To assess the efficacy of phytodolor for the treatment of musculoskeletal pain.

Computerised literature searches were performed to identify all trials of herbal remedies used for treating musculoskeletal pain. Databases searched included: MEDLINE, EMBASE, CISCOM, and the Cochrane Library, all from inception to October 1997. In addition, review articles and books on phytotherapy/herbalism and the author's files were searched for relevant publications. Manufacturers were contacted and asked to contribute published and unpublished trials. Other experts in the field were asked for further relevant material. Bibliographies of retrieved studies and reviews were searched. The aim of this search strategy was to identify one herbal remedy for which the most trial data existed; this emerged as phytodolor.

Study designs of evaluations included in the review

The inclusion criterion was stipulated as placebo-controlled, double-blind, randomised controlled trials (RCTs). However, at least one included three-armed trial comprised an open-treatment arm for the alternative active drug.

Specific interventions included in the review

Phytodolor, a standardised extract of Populus tremula, Fraxinus excelsior, and Solidago virgaurea, were included. Actual regimens used for phytodolor were: 3x30 drops/day at half strength, normal strength, and double strength; 3x40 drops/day; and 2x2 tablets/day (each tablet equivalent to 50 drops). Comparator interventions could be placebo or another active drug. Actual active medications used included diclofenac (3x25 mg/day), piroxicam (20 mg/day), and indomethacin (2x50 mg/day). Treatment duration ranged from two to four weeks.

Participants included in the review

People suffering from musculoskeletal pain (included osteoarthritis, chronic epicondylitis, rheumatic arthritis and various other rheumatic diseases).

Outcomes assessed in the review

No specific outcomes were defined in terms of selection criteria for the trials. The actual outcomes assessed in the review included the following: pain and grip strength; pain and physical impairment; requirement of rescue medication; pain and morning stiffness; pain, swelling, and function; pain, use of rescue medication, and joint function; global assessment and joint mobility; and various clinical symptoms and use of rescue medication. Study end points for outcome assessment ranged from two to four weeks.

How were decisions on the relevance of primary studies made?

The authors do not state how the papers were selected for the review, or how many of the reviewers performed the selection.

The methodological quality of the included trials was assessed using the Jadad score (assesses randomisation, blinding, and treatment of withdrawals) (see Other Publications of Related Interest no.1). The number of reviewers performing the quality assessment was not reported.

The following data were extracted from each trial into structured summary tables: sample size, participant condition, treatment details, main outcome variables, main results, and Jadad score. The number of reviewers performing the data extraction was not reported.

How were the studies combined?

The data were combined in a narrative.

How were differences between studies investigated?

Trials were grouped within the narrative according to whether they had included a placebo arm.

Ten RCTs were included (n=1,135). Three trials included a placebo arm and another active treatment arm (n=200); three were placebo-controlled only(n=115); and four compared phytodolor with another active medication only (n=820).

All included trials obtained a Jadad score of three or four out of a possible maximum of five. Data from the trials suggested that phytodolor is more effective than placebo and as effective as synthetic drugs in the symptomatic treatment of musculoskeletal pain. Few adverse effects were noted with phytodolor use. The action of phytodolor extends from non-inflammatory musculoskeletal pain to inflammatory rheumatic conditions.

Phytodolor is a safe and effective treatment for musculoskeletal pain. However, several caveats exist: several trials comprised heterogeneous patient groups; clinical end points were often subjective; low doses of synthetic drugs were used; and several trials relate to unpublished reports that have not been validated through the peer review process.

Overall, this is a well-conducted and clearly presented systematic review. Adequate information was given relating to study selection criteria and details of individual studies were clearly shown in tables. The narrative summary was appropriate given the obvious heterogeneity between trials, particularly with regard to outcome measurements. The literature search appeared to be reasonably thorough, however, it is a little surprising that the author did not also access the AMED database, a source relating specifically to alternative medicine and therapies. Attempts were made to identify unpublished literature by contacting manufacturers and experts. The search terms used and languages sought were not stated. A quality assessment was carried out according to an established checklist, however, some more details as to the use of this would have been useful. Few details were given as to the process of the review (i.e. how many reviewers involved, how disagreements resolved). Since only one author is listed, it is possible that only a single reviewer was involved, which is likely to have issues for bias and accuracy of the review. The author's conclusions appear to follow on from the evidence found in the review. However, the author's reported caveat regarding unpublished reports seems irrelevant, given that all the included trials were subject to validity assessment as part of the review process.

The authors do not state any implications for practice or further research.

1. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996;17:1-12.

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.