The aim of this study was to determine the clinical effect of Foeniculum vulgare on primary dysmenorrhoea. Sixty virgin girls with complaints of dysmenorrhoea were enrolled in this study, out of which 50 cases were completed the course of treatment and were divided in two groups (study and placebo) and were under treatment for two cycles. In study group a capsule of 30 mg fennel extract, four times a day for three days from start of their menstrual period and in placebo a capsule containing wheat flour in same dose was administered. Intensity of pain was reported by using a 10 - point linear analogue technique. In study group the mean age of menarche was 13.1 ± 0.1 and onset age of dysmenorrhoea was 14.5 ± 0.1 years. Both groups were relieved but there was significant difference between study and placebo group. Study group shown more effective results than placebo in pain relief (P`0.05). Based on the observations, it can be concluded that, fennel is an effective herbal drug for menstrual pain.
Fennel; Foeniculum vulgare; pain; primary dysmenorrhoea
The aim of this Phase III, multicentre, open-label, randomised study was to compare the efficacy and safety of ethinylestradiol (EE)/drospirenone (DRSP) in a new flexible extended regimen that allowed the management of intracyclic (breakthrough) bleeding (MIB) with that of EE/DRSP in a conventional 28-day regimen in women with moderate-to-severe primary dysmenorrhoea.
Women (aged 18–40 years) with moderate-to-severe primary dysmenorrhoea-related pain received a flexible extended regimen with MIB (flexibleMIB; minimum 24, maximum 120 days of continuous tablet intake for a flexible number of cycles to reach a treatment duration of at least 140 days with 4-day breaks between cycles) or a conventional 28-day regimen (24 active and four placebo tablets for five cycles) of EE/DRSP. The primary outcome was the number of days with dysmenorrhoeic pain over 140 days. Secondary outcomes included other dysmenorrhoea-related pain outcomes, bleeding profile, satisfaction and safety.
Overall, 223 patients received study medication. There were significantly fewer days with dysmenorrhoeic pain with the flexibleMIB regimen than the conventional regimen (difference −4.2 days, 95% CI −6.5 to −2.0; p=0.0003), as well as considerably fewer days with at least moderate dysmenorrhoeic pain (difference −2.5 days, 95% CI −3.7 to −1.3), dysmenorrhoeic pain that interfered with daily activities (difference −2.2 days, 95% CI −4.2 to −0.1) and pelvic pain (difference −3.4 days, 95% CI −5.9 to −0.9). Adverse events were similar with both regimens.
Compared with the conventional regimen, the flexible extended regimen of EE/DRSP with MIB was associated with a significantly greater reduction in days with dysmenorrhoeic pain in women with moderate-to-severe primary dysmenorrhoea. The flexibleMIB regimen was also associated with greater improvements in dysmenorrhea according to the Clinical Global Impression rating scale and was generally well tolerated.
Introduction. Noni (Morinda citrifolia) has been used for many years as an anti-inflammatory agent. We tested the efficacy of Noni in women with dysmenorrhea. Method. We did a prospective randomized double-blind placebo-controlled trial in 100 university students of 18 years and older over three menstrual cycles. Patients were invited to participate and randomly assigned to receive 400 mg Noni capsules or placebo. They were assessed for baseline demographic variables such as age, parity, and BMI. They were also assessed before and after treatment, for pain, menstrual blood loss, and laboratory variables: ESR, hemoglobin, and packed cell volume. Results. Of the 1027 women screened, 100 eligible women were randomized. Of the women completing the study, 42 women were randomized to Noni and 38 to placebo. There were no significant differences in any of the variables at randomization. There were also no significant differences in mean bleeding score or pain score at randomization. Both bleeding and pain scores gradually improved in both groups as the women were observed over three menstrual cycles; however, the improvement was not significantly different in the Noni group when compared to the controls. Conclusion. Noni did not show a reduction in menstrual pain or bleeding when compared to placebo.
In this preliminary trial we investigated the effects of dry cupping, an ancient method for treating pain syndromes, on patients with chronic non-specific neck pain. Sensory mechanical thresholds and the participants' self-reported outcome measures of pain and quality of life were evaluated.
Fifty patients (50.5 ± 11.9 years) were randomised to a treatment group (TG) or a waiting-list control group (WL). Patients in the TG received a series of 5 cupping treatments over a period of 2 weeks; the control group did not. Self-reported outcome measures before and after the cupping series included the following: Pain at rest (PR) and maximal pain related to movement (PM) on a 100-mm visual analogue scale (VAS), pain diary (PD) data on a 0-10 numeric rating scale (NRS), Neck Disability Index (NDI), and health-related quality of life (SF-36). In addition, the mechanical-detection thresholds (MDT), vibration-detection thresholds (VDT), and pressure-pain thresholds (PPT) were determined at pain-related and control areas.
