Topical indomethacin in overuse injuries in athletes. A randomized double-blind study comparing Elmetacin with oral indomethacin and placebo. [Local anti-inflammatory treatment with a ketoprofen gel: current clinical findings]. [Efficacy and tolerability of ketoprofen lysine salt foam for topical use in the treatment of traumatic pathologies of the locomotor apparatus]. Portable thermogram technique for topically applied benzydamine cream in acute soft-tissue injuries. Ketoprofen 2.5% gel versus placebo gel in the treatment of acute soft tissue injuries. Analgesic efficacy of a lecithin-vehiculated diclofenac epolamine gel in shoulder periarthritis and lateral epicondylitis: a placebo-controlled, multicenter, randomized, double-blind clinical trial. A double-blind comparison of naproxen gel and placebo in the treatment of soft tissue injuries. Piroxicam 0.5% topical gel compared to placebo in the treatment of acute soft tissue injuries: a double-blind study comparing efficacy and safety. Diclofenac patch for topical treatment of acute impact injuries: a randomised, double blind, placebo controlled, multicentre study. Comparative efficacy of a proprietary topical ibuprofen gel and oral ibuprofen in acute soft tissue injuries: a randomized, double-blind study. A double-blind study of the efficacy of topical ketorolac tromethamine gel in the treatment of ankle sprain, in comparison to placebo and etofenamate. Double-blind controlled clinical study of the efficacy and tolerability of diclofenac-N-(2-hydroxyethyl)-pyrrolidine lecithin gel compared with diclofenac-N-(2-hydroxyethyl)-pyrrolidine gel in patients with peri and extraarticular inflammatory diseases. Topical ketoprofen patch in the treatment of tendinitis: a randomized, double blind, placebo controlled study. Efficacy of a proprietary ibuprofen gel in soft tissue injuries: a randomised, double-blind, placebo-controlled study. Topical ketoprofen patch (100 mg) for the treatment of ankle sprain: a randomized, double-blind, placebo-controlled study. Soft tissue trauma: a randomised controlled trial of the topical application of felbinac, a new NSAID. Effects of meclofenamic acid in the treatment of lesions deriving from minor traumatology. Evaluation of topical ibuprofen cream in the treatment of acute ankle sprains. [Treatment of soft tissue trauma with BPAA gel. Results of an Italian multicenter study vs. placebo]. Double-blind, randomized, controlled study on the efficacy and safety of a novel diclofenac epolamine gel formulated with lecithin for the treatment of sprains, strains and contusions. [Treatment of sprained ankles with 5% benzydamine creme. A double-blind study]. Flurbiprofen local action transcutaneous (LAT): clinical evaluation in the treatment of acute ankle sprains. Clinical evaluation of niflumic acid gel in the treatment of uncomplicated ankle sprains. Controlled clinical trial with Fentiazac cream in sport microtraumatology. A double-blind clinical study with benzydamine 3% cream on soft tissue injuries in an occupational health centre.
In this double-blind trial in 70 athletes with superficial overuse injuries, the effect of topically and systemically administered indomethacin was compared with a placebo control. The treatment period was 2 weeks and blindness was secured by the double-dummy technique. The basic data of the patients showed no significant differences on entry to the study. The majority of cases were acute or subacute, the mean duration of symptoms being 7.4 weeks. The results showed a marked therapeutic effect after 3-7 days of treatment and statistically significant differences between the topical formulation and the placebo were reached in the parameters patients assessment of improvement and pain in connection with daily activity within the first week of treatment. However, during the second week the statistical significances were lost. Only in the topically treated patients local adverse reactions were observed. In the oral indomethacin group all reactions were systemic, GI- and CNS-complaints being predominant. The results on efficacy as well as adverse reactions favour the use of topical indomethacin in superficial overuse injuries in athletes. nan In this study the authors evaluated the efficacy and tolerability of a foam of 15% ketoprofen lysine salt versus placebo in patients with articular traumas, pains and strains, distortions etc. All parameters considered were statistically significantly decreased after 7 days of active treatment as compared to placebo. Pain score decreased significantly at pressure (p < 0.001), pain on active movement (p < 0.005), pain on passive movement and pain at rest. Efficacy of the active foam was graded as satisfactory in 81.7% and its tolerability in 92.7% versus 44% and 29% with placebo respectively. Patients reported high acceptability (89%) of the new foam formulation. No systemic or local side effects were observed or reported. The 15% ketoprofen lysine salt foam for topical use can be considered an effective antiinflammatory and analgesic drug for the treatment of minor orthopedic and traumatic disorders, and was found to be perfectly tolerated. A double-blind, parallel trial was undertaken with 3% benzydamine cream compared with a matching placebo, on patients suffering acute soft-tissue injuries. 