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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.

Objective To assess the efficacy of enzyme potentiated desensitisation in the treatment of severe summer hay fever poorly controlled by pharmacotherapy.

Design Double blind randomised placebo controlled parallel group study.

Setting Hospital in Hampshire.

Participants 183 participants aged between 18 and 64 with a history of severe summer hay fever for at least two years; all were skin prick test positive to timothy grass pollen. 90 randomised to active treatment; 93 randomised to placebo.

Interventions Active treatment: two injections of enzyme potentiated desensitisation, given between eight and 11 weeks apart, each comprising 200 Fishman units of glucuronidase, 50 pg 1,3-cyclohexanediol, 50 ng protamine sulphate, and a mixed inhaled allergen extract (pollen mixes for trees, grasses, and weeds; allergenic fungal spores; cat and dog danders; dust and storage mites) in a total volume of 0.05 ml of buffered saline. Placebo: two injections of 0.05 ml buffered saline solution.

Main outcome measures Proportion of problem-free days; global rhinoconjunctivitis quality of life scores assessed weekly during pollen season.

Results The active treatment group and the placebo group did not differ in the proportion of problem-free days, quality of life scores, symptom severity scores, change in quantitative skin prick provocation threshold, or change in conjunctival provocation threshold. No clinically significant adverse reactions occurred.

Conclusions Enzyme potentiated desensitisation showed no treatment effect in this study.

Background In the investigation of seasonal allergic rhinoconjunctivitis (SAR), quantitative skin and conjunctival allergen challenge tests are used to measure individual allergen sensitivity. These tests are reproducible and relate well to prevalence but their relationship to symptom severity is less well established.

Objective We wished to determine if quantitative skin prick tests (QSPT) and conjunctival provocation tests (CPTs) using a single grass pollen allergen extract are reproducible and predict symptom severity in SAR.

Methods We retrospectively analysed data from 91 participants in a previously published randomized placebo controlled study of low dosage allergen immunotherapy who were randomized to receive placebo treatment. We examined the relationship between pre-seasonal QSPT, CPT and SAR symptoms.

Results We found a high level of reproducibility when repeated measures were compared for both the QSPT (P<0.001) and the CPT (P<0.001) and moderate correlation (0.49) between the standard skin prick test (SPT) and the QSPT (P<0.001). We found weak negative correlation (−0.27) between the QSPT and the CPT (P<0.001). We found no correlation between seasonal symptom, use of rescue medication or quality of life (QOL) scores and pre-seasonal QSPT or CPT.

Conclusion In the assessment of seasonal rhinoconjunctivitis, quantitative skin and conjunctival allergen challenge tests are strongly reproducible, although there is no correlation between these tests and seasonal symptom, use of rescue medication or QOL scores.

Complementary treatments for osteoarthritis (OA) are sought by patients for symptomatic relief and to avoid the iatrogenic effects of non-steroidal antiinflammatories

This systematic review evaluates the efficacy of the nutritional supplement Perna Canaliculus (green-lipped mussel, GLM) in the treatment of OA and substantially adds to previous work by focussing solely on GLM use in OA as well providing a re-analysis of the original trial data.
Randomized or quasi-randomized controlled trials (comparative, placebo-controlled or crossover) were considered for inclusion from Cochrane Library, Medline, Embase, Amed, Cinahl, Scopus and NeLH databases where adults with OA of any joint were randomized to receive either GLM vs. placebo, no additional intervention (usual care), or an active intervention. The methodological quality of the trials was assessed using the JADAD scale. Four RCTs were included, three placebo controlled, the fourth a comparative trial of GLM lipid extract vs. stabilized powder extract. No RCTs comparing GLM to conventional treatment were identified. All four studies assessed GLM as an adjunctive treatment to conventional medication for a clinically relevant time in mild to moderate OA. All trials reported clinical benefits in the GLM treatment group but the findings from two studies cannot be included in this review because of possible un-blinding and inappropriate statistical analysis. The data from the two more rigorous trials, in conjunction with our re-analysis of original data suggests that GLM may be superior to placebo for the treatment of mild to moderate OA. As a credible biological mechanism exists for this treatment, further rigorous investigations are required to assess efficacy and optimal dosage.

Objective Conventional treatment of osteoarthritis (OA) with non-steroidal anti-inflammatory drugs is associated with serious gastrointestinal side effects and in view of the recent withdrawal of some cyclo-oxygenase-2 inhibitors, identifying safer alternative treatment options is needed. The objective of this systematic review is to evaluate the existing evidence from randomised controlled trials of two chemically related nutritional supplements, dimethyl sulfoxide (DMSO) and methylsulfonylmethane (MSM) in the treatment of OA to determine their efficacy and safety profile.

