No pain relief by virtual reality during hysterosalpingography (HSG): results from a randomized controlled trial.

STUDY QUESTION: Is virtual reality (VR) an effective non-pharmacological tool to reduce procedural pain during hysterosalpingography (HSG)? SUMMARY ANSWER: An HSG with VR does not reduce procedural pain scores compared to an HSG without VR. WHAT IS KNOWN ALREADY: An HSG is often experienced as painful and uncomfortable. VR has been proven successful to reduce acute procedural pain during a variety of medical procedures and interventions. STUDY DESIGN, SIZE, DURATION: We performed a two-centre open-label randomized controlled trial between January 2021 and October 2022. PARTICIPANTS/MATERIALS, SETTING, METHODS: Women scheduled for HSG as part of their infertility work-up were screened for participation. After informed consent, women were randomized between HSG with or without VR. Due to the nature of the intervention, the study was not blinded. VR was administered by a head-mounted device displaying nature movies and/or relaxation exercises. The primary endpoint was procedural pain measured using VAS (scale 0.0-10.0 cm). Procedural pain was divided into overall pain score and peak pain score during the procedure. It was measured immediately after HSG. Secondary endpoints included patient satisfaction, VR preferences, and adverse effects of VR. MAIN RESULTS AND THE ROLE OF CHANCE: We included a total of 134 women, 69 to the intervention group (HSG with VR) and 65 to the control group (HSG without VR). The mean VAS for peak pain was 6.80 cm (SD 2.25) in the intervention group versus 6.60 cm (SD 2.40) in the control group (mean difference 0.28 (95% CI -0.57, 1.12), P = 0.52). The mean VAS for overall pain was 5.00 cm (SD 2.10) in the intervention group versus 4.90 cm (SD 2.13) in the control group (mean difference 0.06 (95% CI -0.71, 0.84), P = 0.88). The expectation that VR would be a good distraction from pain during HSG was correlated with both overall and peak pain scores. When correcting for this expectation, we found that women in the intervention group reported significantly higher scores, both in peak (adjusted MD 0.58 (95% CI -0.81, 1.97), P = 0.021) and overall (adjusted MD 0.43 (95% CI -0.84, 1.71), P = 0.013) pain, compared to the control group. There were no differences in the prevalence of symptoms that were considered as adverse effects of VR. LIMITATIONS, REASONS FOR CAUTION: The study was not blinded. Reasons for declining participation in the study were anxiety or wanting full control during HSG, which might have created selection bias. The distraction score possibly indicates that the level of VR immersiveness was not optimal due to the lack of sound and/or the type of VR applications. Future studies should investigate whether more immersive or interactive VR applications could decrease procedural pain scores during HSG. WIDER IMPLICATIONS OF THE FINDINGS: Since VR does not reduce procedural pain, this additional tool should not be used during HSG. STUDY FUNDING/COMPETING INTEREST(S): There was no external funding for this study. KR and AvH report receiving a travel grant from Merck outside the scope of this study. BM is supported by a National Health and Medical Research Council (NHMRC) investigator grant (GNT1176437) and BM reports consultancy for Merck, Organon, and Norgine and travel and research funding from Merck. BM holds stock for ObsEva. CL reports receiving research grants from Merck, and Ferring. KD and VM report receiving travel and speaker's fees from Guerbet and research grants from Guerbet. VM also reports research grants from Merck and Ferring. The remaining authors have nothing to declare. TRIAL REGISTRATION NUMBER: The trial is registered prospectively in the Netherlands Trial Register (trialregister.nl registration number NL9203, currently accessible on trialsearch.who.int). TRIAL REGISTRATION DATE: 16-01-2021. DATE OF FIRST PATIENT'S ENROLMENT: The first participant was enrolled on 19 January 2021.

A novel, nonopiod-based treatment approach to men with urologic chronic pelvic pain syndrome using ultrasound-guided nerve hydrodissection and pelvic floor musculature trigger point injections.

