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Abstract

Objective:

To provide a retrospective case analyses of Bill Henderson Protocol adherence, a dietary cancer treatment regimen. Design. Case study analysis based on the National Cancer Institute’s Best Case Series approach. Subjects. Using Mr Henderson’s listserv (N = 31 000), members meeting certain criteria were invited to submit case documentation (diagnostic, treatment, outcome information). Ninety-two people responded.

Results:

Two people met the Best Case criteria. Both used conventional treatment initially (surgery, radiation, chemotherapy), but later turned exclusively to the Bill Henderson Protocol. Each case perceived benefit. One person eventually passed away. The second has returned to full health.

Conclusions:

The 2 cases provide a preliminary, detailed description of Bill Henderson Protocol adherence. They do not provide clear evidence of the protocol’s effectiveness but do suggest further research be undertaken to assess the extent to which the Bill Henderson Protocol is followed in real-world settings, including consideration of adherence, side effects, and outcomes.

Keywords

cancer dietary modification complementary therapies dental therapies

Introduction

A considerable number of people with cancer are using complementary or alternative dietary approaches in the hopes of treatment or cure.^1,2 The Bill Henderson Protocol is one such intervention. It was developed by Mr Bill Henderson, a self-proclaimed entrepreneur and crusader against cancer. Mr Henderson does not have any formal health care training and acknowledges that the protocol has arisen from his personal experiences with, and opinions about, cancer.

Mr Henderson promotes this anticancer regimen through books, electronic newsletters, and a Web site.^3–6 The protocol has found an audience online, evidenced by numerous commentaries and anecdotes on various Web sites and blogs.⁷ The fourth edition of his book, Cancer-Free—Your Guide to Gentle, Non-toxic Healing, was recently released.⁸

The central components of this dietary intervention are raw fruits and vegetables, gluten-free whole grains, legumes, and a cottage cheese/flaxseed oil combination in prescribed proportions. The Bill Henderson Protocol dictates restriction of animal proteins, alcohol, sugar, processed food, and dairy (with the exception of cottage cheese) and the inclusion of an extensive array of supplements. Supplements include β-glucan, barley grass, a multivitamin/mineral/herbal complex, and a nutrient combination of green tea, L-lysine, L-proline, and vitamin C (Table 1). The removal of root-canalled teeth, believed to be a source of anaerobic bacterial toxins, is strongly recommended. According to Mr Henderson, this protocol targets the 4 characteristics common to all cancers: lack of oxygen to the cells, a weak immune system, excessive acidity, and toxicity in the body associated with substances such as tobacco, alcohol, asbestos, and “dental toxins” associated with root canals.^5,8

Table 1.

Specific Brands and Doses for Supplements Suggested in the Bill Henderson Protocol.

Component	Source Recommended by BHP	Daily Dose Recommended While on the BHP
Cottage cheese	Organic, low fat	2/3 Cup (mixed with flaxseed oil)
Flaxseed oil	Barleans	6 Tablespoons (mixed with cottage cheese)
Beta glucan	Transfer Point	500 mg/23 kg body weight
Barley Grass	Green Supreme	20 tablets divided into 3 doses
Heart Plus	Our Health Coop	2 capsules/TID, to be taken with green tea extract
Green Tea Extract	Our Health Coop	1 capsule/TID, to be taken with Heart Plus
Daily Advantage Multi	Mountain Home Nutritionals	1 packet/BID (8 capsules/packet)

Abbreviation: BHP, Bill Henderson Protocol.

Anecdotal reports of the protocol’s success are found in Mr Henderson’s materials; however, evidence of the protocol’s safety and effectiveness has not been established. Nonetheless, there is some limited evidence for the efficacy of a few of its components, such as β-d-glucan and the nutrient combination of green tea, L-lysine, L-proline, and vitamin C.⁹ The Bill Henderson Protocol has a significant number of adherents.^7,10

The purpose of this study was to provide a detailed case review of people who had used the Bill Henderson Protocol to treat their cancer.

Methods

A review of medical records and history was undertaken following the approach outlined by the National Cancer Institute’s Best Case Series program. The intent of this program is to identify potentially effective complementary and alternative medicine cancer therapies and to bring them to the attention of the scientific community for further study. Specific criteria are required for cases to be considered including definitive diagnosis, documentation of disease response, absence of other simultaneous treatments, and documentation of treatment history.¹¹

Mr Henderson maintains a listserv of people who have agreed to receive notices and newsletters about his protocol. This group includes those with cancer, their family members, and others interested in the protocol. At the time the invitation for the case series evaluation was distributed, Mr Henderson reported there were about 31 000 names on the list, with 25 to 30 new names being entered daily. Email addresses to which deliveries failed were regularly removed.