21 patients received active material and 22 received placebo material. Patients applied the cream lightly 6 times a day for 6 days. Assessments were made (by the same physician) on days 0, 2, 4 and 6, and signs and symptoms were graded as "absent", "slight", "moderate" or "severe". Thermograms were taken on day 0 and day 6. The results showed significant relief of spontaneous pain, significant reduction in tenderness on pressure and in swelling on days 2, 4 and 6 of the trial, and a significant reduction in functional impairment on days 4 and 6, in the patients who had received the 3% benzydamine cream. A parallel, double-blind, placebo controlled and randomized study in a single center was done with ketoprofen 2.5% gel to treat acute soft tissue injuries. Patients applied the gel twice a day for seven days, corresponding to 250 mg of ketoprofen per day. Assessments were made on the third and seventh day by VAS, subjective evaluation and pain threshold algometry. The study group consisted of 29 patients and the control group 27 patients. Pain at rest was significantly relieved in the ketoprofen group, whereas in the placebo group the difference was not significant. In terms of side-effects, no difference between the groups was noticed. In both groups, local dermal irritation was found. Our results suggested that ketoprofen 2.5% gel was safe and superior to placebo in the treatment of soft tissue injuries. Diclofenac epolamine (2-hydroxyethyl-pyrrolidine) (DHEP) is a diclofenac salt endowed with enhanced cutaneous permeation. To optimize its absorption after topical application, a lecithin-enriched DHEP 1.3% gel has been developed (DHEP lecithin gel) and investigated in patients with shoulder periarthritis and lateral epicondylitis in a placebo-controlled, multicenter double-blind clinical trial. One hundred fifty-eight patients were randomized to a 10-day treatment with DHEP lecithin gel or placebo (5 g t.i.d. applied on the painful area). The efficacy criteria were pain measured by visual analog scale (VAS) while performing a specific standardized movement, intake of rescue medication (paracetamol), and the disabilities of the arm, shoulder and hand (DASH) questionnaire. VAS scores indicated a consistently higher analgesic activity of DHEP lecithin gel. At day 3, pain was reduced by -20.1 +/- 20.2 and -9.9 +/- 12.7 mm in the DHEP lecithin gel- and placebo-treated patients, respectively (p < 0.001); at day 6 of treatment, DHEP lecithin gel induced a pain reduction of -33.2 +/- 26.1 mm, while the reduction achieved with placebo was only -21.2 +/- 18.8 mm (p < 0.001). The mean changes in DASH questionnaire indicated that DHEP lecithin gel was more effective than placebo in improving patient well-being and reducing difficulties in performing the activities most severely impaired by rheumatism, while no difference was observed between the two treatments in consumption of rescue medication. In conclusion, these results indicate that DHEP lecithin gel is a topically effective analgesic product in patients with shoulder periarthritis or lateral epicondylitis and provide further evidence on the use of topical nonsteroidal anti-inflammatory drugs as an optimal approach to the treatment of localized musculoskeletal disorders. A double-blind study was carried out in 120 patients who had received soft tissue injuries within the preceding 48 hours to compare the effectiveness of naproxen gel (10%) with placebo gel (base alone). The injuries were predominantly synovitis and tendinitis. Standard clinical evaluations of the patients' condition were made by physicians and patients on entry and after 3 and 7 days of treatment. Both treatments resulted in a significant improvement in symptoms, but naproxen gel was significantly superior to placebo gel (p less than 0.05). The response produced by naproxen was more rapid; all symptoms were significantly improved by Day 3 (p less than 0.05). The greater efficacy of naproxen was reflected in a lower usage of active drug compared with placebo which was consistent throughout the study. While the physicians' global assessments of the two gels did not differ significantly, the patients showed a preference in favour of naproxen (p less than 0.05) Naproxen gel was well tolerated; only 1 adverse event of itching occurred. It is suggested that naproxen gel offers an effective and convenient alternative to systemic non-steroidal anti-inflammatory drugs for patients where side-effects are to be avoided or when oral administration is undesirable. Piroxicam 0.5% gel, administered as 5 mg q.i.d. was compared to placebo gel in a double-blind study of the treatment of selected acute soft tissue injuries (ankle or acromioclavicular sprains, supraspinatus, or achilles tendinitis). A total of 200 patients (100 per treatment) were evaluated. Six patients (6%) in the piroxicam group discontinued treatment due to inefficacy, compared to 42/100 in the placebo group (p less than 0.001). Significantly greater reduction in pain (spontaneous and on movement), degree of joint restriction, pressure threshold and tenderness of the affected site were observed with piroxicam gel compared to placebo gel. The time to improvement was significantly less with the piroxicam gel. The overall evaluation of efficacy and of benefit to injury favoured piroxicam over placebo (p less than 0.0001). Both piroxicam and placebo gels were well tolerated, with 7 piroxicam and 15 placebo patients reporting primarily skin-related adverse effects. This study indicates that piroxicam 0.5% gel, administered as 5 mg q.i.d. is an effective treatment of musculoskeletal injuries (sprains and tendinitis), is significantly more effective than placebo, and is well tolerated. To investigate the clinical efficacy and safety of a newly developed diclofenac patch in the topical treatment of blunt impact injuries.
