A placebo controlled trial of ultrasound therapy in chronic leg ulceration.

A controlled study of the effects of ultrasound on healing chronic leg ulcers was carried out in conjunction with standard treatment on 38 patients divided randomly into two groups. All patients received standard treatment (paste impregnated bandage and a self-adhesive elastic bandage plus placebo ultrasound or ultrasound (1.0 watt/cm2 at 1 MHz, for 10 min) twice weekly for 8 weeks. Percentage healed ulcer area and number of healed ulcers were compared after 2, 4, 6 and 8 weeks. There were no significant differences in the proportion of healed ulcers or ulcer area in the ultrasound group as compared with the placebo group.     

Ketanserin in reflex sympathetic dystrophy. A double-blind placebo controlled cross-over trial

Ketanserin, a selective S2 serotonergic antagonist, was assessed against placebo in a double-blind cross-over study of 16 patients with chronic peripheral burning pain. Nine of these had signs of reflex sympathetic dystrophy (RSD). All patients underwent 4 intravenous regional treatments, 2 with ketanserin (10 mg for upper limb pain, 20 mg for lower limb pain) and 2 with placebo. In those patients with RSD ketanserin and not placebo provided significant (P less than 0.05) sustained pain relief as assessed by linear analogue scales. In patients who did not fulfil the criteria for RSD no significant relief was seen with placebo or ketanserin. Following tourniquet release, drowsiness, shakiness and faintness were reported at a higher (P less than 0.05) frequency after ketanserin than after placebo. All side effects were mild and transient, and no changes occurred in heart rate or blood pressure following ketanserin that were significantly different from those seen following placebo. A role for serotonin in the pathogenesis of RSD is proposed.     

A controlled trial of the treatment of migraine by acupuncture

A randomised controlled trial comparing true and sham acupuncture was conducted on 30 patients suffering from chronic migraine. Diary measures of headache and medication intake were recorded throughout the study, and measures of headache quality, anxiety, and pain behaviour were taken. The credibility of the true and sham treatment procedures was also assessed. True acupuncture was significantly more effective than the control procedure in reducing the pain of migraine headache. Posttreatment reductions in pain scores and medication of 43 and 38%, respectively, were recorded in the true acupuncture group and were maintained at 4-month and 1-year follow-up.     

Ketotifen in childhood asthma: a double-blind placebo controlled trial.

In a three week double-blind cross-over controlled trial in twenty asthmatic children, ketotifen (HC 20-511, 'Zaditen', Sandoz) showed no significant difference from placebo, although there was a consistent trend in favour of the active drug.     

A randomized, controlled trial of acupuncture for chronic daily headache

BACKGROUND: Approximately 4% of adults experience headaches nearly every day. Nonpharmacologic interventions for frequent headaches may be appropriate because medical management alone is often ineffective. OBJECTIVE: To assess the efficacy of acupuncture as an adjunct to medical management for chronic daily headache (CDH). METHODS: We conducted a randomized, controlled trial of 74 patients with CDH that compared medical management provided by neurologists to medical management plus 10 acupuncture treatments. Primary outcome measures were daily pain severity and headache-related quality of life (QoL). RESULTS: Patients who received only medical management did not demonstrate improvement in any of the standardized measures. Daily pain severity scores trended downward but did not differ between treatment groups (P= .60). Relative to medical management only, medical management plus acupuncture was associated with an improvement of 3.0 points (95% CI, 1.0 to 4.9) on the Headache Impact Test and an increase of 8 or more points on the role limitations due to physical problems, social functioning, and general mental health domains of the Short Form 36 Health Survey. Patients who received acupuncture were 3.7 times more likely (CI, 1.7 to 8.1) to report less suffering from headaches at 6 weeks (absolute risk reduction 46%; number needed to treat 2). CONCLUSION: Headache-specialty medical management alone was not associated with improved clinical outcomes among our study population. Supplementing medical management with acupuncture, however, resulted in improvements in health-related QoL and the perception by patients that they suffered less from headaches.     

The effects of acupuncture versus placebo in the treatment of headache

Forty-eight patients were entered into a placebo (mock TNS) versus acupuncture study to assess the effect of these therapies on headache. Treatment was evaluated by the use of patient diaries; each patient completed a daily diary for 4 weeks prior to treatment during 6 weeks of therapy and for 24 weeks of follow-up. Thirty-nine patients completed treatment and follow-up. At most acupuncture appears to be approximately 20% more effective than a placebo in alleviating headache but no statistically significant difference between these two treatments could be demonstrated. The implications of this result particularly with respect to determining treatment success and study method employed are discussed.     

Iontophoresis of vincristine versus saline in post-herpetic neuralgia. A controlled trial

Twenty patients with post-herpetic neuralgia (median duration 28.5 months) were randomly allocated to receive transdermal iontophoresis of either vincristine or saline. Although significant improvement in pain by word score and visual analogue scale (P = 0.05) was reported by 6 out of 10 of the vincristine group, none of the patients considered themselves 'cured.' There was no significant change in the saline group. No adverse haematological or neurological side effects were seen, but skin irritation and painless electrical burns were common in both groups. The dramatic relief of pain in patients with post-herpetic neuralgia of 3 months or less reported elsewhere was not seen in our group who had pain of a longer duration. This present trial does not confirm the value of vincristine iontophoresis in the treatment of post-herpetic neuralgia of over 6 months duration.     