INTRODUCTION: Urological chronic pelvic pain syndrome (UCPPS) represents a group of pain symptoms relating to patients with pelvic pain for which treatment is largely unsatisfactory. The objective of this study is to analyze the effects of a novel treatment strategy in males suffering from UCPPS. METHODS: This retrospective, institutional review board-approved study analyzed eight male patients aged 24 to 61 with UCPPS. All the patients had a trial of antibiotic therapy, NSAIDs, and pelvic floor physical therapy before the study. The Visual Analog scale (VAS) and Functional Pelvic Pain scale (FPPS) were collected pretreatment. While continuing physical therapy, patients underwent weekly ultrasound-guided pelvic floor trigger point injections to the iliococcygeus, pubococcygeus, and puborectalis with lidocaine 1%. Concomitantly, patients received peripheral nerve hydrodissection performed on the pudendal nerve and the posterior femoral cutaneous nerve. The first two injections combined 1% lidocaine with dexamethasone, while the next four injections consisted of 1% lidocaine with traumeel (a homeopathic, plant-derived anti-inflammatory medication). At the 6-week follow-up, each patient retook the VAS and FPPS. RESULTS: The mean age of our patients was 31.8 years and the average duration of symptoms of the UCPPS was 21 months. Pretreatment, the mean VAS was 3.3 (STD 1.7) and the mean VAS posttreatment was 1.8 (STD 1.4); P < .05; 95% CI, 0.73 to 2.27. The mean FPPS pretreatment was 11.0 (STD 8.0) and the mean FPPS posttreatment was 6.3 (STD 5.3); P < .05; 95% CI, 0.03 to 9.22. CONCLUSION: Our results show promise for a novel, nonopioid-based treatment for UCPPS.

Physiotherapy and a Homeopathic Complex for Chronic Low-back Pain Due to Osteoarthritis: A Randomized, Controlled Pilot Study.

CONTEXT: Osteoarthritis (OA) is a common cause of chronic low-back pain (CLBP) and can be managed with drug therapy and physiotherapy. Homeopathic remedies may assist managing OA; however, research that supports their effectiveness is limited. OBJECTIVES: The study aimed to investigate the efficacy of a homeopathic complex in combination with physiotherapy in treating CLBP due to OA. DESIGN: The study was a 6-wk, randomized, double-blind, placebo-controlled pilot. SETTING: The study took place in a private physiotherapy practice in Gauteng, South Africa. PARTICIPANTS: The participants were 30 males and females, aged 45-75 y, who were receiving physiotherapy treatment for OA of the lumbar spine from a therapist in private practice. INTERVENTIONS: The intervention and control groups both received standard physiotherapy treatment-massage, thermal therapy, and joint mobilization-every 2 wk. In addition, the treatment group received a homeopathic complex-6cH each of Arnica montana, Bryonia alba, Causticum, Kalmia latifolia, Rhus toxicodendron, and Calcarea fluorica. The control group a received a placebo. OUTCOME MEASURES: The primary measure was a visual analogue scale (VAS) for pain. Secondary outcome measures included the Oswestry Disability Index (ODI), an evaluation of each patient's range of motion (ROM) of the lumbar spine, and a determination of each patient's need for pain medication. RESULTS: Intergroup analysis revealed that the treatment group significantly outperformed the control group with regard to pain, daily functioning, and ROM. No difference existed between the groups, however, in the need for conventional pain medication. CONCLUSIONS: The study was too small to be conclusive, but results suggest the homeopathic complex, together with physiotherapy, can significantly improve symptoms associated with CLBP due to OA.

[THE APPLICATION OF ANTIHOMOTOXIC DRUG PREPARATIONS IN THE COMPLEX TREATMENT IN PATIENTS WITH NEUROLOGICAL MANIFESTATIONS OF LUMBAR OSTEOCHONDROSIS].

The expediency of application homeosyniatry by preparations of Traumel S and Placenta Compositum after the offered chart in relation to a complex with classic acupuncture and in relation to the group of the generally accepted treatment has been proved in complex treatment patients with reflex syndromes of lumbar osteochondrosis. A similar conclusion was done after the statistically reliable (P < 0.05) dynamics of parameters of endogenous intoxication, liperoxydation and antioxydant systems of the protection (by the level of katalase, superoxyddismutase, SH-groups, ceruloplasmine).

Efficacy of Individualized Homeopathic Medicines in the Treatment of Sciatica Pain: Double-Blind, Randomized, Placebo-Controlled Trial.