The first invitation to this study asked that interested participants provide their case information, as defined by the Best Case Series criteria, to the researchers. Eligibility criteria were the following: aged 18 years or older, having a diagnosis of cancer, having ceased conventional therapies for at least 6 weeks (ie, chemotherapy, radiation, or surgery), exclusively adhering to the Bill Henderson Protocol, and being seen by a health practitioner (eg, medical doctor, naturopath, doctor of traditional Chinese medicine, herbalist). Surrogates could respond on behalf of family members.

Potential participants responding to this invitation were sent a study information letter and consent form. The study letter outlined the Best Case Series eligibility criteria again and provided further detail on what documentation would be required for the case review, which included the following:

Documentation of disease diagnosis (eg, biopsy, blood test)

Documentation of disease response, shown by previously taken x-rays or other diagnostic imaging, or through other validated indicators of tumor response (eg, blood tests) during treatment with the Bill Henderson Protocol

Absence of simultaneous treatments with known therapeutic potential (eg, combining alternative treatments with chemo-therapy or radiation therapy) and 6 weeks minimum between the end of any conventional therapy (including surgery) and the beginning of an alternative therapy

Documentation of treatment history, including dates of interventions/treatment cessations and disease responses to all interventions received (eg, physician or practitioner case notes)

Once the consent form was received, the research coordinator worked with the potential subjects to confirm eligibility, record the subject’s medical history, and obtain corroborating documentation. Case review was undertaken by the researchers (LHB and CM) independently and then collaboratively until consensus was achieved.

Results

The response rate iterations are presented in Table 2. Ninety-two people replied to the first invitation and were contacted by the research coordinator. Further details about the study’s inclusion criteria were provided and specific questions raised by potential study subjects were addressed. Thirty-eight people confirmed their interest in the study. Through further communication, 18 of these individuals were judged ineligible. In some cases, subjects were in remission and adhering to the Bill Henderson Protocol as a maintenance protocol rather than as a primary cancer treatment. In other cases, investigation of each subject’s specific regime showed that they were using additional alternative or conventional therapies alongside the Bill Henderson Protocol or only certain components of the Bill Henderson Protocol and thus would not provide an accurate representation of Bill Henderson Protocol use. These exclusions left 20 people who met the preliminary inclusion criteria.

Table 2.

Study Population and Response Rates.

Number in Listserv	First Responders	Those Confirming Interest	Those Screened as Eligible Initially	Those Completing Detailed Screening	Those Eligible Fusing the BCS criteria
31 000	92	38	20	6	2

Abbreviation: BCS, National Cancer Institute’s Best Case Series.

A detailed recruitment letter and consent form was sent to this group (N = 20). Seven returned consent forms and were asked to complete detailed screening questionnaires to confirm eligibility and capture case specifics. Of these 7 people, 3 appeared to meet the eligibility criteria of the Best Case Series method. Of these 3, one person chose to withdraw prior to providing any case details or documentation as his condition worsened and conventional therapy was initiated. Four were excluded because they could not provide the required medical records.

Case 1

Case 1 was a man (born 1948) from the United States who was diagnosed in August 2008 with stage IV (T1 N2b) invasive, poorly differentiated squamous cell carcinoma of the tonsil. The patient underwent a tonsillectomy in September 2008, followed by 3 rounds of chemotherapy (cisplatin) and concurrent radiation, both completed in November 2008. In December, residual lymphadenopathy was observed. Neck dissection of the left side was undertaken in January 2009, and the pathology report showed 2 positive lymph nodes (no extracapsular invasion). This metastasis was taken as an indication that cancer was still possibly present, and follow-up positron emission tomography scans were undertaken to monitor his status.

In March 2009, the patient started following the Bill Henderson Protocol. He deviated from the protocol slightly, substituting his MD’s recommended multivitamin due to concerns over fillers present in the Bill Henderson Protocol recommended multivitamin. The patient followed the protocol recommendation and had all root-canaled teeth removed (September 2009). Positron emission tomography scans from April 17, 2009; September 14, 2009; March 2, 2010; September 16, 2010; July 26, 2011; March 7, 2012 and July 9, 2013 were clear. The patient’s spouse, who acted as the patient’s primary caregiver, reported no negative side effects from the Bill Henderson Protocol. This patient reports he is well and disease free at the present time (July 2013).

