Biomedical subjects

H J McQuay

Publications and source records attributed to H J McQuay.

At least 19 recordsLinked to original sources

PubMed2005

Algorithm for neuropathic pain treatment: an evidence based proposal.

New studies of the treatment of neuropathic pain have increased the need for an updated review of randomized, double-blind, placebo-controlled trials to support an evidence based algorithm to treat neuropathic pain conditions. Available studies were identified using a MEDLINE and EMBASE search. One hundred and five studies were included. Numbers needed to treat (NNT) and numbers needed to harm (NNH) were used to compare efficacy and safety of the treatments in different neuropathic pain syndromes. The quality of each trial was assessed. Tricyclic antidepressants and the anticonvulsants gabapentin and pregabalin were the most frequently studied drug classes. In peripheral neuropathic pain, the lowest NNT was for tricyclic antidepressants, followed by opioids and the anticonvulsants gabapentin and pregabalin. For central neuropathic pain there is limited data. NNT and NNH are currently the best way to assess relative efficacy and safety, but the need for dichotomous data, which may have to be estimated retrospectively for old trials, and the methodological complexity of pooling data from small cross-over and large parallel group trials, remain as limitations.

Algorithms↗

PubMed2005

Carbamazepine for acute and chronic pain.

BACKGROUND: Anticonvulsant drugs have been used in the management of pain since the 1960s. The clinical impression is that they are useful for chronic neuropathic pain, especially when the pain is lancinating or burning. OBJECTIVES: To evaluate the analgesic effectiveness and adverse effects of the anticonvulsant medicine carbamazepine for pain management in clinical practice and to identify a clinical research agenda. Migraine and headache studies are not included in this review. SEARCH STRATEGY: Randomised trials (RCTs) of anticonvulsants in acute, chronic or cancer pain were identified by MEDLINE (1966-2004), EMBASE (1994-2004), SIGLE (1980-2004) and the Cochrane Controlled Trials Register (CENTRAL/CCTR) (Cochrane Library Issue 3, 2003). In addition, 41 medical journals were hand searched for a previous version of this review. Additional reports were identified from the reference list of the retrieved papers, and by contacting investigators. Date of most recent search: November 2004. SELECTION CRITERIA: Randomised trials reporting the analgesic effects of carbamazepine in patients, with subjective pain assessment as either the primary or a secondary outcome. DATA COLLECTION AND ANALYSIS: Data were extracted by two independent reviewers, and trials were quality scored. Numbers-needed-to-treat (NNTs) were calculated from dichotomous data for effectiveness, adverse effects and drug-related study withdrawal, for individual studies and for pooled data. MAIN RESULTS: Twelve studies were included (404 participants). Four studies included trigeminal neuralgia patients. Two studies which provided evaluable data yielded an NNT for effectiveness of 1.8 (95%CI 1.4-2.8). For diabetic neuropathy there was insufficient data for an NNT to be calculated.Numbers-needed-to-harm (NNHs) were calculated where possible by combining studies for each drug entity irrespective of the condition treated. The results were, for minor harm, carbamazepine 3.7 (CI 2.4-7.8), NNHs for major harm were not statistically significant for carbamazepine compared with placebo. There is no evidence that carbamazepine is effective for acute pain. AUTHORS' CONCLUSIONS: There is evidence to show that carbamazepine is effective but trials are small.

Acute Disease↗

PubMed2005

Gabapentin for acute and chronic pain.

