Functional Somatic Disorders, Their Subtypes, and Their Association With Self-Rated Health in the German General Population.

OBJECTIVE: The heterogeneous conceptualizations and classifications of persistent and troublesome physical symptoms impede their adequate clinical management. Functional somatic disorder (FSD) is a recently suggested interface concept that is etiologically neutral and allows for dysfunctional psychobehavioral characteristics as well as somatic comorbidity. However, its prevalence and impact are not yet known. METHODS: We analyzed 2379 participants (mean age = 48.3 years, 52.5% female) from a representative German community survey using operationalized FSD criteria. These criteria defined FSD types based on somatic symptom count, type, and severity assessed by the Bodily Distress Syndrome Checklist. In addition, the associations of those types with health concerns, comorbidity, psychological distress, and self-rated health were determined. RESULTS: There were four clearly demarcated groups with no relevant bothering symptoms, with one or with few bothering symptoms from one organ system, and with multiple bothering symptoms from at least two organ systems. Psychological distress, health concerns, and comorbidity steadily increased, and self-rated health decreased according to the number and severity of symptoms. Somatic symptom burden, health concerns, and comorbidity independently predicted self-rated health, with no interaction effect between the latter two. CONCLUSIONS: Our data support an FSD concept with two severity grades according to persistent and troublesome symptoms in one versus more organ systems. The delimitation of subtypes with psychobehavioral characteristics and/or with somatic comorbidity seems useful, while still allowing the demarcation of a group of participants with high symptom burden but without those additional characteristics.

Cannabis-based medicines and medical cannabis for adults with cancer pain.

BACKGROUND: Pain is a common symptom in people with cancer; 30% to 50% of people with cancer will experience moderate-to-severe pain. This can have a major negative impact on their quality of life. Opioid (morphine-like) medications are commonly used to treat moderate or severe cancer pain, and are recommended for this purpose in the World Health Organization (WHO) pain treatment ladder. Pain is not sufficiently relieved by opioid medications in 10% to 15% of people with cancer. In people with insufficient relief of cancer pain, new analgesics are needed to effectively and safely supplement or replace opioids. OBJECTIVES: To evaluate the benefits and harms of cannabis-based medicines, including medical cannabis, for treating pain and other symptoms in adults with cancer compared to placebo or any other established analgesic for cancer pain. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 26 January 2023. SELECTION CRITERIA: We selected double-blind randomised, controlled trials (RCT) of medical cannabis, plant-derived and synthetic cannabis-based medicines against placebo or any other active treatment for cancer pain in adults, with any treatment duration and at least 10 participants per treatment arm. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. The primary outcomes were 1. proportions of participants reporting no worse than mild pain; 2. Patient Global Impression of Change (PGIC) of much improved or very much improved and 3. withdrawals due to adverse events. Secondary outcomes were 4. number of participants who reported pain relief of 30% or greater and overall opioid use reduced or stable; 5. number of participants who reported pain relief of 30% or greater, or 50% or greater; 6. pain intensity; 7. sleep problems; 8. depression and anxiety; 9. daily maintenance and breakthrough opioid dosage; 10. dropouts due to lack of efficacy; 11. all central nervous system adverse events. We used GRADE to assess certainty of evidence for each outcome. MAIN RESULTS: We identified 14 studies involving 1823 participants. No study assessed the proportions of participants reporting no worse than mild pain on treatment by 14 days after start of treatment. We found five RCTs assessing oromucosal nabiximols (tetrahydrocannabinol (THC) and cannabidiol (CBD)) or THC alone involving 1539 participants with moderate or severe pain despite opioid therapy. The double-blind periods of the RCTs ranged between two and five weeks. Four studies with a parallel design and 1333 participants were available for meta-analysis. There was moderate-certainty evidence that there was no clinically relevant benefit for proportions of PGIC much or very much improved (risk difference (RD) 0.06, 95% confidence interval (CI) 0.01 to 0.12; number needed to treat for an additional beneficial outcome (NNTB) 16, 95% CI 8 to 100). There was moderate-certainty evidence for no clinically relevant difference in the proportion of withdrawals due to adverse events (RD 0.04, 95% CI 0 to 0.08; number needed to treat for an additional harmful outcome (NNTH) 25, 95% CI 16 to endless). There was moderate-certainty evidence for no difference between nabiximols or THC and placebo in the frequency of serious adverse events (RD 0.02, 95% CI -0.03 to 0.07). There was moderate-certainty evidence that nabiximols and THC used as add-on treatment for opioid-refractory cancer pain did not differ from placebo in reducing mean pain intensity (standardised mean difference (SMD) -0.19, 95% CI -0.40 to 0.02). There was low-certainty evidence that a synthetic THC analogue (nabilone) delivered over eight weeks was not superior to placebo in reducing pain associated with chemotherapy or radiochemotherapy in people with head and neck cancer and non-small cell lung cancer (2 studies, 89 participants, qualitative analysis). Analyses of tolerability and safety were not possible for these studies. There was low-certainty evidence that synthetic THC analogues were superior to placebo (SMD -0.98, 95% CI -1.36 to -0.60), but not superior to low-dose codeine (SMD 0.03, 95% CI -0.25 to 0.32; 5 single-dose trials; 126 participants) in reducing moderate-to-severe cancer pain after cessation of previous analgesic treatment for three to four and a half hours (2 single-dose trials; 66 participants). Analyses of tolerability and safety were not possible for these studies. There was low-certainty evidence that CBD oil did not add value to specialist palliative care alone in the reduction of pain intensity in people with advanced cancer. There was no difference in the number of dropouts due to adverse events and serious adverse events (1 study, 144 participants, qualitative analysis). We found no studies using herbal cannabis. AUTHORS' CONCLUSIONS: There is moderate-certainty evidence that oromucosal nabiximols and THC are ineffective in relieving moderate-to-severe opioid-refractory cancer pain. There is low-certainty evidence that nabilone is ineffective in reducing pain associated with (radio-) chemotherapy in people with head and neck cancer and non-small cell lung cancer. There is low-certainty evidence that a single dose of synthetic THC analogues is not superior to a single low-dose morphine equivalent in reducing moderate-to-severe cancer pain. There is low-certainty evidence that CBD does not add value to specialist palliative care alone in the reduction of pain in people with advanced cancer.