Patients of the TG had significantly less pain after cupping therapy than patients of the WL group (PR: Δ-22.5 mm, p = 0.00002; PM: Δ-17.8 mm, p = 0.01). Pain diaries (PD) revealed that neck pain decreased gradually in the TG patients and that pain reported by the two groups differed significantly after the fifth cupping session (Δ-1.1, p = 0.001). There were also significant differences in the SF-36 subscales for bodily pain (Δ13.8, p = 0.006) and vitality (Δ10.2, p = 0.006). Group differences in PPT were significant at pain-related and control areas (all p < 0.05), but were not significant for MDT or VDT.
A series of five dry cupping treatments appeared to be effective in relieving chronic non-specific neck pain. Not only subjective measures improved, but also mechanical pain sensitivity differed significantly between the two groups, suggesting that cupping has an influence on functional pain processing.
The trial was registered at clinicaltrials.gov (NCT01289964).
Cupping is used in various traditional medicine forms to relieve pain in musculoskeletal diseases. The aim of this study was to investigate the effectiveness of cupping in relieving the symptoms of knee osteoarthritis (OA).
In a two-group, randomized controlled exploratory pilot study patients with a clinically and radiological confirmed knee OA (Kellgren-Lawrence Grading Scale: 2-4) and a pain intensity > 40 mm on a 100 mm visual analogue scale (VAS) were included. 40 Patients were randomized to either 8 sessions of pulsatile dry cupping within 4 weeks or no intervention (control). Paracetamol was allowed on demand for both groups. Outcomes were the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score, the pain intensity on a VAS (0 mm = no pain to 100 mm = maximum intensity) and Quality of Life (SF-36) 4 and 12 weeks after randomization. Use of Paracetamol was documented within the 4-week treatment period. Analyses were performed by analysis of covariance adjusting for the baseline value for each outcome.
21 patients were allocated to the cupping group (5 male; mean age 68 ± SD 7.2) and 19 to the control group (8 male; 69 ± 6.8). After 4 weeks the WOMAC global score improved significantly more in the cupping group with a mean of 27.7 (95% confidence interval 22.1; 33.3) compared to 42.2 (36.3; 48.1) in the control group (p = 0.001). After 12 weeks the WOMAC global score were still significantly different in favor for cupping (31.0 (24.9; 37.2) vs. 40.8 (34.4; 47.3) p = 0.032), however the WOMAC subscores for pain and stiffness were not significant anymore. Significantly better outcomes in the cupping group were also observed for pain intensity on VAS and for the SF-36 Physical Component Scale compared to the control group after 4 and 12 weeks. No significant difference was observed for the SF-36 Mental Component Scale and the total number of consumed Paracetamol tablets between both groups (mean 9.1, SD ± 20.0 vs. 11.5 ± 15.9).
In this exploratory study dry cupping with a pulsatile cupping device relieved symptoms of knee OA compared to no intervention. Further studies comparing cupping with active treatments are needed.
Clinicaltrials.gov Identifier: NCT01057043
Cupping; Complementary and alternative medicine; Randomized controlled trial; Knee osteoarthritis
Individual patient meta-analysis to determine the analgesic efficacy and adverse effects of single-dose rofecoxib in primary dysmenorrhoea.
Individual patient information was available from three randomised, double blind, placebo and active controlled trials of rofecoxib. Data were combined through meta-analysis. Number-needed-to-treat (NNT) for at least 50% pain relief and the proportion of patients who had taken rescue medication over 12 hours were calculated. Information was collected on adverse effects.
For single-dose rofecoxib 50 mg compared with placebo, the NNTs (with 95% CI) for at least 50% pain relief were 3.2 (2.4 to 4.5) at six, 3.1 (2.4 to 9.0) at eight, and 3.7 (2.8 to 5.6) at 12 hours. For naproxen sodium 550 mg they were 3.1 (2.4 to 4.4) at six, 3.0 (2.3 to 4.2) at eight, and 3.8 (2.7 to 6.1) at 12 hours. The proportion of patients who needed rescue medication within 12 hours was 27% with rofecoxib 50 mg, 29% with naproxen sodium 550 mg, and 50% with placebo. In the single-dose trial, the proportion of patients reporting any adverse effect was 8% (4/49) with rofecoxib 50 mg, 12% (6/49) with ibuprofen 400 mg, and 6% (3/49) with placebo. In the other two multiple dose trials, the proportion of patients reporting any adverse effect was 23% (42/179) with rofecoxib 50 mg, 24% (45/181) with naproxen sodium 550 mg, and 18% (33/178) with placebo.