Methods The electronic databases [Cochrane Library, Medline, Embase, Amed, Cinahl and NeLH (1950 to November 2007)] were searched. The search strategy combined terms: osteoarthritis, degenerative joint disorder, dimethyl sulfoxide, DMSO, methylsulfonylmethane, MSM, clinical trial; double-blind, single blind, RCT, placebo, randomized, comparative study, evaluation study, control. Inclusion and exclusion criteria were applied. Data were extracted and quality was assessed using the JADAD scale.
Results Six studies were included [evaluating a total of 681 patients with OA of the knee for DMSO (N = 297 on active treatment); 168 patients for MSM (N = 52 on active treatment)]. Two of the four DMSO trials, and both MSM trials reported significant improvement in pain outcomes in the treatment group compared to comparator treatments, however, methodological issues and concerns over optimal dosage and treatment period, were highlighted.
Conclusion No definitive conclusion can currently be drawn for either supplement. The findings from all the DMSO studies need to be viewed with caution because of poor methodology including; possible unblinding, and questionable treatment duration and dose. The data from the more rigorous MSM trials provide positive but not definitive evidence that MSM is superior to placebo in the treatment of mild to moderate OA of the knee. Further studies are now required to identify both the optimum dosage and longer-term safety of MSM and DMSO, and definitive efficacy trials.

Objective: To assess the effectiveness of oral vanadium supplementation for glycaemic control in type 2 diabetes by conducting a systematic review of the literature.
Design and Methods: Eligible studies were identified by searching 14 databases using standardized terms. Experts, study authors and manufacturers were also contacted. Hand-searching was not undertaken. Selection criteria for inclusion in the review were controlled human trials of vanadium vs. placebo in adults with type 2 diabetes of minimum 2 months duration, and a minimum of 10 subjects per arm. Data extraction, assessment of study quality and outcome analysis were undertaken by two independent reviewers.
Results: One hundred and fifty one studies were found but none met the inclusion criteria. We proceeded to summarize the state of existing evidence and plan for a future clinical trial by applying revised, less restrictive criteria to our search, for clinical trials of 30–150 mg daily oral vanadium supplementation in diabetic humans. Only five were identified. These demonstrated significant treatment effects, but due to poor study quality, must be interpreted with caution. Treatment with vanadium often results in gastrointestinal side–effects.
Conclusion: There is no rigorous evidence that oral vanadium supplementation improves glycaemic control in type 2 diabetes. The routine use of vanadium for this purpose cannot be recommended. A large-scale randomized controlled trial is needed to address this clinical question.

Background Endometriosis is characterized by the presence of tissue that is morphologically and biologically similar to normal endometrium in locations outside the uterus. Surgical and hormonal treatment of endometriosis have unpleasant side effects and high rates of relapse. In China, treatment of endometriosis using Chinese herbal medicine (CHM) is routine and considerable research into the role of CHM in alleviating pain, promoting fertility, and preventing relapse has taken place.
Objectives To review the effectiveness and safety of CHM in alleviating endometriosis-related pain and infertility.
Search strategy We searched the Menstrual Disorders and Subfertility Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library) and the following English language electronic databases (from their inception to the present): MEDLINE, EMBASE, AMED, CINAHL, NLH on the 30/04/09.
We also searched Chinese language electronic databases: Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), Chinese Sci & Tech Journals (VIP), Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS), and Chinese Medical Current Contents (CMCC).
Selection criteria Randomised controlled trials (RCTs) involving CHM versus placebo, biomedical treatment, another CHM intervention, or CHM plus biomedical treatment versus biomedical treatment were selected. Only trials with confirmed randomisation procedures and laparoscopic diagnosis of endometriosis were included.
Data collection and analysis Risk of bias assessment, and data extraction and analysis were performed independently by three review authors. Data were combined for meta-analysis using relative risk (RR) for dichotomous data. A fixed-effect statistical model was used, where appropriate. Data not suitable for meta-analysis are presented as descriptive data.
Main results Two Chinese RCTs involving 158 women were included in this review. Both these trials described adequate methodology. Neither trial compared CHM with placebo treatment.
There was no evidence of a significant difference in rates of symptomatic relief between CHM and gestrinone administered subsequent to laparoscopic surgery (95.65% versus 93.87%; risk ratio (RR) 1.02, 95% confidence interval (CI) 0.93 to 1.12, one RCT). The intention-to-treat analysis also showed no significant difference between the groups (RR 1.04, 95% CI 0.91 to 1.18). There was no significant difference between the CHM and gestrinone groups with regard to the total pregnancy rate (69.6% versus 59.1%; RR 1.18, 95% CI 0.87 to 1.59, one RCT).
CHM administered orally and then in conjunction with a herbal enema resulted in a greater proportion of women obtaining symptomatic relief than with danazol (RR 5.06, 95% CI 1.28 to 20.05; RR 5.63, 95% CI 1.47 to 21.54, respectively).
Overall, 100% of women in all the groups showed some improvement in their symptoms.
Oral plus enema administration of CHM showed a greater reduction in average dysmenorrhoea pain scores than did danazol (mean difference (MD) -2.90, 95% CI -4.55 to -1.25; P < 0.01).
Combined oral and enema administration of CHM showed a greater improvement, measured as the disappearance or shrinkage of adnexal masses, than with danazol (RR 1.70, 95% CI 1.04 to 2.78). For lumbosacral pain, rectal discomfort, or vaginal nodules tenderness, there was no significant difference either between CHM and danazol.
Authors' conclusions Post-surgical administration of CHM may have comparable benefits to gestrinone but with fewer side effects. Oral CHM may have a better overall treatment effect than danazol; it may be more effective in relieving dysmenorrhea and shrinking adnexal masses when used in conjunction with a CHM enema. However, more rigorous research is required to accurately assess the potential role of CHM in treating endometriosis.