BACKGROUND: Anticonvulsant drugs have been used in the management of pain since the 1960s. The clinical impression is that they are useful for chronic neuropathic pain, especially when the pain is lancinating or burning. OBJECTIVES: To evaluate the analgesic effectiveness and adverse effects of gabapentin for pain management in clinical practice. SEARCH STRATEGY: Randomised trials of gabapentin in acute, chronic or cancer pain were identified by MEDLINE (1966-Nov 2004), EMBASE (1994-Nov 2004), SIGLE (1980-Jan 2004) and the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library Issue 4, 2004). Additional reports were identified from the reference list of the retrieved papers, and by contacting investigators. Date of most recent search: January 2004. SELECTION CRITERIA: Randomised trials reporting the analgesic effects of gabapentin in patients, with subjective pain assessment as either the primary or a secondary outcome. DATA COLLECTION AND ANALYSIS: Data were extracted by two independent reviewers, and trials were quality scored. Numbers-needed-to-treat (NNTs) were calculated, where possible, from dichotomous data for effectiveness, adverse effects and drug-related study withdrawal. MAIN RESULTS: Fourteen reports describing 15 studies of gabapentin were considered eligible (1468 participants). One was a study of acute pain. The remainder included the following conditions: post-herpetic neuralgia (two studies), diabetic neuropathy (seven studies), a cancer related neuropathic pain (one study) phantom limb pain (one study), Guillain Barré syndrome (one study) , spinal chord injury pain (one study) and various neuropathic pains (one study). The study in acute post-operative pain (70 participants) showed no benefit for gabapentin compared to placebo for pain at rest. In chronic pain, the NNT for improvement in all trials with evaluable data is 4.3 (95%CI 3.5-5.7). Forty two percent of participants improved on gabapentin compared to 19% on placebo. The number needed to harm(NNH) for adverse events leading to withdrawal from a trial was not significant. Fourteen percent of participants withdrew from active arms compared to 10% in placebo arms. The NNH for minor harm was 3.7 (95% CI 2.4 to 5.4). The NNT for effective pain relief in diabetic neuropathy was 2.9 (95% CI 2.2 to 4.3) and for post herpetic neuralgia 3.9 (95% CI 3 to 5.7). AUTHORS' CONCLUSIONS: There is evidence to show that gabapentin is effective in neuropathic pain. There is limited evidence to show that gabapentin is ineffective in acute pain.

Acute Disease↗

PubMed2005

Single dose oral rofecoxib for postoperative pain.

BACKGROUND: Editor's note: The anti-inflammatory drug rofecoxib (Vioxx) was withdrawn from the market at the end of September 2004 after it was shown that long-term use (greater than 18 months) could increase the risk of heart attack and stroke. So far, other similar anti-inflammatory drugs are unaffected. Further information is available at www.vioxx.com. Rofecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor that was licensed in the UK and the US for acute pain treatment and is associated with fewer gastrointestinal adverse events than conventional NSAIDs. Rofecoxib is believed to be at least as effective as conventional non-steroidal anti-inflammatory drugs (NSAIDs) for postoperative pain. OBJECTIVES: To assess the analgesic efficacy and adverse effects of a single oral dose of rofecoxib for moderate to severe postoperative pain, and to compare its effectiveness with other analgesics used for treating acute pain. SEARCH STRATEGY: We searched Cochrane Library (Issue 1, 2002), MEDLINE (1966 to March 2002), Biological Abstracts (1985 to Dec 2001), CINAHL (1982 to Dec 2001), Psychinfo (1967 to Jan 2002), PubMed (March 2001) and the Oxford pain database. SELECTION CRITERIA: Randomised controlled trials of adult patients who received either rofecoxib or placebo for postoperative pain. DATA COLLECTION AND ANALYSIS: Trials were quality scored and the data extracted by two reviewers independently. Summed pain relief (TOTPAR) or pain intensity difference (SPID) was extracted and converted into dichotomous information yielding the number of patients with at least 50% pain relief. These derived results were used to calculate the relative benefit (RB) and number-needed-to-treat (NNT) for one patient to achieve at least 50% pain relief. MAIN RESULTS: Seven studies met the inclusion criteria. All the trials were funded by Merck & Company, the manufacturer of rofecoxib. In total, 667 patients were treated with rofecoxib 50 mg and 315 with placebo. The NNT for rofecoxib 50 mg was 2.2 (95% CI 1.9 to 2.4), ie, for every two patients treated with rofecoxib 50 mg, one patient experienced at least 50% pain relief that would not have done had they received placebo. All the studies were of short duration, and reported adverse events occurred less frequently with rofecoxib 50 mg than with placebo. AUTHORS' CONCLUSIONS: Rofecoxib 50 mg (a dose 2 to 4 times the standard daily dose for chronic pain) is an effective single dose oral analgesic for acute postoperative pain.

Administration, Oral↗

PubMed2005

Acute pain: individual patient meta-analysis shows the impact of different ways of analysing and presenting results.