Objectives: Sciatica is a debilitating condition that causes pain in its distribution or in the lumbosacral nerve root that is connected to it. Although there are claims that homeopathy can reduce sciatica pain, systematic scientific proof is currently lacking. The objective of the trial was to determine whether individualized homeopathic medicines (IHMs) were as effective as identical-looking placebos in treating sciatica pain. Design: This is a double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. Setting: The study was conducted at Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, West Bengal, India. Subjects: Sixty participants with sciatica pain were included in this study. Interventions: Verum (n = 30; IHMs plus concomitant care) versus control (n = 30; placebos plus concomitant care). Outcome measures: Primary-Sciatica Bothersome Index (SBI) and Sciatica Frequency Index (SFI) scores and secondary-Roland Morris Pain and Disability Questionnaire (RMPDQ), Short Form McGill Pain Questionnaire (SF-MPQ), and Oswestry Low Back Pain Questionnaire (OLBPQ) scores: all of them were measured at baseline, and every month, up to 3 months. Results: Intention-to-treat sample (n = 60) was analyzed. Group differences were examined by two-way (split-half) repeated measure analysis of variance, primarily accounting for between groups and time interactions, and additionally, by unpaired t tests comparing the estimates obtained individually every month. The level of significance was set at p < 0.025 and <0.05 two tailed for the primary and secondary outcomes, respectively. Group differences could not achieve significance in SBI (p = 0.044), SFI (p = 0.080), and RMPDQ scores (p = 0.134), but were significant for SF-MPQ (p = 0.007) and OLBPQ (p = 0.036). Gnaphalium polycephalum (n = 6; 10%) was the most frequently prescribed medicine. No harm, serious adverse events, or intercurrent illnesses were recorded in either of the groups. Conclusions: The primary outcome failed to demonstrate evidently that homeopathy was effective beyond placebo, and the trial remained inconclusive. Independent replications are warranted to confirm the findings. Clinical Trial Registration Number: CTRI/2020/10/028617.

[Complementary and alternative therapies for fibromyalgia syndrome. Systematic review, meta-analysis and guideline]. / Komplementäre und alternative Verfahren beim Fibromyalgiesyndrom. Systematische Übersicht, Metaanalyse und Leitlinie.

BACKGROUND: The scheduled update to the German S3 guidelines on fibromyalgia syndrome (FMS) by the Association of the Scientific Medical Societies ("Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften", AWMF; registration number 041/004) was planned starting in March 2011. MATERIALS AND METHODS: The development of the guidelines was coordinated by the German Interdisciplinary Association for Pain Therapy ("Deutsche Interdisziplinären Vereinigung für Schmerztherapie", DIVS), 9 scientific medical societies and 2 patient self-help organizations. Eight working groups with a total of 50 members were evenly balanced in terms of gender, medical field, potential conflicts of interest and hierarchical position in the medical and scientific fields. Literature searches were performed using the Medline, PsycInfo, Scopus and Cochrane Library databases (until December 2010). The grading of the strength of the evidence followed the scheme of the Oxford Centre for Evidence-Based Medicine. The recommendations were based on level of evidence, efficacy (meta-analysis of the outcomes pain, sleep, fatigue and health-related quality of life), acceptability (total dropout rate), risks (adverse events) and applicability of treatment modalities in the German health care system. The formulation and grading of recommendations was accomplished using a multi-step, formal consensus process. The guidelines were reviewed by the boards of the participating scientific medical societies. RESULTS AND CONCLUSION: Meditative movement therapies (qi gong, tai chi, yoga) are strongly recommended. Acupuncture can be considered. Mindfulness-based stress reduction as monotherapy and dance therapy as monotherapy are not recommended. Homeopathy is not recommended. In a minority vote, homeopathy was rated as "can be considered". Nutritional supplements and reiki are not recommended. The English full-text version of this article is available at SpringerLink (under "Supplemental").

Observational study of the use of Symphytum 5CH in the management of pain and swelling after dental implant surgery.

OBJECTIVE: To assess the effect of Symphytum 5CH on the postoperative pain and swelling after placement of a titanium dental implant. MATERIAL AND METHODS: Data on pain and swelling following pure titanium implants were reviewed. Patients were treated postoperatively with ketoprofen only or ketoprofen and Symphytum 5CH, according to the treating dentist's usual practice. Demographics and baseline characteristics were recorded and compared. Pain and swelling were compared between the two treatment groups using the Wilcoxon rank sum test and ordinal logistic regression, estimating odds ratios and confidence intervals. RESULTS: 100 implants in 57 patients (28 males, 29 females) were treated with ketoprofen alone; 100 implants in 60 patients (14 males, 46 females) with ketoprofen and Symphytum. The group treated with ketoprofen and Symphytum appeared to have a better response in terms of both pain and swelling. Ordinal logistic regression: pain 0.23, 95% CI 0.13-0.41; swelling 0.24, 95% CI 0.13-0.44. Correction for demographics and implant characteristics greatly widened the confidence intervals so that the results were no longer statistically significant (pain: OR = 0.15, 95% CI 0.07-34.56; swelling OR = 0.18, 95% CI 0.07-46.78). CONCLUSIONS: Adding Symphytum 5CH to conventional analgesia may reduce pain and swelling after minor dental implant surgery. No firm conclusion can be drawn since the results are confounded by baseline differences, principally gender. Further, randomized, studies should be conducted.

