Our Research:

Background Osteoarthritis (OA) is a highly prevalent musculoskeletal disorder. Conventional treatment (i.e. the use of non steroidal anti-inflammatory drugs) is associated with well documented adverse effects. Devil’s Claw, a traditional South African herbal remedy used for rheumatic conditions may be a safer treatment option. To date 14 clinical trials have assessed its efficacy/effectiveness in OA.
Aim To address the two main questions of importance to clinicians i.e.  (1) Does Devil’s Claw work for the treatment of OA and (2) is it safe?
Methods A review of the literature on Devil’s Claw and OA from 1966-2006 was performed using multiple search databases, Monographs and grey literature. Relevant trials in all languages were identified and included. Both internal validity (i.e. was the dosage and period of treatment adequate for this condition, reporting of randomisation, rates of drop out, blinding, and statistical analysis) and external validity (i.e. inclusion/ exclusion criteria, baseline characteristics of the study populations, trial setting, and the appropriateness of the outcome measures of the trials) were assessed.
Results 14 studies were identified; eight observational studies;  two comparator trials (one open the other randomised to assess clinical effectiveness); and four double-blind, placebo-controlled RCT to assess efficacy. Many of the published trials lacked certain important methodological quality criteria. However, the data from the higher quality studies suggest that Devil’s Claw appeared effective in the reduction of the main clinical symptom of pain. The assessment of safety is limited by the small populations generally evaluated in the clinical studies.  From the current data, Devil’s Claw appears to be associated with minor risk (relative to NSAID ) but further long term assessment is required.
Conclusion The methodological quality of the existing clinical trials is generally poor, and although they provide some support, there are a considerable number of methodological caveats that make further clinical investigations warranted. The clinical evidence to date cannot provide a definitive answer to the two questions posed, does it work and is it safe. A definitive high quality trial which addresses the necessary methodological improvements noted is needed to answer these important clinical questions.

Extracts of the secondary roots of the southern African plant, Devil’s Claw (Harpagophytum procumbens) provide a herbal drug with a variety of traditional indications. One area of its use that has become very popular in recent years is in the treatment of inflammatory disorders of the musculoskeletal system and of low back pain. There have been several clinical studies recently published that generally support its use in treating osteoarthritis although more studies are required in order to establish this drug as a definite therapeutic option. Here in this review, the pharmacological properties of Devil’s Claw are reviewed in detail and the clinical evidence is briefly summarised. There is good in vitro and in vivo pharmacological evidence of the anti-inflammatory and analgesic properties of this drug, although some negative findings have also been reported. Generally, the pharmacological properties of Devil’s Claw is supportive of its therapeutic potential, but more evidence from clinically relevant models, as well as at the cellular and molecular level, should be sought. Such studies may provide evidence in support of additional indications, both traditional and novel. The clinical data on Devil’s Claw is also very promising.

Background Previous research has suggested that natural killer (NK) cell activity may be reduced in patients with chronic fatigue syndrome (CFS).
Aim To evaluate the effectiveness of a putative NK cell stimulant, BioBran MGN-3, in reducing fatigue in CFS patients.
Design Randomized, double-blind, placebo-controlled trial.
Methods: We recruited 71 patients with CFS (according to the Centers for Disease Control 1994 criteria) attending an out-patient specialist CFS service. Participants were given oral BioBran MGN-3 for 8 weeks (2 g three times per day) or placebo equivalent. The primary outcome measure was the Chalder physical fatigue score.
Self-reported fatigue measures, self-assessment of improvement, change in key symptoms, quality of life, anxiety and depression measures were also included.
Results Data were complete in 64/71 patients. Both groups showed marked improvement over the study duration, but without significant differences. Mean improvement in the Chalder fatigue score (physical scale) was 0.3 (95%CI –2.6 to 3.2) lower in the BioBran group.
Discussion The findings do not support a specific therapeutic effect for BioBran in CFS. The improvement showed by both groups over time highlights the importance of placebo controls when evaluating interventions in CFS.

Background Osteoarthritis (OA) of the knee is the most prevalent joint disorder. Bromelain, an extract from the pineapple plant, has purported anti-inflammatory and analgesic properties and may provide a safer alternative/adjunctive treatment for knee OA than current conventional treatment. Previous trials (uncontrolled or comparative studies) indicate its potential use in this condition.
Aim To assess the specific efficacy of Bromelain as an adjunctive treatment for osteoarthritis of the knee. 
Design Randomised, placebo controlled trial
Methods 47 subjects with a confirmed diagnosis of moderate to severe knee osteoarthritis received treatment in this double-blind, randomized placebo-controlled study. Subjects were randomised and received twelve weeks of treatment intervention (bromelain 800 mg/d or placebo) with a four-week follow-up period. Knee (pain, stiffness and function) and quality of life symptoms were reported monthly in the WOMAC and SF36 questionnaires, respectively.  Adverse events were also recorded. The primary outcome measure was the change in total WOMAC score from baseline to the end of treatment at week 12.  Longitudinal models were used to evaluate outcome.
Results 31 patients completed the trial (N= 14 bromelain; N=17 placebo). No statistically significant treatment group differences were observed (coefficient = 11.16, P=0.27, CI -8.86 to 31.18) in the primary outcome, nor the WOMAC subscales or SF36. Both treatment groups showed clinically relevant improvement in the WOMAC disability subscale only. Adverse events were generally mild in nature.
Conclusion This study has not found that bromelain is efficacious as an adjunctive treatment of moderate to severe OA, but its limitations support the need for a follow up study in patients with moderate to severe osteoathritis.

Bromelain, an extract from the pineapple plant, has been demonstrated to show anti-inflammatory and analgesic properties and may provide a safer alternative or adjunctive treatment for osteoarthritis (OA). All previous trials, which have been uncontrolled or comparative studies, indicate its potential use for the treatment of osteoarthritis. This paper reviews the mechanism of its putative therapeutic actions, those clinical trials that have assessed its use in osteoarthritis to date, as well as considering the safety implications of this supplement for OA and reviewing the evidence to date regarding the dosage for treating this condition.  The data available at present indicates the need for trials to establish its efficacy and its optimum dosage and the need for adequate prospective adverse event monitoring in such chronic conditions as osteoarthritis.