Individual patient meta-analysis using information from clinically homogeneous acute pain trials with observations over 24h was used to investigate different ways trials can be analysed and reported. There were 13 third-molar extraction trials, with 1,330 patients using rofecoxib 50mg, 303 using ibuprofen 400mg, and 570 using placebo. Pain relief scores were available at individual time points, plus time to remedication. Many more patients remedicated with placebo than ibuprofen 400mg, and more with ibuprofen than rofecoxib 50mg. Median time to remedication, the proportion remedicated at various times, or survival curves would be useful outcomes. In dealing with missing data points when patients remedicated, baseline observation carried forward was more conservative than last observation carried forward, resulting in higher (worse) NNTs and lower average pain scores after 12 and 24h. Results based on both methods might be sensible for trials longer than eight hours. The distribution of pain relief was highly skewed, especially at later times, when almost no patient was average. Different cut points for pain relief (at least 25, 50 or 75% maxTOTPAR) and longer duration changed the NNT for ibuprofen compared with placebo, but less for rofecoxib, reflecting longer duration of action of rofecoxib. Reporting for each treatment group the percentage of patients with 25, 50 and 75% pain relief at various times after dose, and reporting the proportion of patients with good or complete pain relief, and inadequate pain relief, at each time point, would improve acute pain trial reporting.

Acute Disease↗

PubMed2005

Effect of preoperative Cox-II-selective NSAIDs (coxibs) on postoperative outcomes: a systematic review of randomized studies.

BACKGROUND: Preoperative use of coxibs has been claimed to reduce postoperative pain and analgesic consumption, and to affect other postoperative outcomes. METHODS: Systematic review of randomized trials comparing preoperative coxib with preoperative placebo, or active comparator. Searching of PubMed and Cochrane Library to August 2004. A qualitative and a quantitative analysis. RESULTS: Twenty-two included trials with 2246 patients had high reporting quality and validity scores, though treatment group sizes were small, with a median size of 30 patients. Most trials used oral preoperative rofecoxib (mainly 50 mg) or celecoxib (mainly 200 mg). Preoperative coxibs significantly reduced both postoperative pain and analgesic consumption compared with preoperative placebo in 15/20 trials. In one further trial postoperative pain was reduced and in one analgesic consumption. There was no significant difference in the incidence of postoperative nausea and vomiting in 13/17 studies or when data were pooled. Postoperative antiemetic use was significantly reduced in all five trials reporting it; the NNT to prevent one patient using postoperative antiemetic was 10 (5.5 to 66). No trial reported any significant difference in intraoperative blood loss or recovery from anaesthesia. Patient satisfaction was significantly increased with preoperative coxib use. No conclusions could be drawn from the three trials comparing preoperative coxib with preoperative NSAID. One study reported significantly improved cost-efficacy with rofecoxib. CONCLUSIONS: Preoperative coxibs had clear benefits in terms of reduced postoperative pain, analgesic consumption and patient satisfaction compared with placebo. Effects on postoperative nausea and vomiting remain uncertain, as do those on recovery from surgery or economic benefit. Future trials should be larger and more pragmatic in nature.

Analgesics↗

PubMed2005

Placebo.

Placebo, used here to mean an inert treatment given as if it was a real treatment, means lots of different things to different people. The structure of the article is that it begins by talking about the technical use of placebos in clinical trials, and the extent of the placebo response, then about the mechanism--"How does the placebo work?"--and last about the ethics of placebo in the contexts of research and in everyday practice.

Controlled Clinical Trials as Topic↗

PubMed2004

Single dose oral naproxen and naproxen sodium for acute postoperative pain.