Single dose rofecoxib 50 mg provided similar pain relief to naproxen sodium 550 mg over 12 hours. The duration of analgesia with rofecoxib 50 mg was similar to that of naproxen sodium 550 mg. Adverse effects were uncommon suggesting safety in short-term use of rofecoxib and naproxen sodium. Future research should include restriction on daily life and absence from work or school as outcomes.
Background: Dysmenorrhoea is the most common gynaecological disorder in women of reproductive age. Despite the association between stress and pregnancy outcomes, few studies have examined the possible link between stress and dysmenorrhoea.
Aims and Methods: Using a population based cohort of Chinese women, the independent effect of women's perceived stress in the preceding menstrual cycle on the incidence of dysmenorrhoea in the subsequent cycle was investigated prospectively. The analysis included 1160 prospectively observed menstrual cycles from 388 healthy, nulliparous, newly married women who intended to conceive. The perception of stress and the occurrence of dysmenorrhoea in each menstrual cycle were determined from daily diaries recorded by the women.
Results: After adjustment for important covariates, the risk of dysmenorrhoea was more than twice as great among women with high stress compared to those with low stress in the preceding cycle (OR = 2.4; 95% CI 1.4 to 4.3). The risk of dysmenorrhoea was greatest among women with both high stress and a history of dysmenorrhoea compared to women with low stress and no history of dysmenorrhoea (OR = 10.4, 95% CI 4.9 to 22.3). Stress in the follicular phase of the preceding cycles had a stronger association with dysmenorrhoea than stress in the luteal phase of the preceding cycles.
Conclusion: This study shows a significant association between stress and the incidence of dysmenorrhoea, which is even stronger among women with a history of dysmenorrhoea.
To investigate the association between self-reported dysmenorrhoea and patterns of female initiation rites at menarche among Amazonian indigenous peoples of Vaupés in Colombia.
A cross-sectional study of all women in seven indigenous communities. Questionnaire administered in local language documented female initiation rites and experience of dysmenorrhoea. Analysis examined 10 initiation components separately, then together, comparing women who underwent all rites, some rites and no rites.
Seven indigenous communities belonging to the Tukano language group in the Great Eastern Reservation of Vaupés (Colombia) in 2008.
All women over the age of 13 years living in the seven communities in Vaupés, who had experienced at least two menstruations (n=185), aged 13–88 years (mean 32.5; SD 15.6).
Primary and secondary outcome measures
The analysis rested on pelvic pain to define dysmenorrhoea as the main outcome. Women were also asked about other disorders present during menstruation or the precedent days, and about the interval between two menstruations and duration of each one.
Only 17.3% (32/185) completed all initiation rites and 52.4% (97/185) reported dysmenorrhoea. Women not completing the rites were more likely to report dysmenorrhoea than those who did so (p=0.01 Fisher exact), taking into account age, education, community, parity and use of family planning. Women who completed less than the full complement of rites had higher risk than those who completed all rites. Those who did not complete all rites reported increased severity of dysmenorrhoea (p=0.00014).
Our results are compatible with an association between traditional practices and women's health. We could exclude indirect associations with age, education, parity and use of family planning as explanations for the association. The study indicates feasibility, possible utility and limits of intercultural epidemiology in small groups.
Intercultural ; Dysmenorrhoea; Tradicional medicine; Initiation rites
Chronic neck pain is a major public health problem with very few evidence-based complementary treatment options. This study aimed to test the efficacy of 12 weeks of a partner-delivered home-based cupping massage, compared to the same period of progressive muscle relaxation in patients with chronic non-specific neck pain. Patients were randomly assigned to self-directed cupping massage or progressive muscle relaxation. They were trained and asked to undertake the assigned treatment twice weekly for 12 weeks. Primary outcome measure was the current neck pain intensity (0–100 mm visual analog scale; VAS) after 12 weeks. Secondary outcome measures included pain on motion, affective pain perception, functional disability, psychological distress, wellbeing, health-related quality of life, pressure pain thresholds and adverse events. Sixty one patients (54.1±12.7 years; 73.8%female) were randomized to cupping massage (n = 30) or progressive muscle relaxation (n = 31). After treatment, both groups showed significantly less pain compared to baseline however without significant group differences. Significant effects in favor of cupping massage were only found for wellbeing and pressure pain thresholds. In conclusion, cupping massage is no more effective than progressive muscle relaxation in reducing chronic non-specific neck pain. Both therapies can be easily used at home and can reduce pain to a minimal clinically relevant extent. Cupping massage may however be better than PMR in improving well-being and decreasing pressure pain sensitivity but more studies with larger samples and longer follow-up periods are needed to confirm these results.