ANTECEDENTES: El dolor es un síntoma común en las personas con cáncer; entre el 30% y el 50% de las personas con cáncer experimentarán dolor de moderado a intenso. Esto puede tener un gran impacto negativo en su calidad de vida. Los fármacos opiáceos (similares a la morfina) se utilizan habitualmente para tratar el dolor por cáncer moderado o intenso, y se recomiendan para este propósito en la escala de tratamiento del dolor de la Organización Mundial de la Salud (OMS). El dolor no se alivia lo suficiente con los medicamentos opiáceos en el 10% al 15% de las personas con cáncer. En las personas con un alivio insuficiente del dolor por cáncer, se necesitan nuevos analgésicos que complementen o sustituyan de forma eficaz y segura a los opiáceos. OBJETIVOS: Evaluar los efectos beneficiosos y perjudiciales de los medicamentos con cannabis, incluido el cannabis medicinal, para tratar el dolor y otros síntomas en adultos con cáncer en comparación con placebo o cualquier otro analgésico establecido para el dolor por cáncer. MÉTODOS DE BÚSQUEDA: Se utilizaron los métodos exhaustivos estándar de búsqueda de Cochrane. La última fecha de búsqueda fue el 26 de enero de 2023. CRITERIOS DE SELECCIÓN: Se seleccionaron los ensayos controlados aleatorizados (ECA) doble ciego de cannabis medicinal, medicamentos derivados de plantas y sintéticos con cannabis versus placebo o cualquier otro tratamiento activo para el dolor por cáncer en adultos, con cualquier duración del tratamiento y al menos 10 participantes por grupo de tratamiento. OBTENCIÓN Y ANÁLISIS DE LOS DATOS: Se utilizaron los métodos estándar de Cochrane. Los desenlaces principales fueron los siguientes: 1. proporción de participantes que declararon dolor leve; 2. Patient Global Impression of Change (PGIC) de mucha o muchísima mejoría y 3. retiros debido a eventos adversos. Los desenlaces secundarios fueron 4. número de participantes que declararon un alivio del dolor del 30% o superior y un consumo general de opiáceos reducido o estable; 5. número de participantes que declararon un alivio del dolor del 30% o superior, o del 50% o superior; 6. intensidad del dolor; 7. problemas de sueño; 8. depresión y ansiedad; 9. dosis diaria de opiáceos de mantenimiento y de inicio; 10. abandonos por falta de eficacia; 11. todos los eventos adversos del sistema nervioso central. Se utilizó el método GRADE para evaluar la calidad de la evidencia de cada desenlace. RESULTADOS PRINCIPALES: Se identificaron 14 estudios con 1823 participantes. Ningún estudio evaluó las proporciones de participantes que declararon un dolor no peor que leve a los 14 días de inicio del tratamiento. Se encontraron cinco ECA que evaluaron nabiximoles oromucosos (tetrahidrocannabinol [THC] y cannabidiol [CBD]) o THC solo, con 1539 participantes con dolor moderado o intenso a pesar del tratamiento con opiáceos. Los periodos doble ciego de los ECA variaron entre dos y cinco semanas. Para el metanálisis se dispuso de cuatro estudios con un diseño paralelo y 1333 participantes. Hubo evidencia de certeza moderada de que no hubo efectos beneficiosos clínicamente relevantes en las proporciones de PGIC de mucha o muchísima mejoría (diferencia de riesgos [DR] 0,06; intervalo de confianza [IC] del 95%: 0,01 a 0,12; número necesario a tratar para lograr un resultado beneficioso adicional [NNTB] 16; IC del 95%: 8 a 100). Hubo evidencia de certeza moderada de que no hubo diferencias clínicamente relevantes en la proporción de retiros debido a eventos adversos (DR 0,04; IC del 95%: 0 a 0,08; número necesario a tratar para lograr un desenlace perjudicial adicional [NNTD] 25; IC del 95%: 16 a infinito). Hubo evidencia de certeza moderada de que no hubo diferencias entre nabiximols o THC y placebo en la frecuencia de eventos adversos graves (DR 0,02; IC del 95%: ­0,03 a 0,07). Hubo evidencia de certeza moderada de que los nabiximoles y el THC utilizados como tratamiento complementario para el dolor por cáncer refractario a los opiáceos no difirieron del placebo en cuanto a la reducción de la intensidad media del dolor (diferencia de medias estandarizada [DME] ­0,19; IC del 95%: ­0,40 a 0,02). Hubo evidencia de certeza baja de que un análogo sintético del THC (nabilona) administrado durante ocho semanas no fue superior a placebo para reducir el dolor asociado con la quimioterapia o la radioquimioterapia en personas con cáncer de cabeza y cuello y cáncer de pulmón de células no pequeñas (dos estudios, 89 participantes, análisis cualitativo). En estos estudios no fue posible realizar análisis de tolerabilidad y seguridad. Hubo evidencia de certeza baja de que los análogos sintéticos del THC fueron superiores a placebo (DME ­0,98; IC del 95%: ­1,36 a ­0,60), pero no superiores a la codeína en dosis bajas (DME 0,03; IC del 95%: ­0,25 a 0,32; cinco ensayos de dosis única; 126 participantes) en cuanto a la reducción del dolor moderado a intenso por cáncer después de la interrupción del tratamiento analgésico previo durante tres a cuatro horas y media (dos ensayos de dosis única; 66 participantes). En estos estudios no fue posible realizar análisis de tolerabilidad y seguridad. Hubo evidencia de certeza baja de que el aceite de CBD no agregó valor a los cuidados paliativos especializados solos en la reducción de la intensidad del dolor en personas con cáncer avanzado. No hubo diferencias en el número de abandonos debido a eventos adversos ni eventos adversos graves (un estudio, 144 participantes, análisis cualitativo). No se encontraron estudios que utilizaran la planta de cannabis. CONCLUSIONES DE LOS AUTORES: Existe evidencia de certeza moderada de que los nabiximoles y el THC por vía oromucosa no son efectivos para aliviar el dolor de moderado a intenso por cáncer refractario a los opiáceos. Hay evidencia de certeza baja de que la nabilona no es efectiva para reducir el dolor asociado con la radio­quimioterapia en personas con cáncer de cabeza y cuello y cáncer de pulmón de células no pequeñas. Hay evidencia de certeza baja de que una dosis única de análogos sintéticos del THC no es superior a una dosis única baja equivalente de morfina para reducir el dolor moderado a intenso por cáncer. Hay evidencia de certeza baja de que el CBD no aporta valor a los cuidados paliativos especializados solos en la reducción del dolor en personas con cáncer avanzado.

