Validation of the Patient-Doctor-Relationship Questionnaire (PDRQ-9) in a Representative Cross- Sectional German Population Survey: Validation of the Patient-Doctor-RelationshipQuestionnaire (PDRQ-9) in a Representative Cross-Sectional German Population Survey

The patient-doctor relationship (PDR) as perceived by the patient is an important concept in primary care and psychotherapy. The PDR Questionnaire (PDRQ-9) provides a brief measure of the therapeutic aspects of the PDR in primary care. We assessed the internal and external validity of the German version of the PDRQ-9 in a representative crosssectional German population survey that included 2,275 persons aged$14 years who reported consulting with a primary care physician (PCP). The acceptance of the German version of this questionnaire was good. Confirmatory factor analysis demonstrated that the PRDQ-9 was unidimensional. The internal reliability (Cronbach’s a) of the total score was .95. The corrected item-total correlations were$.94. The mean satisfaction index of persons with a probable depressive disorder was lower than that of persons without a probable depressive disorder, indicating good discriminative concurrent criterion validity. The correlation coefficient between satisfaction with PDR and satisfaction with pain therapy was r = .51 in 489 persons who reported chronic pain, indicating good convergent validity. Despite the limitation of low variance in the PDRQ- 9 total scores, the results indicate that the German version of the PDRQ-9 is a brief questionnaire with good psychometric properties to assess German patients’ perceived therapeutic alliance with PCPs in public health research

Spa Treatment (Balneotherapy) for Fibromyalgia—A Qualitative-Narrative Review and a Historical Perspective

Aim. To perform a narrative review of spa therapy for management of the fibromyalgia syndrome (FMS), evaluating this traditional time-honored form of therapy in a historical perspective. Methods. Medline was searched using the terms “Spa therapy,” “Balneotherapy,” and “Fibromyalgia” between 1990 (year of ACR fibromyalgia criteria publication) and April 2013. The Cochrane database was also searched. Publications relating to the implementation of spa therapy and related practices over the centuries were identified through references, searched, and reviewed. Results. Reports of balneotherapy were described from diverse locations throughout Europe and Asia, and various forms of water-related therapy have been incorporated for many musculoskeletal indications. In the management of FMS, spa therapy has generally been shown to be well accepted and moderately effective for symptom reduction. Conclusion. While achieving high-quality evidence-based conclusions is difficult for complex natural therapies such as spa therapy, the existing evidence indicates a positive effect in management of FMS. In view of the long history of this modality in the management of rheumatic pain as well as the inherent difficulties related to pharmacological treatment, the role of spa therapy should currently be recognized as part of a therapeutic program for FMS

New treatment options for fibromyalgia: critical appraisal of duloxetine

Fibromyalgia syndrome (FMS) is a chronic condition characterized by widespread pain, tender points, fatigue, and sleep disturbance. FMS leads to high disability levels, poor quality of life, and extensive use of medical care. Effective pharmacological treatment options are rare, and treatment effects are often of limited duration. Duloxetine is a new selective serotonin and norepinephrine reuptake inhibitor that is licensed for the treatment of pain in diabetic neuropathy. So far two randomized, placebo-controlled trials have investigated the short-term safety and efficacy of duloxetine 60 mg/day and 120 mg/day in patients suffering from FMS over a period of 12 weeks. Both dosages were superior to placebo in pain relief, and improvement in quality of life and depressive symptoms. The analgesic effect was largely independent of the antidepressant action of duloxetine. The higher dose of 120 mg/day further reduced the tender point count and elevated the tender point pain thresholds. Only mild to moderate adverse effects were reported. Duloxetine 60 mg/day and 120 mg/day has proven to be beneficial in the treatment of FMS symptoms. As true for other antidepressants further studies are needed to assess the long-term efficacy and safety of duloxetine as an additional pharmacological treatment option in FMS

Spa treatment (Balneotherapy) for fibromyalgia—a qualitative-narrative review and a historical perspective

Aim. To perform a narrative review of spa therapy for management of the fibromyalgia syndrome (FMS), evaluating this traditional time-honored form of therapy in a historical perspective. Methods. Medline was searched using the terms "Spa therapy, " "Balneotherapy, " and "Fibromyalgia" between 1990 (year of ACR fibromyalgia criteria publication) and April 2013. The Cochrane database was also searched. Publications relating to the implementation of spa therapy and related practices over the centuries were identified through references, searched, and reviewed. Results. Reports of balneotherapy were described from diverse locations throughout Europe and Asia, and various forms of water-related therapy have been incorporated for many musculoskeletal indications. In the management of FMS, spa therapy has generally been shown to be well accepted and moderately effective for symptom reduction. Conclusion. While achieving high-quality evidence-based conclusions is difficult for complex natural therapies such as spa therapy, the existing evidence indicates a positive effect in management of FMS. In view of the long history of this modality in the management of rheumatic pain as well as the inherent difficulties related to pharmacological treatment, the role of spa therapy should currently be recognized as part of a therapeutic program for FMS

Subjective Cognitive Dysfunction in Patients With and Without Fibromyalgia:Prevalence, Predictors, Correlates, and Consequences

Background: Subjective cognitive dysfunction (SCD) is common in fibromyalgia (FM), where it has been called 'fibrofog.' But its predictors and correlates are not well understood, including the extent to which SCD is present in fibromyalgia and non-fibromyalgia clinical populations. In addition, there are no studies available concerning SCD and fibromyalgia in the general population. We investigated these issues in a longitudinal rheumatic disease research databank and two cross-sectional general population studies. Methods: 11,150 unselected patients with rheumatoid arthritis completed an assessment of FM and cognitive severity (CS) status using the full 0-3 fibromyalgia 2016 criteria assessment. In addition, CS was dummy coded as present/absent (CS+). Assessments of SCD and fibromyalgia prevalence were available in two German general population studies. Results: Fibromyalgia was present (FM+) in 2,493 (21.7%) of clinical subjects and absent (FM-) in 9,017 (78.3%) by FM 2016 criteria. Cognitive severity was present in 1,304 (52.3%) of those with fibromyalgia and 1,009 (11.2%) of non-fibromyalgia subjects (FM-). In two general population studies, 42.0% to 52.3% of those with fibromyalgia were CS+ as were 1.4% to 5.5% of FM- subjects. Patients with CS+ had more abnormal scores for every measure of rheumatoid arthritis (RA) severity, fibromyalgia severity, and general health. The presence of CS+ was strongly related to somatic and non-somatic symptoms scores and less strongly to pain variables. The best predictor of CS+ in the clinic and the general population was the symptom severity scale (SSS), a criterion of fibromyalgia. Conclusions: Persons with SCD have high counts of somatic and psychological symptoms. Subjective cognitive dysfunction is best predicted by a simple symptoms score, and not by pain extent scores. Although SCD is called fibrofog in patients with FM, 43.6% of CS+ cases occurred in FM- subjects. Fibromyalgia and CS are correlated but appear to be different parts of a symptom severity continuum. 'Fibrofog' as a phenomenon linked only to fibromyalgia is a misnomer because it can be identified in many non-fibromyalgia patients as well

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