The purpose of this study was to evaluate the effect of laser acupuncture (LA) and soft cupping on low back pain. In this study, the subjects were randomly assigned to two groups: active group (real LA and soft cupping) and placebo group (sham laser and soft cupping). Visual analog scale (VAS) and Ryodoraku were used to evaluate the effect of treatment on low back pain in this trial. Laser, 40 mW, wavelength 808 nm, pulse rate 20 Hz, was used to irradiate Weizhong (BL40) and Ashi acupoints for 10 minutes. And the Ryodoraku values were measured 2 times, that is, before and 15 minutes after treatment. The results show that there were significant difference between the first day baseline and the fifth day treatment in VAS in the two groups. Therefore, LA combined with soft cupping or only soft cupping was effective on low back pain. However, the Ryodoraku values of Bladder Meridian of the placebo group have been decreased apparently, and didn't come back to their original values. It means that “cupping” plays the role of “leak or purge” in traditional Chinese medicine (TCM). On the other hand, the Ryodoraku values of Bladder Meridian of the active group have been turned back to almost their original values; “mend or reinforcing” effect is attributed to the laser radiation.
The present study sought to determine if subjects who had consumed coffee before performing a simulated computer office-work task found to provoke pain in the neck and shoulders and forearms and wrists exhibited different time course in the pain development than the subjects who had abstained from coffee intake.
Forty eight subjects all working fulltime, 22 with chronic shoulder and neck pain and 26 healthy pain-free subjects, were recruited to perform a computer-based office-work task for 90 min. Nineteen (40%) of the subjects had consumed coffee (1/2 -1 cup) on average 1 h 18 min before start. Pain intensity in the shoulders and neck and forearms and wrists was rated on a visual analogue scale every 15 min throughout the work task.
During the work task the coffee consumers exhibited significantly lower pain increase than those who abstained from coffee.
Subjects who had consumed coffee before starting a pain provoking office work task exhibited attenuated pain development compared with the subjects who had abstained from coffee intake. These results might have potentially interesting implications of a pain-modulating effect of caffeine in an everyday setting. However, studies with a double blind placebo controlled randomized design are needed.
Computer work; Muscle; Pain; Coffee
Most traditional Chinese herbal formulas consist of at least four herbs. Four-Agents-Decoction (Si Wu Tang) is a documented eight hundred year old formula containing four herbs and has been widely used to relieve menstrual discomfort in Taiwan. However, no specific effect had been systematically evaluated. We applied Western methodology to assess its effectiveness and safety for primary dysmenorrhoea and to evaluate the compliance and feasibility for a future trial.
A randomised, double-blind, placebo-controlled, pilot clinical trial was conducted in an ad hoc clinic setting at a teaching hospital in Taipei, Taiwan. Seventy-eight primary dysmenorrheic young women were enrolled after 326 women with self-reported menstrual discomfort in the Taipei metropolitan area of Taiwan were screened by a questionnaire and subsequently diagnosed by two gynaecologists concurrently with pelvic ultrasonography. A dosage of 15 odorless capsules daily for five days starting from the onset of bleeding or pain was administered. Participants were followed with two to four cycles for an initial washout interval, one to two baseline cycles, three to four treatment cycles, and three follow-up cycles. Study outcome was pain intensity measured by using unmarked horizontal visual analog pain scale in an online daily diary submitted directly by the participants for 5 days starting from the onset of bleeding or pain of each menstrual cycle. Overall-pain was the average pain intensity among days in pain and peak-pain was the maximal single-day pain intensity. At the end of treatment, both the overall-pain and peak-pain decreased in the Four-Agents-Decoction (Si Wu Tang) group and increased in the placebo group; however, the differences between the two groups were not statistically significant. The trends persisted to follow-up phase. Statistically significant differences in both peak-pain and overall-pain appeared in the first follow-up cycle, at which the reduced peak-pain in the Four-Agents-Decoction (Si Wu Tang) group did not differ significantly by treatment length. However, the reduced peak-pain did differ profoundly among women treated for four menstrual cycles (2.69 (2.06) cm, mean (standard deviation), for the 20 women with Four-Agents-Decoction and 4.68 (3.16) for the 22 women with placebo, p = .020.) There was no difference in adverse symptoms between the Four-Agents-Decoction (Si Wu Tang) and placebo groups.