[Updated S1 guideline on long/post-COVID: relevant aspects for pain medicine]. / Aktualisierte S1-Leitlinie Long/Post-COVID: Relevante Aspekte für die Schmerzmedizin.

BACKGROUND: The S1 guideline on long/post-COVID of the AWMF [German Association of the Medical Scientific Societies] registration number 020-027) was updated in August 2022. METHODS: Under the coordination of the German Society of Pneumology, the guideline was updated by 21 scientific associations, two professional associations and clinical centers each and one institute and statutory accident insurance each. Each scientific association was responsible for its own chapter. The German Pain Society prepared the chapter "Pain". The coordinators of each chapter performed a selective literature search and also received approval for the chapter within their scientific association. During an internal period of comments, all representatives of the participating institutions could comment on all chapters. The AWMF task force commented on the draft of the guideline, which was then finally approved by the boards of all participating institutions. RESULTS: Coronavirus disease 2019 (COVID-19) increases the risk of persistent headache and musculoskeletal pain. Long/Post-COVID pain is frequently associated with fatigue and cognitive problems. A specialist assessment might be considered if symptoms with limitations of daily activities persist 3 months after the infection. The diagnostic workup of long/post-COVID-associated pain should be performed according to the standards of pain medicine. Management should follow the pain guidelines of the AWMF. CONCLUSIONS: The updated S1 guideline on long/post-COVID is a clinical manual which offers orientation for diagnostics and treatment despite limited data.

[Benefits and harms of cannabis-based medicines from the viewpoint of patients with chronic pain and their physicians : A cohort study in three pain centers of the German federal state Saarland]. / Nutzen und Schaden von Cannabisarzneimitteln aus Sicht von Patienten mit chronischen Schmerzen und ihren Ärzten : Eine Kohortenstudie in drei saarländischen Schmerzzentren.