Homeopathic medicines substantially reduce the need for clotting factor concentrates in haemophilia patients: results of a blinded placebo controlled cross over trial.

BACKGROUND: Modern management of haemophilia patients is expensive: 90% of expenditure is on clotting factor concentrates. Any intervention which reduces the need for clotting factor concentrates in these patients without compromising the quality of life is of interest. AIMS AND OBJECTIVES: To investigate the effectiveness of individualised homeopathic medicines in reducing the requirement of factor concentrates in haemophilia patients. MATERIALS AND METHODS: In a single blind placebo controlled cross over trial 28 consecutive persons with haemophilia (PWH) with severe (24) or moderately severe (4) disease received standard management with placebo homeopathy for 1 year and active homeopathic treatment in the subsequent year with the same conventional management. There was no wash out period. They received standard managements for any acute emergency during the study period. Development of inhibitor during the study period was a withdrawal criterion. Sample size for the trial was calculated as 24 PWH. Transfusion requirements, bleeding scores, pain scores were evaluated blind by independent experts. Homeopathic medicines were selected by experienced homeopathic physicians depending on clinical condition of the patient. Chi-squared and paired t tests were used in statistical analysis. RESULTS: 28 patients were recruited. Homeopathic medicines improved frequency of bleeding, extent of bleeding, blood products consumed and pain scores (P<0.0001). There was also significant improvement in well being. Plasma levels of clotting factors did not change. No patients developed inhibitors during the study there were no dropouts. CONCLUSION: Individualised homeopathic medicines may have an important supportive role in the management of PWH, where blood products and factor concentrates are not easily available. Larger, perhaps multicentric trials are warranted.

[Analysis of liposoluble constituents in Holotrichia diomphalia by GC-MS and investigation their anti-inflammatory and analgesic activities].

OBJECTIVE: To analysis liposoluble constituents of Holotrichia diomphalia by GC-MS and measure their anti-inflammatory and analgesic activities. METHODS: The composition of liposoluble constituents were determined by GC-MS. The dimethylbenzene-induced mice inflammatory models were established. The pain models were obtained by hot plate and acetic acid in mice. RESULTS: Twenty-two components were identified from the petroleum ether extract of Holotrichia diomphalia. The major components were oleic acid, palmitic acid and palmitoleic acid. The petroleum ether extract was able to significantly inhibit the mice ear edema induced by dimethyl-benzene. The pain in mice caused by acetic acid and hot plate were evidently suppressed by the petroleum ether extract. CONCLUSION: The petroleum ether extract of Holotrichia diomphalia has obvious anti-inflammation and analgesic effects.

[Effectiveness and safety of a homeopathic drug combination in the treatment of chronic low back pain. A double-blind, randomized, placebo-controlled clinical trial]. / Wirksamkeit und Sicherheit eines homöopathischen Komplexpräparates bei chronischen Rückschmerzen. Doppelblinde, randomisierte, placebokontrollierte, klinische Studie.

BACKGROUND: The homeopathic drug combination Lymphdiaral Basistropfen is established in the treatment of edema and swellings. This is the first time the effectiveness and safety was investigated in the treatment of chronic low back pain. METHODS: The study is a randomized, double-blind, placebo-controlled trial. From December 2003 to May 2007 248 patients aged 18 to 75 years were screened, 228 were randomized, 221 started therapy, in 192 the progress was measured (103 verum vs. 89 placebo), 137 completed the study (72 verum vs. 65 placebo). They received 10 drops of verum or placebo solution three times daily for 105 days additionally to an inpatient complex naturopathic treatment. RESULTS: The hannover functional ability questionnaire score (primary outcome measure) tends to increase in the intention-to-treat-analysis (verum: 6.6 vs. placebo: 3.4; p = 0.11) and increases significantly in the per-protocol-analysis (verum: 9.4 vs. placebo: 4.1; p = 0.029). The treatment was well tolerated (92.9% vs. 95.4%). The incidence of adverse reactions and serious adverse reactions was similar in both treatment groups. CONCLUSIONS: This first randomized, double-blind, placebo-controlled trial shows, that the homeopathic drug combination can improve the treatment of chronic low back pain.

Homeopathy has clinical benefits in rheumatoid arthritis patients that are attributable to the consultation process but not the homeopathic remedy: a randomized controlled clinical trial.