Four-Agents-Decoction (Si Wu Tang) therapy in this pilot post-market clinical trial, while meeting the standards of conventional medicine, showed no statistically significant difference in reducing menstrual pain intensity of primary dysmenorrhoea at the end of treatment. Its use, with our dosage regimen and treatment length, was not associated with adverse reactions. The finding of statistically significant pain-reducing effect in the first follow-up cycle was unexpected and warrants further study. A larger similar trial among primary dysmenorrheic young women with longer treatment phase and multiple batched study products can determine the definitive efficacy of this historically documented formula.
Burning mouth syndrome (BMS) is a frequently occurring disease characterized by a burning or painful sensation in the tongue and/or other oral sites without clinical mucosal abnormalities or lesions. Its etiopathology is unknown, although local, systemic, and psychological factors have been associated with BMS. The syndrome is multifactorial, and its management remains unsatisfactory. The purpose of this study was to obtain preliminary data regarding the efficacy and tolerability of amisulpride in BMS treatment.
The subjects were treated with amisulpride (50 mg/day) for 24 weeks. Efficacy assessment included a visual analogue scale (VAS) for pain intensity, the Hamilton Rating Scale for Depression (HAM-D), the Hamilton Rating Scale for Anxiety (HASM-A), and the Clinical Global Impression Scale-Efficacy Index (CGI-EI).
The treatment regimens resulted in a significant improvement in burning mouth symptoms from baseline at week 24, as indicated by the quantitative mean illness duration VAS score, HAM-D, and HAM-A. Amisulpride appears to be effective and patients show a rapid response to treatment. No serious adverse effects were encountered in these patients.
Amisulpride is effective and well tolerated as a short-term treatment. It is particularly efficacious at the start of treatment and has shorter response latency. Double-blind placebo-controlled trials are needed for further assessment of the efficacy of amisulpride in BMS treatment.
Burning mouth syndrome; Amisulpride; Women
Clinical trials of sickle cell disease (SCD) pain treatment usually observe only small decrements in pain intensity during the course of hospitalization. Sub-optimal analgesic management and inadequate pain assessment methods are possible explanations for these findings. In a search for better methods for assessing inpatient SCD pain in adults, we examined several pain intensity and interference measures in both arms of a randomized controlled trial comparing two different opioid PCA therapies. Based upon longitudinal analysis of pain episodes, we found that scores from daily average Visual Analogue Scales (VAS) and several other measures, especially the Brief Pain Inventory (BPI), were sensitive to change in daily improvements in pain intensity associated with resolution of vaso-occlusive pain. In this preliminary trial, the low demand, high basal infusion (LDHI) strategy demonstrated faster, larger improvements in various measures of pain than the high demand, low basal infusion (HDLI) strategy for opioid PCA dosing, however, verification in larger studies is required. The measures and statistical approaches used in this analysis may facilitate design, reduce sample size, and improve analyses of treatment response in future SCD clinical trials of vaso-occlusive episodes.
sickle cell disease; pain; longitudinal models
The aim of this study
was to test the efficacy of shortterm
nerve stimulation (TENS) treatment
in chronic pain with respect
to pain intensity and patients’ satisfaction with treatment results.
We therefore performed
a randomised controlled trial
comparing TENS and sham TENS.
Patients, researchers and therapists
were blinded for treatment
allocation. One hundred and
sixty-three patients with chronic
pain referred to the Pain Centre
entered the study. Conventional
TENS and sham TENS were
applied in the segments of pain,
for a period of ten days. Outcome
measures were pain intensity
(visual analogue scale) and
patients’ satisfaction with treatment
result (yes or no). The proportions
of patients satisfied with
treatment result differed significantly
for TENS compared to
sham TENS (58 and 42.7%
respectively, x2=3.8, p=0.05).
However, no differences in pain
intensity were found for patients
treated with TENS or sham TENS.
Only for patients satisfied with
treatment results pain intensity
gradually decrease equally both
for TENS and sham TENS with
repeated treatment application.
nerve stimulation; Chronic pain; Patient satisfaction; Placebo effect; Duble-blind randomized controlled
Data on the potential efficacy of acupuncture (AC) in controlling intense or very intense pain in patients with Herpes Zoster (HZ) has not been so far adequately assessed in comparison with standard pharmacological treatment (ST) by a controlled trial design.