BACKGROUND: There are no studies available that have simultaneously assessed the benefits and harms of cannabis-based medicines from the viewpoint of patients and their physicians. METHODS: All chronic pain patients at three pain centres in the German federal state of Saarland who had received at least one prescription of cannabis-based medicines (CbMs) in the past from the study centre were included in a cross-sectional study from January 1 to December 31, 2021. Patients and their physicians completed a self-developed questionnaire separately. RESULTS: All 187 contacted patients participated in the study. Since the start of CbM therapy, 44.9% of patients reported to be much or very much, 43.3% to be moderately and 8.0% to be slightly improved overall. A total of 2.7% reported no change and 1.1% a moderate deterioration of overall wellbeing. From the patients' point of view, the symptoms most frequently reported to have substantially improved were sleep problems (36.4%), muscle tension (25.1%) and appetite problems (22.1%). The most frequent bothersome side effects were sweating (6.4%), concentration problems (4.2%) and nausea (4.1%). Physicians noted substantial pain relief in 60.7%, improvement of sleep in 65.7% and of mental well-being in 34.3%. A complete cessation of opioids was achieved in 64.7%, of anticonvulsants in 57.9% and of antidepressants in 60% of patients that had received these medications before the start of CbM therapy. CONCLUSIONS: CbMs can contribute to a clinically relevant reduction in pain, sleep problems and muscle tension and can improve daily functioning in carefully selected and supervised patients with chronic pain. CbM can contribute to the reduction or complete cessation of other pain medications (antidepressants, anticonvulsants, opioids).

Nociplastic pain: towards an understanding of prevalent pain conditions.

Nociplastic pain is the semantic term suggested by the international community of pain researchers to describe a third category of pain that is mechanistically distinct from nociceptive pain, which is caused by ongoing inflammation and damage of tissues, and neuropathic pain, which is caused by nerve damage. The mechanisms that underlie this type of pain are not entirely understood, but it is thought that augmented CNS pain and sensory processing and altered pain modulation play prominent roles. The symptoms observed in nociplastic pain include multifocal pain that is more widespread or intense, or both, than would be expected given the amount of identifiable tissue or nerve damage, as well as other CNS-derived symptoms, such as fatigue, sleep, memory, and mood problems. This type of pain can occur in isolation, as often occurs in conditions such as fibromyalgia or tension-type headache, or as part of a mixed-pain state in combination with ongoing nociceptive or neuropathic pain, as might occur in chronic low back pain. It is important to recognise this type of pain, since it will respond to different therapies than nociceptive pain, with a decreased responsiveness to peripherally directed therapies such as anti-inflammatory drugs and opioids, surgery, or injections.

Migraine in the context of chronic primary pain, chronic overlapping pain disorders, and functional somatic disorders: A narrative review.

OBJECTIVE: To contextualize migraine as the most common primary headache disorder in relation to other chronic primary pain and non-pain functional somatic and mental conditions. BACKGROUND: Migraine is increasingly understood as a sensory processing disorder within a broader spectrum of symptom disorders. This has implications for diagnosis and treatment. METHOD: Narrative review based on a search of the literature of the last 15 years on the overlap of migraine with other symptom disorders. RESULTS: Migraine as the prototypical primary headache disorder not only comprises many non-headache symptoms in itself, it also shows high comorbidity with other chronic pain and non-pain conditions (e.g., fibromyalgia syndrome, irritable bowel syndrome, functional non-epileptic seizures, depression, anxiety, and posttraumatic stress disorder). Such "symptom disorders" share several etiological factors (e.g., female preponderance, psychological vulnerability) and psychophysiological mechanisms (e.g., altered sensory processing, pain expectancy). These facts are acknowledged by several recent integrative conceptualizations such as chronic primary pain, chronic overlapping pain conditions, or functional somatic disorders. Accordingly, migraine management increasingly addresses the total symptom burden and individual contributors to symptom experience, and thus incorporates centrally acting pharmacological and non-pharmacological, that is, psychological and behavioral, treatment approaches. CONCLUSIONS: Migraine and also other primary headache disorders should be seen as particular phenotypes within a broader spectrum of symptom perception and processing disorders that require integrative diagnostics and treatment. A harmonization of classifications and better interdisciplinary collaboration are desirable.

Cannabidiol (CBD) in Rheumatic Diseases (Musculoskeletal Pain).

PURPOSE OF REVIEW: This review will address the many uncertainties surrounding the medical use of cannabidiol (CBD). We will begin with an overview of the legal and commercial environment, examine recent preclinical and clinical evidence on CBD, explore questions concerning CBD raised by healthcare professionals and patients, investigate dosing regimens and methods of administration, and address current challenges in the accumulation of sound evidence. RECENT FINDINGS: CBD has potential for relief of symptoms of pain, sleep, and mood disturbance in rheumatology patients, but sound clinical evidence is lacking. CBD is safe when accessed from a regulated source, whereas wellness products are less reliable regarding content and contaminants. Dosing for symptom relief has not yet been established. As many rheumatology patients are trying CBD as a self-management strategy, the healthcare community must urgently accrue sound evidence for effect.

