis during pregnancy. SEARCH STRATEGY: The Pregnancy and Childbirth Group trials register and the Cochrane Controlled Trials Register were searched. Date of last search: 22 December 1999. SELECTION CRITERIA: Randomised trials comparing antitrichomonas agents during pregnancy. DATA COLLECTION AND ANALYSIS: Eligibility and trial quality was assessed by one reviewer. MAIN RESULTS: One study in which benzoylmetronidazole was compared to no treatment in low risk symptomatic and asymptomatic women was included. Of the treated women, 95% (97/102) and 93% (77/83) were free of infection on day seven and week four respectively. This equates to a relative risk of 0.11, and 95% confidence interval 0.05 to 0.24. About 75% of partners were reported to have taken the treatment. REVIEWER'S CONCLUSIONS: Metronidazole, given as a single dose, is likely to provide parasitological cure for trichomonas, but it is not known whether this treatment will have any effect on pregnancy outcomes. The cure rate could probably be higher if more partners used the treatment.

Antiprotozoal Agents↗

Interventions for treating constipation in pregnancy.

BACKGROUND: Circulating progesterone may be the cause of slower gastrointestinal movement in mid and late pregnancy. OBJECTIVES: The objective of this review was to assess the effects of different methods for treating constipation in pregnancy. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register and Medline (1987 to 1997). SELECTION CRITERIA: Randomised trials of any treatment for constipation in pregnancy. DATA COLLECTION AND ANALYSIS: Trial quality assessments and data extraction were done independently by two reviewers. MAIN RESULTS: One trial of 40 women was included. Fibre supplements increased the frequency of defaecation (odds ratio 0.18, 95% confidence interval 0.05 to 0.67), and lead to softer stools. REVIEWER'S CONCLUSIONS: Dietary supplements of fibre in the form of bran or wheat fibre are likely to help women experiencing constipation in pregnancy.

Constipation↗

Interventions for treating melioidosis.

BACKGROUND: Melioidosis is an infectious disease caused by a bacterium (Burkholderia pseudomallei) found particularly in some areas in the tropics. It is a serious condition which can be fatal. Beta lactam antibiotics have dramatically reduced the risk of death, but mortality still remains high. OBJECTIVES: To summarise evidence from randomised trials on the effects of treatment regimens on death and relapse. SEARCH STRATEGY: Cochrane Controlled Trials Register, MEDLINE, EMBASE, BIOSIS from 1966 to September 2000 using MeSH terms "pseudomallei", "melioidosis" together with the terms "randomized-controlled-trial", "random allocation"; reference lists in articles on melioidosis; contact with trialists. SELECTION CRITERIA: Randomised and quasi-randomised trials assessing treatments in patients with melioidosis. DATA COLLECTION AND ANALYSIS: Eligibility and trial quality was assessed by two reviewers independently. MAIN RESULTS: For intravenous therapy in the acute phase, we identified five trials with a total of 519 patients. Chloramphenicol, doxycycline, and co-trimoxazole (trimethoprim-sulphamethoxazole) combination regimens were associated with a mortality of 50% or more (two studies). Patients randomised to regimens that included ceftazidime were more likely to survive (relative risk [RR] 0.46, 95% confidence interval [CI] 0.30 to 0.71). When ceftazidime-containing regimens were compared with beta lactam or alternative beta lactamase inhibitor regimens such as co-amoxiclav (amoxycillin-clavulanic acid) and cefoperazone-sulbactam, mortality rates were similar (RR 1.10, 95% CI 0.83 to 1.46), as was the case in one trial of imipenem. For oral therapy in the maintenance phase, we found two trials of 188 participants. Results showed that treatment with the conventional regimen (chloramphenicol, doxycycline, and trimethoprim-sulphamethoxazole) resulted in fewer fatalities in patients compared to a regimen of amoxycillin-clavulanic acid and doxycycline alone. REVIEWER'S CONCLUSIONS: Regimens for the acute phase of illness should contain ceftazidime or imipenem. It is not yet clear if combinations of treatments in the early phase reduce relapse. For oral therapy after the acute phase of treatment, trials suggest that conventional four drug regimens can be used for treatment.

Administration, Oral↗

Interventions for vaginismus.