                This was a randomised, placebo controlled, double blind, multicentre study in 120 patients with traumatic blunt soft tissue injury. Within 3 h of the injury participants of sport competitions and training camps were enrolled and treated twice daily with the diclofenac or a placebo patch over a period of 7 days. Patients were randomised (1:1) to two parallel groups. Tenderness produced by pressure was measured twice daily during the first 3 days after enrollment as well as at day 7. Tenderness was defined as the amount of pressure (measured by a calibrated caliper at the centre of the injury) that first produced a pain reaction as reported by the patient.
                The primary efficacy variable was the area under the curve for tenderness over the first 3 days. The diclofenac patch was significantly more effective than placebo (p<0.0001). The treatment effect was 64.7 kp h/cm2 (95% confidence interval 48.7 to 80.9) between diclofenac and placebo patches. These results were supported by all secondary efficacy variables. The diclofenac patch produced rapid pain relief as reflected by the time to reach resolution of pain at the injured site which was significantly shorter compared to placebo (p<0.0001). The diclofenac patch was well tolerated. The most frequently observed adverse events were local cutaneous adverse reactions (pruritus, rash) of minor severity occurring with the same frequency as in the placebo group.
                A newly developed diclofenac patch is effective and safe for the treatment of blunt impact injuries. The efficacy of a novel, proprietary topical formulation of ibuprofen 5% gel (Ibugel) and ibuprofen 400 mg tablets (1200 mg daily) was compared in a double-blind, double-dummy, parallel group study in patients with acute soft tissue injuries. Patients received either active gel plus placebo tablets (n = 50) or active tablets plus placebo gel (n = 50) for at least 7 days. The gel was applied and one tablet was taken three times daily. The two treatments showed similar efficacy. There were no significant differences between the groups for either the primary efficacy endpoint, the median time for the injury to be rated as 'completely better' by the patients (>14 days active gel, 13.5 days active tablets; P = 0.59), or for other efficacy measures including the times to clinically significant relief from pain at rest or on movement and swelling. In summary, ibuprofen gel shows similar efficacy to oral ibuprofen 400 mg and may offer improved tolerability. In a double-blind, placebo-controlled study the efficacy and safety of topical ketorolac tromethamine were assessed in the reduction of inflammation and pain due to ankle sprain. Ketorolac 2% gel was compared with etofenamate and placebo (ketorolac vehicle) in a 15-day study. Patients attended for visits on days 1 (admission), 2, 3, 4, 8, and 15 of the study. Measurements of efficacy were ankle volume, pain measured on visual analogue scales (VAS) and verbal rating of pain. Safety was assessed by volunteered adverse events and vital signs. A total of 37 patients was admitted to the study of whom 13 received ketorolac, 12 placebo, and 12 etofenamate. One patient receiving ketorolac was lost to follow-up on day 15 owing to an unrelated accident. The remaining 36 patients completed the study. Ketorolac was significantly better than placebo in reducing the volume of the injured ankle based on the maximum, the area under the curve, and the day 15 percentage changes in ankle volume. Results for etofenamate were similar to those for ketorolac for all three variables and there were no significant differences between the active treatments. Reductions in VAS pain at rest were more marked in the ketorolac group than either of the other groups at all visits. On day 4 the differences between ketorolac and each of the other groups were statistically significant. Reductions in VAS pain on movement were also greatest for the ketorolac group at all visits. The differences between ketorolac and each of the other groups achieved statistical significance on days 4 and 8, but were marginal in terms of significance on day 2.