Spontaneously reported persistent symptoms related to coronavirus disease 2019 one year after hospital discharge : A retrospective cohort single-center study.

BACKGROUND: There are no outcome studies for coronavirus disease 2019 (COVID-19) survivors one year after hospital discharge in Germany. METHODS: This retrospective cohort study included all patients with polymerase chain reaction (PCR)-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) hospitalized in the departments of internal medicine of the Klinikum Saarbrücken, a tertiary care hospital, between March 15 and December 31, 2020. A telephone interview with survivors was conducted at least 12 months after discharge. The interview was initiated with an open-ended question whether the patient had fully recovered from the disease. In the event of a subjective incomplete recovery, the patient was prompted to report any continuous or frequent symptoms that had not occurred prior to COVID-19. Finally, independent of the open-ended question response, all patients were asked closed questions which addressed new symptom onset of persistent fatigue, cognitive dysfunction, headache, muscle and joint pain following COVID-19. RESULTS: In all, 235 survivors were contacted and 162 could be included in the analysis. In 55 of 162 interviews (34.0%) at least one persistent COVID-19 symptom (PCS) was spontaneously reported. Four of 55 survivors with PCS reported five additional symptoms on the closed questions. One survivor, who responded positively to the open-ended question, reported new onset PCS in response to the closed questions. Physical fatigue (24.7%), cognitive dysfunction (14.8%), shortness of breath (8.6%), muscle and joint pain (6.8%) and headache (6.2%) were the most frequently reported PCS. CONCLUSIONS: Despite an interview technique aimed to reduce attribution bias by patients, one third of COVID-19 inpatient survivors report PCS one year after hospitalization. The complete article is written in English.

Fibromyalgia revisited: do latent class analyses of symptom profiles in the general population confirm 2016 fibromyalgia diagnostic criteria?

OBJECTIVES: The definition of the 2016 diagnostic criteria of fibromyalgia (FM) syndrome and of FM severities was based on studies with clinical samples. We tested if somatic symptom profiles consistent with the symptom pattern of the FM 2016 diagnostic criteria and of severities of FM can be found in the general population. METHODS: Somatic symptom burden was measured by the Somatic Symptom Scale - 8 in 2,531 persons aged ≥14 years representative for the general German population. We used latent class analysis of SSS-8 items to identify somatic symptom profiles. The profiles were described by their association with age, gender, self-reported disabling somatic disease, psychological symptom burden, illness worries and self-perceived health. RESULTS: We identified five somatic symptom profiles. The majority of the population (40.9%) had a profile characterised by the absence of bothering symptoms. 5.9% had a profile defined by "considerable bothering" back and extremities pains, fatigue and sleep problems. This symptom profile was associated with older age, self-reported somatic diseases, psychological symptom burden and fair to poor general health. 63.2% of persons meeting FM 2016 criteria belonged to this profile. 17.8% of the sample were characterized by little perturbation by multiple somatic symptoms and good to fair general health. 36.8% of persons meeting FM 2016 criteria belonged to this profile. CONCLUSIONS: Two somatic symptom profiles consistent with the 2016 FM diagnostic criteria were identified in the general German population. These symptom profiles differed in somatic and psychological symptom burden and general health supporting the distinction of FM severities.

Use of medical cannabis by patients with fibromyalgia in Canada after cannabis legalisation: a cross-sectional study.

OBJECTIVES: Medications have only small to moderate effects on symptoms in fibromyalgia (FM). Cannabinoids, including medical cannabis (MC) may have potential to fill this gap. Since recreational legalisation of cannabis in Canada, patients have easier access and may be self-medicating with cannabis. We have examined the prevalence and characteristics of MC use in FM patients. METHODS: During a two-month period (June-August 2019), consecutive attending rheumatology patients participated in an onsite survey comprising 2 questionnaires: 1) demographic and disease information completed by the rheumatologist, 2) patient anonymous questionnaire of health status, cannabis use (recreational and/or medicinal) and characteristics of use. RESULTS: In a cohort of 1000 rheumatology attendees, 117 (11.7%) were diagnosed with FM. Ever use of MC was reported by 28 (23.9%; 95%CI: 16.5%-32.7%) FM patients compared to 98 (11.1%; 95%CI: 9.1%-13.4%) non-FM patients. Among FM ever users, 17 (61%) patients continued use of MC. FM ever users vs. FM nonusers tended to be younger, 53 vs. 58 years (p=0.072), were more likely unemployed or disabled 39% vs. 17% (p=0.019) and used more medication types (p=0.013) but did not differ in symptom severity parameters. Cigarette smoking and recreational cannabis were more common in ever users. Global symptom relief on a VAS (1-10) was 7.0±2.3. CONCLUSIONS: FM patients have commonly used MC, with more than half continuing use. Reported symptom relief was substantial. Cigarette smoking and recreational cannabis use may play a facilitatory role in MC use in FM. Adjunctive MC may be a treatment consideration for some FM patients.

Cannabis use of patients with inflammatory bowel disease in Germany: a cross-sectional survey.