OBJECTIVES: To assess whether any benefits from adjunctive homeopathic intervention in patients with RA are due to the homeopathic consultation, homeopathic remedies or both. METHODS: Exploratory double-blind, randomized placebo-controlled trial conducted from January 2008 to July 2008, in patients with active stable RA receiving conventional therapy. Eighty-three participants from three secondary care UK outpatient clinics were randomized to 24 weeks of treatment with either homeopathic consultation (further randomized to individualized homeopathy, complex homeopathy or placebo) or non-homeopathic consultation (further randomized to complex homeopathy or placebo). Co-primary outcomes: ACR 20% improvement (ACR20) criteria and patient monthly global assessment (GA). SECONDARY OUTCOMES: 28-joint DAS (DAS-28), tender and swollen joint count, disease severity, pain, weekly patient and physician GA and pain, and inflammatory markers. RESULTS: Fifty-six completed treatment phase. No significant differences were observed for either primary outcome. There was no clear effect due to remedy type. Receiving a homeopathic consultation significantly improved DAS-28 [mean difference 0.623; 95% CI 0.1860, 1.060; P = 0.005; effect size (ES) 0.70], swollen joint count (mean difference 3.04; 95% CI 1.055, 5.030; P = 0.003; ES 0.83), current pain (mean difference 9.12; 95% CI 0.521, 17.718; P = 0.038; ES 0.48), weekly pain (mean difference 6.017; 95% CI 0.140, 11.894; P = 0.045; ES 0.30), weekly patient GA (mean difference 6.260; 95% CI 0.411, 12.169; P = 0.036; ES 0.31) and negative mood (mean difference - 4.497; 95% CI -8.071, -0.923; P = 0.015; ES 0.90). CONCLUSION: Homeopathic consultations but not homeopathic remedies are associated with clinically relevant benefits for patients with active but relatively stable RA. TRIAL REGISTRATION: Current controlled trials, http://www.controlled-trials.com/, ISRCTN09712705.

Pulpa dentis D30 for acute reversible pulpitis: A prospective cohort study in routine dental practice.

BACKGROUND: Pulpa dentis D30 (PD: dental pulp of the calf, prepared in a homeopathic D30 potency) has been used in acute reversible pulpitis for pain relief and to avoid or postpone invasive dental treatment. PRIMARY STUDY OBJECTIVE: To study short-term clinical outcomes of PD therapy for acute reversible pulpitis in routine dental practice. METHODS/DESIGN: Prospective, observational, open-label, single-arm cohort study. SETTING: Eleven dental primary care practices in Germany. PARTICIPANTS AND INTERVENTION: Thirty-two patients starting monotherapy with PD for acute reversible pulpitis without visible or radiological abnormalities. PD was applied as 1-mL submucous injections into the mucobuccal fold, repeated daily as needed. PRIMARY OUTCOME MEASURES: Avoidance of invasive dental treatment (pulp capping, root canal therapy, tooth extraction) and remission of pain, measured on a 0-10 point scale (partial remission: reduction by > or =3 points; complete remission: reduction from > or =4 points to 0-1 points) during the 10-day follow-up period. RESULTS: Median pain duration was 14.0 days. The patients received a median of two PD applications (range 1-7). A total of 81% (n=26/32) of patients did not require invasive dental treatment, and 19% (n= 6) had root canal therapy. Remission status was evaluable in 24 patients. Of these, 63% (n = 15/24) achieved pain remission, 58% (n = 14) remitted without invasive dental treatment (complete remission: n=12, partial remission: n=2), and 29% (n= 7) had a close temporal relationship between PD and remission (ratio "time to remission after first PD application vs pain duration prior to first PD application" <1:10). CONCLUSION: In this study of PD for acute reversible pulpitis, 58% of evaluable patients achieved pain remission without invasive dental treatment. The open-label pre-post design does not allow for conclusions about comparative effectiveness. However, more than one-fourth of evaluable patients remitted with a close temporal relationship between the first PD application and pain remission, suggesting a causal relationship between therapy and remission.

The effect of topical arnica on muscle pain.