(ABSTRACT TRUNCATED AT 250 WORDS) To evaluate the efficacy and tolerability of the new diclofenac-N-(2-hydroxyethyl)-pyrrolidine lecithin gel (DHEP lecithin gel, with 1.3% DHEP and 2.4% lecithin) compared with the efficacy and tolerability of diclofenac-N-(2-hydroxyethyl)-pyrrolidine gel (DHEP gel) in peri and extraarticular inflammatory states, a controlled, randomized, double-blind clinical study was conducted. Two groups of 50 patients each were enrolled and were given one of the two different formulations with a slight massage on the painful area three times a day for 10 consecutive days. Patients received a self-evaluation notebook in which to record daily assessment of spontaneous pain (Huskisson's visual analogue scale). On days 0, 3 and 10, the patients were visited by the investigator. All patients completed the study. The assessment of spontaneous pain showed that although pain decreased in both groups, the decrease was more marked in patients taking DEHP lecithin gel and that it reached a statistically significant difference at days 5, 6, 7 and 8. This decrease was also confirmed by assessments on the ordinal scale. Although periarticular swelling disappeared in both groups, swelling severity decreased sooner in patients taking DHEP lecithin gel. The efficacy and safety of both treatments was judged to be good or excellent by 70% of the patients in each group. The efficacy of the active principle, pyrrolidine salt, is confirmed. Moreover, the formulation containing lecithin passes through the skin lipid barrier more easily than the formulation without lecithin and is as valid as the other in the therapy of rheumatic disorders. Finally, DHEP lecithin gel preparation has a quicker therapeutic action on symptoms, such as spontaneous pain and local swelling, than DHEP gel. To evaluate the efficacy and tolerability of ketoprofen patch in the treatment of tendinitis.
                A multicenter, 14 day, randomized, double blind placebo controlled trial of a once-a-day ketoprofen 100 mg patch in symptomatic tendinitis of recent onset, not requiring orthopedic or surgical treatment. Pain on daily activities scored on a 100 mm visual analog scale was the primary efficacy criterion. Other criteria were spontaneous pain at rest, pain on full passive motion, pain relief, and pain intensity assessed twice daily by the patient (calculation of total pain relief and summed time-weighted pain intensity difference). Statistical analysis was performed on the differences between the 2 groups in the intention-to-treat population.
                One hundred seventy-two patients were included. Good compliance was obtained in 98% of patients. Twenty-six patients (15%) discontinued the study mainly because of adverse events, inefficacy, or cure. Decrease in pain after one week of treatment (primary criterion) was -38.4 +/- 25.6 mm (56%) and -25.8 +/- 24.5 mm (37%) in the ketoprofen and placebo groups, respectively (p = 0.0013). The differences of the secondary criteria during the trial between the 2 groups were significant more often than not. Tolerance was considered satisfactory in both groups, most adverse events reported being local reactions: 47 versus 44 were possibly or probably related to treatment in the ketoprofen and placebo groups, respectively. These local skin reactions resolved spontaneously and rarely led to premature termination of treatment.
                This trial suggested that a 3-14 day course of treatment by ketoprofen patch is useful in nonarticular rheumatisms, the duration of treatment depending on the results obtained. The safety profile revealed no unexpected adverse events. The efficacy of a novel, proprietary topical formulation of ibuprofen 5% gel (Ibugel) was evaluated in a placebo-controlled study in patients with soft tissue injuries. Patients received either active gel (n=40) or placebo gel (n=41) for a maximum of seven days. Pain and interference with physical activity were assessed daily using visual analogue scales. There was a significant difference (p<0.001) in favour of active treatment for the time to achieve clinically meaningful reduction in pain. By day 7, 75% of patients in the active gel group had a clinically meaningful reduction of pain compared with 39% of patients who received placebo. Despite differences between study centres, the data for interference with physical activity also showed an advantage for active treatment. By day 7, 79% of patients in the active gel group had a clinically meaningful reduction in interference with physical activity, compared with 44% of patients who received placebo. Topical nonsteroidal anti-inflammatory drugs offer the advantage of enhanced drug delivery to local affected tissues with low plasma levels and an expected reduced incidence of systemic adverse events (mainly peptic ulcer disease and gastrointestinal hemorrhage).
                To test the efficacy and tolerability of a 100-mg patch of ketoprofen applied once a day.