BACKGROUND: Vaginismus is involuntary vaginal muscle contraction which makes sexual intercourse difficult or impossible. It is one of the more common female psychosexual problems. Various therapeutic strategies for vaginismus, such as sex therapy and desensitization, have been considered in uncontrolled studies. OBJECTIVES: The aim of this review is to determine the clinical effectiveness of treatments for vaginismus and also to examine the role of partner participation in the effectiveness of the treatment. SEARCH STRATEGY: The Cochrane Collaboration Depression, Anxiety & Neurosis Controlled Trials Register (Issue 3, 2000), the Cochrane Controlled Trials Register (Cochrane Library, Issue 2, 2000), MEDLINE (1966 to Apr 2000), EMBASE (1980 to Apr 2000), PsycINFO (1967 to April 2000) and CINAHL (1982 to Mar 2000) were searched. The Journal of Sex Research (1974 to 1999), Sexual & Marital Therapy (1986 to 1999), Sexual Dysfunction (1998 to 1999) and the Journal of Sex and Marital Therapy (1974 to 1999) were handsearched. Reference lists and conference abstracts were searched. Experts in the field were contacted regarding unpublished material. SELECTION CRITERIA: Controlled trials comparing treatments for vaginismus with another treatment, a placebo treatment, treatment as usual or waiting list control. DATA COLLECTION AND ANALYSIS: The reviewers extracted data which were verified with the trial investigator. MAIN RESULTS: Two controlled trials were identified although data were only available from one trial. The second trial compared two forms of systematic desensitization and reported no discernible differences between them. REVIEWER'S CONCLUSIONS: In spite of encouraging results reported from uncontrolled series of patients there is very limited evidence from controlled trials concerning the effectiveness treatments for vaginismus. Further trials are need to compare therapies with waiting list control and with other therapies.

Desensitization, Psychologic↗

Pharmacological interventions for non-ulcer dyspepsia.

BACKGROUND: The commonest cause of upper gastrointestinal symptoms is non-ulcer dyspepsia (NUD) and yet the pathophysiology of this condition has been poorly characterised and the optimum treatment is uncertain. It is estimated that pound450 million is spent on dyspepsia drugs in the UK each year. OBJECTIVES: This review aims to determine the effectiveness of six classes of drugs (antacids, histamine H2 antagonists, proton pump inhibitors, prokinetics, mucosal protecting agents and antimuscarinics) in the improvement of either the individual or global dyspepsia symptom scores and also quality of life scores patients with non-ulcer dyspepsia. SEARCH STRATEGY: Trials were located through electronic searches of the Cochrane Controlled Trials Register (CCTR), MEDLINE, EMBASE, CINAHL and SIGLE, using appropriate subject headings and text words, searching bibliographies of retrieved articles, and through contacts with experts in the fields of dyspepsia and pharmaceutical companies. SELECTION CRITERIA: All randomised controlled trials (RCTs) comparing drugs of any of the six groups with each other or with placebo for non-ulcer dyspepsia (NUD). DATA COLLECTION AND ANALYSIS: Data were collected on dyspeptic symptom scores either individual or global symptom assessments and also quality of life scores and adverse effects. MAIN RESULTS: A total of 11775 citations were obtained. 144 trials were retrieved and 94 trials fulfilled our eligibility criteria. However, subsequent data extraction was not possible in 37 trials. Fifty trials were excluded as they did not meet our eligibility criteria. The final 57 trials were included in the final meta-analysis. Prokinetics (12 trials with dichotomous outcomes generating 829 patients; relative risk reduction [RRR] = 50%; 95% confidence intervals [CI] = 30 to 65%) and H2RAs (8 trials generating 1,125 patients; RRR = 30%; 95% CI = 4 to 48%) were significantly more effective than placebo. Proton pump inhibitors (4 trials generating 1,248 patients; RRR = 12%; 95% CI = -1 to 24%) and Bismuth salts (6 trials generating 311 patients; RRR = 40%; 95% CI = -3 to 65%) were superior to placebo but this was of marginal statistical significance. Antacids (one trial generating 109 patients; RRR = -2%; 95% CI = -36% to 24%) and sucralfate (two trials generating 246 patients; RRR = 29%; 95% CI = -40% to 64%) were not statistically significantly superior to placebo. A funnel plot suggested that the prokinetic result could be due to publication bias. The funnel plot of H2RAs did not show any evidence of publication bias but the quality of the trials was generally poor. REVIEWER'S CONCLUSIONS: There is some evidence that anti-secretory therapy may be effective in NUD. The trials evaluating prokinetic therapy are difficult to interpret as the meta-analysis result could have been due to publication bias. Further research using prokinetics and anti-secretory therapy is required before any firm conclusions can be reached. The effect of these drugs is likely to be small and many patients will need to take them on a long-term basis so the therapies assessed need to be inexpensive and well tolerated.

Dyspepsia↗

Interventions for early stage Hodgkin's disease in children.