A randomized controlled trial of acupuncture added to usual treatment for fibromyalgia

OBJECTIVE: To evaluate the effectiveness of acupuncture for fibromyalgia. METHODS: Fifty-eight women with fibromyalgia were allocated randomly to receive either acupuncture together with tricyclic antidepressants and exercise (n=34), or tricyclic antidepressants and exercise only (n=24). Patients rated their pain on a visual analogue scale. A blinded assessor evaluated both the mean pressure pain threshold value over all 18 fibromyalgia points and quality of life using SF-36. RESULTS: At the end of 20 sessions, patients who received acupuncture were significantly better than the control group in all measures of pain and in 5 of the SF-36 subscales. After 6 months, the acupuncture group was significantly better than the control group in numbers of tender points, mean pressure pain threshold at the 18 tender points and 3 subscales of SF-36. After one year, the acupuncture group showed significance in one subscale of the SF-36; at 2 years there were no significant differences in any outcome measures. CONCLUSION: Addition of acupuncture to usual treatments for fibromyalgia may be beneficial for pain and quality of life for 3 months after the end of treatment. Future research is needed to evaluate the specific effects of acupuncture for fibromyalgia.     

A randomized, double-blind, multicentre controlled trial of ibuprofen versus acetaminophen and placebo for symptoms of acute otitis media in children

Summary— Two hundred and nineteen children (boys: 56%, girls: 44%) were included in a randomized, double-blind, multicentre (4 centres) controlled trial designed to assess the efficacy and safety of ibuprofen (IBU) in the treatment of 1 to 6 year-old children with otoscopically proven acute otitis media (AOM), either unilateral or bilateral. They randomly received 10 mg/kg IBU (n = 71), or acetaminophen (PARA) (n = 73) or placebo (PLA) (n = 75), orally, tid, for 48 hours. All received oral cefaclor (Alfatil®, Lilly, France) for seven days. They were evaluated before (D0) and at the end of treatment (D2). The main criterion of response was the aspect (landmarks and color) of the tympanic membrane assessed on a semi-quantitative scale from 0 to 6. Other criteria, assessed on semi-quantitative scales, included relief of pain (0 or 1), rectal temperature (0 to 2), and overall evaluation by parents of the improvement of quality of life on three items: appetite (0 to 2), sleep (0 to 2) and playing activity (0 to 2). The results at D2 were as follows: there was no significant difference between treatment groups as to the main criterion, but only a trend for IBU and PARA to do better than PLA but not for IBU to do better than PARA. From these data there is no argument to emphasize the utility of nonsteroidal anti-inflammatory drugs (NSAIDs) in treating the inflammatory signs of the tympanic membrane in otitis. There was a statistically significant difference between treatment groups at D2 for pain, IBU being superior to PLA (P < 0.01): 7%, 10% and 25% of the children were still suffering at D2 in the IBU, PARA and PLA treatment groups, respectively. The difference between PARA and PLA for pain was not statistically significant. There was no significant difference between treatment groups for the other criteria. All treatments were well and equally tolerated. Although no significant difference was found between the treatment groups on the aspect of the tympanic membrane, the efficacy of IBU was evidenced on the relief of pain, the symptom that most disturbs the child.     

Homeopathy in HIV infection: a trial report of double-blind placebo controlled study.

OBJECTIVE: This study was aimed to evaluate the immuno-modulator role of homeopathic remedies in Human Immunodeficiency Virus (HIV) infection. METHODOLOGY: A randomised double blind clinical trial was conducted to compare the effect of homeopathic remedies with placebo, on CD4+ve T-lymphocytes in HIV infected individuals, conforming to Centres for Disease Control (CDC) stage II & III. 100 HIV+ve individuals between 18-50 y (71% males) were included in the study. 50 cases conformed to CDC stage II--Asymptomatic HIV infection, and 50 cases to CDC stage III--Persistent Generalised Lymphadenopathy (PGL). Cases were stratified according to their clinical status and CD4+ve lymphocyte counts. The randomisation charts were prepared much before the start of the trial by randomly assigning placebo and verum codes to registration numbers from 1 to 50. A single individualised homeopathic remedy was prescribed in each case and was followed up at intervals of 15 d to one month. A six months study was performed for each registered case. Assessment of progress was made by evaluation of CD+ve lymphocyte counts, which was the prospectively-defined main outcome measure of the study; the results were compared with the base line immune status. RESULTS: In PGL, a statistically significant difference was observed in CD+ve T-lymphocyte counts between pre and post trial levels in verum group (P < 0.01). In the placebo group a similar comparison yielded non-significant results. (P = 0.91). Analysis of change in the pre and post trial counts of CD4+ve cells between groups was also statistically significant (P = 0.04). In asymptomatic HIV infection, differences in absolute CD4+ve lymphocyte counts between pre and post trial levels were not significant. Analysis of changes in pre and post trial CD4 levels of placebo and verum groups for combined strata of asymptomatic and PGL groups was also not significant. CONCLUSION: The study suggests a possible role of homeopathic treatment in HIV infection in symptomatic phase, as evidenced by a statistically significant elevation of base line immune status in persistent generalised lymphadenopathy.     