BACKGROUND: Postoperative pain is often poorly managed. Treatment options include a range of drug therapies such as non-steroidal anti-inflammatory drugs (NSAIDs) of which naproxen is one. Naproxen is used to treat a variety of painful conditions including acute postoperative pain, and is often combined with sodium to improve its solubility for oral administration. Naproxen sodium 550 mg (equivalent to 500 mg of naproxen) is considered to be an effective dose for treating postoperative pain but to date no systematic review of the effectiveness of naproxen/naproxen sodium at different doses has been published. OBJECTIVES: To assess the efficacy, safety and duration of action of a single oral dose of naproxen or naproxen sodium for acute postoperative pain in adults. SEARCH STRATEGY: We searched The Cochrane Library, MEDLINE, EMBASE and the Oxford Pain Relief Database for relevant studies. Additional studies were identified from the reference list of retrieved reports. The most recent search was undertaken in July 2004. SELECTION CRITERIA: Included studies were randomised, double blind, placebo-controlled trials of a single dose of orally administered naproxen or naproxen sodium in adults with moderate to severe acute postoperative pain. DATA COLLECTION AND ANALYSIS: Pain relief or pain intensity data were extracted and converted into dichotomous information to give the number of patients with at least 50% pain relief over four to six hours. Relative risk estimates (RR) and the number-needed-to-treat (NNT) for at least 50% pain relief were then calculated. Information was sought on the percentage of patients experiencing any adverse event, and the number-needed-to-harm was derived. Time to remedication was also estimated. MAIN RESULTS: Ten trials (996 patients) met the inclusion criteria: nine assessed naproxen sodium; one combined the results from two small trials of naproxen alone. Included studies scored well for methodological quality. Meta-analysis of six trials (500 patients) that compared naproxen sodium 550 mg with placebo gave a RR for at least 50% pain relief over 4 to 6 hours of 4.2 (95% confidence interval (CI) 2.9 to 6.0) and an NNT of 2.6 (95% CI 2.2 to 3.2). Three trials (334 patients) assessed naproxen 400 mg and naproxen sodium 440 mg, giving a RR of 4.8 (95% CI 2.75 to 8.38). Two small studies indicated that naproxen 200 mg and naproxen sodium 220 mg may provide effective postoperative pain relief. There was no significant difference between the number of patients experiencing any adverse event on treatment compared with placebo. Weighted mean time to remedication for naproxen sodium 550 mg was 7.6 hours compared with 2.6 hours for placebo. REVIEWERS' CONCLUSIONS: Naproxen sodium 550 mg, naproxen 400 mg and naproxen sodium 440 mg administered orally are effective analgesics for the treatment of acute postoperative pain in adults. A low incidence of adverse events was found but reporting was not consistent.

Acute Disease↗

PubMed2004

Single dose oral indometacin for the treatment of acute postoperative pain.

BACKGROUND: Indometacin is a non-steroidal anti-inflammatory drug (NSAID) used most commonly for the treatment of inflammation and pain resulting from rheumatic disease (arthritis), and less commonly in postoperative pain management. When taken for chronic pain conditions, indometacin has been associated with a high incidence of adverse events. The benefits and harms of orally-administered indometacin for postoperative pain are not clear. OBJECTIVES: To determine the efficacy of a single dose of oral indometacin compared with placebo in treating acute postoperative pain in adults, and to analyse information relating to adverse events. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials in The Cochrane Library (Issue 3, 2004), MEDLINE, EMBASE and the Oxford Pain Relief Database for relevant studies. Additional studies were sought from the reference lists of retrieved reports. SELECTION CRITERIA: Studies were included in the review if they were randomised, double blind, placebo-controlled clinical trials using a single oral dose of indometacin in adults with acute postoperative pain. DATA COLLECTION AND ANALYSIS: Trials were assessed independently by two authors. Pain relief or pain intensity data were extracted and converted into dichotomous information to give the number of patients with at least 50% pain relief over four to six hours. The relative benefit for at least 50% pain relief was calculated. MAIN RESULTS: One trial of 59 women with post-episiotomy pain met the inclusion criteria. The dose of indometacin assessed against placebo was 50 mg, and the results concluded that indometacin was not significantly better than placebo for relieving postoperative pain at four to six hours. There was insufficient information to conduct further efficacy analyses or assess adverse events. REVIEWERS' CONCLUSIONS: Conclusions about the clinical efficacy of indometacin for postoperative cannot be made until more trials are conducted for a variety of surgical procedures, and different doses of indometacin are assessed.

Administration, Oral↗

PubMed2004

Relative efficacy of oral analgesics after third molar extraction.

OBJECTIVES: To compare the relative efficacy of analgesics after third molar extraction from systematic reviews of randomised, double blind studies. DATA SOURCES: Dental trials from systematic reviews of randomised, double-blind studies of analgesics in acute pain. DATA SELECTION: Number of patients with moderate or severe pain achieving at least half pain relief over 4 to 6 hours after a single oral dose of analgesic. DATA EXTRACTION: Independently by two reviewers. DATA SYNTHESIS: Use of dichotomous information from active and placebo treatments, first to calculate the statistical significance using relative risk, and then to evaluate the clinical relevance using number needed to treat (NNT). Non-steroidal anti-inflammatory drugs (NSAIDs) and cyclo-oxygenase-2 (COX-2) inhibitors had the lowest (best) NNTs for the outcome of at least half pain relief over 4-6 hours compared with placebo. With the best performing analgesics, 50-70 patients out of 100 had good pain relief compared with about 10 out of 100 with placebo. Only paracetamol 600/650 mg plus codeine 60 mg was associated with any significant increase in any patient experiencing an adverse event. CONCLUSIONS: NSAIDs and COX-2 inhibitors have the lowest (best) NNTs. They may also have fewer adverse effects after third molar surgery, though conclusive evidence is lacking. At least 80% of analgesic prescribing by UK dentists is in line with the best available evidence on efficacy and safety.