BACKGROUND: Hodgkin's Disease is one of the most curable cancers in children, particularly at the early stages. The debate rests now more with retention of high cures and eliminating treatment sequelae. OBJECTIVES: To assess relapse free survival and overall survival rates in children with Stage l-llA Hodgkin's Disease treated with radiotherapy, chemotherapy or a combination of the two treatments. SEARCH STRATEGY: MEDLINE, EMBASE, CINAHL, Cancer-CD and the Cochrane Library were searched for randomised controlled trials. Key words included 'Hodgkin's Disease', 'Reed-Sternberg cells' and variations of 'child'. SELECTION CRITERIA: Treatments with a combination of the following therapies; involved field radiotherapy, extended field radiotherapy, anthracycline based chemotherapy regimens, or alkylating chemotherapy agents. Patients included children to 19 years of age. DATA COLLECTION AND ANALYSIS: Seven papers were identified as meeting the selection criteria. Of these four were usable, though one only covered a small section of the paper. It was not possible to combine the outcomes as they covered different treatment regimens and the numbers in one study were inaccurate. MAIN RESULTS: The results comparing IF with EF radiotherapy for children are based on one large multi-centred trial. Although the study is substantial and methodologically rigorous, the evidence for efficacy rests simply on this one trial. The results from the other three studies are not generalizable. The outcomes could not be combined as the studies assessed different treatment regimens. In addition there is little evidence to suggest that the methodological quality, particularly in terms of randomisation and simple arithmetic, is of a sufficiently robust nature in two of the studies. REVIEWER'S CONCLUSIONS: The treatment of Hodgkin's Disease Stage l -llA for children has undergone considerable evolution and development in the previous three decades with the introduction and refinement of combined modality treatments. There is now overall consensus that the prognosis for these patients following a short course of chemotherapy and low dose local radiotherapy is very good with a large percentage achieving long-term survival or relapse free survival. The main issues and problems facing practitioners in the field is the reduction and management of late effects and sequelae of treatment. The evidence for this overall agreement is based on a mass of cohort studies that have influenced changes in practice and significantly improved outcomes. However, apart from the collaborative study looking at radiotherapy alone, there is little evidence from randomised controlled trials to support this consensus.

Antineoplastic Agents↗

Interventions for replacing missing teeth: different types of dental implants.

BACKGROUND: Dental implants are available in different materials, shapes and with different surface characteristics. In particular, numerous implant surface modifications have been developed for enhancing clinical performances. OBJECTIVES: To test the null hypothesis of no difference in clinical performance between various root-formed osseointegrated implant types. SEARCH STRATEGY: The Cochrane Oral Health Group Specialised Trials Register, The Cochrane Controlled Trials Register, MEDLINE and EMBASE were searched. Hand searching included several dental journals. Bibliographies of relevant clinical trials and review articles were checked for studies outside the handsearched journals. In addition, authors of all identified trials and fifty-five oral implant manufacturers were contacted to find unpublished or ongoing RCTs. Two extensive personal libraries (ME and AJ) were consulted. The last electronic search was conducted 8th May 2002. SELECTION CRITERIA: All randomised controlled trials of oral implants comparing implants with different materials, shapes and surface properties having a follow-up of at least one year. DATA COLLECTION AND ANALYSIS: Data were independently extracted, in duplicate, by two reviewers (ME & HW). Authors were contacted for details of randomisation and withdrawals and a quality assessment was carried out. The Cochrane Oral Health Group's statistical guidelines were followed. MAIN RESULTS: Thirty publications, representing 13 different RCTs, were identified. Five of these RCTs (seven publications), which reported results from a total of 326 patients, were suitable for inclusion in the review. Six implant systems were compared: Astra, Branemark, IMZ, ITI, Steri-Oss and Southern with a follow-up ranging from one to three years. All implants were made in commercially pure titanium and had different shapes and surface preparations. On a patient rather than per implant basis there were no statistically significant differences for failures and marginal bone level changes on intra-oral radiographs between various implant systems. REVIEWER'S CONCLUSIONS: There was no evidence that any of the implant systems evaluated was superior to the other. However, these findings are based on a few RCTs all having short follow-up periods and few participants. More RCTs should be conducted, with follow-up of at least five years and including a sufficient number of patients, to detect a true difference if any exists. Such trials should be reported according to the CONSORT guidelines (http://www.consort-statement.org/).

Dental Implantation, Endosseous↗

Comparison of long-term usefulness of clopidogrel therapy after the first percutaneous coronary intervention or coronary artery bypass grafting versus that after the second or repeat intervention.

Patients in the Clopidogrel for the Reduction of Events During Observation trial were subgrouped according to whether they underwent index percutaneous coronary artery revascularization procedures only or this procedure plus subsequent percutaneous or surgical revascularization procedures during 1-year follow-up. The relative risk reduction in ischemic events associated with up-front and long-term clopidogrel compared with placebo was 2-fold greater in patients who required repeat revascularization procedures compared with those who did not (42.4% vs 21.7%).

Aged↗