Assessing complementary and alternative medicine (CAM) use remains difficult due to many problems, not the least of which is defining therapies and modalities that should be considered as CAM. Members of the International Society for Complementary Medicine Research (ISCMR) participated in a Delphi process to identify a core listing of common CAM therapies presently in use in Western countries. Lists of practitioner-based and self-administered CAM were constructed based on previous population-based surveys and ranked by ISCMR researchers by perceived level of importance. A total of 64 (49%) ISCMR members responded to the first round of the Delphi process, and 39 of these (61%) responded during the second round. There was agreement across all geographic regions (United States, United Kingdom, Canada, and Western Europe) for the inclusion of herbal medicine, acupuncture, homeopathy, Traditional Chinese Medicine (TCM), chiropractic, naturopathy, osteopathy, Ayurvedic medicine, and massage therapy in the core practitioner-based CAM list, and for homeopathy products, herbal supplements, TCM products, naturopathic products, and nutritional products in the self-administered list. This Delphi process, along with the existing literature, has demonstrated that (1) separate lists are required to measure practitioner-based and self-administered CAM; (2) timeframes should include both ever use and recent use; (3) researchers should measure and report prevalence estimates for each individual therapy so that direct comparisons can be made across studies, time, and populations; (4) the list of CAM therapies should include a core list and additionally those therapies appropriate to the geographic region, population, and the specific research questions addressed, and (5) intended populations and samples studied should be defined by the researcher so that the generalizability of findings can be assessed. Ultimately, it is important to find out what CAM modality people are using and if they are being helped by these interventions.

Background: Non-small cell lung cancer (NSCLC) remains a major global health problem because of its prevalence and poor prognosis. Treatment options are limited and there is a need to explore alternatives.
This systematic review evaluates the role of Chinese herbal medicine (CHM) in association with chemotherapy for NSCLC.
Methods: English and Chinese databases were searched for RCTs comparing CHM with conventional biomedical treatment or placebo. Papers were reviewed systematically and data were analysed using standard Cochrane software Revman 5.
Results: Fifteen Chinese trials involving 862 participants met the inclusion criteria. All trials were of poor quality with a considerable risk of bias. There was a significant improvement in quality of life (QoL) (increased Karnofsky Performance Status) (RR 1.83, 95% CI 1.41–2.38, p < 0.00001 for both stages III, IV only NSCLC and all stages NSCLC) and less anaemia (RR 0.37, 95% CI 0.15–0.91, p = 0.03 for stages III, IV only NSCLC; p = 0.005 for all stages NSCLC) and neutropenia (RR 0.42, 95% CI 0.22–0.82, p = 0.01 for stages III, IV only NSCLC; p < 0.00001 for all stages NSCLC) when CHM is combined with chemotherapy compared to chemotherapy alone. There was no significant difference in short term effectiveness and limited inconclusive data concerning long term survival. Five promising herbs have been identified.
Conclusion: It is possible that oral CHM used in conjunction with chemotherapy may improve QoL in NSCLC. This needs to be examined further with more rigorous methodology.