BACKGROUND: The herb Arnica montana, in topical formulations, has been reputed to decrease bruising and muscle pain. This claim has been inadequately and incompletely addressed. OBJECTIVE: To determine whether topical A. montana cream could decrease subjective leg pain following calf raises. Secondary outcomes were effects on ankle range of motion and muscle tenderness. METHODS: A randomized, double-blind, placebo-controlled trial was conducted in 53 subjects. Active range of motion was measured in both ankles, and then a series of calf-raises were completed according to a standardized protocol. Each participant received 2 tubes of cream, 1 with active arnica and 1 with placebo. The creams were applied to the lower legs immediately after the exercise, and again at 24 and 48 hours postexercise according to the "RIGHT" or "LEFT" labels. At 48 hours postexercise, subjects had their ankle range of motion and muscle tenderness measured. Subjects used the analog scale to rate pain in each leg at baseline, 24 hours, 48 hours, and 72 hours. RESULTS: No significant differences in pain scores were seen before exercise (arnica: 0.07 vs placebo: 0.09, p = 0.32). Pain scores on legs treated with arnica were higher than scores on those receiving placebo 24 hours after exercise (3.04 vs 2.36, respectively; p < 0.005). Pain scores on day 3 (arnica: 3.44 vs placebo: 3.20, p = 0.66) and day 4 (arnica: 2.36 vs placebo: 2.31, p = 0.62) were not significantly different. There was no difference in muscle tenderness (arnica: 1.05 vs placebo: 1.05, p = 1.0). Ankle range of motion did not differ significantly on either day 1 (arnica: 64.70 degrees vs placebo: 66.15, p = 0.352 or day 3 (arnica: 63.32 degrees vs placebo: 65.94, p = 0.058). CONCLUSIONS: Rather than decreasing leg pain, arnica was found to increase leg pain 24 hours after eccentric calf exercises. This effect did not extend to the 48-hour measurement.

A series of case reports: clinical evaluation of a complex homeopathic injection therapy in the management of pain in patients after breast cancer treatment.

OBJECTIVE: In breast cancer patients, posttreatment pain often appears after several months and strongly impairs health-related quality of life. Conventional methods of pain reduction are often ineffective. Injection therapy with Traumeel (Heel GmbH, Baden-Baden, Germany), a medication with analgesic properties used in homotoxicology for treatment of the pain associated with trauma as well as a mediator of inflammation, was proposed as an innovative approach for pain relief after breast cancer treatment. DESIGN: Nine patients, still suffering from a high level of pain after breast cancer therapy despite use of postoperative treatment with conventional analgesics, were invited to participate. A Traumeel and procaine injection was administered once a week for three to 10 sessions. The level of pain was assessed by a pain score and physical and psychological status by a questionnaire before and directly after injection and again at follow-up visits after 3 and 6 months. RESULTS: After the last injection, all patients experienced a marked reduction of their level of pain on average from 7.6 +/- 1.5 to 2.4 +/- 1.4 points on a scale from 1 to 10 points. After a followup observational phase of 3 and 6 months, pain score ratings increased slightly again in some patients but remained consistently low in others. In any case, the ratings of pain levels did not reach the values assessed before the start of Traumeel injection. Similarly, health-related quality of life improved with this injection therapy. The perception of pain relief with Traumeel injection was high in 8 of 9 patients, reflecting an overall perceived positive outcome and tolerability of this treatment. CONCLUSIONS: This case series represents a first encouraging approach to using this complex homeopathic injection for pain relief in breast cancer patients.

[Evaluation of the adequacy of analgesia using sensometry method during sacral anesthesia in proctological operations].

Adequacy of epidural-sacral anesthesia in proctological operations was studied. Sensometry occupies a special place among the methods, estimating the sacral anesthesia adequacy, owing the advantage of possibility for quantitative estimation of such an important index, as a patient reaction on external irritants, including such of a pain. Sensometry, according to A. K. Sangaylo method, using portative apparatus "Nil - 3" was conducted in 50 patients while proctological operations performance for estimation of various variants of sacral anesthesia efficacy. There was established, that sensometry constitutes the most informative quantitative method of estimation of the anesthesia adequacy.

Dextrose Prolotherapy Versus Lidocaine Injection for Temporomandibular Dysfunction: A Pragmatic Randomized Controlled Trial.