Acetaminophen↗

PubMed2004

Single dose oral rofecoxib for postoperative pain.

BACKGROUND: Rofecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor licensed in the UK and the US for acute pain treatment and is associated with fewer gastrointestinal adverse events than conventional NSAIDs. Rofecoxib is believed to be at least as effective as conventional non-steroidal anti-inflammatory drugs (NSAIDs) for postoperative pain. OBJECTIVES: To assess the analgesic efficacy and adverse effects of a single oral dose of rofecoxib for moderate to severe postoperative pain, and to compare its effectiveness with other analgesics used for treating acute pain. SEARCH STRATEGY: We searched Cochrane Library (Issue 1, 2002), MEDLINE (1966 to March 2002), Biological Abstracts (1985 to Dec 2001), CINAHL (1982 to Dec 2001), Psychinfo (1967 to Jan 2002), PubMed (March 2001) and the Oxford pain database. SELECTION CRITERIA: Randomised controlled trials of adult patients who received either rofecoxib or placebo for postoperative pain. DATA COLLECTION AND ANALYSIS: Trials were quality scored and the data extracted by two reviewers independently. Summed pain relief (TOTPAR) or pain intensity difference (SPID) was extracted and converted into dichotomous information yielding the number of patients with at least 50% pain relief. These derived results were used to calculate the relative benefit (RB) and number-needed-to-treat (NNT) for one patient to achieve at least 50% pain relief. MAIN RESULTS: Seven studies met the inclusion criteria. All the trials were funded by Merck & Company, the manufacturer of rofecoxib. In total, 667 patients were treated with rofecoxib 50 mg and 315 with placebo. The NNT for rofecoxib 50 mg was 2.2 (95% CI 1.9 to 2.4), ie, for every two patients treated with rofecoxib 50 mg, one patient experienced at least 50% pain relief that would not have done had they received placebo. All the studies were of short duration, and reported adverse events occurred less frequently with rofecoxib 50 mg than with placebo. REVIEWER'S CONCLUSIONS: Rofecoxib 50 mg (a dose 2 to 4 times the standard daily dose for chronic pain) is an effective single dose oral analgesic for acute postoperative pain.

Adult↗

PubMed2004

Single dose oral diclofenac for postoperative pain.

BACKGROUND: Diclofenac is a benzene-acetic acid derivative that acts, like other NSAIDs, by inhibiting cyclo-oxygenase isoforms that mediate the body's production of the prostaglandins implicated in pain and inflammation. Diclofenac is widely available as a sodium or potassium salt. Diclofenac potassium tablets are known as 'immediate-release' diclofenac as absorption takes place in the gastrointestinal tract whereas 'delayed-release' (enteric-coated) diclofenac tablets resist dissolution until reaching the duodenum. An existing review showed that diclofenac was an effective treatment for acute postoperative pain but did not address the distinction between potassium and sodium salts due to lack of data. The aim of this update is to gather and add appropriate information published subsequently and, data permitting, examine any potential differences between the two different diclofenac formulations. OBJECTIVES: To assess single dose oral diclofenac for the treatment of acute postoperative pain and determine whether there are differences between the different formulations. SEARCH STRATEGY: We searched the Cochrane Library (Issue 2, 2003), MEDLINE (1966 to May 1996), EMBASE (1980 to 1996), Biological Abstracts (1985 to 2003), the Oxford Pain Relief Database (1950 to 1994), PubMed (1996 to 2003) and reference lists of articles. SELECTION CRITERIA: Randomised, double-blind, placebo-controlled clinical trials of single dose, oral diclofenac sodium or diclofenac potassium for acute postoperative pain in adults. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trials for inclusion in the review, quality and extracted data. The area under the pain relief versus time curve was used to derive the proportion of patients prescribed diclofenac or placebo with at least 50% pain relief over four to six hours using validated equations. The number needed to treat (NNT) was calculated. Information on adverse effects was also collected. MAIN RESULTS: One additional trial was included and added to the six trials included in the original review. All seven trials provided data for quantitative analysis: 581 patients were treated with diclofenac and 364 were treated with placebo. The NNT for at least 50% relief over four to six hours with diclofenac 25 mg, 50 mg and 100 mg compared with placebo was 2.8 (95% CI 2.1 to 4.3), 2.3 (2.0 to 2.7) and 1.9 (1.6 to 2.2) respectively. Though higher doses produced lower (better) NNTs, statistical significance was not achieved. There was no significant difference between diclofenac 50 mg and placebo in the proportion of patients experiencing dizziness, headache, nausea or vomiting. The weighted median duration of analgesia was 2 hours for placebo, 6.7 hours for diclofenac 50 mg and 7.2 hours for diclofenac 100 mg. Sensitivity analyses for drug formulation, pain model, trial size and quality did not reveal any statistically significant differences. REVIEWERS' CONCLUSIONS: Oral diclofenac is an effective single-dose treatment for moderate to severe postoperative pain. There was no significant difference between diclofenac and placebo in the incidence of adverse effects, or between diclofenac sodium and potassium, different pain models, smaller and larger trials and trials of higher and lower quality.

