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.

[Impact of conflicts of interest on guideline recommendations : Empirical study within the second update of the German interdisciplinary S3 guidelines on fibromyalgia syndrome]. / Der Einfluss von Interessenkonflikten auf Leitlinienempfehlungen : Eine empirische Studie zur zweiten Aktualisierung der interdisziplinären S3­Leitlinie zum Fibromyalgiesyndrom.

BACKGROUND: The impact of conflicts of interest (COI) in general and of academic COI in particular on guideline recommendations in pain medicine has not yet been studied. Whether the inclusion of patients and of representatives of all relevant healthcare professions into a guidelines group is protective against a systematic bias of decisions of a guidelines group is currently unknown. METHODS: All members of the guidelines group declared their COI before the consensus conferences by a standard form according to the rules and standards of the Association of the German Medical and Scientific Societies. The acceptance or rejection and the strength of consensus of recommendations of the second update of the interdisciplinary guidelines on fibromyalgia syndrome was analyzed twice by first including and then excluding the votes of the guideline group members with COI related to a recommendation from the results of anonymous voting via an internet platform. RESULTS: A total of 42 persons from different healthcare professions and patients participated in the online voting on recommendations. Of the participants 29% had no COI according to the predefined criteria, 53% met the criteria of academic and 33% the criteria of financial COI. In the case of exclusion of participants with a COI related to a specific recommendation, 2 out of 23 recommendations (homeopathy, tramadol) were not accepted. In all votes, there were more participants without COI than with COI. CONCLUSION: Academic COI were more frequent than financial COI in the second update of the German interdisciplinary guidelines group on fibromyalgia syndrome. The impact of COI on guideline recommendations was low. The inclusion of patients and of all relevant healthcare professionals into a guidelines group is a protective factor against the influence of COI on guideline recommendations.

Aplicación de árnica en gel para el manejo del dolor y reabsorción del hematoma profundo / Application of arnica gel for pain management and deep hematoma reabsorption

Árnica es una planta medicinal de la especie Arnica montana, endémica en Europa Central y Meridional, perteneciente a la familia Asteracae; rica en flavonoides y compuestos fenólicos, lactonas, helenalina y ácido hexurónico que le dan propiedades cicatrizantes, antiinflamatorias, analgésicas, antimicrobianas y anticoagulantes. Se utiliza en casos de contusiones, dolores musculares, reumáticos y hematomas profundos. El artículo describe ocho casos, que presentaron hematoma profundo por punción infructuosa, en pacientes con insuficiencia renal crónica terminal con esquema de hemodiálisis, donde se aplicó árnica en gel. Por medio de fotografías se registró cómo los hematomas revirtieron a partir del tercer día, mientras que el dolor disminuyó en un 50% al tercer día. (AU)

Arnica is a medicinal plant of the species Arnica Montana, endemic in Central and Southern Europe, it belongs to the Asteracae family, rich in flavonoids and phenolic compounds, lactones, helenalin and hexuronic acid that give it healing, anti-inflammatory, analgesic, antimicrobial and anticoagulant properties. It is used in cases of bruises, muscle pain, rheumatic pain and deep bruises. The article describes eight patients with terminal chronic renal failure under hemodialysis, who presented deep hematoma due to unsuccessful puncture of their dialysis fistula. All patients were treated with local gel arnica. Verbal analogue scale (VAS) and qualitative visual image analysis (photography) on how the hematomas reverted on the third day was analyzed. (AU)

Considerations for complementary and alternative interventions for pain.

Nurses play an important role in pain management. When considering strategies for effective pain management, nurses must consider and be able to provide information about complementary and alternative therapies. Awareness of alternative interventions for pain extends across herbal therapies, energy medicine, and mind-body exercises. Treatment regimens that integrate conventional therapies with alternative therapies based on the medical systems of non-Western cultures may affect outcomes positively through medical interactions. Nurses should question patients and families about complementary health practices to determine whether they may affect postsurgical recovery and also to determine the level of openness to alternative practices that have evidence of success or equivalency in managing pain.

A double-blind randomized placebo-controlled feasibility study evaluating individualized homeopathy in managing pain of knee osteoarthritis.

UNLABELLED: Few homeopathic complexes seemed to produce significant effects in osteoarthritis; still, individualized homeopathy remained untested. We evaluated the feasibility of conducting an efficacy trial of individualized homeopathy in osteoarthritis. A prospective, parallel-arm, double-blind, randomized, placebo-controlled pilot study was conducted from January to October 2014 involving 60 patients (homeopathy, n = 30; placebo, n = 30) who were suffering from acute painful episodes of knee osteoarthritis and visiting the outpatient clinic of Mahesh Bhattacharyya Homeopathic Medical College and Hospital, West Bengal, India. Statistically significant reduction was achieved in 3 visual analog scales (measuring pain, stiffness, and loss of function) and Osteoarthritis Research Society International scores in both groups over 2 weeks (P < .05); however, group differences were not significant (P > .05). Overall, homeopathy did not appear to be superior to placebo; still, further rigorous evaluation in this design involving a larger sample size seems feasible in future. TRIAL REGISTRATION: Clinical Trials Registry, India (CTRI/2014/05/004589).