Case 2

Case 2 was a Canadian woman (born 1940). In October 2001, she underwent a hysterectomy and bilateral salpingo-oophorectomy and was subsequently diagnosed with stage 2, grade 3 poorly differentiated serous papillary carcinoma of the ovaries and cul-de-sac. Between October 2001 and February 2002, she received 6 rounds of chemotherapy (carboplatin). CA 125 scores were used to help monitor her progress. Scores above 35 U/mL are considered abnormal.^12,13 Prior to surgery, her CA 125 score was 425, but dropped to 99 before chemotherapy and to 6 after her final round of chemotherapy.

In 2005, her CA 125 score rose to 301, and a computed tomography scan in March suggested progressive lymph nodal metastatic disease. In June, a computed tomography scan confirmed recurrent, metastatic ovarian carcinoma. From July to November 2005, the patient received another 6 sessions of chemotherapy (carboplatin and paclitaxel). CA 125 scores went from 1012 in July to 10 in November. Two computed tomography scans performed in September 2005 found no evidence of intrathoracic metastasis or ovarian carcinoma, and all peritoneal nodules were either markedly reduced in size or no longer visible.

From January to July 2006, rapidly rising CA 125 scores suggested another reoccurrence (84 in February, 141 in March, 209 in May, 398 in August). A computed tomography scan in March 2006 showed an aortocaval retroperitoneal lymph node (12 mm), suggesting progressive nodal metastatic disease. At this time the patient started to use alternative therapies. In August, she began adhering to the Bill Henderson Protocol exclusively. From August 2006 to March 2007, her CA 125 scores dropped rapidly (from 398 in August to 74 in March).

In April 2007, the patient was treated for cellulitis, which coincided with the end of her decreasing CA 125 scores. While a computed tomography scan (April 2007) showed a decrease in the aortocaval retroperitoneal lymph node (12 mm to 9 mm), a new node (5 mm) was detected near the aorta. With this upward trend in CA 125 scores, she chose to use additional, alternative interventions including intravenous vitamin C, low-dose naltrexone, melatonin, Essiac tea, Master Mineral Solution, and, later, cesium chloride. In November 2007, a biopsy from her axilla was diagnosed as metastatic papillary serous carcinoma. From January 2 to 15, 2008, she received daily radiation treatments. Between May and July 2008, the tumor was 3% to 5% of its original volume, but by September it had begun to increase in size again. In May 2008, her chief oncologist detected a mass in her pelvic region. A computed tomography scan (June 2008) indicated this was the progression of a heterogeneous pelvic tumor. Over the next few months, declining health and rising CA 125 scores led the patient to request an additional course of chemotherapy. She had 1 session in October 2008. Unfortunately, she passed away on November 5, 2008.

The patient’s spouse reported that during the patient’s first 6 months on the Bill Henderson Protocol, the patient’s energy and general health improved. It was the impression of the care team that the patient presented an atypical ovarian cancer case with fewer than average metastases and a longer survival period after diagnosis. It was also remarked that it was unusual for patients in late-stage cancer to be eating, drinking, and functioning without pain as she was. The patient’s spouse attributed these results to both the Bill Henderson Protocol and other the alternative interventions used.

Discussion

This study described the experiences of 2 people diagnosed with cancer who chose to follow a complementary dietary regimen as a therapeutic intervention, the Bill Henderson Protocol, at some point in the course of their disease. The case study methods used in this study allowed a detailed description of the participants’ illness, care, and response to treatments to be developed.¹⁴ Information was derived from both anecdotal reports and documented, clinical assessments.

In the first case, the Bill Henderson Protocol had been followed subsequent to conventional treatment on the assumption that despite treatments received, cancer may still have remained. The 5-year relative survival rate for patients diagnosed with stage IV tonsil cancer in 2001 was 43%¹⁵; later research has suggested a trend in improved survival with patients diagnosed more recently.¹⁶ At the time, the patient was advised that recurrence was likely within 1 to 2 years; he has remained cancer-free for 4 years. In the second case, 2 rounds of conventional therapy appeared to have successfully treated both the initial cancer and a first reoccurrence. The 5-year relative survival rate for patients diagnosed in 2001 with stage 2, grade 3 ovarian cancer was 57%.¹⁷ Adherence to the Bill Henderson Protocol started after a subsequent recurrence, and it was suggested that longevity was extended. The results of these 2 cases, however, cannot be taken as evidence that the Bill Henderson Protocol is effective; questions remain as to if or how the Bill Henderson Protocol played a role in altering disease course.

