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Biomedical subjects

M Tramèr

Publications and source records attributed to M Tramèr.

11 recordsLinked to original sources

Transcutaneous electrical nerve stimulation (TENS) for chronic pain.

BACKGROUND: Transcutaneous electrical nerve stimulation (TENS) is used in a variety of different clinical settings to treat a range of different acute and chronic pain conditions and has become popular with both patients and health professionals. OBJECTIVES: To evaluate the effectiveness of TENS in chronic pain. SEARCH STRATEGY: The Cochrane Library, Embase, Medline, CINAHL and The Oxford Pain Database were searched. Reference lists from retrieved reports and reviews were examined. Date of the most recent search: March 1999. SELECTION CRITERIA: RCTs were eligible if they included the following treatment comparisons: active TENS versus sham TENS controls active TENS versus no treatment controls active TENS versus active TENS controls (for instance High Frequency TENS vs Low Frequency TENS) Studies of patients suffering chronic pain for three months or more which included subjective outcome measures for pain intensity, or pain relief were eligible for evaluation in this review. No restrictions were made to language or sample size. Data from abstracts, letters, or unpublished studies, and studies of TENS in angina, headache and migraine, and dysmenorrhoea were not included. DATA COLLECTION AND ANALYSIS: Data were extracted and summarised on the following items: patients and details of pain condition, study treatments, study duration, design, methods, subjective pain outcome measures, methodological quality, results for pain outcome measures and adverse effects, and the conclusions made by the authors of the original studies. Extracted data and methodological quality of each report was confirmed by at least three of the reviewers. MAIN RESULTS: Of 107 reports identified from the searches, 88 were excluded as they did not fulfil the pre-defined entry criteria. Nineteen RCTs (from 18 reports) were evaluated. The included trials varied in terms of design, analgesic outcomes, chronic pain conditions, TENS treatments and overall methodological quality. Studies included single and multiple dose treatment comparisons of TENS. The studies were small. The reporting of the methods used and results for the analgesic outcomes were generally poor. TENS treatments and controls were often poorly defined. Few studies evaluated the long-term analgesic effectiveness of TENS and single dose evaluations of TENS are unhelpful in making clinical decisions of the long-term effectiveness of TENS in the management of chronic pain. Meta-analysis was not possible. Overall in 10 of 15 inactive control studies there was a positive analgesic outcome in favour of the active TENS treatments. For the multiple dose treatment comparison studies only three of seven were considered to be in favour of the active TENS treatments. For the active controlled studies, seven studies made direct comparisons between HFTENS and LFTENS. Five of seven studies could find no difference in terms of analgesic efficacy between HFTENS and LFTENS at any time point. REVIEWER'S CONCLUSIONS: The results of this review are inconclusive; the published trials do not provide information on the stimulation parameters which are most likely to provide optimum pain relief, nor do they answer questions about long-term effectiveness. Large multi-centre randomised controlled trials of TENS in chronic pain are urgently needed.

Chronic Disease↗

Propofol anaesthesia and postoperative nausea and vomiting: quantitative systematic review of randomized controlled studies.

We have analysed randomized controlled studies which reported the incidence of postoperative nausea and vomiting (PONV) after propofol anaesthesia compared with other anaesthetics (control). Cumulative data of early (0-6 h) and late (0-48 h) PONV were recorded as occurrence or non-occurrence of nausea or vomiting. Combined odds ratio and number-needed-to-treat were calculated for propofol as an induction or maintenance regimen, early or late outcomes, and different emetic events. This was performed for all control event rates and within a range of 20-60% control event rates. We analysed 84 studies involving 6069 patients. The effect of propofol on PONV was dependent mainly on the method of administration, time of measurement and range of control event rates. When all studies were included the number-needed-to-treat to prevent PONV with propofol was more than 9 when used for induction of anaesthesia and at best 6 when used for maintenance. Within the 20-60% control event rate range, best results were achieved with propofol maintenance to prevent early PONV: the number-needed-to-treat to prevent early nausea was 4.7 (95% confidence interval 3.8-6.3), vomiting 4.9 (4-6.1) and any emetic event 4.9 (3.7-7.1). Within the 20-60% control event rate, of five patients treated with propofol for maintenance of anaesthesia, one will not vomit or be nauseated in the immediate postoperative period who would otherwise have vomited or been nauseated. This may be clinically relevant. In all other situations the difference between propofol and control may have reached statistical significance but was of doubtful clinical relevance. Treatment efficacy should be established within a defined range of control event rates for meaningful estimates of efficacy and for comparisons.

Anesthetics, Intravenous↗

Meta-analytic comparison of prophylactic antiemetic efficacy for postoperative nausea and vomiting: propofol anaesthesia vs omitting nitrous oxide vs total i.v. anaesthesia with propofol.