The effect of Burns & Wounds (B&W)/burdock leaf therapy on burn-injured Amish patients: a pilot study measuring pain levels, infection rates, and healing times.

PURPOSE: The purposes of this pilot study were to measure pain associated with dressing changes, assess the presence of infection, and document healing times of burn-injured Amish in central Ohio using an herbal therapy consisting of Burns and Wounds™ ointment (B&W) and burdock (Arctium ssp.) leaves. B&W contains honey, lanolin, olive oil, wheat germ oil, marshmallow root, Aloe vera gel, wormwood, comfrey root, white oak bark, lobelia inflata, vegetable glycerin, bees wax, and myrrh. DESIGN: A prospective, case series design guided the study within a community-based participatory research framework. METHODS: Amish burn dressers provided burn care. Registered nurses monitored each case and documented findings. Pain scores were noted and burns were inspected for infection during dressing changes; healing times were measured from day of burn to complete closure of the skin. All cases were photographed. RESULTS: Between October 2011 and May 2013, five Amish were enrolled. All had first- and second-degree burns. B&W/burdock leaf dressing changes caused minimal or no pain; none of the burns became infected, and healing times averaged less than 14 days. CONCLUSION AND IMPLICATIONS: The use of this herbal remedy appears to be an acceptable alternative to conventional burn care for these types of burns. The trauma of dressing changes was virtually nonexistent. Nurses working in communities with Amish residents should be aware of this herbal-based method of burn care and monitor its use when feasible.

The effect of complementary therapies on post-operative pain control in ambulatory knee surgery: a systematic review.

Ambulatory knee surgery is a common procedure with over 100,000 knee arthroscopies performed in the U.K. in 2010-2011. Pain after surgery can decrease patient satisfaction, delay discharge, and decrease cost effectiveness. Multi-modal therapies, including complementary therapies, to improve pain control after surgery have been recommended. However, a comprehensive review of the literature regarding the use of complementary therapies to enhance pain control after ambulatory knee surgery is lacking, and this article aims to address this deficit. CINHAL, EMBASE, MEDLINE, AMED and CENTRAL databases were searched. Only Randomised Controlled Trials were included. All eligible papers were quality assessed using the Jadad system, and data was extracted using piloted forms. Two independent reviewers performed each stage of the review. Full details of the study methodology can be found on Prospero, a systematic review register. Five studies satisfied our eligibility criteria: three reporting on acupuncture, one on homeopathy, and one on acupoints. Acupoint pressure was the only study that demonstrated reduced pain compared with placebo. This study was the least methodologically robust. Arnica, although demonstrating a significant reduction in swelling, did not affect post-operative pain. Acupuncture did not affect post-operative pain; however, a reduction in ibuprofen use was demonstrated in two studies. Before recommending complementary therapy for routine use in ambulatory knee surgery, further work is required. Two areas of future research likely to bear fruit are demonstrating robust evidence for the effect of acupoint pressure on post-operative pain, and quantifying the positive effect of homeopathic arnica on post-operative swelling.

Complementary and alternative medicine for pediatric otitis media.

OBJECTIVE: To review the literature involving complementary and alternative medicine (CAM) for pediatric otitis media. Multiple modalities are discussed, including prevention involving breastfeeding, nutrition, and vaccination; symptomatic treatment involving homeopathy, natural health products, and probiotics; manual manipulations involving osteopathy and chiropractics; and traditional Chinese and Japanese medicine. The information presented will assist physicians in advising patients on their decision-making during the early stages of otitis media when antibiotics and surgery are not yet indicated. METHODS: A systematic literature search was conducted through January 2012 in PubMed using MESH term "otitis media" in conjunction with "complementary therapies," "homeopathy," "manipulation, osteopathic," "manipulation, chiropractic," "acupuncture therapy," "probiotics," "naturopathy," and "xylitol." Theses searches yielded 163 unique results. Abstracts and titles were evaluated for relevance. Case reports, case series, randomized controlled trials, and basic science research were included. Publications not relevant to the discussion of alternative medicine in otitis media were excluded. Bibliographies were checked for further publications. Thirty-six unique publications were reviewed. RESULTS: Of all therapies in complementary and alternative medicine, only xylitol has been studied in well-designed, randomized, blinded trials; it is likely effective, but compliance limits its applicability. CONCLUSIONS: Management of acute otitis media begins with watchful waiting. Herbal eardrops may help relieve symptoms. Homeopathic treatments may help decrease pain and lead to faster resolution. Prevention should be emphasized with elimination of risk factors, such as second hand smoke and bottle-feeding, as well as maintaining nutrition and vaccinations. Vitamin supplementation may be helpful. Probiotics and xylitol may be beneficial as well. Traditional Chinese/Japanese therapies show promising results but remain speculative until further research is conducted. Severe cases of otitis media with complications or those that fail to improve with observation or CAM (after 48-72h) should be treated with antibiotics and, in some cases, surgical intervention. It is best to consult a physician when making treatment decisions for full guidance on the risks and benefits of any treatment option.