Within the VZV Pescara study, pain was assessed in HZ patients on a Visual Analogue Scale (VAS) and by the McGill Pain Questionnaire (MPQ) both at the beginning and at the end of treatment. Response rates, mean changes in pain intensity, differences in total pain burden with an area-under-the-curve (AUC) method over a 1-year follow-up and differences in the incidence of Post-Herpetic Neuralgia (PHN) were evaluated.
One hundred and two patients were randomized to receive either AC (n = 52) or ST (n = 50) for 4 weeks. Groups were comparable regarding age, sex, pain intensity at presentation and missed antiviral prescription. Both interventions were largely effective. No significant differences were observed in response rates (81.6% vs 89.2%, p = 0.8), mean reduction of VAS (4.1 +/- 2.3 vs 4.9 +/- 1.9, p = 0.12) and MPQ scores (1.3 +/- 0.9 vs 1.3 +/- 0.9, p = 0.9), incidence of PHN after 3 months (48.4% vs 46.8%, p = 0.5), and mean AUC during follow-up (199 +/- 136 vs 173 +/- 141, p = 0.4). No serious treatment-related adverse event was observed in both groups.
This controlled and randomized trial provides the first evidence of a potential role of AC for the treatment of acute herpetic pain.
Fibromyalgia is a chronic musculoskeletal pain disorder. The pain can be intractable and may not respond to commonly-used treatments, such as tricyclic antidepressants and opioids.
To evaluate pregabalin response in the subset of patients with fibromyalgia whose pain had been judged refractory to other treatments.
Patients had previously participated in a controlled trial of pregabalin and had moderate to severe pain despite treatment with gabapentin, a tricyclic antidepressant, and a third medication (e.g., other anticonvulsants, opioid, selective serotonin reuptake inhibitors, tramadol). Flexible-dose pregabalin 150-600 mg/day was added for 3-month treatment cycles, each followed by 3- to 28-day pregabalin “drug holiday” that lasted until a relapse occurred. Pain intensity was measured using the visual analogue scale of the Short-Form McGill Pain Questionnaire completed at baseline, the end of each 3-month treatment period and at the relapse visit. Analysis was at 15 months (after 5 cycles).
In total, 25 patients were included and 19 completed the 15-month analysis period. At baseline, 88% were receiving ≥1 pain medication. Pregabalin 150-600 mg/day was associated with statistically significant, clinically meaningful pain reduction during each treatment cycle. Pain quickly returned to baseline levels during the “drug holidays” in a median time of 2-4 days. Somnolence (n=5) and dizziness (n=4) were the most common adverse events.
These results suggest that pregabalin may be beneficial in patients with fibromyalgia who have had an unsatisfactory response to treatment with other medications.
Pregabalin; anticonvulsant; fibromyalgia; pain; refractory; relapse; chronic widespread pain; open-label.
The effectiveness of injection therapy for low-back pain is still debatable. We compared the efficacy of local injections of the homeopathic preparation Disci/Rhus toxicodendron compositum (verum) with placebo injections and with no treatment in patients with chronic low back pain.
In a randomized controlled partly double blind multicenter trial patients with chronic low back pain from 9 German outpatient clinics were enrolled and randomly allocated in a 1∶1∶1 ratio to receive subcutaneous injections (verum or placebo) into painful sites on the lower back over 12 treatment sessions within eight weeks, or no treatment (rescue pain medication with paracetamol or NSAIDs). All trial personnel and participants were masked to treatment allocation. The primary outcome measure was the average pain intensity over the last seven days on a visual analogue scale (0–100 mm, 0 = no pain, 100 = worst imaginable pain) after eight weeks. Follow-up was 26 weeks. Primary analysis was by intention to treat. Between August 2007 and June 2008, 150 patients were randomly allocated to three groups (51 verum, 48 placebo and 51 no treatment). The mean baseline-adjusted low back pain intensity at week eight was: verum group 37.0 mm (97.5% CI 25.3;48.8), no treatment group 53.0 (41.8;64.2), and placebo group 41.8 (30.1;53.6). The verum was significantly superior to no treatment (P = 0.001), but not to placebo (P = 0.350). No significant side effects were reported.
The homeopathic preparation was not superior to placebo. Compared to no treatment injections resulted in significant and clinical relevant chronic back pain relief.
Objectives: To compare the efficacy and safety of lumiracoxib with placebo and celecoxib for osteoarthritis OA in a 13 week, multicentre, randomised, double blind study.
Methods: After a 37 day washout period for nonsteroidal antiinflammatory drugs, 1702 patients with knee OA were randomised to lumiracoxib 200 or 400mg once daily od, celecoxib 200mg od, or placebo 2221. A visual analogue scale VAS pain intensity 40mm was required. Primary efficacy variables were OA pain intensity VAS mm in the target knee, patients global assessment of disease activity VAS mm, and WOMAC pain subscale and total scores at 13weeks. OA pain intensity, patients and physicians global assessment of disease activity, and WOMAC total and all subscale scores were analysed by visit as secondary variables.