Administration, Oral↗

PubMed2003

Single dose oral celecoxib for postoperative pain.

BACKGROUND: Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor prescribed for the relief of chronic pain in osteoarthritis and rheumatoid arthritis. The drug is believed to be associated with fewer adverse effects than conventional non-steroidal anti-inflammatory drugs (NSAIDs). However, the effectiveness of celecoxib in the treatment of acute pain has not yet been assessed by systematic review. OBJECTIVES: To assess the analgesic efficacy and adverse effects of a single oral dose of celecoxib for moderate to severe postoperative pain. SEARCH STRATEGY: We searched the Cochrane Library Controlled Trials Register, MEDLINE, Biological Abstracts, PubMed and the Oxford Pain database. Date of the most recent search: May 2002. SELECTION CRITERIA: Randomised controlled trials (RCTs) of adults prescribed any dose of oral celecoxib or placebo for acute postoperative pain were included. DATA COLLECTION AND ANALYSIS: Two trials (418 subjects) met the inclusion criteria for this review. The trials were assessed for quality and the data extracted by two independent reviewers. Summed pain relief (TOTPAR) or pain intensity difference (SPID) was extracted and converted into dichotomous information yielding the number of patients with at least 50% pain relief over 4-6 hours. These derived results were used to calculate the relative benefit (RB) and number-needed-to-treat (NNT) for one patient to achieve at least 50% pain relief. MAIN RESULTS: The number-needed-to-treat for celecoxib 200 mg compared with placebo was 4.5 (CI 3.3 to 7.2). For every 4.5 patients experiencing moderate to severe acute pain treated with celecoxib 200 mg one more will experience at least 50% pain relief that would not have done had they received placebo. The median time to remedication over 24 hours was 5.1 hours with celecoxib 200 mg and 1.5 hours with placebo. Quantitative analysis of adverse effects was not possible but no serious or unexpected adverse effects were reported. REVIEWER'S CONCLUSIONS: Single dose oral celecoxib is an effective means of postoperative pain relief, similar in efficacy to aspirin 600/650 mg, and paracetamol 1000 mg. The two trials included used celecoxib 200 mg, a dose 50% less than is recommended for acute pain. More trials are needed to estimate efficacy for recommended dose of 400 mg, and to reinforce current findings for 200 mg, and provide data for pooled quantitative estimates of adverse effects.

Celecoxib↗

PubMed2002

Sildenafil (Viagra) for male erectile dysfunction: a meta-analysis of clinical trial reports.

BACKGROUND: Evaluation of company clinical trial reports could provide information for meta-analysis at the commercial introduction of a new technology. METHODS: Clinical trial reports of sildenafil for erectile dysfunction from September 1997 were used for meta-analysis of randomised trials (at least four weeks duration) and using fixed or dose optimisation regimens. The main outcome sought was an erection, sufficiently rigid for penetration, followed by successful intercourse, and conducted at home. RESULTS: Ten randomised controlled trials fulfilled the inclusion criteria (2123 men given sildenafil and 1131 placebo). NNT or NNH were calculated for important efficacy, adverse event and discontinuation outcomes. Dose optimisation led to at least 60% of attempts at sexual intercourse being successful in 49% of men, compared with 11% with placebo; the NNT was 2.7 (95% confidence interval 2.3 to 3.3). For global improvement in erections the NNT was 1.7 (1.6 to 1.9). Treatment-related adverse events occurred in 30% of men on dose optimised sildenafil compared with 11% on placebo; the NNH was 5.4 (4.3 to 7.3). All cause discontinuations were less frequent with sildenafil (10%) than with placebo (20%). Sildenafil dose optimisation gave efficacy equivalent to the highest fixed doses, and adverse events equivalent to the lowest fixed doses. CONCLUSION: This review of clinical trial reports available at the time of licensing agreed with later reviews that had many more trials and patients. Making reports submitted for marketing approval available publicly would provide better information when it was most needed, and would improve evidence-based introduction of new technologies.