Data from two published and one new meta-analysis were reviewed to compare the antiemetic efficacy of three different anaesthetic regimens: (i) propofol anaesthesia compared with another anaesthetic (control); (ii) anaesthesia without nitrous oxide compared with the same anaesthetic with nitrous oxide (control); (iii) propofol anaesthesia without nitrous oxide (TIVA) compared with another anaesthetic with nitrous oxide (control). Efficacy (prevention of postoperative nausea and vomiting compared with control) was estimated using odds ratio and number-needed-to-treat methods, and compared within a range of 20-60% control event rates for early efficacy (0-6 h) and 40-80% for late efficacy (0-48 h). Propofol anaesthesia or omitting nitrous oxide had similar effects on vomiting, both early and late. Propofol (but not omitting nitrous oxide) decreased the incidence of nausea. TIVA studies were documented poorly; appropriate comparison with other interventions were not possible. Efficacy of treatments should be compared within a setting-specific range of control event rates. There is insufficient evidence that TIVA with propofol is an anaesthetic technique with a low emetogenic potency.

Anesthetics, Combined↗

Transcutaneous electrical nerve stimulation in labour pain: a systematic review.

OBJECTIVE: To review the effectiveness and safety of transcutaneous electrical nerve stimulation (TENS) for labour pain. DESIGN: A systematic review of randomised controlled trials of TENS in pain during labour. SAMPLE: Eight reports involving 712 women were included; 352 women received active TENS and 360 acted as controls. METHODS: Reports were sought by searching MEDLINE and the Oxford Pain Relief Database. MAIN OUTCOME MEASURES: Analgesic and adverse effect outcomes. RESULTS: Evidence for reduced pain using TENS in labour was weak. Additional analgesic interventions may be less likely with TENS (odds ratio 0.57; 95% CI 0.34-0.96), number-needed-to-treat 14 (95% CI 7.3-119). CONCLUSIONS: Randomised controlled trials provide no compelling evidence for TENS having any analgesic effect during labour. Weak positive effects in secondary (analgesic sparing) and tertiary (choosing TENS for future labours) outcomes may be due to inadequate blinding causing overestimation of treatment effects.

Female↗

A systematic review of antidepressants in neuropathic pain.

The objective of this study was to review the effectiveness and safety of antidepressants in neuropathic pain. In a systematic review of randomised controlled trials, the main outcomes were global judgements, pain relief or fall in pain intensity which approximated to more than 50% pain relief, and information about minor and major adverse effects. Dichotomous data for effectiveness and adverse effects were analysed using odds ratio and number needed-to-treat (NNT) methods. Twenty-one placebo-controlled treatments in 17 randomised controlled trials were included, involving 10 antidepressants. In six of 13 diabetic neuropathy studies the odds ratios showed significant benefit compared with placebo. The combined odds ratio was 3.6 (95% CI 2.5-5.2), with a NNT for benefit of 3 (2.4-4). In two of three postherpetic neuralgia studies the odds ratios showed significant benefit, and the combined odds ratio was 6.8 (3.5-14.3), with a NNT of 2.3 (1.7-3.3). In two atypical facial pain studies the combined odds ratio for benefit was 4.1 (2.3-7.5), with a NNT of 2.8 (2-4.7). Only one of three central pain studies had analysable dichotomous data. The NNT point estimate was 1.7. Comparisons of tricyclic antidepressants did not show any significant difference between them; they were significantly more effective than benzodiazepines in the three comparisons available. Paroxetine and mianserin were less effective than imipramine. For 11 of the 21 placebo-controlled treatments there was dichotomous information on minor adverse effects; combining across pain syndromes the NNT for minor (noted in published report) adverse effects was 3.7 (2.9-5.2). Information on major (drug-related study withdrawal) adverse effects was available from 19 reports; combining across pain syndromes the NNT for major adverse effects was 22 (13.5-58). Antidepressants are effective in relieving neuropathic pain. Compared with placebo, of 100 patients with neuropathic pain who are given antidepressants, 30 will obtain more than 50% pain relief, 30 will have minor adverse reactions and four will have to stop treatment because of major adverse effects. With very similar results for anticonvulsants it is still unclear which drug class should be first choice. Treatment would be improved if we could harness the dramatic improvement seen on placebo in some of the trials.

Antidepressive Agents↗

Omitting nitrous oxide in general anaesthesia: meta-analysis of intraoperative awareness and postoperative emesis in randomized controlled trials.

We have reviewed randomized controlled trials to assess the effectiveness and safety of anaesthetics which omitted nitrous oxide (N2O) to prevent postoperative nausea and vomiting (PONV). Early and late PONV (6 and 48 h after operation, respectively), and adverse effects were evaluated using the numbers-needed-to-treat (NNT) method. In 24 reports with information on 2478 patients, the mean incidence of early and late vomiting with N2O (control) was 17% and 30%, respectively. Omitting N2O significantly reduced vomiting compared with a N2O regimen; the combined NNT to prevent both early and late vomiting with a N2O-free regimen was about 13 (95% confidence intervals (CI) 9, 30). The magnitude of the effect depended on the incidence of vomiting in controls. In studies with a baseline risk higher than the mean of all reports, the NNT to prevent both early and late vomiting with a N2O-free anaesthetic was 5 (95% CI 4, 10). When the baseline risk was lower than the mean, omitting N2O did not improve outcome. Omitting N2O had no effect on complete control of emesis or nausea. The NNT for intraoperative awareness with a N2O-free anaesthetic was 46 compared with anaesthetics where N2O was used. This clinically important risk of major harm reduces the usefulness of omitting N2O to prevent postoperative emesis.