Results: Lumiracoxib showed significant improvements in all primary and secondary variables compared with placebo. Lumiracoxib 200mg od and celecoxib 200mg od achieved similar improvements in OA pain intensity and functional status. Lumiracoxib 400mg od demonstrated better efficacy for OA pain intensity and patients global assessment of disease activity at weeks 2, 4, and 8 and similar efficacy at week 13 compared with celecoxib 200mg od. The incidence of adverse events AEs, serious AEs, and discontinuations due to AEs was similar in each group.
Conclusion: Lumiracoxib demonstrated significant improvement in OA pain intensity, patients global assessment of disease activity, and the WOMAC pain subscale and total scores compared with placebo. Lumiracoxib was well tolerated in this study, with overall tolerability similar to that of placebo and celecoxib.
Cyclo-oxygenase-2 selective inhibitors are frequently used to manage osteoarthritis. We compared the analgesic efficacy of the novel cyclo-oxygenase-2 selective inhibitor lumiracoxib (Prexige®) versus placebo and celecoxib in patients with knee osteoarthritis. This seven day, double-blind, placebo and active comparator controlled, parallel group study included 364 patients aged ≥50 years with moderate-to-severe symptomatic knee osteoarthritis. Patients received lumiracoxib 400 mg/day (four times the recommended chronic dose in osteoarthritis; n = 144), placebo (n = 75), or celecoxib 200 mg twice daily (n = 145). The primary variable was actual pain intensity difference (100 mm visual–analogue scale) between baseline and the mean of three hour and five hour assessments after the first dose. Actual pain intensity difference, average and worst pain, pain relief and functional status (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC™]) were measured over seven days. Patients also completed a global evaluation of treatment effect at study end or premature discontinuation. For the primary variable, the superiority of lumiracoxib versus placebo, the noninferiority of lumiracoxib versus celecoxib, and the superiority of lumiracoxib versus celecoxib were assessed by closed test procedure adjusting for multiplicity, thereby maintaining the overall 5% significance level. In addition, celecoxib was assessed versus placebo in a predefined exploratory manner to assess trial sensitivity. Lumiracoxib provided better analgesia than placebo 3–5 hours after the first dose (P = 0.004) through to study end. The estimated difference between lumiracoxib and celecoxib 3–5 hours after the first dose was not significant (P = 0.185). Celecoxib was not significantly different from placebo in this analysis (P = 0.069). At study end 13.9% of lumiracoxib-treated patients reported complete pain relief versus 5.5% and 5.3% of celecoxib and placebo recipients, respectively. WOMAC™ total and subscales improved for both active treatments versus placebo except for difficulty in performing daily activities, for which celecoxib just failed to achieve significance (P = 0.056). In the patient's global evaluation of treatment effect, 58.1% of patients receiving lumiracoxib rated treatment as 'excellent' or 'good', versus 48.6% of celecoxib and 25.3% of placebo patients. Lumiracoxib was well tolerated. The overall incidence of adverse events was similar across treatment groups.
Objectives: The present study was designed to evaluate the usefulness of deep dry needling in the treatment of temporomandibular myofascial pain.
Study Design: We selected 36 patients with myofascial pain located in the external pterygoid muscle (30 women/6 men, mean age=27 years with SD±6,5). We studied differences in pain with a visual analog scale and range of mandibular movements before and after intervention.
Results: We found a statistically significant relationship (p<0,01) between therapeutic intervention and the improvement of pain and jaw movements, which continued up to 6 months after treatment. Pain reduction was greater the higher was the intensity of pain at baseline.
Conclusions: Although further studies are needed, our findings suggest that deep dry needling in the trigger point in the external pterygoid muscle can be effective in the management of patients with myofascial pain located in that muscle.
Key words:Temporomandibular joint, myofascial pain, external pterygoid muscle, trigger point, deep dry needling.