BACKGROUND AND AIMS: Progressive legalization and increasing utilization of medical cannabis open up potential new applications, including for inflammatory bowel disease (IBD). This study aimed to collect current figures on the use of and experience with cannabis among IBD patients in Germany. METHODS: A 71-item questionnaire was mailed to a randomly selected representative sample of 1000 IBD patients. RESULTS: Questionnaires were returned by 417 patients (mean age 49.1 ±â€Š17.0 years; 55.8 % women; 43.4 % ulcerative colitis and 54.7 % Crohn's disease). Seventy-three respondents (17.5 %) stated past cannabis use for recreational purposes, while 12 users mentioned usage at the time the questionnaire was completed (2.9 %). Seventeen patients (4.1 %) indicated past use of cannabis, and 18 participants (4.3 %) reported current use of cannabis to treat IBD. Perceived benefits of cannabis use by its users included reduced abdominal pain, improved sleep quality, and relief of unease and worry. They reported lower quality of life and higher levels of anxiety or depression than non-users. Of notice, 52.9 % of cannabis users obtained their cannabis from the black market. A total of 76.5 % of former and 50 % of current users did not report their cannabis use to the physician. CONCLUSION: This survey reveals the largest data set on cannabis use among IBD patients in Germany, with the potential for further research. Cannabis is mainly procured from the black market, with unknown quality.

[Endometriosis and chronic overlapping pain conditions]. / Endometriose und chronische überlappende Schmerzsyndrome.

BACKGROUND: The concept of chronic overlapping pain conditions (COPC) is relatively unknown in German pain medicine. AIMS: Definition, prevalence, shared etiological and pathophysiological mechanisms of COPC. Summary of recommendations of the interdisciplinary S2k guidelines on diagnostics and treatment of endometriosis relevant for pain physicians. METHODS: Selective search of literature in PubMed and selection of recommendations of the S2k guidelines on diagnostics and treatment of endometriosis. RESULTS: According to the US National Institutes of Health, COPCs comprise chronic fatigue syndrome, chronic (unspecific) low back pain, chronic tension headache, endometriosis, fibromyalgia syndrome, migraine, painful bladder syndrome, temporomandibular disorder and vulvodynia. Shared etiological factors are family aggregation, childhood adversities and major or traumatic life events. A major shared pathophysiological mechanism is altered processing of stimuli in the central nervous system. Patients with endometriosis should be screened for other chronic pain conditions and psychological distress. The physical examination should check for local (myofascial trigger points) and generalized signs of hyperalgesia and allodynia indicating central sensitization. In cases of endometriosis with COPCs repeated surgery for pain relief should be avoided. Amitriptyline and duloxetine can be considered as pharmacological treatment options. DISCUSSION: Pain physicians can play a role in the management of patients with endometriosis and COPCs. A multimodal therapy should include physiotherapy and pain-related psychological treatment and possibly centrally acting pain modulation medication.

All-cause mortality in patients with long-term opioid therapy compared with non-opioid analgesics for chronic non-cancer pain: a database study.

BACKGROUND: Hitherto only studies with selected populations have found an increased all-cause mortality of some selected opioids compared to selected non-opioids for chronic non-cancer pain (CNCP). We have examined the all-cause mortality for CNCP associated with all established opioids compared to non-opioid analgesic therapy (anticonvulsants, antidepressants, dipyrone, non-steroidal agents). METHODS: The study used the InGef (Institute for Applied Health Research Berlin) database which is an anonymized healthcare claims database including 4,711,668 insured persons who were covered by 61 German statutory health insurances between 2013 and 2017.The health insurance companies are the owners of the database. All-cause mortality was determined from death certificates. Adjusted hazard ratios (HRs) including age, gender, comorbidity index, and propensity score as covariates and risk differences (RD) in incidence of death between patients with long-term opioid therapy (LTOT) and control-drug therapy were calculated. RESULTS: The mean age of participants was 66 years; 55% were women. There were 554 deaths during 10,435 person-years for the LTOT patients, whereas there were 340 deaths during 11,342 person-years in the control group. The HR for all-cause mortality was 1.59 (95% CI, 1.38-1.82) with a risk difference of 148 excess deaths (95% CI 99-198) per 10,000 person-years. The elevated risk of death for LTOT was confined to the out-of-hospital deaths: LTOT patients had 288 out-of-hospital deaths during 10,435 person-years (276 per 10,000 person-years) whereas there were 110 deaths during 11,342 person-years (97 per 10,000 person-years) in the control group. HR was 2.29 (95% CI 1.86, 2.83). Although our propensity score matching model indicated a good classification, residual confounding cannot be fully excluded. The opioid group had a higher prevalence of heart failure and a higher use of anti-thrombotic and antiplatelet agents and of psycholeptics. CONCLUSIONS: LTOT for CNCP compared to non-opioid analgesics was associated with an increased risk for all-cause mortality. When considering treatment options for patients with CNCP, the relevant risk of increased all-cause mortality with opioids should be discussed. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03778450, Registered on 7 December 2018.