Anesthesia, General↗

Randomization is important in studies with pain outcomes: systematic review of transcutaneous electrical nerve stimulation in acute postoperative pain.

We set out to examine the evidence for the importance of randomization of transcutaneous electrical nerve stimulation (TENS) in acute postoperative pain. Controlled studies were sought; randomization and analgesic and adverse effect outcomes were summarized. Forty-six reports were identified by searching strategies. Seventeen reports with 786 patients could be regarded unequivocally as randomized controlled trials (RCT) in acute postoperative pain. No meta-analysis was possible. In 15 of 17 RCT, we judged there to be no benefit of TENS compared with placebo. Of the 29 excluded trials, 19 had pain outcomes but were not RCT; in 17 of these 19 TENS studies, the authors concluded that TENS had a positive analgesic effect. No adverse effects were reported. Non-randomized studies overestimated treatment effects.

Acute Disease↗

Prevention of vomiting after paediatric strabismus surgery: a systematic review using the numbers-needed-to-treat method.

Randomized controlled studies were reviewed to assess the effectiveness and safety of antiemetics used for prophylaxis in paediatric strabismus surgery. Early and late vomiting (6 and 48 h after operation, respectively), and adverse effects were evaluated using the numbers-needed-to-treat method. In 27 reports with information on 2033 children, the mean incidence of early vomiting was 54% and of late vomiting 59%, without prophylaxis. Only three drugs were studied sufficiently for firm conclusions to be drawn. In the best documented regimen (droperidol 75 micrograms kg-1), four children have to be given the drug to prevent one vomiting; of the three others, one may vomit and two would not have vomited anyway; fewer than one child in 100 may have an extrapyramidal reaction and 16 may have minor adverse effects. Metoclopramide 0.15 and 0.25 mg kg-1 was significantly better than control only for early vomiting. Propofol had a high incidence of oculocardiac reflex without conferring any significant antiemetic effect: it should not be used. The benefits of prophylactic antiemetic therapy are not proven.

Antiemetics↗

A comparison of nimesulide beta cyclodextrin and nimesulide in postoperative dental pain.

The aim of this study was to assess the efficacy and tolerability of single doses of nimesulide beta cyclodextrin compared with nimesulide in patients with dental pain following surgical procedures. This was a randomised, double-blind, between-patient, multicentre study involving 148 outpatients suffering from moderate to severe pain, who received single doses of either 400 mg nimesulide beta cyclodextrin or 100 mg nimesulide. The principal criterion for efficacy was pain intensity assessed on a visual analogue scale (VAS) 15 minutes after drug intake. Pain intensity was further evaluated 30, 45, 90, 120, 180, 240 and 360 minutes after dosing. Pain relief was evaluated at the same time points by means of a categorical scale. The time point of first pain relief, the use of rescue medication and the global evaluation of efficacy were also recorded. The reduction in pain intensity was significantly more pronounced in the nimesulide beta cyclodextrin group at 15, 30, 45 and 60 minutes (p < 0.01). Pain relief was significantly greater (p < 0.05) and more rapid with nimesulide beta cyclodextrin. In the patient overall assessment of efficacy, nimesulide beta cyclodextrin and nimesulide were rated excellent or good by 95% and 92% respectively; only one patient in the nimesulide beta cyclodextrin group needed rescue medication. Both study drugs were effective and well tolerated in the treatment of acute dental pain, with nimesulide beta cyclodextrin showing a faster onset of analgesic action.

Adolescent↗

[Efficacy and safety of mouthwash diclofenac in oral or periodontal surgery].

BACKGROUND: In a multicentre clinical study was evaluated the efficacy and safety of a mouthwash containing diclofenac 0.074% in patients undergone to oral or periodontal surgery. METHODS: Multicentre clinical open study. The patients rinsed for 1 min twice a day with diclofenac mouthwash for 7 days. After the baseline measurements of all parameters, spontaneous pain and burning were evaluated daily, while redness and oedema after 3 and 7 days of treatment. Seventy-nine patients (48 F, 31 M), mean aged 42.5 years+/-13.1 SD, with pain intensity at the end of anaesthesia effect equivalent to 54.8 mm+/-15.1 SD of a visual analogue scale were evaluated for efficacy. RESULTS: Spontaneous pain was significantly reduced by diclofenac mouthwash, versus baseline, in the first day of treatment. After a week of treatment, intensity was reduced more than 88% (p<0.01). Burning, redness and oedema too evidenced a similar behaviour, with absence of the sign respectively superior to 87%, 72% and 91 % (p<0.01). The physician's and patient's final judgement overlapped, recording a resolution/improvement in 94.1% of cases, particularly improvement in 77.2% for the physician and in 70.9% for the patients. Palatability was judged pleasant/acceptable in all cases. CONCLUSIONS: Diclofenac mouthwash is endowed by very good efficacy and safety in the treatment of inflammatory condition of the buccal cavity following oral or periodontal surgery.

Adolescent↗