Pain is a major cause for visiting a primary care physician. There are, however, few studies on the assessment of pain patients at the primary care level. The aim of this cross-sectional study was to investigate the concordance between general practitioners' (GPs') and patients' assessments of pain intensity and whether this assessment is influenced by the duration or intensity of pain. Seven hundred and thirty-eight patients aged 16 to 75 years, who were visiting a GP because of pain, participated. Both the patients and the GPs rated pain intensity using the horizontal 100 mm Visual Analogue Scale (VAS). Means and correlations were calculated using non-parametric tests. The VAS scales were arbitrarily divided into five grades (one unit = 20 mm) to investigate the concordance between GPs' and patients' assessments of pain intensity. Spearman 's correlation coefficient between GPs' and patients' assessments was 0.31 for non-chronic pain (of duration less than six months) and 0.20 for chronic pain. GPs evaluated graded pain intensity at least one unit lower than patients in 37% of the visits. In one-fifth of the visits (20.5%), the GP's rating was at least two units lower than the patient's rating. The more severe the pain as assessed by patients, the greater the non-concordance between patients' and GPs' assessments. There was considerable non-concordance between GPs' and patients' assessments of pain intensity. GPs tended to estimate their patients' pain intensity as clinically significantly lower than the patients themselves, particularly in chronic and severe pain.
There is a belief that the amount of pain perceived is merely directly proportional to the extent of injury. The intensity of postoperative pain is however influenced by multiple factors aside from the extent of trauma. The purpose of the study was to evaluate the relationship between preoperative factors that have been shown to predict postoperative pain and the self-reports of pain intensity in a population of 155 men undergoing radical prostatectomy (RP), and also to investigate if previous pain score could predict the subsequent pain score.
The correlation between potential pain predictors and the postoperative pain experiences during three postoperative days was tested (Pitmans' test). By use of a logistic regression analysis the probability that a Visual Analogue Scale (VAS) score at one occasion would exceed 30 mm or 70 mm was studied, depending on previous VAS score, age, depression and pain treatment method.
Age was found to be a predictor of VAS > 30 mm, with younger patients at higher risk for pain, and preoperative depression predicted VAS > 70 mm. The probability that VAS would exceed 30 mm and 70 mm was predicted only by previous VAS value. Day two however, patients with epidural analgesia were at higher risk for experiencing pain than patients with intrathecal or systemic opioid analgesia.
The results show that it would be meaningful to identify RP patients at high risk for severe postoperative pain; i.e. younger and/or depressive patients who might benefit from a more aggressive therapy instituted in the very early postoperative period.
At least 50 % of female migraineurs experience migraine associated with the perimenstrual period, even though they may also suffer from attacks at other times of the cycle (menstrually related migraine, MRM). MRM attacks tend to be longer and more intense than those arising in other phases of the menstrual cycle, and are often aggravated by more pronounced vegetative phenomena. In this open preliminary trial, we tested the efficacy of associating frovatriptan and dexketoprofen for the treatment of an acute attack of MRM, diagnosed according to the criteria of the International Headache Society, in 24 patients between 19 and 45 years of age (mean 31.33 ± 7.33). Twenty-one of them completed the study. Pain relief was achieved by 76 % of patients at 2 h and by 86 % at 4 h. A pain-free state was achieved by 48 % at 2 h and by 62 % at 4 h from taking the product. A pain-free state at 24 h was present in 76 % of MRM sufferers, 33 % of whom showed a sustained pain-free state at 24 h. A rescue medication was needed by eight patients. While decidedly encouraging, the data of this study obviously need confirmation with double blind studies involving a greater number of patients.
Dexketoprofen; Frovatriptan; Menstrually related migraine
It has been suggested that pancreatic ductal hypertension, secondary to pancreatic outflow obstruction, is a cause of pain in chronic pancreatitis. This study investigated the effect of inhibiting pancreatic secretion with octreotide in chronic pancreatitis pain. Ten patients with chronic alcoholic pancreatitis and severe daily pain were included in an intraindividual double blind crossover study. All patients received octreotide (3 x 100 micrograms/day subcutaneously) and placebo (3 x 0.9% saline solution subcutaneously) for three days at random. Between both treatment phases a two day washout period was interposed. Intensity of pain (visual analogue scale) and analgesic consumption were carefully registered. Pancreatic secretion was monitored daily by measuring faecal chymotrypsin concentration. It was found that during the administration of octreotide, pancreatic secretion was strongly inhibited (faecal chymotrypsin mean (SD) 1.7 (0.6) U/g) with respect to placebo (9.6 (4.2) U/g) and washout (7.6 (3.1) U/g) periods (p < 0.001). Pain score (29.6 (4.5) v 28.7 (5.8)) and consumption of analgesics were no different during the octreotide and placebo periods. It is concluded that short term inhibition of pancreatic secretion does not result in pain relief in patients with chronic pancreatitis. This finding is in contrast with the hypothesis that outflow obstruction of pancreatic secretion with consequent ductal hypertension is an important cause of severe persistent pain in chronic pancreatitis.