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Background: The effects of balneotherapy on rheumatoid arthritis RA are still controversial partly due to poor methodology used in randomized controlled trials, as reported in the international medical literature. Objectives: To determine whether spa therapy plus pharmacological treatment offers any benefit in the management of RA as compared to pharmacological treatment alone. Methods: We conducted a prospective, controlled, unblinded randomly assigned study of patients with RA according to American College of Rheumatology criteria.
Patients who were severely disabled, had taken systemic steroids in the previous 6 months or had withdrawn from DMARD therapy in the previous 12 months were excluded. Two series of medicines were used. Complex homeopathy involves homeopathic mixtures of commonly prescribed remedies for specific problems and can be used without a consultation. The aim was to identify whether therapeutic benefits were attributable to the homeopathic remedy, the homeopathic consultation or both.
The trial was exploratory as we wished to explore how the consultation process may potentially be eliciting clinical benefit using relevant measures. Patients provided written informed consent. Patients were randomized into five groups Fig. Randomization is described in Table 1. Of the five groups, three received a homeopathic consultation Groups 1—3 and two Groups 4 and 5 did not.
The consultation groups were further randomized to individualized treatment Group 1 , a homeopathic complex for RA Group 2 or placebo Group 3. Non-consultation participants were allocated complex Group 4 or placebo Group 5 ; individualized homeopathy can only be prescribed through a consultation.
The study design enabled the following comparisons:. Contrast 1: the effect of the consultation; by comparing the consultation and non-consultation groups; Groups 2 and 3 vs Groups 4 and 5.
Those receiving individualized homeopathic treatment were excluded because there was no direct comparison for the non-consultation group. Contrast 2: the effect of the complex treatment; comparing Groups 2 and 4 with Groups 3 and 5. Contrast 3: the difference in effect between individualized treatment and complex; comparing Groups 1 and 2. Figure 2 outlines the study procedures; all clinics were held in secondary care. Patients were screened at baseline clinic Visit 1 then randomized.
The trial period was 40 weeks; patients attended for seven further clinic visits on a 4 weekly basis during treatment Visits 2—8 ; follow-up was Week 40 Visit 9.
All clinic visits were standardized; all participants saw a study nurse where assessments and outcome measures were recorded. Two qualified experienced non-medical homeopaths each with 15 years experience, classically trained prescribed individualized homeopathic treatment at each visit mirroring normal practice. In between clinic visits, patients also completed weekly diaries recording pain, global assessment GA and adverse events.
Further details of the intervention using standardized homeopathic reporting guidelines [ 18 ] can be obtained from the authors.
This was posted to participants after clinic Visits 2—7 by an off-site homeopathic pharmacist, in accordance with randomization allocation and taken twice daily during the treatment phase; this dosing regimen is appropriate in chronic conditions such as RA [ 19 ]. The interventions were:. Individualized homeopathy prescribed as tablets Group 1 only.
The homeopaths prescribed from the entire homeopathic repertoire. A post-analysis review confirmed that all individualized homeopathy was prescribed at ultra-molecular doses all fifty millesimal potency scale potencies.
A standardized commercial homeopathic complex Groups 2 and 4 previously reported as efficacious for RA [ 8 , 9 ]; Rheumaselect Dreluso, Hessisch Oldendorf Germany. Two placebos were prepared identical in colour, taste and consistency to the homeopathic tablets and complex Groups 3 and 5.
Consultations were conducted as in normal practice. The process of the consultation was standardized in that specific topics were covered e. Details of the homeopathic consultations are reported in our nested qualitative study Brien et al.
Patients and study staff were aware of consultation allocation but were all blinded to treatment allocation. All patients received one bottle of tablets individualized remedy or placebo as appropriate and a bottle of liquid either homeopathic complex or equivalent placebo with a standardized dosing frequency ensuring blinding. All preparations were indistinguishable in appearance, taste and smell.
The security of the blinding process was assessed by asking participants, homeopaths and the study nurse to guess which treatment they believed the participant received at Visits 4 and 8.
ACR20 [ 21 ] is a validated rheumatological composite measure giving a binary outcome of treatment success achieved or not achieved. It is the standard European research outcome measure comparable with the ACR criteria [ 25 ].
Adverse events were recorded at clinic visits study nurse and between visits patient recorded using standardized forms. No study has previously determined the effect size ES of the consultation or how relative this effect is to the specific treatment effect. The power calculation was estimated on the dichotomous primary outcome, ACR20 [ 33 ]. The randomization code was broken by the statistician after data entry was completed, the primary outcome determined and any data queries resolved. Logistic regression analysis assessed dichotomous data and analysis of covariance assessed continuous data comparing changes in scores from baseline to the end of treatment.
Means s. Longitudinal analysis using first-order autoregressive correlation structure and generalized estimating equations Stata version No missing values were imputed for longitudinal analysis since this method fits all available data to the model; thus data on patients who withdrew were included in the analysis to the point of withdrawal.
The four contrasts were evaluated on each outcome measure to assess particular comparisons. ESs, i. Adverse events were reported using descriptive statistics.
Participant flow is shown in Fig. A total of 83 participants were randomized to treatment, of which 6 patients dropped out after randomization before treatment; 77 patients were included into the ITT. No group differences were observed between those who withdrew between randomization and end of treatment. Patients withdrew commonly for i. Baseline characteristics of the ITT population did not significantly differ for any variable Table 2. Mean baseline DAS was 4.
Baseline characteristics of patients allocated to treatment group ITT population including withdrawals. Values are means s. Logistic regression analyses of all randomized patients for the four contrasts are reported in Table 4. No significant differences were identified for the effects of consultation or treatment allocation for either of these primary outcomes.
The mean score differences for all secondary outcomes of completers from baseline to end of treatment are reported in Table 5. The percentages are based on all 77 ITT patients; there were no significant group differences. Secondary outcome measures after 24 weeks of treatment: mean differences s.
The negative mood construct of the PANAS was adjusted accordingly so that a negative sign indicates improvement. Longitudinal analysis adjusted for significant covariates for each contrast for all patients randomized, are reported in Table 6.
Receiving a homeopathic consultation resulted in significant improvement over time in DAS compared with no consultation [mean group difference s. In addition, receiving a homeopathic consultation was significantly associated with reduction in the number of swollen joints group difference 3. No significant differences due to treatment were identified for any rheumatology measures for either Contrast 2, 3 or 4.
Longitudinal analysis adjusted for significant covariates for each contrast are reported in Table 6. Receiving a homeopathic consultation compared with no consultation significantly reduced weekly pain group difference 6.
No other significant effects were identified. The number and type of most frequently reported adverse events recorded during the study are reported in Table 7. No significant differences were identified between treatment groups.
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