Objective: Several intraarticular injections, including dextrose and lidocaine, are reported to reduce pain and dysfunction in temporomandibular dysfunction (TMD) and increase maximal jaw opening; our goal was to determine whether dextrose/lidocaine outperforms sterile water/lidocaine for TMD. Design: Pragmatic randomized controlled trial. Setting: Outpatient clinic. Subjects: Chronic (≥3 months) of moderate-to-severe (≥6/10) jaw or facial pain meeting research-specific TMD criteria. Intervention: Blinded intraarticular dextrose prolotherapy (DPT) (20% dextrose/0.2% lidocaine) versus intraarticular lidocaine (0.2% lidocaine in sterile water) at 0, 1, and 2 months. Participants were then unblinded and offered DPT by request for 9 additional months. Main outcome measures: Primary: Numerical Rating Scale (0-10 points) score for facial pain and jaw dysfunction; percentage achieving ≥50% improvement in pain and dysfunction (0, 3, and 12 months). Secondary: Maximal interincisal opening (MIO; 0 and 3 months). Intention-to-treat analysis was by joint using mixed-model regression. Results: Randomization of 29 participants (25 female, 47 ± 17 years, 43 joints) produced similar groups. Three-month pain and dysfunction improvements were similar, but more DPT-treated joints improved by ≥50% in pain (17/22 vs. 6/21; p = 0.028). The MIO improved in both groups (5.6 ± 5.8 mm vs. 5.1 ± 7.0 mm; p = 0.70). From 3 to 12 months, minimal DPT was received by original DPT and lidocaine recipients, 0.5 ± 0.9 and 0.6 ± 1.5 injections, respectively, with only 2 out of 21 joints in the original lidocaine group receiving more than 1 dextrose injection after 3 months. Twelve-month analysis revealed that joints in the original DPT group improved more in jaw pain (4.8 ± 2.4 points vs. 2.6 ± 2.9 points; p = 0.026) and jaw dysfunction (5.3 ± 2.6 points vs. 2.7 ± 2.3 points; p = 0.013). More DPT than lidocaine-treated joints improved by ≥50% in both pain (19/22 vs. 5/21; p = 0.003) and dysfunction (17/22 vs. 7/21; p = 0.040). There were no adverse events; satisfaction was high. Conclusions: Intraarticular DPT resulted in clinically important and statistically significant improvement in pain and dysfunction at 12 months compared to lidocaine injection (ClinicalTrials.gov identifier NCT01617356).

A twelve-week, four-arm, randomized, double-blind, placebo-controlled, phase 2 prospective clinical trial to evaluate the efficacy and safety of an anthroposophic multimodal treatment on chronic pain in outpatients with postpolio syndrome.

INTRODUCTION: Chronic pain and fatigue are the main symptoms of postpoliomyelitis syndrome (PPS). This study aimed to evaluate the efficacy and safety of an anthroposophic multimodal treatment for chronic pain in PPS outpatients. METHODS: A twelve-week, four-arm, randomized, double-blind, placebo-controlled, phase 2 prospective clinical trial was designed to compare four groups (n = 48): groups A and B received daily active experimental transdermal gel (ETG) or placebo gel (PTG), respectively; groups C and D received weekly external therapies, art therapies, and neurofunctional reorganization, plus either daily ETG or PTG, respectively. The pain symptoms were evaluated through a visual analogue scale (VAS), the McGill questionnaire, and thermography. Quality of life and resilience were evaluated by the WHOQOL-BREF and Antonovsky sense of coherence questionnaires applied at baseline and after the interventions. RESULTS: No related adverse events occurred, and 10% of the patients reports dysphagia improvement. In the groups C and D, pain reduction was statistically significant in both the placebo group (p = .02, d = 1.315) and in the ETG (p = .005, d = 2.035). However, following the week-to-week evolution of pain with the concomitant use of the ETG, this significant pain reduction occurred earlier from the 4th week and continued to decrease (p = .016, d = 1.369). In the group that received the complete multimodal treatment, the greatest significant benefit in increasing quality of life occurred in the physical domain and elevation in resilience with an emphasis on meaning and comprehension domains. CONCLUSIONS: The anthroposophic multimodal treatment group presented both safety and efficacy as an analgesic in the groups that received the nonpharmacological therapies, much earlier when associated with the ETG. The multimodal approach corresponded to the pattern of better efficacy for both pain reduction and improvement in quality of life and resilience.

[Evaluation and correction of the pain syndrome in premature newborns with CNS infringement].

Premature newborn may feel different kinds of pain, thus incomplete diagnostics and unjustified therapy may lead to unfavourable physiological effects. All the pain feelings that a child experiences are acute and recurrent or persistent leading to a pain syndrome if there is no intervention. Currently a huge arsenal of pharmacological drugs is available to control pain. There are a lot of researches described in the literature on the effectiveness of the pharmacodynamics, pharmacokynetics and complications related to administration of different analgetics in newborns. However the unfavorable complications identified prevent their use in newborns. Analgesic effect can be made not only by proper analgetics, but combined homeopathic medications as well. One of such medications, which has no side effects is traumel S. The current paper reflects outcomes of the clinical research took place over the 79 pre-term newborns with infringement of the CNS who are subject of a big number of the prescribed treatment manipulation and procedures whereas most of them are quite painful. There is necessity of applying anesthesia treatment for avoiding clinical and biochemical consequences of the pain syndrome. Application of the traumel C intramuscularly or traumel C ointment per os just before and during painful manipulation affect drop pain level of a newborn. Appreciation of pain is subject to the level of CNS lesions because during severe disorders behavioral reaction to pain is certainly reduced. Premature newborns from control group, in the dynamics of neonatal period, manifested reliable reduction (R<0,05) of neurokinin A from 17.52 to 2.08 ng/ml, substance P from 2.5 to 0.3 n/ml compare to seek newborns. During comparison of the results it was revealed that premature newborns, with hypoxemic-ischemic lesion of CNS, treated based on traditional allopathic therapy from the first day of life, manifest significantly high level of neurokinin A and substance P, maintained until the end of first month of life. It was also determined that during the use of allopathic therapy on 7-10th days of life neurokinin A and substance P form 76.86 and 14.46 ng/ml respectively, confirming the development of pain syndrome.