                Randomized controlled clinical trial; Level of evidence, 1.
                The 2-week trial included patients suffering painful (spontaneous pain >or=50 mm on a 0- to 100-mm visual analog scale), benign (grade I or II), recent (<2 days) ankle sprains as a model of general traumatic soft tissue injuries. The primary efficacy criterion was spontaneous pain change after 7 days of treatment in the intention-to-treat population. One hundred sixty-three patients were randomized (ketoprofen, 81; placebo, 82).
                After 1 week of treatment, the decrease in spontaneous pain was -50+/-20 mm for ketoprofen and -38+/-24 mm for the placebo, showing a statistically significant intergroup difference (P=.0007). The majority of the secondary criteria were also statistically significant in favor of the ketoprofen patch. Tolerance was good in both groups, adverse events being mostly local.
                This trial suggested that a 7-day course of treatment with a ketoprofen patch is useful in benign ankle sprain, without revealing unexpected adverse events. Two hundred and thirty-one patients with acute soft tissue injuries were treated in a double-blind placebo-controlled study of felbinac (biphenylacetic acid) gel applied three times daily to the injured site. Those treated with felbinac had significantly greater improvement at Day 4 (p less than 0.001) and Day 7 (p less than 0.02) than those who received placebo. Patients' self-assessment diary cards confirmed superiority of the active treatment as early as Day 2 of the study. Local skin reactions were few (three per cent), mild and recovered spontaneously. Felbinac is an effective management for acute soft tissue injuries and because of its topical application may be safer than oral non-steroidal anti-inflammatory drugs for the treatment of these conditions. The clinical efficacy and tolerability of topical 5% meclofenamic acid gel versus placebo and oral sodium meclofenamate versus sodium naproxen were evaluated in patients affected with minor traumatologies. Ninety patients were studied: 60 were treated with either meclofenamic acid gel or placebo for 10 days, and 30 were administered with either sodium meclofenamate capsules or sodium naproxen capsules for 7 days. The 5% meclofenamic acid gel and its sodium salt in capsules proved significantly more rapid and efficient than did the reference compounds in reducing pain symptomatology. In the patients treated with 5% meclofenamic acid gel, a greater effect was seen as regards rapidity of spontaneous movement and nocturnal pain reduction. In other variables examined, that is, surface and deep hyperalgesia, and swelling and functional restriction, there was also a significantly higher efficacy than with placebo. Confirmation of the therapeutic efficacy of meclofenamic acid (sodium salt) was obtained with the capsule formulation, that was seen to exert a significant analgesic and antiphlogistic action; the onset of this action was particularly rapid. Both formulations of meclofenamic acid (gel and capsules) were found to be well tolerated. Thus, in the examined formulations, meclofenamic acid proved to be a useful tool in the treatment of lesions in the minor traumatology category. One hundred patients who presented to the accident and emergency (A&E) department with an acute ankle sprain were entered into a study to determine the efficacy of topical ibuprofen cream by using a double-blind placebo controlled design in a single type of soft-tissue injury. The subjects were given either topical ibuprofen cream or a placebo cream in addition to the standard management of the department. Patients kept diaries recording walking ability and pain visual analogue scales for resting, standing and walking. A total of 51 patients returned diaries that were suitable for analysis. Patients using the topical ibuprofen cream had significant reduction in pain scores over the first 48 h of treatment. A double-blind study vs placebo was carried out on 82 pts suffering from soft tissue trauma, to evaluate the efficacy and tolerance of a new anti-inflammatory, non-steroidal analgesic for topical use, 3% BPAA. Clinical results obtained by the group treated with BPAA gel were highly significant (p = 0.01) and positive, showing absence of local and systemic side-effects. Accordingly, BPAA gel can be recommended for treatment of soft tissue trauma. To evaluate the efficacy of the new diclofenac-N-(2-hydroxyethyl)-pyrrolidine gel formulated with lecithin (DHEP lecithin) compared with diclofenac-N-(2-hydroxyethyl)-pyrrolidine gel (DHEP gel) without lecithin in mild-to-moderate posttraumatic injuries (grade 1 ankle, knee and muscle injuries), a multicenter, double-blind, controlled study was carried out. A total of 100 patients were enrolled and randomly assigned to either DHEP lecithin (n = 52) or DHEP gel (n = 48) treatment. All patients concluded the treatment period except for five, who did not turn up to their respective investigational sites for the follow-up visits. According to an intention-to-treat approach, they were all included in the statistical analysis. As for the efficacy and safety analysis, the primary