Erectile Dysfunction↗

PubMed2002

Single dose dipyrone for acute renal colic pain.

BACKGROUND: Renal colic pain is extremely painful and requires immediate treatment with strong analgesics. Dipyrone is the most popular non-opioid first line analgesic in many countries but in others it has been banned (e.g. USA, UK) because of its association with blood dyscrasias such as agranulocytosis. Since dipyrone is used in many countries (e.g. Brazil, Spain) there is a need to determine the benefits and harms of its use to treat renal colic pain. OBJECTIVES: To assess quantitatively the analgesic efficacy and adverse effects of single-dose dipyrone in adults with moderate to severe renal colic pain. SEARCH STRATEGY: Published reports were identified from electronic databases (MEDLINE, EMBASE, the Cochrane Library, LILACS) and additional studies were identified from the reference lists of retrieved reports. Date of the most recent search: January 2000. SELECTION CRITERIA: Inclusion criteria were: full journal publication; RCT with a double-blind design; adult patients with baseline renal colic pain of moderate or severe intensity; treatment arms which included dipyrone (oral, intramuscular or intravenous administration) and a control; single dose data. DATA COLLECTION AND ANALYSIS: Summed pain intensity and pain relief data were extracted and converted into dichotomous information to yield the number of patients with at least 50% pain relief over 15-30 minutes, 1-2 hours and six hours. The proportion of patients with at least 50% pain relief was calculated. Single dose adverse effect data were collected. MAIN RESULTS: Eleven studies with 1053 patients (550 on dipyrone) met the inclusion criteria. Unfortunately, few data were available for analysis; most analyses were based on the results of single, small trials and statistical pooling of the results was inappropriate. Efficacy estimates were calculated as the weighted mean percent of patients achieving at least 50% pain relief with the range of values from trials contributing to the analysis. However, these estimates were not robust. Commonly reported adverse effects with intravenous dipyrone were dry mouth and somnolence, and one study reported pain at the injection site. Insufficient information was available for safety analyses to be conducted. REVIEWER'S CONCLUSIONS: Limited available data indicated that single dose dipyrone was of similar efficacy to other analgesics used in renal colic pain, although intramuscular dipyrone was less effective than diclofenac 75 mg. Combining dipyrone with antispasmolytic agents did not appear to improve its efficacy. Intravenous dipyrone was more effective than intramuscular dipyrone. Dry mouth and somnolence were commonly reported with intravenous dipyrone. None of the studies reported agranulocytosis.

Acute Disease↗

PubMed2001

Are cannabinoids an effective and safe treatment option in the management of pain? A qualitative systematic review.

OBJECTIVE: To establish whether cannabis is an effective and safe treatment option in the management of pain. DESIGN: Systematic review of randomised controlled trials. DATA SOURCES: Electronic databases Medline, Embase, Oxford Pain Database, and Cochrane Library; references from identified papers; hand searches. STUDY SELECTION: Trials of cannabis given by any route of administration (experimental intervention) with any analgesic or placebo (control intervention) in patients with acute, chronic non-malignant, or cancer pain. Outcomes examined were pain intensity scores, pain relief scores, and adverse effects. Validity of trials was assessed independently with the Oxford score. DATA EXTRACTION: Independent data extraction; discrepancies resolved by consensus. DATA SYNTHESIS: 20 randomised controlled trials were identified, 11 of which were excluded. Of the 9 included trials (222 patients), 5 trials related to cancer pain, 2 to chronic non-malignant pain, and 2 to acute postoperative pain. No randomised controlled trials evaluated cannabis; all tested active substances were cannabinoids. Oral delta-9-tetrahydrocannabinol (THC) 5-20 mg, an oral synthetic nitrogen analogue of THC 1 mg, and intramuscular levonantradol 1.5-3 mg were about as effective as codeine 50-120 mg, and oral benzopyranoperidine 2-4 mg was less effective than codeine 60-120 mg and no better than placebo. Adverse effects, most often psychotropic, were common. CONCLUSION: Cannabinoids are no more effective than codeine in controlling pain and have depressant effects on the central nervous system that limit their use. Their widespread introduction into clinical practice for pain management is therefore undesirable. In acute postoperative pain they should not be used. Before cannabinoids can be considered for treating spasticity and neuropathic pain, further valid randomised controlled studies are needed.