A double-blind controlled study of seratonin uptake inhibitor (Zimelidine) versus placebo in chronic pain patients.

Forty patients with pain syndromes of both organic and psychogenic origin of at least 6 months' duration were included in a double-blind controlled study of a new rather selective serotonin uptake inhibitor, Zimelidine, versus placebo. Patients in the Zimelidine group experienced significantly more pain relief and tended to be able to reduce their need for analgesics more often than the patients in the placebo group. In the Zimelidine group 4 patients were excluded due to nausea and intestinal troubles versus only 1 patient in the placebo group. However, among the patients who completed the trial the side-effects were mild.     

Massage or music for pain relief in labour: A pilot randomised placebo controlled trial

Research on massage therapy for maternal pain and anxiety in labour is currently limited to four small trials. Each used different massage techniques, at different frequencies and durations, and relaxation techniques were included in three trials. Given the need to investigate massage interventions that complement maternal neurophysiological adaptations to labour and birth pain(s), we designed a pilot randomised controlled trial (RCT) to test the effects of a massage programme practised during physiological changes in pain threshold, from late pregnancy to birth, on women's reported pain, measured by a visual analogue scale (VAS) at 90min following birth. To control for the potential bias of the possible effects of support offered within preparation for the intervention group, the study included 3 arms – intervention (massage programme with relaxation techniques), placebo (music with relaxation techniques) and control (usual care). The placebo offered a non‐pharmacological coping strategy, to ensure that use of massage was the only difference between intervention and placebo groups. There was a trend towards slightly lower mean pain scores in the intervention group but these differences were not statistically significant. No differences were found in use of pharmacological analgesia, need for augmentation or mode of delivery. There was a trend towards more positive views of labour preparedness and sense of control in the intervention and placebo groups, compared with the control group. These findings suggest that regular massage with relaxation techniques from late pregnancy to birth is an acceptable coping strategy that merits a large trial with sufficient power to detect differences in reported pain as a primary outcome measure.     

Comparing the analgesic efficacy of morphine plus ketamine versus morphine plus placebo in patients with acute renal colic: A double-blinded randomized controlled trial

ObjectivesRenal colic (RC) is a common cause for emergency department visits. This study was conducted to compare the analgesic efficacy of morphine plus ketamine (MK) versus morphine plus placebo (MP) in patients with acute renal colic.MethodUsing a single center, double-blind, two-arm, parallel-group, randomized controlled trial, 200 patients were equally and randomly divided to receive 0.1 mg/kg morphine plus normal saline and 0.1 mg/kg morphine plus 0.2 mg/kg ketamine. The severity of renal colic was assessed by VAS at baseline, 20 and 40 min after drug injection. The number of adverse events also was recorded.ResultsTotally, 200 patients completed the study. Mean age of the patients was 35.60 ± 8.17 years. The patients were mostly men (68.5%). The severity of pain between the groups was not significantly different at baseline. Both groups showing a significant reduction in VAS scores across the three time points. The main effect comparing the two types of intervention was significant (F = 12.95, p = 0.000), suggesting a significant reduction in pain severity of patients in the MK group. The number of patients who suffered from vomiting was significantly higher in MP group than that of MK group (13 and 3, respectively (P = 0.009)). However, the risk of dizziness in the MK group was >2 times higher than MP group (relative risk: 2.282, 95% CI: 1.030–5.003, P = 0.039). The number of patients who needed rescue analgesia was significantly lower in the MK group (OR, 0.43 (0.22–0.83)).ConclusionAdding 0.2 mg/kg ketamine to 0.1 mg/kg morphine can reduce the renal colic pain, nausea and vomiting more than morphine alone; however, it was associated with higher number of patients with dizziness.     

Cophenylcaine spray vs. placebo in flexible nasendoscopy: a prospective double-blind randomised controlled trial

Practices vary across the UK on the use of topical preparation prior to flexible fibreoptic nasendoscopy. In this double-blind study, we randomised 98 patients to receive cophenylcaine or placebo nasal spray before flexible nasendoscopy. A visual analogue scale (1-100) was used to record pain, unpleasantness of taste and overall discomfort experienced. Overall, the procedure was associated with minimal pain and discomfort in both groups. There was no significant difference in pain or overall discomfort experienced between the two groups; however, the sensation of bad taste was significantly worse in the cophenylcaine group. In linear regression, factors that predicted the overall unpleasantness of the experience were primarily pain experienced and secondarily unpleasantness of taste. We conclude that the routine use of cophenylcaine for nasal preparation is not justified before flexible nasendoscopy.