variable was "pain on movement" as measured by a Huskisson visual analog scale. During the first 3 days of treatment each group recorded a significant within-group decrease, but patients treated with DHEP lecithin showed a decrease in absolute value that was statistically greater than that obtained with DHEP gel (p = 0.025). At the end of the treatment period (day 10) the difference between groups was still statistically significant (p = 0.036). The statistical analysis of the secondary efficacy variables showed significant results in favor of DHEP lecithin treatment. These were superimposable on the results found for the primary variable. The global efficacy and tolerability judgments, reported either by patient or by physician, showed no statistical difference between treatment groups. Due to the presence of lecithin in the new gel formulation, DHEP lecithin showed a faster and significantly more marked therapeutic effect compared with that of DHEP gel. nan One hundred and thirty-one male and female outpatients, aged 18-70 yr, with acute pain in the ankle joint caused by a post-traumatic sprain, entered a multicentre, randomised, double-blind, parallel-group, study. The patients were assigned to a 40 mg flurbiprofen patch (n = 65) or a non-medicated (but otherwise identical) control (n = 66), 12-hourly over 7 days, and were assessed at entry and after 3 and 7 days treatment. On day 7, spontaneous pain (the prime efficacy parameter), as evaluated by the patient on a visual analogue scale in the physician's office, showed significant improvement in the 40 mg flurbiprofen patch group compared to control (change from baseline) (p = 0.039), a result corroborated by the evaluation of the periarticular oedema: a reduction of 77.4% was observed in the 40 mg flurbiprofen patch group, compared with 63.8% in the control group (p = 0.025). The other selected efficacy criteria showed changes with a trend in favour of the 40 mg flurbiprofen patch but without statistical significance. Two mild and local adverse events were reported by two flurbiprofen patch patients, but neither patients discontinued the treatment prematurely. Physicians and patients found the flurbiprofen patch to be efficacious and well tolerated. Compliance was excellent in both groups. The efficacy and tolerability of the 40 mg flurbiprofen patch are therefore confirmed in the treatment of acute ankle sprains. A double-blind, placebo-controlled, multi-centre study was carried out to assess the efficacy and tolerability of percutaneous niflumic acid gel in the treatment of uncomplicated ankle sprains. Sixty patients were enrolled in three centres and were randomly allocated to receive treatment with 2.5% percutaneous niflumic acid gel or placebo gel applied 3-times daily for 7 days. Clinical evaluations were made on entry to the study, after 3 days and at the end of treatment. The major efficacy criteria were the pain felt by the patient and the investigators' and patients' global evaluation of effectiveness of the treatment. Adverse events that occurred were also noted. The results showed that topically applied 2.5% niflumic acid gel was superior to placebo in the treatment of ankle sprains in respect of all major parameters studied. Niflumic acid gel and the placebo were shown to be equally well tolerated. The study findings indicate that treatment with topical niflumic acid gel is effective in treating uncomplicated ankle sprains and results in improved clinical signs on Day 4 and after 7 days. Fentiazac 5% cream was applied topically on limited articular and extra-articular inflammatory lesions in the course of a double-blind clinical trial versus placebo. The drug proved to be satisfactorily tolerated and also therapeutically effective since it changed significantly (p less than 0.05--less than 0.01) the spontaneous course of the microtraumatic pathologic pattern producing an early attenuation and resolution of the painful and functional symptomatic pattern. A double-blind, controlled clinical study with benzydamine hydrochloride 3% cream was conducted in an Occupational Health Centre on fifty patients with soft tissue injuries (two mild, ten moderate and thirteen severe cases in the placebo group and one mild, thirteen moderate and twelve severe cases in the active group). The trial demonstrated the significant therapeutic superiority of 3% benzydamine cream over inactive placebo in all six qualitative parameters for traumatic inflammatory changes at the end of a six-day assessment and a marked improvement of symptoms event two days after the onset of therapy. In addition, tbe incidental use of ultrasound therapy together with the standard treatment revealed the value of the active drug as an effective couplant. Neither group suffered any side-effects. Although the size of population studied was small, it was apparent that active treatment with benzydamine was a distinct aid to healing of soft tissue injuries and this should be confirmed with further large-scale clinical trials.
Topical NSAIDs can provide good levels of pain relief, without the systemic adverse events associated with oral NSAIDs, when used to treat acute musculoskeletal conditions.