Submited on: 03 Mar 2011 05:38:51 AM GMT
Published on: 03 Mar 2011 06:51:30 PM GMT
CHM06 and Chemotherapy
Posted by Dr. Miguel Lopez-Lazaro on 07 Mar 2011 05:44:48 PM GMT

1 Is the subject of the article within the scope of the subject category? Yes
2 Are the interpretations / conclusions sound and justified by the data? Yes
3 Is this a new and original contribution? Yes
4 Does this paper exemplify an awareness of other research on the topic? Yes
5 Are structure and length satisfactory? Yes
6 Can you suggest brief additions or amendments or an introductory statement that will increase the value of this paper for an international audience? No
7 Can you suggest any reductions in the paper, or deletions of parts? Yes
8 Is the quality of the diction satisfactory? Yes
9 Are the illustrations and tables necessary and acceptable? Yes
10 Are the references adequate and are they all necessary? Yes
11 Are the keywords and abstract or summary informative? Yes
  • Other Comments:


    Despite limited scientific evidence, many cancer patients seek complementary and alternative medicine to palliate chemotherapy toxicity and/or to increase its activity. Additional studies are needed to evaluate the efficacy and safety of these therapies. In this work, the authors have evaluated the safety and tolerability of a Chinese herbal medicine containing 12 herbal extracts (CHM06) in cancer patients receiving chemotherapy.


    I believe that the results are presented clearly and that the merits and limitations of the study are discussed properly. They also achieve their objective, which is the assessment of the feasibility of administration of CHM06 in cancer patients undergoing chemotherapy in terms of patient acceptance and the safety and tolerability of CHM06, prior to planning a phase II clinical trial. They conclude that the study of CHM 06 in cancer patients undergoing palliative chemotherapy is feasible and may be safe, which could serve as the basis for designing a phase II randomised trial for the use of this combination herbal preparation concurrently with chemotherapy.


    In my opinion, the main limitation of this study is that it does not provide data regarding the effects of CHM06 on chemotherapy efficacy. Although the authors mention that this was not the aim of their study, I believe that this information would be valuable before designing a phase II clinical trial. The authors observed that, of sixteen patients, two experienced adverse effects (diarrhea and biliary obstruction) and ceased taking CHM06 before chemotherapy. On the positive side, they observed that three patients had less than expected toxicity from chemotherapy. Because the positive effects of CHM06 on tolerability seem to be limited, it is important to evaluate if CHM06 has a positive or negative effect on chemotherapy efficacy. If the effect is positive (or at least not negative) CHM06 could be evaluated further in a phase II clinical trial. If the effect is negative, however, I do not think that a future phase II clinical trial would be a good idea. Perhaps the authors could evaluate and report if the survival of the patients receiving chemotherapy plus CHM06 (if or when available) is higher, similar or lower than the expected in patients with the same types of cancer receiving similar chemotherapy regimens. I believe that this information would be important to decide whether CHM06 deserves further study in Phase II clinical trials.

  • Competing interests:
  • Invited by the author to review this article? :
  • Have you previously published on this or a similar topic?:
  • References:
  • Experience and credentials in the specific area of science:

    Cancer research, Pharmacognosy

  • How to cite:  Lopez-Lazaro M .CHM06 and Chemotherapy[Review of the article 'The Safety and Tolerability of Chinese Herbal Medicine in Cancer Patients Receiving Chemotherapy: Pilot Study ' by Clarke S].WebmedCentral 2011;2(3):WMCRW00554
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