This study illustrates some of the complexities involved in the evaluation of complementary and alternative medicine interventions. It is striking that of the 31 000 people in Mr Henderson’s database, only 92 (0.003%) responded to the initial invitation and 38 (0.0012%) subsequently confirmed their interest in participating in this study. There are varied explanations for this low rate of participation including disinterest, serious morbidity or mortality, and ineligibility.

The demands on participants for this observational study were not unduly burdensome, requiring completion of a questionnaire, possible phone interview, and obtaining copies of their medical records. In contrast, compliance with the Bill Henderson Protocol is quite onerous.¹⁰ Of those who responded and were screened, a significant number (18/38; 47%) were not following all elements of the Bill Henderson Protocol, making them ineligible. Previous work that we have undertaken demonstrated that for some people adherence to this diet is particularly problematic. In addition to being extremely restrictive, close to 1/5 people reported that dietary compliance was associated with problems or ill effects including digestive upset, fatigue, weight loss, and abnormal liver function.¹⁰

As well as following the diet, complete protocol adherence suggests that consumers decline the use of conventional treatment approaches. Previous research has shown that many people with cancer use complementary treatment approaches in conjunction with conventional approaches.^1,18,19 While some patients with cancer use complementary and alternative medicine treatment to the exclusion of all conventional treatment, this is a much smaller proportion with estimates ranging from <1.0% to 10%.^20–22

Another proportion were ineligible as they did not have supporting documentation of their protocol adherence and outcome measures, which may reflect lack of engagement of a health care practitioner for this aspect of their care plan. This is not surprising given that the required outcome indicators rely primarily on conventional diagnostic assessments and the protocol promotes the use of assessments that are not recognized by conventional medicine. Others have found that patients choosing to pursue complementary and alternative medicine interventions do not return for conventional follow-up.²³ Moreover, there is a significant body of literature that reflects the resistance or reluctance of many conventional practitioners to engage supportively with patients who opt to pursue complementary and alternative therapies.^24,25

Finally, the low number of potentially eligible cases is reflective of the very restrictive inclusion criteria of the Best Case Series approach. The 2 cases presented here met the criteria, but only just. In Case 1, the authors accepted the opinion that cancer was still possibly present as an indication of diagnosis. Case 2 was included as there was a year-long interval where the patient followed the Bill Henderson Protocol exclusively, although she later included additional therapies, both conventional and complementary.

Strengths, Limitations, and Future Research

Case series, such as these, are limited in the amount of generalizable information they produce and cannot be taken as providing clear evidence of treatment effects. Considering these cases specifically, the multiple components and confounders within the regimen followed by the cases make definitive attributions impossible.

The strength of this investigation lies in the amount of detailed information reviewed on the experiences of the 2 people presented as cases. This has allowed the hypothesis of a therapeutic effect of the Bill Henderson Protocol to be raised. Taken together with the number of people using the protocol to greater or lesser extents, future research should be considered. Treatment protocols such as the Bill Henderson Protocol do not lend themselves to the traditional randomized control trial design.²⁶ Practically, future studies should assess how the Bill Henderson Protocol is being followed in real-world settings, as a component to a comprehensive cancer plan, to determine whether or not the protocol improves cancer outcomes and to better describe the adverse effects of adherence.

Footnotes

Acknowledgement

This work was conducted under the auspices of the University of Calgary, Department of Community Health Sciences.

Author Contributions

All authors contributed to the design, execution, analysis, and write up of this article.

Declaration of Conflicting Interests

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: This study was funded by the Holistic Health Research Foundation of Canada, a charitable organization. One of the Foundation’s donors was the spouse of the patient presented as Case 2. As researchers affiliated with the University of Calgary, the authors did not receive any direct financial benefit from undertaking the study. The grant was administered through an institutional research account with funds spent on study expenses. The donor was not involved in the design or conduct of the study; however, the donor did have a personal interest in the project and requested study updates periodically. These took the form of reports submitted through the Foundation as well as an occasional email sent directly from the funder to the researchers. The researchers were aware that the donor’s bias was for positive outcomes to be associated with the protocol and were mindful to report all findings objectively.

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This project was funded by a grant from the Holistic Health Research Foundation of Canada.

Ethical Approval

The project received approval from the Conjoint Health Research Ethics Board at the University of Calgary.

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Retrospective Case Analyses of Two People With Cancer Who Followed the Bill Henderson Protocol

Abstract

Objective:

Results:

Conclusions:

Keywords

Introduction

Methods

Results

Case 1

Case 2

Discussion

Strengths, Limitations, and Future Research

Footnotes

Acknowledgement

Author Contributions

Declaration of Conflicting Interests

Funding

Ethical Approval

References