Diagnosis of fibromyalgia: comparison of the 2011/2016 ACR and AAPT criteria and validation of the modified Fibromyalgia Assessment Status.

OBJECTIVE: To compare the concordance of the three diagnostic criteria, respectively the 2011 ACR criteria (ACR 2011 Cr), the ACR 2016 criteria (ACR 2016 Cr) and the Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations Opportunities and Networks (ACTTION)-APS Pain Taxonomy criteria (AAPT Cr), and to explore the performance of an additional set of criteria, the modified Fibromyalgia Assessment Status (FAS 2019 modCr), in the diagnosis of FM syndrome. METHODS: Consecutive patients with chronic widespread pain, referred by the primary care setting, underwent rheumatologic assessment that established the presence or not of FM and were investigated through the four sets of proposed criteria. For the FAS 2019 modCr, discriminant validity to distinguish patients with FM and non-FM was assessed with receiver operating characteristic curve analysis. RESULTS: A total of 732 (405 with FM and 327 with other common chronic pain problems) patients were evaluated. Against the clinical diagnosis of FM, the sensitivity, specificity and correct classification were, respectively: 79.8, 91.7 and 85.1% for ACR 2011 Cr; 78, 90.5 and 83.6% for the ACR 2016 Cr; and 73.8, 91.7 and 81.8% for the AAPT Cr. The alternative set, proposed on the FAS 2019 modCr, provided a maximal diagnostic accuracy with a score ≥20 (Youden's index), with a sensitivity of 84.2%, specificity 89.0% and positive likelihood ratio 7.65. CONCLUSION: There is a considerable agreement between criteria-based diagnoses of FM, although the AAPT Cr perform least well in terms of percentage of correct classification. The FAS 2019 modCr had comparable characteristics.

[Method report of the second update of the guidelines on long-term opioid therapy for chronic noncancer pain]. / Leitlinienreport der zweiten Aktualisierung der S3-Leitlinie "Langzeitanwendung von Opioiden bei nicht-tumorbedingten Schmerzen ­ LONTS".

BACKGROUND: The update of the German S3 guidelines on long-term opioid therapy of chronic noncancer pain (CNCP), the LONTS (AWMF registration number 145/003), was scheduled for February 2020 due to the expiry of the validity period. METHODS: The guidelines were updated by 28 scientific societies and 2 patient self-help organizations under the coordination of the German Pain Society and the Association of the Scientific Medical Societies in Germany (AWMF). RESULTS: A systematic literature search was performed in the CENTRAL, MEDLINE and Scopus databases from October 2013 to December 2018. The previous meta-analyses of randomized controlled trials (RCT) of opioids in CNPC syndromes with a study duration of ≥4 weeks were updated. Levels of evidence were assigned according to the Oxford Centre for Evidence-Based Medicine version 2009 classification system. The formulation and strength of recommendations was established in a multistep formalized consensus procedure, in accordance with AWMF rules and standards. The guidelines were reviewed by four experts not involved in the development of the guidelines. The public was given the opportunity to comment on the guidelines. The guidelines were approved by the executive boards of the societies that were engaged in development of the guidelines. CONCLUSION: The guidelines will be published in several forms: complete and short scientific versions as well as clinical practice and patient versions.

[Recommendations of the second update of the LONTS guidelines : Long-term opioid therapy for chronic noncancer pain]. / Empfehlungen der zweiten Aktualisierung der Leitlinie LONTS : Langzeitanwendung von Opioiden bei chronischen nicht-tumorbedingten Schmerzen.

BACKGROUND: The second scheduled update of the German S3 guidelines on long-term opioid therapy for chronic noncancer pain (CNCP), the LONTS (AWMF registration number 145/003), was started in December 2018. METHODS: The guidelines were developed by 28 scientific societies and 2 patient self-help organizations under the coordination of the German Pain Society. A systematic literature search in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Scopus databases (up until December 2018) was performed. The systematic reviews with meta-analyses of randomized controlled trials with opioids for CNCP from the previous versions of the guideline were updated. Levels of evidence were assigned according to the classification system of the Oxford Centre for Evidence-Based Medicine. The strength of the recommendations was established by formal multistep procedures in order to reach a consensus according to the Association of the Medical Scientific Societies in Germany (AWMF) regulations. The guidelines were reviewed by four external pain physicians. Public comments were possible for 4 weeks. RESULTS: Opioid-based analgesics are a drug-based treatment option for short-term (4-12 weeks), intermediate-term (13-25 weeks) and long-term (≥26 weeks) therapy of chronic osteoarthritis, diabetic polyneuropathy, postherpetic neuralgia and low back pain. Contraindications are primary headaches as well as functional somatic syndromes and mental disorders with the (cardinal) symptom pain. Based on a clinical consensus the guidelines list other medical conditions for which a therapy with opioids can be considered on an individual basis. Long-term therapy of CNCP with opioids is associated with relevant risks. CONCLUSION: A responsible administration of opioids requires consideration of possible indications and contraindications as well as regular assessment of efficacy and adverse effects. Opioids remain a treatment option for CNCP if nonpharmacological therapies are not effective and/or other drugs are not effective, are not tolerated or are contraindicated.