Analgesics, Non-Narcotic↗

PubMed2001

Cannabinoids for control of chemotherapy induced nausea and vomiting: quantitative systematic review.

OBJECTIVE: To quantify the antiemetic efficacy and adverse effects of cannabis used for sickness induced by chemotherapy. DESIGN: Systematic review. DATA SOURCES: Systematic search (Medline, Embase, Cochrane library, bibliographies), any language, to August 2000. STUDIES: 30 randomised comparisons of cannabis with placebo or antiemetics from which dichotomous data on efficacy and harm were available (1366 patients). Oral nabilone, oral dronabinol (tetrahydrocannabinol), and intramuscular levonantradol were tested. No cannabis was smoked. Follow up lasted 24 hours. RESULTS: Cannabinoids were more effective antiemetics than prochlorperazine, metoclopramide, chlorpromazine, thiethylperazine, haloperidol, domperidone, or alizapride: relative risk 1.38 (95% confidence interval 1.18 to 1.62), number needed to treat 6 for complete control of nausea; 1.28 (1.08 to 1.51), NNT 8 for complete control of vomiting. Cannabinoids were not more effective in patients receiving very low or very high emetogenic chemotherapy. In crossover trials, patients preferred cannabinoids for future chemotherapy cycles: 2.39 (2.05 to 2.78), NNT 3. Some potentially beneficial side effects occurred more often with cannabinoids: "high" 10.6 (6.86 to 16.5), NNT 3; sedation or drowsiness 1.66 (1.46 to 1.89), NNT 5; euphoria 12.5 (3.00 to 52.1), NNT 7. Harmful side effects also occurred more often with cannabinoids: dizziness 2.97 (2.31 to 3.83), NNT 3; dysphoria or depression 8.06 (3.38 to 19.2), NNT 8; hallucinations 6.10 (2.41 to 15.4), NNT 17; paranoia 8.58 (6.38 to 11.5), NNT 20; and arterial hypotension 2.23 (1.75 to 2.83), NNT 7. Patients given cannabinoids were more likely to withdraw due to side effects 4.67 (3.07 to 7.09), NNT 11. CONCLUSIONS: In selected patients, the cannabinoids tested in these trials may be useful as mood enhancing adjuvants for controlling chemotherapy related sickness. Potentially serious adverse effects, even when taken short term orally or intramuscularly, are likely to limit their widespread use.

Antiemetics↗

PubMed2001

Systematic review of the use of honey as a wound dressing.

OBJECTIVE: To investigate topical honey in superficial burns and wounds though a systematic review of randomised controlled trials. DATA SOURCES: Cochrane Library, MEDLINE, EMBASE, PubMed, reference lists and databases were used to seek randomised controlled trials. Seven randomised trials involved superficial burns, partial thickness burns, moderate to severe burns that included full thickness injury, and infected postoperative wounds. REVIEW METHODS: Studies were randomised trials using honey, published papers, with a comparator. Main outcomes were relative benefit and number-needed-to-treat to prevent an outcome relating to wound healing time or infection rate. RESULTS: One study in infected postoperative wounds compared honey with antiseptics plus systemic antibiotics. The number needed to treat with honey for good wound healing compared with antiseptic was 2.9 (95% confidence interval 1.7 to 9.7). Five studies in patients with partial thickness or superficial burns involved less than 40% of the body surface. Comparators were polyurethane film, amniotic membrane, potato peel and silver sulphadiazine. The number needed to treat for seven days with honey to produce one patient with a healed burn was 2.6 (2.1 to 3.4) compared with any other treatment and 2.7 (2.0 to 4.1) compared with potato and amniotic membrane. For some or all outcomes honey was superior to all these treatments. Time for healing was significantly shorter for honey than all these treatments. The quality of studies was low. CONCLUSION: Confidence in a conclusion that honey is a useful treatment for superficial wounds or burns is low. There is biological plausibility.

Anti-Bacterial Agents↗