Hypericum perforatum to improve post-operative Pain Outcome after monosegmental Spinal microdiscectomy (HYPOS): a study protocol for a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Spinal disc herniation is a frequently occurring degenerative disease of the spine. Many patients undergoing surgery suffer from radicular pain, known as memory pain, beginning from the third post-operative day. This results in the prescription of high-dose opioid medications. In homeopathy, Hypericum perforatum is known as a remedy for unbearable, shooting or jabbing pain especially when neural damage is involved. Reduction of pain after application of H. perforatum has been observed in previous studies. This study is aimed to investigate whether homeopathic H. perforatum in a potentisation of C200 leads to the reduction of post-operative pain and a decrease of pain medication compared to placebo. METHODS/DESIGN: This is a monocentric, double-blind, randomised placebo-controlled trial conducted at the Department of Neurosurgery at the Community Hospital Herdecke, Germany. One hundred study participants are being recruited from inpatients undergoing elective, monosegmental, lumbar microdiscectomy surgery. Patients are randomly allocated to receive homeopathic treatment or placebo in addition to usual pain management after surgery. The primary clinical outcome is pain reduction after 3 days of inpatient care as measured by pain reduction of subjective pain on a 100-mm Visual Analogue Scale (VAS) at the third post-operative day. Statistical analysis will be carried out by means of a covariance model with adjustment for baseline values and patient expectation for all randomised patients. DISCUSSION: This study is the first trial of classical homeopathy that will evaluate the efficacy of homeopathic H. perforatum after monosegmental spinal microdiscectomy. We intend to clarify the potential of homoeopathic H. perforatum to reduce surgery-associated pain. TRIAL REGISTRATION: German Clinical Trials Register, ID: DRKS00007913 . Registered on 17 October 2014. EudraCT - Nr: 2013-001383-31. Data sets from the German Clinical Trials Register (DRKS, Deutsches Register Klinischer Studien) are updated every 4 weeks automatically to the International Clinical Trials Registry Platform of World Health Organisation: http://apps.who.int/trialsearch/ . Responsibilities Sponsor: Witten/Herdecke University Alfred-Herrhausen-Straße 50 58,448 Witten Deputy of the sponsor: Dr. Wolfgang Eglmeier (Head of Centre for Clinical Trials Witten/Herdecke) Alfred-Herrhausen-Straße 50 58,448 Witten E-mail: wolfgang.eglmeier@uni-wh.de Principal investigator: Prof. Dr. med. Wolfram Scharbrodt Community Hospital Herdecke Department for Neurosurgery Gerhard-Kienle-Weg 4 58,313 Herdecke w.scharbrodt@gemeinschaftskrankenhaus.de Project coordination: Christa Raak Faculty for Health (Department for Integrative and Anthroposophic Medicine) University Witten/Herdecke gGmbh Gerhard-Kienle-Weg 4 58,313 Herdecke christa.raak@uni-wh.de Project manager/data analysis/biometry: Prof. Dr. Thomas Ostermann Faculty for Health (Department for Psychology and Psychotherapy) University Witten/Herdecke gGmbh Alfred-Herrhausen-Straße 50 58,448 Witten thomas.ostermann@uni-wh.de.

The duration of spinal anesthesia with 5% lidocaine in chronic opium abusers compared with nonabusers.

BACKGROUND: It has been demonstrated that chronic opium abusers have lower thresholds for pain. In this study we sought to determine whether chronic opium abuse has any effect on the duration of spinal block by local anesthetics. METHODS: In a case-controlled study, 50 opium abusers and 50 nonabusers undergoing lower abdomen operations were selected from among the patients admitted to a university hospital for elective surgery. All patients received 100 mg hyperbaric preservative-free 5% lidocaine in dextrose, intrathecally. RESULTS: The duration of anesthesia was much shorter in the opium abusers (60 +/- 7 min) than in the nonabusers (83 +/- 10 min) (P < 0.0001). CONCLUSION: The study documents a shortened duration of spinal block in opium abusers.