Fibromyalgia syndrome: under-, over- and misdiagnosis.

Fibromyalgia syndrome (FM) is an enigma. During the past three decades, with the gradual acceptance of the validity of FM, it is variously under-, over and misdiagnosed. Evidence-based interdisciplinary guidelines have suggested a comprehensive clinical assessment to avoid this diagnostic conundrum. Every patient with chronic pain should be screened for chronic widespread pain (pain in four of five body regions) (CWP). Those with CWP should be screened for presence of additional major symptoms of FM: unrefreshed sleep and fatigue. A complete medical (including drug) history and complete physical examination is mandatory in the evaluation of a patient with CWP in order to consolidate the diagnosis of FM or identify features that may point to some other condition that may have a presentation similar to FM. Limited simple laboratory testing is recommended to screen for possible other diseases. The 2016 criteria may be used to further confirm the clinical diagnosis of FM. In consideration of the differential diagnosis of FM, attention should be paid to the presence of other chronic overlapping pain conditions and of mental disorders. FM as a stand alone diagnosis is however rare, as most patients with FM meet criteria for other chronic overlapping pain conditions or mental disorders. The severity of FM should be assessed in order to direct treatment approaches and help inform the likely outcome for an individual patient.

Efficacy, tolerability and safety of cannabis-based medicines for cancer pain : A systematic review with meta-analysis of randomised controlled trials.

BACKGROUND: The importance of medical cannabis and cannabis-based medicines for cancer pain management needs to be determined. METHODS: A systematic literature search until December 2018 included CENTRAL, PubMed, SCOPUS and trial registers. Randomised controlled trials (RCTs) investigating medical cannabis and/or pharmaceutical cannabinoids for pain control in cancer patients with a study duration of at least 2 weeks and a sample size of at least 20 participants per study arm were included. Clinical outcomes comprised efficacy (pain intensity, patient impression of improvement, combined responder, sleep problems, psychological distress, opioid maintenance and breakthrough dosage), tolerability (dropout rate due to adverse events) and safety (nervous system, psychiatric and gastrointestinal side effects; serious adverse events). The quality of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE). RESULTS: Five RCTs with oromucosal nabiximols or tetrahydrocannabinol (THC) including 1534 participants with moderate and severe pain despite opioid therapy were identified. Double blind period of the RCTs ranged between 2 and 5 weeks. Four studies with a parallel design and 1333 patients were available for meta-analysis. The quality of evidence was very low for all comparisons. Oromucosal nabiximols and THC did not differ from placebo in reducing pain, sleep problems, opioid dosages and in the frequency of combined responder, serious adverse events and psychiatric disorders side effects. The number of patients who reported to be much or very much improved was higher with oromucosal nabiximols and THC than with placebo (number needed to treat for an additional benefit 16; 95% confidence interval [CI] 8 to infinite). The dropout rates due to adverse events (number needed to treat for an additional harm [NNTH]: 20; 95% CI 11-100), the frequency of nervous system (NNTH: 10; 95% CI 7-25) and of gastrointestinal side effects (NNTH: 11; 95% CI 7-33) was higher with oromucosal nabiximols and THC than with placebo. CONCLUSIONS: Very low quality evidence suggests that oromucosal nabiximols and THC have no effect on pain, sleep problems and opioid consumption in patients with cancer pain with insufficient pain relief from opioids. The complete manuscript is written in English.

[Position paper on medical cannabis and cannabis-based medicines in pain medicine]. / Ein Positionspapier zu medizinischem Cannabis und cannabisbasierten Medikamenten in der Schmerzmedizin.

Since March 2017, the prescription of medical cannabis at the expense of the statutory health insurance is possible after approval by the respective medical services. Chronic pain is the most common indication, as health claims data and the accompanying survey show. From the point of view of the law, a prescription is indicated in cases of serious illness, missing or not indicated established therapeutic approaches and a not entirely remote prospect of improvement of the illness or its symptoms. This describes a broader indication spectrum than can currently be based on randomised controlled clinical trials. There is weak evidence of low efficacy for neuropathic pain. For pain related to spasticity and cancer-related pain there is evidence of improvements in quality of life, but effects on pain are of little relevance. For all other indications, only an individual therapeutic trial can be justified based on the available external evidence. However, this usually corresponds to the demand of "a not entirely remote prospect" of a noticeably positive effect of medical cannabis. It is also problematic that almost no long-term studies for the application and efficacy of flowers and extracts are available.Current knowledge on the use of cannabis-based drugs and, more clearly, medical cannabis for chronic pain is insufficient. The increase in the number of countries with marketing authorisations or exemptions for medicinal cannabis or cannabis-based drugs for chronic pain will also pave the way for larger empirical and population-based studies that will further improve the evidence base of research and clinical use.