Zitman 1990.
| Study characteristics | ||
| Methods | Design: parallel Duration: 6 weeks Assessment: baseline, 2 weeks, post‐intervention, follow‐up (6 weeks post‐intervention) Country: Netherlands |
|
| Participants | Pain condition: chronic pain of various origins Population: adults aged 30‐60 with chronic pain of various origins Minimum pain intensity: no Inclusion criteria
Exclusion criteria
Total participants randomised: 49 Age in years (mean, SD): 45.2 (1.3) Gender: 20/49 were female Pain duration in years (mean, SD): 5.1 (3.4) |
|
| Interventions | Placebo (riboflavin 15 mg)
Amitriptyline 75 mg + placebo (riboflavin 15 mg)
|
|
| Outcomes | Pain intensity Mood Withdrawal |
|
| Missing data methods | Completer analysis | |
| Funding source | NR | |
| Conflicts of interest | NR | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomisation methods not specified |
| Allocation concealment (selection bias) | Unclear risk | Allocation procedures not specified |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Says double‐blind but no information given regarding appearance of tablets etc. Also the 12‐week follow‐up was open‐label and participants could choose what they wanted. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Self‐reported outcomes, but unsure of blinding conditions |
| Incomplete outcome data (attrition bias) All outcomes | High risk | No missing data methods given, completer analysis only Attrition Total: 10/49 (20.4%) Placebo: 4/24 (16.7%) Amitriptyline 75 mg: 6/25 (24.0%) |
| Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration found |
| Other bias | High risk | A lot of imbalances at baseline. Authors class vitamin B as a placebo, but this could have a beneficial effect on mood. |
ACR: American College of Rheumatology; AE: adverse events; ARA: American Rheumatism Association; BAI: Beck Anxiety Inventory; BDI: Beck Depression Inventory; BMI: body mass index; BOCF: baseline observation carried forward; BPI: Brief Pain Inventory; CBT: cognitive behavioural therapy; CoI: conflict of interest; DMS‐IV:Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition; DSM‐IV‐TR:Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision; ECG: electrocardiogram; FIC: functional impairment checklist; FIQ: Fibromyalgia Impact Questionnaire; FM: fibromyalgia; GAD: generalised anxiety disorder; HADS: Hospital Anxiety and Depression Scale; IBS: irritable bowel syndrome; ICD‐10:International Classification of Diseases 10th Revision; IQR: interqurtile range; ITT: intention‐to‐treat; LOCF: last observation carried forward; MADRS: Montgomery–Åsberg Depression Rating Scale; MAOI: monoamine oxidase inhibitors; mBOCF: mean baseline observation carried forward; MDD: major depressive disorder; MINI: Mini International Neuropsychiatric Interview; MMRM: mixed models for repeated measures; MNSI: Michigan Neuropathy Screening Instrument; NaRI: noradrenaline reuptake inhibitors; NaSSA: noradrenergic and specific serotonergic antidepressant; NR: not reported; NRS: numerical rating scale; NSAID: non‐steroidal anti‐inflammatory drug; OA: osteoarthritis; ODI: Oswestry Disability Index; PGIC: Patient Global Impression of Change; RA: rheumatoid arthritis; SAE: serious adverse events; SARI: serotonin antagonist and reuptake inhibitors; SD: standard deviation; SDI: Sleep Disorders Inventory; SNRI: serotonin‐noradrenalin reuptake inhibitors; SSRI: selective serotonin reuptake inhibitors; TCA: tricyclic antidepressants; TeCA: tetracyclic antidepressants; TENS: transcutaneous electrical nerve stimulation; VAS: visual analogue scale; WOCF: worst observation carried forward; WOMAC: Western Ontario and McMaster Universities Osteoarthritis pain scale